Home

Food Safe Pro! L1 User Manual

1. 352 353 354 355 356 357 358 359 360 361 362 DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Who provides our Humane Handling Training Curriculum Field Enter a detailed description of your Humane handling training curriculum Attach Documents Field In the document library Attach documents click on the library icon click button and navigate to the place on your computer where you have stored the file highlight the file and click open Repeat until you have added all of the supporting documents that you used to in your decision process What is our procedure for a miss stun Field Enter a detailed description of your procedures for a miss stun Attach Documents Field In the document library Attach documents click on the library icon click button and navigate to the place on your computer where you have stored the file highlight the file and click open Repeat until you have added all of the supporting documents that you used to in your decision process What is our procedure for dealing with the disabled Field Enter a detailed description of your procedures for handling slow animals downers Attach Documents Field In the document library Attach documents click on the library icon click button and navigate to the place on your computer where you have stored the file highlight the file and click open Repeat until you have added all
2. 36 37 38 39 40 DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Pre Operational Sanitation Field Next click on the pre operational sanitation tab that is at the top of the screen Please note that the dictionary that comes with FSP is basic as you go through you can add words that it does not recognize and it will remember them Floors Field You will add the procedures you use to clean and sanitize Floors in the procedures fields the frequency that the procedures are performed in the frequency field your monitoring procedure to include frequency of monitoring in the monitoring procedures field and then attach blank records by clicking the button in the records field When you press the button navigate to where you have the blank form stored on your computer click open and it is attached Then Click save and next You will repeat the instructions in block 28 for walls Ceilings stationary equipment mobile equipment and personal equipment When you have finished entering them all click save Operational Sanitation Field Next select the Operational Sanitation Tab Operational Sanitation opens with Product Hygiene The basic instructions are the same as in block 28 You will add the procedures you use to maintain Product Hygiene during operations in the procedures fields the frequency that the procedures are performed in the frequency field your monitoring procedure t
3. HACCP PRINCIPLES Principle 1 Conduct a hazard analysis Principle 2 Determine the critical control points CCPs Principle 3 Establish critical limits Principle 4 Establish monitoring procedures Principle 5 Establish corrective actions Principle 6 Establish verification procedures Principle 7 Establish record keeping and documentation procedures We are going to go through the process of developing a HACCP system based on the USDA FSIS and FDA models Preliminary Steps to utilizing HACCP HACCP experts believe that a company will do a better job of HACCP plan development if it takes some preliminary steps before it attempts to apply the seven principles and write a plan Take the following steps to get started Page 65 of 79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 1 Assemble the HACCP team including one person consultant employee or other resource who is HACCP trained 2 Describe the product and its method of production and distribution identify the intended use and consumers of the products 3 Develop and verify process flow diagram s Assemble the HACCP team including one person who is HACCP trained HACCP system development is one of those tasks that is probably better done by more than one person even in a very small company HACCP is an overall process control s
4. Animal Feed CGMPS If you are an animal feed establishment you have an additional set of requirements There are four basic types of requirements for feed establishments Pet Food Warehousing and Distribution Medicated and non medicated feed all are very similar to Food CGMPs and you will follow Food CGMPs in your production In most cases you will have developed a program for another purpose that covers the requirements for example training Your training program GMP is there because you need to train employee s to be efficient however it also serves a food safety purpose if the employees are properly trained they won t make mistakes causing food safety issues We recommend printing the self audit for the type of feed you are producing and use it as a template to design your programs most will be Ancillary SSOP s Getting started with Allergen control Your Allergen control program identifies the allergens you use the date that you received the letters of guarantee You then through a series of questions put together some general requirements to control allergens identify how you handle changes between allergen and non allergen or different allergen Page 29 of 79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 containing products You will also be able to either link to your Allergen GMP or create a new one tha
5. Who will be responsible for keeping the records of everything we do in response to a deviation from a critical limit at this CCP If any person who has a responsibility in our corrective action plan is not available who will be the back up Is this set of corrective actions feasible at all times PRINCIPLE VI ESTABLISH RECORDKEEPING PROCEDURES HACCP principle number 6 is to establish effective recordkeeping procedures that document the HACCP system The regulatory recordkeeping requirements for both the USDA and FDA are quite comprehensive Your team should review them carefully At a minimum it is recommended that all records be maintained for a minimum of two years All validation data should be kept indefinitely Page 73 of 79 This material is protected by US and international Copyright laws All rights reserved EA Gy DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Recordkeeping is an essential feature of a HACCP system and must be planned and carried out as carefully as any other element This principle requires the development and maintenance of records about both plan development and the operation of the system One way to approach development of the recordkeeping requirements of your HACCP system is to review the records you already keep and see if they are suitable in their present form or with minor modifications to serve the purposes of your HACCP system The best recordkeeping syste
6. Food Safe Pro L1 User Manual The complete guide to getting the most out of Food Safe Pro L1 As you go through Food Safe Pro TM L1 we recommend that you keep a copy of the user manual available it includes the before you start section step by step instructions and advice on how to get the most out of Food Safe Pro TM L1 as well as refresher HACCP training definitions and much more den Sa N wy The Home of We R Food Safety and Food Safe Pro Welcome to Food Safe Pro TM Congratulations and thank you for purchasing Food Safe Pro You will find your product registration number on your receipt and on the inside cover of your DVD for downloads it is also your receipt number If you have any questions or can t find your product registration number please email foodsafepro werfoodsafety com This user manual is broken down into several sections we recommend you explore it there is a lot of useful information Before you get started we strongly recommend that you fill out the flow table that is attached You will also want to have access to your company logo any supporting documentation you use preferably on your computer in the form of a PDF or word document and your current food safety program Food Safe Pro is a very powerful tool that you will use to help design and implement your food safety program To maximize its functions you need to have a very firm grasp of HACCP and your establishment s proce
7. Who Performs the Monitoring Procedure field select the person who actually performs the monitoring function We suggest you have a Designated Employee set up for L1 who is selected See System Administration Step 448 to set up an employee Frequency Monitoring Field Enter the frequency that you monitor in the frequency of monitoring field Page 45 of 79 This material is protected by US and international Copyright laws All rights reserved AN ELA Ge 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Justification of Frequency Field Give a detailed justification why the frequency of monitoring is sufficient to assure your system is in control in the Justification of Frequency field Next click the Verification Tasks button You will be at the Direct Observation verification function Person who performs the Function Field Select the person who performs the verification task Frequency Field Select the frequency of the verification Task Monitoring Procedure Field Give a detailed description of the monitoring procedure used for the verification task Records Field Attach blank records used to perform the verification task In the document library Attach supporting documents click on the library icon click button and navigate
8. you select yes or no and then make comments The questions include recommend times or other industry standards As you answer the questions the questions you are building your GCP s After you have completed answering the questions your Poultry GCP s are ready to be implemented The final comments concerning designing Poultry Current Good Commercial Practices handling program is to make sure that you perform self audits We strongly recommend that you have both people familiar with your program and someone who knows nothing about your program perform the self audit This will give you a new set of eyes and a different perspective The purpose of your self audit is to find ways to improve the program without wasting a lot of time A note about medical residues and antibiotics vou will address both in your HACCP Plan or some other part of your program if you produce from the farm to the slaughter facility The public and by extension the regulatory agencies are putting more emphasis on this area It is not worth the trouble a positive gives you if you have a sick animal and it has been treated don t bother going to slaughter with it It will be tested at the slaughter plant and you will be getting a visit from the FDA It s just not worth it Producers stockyards etc need to keep good records you need to be in a position to prove you met the withdraw time if you are shipping animals that have been treated We can t Page 32 of 79 This material is pr
9. Allergen issue is very remote when used to support decisions in the HACCP system they need to be supported and validated this includes record keeping As mentioned earlier they typically don t have the intense record keeping requirements of HACCP records however they do require sufficient records to demonstrate that they are being done in order to support the decision in the HACCP Plan Prerequisite programs Pre Requs are programs that you utilize much like a GMP however they typically are customer driven and are related to quality issues more than food safety issues However they can and do have an impact on your food safety program and can influence decisions you make in your hazard analysis Much like GMP s they typically don t have the intense record keeping requirements of HACCP records but they do require sufficient records to demonstrate that they are being done in order to support the decision in the HACCP Plan Preventive Controls PCs USDA Preventive Controls again these are very similar to GMP s however they typically are used together to form a multi hurdle approach to control food safety hazards An easy way to think about them is that they don t meet the criteria to be able to control a hazard in the HACCP Plan however they have a greater impact on food safety than a GMP Unlike GMP s they typically do have the intense record keeping requirements of HACCP records FDA Something to keep in mind is that the FDA uses the term Preve
10. Click Save and Next On this page select the appropriate program area that applies to the question If you don t have a GMP you can create one by clicking the create GMP button Click Save Next go to the Allergen Control Program in the left screen menu and click the sign button Sign Field Select the person with authority to sign the program Click the exit allergen control button Page 50 of 79 This material is protected by US and international Copyright laws All rights reserved RTE LM Program 207 Next Click the RTE LM Program button on the left Navigation page 208 Prepared By Field Select the person who prepared the program 209 Effective Date Field Enter the date the program is going to be effective 210 Reason Modified Reassessed Enter the reason that the program is being modified or reassessed 211 What Alternatives Field Select what alternative you use in your facility See compliance guide for help 212 For Alternative 1 check the alternative one box 213 Alternative 1 Products Field Click the button to add the specific product produced that is covered under Alternative one You can also add the product SKU 214 Click save 215 Repeat until you have added all the products that are covered by alternative 1 216 Click Save amp Next 217 What Post Lethality Treatment do you use Field Select the post lethality treatment you use 218 Where is it identified in your HACCP plan Field Select
11. DSDS Menomonie WI 54751 is a regulatory requirement you reference the requirement it s the law no challenge study needed You do have to validate that your systems of monitoring and verifying are sufficient to demonstrate your system is in control Another example is that you are basing your critical limit on a scientific document You are spraying your product with a lactic acid to reduce the bacteria load If you are a beef slaughter plant how can you validate that it really works in your establishment One way might be to take a series of samples from the carcass as it moves through your system you can start at the hide on station and test at different points throughout the process all the way to the cooler Your data will show positives at the beginning and if the system is working be negative by the time the carcass is in the cooler If you just test the carcass as it comes out of the lactic acid cabinet you really don t know if the lactic acid is working or not the carcass might have been negative before it enters the cabinet When you match this data up with the other data you have recorded demonstrating that you meet the critical operating parameters such as sufficient pressure proper temperature etc you can clearly demonstrate your system is valid Another example is that you have a manufactures instructions that states that in order to dry the product you must reduce the water activity to less than 94 prior to grinding this is your crit
12. GMP Monitoring Logs Field Use the button to add blank records used with the GMP If you wish to remove a record highlight it and select the arrow GMP Supporting Documents Field Use the button to add supporting documents that are ad used to support the GMP If you wish to remove a record highlight it and select the arrow Signature Field The person with overall authority then selects their name from the drop down and clicks the signed button The date automatically appears and the GMP is active Repeat as necessary to add all of your GMP s Prerequisite Programs 50 51 52 53 54 55 56 57 Click the Add New Prerequisite Program Button Put the title of the program into the Prerequisite Program Name field Program Procedure Field Put the procedure that is followed in the Prerequisite Program Procedure field Program Monitoring Field Put the monitoring procedure for the Prerequisite Program in the Prerequisite Program Monitoring field Monitoring Logs Field Use the button to add blank records used with the Prerequisite Program If you wish to remove a record highlight it and select the arrow Supporting Documents Field Use the button to add supporting documents that are used to support the Prerequisite Program If you wish to remove a record highlight it and select the arrow Signature Field The person with overall authority then selects their
13. GMP s Pre Reqs Preventive Controls etc Working with ongoing validation Ongoing validation this is NOT verification Remember you verify that you are following your plan you validate that the plan prevents unsafe food from being produced You will want to periodically test your system to make sure you don t end up with what the military calls mission creep Has your system subtly changed over time The employees were much more focused when you first rolled out the program however now its old hat and are they cutting corners Has equipment become more or less efficient How do you know when any of this happens You build in stress tests we recommend every six months or so and retest the system We recommend that you include product sampling to these tests for indicator organisms If something is drifting you want to catch it before it becomes an issue How you do this really depends on how you have designed your system however a good example is how many grinders focus on this ongoing validation in February and April before the E coli season really starts going It helps them get a good view of how their system is currently working and helps them head off any weaknesses that have developed that could result in positive product when the prevalence of E coli is at its highest summer months Again this isn t a verification activity and while it can support a reassessment it isn t designed to be the reassessment Design your ongoing validation
14. No you will use the supporting documents Page 27 of 79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 that you do have that show that the critical limit that is acceptable is less than your CCP document your thought process ie people in space can t get to the doctor so you are following the NASA document and then you validate that you are actually able to reach that temperature time combination the critical parameters You do this by testing your smoke house for cold spots based on the configurations you use to load it you validate that your monitoring and verification frequencies are sufficient to catch any potential failures in your system etc You then look at how to validate your RTE program Again you are using a compliance guideline so you don t need to validate the guideline merely that you meet those parameters You are validating your post packaging lethality treatment you have a scientific document that is peer reviewed and you follow it exactly you again validate that you are in fact able to meet it exactly You then validate that you use the lactate as outlined in the compliance guideline and manufacturer s instructions You haven t spent a lot of money on lab sampling and you didn t waste any time you know your system is valid You need to make sure that you validate your entire program that includes
15. R Food Safety and Food Safe Pro Food Safe Pro L1 User Manual 6V22S20132 Table of Contents e Lee Kee DEE 6 EXAMPLE Facility Flow Table sc 5 in e acre evades aae ea NEEN 6 Blank Facility Flow Tables 5 2 tt ret rep ee tetuer deeem Ee Seegen E 9 Section 1 General Overview of Food Safe Prol nnne nnren nennen ness 10 ESPI SpelbClieck8rs EE 11 Document libra yt eege Eeer eege eege Ee dete e edP 11 ix Ez Tero GUE c 11 Key Point to using FSP ae 13 How to duplicate a HACCP Plan or other plans in FSP cccccscccssssccecsssceceesssceeeesseeeceeseeseeseseeseeeesesseeeesseaeees 14 RI Halet EE 14 Integrated Food Safety Program 14 HACCP JE ELE 14 VerificatiOn ACtlONS Hc EIER 14 VUE Ve A P 15 Sanitation Standard Operating Procedures GGObel enne nne nnnn nnne rn nnns nnn nnn 15 Food Safety Programs Individual includes GMPs Ancillary SSOPs Prerequisite programs and Preventive Well TRRRN 16 Under both the FDA and USDA these are the programs that are used to support the HACCP Plan They all tend to address one issue each see below for specific details concerning hem 16 Good Manufacturing Practices GMPs eese enne enne nnne enne nni en nnns nennen nnns 16 Prerequisite programs Pre Requs ccccssccccesssscecessececsssaeeecsesseeecsessececeesaeeecsesaececeesaeseceesaececeesaeeeceesaeeeeeeaaes 16 Preven
16. Rejected 0 Rejection Reason Date Lot 5 18 2013 518131 z Cancel Save Receiving Record Assigned Receiving Lot 518131 Assign Next Lot g Page 350f79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Figure 2 batching record Batching Record Detail 3 Final Product Bread 1LBS Wholesale sl 3 Qty Ibs Produced 225 Product Lot 5062013 Qty final packages Produced 225 Production Date Time 00 00 0000 Production Oporator Drew Ex UPC SKU amp 0194613257 Packaging Oporator Supervisor 1 x Ingredients Used In Batch s Ingredient Name Amount Used Lot Flour bulk 200 5062013 Figure 3 Shipping Record Shipping Record Detail 2 Date 5 18 2013 Customer We like Bread E Contact Person Mr Donovan Rare Shipped Phone 1111111111 EMail Address donovanM werlikebread com m P O Invoite SS n Shipping Item Name bread 1 LBS Leila Billing Address 1111 Bread way ou ZE Lot 5062013 Shipping Address 1111 Bread way Cancel Page 36 of 79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Softwar
17. Repeat until you have added all the products that are covered by alternative 3 Click Save amp Next How many packaging lines do you have Field Enter how many packaging lines you have Test per Line Field Enter how many Food contact Tests you take per line per testing period Why is the Testing Frequency Sufficient Field Enter the testing frequency Monthly as an example Enter your justification as to why this frequency is sufficient Program Used Field Select the program that you use to control you testing program Do you test for Field Check the appropriate organism or add what it is that you check for in other by checking the box Where are the locations you test Field Enter the locations that you test What is the size of the test site Field Enter the size of the test site typically 12 square inches or the entire surface if it is smaller Conditions to implement test and hold field Enter the conditions that result in test and hold Attach a test and hold document field Attach the document that supports your test and hold procedures for example the compliance guide What testing methodologies do the laboratories use Field Enter the testing methodology that your laboratory uses to test your product Attach a lab methodology document field Attach a copy of the lab kit insert or other supporting document What is the sample collection procedure field Describe the sample collection procedure Attach a collection pr
18. Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Once you have your flow table filled out you are ready to start the software and get started building your food safety plan As mentioned earlier you will use the information that you have gathered to identify your process steps you will put them into FSP in the HACCP module and will then analyze each process step for hazards After each process step has been added you can create your flow diagram There is more specific help for this later in this document Section 1 General Overview of Food Safe Pro If you haven t developed a HACCP Plan before we strongly encourage you to develop a step by step process flow of production at your facility that is identified in the Before you Start section it will help you as you go through the program as described earlier in the manual You will also want to have a firm grasp of the things that have or can go wrong with your food safety program FSP Is only as good as the information you put in We have developed FSP in a modular format You can navigate between your different modules or food safety programs using the left hand screen Each Module is set up to run a bit differently intuitively based on the subject area The final master output is the decision document This document captures everything you have entered into the program except your Food Defense and Validation plans and is very useful when dealing with regulators tr
19. Street DSDS Menomonie WI 54751 The second step in performing a hazard analysis is to identify preventive measures that could be used to control each hazard Preventive measures are the physical chemical or other means that can be used to control a food safety hazard More than one preventive measure may be needed to control a food safety hazard and more than one food safety hazard may be controlled by a specific preventive measure It is critical that the hazard analysis is done correctly This is often a difficult and time consuming step and one that requires all the various technical and scientific resources you can obtain Doing a good job and taking your time here is worth the effort You cannot expect to develop a good HACCP system if you have not been careful and thorough in your hazard analysis PRINCIPLE II IDENTIFY THE CRITICAL CONTROL POINTS The second HACCP principle is to identify the critical control points CCPs in the process A CCP is a point step or procedure in a process at which control can be applied and as a result a hazard can be prevented eliminated or reduced to acceptable levels So far in developing the HACCP plan your HACCP team has identified biological chemical and physical hazards in the raw materials and the ingredients you use as well as in the steps of your process For each safety hazard reasonably likely to occur you have identified a preventive measure Your next step is to find the point or
20. be that all meat passes through the metal detector prior to packaging and that the system is operating as designed It is monitored by an employee who verifies that all meat passes through it and periodically sends seeded samples through to verify that it is kicking out anything with metal above the 3mm size As you can see how you design your program can have a huge impact on your day to day operations Trying to deal with 5 deviations a day versus being confident that the product you are producing is safe allows everyone in the organization to focus on producing safe product If you were busily running around trying to deal with those metal deviations instead of focusing on producing product what is the impact Do you really have the time to waste Putting the time in during your design and validation phases will pay huge dividends later on Getting started with Verification tasks What is verification Simple it s making sure you are doing what your program says you are going to do You verify that people are monitoring correctly by direct observation of them doing the task timely etc You verify that your equipment is calibrated you verify that records are properly filled out and you verify corrective actions are done according to your plan As you set up your HACCP Plan if you develop a critical limit the system will walk you through developing verification tasks to include Direct observation Direct observation is not to observe what
21. chart and you are ready to get started EXAMPLE Facility Flow Table Facility Flow Table Facility Name We R Food Safety Sausage Plant_ Date Completed _01 01 2013 By Mr Andrew Lorenz Step 1 Receiving Raw Ingredients Step2 Receiving Packaging Material Step3 Store Packaging Material Step4 Receiving Spices Step 5 Store Spices Step 6 Store Raw Ingredients Step7 Thaw Raw meat Step 8 Cut up meat Step 9 Chop meat in bowl chopper Step 10 Grind meat fruit and vegetables Step 11 Mix ground product with pre made spice mix Step 12 Stuff into casings Step 13 Package raw sausage Step 14 Store raw sausage Step 15 Ship raw sausage Page 6 of 79 This material is protected by US and international Copyright laws All rights reserved DI M PA Gy Step 16 Smoke Cook Sausage RTE Step 17 Cool RTE Sausage Step 18 Package RTE Sausage Step 19 Store RTE Sausage Step 20 Ship RTE Sausage The Home of We R Food Safety and Food Safe Pro Page 7 of 79 This material is protected by US and international Copyright laws All rights reserved Sa GC The Home of We R Food Safety and Food Safe Pro DND amp Associates Consulting Group LLC 2015 Wilson Street Menomonie WI 54751 All Rights Reserved Step 1 Receive raw Step 4 Receiving spices Step 2 Receive packing material Ingredients Step 6 Store Raw Step 5 Store Spices Step 3 store packing Ingredients WI material Step 7 Thaw Temper Raw Step 10 Grind meat Fruit bs St
22. in the first place Is it a regulatory requirement Is it based on a scientific document Are you basing it on an in house challenge study The purpose of the critical limit is to control a hazard for example if you are cooking a meat product and are using FSIS regulatory guidance on how hot it has to be to get the log reduction you want your validation protocol is going to be pretty straight forward You will upload a copy of the regulation compliance guideline or other government document into FSP and reference it in your decision You will then determine that you are actually meeting the critical parameters that the reference calls for For example if you have a smoke house and are using Appendix A the requirements aren t just time and temperature they include humidity If you set your critical limit at 160 F for instant lethality yet fail to provide some sort of control for humidity you will be found to be noncompliant Your validation of the critical limits needs to address all of the requirements that you are basing it on In your smoke house don t forget to validate your cold spots Where are they Do they change based on product Another example might be that you have a critical limit of maintaining product in a buffet line at over 140 F How do you validate the 140 F is valid As it Page 25 of 79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street
23. next to the field these help sections are displayed For more detailed help please right click on the button or see the designing your food safety program section This section is provided for your information everything in this section is available via pop up menus in FSP L1 Registration 1 Serial number field Enter serial number note you can click the tab button on your keyboard or use your mouse to move to the next field Company Name Field Enter Company name Doing Business as Field Enter your primary Doing Business as Address Field Enter your address City State and Zip Field Enter your city state and zip Phone Field Enter the business primary phone number Email Address Field Enter the business primary email address O9 xD OY At oU CJ Administrator Name Field Enter the person s name who is going to be the primary administrator for Food Safe Pro 9 Password Field Create a strong password See the user manual for help creating a strong password 10 Password Field 2 Renter your password and click tab 11 Facility Field Select the type of facility that best describes your company you may select more than one Click continue 12 Primary Regulator Field Select who the primary regulator is If you are not sure select Duel Jurisdiction Click continue 13 System Users Field Using the key add authorized users for Food Safe Pro If you make a ad mistake or wish to delete someone highlight their name and c
24. nothing to show a radiological hazard and we can t identify any place in the system where one would be introduced When we looked at Chemical hazards we can t think of any either The raw material is plastic Someone asks about that time we got the new supplier they had the PST produced plastics and we had to throw the whole lot out because it wasn t food grade After some discussion you determine you have a potential chemical hazard Next you ask is it likely to occur You determine that it is not very probable for it to happen however if it did the results would be catastrophic People could die from eating the bread So while the probability isn t high the fact that it has occurred and might again if you don t watch for it tells your team that this is a critical step in your process In fact it is the critical control point in your process to control the composition of your product The next question is how do you control this You determine that the only way to control it is to require that your suppliers provide you with 100 High Density Polyethylene Then you think how will I know that it s really High Density Polyethylene How do I monitor this critical limit You determine that you must receive a certificate of analysis showing that the product is High Density Polyethylene for each load and that the person receiving the load will verify the certificate before receiving it into your storage silos What happens if something goes wron
25. old plan and select Archive Definitions Integrated Food Safety Program is defined as The HACCP plan in operation including the hazard analysis the supporting documentation including prerequisite programs GMPs Preventive Controls etc used in supporting decisions in the hazard analysis HACCP and other records In other words everything you do to make a safe product for the consumer HACCP Plans Hazard Analysis Critical Control Point This is the frame work your food safety program is built around To simplify it you are going to use HACCP to create your food safety program You do this by taking all the parts of what you do and analyze them together to figure out where something could go wrong and use HACCP to help you fix it before it breaks When you create your HACCP Plan you will go through a wizard process that helps make sure you haven t missed anything It asks questions and you have to enter data to help you not just formulate your food safety program to identify and control hazards but it helps make sure you are meeting all the regulatory requirements that your government inspectors and auditors are looking for Verification Actions These are the actions that you take to verify that your program is working as designed In FSP L1 and L2 the menu on the left is turned off as these are used to input data in L3 and L4 You will designate your verification activities in your HACCP Plans as you go create your HACCP Plan In L3 and L4
26. out that the sauce and vegetables were not getting heated enough The point of this is to validate the best place to put the CCP not spend a lot of extra money or time Validation of procedures Implementation of those critical parameters and how they are implemented in your establishment verification activities etc you need to validate your procedures For example if you make a large diameter sausage and just take a surface temperature to verify your lethality temperature you probably can t support that procedure How do you find out Easy you had your team take temperatures from the surface middle ends etc of the product You find that in order to get the lowest temperature reading you have to take a temperature in the middle of the product or maybe you are doing rotisserie chicken and you find that the coolest place in the bird is in the thigh along the bone Until you test the procedure you just won t know Don t forget to make sure your verification activities are going to be good enough to catch when your system is failing before you ship product Do you do enough verification checks Are you calibrating your equipment frequently enough to make sure they aren t out of tolerance does your record review give you enough time to find out that the operator missed a check or didn t realize that there was a deviation and still keep control of the product While this can appear to be overwhelming when you are setting up your initial validation
27. the appropriate process step in your HACCP System that covers the post lethality treatment 219 What anti microbial agent do you use Field Enter the Anti microbial agent that you use 220 Where is it identified in Field Select the program that covers the anti microbial agent 221 Click save and next 222 Annual Production Volume Field Enter your annual production volume 223 Date Last Reported to USDA Field If you are regulated by the USDA enter the date you last reported your volume the set reminder will not work in L1 224 Do you test for Field Select what you test your product for 225 Product Testing Frequency Field Enter your product testing frequency 226 Conditions to implement test and hold field Enter the conditions that result in test and hold 227 Attach a Test and hold document field Attach the document that supports your test and hold procedures for example the compliance guide 228 Testing methodologies the laboratories use field Enter the testing methodology that your laboratory uses to test your product 229 Attach a lab methodology document field Attach a copy of the lab kit insert or other supporting document 230 The Sample Collection procedure field Describe the sample collection procedure 231 Collection procedure document field Attach support for your sample collection procedure DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Page510f79 This materi
28. the employee is recording when they are doing a monitoring task it is to verify that the monitoring is being done correctly Calibration of monitoring equipment Calibration of monitoring equipment is just that you need to know that the value your equipment records is accurate so you need to determine how often you verify that it is accurate We recommend that you use the manufactures recommendations when determining calibration frequency Records Review You review your records to make sure they are complete and that there are no errors This includes missing monitoring or direct observation checks deviations that the operator or monitor missed etc Page220f79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Corrective Actions You verify that corrective actions are taken in accordance with your plan and that you haven t shipped product that is adulterated contaminated or is otherwise unfit Working with corrective actions and unforeseen hazards The same scenario plays out as you get to your potential corrective actions If you have the proper design to your system you will not have many corrective actions those that you do have will tend to be for something unforeseen It is very hard to plan for something you didn t know was coming We strongly recommend that you identify the regulatory requirements for correct
29. to mirror what you are actually doing and in many cases they do not That is not to say that they are not helpful they are because they often point you in the right direction when you are trying to develop a control Regardless of what you use to start off you need documents that match what you are doing that demonstrate the typical bacteria load reduction and that clearly state the operational parameters those key things that have to be done used to achieve the bacteria load reduction If the study you are using matches your process very well it describes the bacteria load reduction Specific pathogens that you are addressing and has clearly defined operational parameters you may not need to do additional laboratory testing however very often the scientific support you have won t be this clearly defined In the case were you don t have clearly defined scientific support you will need to put together your own validation document It may include a computer modeling program for bacteria several scientific documents that closely match your process laboratory testing for the pathogens or in some cases indicator organisms in house testing of critical parameters such as temperature PH water activity pressure etc and possibly subject matter expert specific statements or guidance Remember to identify what critical operating parameters that you are validating in your validation protocol Sanitation Standard Operating Procedures SSOPs These a
30. to the place on your computer where you have stored the file highlight the file and click open Repeat until you have added all of the supporting documents used to identify the critical limit Click Save Process Step button Calibration of Equipment Field You will be at the Calibration of Equipment verification function Person Who Performs this Function Field Select the person who performs the verification task Frequency Field Select the frequency of the verification Task Monitoring Procedure Field Give a detailed description of the monitoring procedure used for the verification task Records Field Attach blank records used to perform the verification task In the document library Attach supporting documents click on the library icon click button and navigate to the place on your computer where you have stored the file highlight the file and click open Repeat until you have added all of the supporting documents used to identify the critical limit Click Save Process Step Button You will be at the Records Review verification function Person Who Performs this Function Field Select the person who performs the verification task Frequency Field Select the frequency of the verification Task Monitoring Procedure field Give a detailed description of the monitoring procedure used for the verification task Records Field Attach blank records used to perform the verification task In the document library Att
31. trn nn nt nnnis 67 1 Biological Hazards EE 67 Ee ucc 67 3 Physical H zard Soses TR 68 Radiological ER EE 68 PRINCIPLE Il IDENTIFY THE CRITICAL CONTROL POINTS esses enne nennen nennen nnn tnnt nennt nnns 69 PRINCIPLE IIl ESTABLISH CRITICAL LIMITS FOR EACH CRITICAL CONTROL POINT eene 69 PRINCIPLE IV ESTABLISH MONITORING PROCEDURES nennen tnnt trennen tnnt tnter nnne nnne 70 PRINCIPLE V ESTABLISH CORRECTIVE ACTIONS enne enne enne se nnne trs inns tnnt n nent nn nennt nnnis 71 PRINCIPLE VI ESTABLISH RECORDKEEPING PROCEDURES nenne nnen nnne nnne nnne nnns 73 PRINCIPLE VII ESTABLISH VERIFICATION PROCEDURES isset enne nennen then nestnnnn nnne tnnt nter 74 Practical exercise Let s get started eine tin EE RERR E E E oa eR 76 The key point to remember with HACCP cccccccccccssssssssecececesseseseeaeeeeeceseesesaeeeeeescessesaeaeeeeeeesesseseaeeeeeeseeeaes 79 Page 5 of 79 This material is protected by US and international Copyright laws All rights reserved den FA X wy The Home of We R Food Safety and Food Safe Pro Before you Start Below is the example of a facility flow table an example of a flow diagram don t worry FSP will help you generate a flow diagram and a blank chart for you to use to help identify the steps in your process This is critical as you will need this information to properly design your food safety program Fill out the blank
32. you designed your system you reviewed multiple scientific documents spoke with subject matter experts used your experience etc All of these documents are in truth the first part of validation Note if you used experience make sure you documented your thought process and attach it as supporting documentation For initial validation there are several parts we will address them separately and then pull them altogether Initial Validation Initial Validation is typically done over the first 90 days of operation of the new or revised plan If you have developed a completely new plan you will need to validate all parts of the plan this includes your prerequisite programs preventive controls GMP s and all HACCP components If you have just made a Page 23 0f79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 modification to an existing plan generally you only need to validate that portion of the plan that is impacted by the change The initial validation focuses on making sure that the critical parameters that you have identified are actually valid or working to keep product safe in your establishment and that the functions you use to monitor the plan are effective In the validation module you will select the plan and or step you wish to validate You will enter the necessary information at this point you sign an
33. 54751 In the FDA CGMP Supporting documents field select the documents that support your CGMP s if not already selected earlier in your program You can also select the appropriate regulations from the resource folder that loads with FSP Prepared By Field Select the person who has prepared the plan Signed By Field Select the person who is signing the plan please note that the person who is signing the plan must be logged into FSP in order to sign it Click in the check box under signed and the date will populate Click save and close Your FDA CGMP s are done Animal Feed Feed Plant GMPs 174 175 176 177 178 179 180 181 182 183 184 185 Click the GMP s Feed Plant button on the left hand navigation screen Click the Enter new GMP Button GMP Name Field At the top of the pop up window name the GMP Animal Feed is suggested Change the effective Date to the date you wish The created on date will self populate Created by field Enter your name Enter your GMP Statement This is a general operating statement that you will use to identify key areas of your operation it should be two to three lines and is intended as a summary for example Salmonella is our key concern in the production of our feed products please see our HACCP Plan for specific controls Click Save and next In training put down how often you review or audit your program of often your review or audit personnel and then
34. FSP Page 570f79 This material is protected by US and international Copyright laws All rights reserved 363 DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Click Exit Human Handling Program Poultry Good Commercial Practices 364 365 366 367 368 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383 Click the Poultry GCP button on the main left navigation screen Date Prepared Field Enter the date prepared Prepared By Field Select the person who prepared the document Effective Date Field Enter the effective date Reason Modified Reassessed Field Enter the reason the plan has been modified reassessed How often do employees who handle animal receive animal training Field Enter how often employees receive animal handling training Who performs the training Field Enter the person who conducts the training Who where was the curriculum developed Field Enter the developer of the training Emergency Response and Recovery GMP States Field Enter a brief description of your emergency response and recovery GMP GMP Field Select your Emergency Response GMP If you don t have an emergency response and recovery GMP you can create one by clicking on create GMP Answer the next three questions by checking yes no or N A What is our policy about loose birds Field Describe your loose bird policy Click Save and
35. Next Our holding times are kept to a minimum unless an unforeseen event occurs field Select yes or no to your holding times Enter comments concerning your holding times How do we track DOA s and document the number Field Enter the procedure you use to track DOA s Dead on Arrival What 96 of daily DO s trigger corrective actions Field Enter the percentage of DOA s that it takes to trigger corrective actions Answer the next two questions by selecting the appropriate box make appropriate comments about the subject in the comments box How often are coops inspected Field Enter how often you inspect coops daily per load weekly etc Answer the next two questions by selecting the appropriate box make appropriate comments about the subject in the comments box Page 580f79 This material is protected by US and international Copyright laws All rights reserved Ge 384 385 386 387 388 389 390 391 392 393 394 395 396 397 398 399 400 401 402 403 DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 How are birds protected from extreme cold and heat Field Describe how you protect the birds from extremes of heat and cold If for some reason we cannot process all our birds our plan on how to handle them is to Field Describe how you deal with extended power outages equipment breakdowns How do we keep feed and water withdrawal to the minimum Field Des
36. Ps are the basic foundation of your food safety program Some of the things you need to consider are how often we clean our floors walls ceilings overheads equipment etc How do we do it What sanitizers do we use You want your SSOP to be simple and easy to follow If you create complex cleaning regimens your employees will often fail to follow them keep them simple and easily implemented Schedule when you are going to do your maintenance cleaning such as hallways ceilings office spaces etc that you utilize in the facility as well as the production areas You can have the cleanest processing room in the world however if your employees are walking through filth to get to them you have a potential cross contamination issue If you are regulated by the FDA many of the basic sanitation operations are requirements Use your SSOP to make sure that you are meeting those requirements Working with your individual food safety programs GMPs prerequisite ancillary SSOPs and preventive control programs The next area we recommend that you work on is your prerequisite programs GMPS Preventive controls and ancillary SSOPs These are programs that you do for a variety of reasons such as multi functional programs like receiving raw ingredients You are primarily doing it to verify that you are Page 200f79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Str
37. Step 3 transferring raw kt and formed into plastic bags material to production hopper 1 Process Step 5 plastic bags are Process Step 6 plastic bags are transferred via conveyer to the printed and bundled printer Process Step 8 plastic bags shipped to Process Step 7 plastic bags are LL our customers palletized and stored Please note that this example does not include all steps or potential hazards in this production process and is merely being used as an example to demonstrate the thought process Now that you have a flow diagram each step is assessed for hazards and things that could go wrong with the process Because we are making a product that will come in direct contact with food we need to look at the four categories associated with food Chemical Physical Radiological and Biological for each step At process step one we review our process for Biological hazards We can t think of any and our experts determine that because of our process there are none For Physical hazards and Page 77 of 79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Radiological hazards we again can t think of any and neither can our outside experts When they reviewed our receiving records there were never any physical or biological hazards identified There is
38. ach supporting documents click on the library icon click button and navigate to the place on your computer where you have stored the file highlight Page 46 0f79 This material is protected by US and international Copyright laws All rights reserved AN ELA Ge 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 the file and click open Repeat until you have added all of the supporting documents used to identify the critical limit Click Save Process Step Button You will be at the Corrective Actions verification function Person Who Performs this Function Field Select the person who performs the verification task Frequency Field Select the frequency of the verification Task Monitoring Procedure Give a detailed description of the monitoring procedure used for the verification task Records Field Attach blank records used to perform the verification task In the document library Attach supporting documents click on the library icon click button and navigate to the place on your computer where you have stored the file highlight the file and click open Repeat until you have added all of the supporting documents used to identify the critical limit Click Save Process Step Button You are now at the corrective actions screen You may enter your own corre
39. aining new employees and for giving you a good in depth review of what exactly your food safety program calls for You can print the Food Defense and Validation plans from the print menu under system forms You will have several printed outputs the decision document your hazard analysis and your HACCP Plan to name a few We recommend that you print them out individually or to print them all print the decision document Please be aware though that if you decide to print the decision document you will have a very large document When you print a document it will open as a PDF that you can print or save We recommend that if you are not doing FSP L2 that you save these documents to a thumb drive or some other media that you keep offsite Please note that the Recall plans for FDA and USDA are opened and modified in the recall module and that they go straight to the printer This will be changed in the next maintenance update 7 25 2013 Page 10 of 79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 FSP Spell Checker FSP comes with a basic spell checker The spell checker will work in text fields within the program It s a very basic spell checker however it can learn when it comes up with a word that it doesn t know just click add and it temembers the word With the acronyms and proprietary systems being used in food
40. al is protected by US and international Copyright laws All rights reserved AN ELA Ge 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Attach an additional testing document field Attach any other supporting documents Other Validation Used Field Describe any other Validation that you use Click Save and Next What alternatives you use field For Alternative 2 check the alternative 2 box Alternative 2 Products Field Click the button to add the specific product produced that is covered under Alternative 2 You can also add the product SKU Click save Repeat until you have added all the products that are covered by alternative 2 Click Save amp Next Select the appropriate category requirement either post lethality treatment or antimicrobial agent What post lethality treatment do you use Field If you use a post lethality treatment select the post lethality treatment you use Where is it identified in your HACCP plan Field Select the appropriate process step in your HACCP System that covers the post lethality treatment What antimicrobial agent do you use Field If you use an antimicrobial agent enter the Anti microbial agent that you use Where it is identified field Select the program tha
41. all things are equal use the product that you produce the largest volume of You want to take this product and show how your critical parameters are used and how they prevent the hazard For example if you make a hot dog product it s considered high risk for Listeria monocytogenes You have identified that the critical parameters for this product are the lethality temperature 160 F and the proper implementation of your RTE program When you do your initial validation you are going to perform a statistically valid number of tests to make sure your systems monitoring frequency is valid SQC is a great online tool to determine inspection frequencies you can find a link on our website https werfoodsafety com Services html scroll to the bottom of the page for the link You are also going to validate your RTE program If you are using strictly sanitation to control LM you will increase your checks increase your sampling frequencies etc All too often someone tries to save a dime by only taking one or two samples and when one is positive they say it is an outlier if you don t have statistically valid sampling plans your results be they positive or negative won t tell you what is actually going on ie if your plan is valid or not The other thing to consider is that if you are strictly following a FDA or USDA compliance guideline you are validating that you can implement that guideline not if the guideline is valid Many people use the guidelines and the
42. analysis They write down the analysis findings sign it and date it They then attach the certificate to the form You also make a block for the QA manager to verify that the operator has checked it correctly It also includes blocks for signing and dating The final thing you do is set up a file system where you will keep the paperwork as well as the laboratory results you get from your verification samples You also designate the QA manager to review all the paperwork once a month as an added verification step You then review the rest of your process steps and can t find any other process steps that have any hazards Then one of the team members asks if the daily clean up program or the pest control program should be added to this After all if the plant is dirty or there are rodents running all over the plastic bags they shouldn t be used to store bread After some thought you determine no those are really your pre requisite programs and while they support that your product is safe to use as a food container they really aren t part of the HACCP Plan they actually support it You then decide that while you don t plan on getting any new equipment or employees you will reassess the HACCP plan every year just to make sure nothing has changed The final thing you decide to do is make sure that before you ship any product that you perform a pre shipment review of all documentation that you have to make sure each and every shipment is safe Yo
43. ary of your findings be detailed and descriptive Enter your final determination is the plan valid or not Attach the records all records associated and generated with the validation protocol Go to the plan complete field and select the person with the authority to sign the plan Click Complete plan Page 63 of 79 This material is protected by US and international Copyright laws All rights reserved 495 496 497 498 499 500 DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Click save Click the System Administration button on the left main navigation menu This is the information captured when you set up FSP you can edit the information and then Click save Please note that the Show Ads button is turned off If you wish to receive notices announcements about upgrades and offers from our allied business s you can check this box and they will display in the main screen the system will need to be connected to the internet for this option to function Also the show help buttons is displayed this is not active however it will be turned on in the upcoming maintenance update Click authorized users tab at the top of the screen To add a user click the button To remove a user click on the user and select the button The basic instructions for adding a user on step 13 apply Again thank you for purchasing FSP if we can assist you in any way please don t hesitate
44. asures put in place at CCPs A critical limit will usually be a reading or observation such as a temperature a time a product property such as water activity or a chemical property such as available chlorine salt concentration or pH Critical limits need to be exact and specific When deciding what your critical limits should be there are several sources to consider First are the regulatory requirements which apply to your processes These must be met For example if you produce cooked beef products you must have critical limits that meet the current FSIS regulatory requirements for those products If you product fresh shell eggs you must meet the FDA temperature requirements There may be other sources of critical limits such as the times and temperatures that you use in making the products you produce In any case you need to establish a critical limit for each preventive measure you intend to apply at your CCPs There are two types of critical limits A critical limit can be an upper limit where a set amount or level cannot be exceeded A critical limit can also be a lower limit where a minimum amount is required to produce the safe effect To address the hazard in ground product of metal fragments from the grinding equipment the upper critical limit for the preventive measure could be no sharp metal fragments more than 1 32 inch A grinding room temperature of 50 F to help control pathogen growth is another kind of upper critical limit A
45. by US and international Copyright laws All rights reserved AN ELA Ge 332 333 334 335 336 337 338 339 340 341 342 343 344 345 346 347 348 DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Reason Modified Reassessed Field Enter the reason you have modified or reassessed the plan Initial Review of Humane Handling Practices Field Conduct the initial review of the Humane Handling practices you use Select Yes or No for each question and make any applicable remarks Remarks should either clarify how you do something or make a recommendation for improvement Click Save and next Continue to answer the initial review questions General Provisions of our Humane Handling Program Field In the general provisions section enter any information that is in a general nature about your program Click Save and Next Prior to starting on this screen review the findings of your initial review and make any changes Who has oversight of our Humane Handling program Field Enter who has oversight of the Humane Handling program How often do we review our Humane Handling Program Field Enter the frequency of reviews of the humane handling program How often do we perm Self Audits Field Enter how often you do Self Audits Attach Self Audit Field You can attach your own self audit checklist or print the blank self audit checklist that comes with FSP What is o
46. cation of Critical Control Point Monitoring Give the specific location of the critical control point In the document library Attach supporting documents click on the library icon click button and navigate to the place on your computer where you have stored the file highlight the file and click open Repeat until you have added all of the supporting documents used to identify the critical limit Justification of Monitoring Location Give a detailed justification of why this location is the best to monitor the CCP In the document library Attach supporting documents click on the library icon click button and navigate to the place on your computer where you have stored the file highlight the file and click open Repeat until you have added all of the supporting documents used to identify the location of the CCP monitoring Click Continue In the monitoring Procedure field enter a detailed description of how you monitor the critical control point In the justification for Monitoring Procedure field justify why this procedure is adequate at assuring the process is under control In the document library Attach supporting documents click on the library icon click button and navigate to the place on your computer where you have stored the file highlight the file and click open Repeat until you have added all of the supporting documents used to support the monitoring procedure and the frequency of monitoring In the
47. cation to that process Now you have a preventive control The preventive control again supports the decision that you don t have a hazard reasonably likely to occur please keep in mind when dealing with Preventive Controls that the USDA and FDA have slightly different take on them As you go through and design your HACCP system remember that at most steps you won t be dealing with a hazard however you want to thoroughly explore each step for hazards When you do come across a hazard you really have to put some time into designing the control We will use metal Page210f79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 detection as an example If you determined that at your trim step that metal contamination is a hazard likely to occur how you do handle it Most people will put in a metal detector and say the critical limit is no metal in their product The first time they find metal in product because the metal detector is working they now have a deviation from a critical limit Instead had they said that their critical limit is that they utilize a functioning metal detector that is sensitive enough to kick out any meat with metal that is larger than 3mm and that all trim passes through a metal detector when the metal detector kicks out meat with metal in it they have a properly operating system The critical limits will then
48. compliance guide What testing methodologies do the laboratories use Field Enter the testing methodology that your laboratory uses to test your product Attach a lab methodology document field Attach a copy of the lab kit insert or other supporting document What is the sample collection procedure Field Describe the sample collection procedure Attach a collection procedure document field Attach support for your sample collection procedure Attach an additional testing document field Attach any other supporting documents Describe any other Validation that you use Click Save and Next Special controls for Hot Dog Deli Products Field You may change or keep the text for Special controls for Hot Dog Deli Products Click Save amp Next What is your annual production volume Field Enter your annual production volume Date last reported to USDA Field If you are regulated by the USDA enter the date you last reported your volume the set reminder will not work in L1 Do You Test For Field Select what you test your product for Product Testing Frequency Field Enter your product testing frequency Conditions to implement test and hold field Enter the conditions that result in test and hold Attach a test and hold document field Attach the document that supports your test and hold procedures for example the compliance guide What testing methodologies do the laboratories use Field Enter the testing methodology that your laborato
49. cribe you water and feed withdrawal programs How do we assure that unloading is conducted in a manner as not to injure birds Field Describe your unloading procedures Answer the next two questions by selecting the appropriate check box make appropriate comments about the subject in the comments box How are stunning and processing equipment monitored to insure proper functioning for humane processing field Describe your monitoring procedures for your stunning equipment How do we verify that birds are insensible to pain when euthanized field Describe how you verify birds are insensible to pain when euthanized Select yes or no to automatic knife use and describe details if you do use them such as voltage amp requirements If we use an automatic knife how do we verify that is at least 98 effective Field Describe how you verify the effectiveness if you use an automatic knife Click Save and Next Select yes or no to back up personnel and briefly comment about their placement and how they function Select yes or no to the question of verifying that all birds are dead prior to entering the scalder make comments in reference to how you do this Broken wings and legs are monitored at the following location field Describe the location and procedure for monitoring broken legs and wings At what level do we take corrective actions if broken or dislocated wings are observed Field Describe the action level 96 of birds of broken or dislocate
50. ctive actions however FSP recommends that you accept the pre printed text To do so click the arrows for the four steps in corrective action You can modify the text after it has moved into the text field Designated Employee Field Select the employee who performs corrective actions functions FSP recommends you select Designated Employee for L1 versions Use the to add blank records used as part of corrective actions To do so click button and navigate to the place on your computer where you have stored the file highlight the file and click open Repeat until you have added all of the Documents you use Click Save and next You are now in the unforeseen hazard screen You may enter your own actions to take in response to an unforeseen hazard however FSP recommends that you accept the pre printed text To do so click the arrows for the four steps you will take if you have an unforeseen hazard You can modify the text after it has moved into the text field Designated Employee Field Select the employee who performs the actions you take in the event of an unforeseen hazard FSP recommends you select Designated Employee for L1 versions Use the to add blank records used as part of an unforeseen hazard To do so click button and navigate to the place on your computer where you have stored the file highlight the file and click open Repeat until you have added all of the Documents you use Click Sa
51. d clicks save Please note that this person must be signed in to FSP We have provided a word document in the supporting documents folder called TraceBack that you can use to create your Trace Back Program we recommend that it be done as four separate GMP s In FSP L3 these are automated Click Exit Trace Back button at the bottom of the page Page 600f79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Recall Management 423 424 425 426 427 428 429 430 431 432 433 434 435 436 437 438 439 440 441 442 443 Next select Recall Management from the main left navigation menu Date Prepared Field Enter the date prepared Prepared By Field Enter the person who prepared this program Effective Date Field Enter the effective date for the program Who is our Recall Coordinator Field Select the Recall Coordinator enter his her cell phone and email Backup Recall Coordinator Field Select the backup recall coordinator enter his her cell phone and email Mgr With Recall Authority Field Select the person with the authority to initiate a recall enter his her cell phone number and email Employee s on Recall Team Field Click the button to add the members to the recall team In the pop up enter their name phone number email address and fax number Click
52. d date it This then becomes an active plan You don t fill out the summary or findings until after the validation is complete this typically runs approximately 90 days depending on your production So you spend the next 90 or so days collecting data and then you review it If there are no problems you will go back into FSP and update that validation step by opening the active validation program and then completing the summary and the findings portions Attach the records you generated and then sign and date it again The plan now lists in the completed column If something didn t work out you enter that also and make the changes to your plans and processes and then revalidate the changes following the same procedures WARNING Don t forget to capture what the critical operating parameters that you are validating are in your validation protocols we recommend that you identify them in the first sentence Identifying a product for validation The USDA recommends that you identify one product from each HACCP category Raw Not Ground Process Raw Ground Process Fully Cooked Not Shelf Stable Process Heat Treated Not Fully Cooked Process Not Heat Treated Shelf Stable Process Heat Treated Shelf Stable Process Secondary Inhibitors Not Shelf Stable Process Irradiation Process and Thermally Processed Commercially Sterile Process to gather in plant validation from They recommend that you use the worst case scenario product ie the most risky product If
53. d wings that are observed We euthanize any live birds that are culled at the plant by Field Select the way you euthanize cull birds please note industry terms are head removal rapid decapitation ringing the neck rapid cervical disarticulation gassed gassing with nitrogen etc Additional Information concerning our Poultry Good Commercial Practices Field Enter any additional information concerning your poultry good commercial practices Click save and next Sign Field Click the sign button and the person with overall authority to sign is selected Please note that the person with authority to sign must be logged into FSP Select the name of the person who is signing and click sign Click exit poultry GCP Page 590f79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Product Trace Back 404 405 406 407 408 409 410 411 412 413 414 415 416 417 418 419 420 421 422 Select Product Trace Back from the main left hand navigation menu Prepared By Field Enter the person who has prepared this document Written Plan Field If you have a written plan click the button and navigate to it highlight it and click open Trace Back Written Plan Documents Field If you have Trace Back written documents attach them by clicking the button and navigate
54. deviation they know exactly what they need to do to stop the product from entering commerce Page 72 of 79 This material is protected by US and international Copyright laws All rights reserved EA Gy DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 For each CCP your team needs to devise a standardized set of actions that company employees will follow when there is a deviation from a critical limit These are some questions they might ask in developing corrective actions How will people be informed when the deviation occurs If a person is performing the monitoring procedure who will that person contact Who will be responsible for controlling the product that may have been affected by the deviation How should that person decide how much product needs to be controlled Who will be involved in deciding what to do about the product which might have been affected by the deviation How will we decide what was the cause of the deviation If we need technical experts outside the company how do we get them Once we have figured out what was the cause of the deviation who will be involved in deciding how to get the process back in control and prevent recurrence of the deviation If our HACCP trained individual is not available in the plant immediately how can we get HACCP expertise to help decide if our plan needs to be modified Who in the company needs to sign off on any modifications to our plan
55. ds Verification Those activities other than monitoring that determine the validity of the HACCP plan and that the system is operating according to the plan Practical exercise Let s get started As we said earlier HACCP is a management system in which food safety is addressed through the analysis and control of biological chemical radiological and physical hazards from raw material production procurement and handling to manufacturing distribution and consumption of the finished product If HACCP is going to work in your facility everyone must be strongly committed to it from your CEO to the production employee on the floor So how do we actually implement HACCP We start by looking at what we do and then analyzing it for hazards Conducting a Hazard Analysis What is it that we make Plastic Bread Bags Page 76 0f79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Who uses it Our bakery clients How do they use it They load the bags into their packaging machine They are then stuffed with the bread tied with a plastic tie shipped to retail stores and sold to the general public Your team develops the flow diagram of your facility for example Process Step 1 receiving raw Process Step 2 storing raw material material Process Step 4 raw beads are melted Process
56. dsafety com Page 79 of 79 This material is protected by US and international Copyright laws All rights reserved
57. dures and also determine your product testing frequency as part of your ongoing validation In the event you just use sanitation to control LM on your RTE product you go through a much more detailed set of screens to develop your program We strongly encourage both FDA and USDA regulated facilities to read the documents in the support library under LM control It is a lot of reading however the concepts such as rotating sanitizers can be of great assistance when putting together a solid LM RTE program Getting started with Product Trace Back Product trace back is a requirement for both USDA and FDA regulated facilities FSP comes with a preloaded program or you can develop your own The key to trace back is making a system that is simple and works You need to know who you sold your products to and what they were made with to include who you received them from The forms that we have developed will assure that you have the information you need should you find yourself in a situation where you need to rapidly trace product either back to who sold it to you or product that your customers have received that you have to get back When coupled with your recall program you will be able to minimize the amount of time you may have to spend as well as limit the damage to your company by maintaining good records We have included a section of the user manual that has more detailed information concerning Trace Back later in this manual Page 300f79 This materia
58. e 71 of 79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 a Processors may develop written corrective action plans which become part of their HACCP plans in accordance with 120 8 b 5 by which processors predetermine the corrective actions that they will take whenever there is a deviation from a critical limit A corrective action plan that is appropriate for a particular deviation is one that describes the steps to be taken and assigns responsibility for taking those steps to ensure that 1 No product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation and 2 The cause of the deviation is corrected b When a deviation from a critical limit occurs and the processor does not have a corrective action plan that is appropriate for that deviation the processor shall 1 Segregate and hold the affected product at least until the requirements of paragraphs b 2 and b 3 of this section are met 2 Perform or obtain a review to determine the acceptability of the affected product for distribution The review shall be performed by an individual or individuals who have adequate training or experience to perform such review 3 Take corrective action when necessary with respect to the affected product to ensure that no product enters commerce that is
59. e Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Figure 4 Inedible record Inedible Record Detail 2 Date 05 18 2013 Lots 518131 Product Flour Bulk y 0 Qty 775 Reason Roof Collapse soaked the flour Disposal Method Moved into normal inedible denatured W Ink Cancel Save Inedible Item Here is the FSP Recommended Trace Back Program you can easily copy and paste this into your Trace Back GMP from the Trace Back module FSP L1 Recommended Trace Back Program 1 Receiving 2 Batching 3 Shipping 4 Spillage Waste 5 Operations 1 Recieving When we receive products be they spices raw ingredients like flour our primal cuts of meat packaging material chemicals etc we capture the basic information about that product and assign it a unique code Codes are assigned as follows Product name the date it is received Month Day Year sequential letter and number For example 3 shipments of flour received on May 1 2012 would be identified like this Flour Bulk 05012012A1 Flour Bulk 05012012A2 and Flour Bulk05012012A3 Codes are attached to the product and its placard used to identify its storage location Page 370f79 This material is protected by US and international Copyright laws All rights reserved EA DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Information that is collected during receiving is recorded on the receiving form T
60. e office and the amounts are cross referenced with batching sheets and the spillage report to verify that all product is accounted for The receiving record is then filed in the receiving file under our suppliers name by receipt date When batch sheets are completed they are filed in the pending file along As the lot is shipped the shipping date of the lot and quantity are documented on the back of the batching record for each shipment until inventory is exhausted When inventory is exhausted and the batch sheets have been reconciled with the receiving sheet they are filed by production date The shipping records are filed by shipping date Spillage is filed in the spillage file by date In the event that our suppliers notify us of a problem we will pull the applicable product receiving sheet and use it to pull the batch sheets shipping sheets and spillage sheet and provide them to the Recall team Page 38 of 79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 If we are notified of a problem with product that is in commerce we will pull the applicable batching sheet and use it to identify our shipping records and then provide the packet to the Recall team Signed by Date Title Step by Step instructions These instructions correspond to the fields you will go through is FSP When you left click on the button
61. e records you generated and then sign and date it again The plan now lists in the completed column If something didn t work out you enter that also and make the changes to your plans and processes and then revalidate the changes following the same procedures FDA Food CGMPS Now if you are a FDA regulated facility you need to go into the Food CGMP s These are regulatory requirements and you have to meet them however depending on your process there may be some that just don t apply We recommend that if something is applicable that you use the standard text You should also add the referenced GMP Pre Req SSOP HACCP plan that applies to it For example you have a GMP for employee hygiene does it cover people that have an open lesion Maybe not specifically however if you require people to be in good health and don t allow them to work if they have any transmittable disease in your employee hygiene GMP you have addressed the FCGMP Another example might be that you have copies of your water testing from your municipal water supply on hand You can attach scanned copies and you now demonstrate your support for the CGMP FCGMP s will print off in your decision document they are an integral part of your plan For establishments regulated by the USDA you are required to meet the same requirements however it is up to you to design them While not required of USDA inspected establishments the FCGMP s can be good tools to make sure you haven t missed anything
62. eassessment at six months after implementation The reason is that many employees will be comfortable with the program by then you will find areas that you can change to make it more efficient and areas where people are starting to cut corners In FSP its easy to do open the HACCP Plan archive the old plan and make any modification or none depending on what you determine You put the reason for the reassessment in the system so it tracks it for you Printing You will find in some sections you can print a blank form Product trace back or a program Recall Management you can also go to the printing menu and print your programs and blank forms Emailing or Sharing your documents When you create a document be it a decision document HACCP Plan Hazard Analysis etc you can open that document from the printing page merely select the document you want and click print it will open Page 33 0f79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 up in Adobe PDF format You can either print or save the file For more information using PDF files please see http helpx adobe com acrobat html on the internet Product Trace Back in depth Each firm or establishment must be able to follow or trace product both forward and backward in its supply chain What does this mean Simply put you need to have records of ev
63. ecklist there are several available by using Bing or Google search engines to search the internet Poultry Good Commercial Practices PGCP The poultry good commercial practices incorporate your written program with a self audit As you go through the wizard you will be asked a series of questions you select yes or no and then make comments The questions include recommend times or other industry standards As you answer the questions the questions you are building your GCP s After you have completed answering the questions your Poultry GCP s they are ready to be implemented There is also the self audit form that you can use to make sure you are on track It is very similar to what is used by FSIS Plant Operation Controls This module is turned off in L1 and L2 In L3 and L4 it is where you manage your different systems such as inventory control employee training automated temperature checks etc System Alerts SAs this module is turned off in L1 and is partially active in L2 You can set specific reminders in L2 that are emailed or sent as a text message to whomever you designate In L3 Page 18 of 79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 and L4 it is where you manage your different systems alerts such as positives deviations from critical limits missed checks failed checks etc Sampling This m
64. ed HACCP System The result of the implementation of the HACCP Plan HACCP Team Page 75 0f79 This material is protected by US and international Copyright laws All rights reserved EA DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 The group of people who are responsible for developing implementing and maintaining the HACCP system Hazard A biological chemical physical radiological agent that is reasonably likely to cause illness or injury in the absence of its control Hazard Analysis The process of collecting and evaluating information on hazards associated with the food under consideration to decide which are significant and must be addressed in the HACCP plan Monitor To conduct a planned sequence of observations or measurements to assess whether a CCP is under control and to produce an accurate record for future use in verification Prerequisite Programs Procedures including Good Manufacturing Practices which address operational conditions providing the foundation for the HACCP system Severity The seriousness of the effect s of a hazard Step A point procedure operation or stage in the food system from primary production to final consumption Validation That element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazar
65. ed eas A canteadea Garseescaeaie 43 FDAsFOOd Re e 48 Animal Feed Feed Plant GM 49 TE Re ue EE 50 GA Sdt EE 51 d naPIJ lle aetnecnete 55 H mane HAN ADs oss csc i teet o terruit terr otto lente ueterem eene aaus 55 Poultry Good Commercial Practices icri ceste ctf ice needs casa cereo giu ENEE AE 58 Page 4 of 79 This material is protected by US and international Copyright laws All rights reserved Zen PA ies The Home of We R Food Safety and Food Safe Pro dior Uiudilica q ru m L 60 Recall Management eie eee tette deed caste eue in s oi Petre dn eee eet e eua Od ee TE Ee E e ce e cand d tan ER Erde 61 System Administration 62 Food Satety Validation DEE 62 Refresher HACCP Training for FSP UL 65 SO What 1S HACCP IER 65 HACCP PRINCIPLES jscs csssss 65 Preliminary Steps to Utilizing HACCP iineoae ot ret ete eee ere t eei te mede te e Tiene eaaeeeeese 65 Assemble the HACCP team including one person who is HACCP trained ccccccccssssssseeeeecessessstseeeeeeens 66 Describe the product and its method of production and distribution identify the intended use and consumers or the ege e EE 66 Develop and verify process flow dagramisl nennen nnns nennen tranne nnnns 66 PRINCIPLE I CONDUCT A HAZARD ANALYSIS ssssesssseesesee eerte enne enin nn sn th sn ths ntes nnn nnne
66. eeks you check the machine every 30 minutes for the next two weeks one time every 45 minutes then the next two weeks you check it every hour the next two weeks you check it every two hours the next two weeks you check it every three hours You need to monitor system failures as you reduce the time between checks you will notice that the first two checks only move 15 minutes This is on purpose as it is building a lot of data for you to look at that is similar At the end of the validation period you go back and you have no failures until three hours starts 2596 of those checks resulted in a failure If this happens you can t support every four hours it just doesn t make sense You will then adjust your frequency to every two hour or maybe you will put a calibration step in at every 2 hours You will have to decide however the point is that the validation data gave you the information you needed to support your frequency Another example is that you never had a failure all those checks and nothing ever went wrong You have supported your four hour check you could even support less checks however keep in mind the financial impact if you only check one time a day and find out at the end of the shift the metal detector wasn t working can you afford to rework an entire days production These are the decisions you have to make Validation of Critical Limits Validating critical limits can be a little more challenging Why did you pick the critical limit
67. eet DSDS Menomonie WI 54751 getting what you ordered however you also verify food safety issues such as there are no unknown to you allergens coming into your facility that temperatures and product condition is acceptable etc You also collect information you may need in a trace back or recall situation You may also have a program that is required by a customer that has minimal if no impact but you still must do it good example of a pre requisite program such as using a certain lot numbering system requiring that you use hot water as a sterilizer instead of chlorine or not producing pork and beef in the same facility At this point you may have also generated some preventive controls The easiest way to think of something that is a preventative control is the multi hurdle approach By themselves none of them have the ability to control the hazard however when put together they can have a major impact on the potential hazard Be careful when designing preventive controls the critical parameters can often be confusing resulting in identifying them as a CCP if it is actually a critical control point address it in the HACCP Plan You will typically develop an ancillary SSOP in response to a sanitation issue for example condensation control Another example might be that you need a specific clean out procedure after running a specific item the ancillary SSOP is the type of program you will use its specific in nature and addresses a sanitation iss
68. either injurious to health or is otherwise adulterated as a result of the deviation 4 Take corrective action when necessary to correct the cause of the deviation and 5 Perform or obtain timely verification in accordance with 120 11 by an individual or individuals who have been trained in accordance with 120 13 to determine whether modification of the HACCP plan is required to reduce the risk of recurrence of the deviation and to modify the HACCP plan as necessary c All corrective actions taken in accordance with this section shall be fully documented in records that are subject to verification in accordance with 120 11 a 1 1v B and the recordkeeping requirements of 120 12 While the FDA set looks to be much more extensive it is really the same requirement HACCP is a preventive system to correct problems before they affect the safety of the food products people or animals actually consume Deviations from critical limits will occur therefore you need to have a plan to make sure those deviations do not lead to unsafe products Planned corrective actions are the way you do this Your HACCP team needs to understand how important it is to carefully carry out this principle The problem is that if you have a very well designed and implemented system you won t be able to know what those deviations are as you will have already covered them the key is to make sure your employees follow the regulatory requirements that if there is a
69. emicals have been associated with both acute cases of foodborne illness and chronic illness Naturally occurring chemical hazards are those that are natural constituents of foods and not the result of environmental industrial or other contamination They include aflatoxins mycotoxins and shellfish toxins Added chemical hazards are those which are intentionally or sometimes unintentionally added to food during the growing harvesting storage processing packaging or distribution phases of production This group of chemical hazards is very broad and might include components of animal feed or drinking water animal drugs pesticides food ingredients or chemicals used in the processing establishment such as lubricants cleaners paints and coatings 3 Physical Hazards A physical hazard is a physical component of a food that is unexpected and may cause illness or injury to the person consuming the food Foreign materials such as glass metal or plastic are familiar physical hazards in meat and poultry products usually found because a process or a piece of equipment has not been properly controlled while the food was being produced Radiological Hazards A radiological hazard is typically exposure through ingestion or exposure through environment Ingestion is the risk if the product has a radiological source in it For example some grains grown in contaminated soil pick up the isotope and store it When a person or animal eats that isoto
70. ep 11 Mix in Spices pre Meat Vegetables made spice mix 6 Step 8 Cut up meat Step 9 Chop meat in bowl Step 12 Stuff into casings chopper Step 14 Store Raw Sausage Step 13 Package Raw Sausage Casings Step 16 Smoke Cook product make it RTE Step 17 Cool RTE Sausage Step 15 Ship Raw Sausage Step 18 Package RTE Sausage Step 20 Ship RTE Sausage Step 19 Store RTE Sausage Blue flow lines annotate raw products red flow lines annotates product that has been cooked Step numbers don t necessarily follow each other that is the purpose of the flow lines to show how everything flows through your process while it can become confusing it also is critical to determine the relationship of your potential hazards for example your packaging material and cooked product come together how do you know LM isn t being brought in on your packaging material This is an example and is missing steps from the normal sausage production flow www werfoodsafety com Page 8 of 79 This material is protected by US and international Copyright laws All rights reserved KH The Home of We R Food Safety and Food Safe Pro Blank Facility Flow Table Facility Name By Date Completed If needed please use a blank piece of paper to add additional steps Page 9 of 79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software
71. erything you receive and be able to quickly and easily tie them into what you produce and then track it to your customer again quickly and easily This can be a huge paperwork burden however it is a legal requirement for both USDA and FDA regulated facilities There are numerous ways you can do this if you use electronic records Food Safe Pro can do this for you by utilizing its trace back module Often times you already are doing those things necessary for a trace back and often times establishments have these procedures in their GMP s In Food Safe Pro L1 and L2 you can link your trace back procedures directly from you GMP to the Trace back plan or if you aren t you can use the trace back plan to put these programs in place If you rely on paper you have a larger challenge For example if you purchase bulk Spices and other items such as meat trim to make sausage bulk loads of casings and you only make 15 pounds of sausage a week you may have issues figuring out what to recall if your spice mix is implicated in a recall and you don t have any records or minimal records Or maybe you get your meat trim from multiple suppliers and you used some of the lean in different sausage blends then there is a recall by one of your suppliers Do you know what was implicated Another example is that you get in flour for your bakery items it comes in bulk or pre weight Your bakery products are found to be contaminated with glass however you didn t ha
72. f this document is directly related to our process Check yes no or N A if this is a challenge study validation If it is a challenge study click the button to add the challenge study documents procedures protocols letters of approval etc Enter the hazard of concern be specific such as E coli0157 H7 Metal fragments greater than 7 MM etc Enter the product you are using for validation remember to select the product with the highest risk such as hot dogs for RTE LM instead of a shelf stable sausage Page 62 of 79 This material is protected by US and international Copyright laws All rights reserved Ge 463 464 465 466 467 468 469 470 471 472 473 474 475 476 477 478 479 480 481 482 483 484 485 486 487 488 489 490 491 492 493 494 DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Enter a descriptive narrative of the protocol you are using to validate the process please remember to include the critical parameter that you are validating we strongly recommend that you state it in the first sentence Skip down to the Prepared on field and enter the date it was prepared Enter the person who prepared the validation protocol Select the person with authority to sign this plan Click the activate plan button Click the Save button The plan is now active Come back into the plan after you have completed the validation
73. g and they ship you something other than High Density Polyethylene You decide that you will take the following steps 1 Verify that you ordered High Density Polyethylene assuming you did ask them why they shipped this to you 2 Reject the load back to your supplier without putting it in the silo 3 Double check the certificate of analysis from the previous shipment from this supplier 4 Change suppliers Now you need to be able to figure out how you are going to validate and verify that your system is working at this point To validate your system you decide that you are going to send off samples from the first five shipments from each supplier every year to a laboratory for testing to verify their composition To verify that you are implementing your program you are going to do a direct observation of the employee who is responsible for checking the certificate of analysis for each load once a week to make sure he or she is actually checking them before offloading The last thing you need to do at this step is figure out how you are going to record everything you are doing You develop a simple record keeping log for the employee on the receiving dock Every time he or she receives a load they open the paper work and review the certificate of Page 78 of 79 This material is protected by US and international Copyright laws All rights reserved EA DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751
74. he receiving form is used as the product placard as the product is used the placard is updated to show what products that it was used in 2 Batching When we make product we capture basic information on the batching record and assign it a lot number Lot numbers are assigned as follows Product name the date Month Day year time it was made Final packaging date time for multi day production and a sequential letter and number For example for three lots of bread made on May 10 2012 the lot number reads 1 White Bread 051020121032A1 1 White Bread 0510201211241A2 and 1 White Bread 051020121334A3 The first lot finished packing at 10 31AM the second lot finished packaging at 12 41PM and the third lot finished packing at 1 34PM 3 Shipping When we ship product we capture basic information on the shipping record that includes the lot number who it was shipped to etc 4 Spilliage waste Anytime product is lost we record the amount on our inedible spillage waste record to include the lot number we have assigned to it 5 Operations When product is received we write our receiving code on each case of product and then attach the receiving record to the placard location in storage As the product is used in production the batch lots and amount used are recorded on it In the event that the sheet is full and there is still product we attach an additional sheet to the original sheet When the product has been used up the sheet is turned into th
75. ical control for Salmonella How do you validate that water activity of less than 94 works Again you can start testing product for moisture activity before the drying process starts and at points throughout the process for whatever it is you re focusing on Salmonella will die out at water activity that is low enough however it can literally take years for that to happen If you have a product that is very high in fat and very low in moisture such as chocolate or certain meat products you know that Salmonella is relatively resistant to drying and can survive on food production surfaces for some time you may find through your testing that your process is too slow allowing the Salmonella to survive your process The only way to know if your system is valid is to test it ie validate it Validate the location of the CCP or other control Is the CCP in the right place of our process In some cases it is a regulatory requirement such as cooling in others it is not so clear If we have a lethality step and then put raw ingredients on after the lethality do we have an issue Should there be two critical control points or should we move the CCP location An example might be an ethnic dish that requires you to cook the meat portion then add vegetables sauces and spices and briefly reheat Is the CCP just the heating of the meat item or is it a combination of heating the meat and then reheating the combined ingredients Or maybe you heat the vegetables sa
76. ight laws All rights reserved 444 445 DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Sign Field Click the sign button in the pop up window select the person with authority to implement this program Please realize that the person must be signed in to FSP then click sign Click Exit Recall Management System Administration 446 447 448 449 450 451 452 453 Select System Administration button in the main left hand navigation menu In the opening screen you can turn on and off Show Ads and show help buttons by selecting the check box You can upload your logo Click the authorized Users tab at the top Here you can add users by clicking button to bring the pop up screen that allows you to add users To subtract users highlight the user and click the button All other fields are pre filled or are for use in the L3 and L4 versions Click the exit system administration menu Food Safety Validation 454 455 456 457 458 459 460 461 462 Click the validation button on the main left menu In the select plan area select the plan you wish to prepare validation for For HACCP plans you will see a second menu that allows you to select the specific process step to validate Click the add initial validation plan button Using the button add supporting documents that are used in the validation process Check Yes or No i
77. ile not legally required to be as stringent as livestock production does have the same basic rules If you don t treat the birds correctly you fail to maximize your return on your investment No matter if you are a farmer or a slaughter establishment you must create your program so that you provide the maximum care for the live birds In range birds controlling predation can be a major issue injured birds easily become susceptible to disease that they then spread How do you deal with them How often do you check for injured birds While the CGCPs are designed for the slaughter establishment they are totally applicable for all phases of raising poultry and bringing them to market Any goose raising operation will tell you in large flocks there are always some birds that become slows they are much like swine they will sit in place given time they will become ambulatory and follow the rest of the birds If you design your plan knowing the species you are dealing with you will be able to take these types of factors into account Again training is paramount An employee that is properly trained knows how to move birds handle them without injuring them and can keep them calm An untrained employee can cost you five times his or her salary due to product lost because of broken wings joint damage etc The poultry good commercial practices incorporate your written program with a self audit As you go through the wizard you will be asked a series of questions
78. illary SSOP 66 Click the Add New Ancillary SSOP Button 67 SSOP Name Field Put the title of the program into the SSOP Name field 68 SSOP Procedure Field Put the procedure that is followed in the SSOP Procedure field 69 Prerequisite Program Monitoring Filed Put the monitoring procedure for the SSOP in the Prerequisite Program Monitoring field 70 Monitoring Logs Field Use the button to add blank records used with the SSOP If you wish to remove a record highlight it and select the arrow 71 Supporting Documents Field Use the button to add supporting documents that are used to support SSOP If you wish to remove a record highlight it and select the arrow 72 Signature Field The person with overall authority then selects their name from the drop down and clicks the signed button The date automatically appears and the SSOP is active 73 Repeat as necessary to add all of your unique SSOPs HACCP 74 List Active Plans Field In the left hand menu select List Active Plans under HACOP 75 New Plan Field Click New Plan 76 Plan Label Field Name the plan in the plan label field 77 Effective Date field Put the effective date in the effective date field It will default to today s date 78 Reason Modified reassessed Field Explain why the plan was modified reassessed 79 Products Covered Under This Plan Field To add products covered under this plan click the button T
79. ing to ask who you sold the missing product to See Figure 4 for an example The key is being able to quickly reach into the file and pull out what you need There are many ways to set a paper based system up In most cases the finished product is the main folder and is organized by date If you have a problem with a product you generally know what date you made it on You can then pull it and cross reference your batch sheets which in turn allows you to cross reference your receiving records Food Safe Pro L1 and L2 both come with forms to meet your needs and print for your use you can either describe your trace back plan in the text area or upload a file if you already have one created Once it is in Food Safe Pro you don t have to worry about losing the plan or the forms they are always available in the program Maintaining paper records is extremely time consuming that s why we developed the Trace back module for Food Safe Pro L3 It automates your receiving batching and shipping logs all in one place and it s customized for your facility so that it works for you Figure 1 Receiving record Receiving Record Detail 3 Product Flour bulk 1 Items Received Date 05 04 2013 Qty 1000 LBS Es Shipping Company Wisky Flour shippers e 2 Vehicle 562356 Invoice P O 55452157 UPC SKU DKM569856 Supplier Wisky Flour Manufactures Y 1 Supplier Lot 777777 Product Condition Excellent v Product Temp 0 Amount
80. ive actions in your plan and then when something does happen utilize them as a process to correct whatever it was that happened If you find yourself constantly redoing the same corrective actions over and over I have seen training used so much that the many companies should be issuing Doctorate degrees you have a system issue that should be addressed not a corrective actions issue Our metal detection scenario is a good example instead of performing corrective actions over and over you reassess your system and design it so that it prevents the hazard and is something that is doable In the end you meet the regulatory requirements minimize wasted time and used good sound science to come to your conclusions Validating your process After you have addressed corrective actions and unforeseen hazards you need to sit back and really look at what you have designed to determine if it is valid You are going to design a two part validation protocol for your system an initial validation and ongoing validation Please don t confuse these with verification Too many people are afraid of validation it takes time and effort and a lot of folks just don t want to do it In addition to that it s not well defined and validation has become a twisted mess in many places Validation is actually very simple is your system designed to produce a safe product by controlling potential hazards You test your system to make sure that it does what it s supposed to As
81. ke sure that you perform self audits We strongly recommend that you have both people familiar with your humane handling system and someone who knows nothing about your humane handling system perform the self audit This will give you a new set of eyes and a different perspective The checklist for the self audit in FSP L1 unlike many other checklists it is not scored it s a pass or fail Fail any one area and the entire audit is a failure pending your corrective action Remember the purpose of the checklist is to review your program with the intent to find ways to improve the program without wasting a lot of time If you wish to use a scored checklist please use Bing or Google search engines there are a lot of them out there One word of Page310f79 This material is protected by US and international Copyright laws All rights reserved EA DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 caution concerning scored audits they take a lot more time and in the end aren t as effective because if you pass you think you are ok Most regulators use a pass fail system Either you pass or you fail The self audit is worthless if you pass it and then fail the regulatory audit Getting started with Poultry GCP Poultry GCP While most poultry is vertically integrated the rise in small poultry producers and the move to organic and free range poultry has had a dramatic impact on poultry handling Poultry production wh
82. l is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Getting started with Food Defense Food Defense is set up so that you can check specific pre loaded blocks and or add your own information It is very self explanatory The key to a good food defense plan is the same for all of your programs make it simple something that is easy to implement and something that you actually do The food defense plan also address information security please remember that FSP is part of your information security don t give anything but read access to those that don t need it Getting started with Humane Handling Humane Handling If you slaughter livestock the law is very clear you must treat the animals that you slaughter humanely Our humane handling module is based off the same regulatory checks used by the USDA It is very straight forward Humane handling of livestock isn t just the right thing to do because consumer groups want you to it has a direct impact on the quality and in some cases the wholesomeness of the meat you produce FSIS is under a lot of pressure to take actions and shutter plants that abuse animals as you are aware the definition of abuse can be a moving target Some of the areas that can be easily taken care of our your barn and receiving facilities go through them with an eye to injury potential and the ease of movement of ani
83. lepopioe e ER 19 Starting with sanitatiOn iie tree tacet near e tace da Oden rea ce o EA REN e Ra deed esa acide ve e deu AREEN EE AE 20 Working with your individual food safety programs GMPs prerequisite ancillary SSOPs and preventive eege Lu EE 20 Getting into the HACCP PrOCeSs rote eet o ttn EEN 21 Getting started with Verification tasks sissies taen earrannan aaaea aana ETE EA E E Raa aaa T a ant 22 Working with corrective actions and unforeseen haarde 23 VEH lee Ile ele E 23 hs EI E 23 Working with ongoing validation enne nnne nnne nennt nena nnns daiaire diaa 28 FDA Fogd CGMP ED 29 Animal Feed CGM ce r 29 Getting started with Allergen Control 29 Getting started with RfEiLMeontrol ennemi ennrnr entrar terrier sn tris en nnnin 30 Getting started with Product Trace Back 30 Getting started with Food Defense iessen eee entr ie ote oe Von e nS DES YR XY Ee Enea e RR eet 31 Getting started with Humane Handling 31 Getting started with Poultry GCH eene nn tern nana asas ss sn neris assai sss seat sa ganas sss essi 32 Page 3 of 79 This material is protected by US and international Copyright laws All rights reserved den PA ies The Home of We R Food Safety and Food Safe Pro A note about medical residues and antibiotics AN 32 Reassessing your Food Safety Program cssssccccccssssssssseeececsssesseaeseecescssseeaeeeeeces
84. lick the arrow We strongly Page 39 of 79 This material is protected by US and international Copyright laws All rights reserved 14 15 16 17 18 19 20 21 22 23 SSOP 24 25 26 27 28 29 30 31 32 DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 recommend that you add designated Employee this will allow you more flexibility in FSP L1 User Detail Pop up Field System User Detail Pop up Please note that you can add and modify later in the administrative screens Employee Name Field Enter the user name of the employee Employee Password Field Enter a strong password for the employee see the user manual section on security You will skip the location field this is only available in the L3 and L4 modules In access level you will select the level of authority you wish the user to have Company Phone Number Field Enter their phone number in the establishment Employee phone number Field Enter a mobile number if they have one Employee Email Address Field Enter their email address if they have one Click save and repeat as necessary to add all of your authorized users Logo Field Click the upload logo and navigate to your computer to where your logo is Logo s work best when they are rectangles however using a picture editor you can modify and reload as necessary later in the administrative screens Click Save At this point you a
85. m The FSP Allergen program helps you identify when you verified your labels gives you the ability to attach your GMPS and SSOPs that address how you operate in reference to Allergens and provides you a self audit that you can use to assure that you are following your program and minimizing your risk of an allergen related incident RTE LM Program Ready to Eat Listeria Monocytogenes program is based on the compliance guidelines developed by the USDA as well as the FDA They are designed to flow along the same lines as 9 CFR 430 as this CFR covers all aspects of LM control specifically in Deli products but is also very good at helping control LM in everything from Dairy products to Dog food to melons growing in the field The gist of it is that based on how you make your products you determine what controls you will need how often you will need to test for LM in product and in the environment It also includes test and hold Page 170f79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 procedures as well as validation procedures The email alert system is not functional in L1 however it is available for L2 L3 and L4 Both FDA and USDA FSIS guidance documents are in the document library Product Trace Back The FSP Trace Back module helps you design a trace back program that works In the FDA arena many operators are receivi
86. m is usually the simplest one that can be easily integrated into the existing operation When you are setting up your recordkeeping system think about who will be in the best position to make the record entry who will need to review the record prior to shipping and when and where will be the best place to keep the records Think about making simple understandable forms that will work well in your situation Make sure your employees know exactly what is expected if they are responsible for making a record entry It is extremely important that they sign and date the records at the time the specific event occurs PRINCIPLE VII ESTABLISH VERIFICATION PROCEDURES HACCP principle seven is to establish verification procedures to make sure the plan is working correctly Your team needs to decide on what procedures the plant will perform to verify that the HACCP system is working effectively and how often these actions will be performed Verification uses methods procedures or tests in addition to those used in monitoring to see whether the HACCP system is in compliance with the HACCP plan or whether the HACCP plan needs modification There are three types of verification Validation is the initial phase in which the plan is tested and reviewed The choices made while working through the preliminary steps and HACCP principles must be repeatedly tested and shown to prevent or control identified hazards in the real world In this phase microbial
87. mals What works for one species does not work for another There is a lot of information available about designing your facility so we won t go into that however we have seen time and time again something as simple as changing the way a gate swings or blocking an area from the animals view totally change the way animals move The other thing to remember is that consumer groups hate shock prods If you have one in your facility you are often guilty of abuse even if the thing hasn t been used in ten years We strongly recommend that your employees who handle live animals be carefully selected a good employee can move just about any animal without touching them Poorly trained employees or those that are rushing will get you in trouble Your stunning system needs to work right every time There is no excuse Back up knocking mechanisms are necessary they must work Have a plan on how to deal with very large animals When extremely large bulls show up you may want to switch to a shotgun Sounds extreme however go through the lists of plants suspended and you will find pneumatic bolts hand held captive bolt devices 357 Mag pistols 30 30 rifles etc have all failed to render large bulls unconscious Again we can t emphasize enough the role of having a properly trained team of employees play in the success of your humane handling system No one wants to be named in as a violator The final comments concerning designing your humane handling program are to ma
88. n Be specific and detailed In the document library Attach supporting documents click on the library icon click button and navigate to the place on your computer where you have stored the file highlight the file and click open Repeat until you have added all of the supporting documents used to Page440f79 This material is protected by US and international Copyright laws All rights reserved AN ELA Ge 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 identify the hazard determine controls and to determine if the hazard is likely to occur then click save You will then answer if this is a critical control point or not If no check no and then click save process step Repeat adding process steps If you finish adding all process steps and there aren t any critical control points identified go to step 153 however if you identify a critical control point and check yes You will be taken to another screen Description of Critical Control Point Put a description of the Critical operation values etc related to the critical control point Attach Blank CCP Documents Attach any blank forms you use to monitor the CCP Critical Limit Put the specific critical limits that apply to the CCP here Justification of Critical Limit Give a detailed justification of the critical limits Lo
89. n example of a lower critical limit would be the addition of an acidifier to inhibit bacterial growth PRINCIPLE IV ESTABLISH MONITORING PROCEDURES To carry out HACCP principle four your team needs to establish monitoring procedures Monitoring procedures are those things which are done routinely either by employee or by mechanical means measure the process at a given CCP The key is that they create a record Some monitoring procedures are employee observations or checks such as checking the documentation accompanying incoming materials Some monitoring procedures are records from instruments such as recording thermometers Continuous monitoring is always preferred when it is feasible When it is not possible your HACCP team will need to decide what will be their non continuous monitoring procedures and how frequently they will be performed There are several issues to consider when deciding the frequency of non continuous monitoring checks the most important is that the procedures must be performed sufficiently often to accurately reflect that the process is under control Expert advice from people with knowledge of practical statistics and statistical process control will be important in making your decisions about frequency Page 700f79 This material is protected by US and international Copyright laws All rights reserved EA Gy DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Another factor tha
90. n late summer and will be provided to all customers free of charge as part of the normal maintenance update As part of your policy you must address the accuracy of your computers clocks ie that they are set up and are not changed without authorization failure to implement and enforce this policy will result in the failure of FSP to meet Title 11 requirements Accounts for Guests should only be given read only access This is not functional in FSP L1 to give read only access you must save the plans in PDF format by printing them from the print menu and then opening them outside the program For FDA only If the current proposal for Title 11 is passed you will need to submit a certificate to FDA Office of Regional Operation HFC 100 12420 Parklawn Drive RM 3007 Rockville MD 20587 that includes the user name and hand written signature At this time it is not necessary to do so as it is not a legal requirement Passwords need to be periodically updated to maintain security FSP data is encrypted in such a way that the data itself is not readable outside of the program ie even if someone were to get a copy of your data without password access they will not be able to access the data again the emphasis is on protecting your passwords Strong passwords are those that are not easily discernible but are easy for you to remember Using family names or birthdays are not strong passwords FoodSafePro is not a strong password as if someone is tr
91. n turn around and waste money by revalidating the premises in the guideline instead of focusing on validating that they can implement the guideline Page240f79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Validation of frequencies This is probably the easiest part of your program to validate If you have continuous monitoring there is nothing to validate the frequency is continuous right The answer is maybe You have to look at the critical operating parameters around whatever the process is to include continuous monitoring and make sure you are meeting them Let us use our metal detection scenario as an example You have designed the system so the operator tests the metal detector with a metal see before product goes through and every four hours of operation after that so basically three checks a day Once before and twice during operations The question is that enough checks a day to make sure that the CCP is under control The reality is you can t afford to pay an employee to monitor the machine every five minutes however you also can t afford to rework four hours of product You have several options you can do a statistical analysis based on the amount of product operating time etc and increase your monitoring for the first 90 days Another viable option is to use a regressive sampling protocol for the first two w
92. name from the drop down and clicks the signed button The date automatically appears and the Prerequisite Program is active Repeat as necessary to add all of your Prerequisite Program s Preventive Controls 58 59 60 61 62 Click the Add New Preventive Control Button Name Field Put the title of the program into the Preventive Control Name field Preventive Control Procedure Field Put the procedure that is followed in the Preventive Control Procedure field Program Monitoring Field Put the monitoring procedure for the Preventive Control in the Prerequisite Program Monitoring field Monitoring Logs Field Use the button to add blank records used with the Preventive au Control If you wish to remove a record highlight it and select the arrow Page 42 of 79 This material is protected by US and international Copyright laws All rights reserved EA DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 63 Supporting Documents Field Use the button to add supporting documents that are used to support the Preventive Control If you wish to remove a record highlight it and select the arrow 64 Signature Field The person with overall authority then selects their name from the drop down and clicks the signed button The date automatically appears and the Preventive Control is active 65 Repeat as necessary to add all of your Preventive Controls Add a Anc
93. ng warning letters for failing to be able to trace back and forward the same is happening in the USDA arena The FSP program for L1 and L2 is paper based and allows you to generate the blank forms you need to implement it In the L3 L4 versions trace back is integrated with your inventory system and your recall management system resulting in rapid and accurate responses to issues See the Trace Back section later in this manual for more information concerning Trace Back Food Defense Plan FDP The food defense plan in FSP is very simple to design You select the items that apply to you or add them in the text box save print and implement it s that easy Humane Handling HH We have broken the humane handling portion into three main parts The first is the pre planning phase this is where you will answer a series of questions after you have completed answering the questions you then review your current plan and make any necessary changes The next phase of FSP humane handling is where you will enter your actual plan it includes the ability to upload documents to support the different features of your plan and also gives you the ability to set a frequency of self audits The third part is a self audit checklist Unlike many other checklists it is not scored it is pass or fail the purpose of the checklist is to review your program with the intent to find ways to improve the program without wasting a lot of time If you wish to use a scored ch
94. ntive Control to describe what you do at Critical Control Points in your HACCP Plan This is a bit different than how the USDA views them If you are a FDA inspected establishment your Preventive Controls will be the equivalent of your CCP s The way the FDA looks at it is that you perform your hazard analysis and then develop preventive controls for the hazards you identify This is just another way of saying you perform a hazard analysis and identify controls at those critical points in your process In FSP we recommend that you utilize the HACCP process fully utilizing the system i e developing CCP s monitoring etc and use the GMP s Prerequisite Programs and then develop Preventive controls for anything you haven t already addressed such as multi hurdle approaches used to control Salmonella Page 16 of 79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Ancillary SSOP s These are SSOP s that are created to address a specific issue for example condensation in the smoke house or how to clean the buffet line during high volume service or maybe how to clean out the seeder after using a coated seed to plant The have the same record keeping requirements as your standard SSOP s You will often use them to address specific sanitation issues that have the potential to affect food safety Food and Drug Administration Food Cu
95. nts start getting old the minute we ship you FSP as we don t provide updates in L2 L3 and L4 we will keep these documents current utilizing our server Designing a food safety program What exactly is a food safety program or as some people call it food safety system In short it is what you do to produce a safe product In many if not all cases it has to be in writing and someone is going to check and see if you are following what you wrote down Why is this important Simple don t create a monster in writing that you can t actually do on a day to day basis Getting started To think about To get started what is it that you do What do you make How do you make it Where do the raw material the packaging material and anything and everything that goes into your product come from These are all questions that people try to start from and in the end they all have to be answered Page 19 of 79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 however the first question that you really need to ask is How does food safety fit into our company Is your company one that has a separate QA department that monitors everything or is you company one where each production employee is responsible for monitoring food safety Are you a very small shop where everyone has to do a lot of different things In the end in order fo
96. o include frequency of monitoring in the monitoring procedures field and then attach blank records by clicking the button in the records field When you press the button navigate to where you have the blank form stored on your computer click open and it is attached Then Click save and next You will repeat the instructions in block 31 for Operational Hygiene non meat ingredient hygiene and packaging material When you have finished entering them all click save and close Designees Field Next click the Designee s tab You will then click the button to add sanitation monitors and other employees that you want to identify with having sanitation responsibilities If you wish to remove an employee select them from the list and click the button Food Safety Plans GMPs 41 42 43 44 GMP s Field Next click on GMP s Prerequisites Preventive Controls Add SSOP link on the left navigation screen Add GMP Field Click the Add New GMP Button GMP Name Field Put the title of the program into the GMP Name field GMP Procedure Field Put the procedure that is followed in the GMP Procedure field Page410f79 This material is protected by US and international Copyright laws All rights reserved 45 46 47 48 49 DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 GMP Monitoring Field Put the monitoring procedure for the GMP in the GMP Monitoring field
97. o remove a product highlight it and click the button 80 New Products Pop Up Screen 81 Products Field Enter the name and type of product in the products field for example Raw not Ground Beef Steaks or Produce watermelon Individual products such as T Bone 2 inch are entered in Trace Back module for versions L3 and LA Page 43 of 79 This material is protected by US and international Copyright laws All rights reserved AN ELA Ge 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Type of Package Field List all types of packaging used in the type of package field Expected Shelf Life Field List the expected shelf life at both refrigerated and frozen state if they are both applicable or in the case of produce or alfalfa at normal storage temperatures Label Approval Field If you have approved labels from the USDA click yes otherwise select no for label approval Distribution Controls Field If special distribution controls are needed list them here Generally you will state keep refrigerated or frozen as applicable and protect from contamination with filth Intended use this field prepopulates with retail amp Wholesale change if you have a different intended use Expected Customer this field prepopulates with General Public if your customers are a high risk population iden
98. ocedure document field Attach support for your sample collection procedure Attach an additional testing document field Attach any other supporting documents Describe any other Validation that you use Click Save and Next Do you test for field For environmental sampling select the organism that you test for Where are the locations you test Field Enter the locations that you perform environmental sampling non food contact non product testing Justification for these site locations field Justify why you have selected these sites What is the size of the test site Field Enter the size of the test site typically 12 square inches or the entire surface if it is smaller Justification for size of test site field Justify the size of the test site Do you produce Hot Dog Deli Products Field Check yes or no as applicable if you produce Deli or hot dog products Conditions to implement test and hold field Enter the conditions that result in test and hold Page 53 of 79 This material is protected by US and international Copyright laws All rights reserved AN ELA Ge 288 289 290 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Attach a test and hold document field Attach the document that supports your test and hold procedures for example the
99. odule is turned off in L1 and is partially active in L2 You can set specific reminders in L2 that are emailed or sent as a text message to whomever you designate to take samples on dates you designate In L3 and L4 it is where you manage your different sampling programs and the results of tests review trend analysis etc System Administration in the system administration screen you administer FSP by designating employee s uploading your logo setting permissions determining your regulator and business type You can also upgrade to L2 and see your current software information etc There are two tabs that are not functional in L1 and L2 the facility schematic is used to generate a detailed overlay that is integrated into the sampling and other modules The database storage is used to show how much data you have on the server locations connecting users etc In L2 L3 and L4 your data is backed up on our main servers and also on our offsite servers as well as on your local computer giving you a high level of confidence that your data is secure and safe Printing Menu The printing menu is used to generate the paper copies that you print to either maintain locally provide regulators customers etc It is also where you generate your PDFs Electronic format System Help amp Support system help and support is where you find out how to do something in FSP we have included training help documents etc Please note with L1 these docume
100. of the supporting documents that you used to in your decision process Are we audited by a third party if so attach the latest audit Field Enter a detailed description of your latest third party audit Attach Documents Field In the document library Attach documents click on the library icon click button and navigate to the place on your computer where you have stored the file highlight the file and click open Repeat until you have added all of the documents from your third party audit How often do our employees receive refresher training Field Enter a detailed description of how often your employees receive refresher training concerning humane handling Attach Documents Field In the document library Attach documents click on the library icon click button and navigate to the place on your computer where you have stored the file highlight the file and click open Repeat until you have added all of the supporting documents that you used to in your decision process Click Save and Next The next three pages are the built in version of the humane handling self audit they system will not allow you to use them on a tab or your phone unless you have the L3 or L4 versions Click save and next and you will be brought back to the main screen Sign Field Sign the humane handling program by having the person with the authority to sign it click the sign button Please note that the person who signs it will need to be logged into
101. otected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 emphasis this enough the slaughter plants are being pushed very hard to stop purchasing animals from violators Currently they are being advised to stop purchasing for repeat violators however government regulators are pushing to stop them from purchasing after a single positive Reassessing your Food Safety Program Reassessment What is reassessment It is simply looking over your food safety programs and determining if you need to make a change When should do a reassessment You should reassess your food safety program whenever you make a change that impacts your process this might be using a new or different piece of equipment changing personnel changing the formula or process that you use or if you have a unforeseen hazard or a deviation from a critical limit Most regulatory requirements are for you to reassess yearly if there are no changes or events that trigger a reassessment Reassessment at six months So you have built your SSOP some GMP s Pre Requisite programs HACCP Plan etc You have validated it you are done right Not quite you need to give it a good go over and determine if you need to make any changes After making major changes you typically will be validating for the first 90 days as we said earlier We recommend that you perform another review complete review r
102. otection do we use Field Put in the type of virus protection that you use If you are using windows basic setup you will list windows Defender What Anti Spyware Malware do we use Field Enter the type of anti spyware malware that you use If you are using windows basic setup you will list windows Defender What firewall system do we use Field Enter the firewall you use If you are using windows basic setup you will list windows Firewall How often do we require password changes Field How often do you require people to change their passwords Check the applicable check boxes for the remainder of this section and continue with the food defense module until you come to the Review section Additional Information for our Food Defense Plan Field Enter any additional Food Defense information in the text field When you review the plan fill out the Food Defense Reviewed section Check Yes enter the date and select who performed the review Prepared By Field Enter the person who prepared the Food Defense Plan Signed By Field The person who has authority is to sign the plan please note they must be logged in Click on Save and Close Humane Handling 328 329 330 331 Next click on Humane Handling Date Prepared Field Enter the date prepared Prepared By Field Select the person who prepared the program Effective Date Field Enter the date that the program is effective Page 55 of 79 This material is protected
103. our documentation and it is also maintained in PDF format that is Page 13 of 79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 locked to prohibit changing historical records Please note that archived records are locked in such a way that they CANNOT be unlocked This insures the integrity of your data If you find a glaring typo after you have set your plan to active in your reassessment area identify the reason i e reassessment to correct typo XYZ As your regulator reviews your plan it is clear why you made the change and you are not in noncompliance as you found and corrected the issue We cannot emphasize enough that if you archive without keeping an active plan or duplicating the plan you will have to reenter everything there is no way to unlock the data once you have archived it How to duplicate a HACCP Plan or other plans in FSP When you wish to modify an active plan open the active plan list and double click on the active plan you wish to work with You will receive a pop up window that asks if you wish to archive or duplicate WARNING if you select Archive you cannot undo this change To modify select duplicate and check the box to keep active You will then have a draft plan to work on while your plan remains active When it is time to start using the active plan sign it and click save then double click the
104. pe it can cause cancer radiation poisoning etc There are locations throughout the world where the soil is naturally contaminated and products produced on them may or may not also be contaminated Exposures to environmental sources are typically associated with natural disasters that expose the radiation source and contaminate the product ingredient animal or human For example when the power plants in Japan failed due to the tsunami the radioactive water contaminated product packaging people and animals in the near proximity and they became ill from the radiation While radiological hazards are real and the results of exposure can be devastating they are very rare There are a number of situations that can contribute to physical hazards in foods They include contaminated raw materials poorly designed or poorly maintained facilities and equipment contaminated packaging materials and inattention to details by employees with key responsibilities This first step in identifying hazards which might be associated with your production process might be considered like a brainstorming session Your HACCP team should use the flow diagram and product description which you created in your preliminary steps and systematically think about what could occur at each step in the process Page 680f79 This material is protected by US and international Copyright laws All rights reserved EA Gy DKM Integrated Software Solutions LLC 2015 Wilson
105. period Enter the summary of your findings be detailed and descriptive Enter your final determination is the plan valid or not Attach the records all records associated and generated with the validation protocol Go to the plan complete field and select the person with the authority to sign the plan Click Complete plan Click save Click the add ongoing validation plan button Using the button add supporting documents that are used in the validation process Check Yes or No if this document is directly related to our process Check yes no or N A if this is a challenge study validation If it is a challenge study click the button to add the challenge study documents procedures protocols letters of approval etc Enter the hazard of concern be specific such as E coli 0157 H7 Metal fragments greater than 7 MM etc Enter the product you are using for validation remember to select the product with the highest risk such as hot dogs for RTE LM instead of a shelf stable sausage Enter a descriptive narrative of the protocol you are using to validate the process Skip down to the Prepared on field and enter the date it was prepared Enter the person who prepared the validation protocol Select the person with authority to sign this plan Click the activate plan button Click the Save button The plan is now active Come back into the plan after you have completed the validation period Enter the summ
106. points in the process where these preventive measures should be applied The location of your Critical Control Points is vitally important The location in your process must be well thought out and defendable An example is allergens in product It is critical that you know what products have been exposed to allergens Having a CCP at the end of the process without knowing what products have been exposed fails to make sense there is no control at the end of the process Instead the CCP should be at the adding ingredient step where every product that has an allergen added or is exposed to an allergen is labeled appropriately PRINCIPLE III ESTABLISH CRITICAL LIMITS FOR EACH CRITICAL CONTROL POINT HACCP principle three instructs your team to establish critical limits for each preventive measure you will carry out at each CCP This step involves establishing a criterion that must be met for each preventive measure associated with a CCP The USDA FSIS defines a critical limit as the maximum or minimum value to which a physical biological or chemical hazard must be controlled at a critical control point to prevent eliminate or reduce to an acceptable level the occurrence of the identified hazard Page 69 of 79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Critical limits are the boundaries of safety for preventive me
107. program to give you an early warning if something is drifting the wrong way You can use the data you collect to support decisions when you do a reassessment and if you do detect something wrong you are automatically going to go into reassessment mode The process is the substantially same in FSP for initial validation and ongoing validation the difference is the time spent In ongoing validation you will only run the validation for a very short period of time sometimes only a single day periodically throughout the year A good example is testing product for LM as ongoing validation you may submit a product sample quarterly in addition to your normal environmental samples In the ongoing validation module you will select the plan and or step you wish to validate You will enter the necessary information at this point you sign and date it This then Page 28 0f79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 becomes an active plan You don t fill out the summary or findings until after the validation is complete You collect the data and review it using our LM sample it might be as simple as looking at the laboratory testing results If there are no problems you will go back into FSP and update that validation step by opening the active validation program and then completing the summary and the findings portions Attach th
108. protocol you will find that it is just good management and business sense Fixing a problem before it ruins your business is always good For example You produce a specialty hot dog for a space program Your hot dogs are exposed to a lethality of 189 F for ten seconds in your HACCP Plan as a CCP have add lactate to the product and then after its packaged you post pasteurize the product in package This is also in the HACCP Plan as a CCP In your RTE program you are making an alternative 1 product because you have both an antimicrobial agent added to your product and you use a post exposed treatment for LM and you use the USDA compliance guideline for your supporting document When you design your initial validation protocol you are going to want to validate the critical parameters that you use to control the LM Let s start with your lethality critical limit You made the decision for your lethality temperature based on the high fat content of your hot dogs and the fact that you heard somewhere that space programs demand that it be cooked to at least 189 F for ten seconds You can t find any support for this temperature in scientific documents everything is lower You did find a document from 1959 that NASA and the US Army wrote that references this temperature but it doesn t meet current standards for supporting your CCP You also have the USDA Appendix A guidelines How do you validate the temperature Do you need to take a bunch of lab samples
109. pyright laws All rights reserved EA DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 A flow diagram is a simple schematic picture of the process you use in your plant to produce the product It needs to be an accurate clear sketch of the process used in your plant to make the product The best means to make sure your flow diagram is accurate is to have the HACCP team verify it by walking through the plant and making sure all the steps in the process you carry out are included in the flow diagram It is also a common means by which auditors or inspectors verify that a particular flow diagram is correct and complete When you are certain that you have an accurate flow diagram and your team has verified it you have completed the preliminary steps that will prepare you for HACCP system development It is time for your team to apply the seven principles of HACCP and develop your HACCP plan PRINCIPLE I CONDUCT A HAZARD ANALYSIS The first principle of HACCP is to conduct a hazard analysis Conducting a hazard analysis is generally considered to be a two step process The first step is to identify the threats to human health which might be introduced into food products as those products are produced These hazards are usually grouped into three categories Biological including microbiological Chemical and Physical The FDA requires a fourth category Radiological 1 Biological Hazards Biological ha
110. r a company to produce a safe product everyone from the top to the bottom has to buy in to the fact that food safety isn t a separate event or group of tasks it is an integral and dynamic day to day part of what you do Once you figure out the answer to how food safety fits into your business culture you can begin to put together your food safety team If you are a very small shop there might not be a team to help develop the plan maybe they only have time to look it over That s fine however we recommend that someone from all aspects of your operation be part of the food safety design team The next thing you have to do is realize that food safety falls into three realms Scientific Regulatory and what can actually be done or as a lot of people in the business say Common Sense Science may tell you that you should do something like test and hold every animal coming into the facility for medical residues When you look at what you can actually do that isn t feasible you will be out of business shortly Regulatory says that you have to do something So how do you reconcile these three dynamics We wish we could say it was easy however it is not FSP will help you build a plan that addresses your regulatory requirements but it can t actually fill in the blanks Putting the right information into the right place is up to you Starting with sanitation We recommend that you start with sanitation Your Sanitation Standard Operating Procedures SSO
111. rate them into your food safety plan you can use the down arrow to accept the text from the regulation The text can be modified to meet your specific needs 162 Reference Field In the reference section use the drop down arrow to select any other programs you have that address this requirement 163 FDA CGMP Supporting Documents Field In the Supporting document section use the arrow to open the selection window navigate to where the supporting document is kept highlight it and click open Repeat until you have attached all documents that support this part of your CGMP 164 Click Save amp Next 165 Repeat step 161 through 164 until you get to the self audit amp Approval section 166 Inthe Frequency field for self audit enter the frequency that you perform them 167 Who performs the self Audit Field Use the down arrow to select the person responsible for the self audit 168 Click the Upload Self Audit if you have one that you use otherwise you can use the one that comes with FSP it can be printed in the print menu or by using the button at the bottom of this page 169 Reference GMP Pre Req SSOP HACCP Plan Field In the reference section select the program you use for conducting self audits if you have one Page 48 of 79 This material is protected by US and international Copyright laws All rights reserved 170 171 172 173 DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI
112. re in the main screen for FSP We suggest that you start with your SSOP Click SSOP in the left screen Person with overall responsibility field Select the person with overall responsibility in the establishment for sanitation If you have not entered them see system Administration step 496 of this document for instructions on how to enter them Establishment Schematic Field Next click Browse under the Establishment Schematic and navigate to where you have your establishment schematic stored on your computer This step may be bypassed Lock out Tag Out Program Field Next click Browse next to the Lock out Tag out Program and navigate to your lock out tag out program this step may be bypassed SSOP Pre Op Monitor Filed Next select the person who will be the SSOP Pre Op Monitor for very small plants or the SSOP monitor Supervisor for larger establishments SSOP Operational Monitor Field Next select the person who will be the SSOP Operational Monitor for very small plants or the SSOP monitor Supervisor for larger establishments General Sanitation Discussion Field Next fill in the General Sanitation Discussion field In this field you will enter basic information concerning sanitation such as your company s general policy if you use an outside cleaning company your sanitation philosophy etc Next click save plan data Page 40 of 79 This material is protected by US and international Copyright laws All rights reserved 33 34 35
113. re the basic sanitation practices you use routinely throughout your facility for example how often you clean your floors walls etc In essence your SSOP gives you the basics for making of sure your level sanitation before and during operations are sufficient to keep you from producing an adulterated product They often overlap with the FDA s CGMP s in many ways the SSOP is your basic sanitation foundation it is what you are going to use to build your food safety program Without basic sanitation it doesn t matter what you do your risk of producing an adulterated product is extremely high Page 150f79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Food Safety Programs Individual includes GMPs Ancillary SSOPs Prerequisite programs and Preventive Controls Under both the FDA and USDA these are the programs that are used to support the HACCP Plan They all tend to address one issue each see below for specific details concerning them Good Manufacturing Practices GMPs These are the Good Manufacturing Practices that you have developed for your establishment and production Often they don t have the intense record keeping requirements that HACCP records They often support that you don t have a hazard for example if your receiving GMP states that you reject any product with Allergens the likelihood of you having an
114. residue or chemical testing can be used effectively to verify that the process is in control and is producing acceptable product Such testing provides clear evidence that the techniques and methods adopted by the plant to control hazards are not just effective in theory but will work in this specific plant Ongoing Verification ensures that the HACCP plan is working effectively on a day to day basis This type of verification includes such tasks as calibrating monitoring instruments observing monitoring activities and corrective actions and reviewing HACCP records to see that they are being made and kept according to the plan Reassessment is an overall review of the plan whenever any changes occur that could affect the hazard analysis or alter the HACCP plan Reassessment is similar to validation in that it considers whether the plan is adequate in general rather than focusing on the plan s daily operations It is also similar to Page 740f79 This material is protected by US and international Copyright laws All rights reserved EA DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 validation in that it must be done by a HACCP trained person USDA FSIS requires that a reassessment must be performed at least annually Another way to think about it is this You validate that your plan is the right plan for your system you monitor it so that you know what it is finding you verify that you are implementing i
115. results They must have complete access to the CCP being monitored and to the process monitoring instruments being used The people performing monitoring must record exact values where exact values are indicated not yes no or OK observations This means that if the critical limit is a minimum internal temperature of 160 F the observations on the monitoring record would be recorded as 162 F 163 F rather than yes or OK Another example might be if a certificate of analysis is required for each incoming load of raw material that the specific criteria that it was tested for such as 100 High Density Polyethylene The record should indicate 100 Polyethylene received and not ok PRINCIPLE V ESTABLISH CORRECTIVE ACTIONS HACCP principle five says Establish corrective actions to be taken when monitoring shows that there is a deviation from a critical limit USDA FSIS regulation 9 CFR 417 3 identifies the four features of corrective actions that FSIS regulators will be checking They are 1 Has the cause of the deviation been identified and eliminated 2 Will the CCP be under control after the corrective action has been taken 3 Have measures to prevent recurrence of the deviation been established 4 Do the corrective action procedures make sure that no product which is injurious to health or otherwise adulterated because of the deviation enters commerce The FDA has a more extensive list Pag
116. rrent Good Manufacturing Practices FDAFCGMP These are things you are required to do by the FDA In many cases they overlap with your Sanitation Standard Operating Procedures SSOP and your GMP s We have set up FSP to allow you to put those that you have added additional information to into a GMP those that you don t specifically want to have extra writing about are still in the program so you can accept them the way they are There is also a self audit included that you can use to perform self audits to verify that you are meeting all of these requirements Animal Feed Current Good Manufacturing Practices AFCGMP s These are the Current Good Manufacturing Practices used by animal food manufactures and include medicated and non medicated feed manufacturing They are similar in scope to the FDA Food CGMP s in many cases the GMP s that you already use will address the concerns that the AFCGMP s address Recall Management Here you will design your recall plan You will be able to input the key people you need to contact Depending on who regulates you the requirements between USDA and FDA are sufficiently different that we developed two separate plans You can either accept and use the plans we have developed or upload your own plan Even if you accept the plans we developed there is an area for you to add additional information The FSP L3 L4 module is turned off in L1 and L2 it automates the recall process dramatically Allergen Control Progra
117. ry uses to test your product Attach a lab methodology document field Attach a copy of the lab kit insert or other supporting document What is the sample collection procedure Field Describe the sample collection procedure Attach a collection procedure document field Attach support for your sample collection procedure Attach an additional testing document field Attach any other supporting documents Describe any other Validation that you use Click Save and Next Sign field Click the sign button Select the person with the authority to sign the document Please note that they have to be signed in to FSP in order to sign Page 540f79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Food Defense 313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 Next click on the Food Defense button on the main left side navigation screen Physical Security Field For the food defense check the statements that apply to your facility and add any additional measures you take for the area covered in the other text field You will start with Physical Security Click Save amp Next Repeat until you get to the information security section Who is the Information system administrator Field Enter the person who administers your computer system What virus pr
118. safety taking time to educate by adding the program you will save a lot of time down the road Document Library FSP comes with a set of folders that contain FSIS USDA OSHA etc regulations They are current as of the date the software was saved to ship to you You can either access them through FSP on the main page or navigate to them using your file manager to point to the where you saved FSP then under the database folder you should point to either regulatory resources scientific support or supporting documents As you link your supporting documents to the program copies will be saved to these folders Remember the house in the top left is your home button clicking it takes you to the main screen FSP and Security To use FSP L1 you will create your own user name and password You will then be able to administer the user name and passwords of others that you wish to give access to In FSP L1 user names and authority delegation isn t active ie anyone can set up and sign In order to maintain compliance with FDA and USDA electronic record keeping requirements there are a few things that you have to do 1 Verify that the people whom you give access to FSP are actually who they say they are In the regulations the Government requires that you verify the biometrics of the user this means that you have visual proof that the person whom you are giving access to is who they say they are Generally 2 forms of picture ID are sufficien
119. save team member and repeat until all members have been added Consultants or other experts that will be used to assist with recalls Fields Click the button to add outside experts that will assist you during a recall Enter their information and click save Media Outlets Fields Click the button to add media outlets enter the contacts information and click save Federal and State Agency personnel who will be notified in the event of a recall Field Add regulatory agency personnel that must be notified links to determine who your local contact is provided Add by clicking the button and adding them Click Save and Next If you are regulated by the USDA stay on the USDA tab if you are regulated by the FDA select the FDA Tab Launch USDA Recall Plan Field In the USDA tab select if you want to use the USDA recall plan If you do you can launch it either to view or to print Upload Recall Plan Documents Field Click the button to upload recall plan documents You can type in additional information that will print at the header of the FSP recall plan Click Save In the FODA tab select if you want to use the FDA recall plan If you do you can launch it either to view or to print Click the button to upload recall plan documents You can type in additional information that will print at the header of the FSP recall plan Click Save Page 61 of 79 This material is protected by US and international Copyr
120. se FSP to create your plans and then print them and then sign them you are exempt from the title 11 requirements the printed and signed copies are the official documents of record Many people want to have a single place where everything is and FSP meets that need regardless if it is the sole repository of your information or if it is the interface tool just used to create you food safety program Key Point to using FSP One of the keys to using FSP is to take your time and get the right data in Government regulators want to see what your thought process was when you designed your program In FSP you will capture that information as you enter data into the applicable fields we recommend that you share your decision document with them along with the hazard analysis and HACCP plans themselves The decision document is extremely large we recommend that it be shared electronically and NOT printed as a typically establishment with 4 HACCP Plans can have over 500 pages in the decision document In the next maintenance update we are going to give you the option of turning off portions of FSP that you don t use for example Animal Food If you already have a written food safety program and just want to get it into the software you can copy your information directly into FSP to quickly generate your documents by copying and pasting the text and then attaching supporting documents You can also contact us about our data entry service There are se
121. sesesasaeeeeecssseseaaeaeeseseessesnaees 33 REASSESSIMEN m 33 Reassessment at six months eere pete eene eee re rep e aan aa ae Pens e Renee slide tuo renean Pe ERREUR 33 lu du 33 Product Trace Back in depth eene een nnn nennen tana nass eE aree assa a Ea Nenen saa ga nis 34 Figure 1 RECEIVING recordi eerie tote pode Pi e ore e eek eee deed deae Eege tenemus 35 Figure 2 Batching records e ned de tete m as ies f Eire b Den twee te ie ener tei tie ERU 36 Figure 3 Shipping RECOM MR m 36 Figure4 Inedible recordi EE 37 e ET E 37 D Eege 38 Se ale 38 4 Spilliage Waste coiere eterne casa tet idee tado dai ene Rea ade coettaundusvsedecose EO RE ud ec Todo a d Rd 38 DRenrIcueumeee eE 38 Step by SEP instPUCtlODs ioiee riore roo eaae to pene ere dore x eas a ead suspen eue adesto guns V s eges ee TEENE A ER E ETTE e yea gs 39 Registration eese eege ed ee eege ee EA 39 ell 40 Food Safety Plans iis iecit cu eee peec cce repair a etes etre dieses ee ed coud sducdeaceavodds Passive reir NP esed ren 41 enu EN 41 Prerequisite lee Lu EE 42 Preventive Controls coeete essiensa aiia aa ea aaa aaa ia a e E 42 Add a Ancillary EI 43 alte tees vestvaguasnscgunaatecasusdad Fezsteshagquaat insu seeu lt aeeaated fessyessegeuedsuoevadh eaateagea
122. ss If you are unfamiliar with HACCP or haven t had any refresher training in a while we recommend that you read over the HACCP refresher module that is in this user manual before you start entering your food safety information To fill out the flow table form please print the form found in the Before you Start section and then walk your processes this means identify the different process steps that you take to manufacture your products you can skip this if you already have a HACCP Plan We recommend that you start at your receiving dock and work your way to your shipping dock You want to identify every step in your process Later you will consolidate these however each step and location will be entered into Food Safe Pro FSP this will allow you to create a flow diagram to be used in sampling and other modules in the program An example is attached TM As you navigate your way through Food Safe Pro the help system is available by left clicking the button more detailed help is available by right clicking the button You can turn the help system off at the top of the screen when you no longer need it TM Again thank you for purchasing Food Safe Pro Sincerely Andrew A Lorenz Andrew Lorenz Senior Consultant DND amp Associates Consulting Group LLC We R Food Safety Page 1 of 79 This material is protected by US and international Copyright laws All rights reserved den PA N wy The Home of We
123. supervision You can add additional comments to the right in the remarks area You will put in the date of the last audit and the program area that covers the audit such as a Self Audit GMP prerequisite program etc Specific Requirements are found in the resource folder that came with FSP and can be printed from the printing module Click Save amp Next you will go through all of the screens for animal feed if they do not apply you can skip them until you come back to the main screen that has the GMP Name effective date etc fields Click the sign button Select the person with the authority to sign the document Next click the Exit Animal Feed CGMPs button to close the Feed GMP Page 49 of 79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Allergen Control 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 Next click the Allergen Control Program in the main left navigation screen Prepared By Field Enter the person who prepared the program Effective Date Field Enter the effective date Reason Modified Reassessed Enter the reason the program was modified or reassessed Select the allergens that you use in your facility then select the date you received label approval USDA regulated then enter the date you recei
124. t 2 That you enforce a strict security policy no one should share passwords Each user must have a unique user name and password You must have a written policy about information security that clearly states that passwords are not to be shared In addition FSP includes IT security as part of the Food Defense Plan 3 To insure integrity of your system depending on the system you use you can purchase a program that will lock the clocks on your computer However because we don t believe that purchasing additional software makes sense you can also just set your computer clocks to use internet time We are also building a free update feature that runs in the background FSP will ping our servers and the national clock and will use the official time NIST to record dates and times By using the NIST NTP Network Time Protocol to time date stamp your signatures and entries you meet Title 11 requirements for data Page 110f79 This material is protected by US and international Copyright laws All rights reserved K EA Ge DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 integrity In the event that you don t have an internet connection the system defaults to using your computer s internal clock FSP will detect that there is a difference between your computer clock and the official time It will then notify you so that you can update your internal clock This update is expected to be published i
125. t addresses specific both to USDA and FDA regulated facilities The end product is your allergen program Specific cleaning and handling procedures will be captured as either GMPs Ancillary SSOPs and or Preventive Controls You will link to these in the Allergen Module Getting started with RTE LMcontrol We have designed the RTE LM program using the USDA s compliance guidelines as well as utilizing FDA requirements The format we decided to use was the USDA s as it is the more comprehensive and hence meets the requirements of the FDA also The basic gist of it is that you determine how you control LM in your products The Compliance Guideline is in the reference library Do you use both an antimicrobial agent and a post lethality treatment If so you are alternative 1 You will have addressed the adding of an antimicrobial agent in the HACCP Plan SSOP or a GMP If you used a post lethality treatment you will have identified it in the HACCP Plan Those documents will be your references If you just add an antimicrobial agent or just a post lethality treatment you are alternative 2 Again you will identify what program you use to control it however you will also answer some questions like how many packaging lines do you have how many tests per line do you take the frequency etc You will also answer questions concerning environmental testing to include how many samples locations etc You will have the ability to attach your test and hold proce
126. t HACCP teams must consider is the capacity of the plant to take corrective actions when monitoring procedures reveal that there have been deviations from critical limits When monitoring procedures show that there has been a deviation from a critical limit corrective actions need to be applied to all the potentially noncomplying product This usually includes all of the product produced since the time of the last successful monitoring procedure result So if your monitoring procedure was to perform a physical check on arriving product and your team decided to do this only once per shift a deviation from the critical limit would mean that you needed to apply corrective actions to all the product which had arrived during that shift Another matter for your HACCP team to consider when they are deciding on what should be the monitoring procedures and how frequently they should be performed is the need for rapid real time feedback Generally physical and chemical procedures are preferred over microbial approaches for monitoring because they provide more rapid feedback Monitoring procedures need to be well planned and effective because of the potentially serious consequences of loss of control Employees monitoring CCPs should be trained in the technique the monitoring procedure to be used to monitor each preventive measure or control They should fully understand the purpose and importance of monitoring and accurately report monitoring activities and
127. t correctly and you reassess it anytime there is a change Before we go any further please review some of the definitions we are going to use DEFINITIONS CCP Decision Tree A sequence of questions to assist in determining whether a control point is a CCP Control a To manage the conditions of an operation to maintain compliance with established criteria b The state where correct procedures are being followed and criteria are being met Control Measure Any action or activity that can be used to prevent eliminate or reduce a significant hazard Control Point Any step at which biological chemical or physical factors can be controlled Corrective Action Procedures followed when a deviation occurs Criterion A requirement on which a judgment or decision can be based Critical Control Point A step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level Critical Limit A maximum and or minimum value to which a biological chemical or physical parameter must be controlled at a CCP to prevent eliminate or reduce to an acceptable level the occurrence of a food safety hazard Deviation Failure to meet a critical limit HACCP A systematic approach to the identification evaluation and control of food safety hazards HACCP Plan The written document which is based upon the principles of HACCP and which delineates the procedures to be follow
128. t covers the anti microbial agent Click save and next Enter your annual production volume If you are regulated by the USDA enter the date you last reported your volume the set reminder will not work in L1 Select what you test your product for Add Product after the for Enter your product testing frequency Enter the conditions that result in test and hold Attach the document that supports your test and hold procedures for example the compliance guide Enter the testing methodology that your laboratory uses to test your product Attach a copy of the lab kit insert or other supporting document Describe the sample collection procedure Attach support for your sample collection procedure Attach any other supporting documents Describe any other Validation that you use Click Save and Next What Alternatives do you use Field For Alternative 3 check the alternative 3 box Alternative 3 Products Field Click the button to add the specific product produced that is covered under Alternative 3 You can also add the product SKU Page 520f79 This material is protected by US and international Copyright laws All rights reserved AN ELA Ge 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Click save
129. these modules are turned on and give you greater control Page 14 0f 79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Validation Validation is the act of designing and testing your system to make sure that you produce a safe product by controlling potential food safety hazards Both the USDA and FDA have documents about validating that are available in the resource folder in Food Safe Pro Validation starts when you start designing your system because as you look at your system identify hazards develop controls etc you are in fact reviewing scientific support and your experience against what you can and cannot do Those documents are the basis for your validation plan There is more detailed information concerning validation later in this document and in the resource folder Some of the key points you need to be aware of immediately are that when you select supporting documents they need to be as close to your actual process as possible Selecting a scientific study about protozoa survival in the ocean when you are worried about mold growth on beef jerky doesn t pass the common sense test Some good sources of information are compliance guidelines and to a lesser extent peer reviewed journal articles challenge studies subject matter experts and modeling programs Please be cautious when using journal articles they need
130. tify them here Click save repeat as needed to enter all products covered under this HACCP Plan Process Steps Covered Field To add process steps click the key Step Label Field In the step label enter the step for example Prepare ground for planting or receive raw meat Step Description Field Step Description Add a detailed description about the process step include relevant facts concerning the location or event Include the overview of the documentation you reviewed to determine if there are hazards associated or not Chemical Physical biological or Radiological You will select no if there is no hazard identified the system will automatically enter None Identified in the block If you have identified a hazard select yes and a pop up window will appear that will take you through a series of screens Selecting yes to a hazard Screen title is Hazard Type and the type of hazard Hazard Identified Field In hazard identified put the specific hazard you have identified Reason for Decision Field In the Reason for the decision describe in detail why you consider this a hazard Controls in Place Field In controls in place list all the controls you have in place You may determine you have a hazard but due to several different controls it isn t likely to occur this may be a preventive control In the Hazard Likely to Occur block select yes or no and then in the text area describe your reason for making the decisio
131. tive Controls Delega i RE ERG RRE E HERE TE DENEN RR 16 Ancillary SSOP EE 17 Food and Drug Administration Food Current Good Manufacturing Practices FDAFCGMP 17 Animal Feed Current Good Manufacturing Practices AFCGMDsl enne nnns 17 Recall Management EE 17 Allergen Control Programs eegenen ereechen 17 Page 2 of 79 This material is protected by US and international Copyright laws All rights reserved den FPA ies The Home of We R Food Safety and Food Safe Pro RTE UMIPEOBEGAITIS iicet seen riii nieto e Ferca orte Perrin or il eee ce ect ue reve gone dE Dra a De eee Dr Ig 17 deer Te geen u ade deeed 18 Food MOI REAMEDMPUHE 18 Humane Handling AA ier otn te Eten e diet AaS e tea wee xaT ee ENEE PY ERR 18 Poultry Good Commercial Practices PGCP cc ccccssscccssssssecsessececsesseeeceesaeeecsesaeeeceesaeeecsesaeeecsesaeeeeeesaeeeeeeaaes 18 Etude Denge tot E 18 System Alerts SAS geegent genge ees utin on desea e cua aequa ster ees eessen 18 Sampling ER RN 19 System AdrninistratiOni EE 19 Printinge MORE succes utecsatedeccntucactvoaetdebsescdacndeccedensatedacetdecctaebentateendacdedaagetedacdbea ddenaescdacndeacedensatedacshie soie REN Rd i aSEY RUE 19 System Help Se SUP DONE d Em 19 Designing a food safety program iecore sie SEENEN EE REESEN ENEE AO EEEE iE eieaa 19 Gettinp Started x oin m PME SEU bU EE 19 Module S
132. to contact us We will be adding maintenance updates to the software that will be based on your feedback If there is a form you think would be useful or a function that needs to be simplified don t hesitate to contact us at support dkmiss com Page 640f79 This material is protected by US and international Copyright laws All rights reserved EA Gy DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Refresher HACCP Training for FSP L1 So what is HACCP HACCP is a systematic approach to the identification evaluation and control of production hazards based on seven principles While it is primarily a system used in the food industry it is also used by other industries worldwide The acronym stands for Hazard Analysis and Critical Control Point The system was developed in the 1950 s and 1960 s by Pillsbury NASA and the US Army to make sure food was safe HACCP is an evolving system In the United States there are two regulatory authorities that mandate HACCP for the production of certain products The USDA FSIS mandates HACCP for the products produced under the Federal Meat Inspection Act and the Poultry Inspection Act and the FDA mandates HACCP for the production of juice products Please note that the majority of food producers utilize HACCP however what is required of them under the regulations varies HACCP is also part of two other larger systems ISO 22000 and Integrated Food Safety Systems
133. to it select it and click open Repeat until all of your documents are attached Selected GMP Field In the receiving tab select you re receiving GMP prerequisite program using the down arrow Receiving Record Field Attach your blank receiving record If you don t have one you can use the one that comes with FSP The receiving records buttons will work however they will not integrate in FSP L1 Selected GMP Field In the batching tab select your batching GMP prerequisite program using the down arrow Batching Record Field Attach you blank batching record If you don t have one you can use the one that comes with FSP The batching records buttons will work however they will not integrate in FSP L1 Selected GMP Field In the shipping tab select your shipping GMP prerequisite program using the down arrow Shipping Record Field Attach you blank shipping record If you don t have one you can use the one that comes with FSP The shipping records buttons will work however they will not integrate in FSP L1 Selected GMP Field In the Spillage waste tab select your inedible GMP prerequisite program using the down arrow Inedible Record Field Attach you blank inedible record If you don t have one you can use the one that comes with FSP The Inedible records buttons will work however they will not integrate in FSP L1 Sign Field Click the sign button When the pop up opens up the person with the authority to sign selects their name an
134. u designate the QA manager to perform this and put controls in place in your shipping program that will stop a shipment from going out if it hasn t gone through the pre shipment process You determine you will look at the HACCP Paperwork your clean up paperwork and your pest control paperwork at a minimum You put your plan in place train the employees who are implementing it and review your records You are all set to go The key point to remember with HACCP HACCP is a management system in which food safety is addressed through the analysis and control of biological radiological chemical and physical hazards from raw material production procurement and handling to manufacturing distribution and consumption of the finished product For successful implementation of a HACCP plan management must be strongly committed to the HACCP concept A firm commitment to HACCP by top management provides company employees with a sense of the importance of producing a safe product Congratulations you have now gone through the basics of HACCP This training has been developed utilizing US Federal Government Guidelines for basic HACCP compliance It is strongly encouraged that all employees on the HACCP Team review this information prior to developing a food safety program Utilizing Food Safe Pro along with this training will enable you to quickly and systematically develop your food safety program For more information please contact us at info Q werfoo
135. uces and spices separately and combine them just prior to serving Where is that critical control point really supposed to be Initially you set the plan up with the CCP after you heat the chicken however while that works for the chicken you find that your sauce which is added frozen fails to be exposed to high enough temperature to kill whatever pathogen you are worried about and you get bacteria from the vegetables that are able to survive because the frozen sauce keeps them from being heated to a lethality temperature Your system is not valid and if you hadn t gone through the validation process you would have potentially served a very dangerous meal You determine that after some adjustments you need a tempering step for the sauce so it is added as a cooked liquid instead of froze cubes you move the location of the Page 26 of 79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 monitoring to the final combined product temperature and suddenly the process works your system is now valid So how did you figure it all out Did you spend a lot of money on lab tests No you took your scientific support that says bacteria grows on vegetables and meat and you used the critical operating parameters identified in the scientific support you made sure that you took temperature tests throughout your entire process That s how you found
136. ue that has an impact on the other programs and food safety Getting into the HACCP Process The next step is HACCP process As you work your way through the module you will be asked questions such as what products do you make what is your process etc As you answer the questions and put your data in you will often make a determination that you don t have a hazard because of something you do You will also relook at the SSOPs GMPs etc and make changes while it seems like a lot of work in the end it will pay a huge dividend in time saved At the point you are making a decision as to the impact of your ancillary programs Is it a GMP something that you have in place that may impact on your ability to produce a safe product Or is it a program you do for a customer that is strictly a quality control issue Is it in fact a preventive control For example if you have a metal detection program because of a customer requirement it may only be a pre requisite program However let s say the reason you have a metal detection program is because you have found metal particles in your product it s in the realm of a safety concern however it doesn t rise to the level of a hazard that is reasonably likely to occur now it s a GMP one that reinforces that your decision that the hazard isn t reasonably likely to occur Maybe you require your suppliers to run your raw material through a metal detector prior to you receiving it and that they have to send certifi
137. ur stunning procedure Field Enter a detailed description of your stunning procedure Attach Documents Field In the document library Attach documents click on the library icon click button and navigate to the place on your computer where you have stored the file highlight the file and click open Repeat until you have added all of the supporting documents that you used to in your decision process What is our procedure for inclement weather Field Enter a detailed description of your procedures for dealing with inclement weather Attach Documents Field In the document library Attach documents click on the library icon click button and navigate to the place on your computer where you have stored the file highlight the file and click open Repeat until you have added all of the supporting documents that you used to in your decision process How often do we check animals that are kept overnight Field Enter a detailed description of your animal checks Overnight Attach Documents Field In the document library Attach documents click on the library icon click button and navigate to the place on your computer where you have stored the file highlight the file and click open Repeat until you have added all of the supporting documents that you used to in your decision process Page 56 0f79 This material is protected by US and international Copyright laws All rights reserved AN ELA Ge 349 350 351
138. ve and close Repeat until all hazards that have been identified are complete From step 93 to 152 Page 47 of 79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 153 After all hazards have been identified as either yes or no for chemical physical Biological or in the case of FDA regulated Duel Jurisdiction regulated facilities Radiological click save process step 154 Continue adding process steps until all process steps are complete If you have to take a break click the save button to save your work 155 Prepared By Field After all process steps have been added and you are ready to turn the HACCP Plan on or make it active enter the person s name who prepared the document 156 Sign Field Then click the Sign Button 157 The person who is signing must be the person logged into FSP to sign and meet the requirements of Title 11 If Title 11 doesn t apply to your facility and you intend to print and sign the printed copy use the person logged on to FSP for the signature 158 Click Sign 159 Now click the Save button The plan is now active FDA Food CGMPs 160 FDA Food CGMP s Field Now click FDA Food CGMP s on the left side navigation menu 161 USE Standard FDA Regulation Field FDA CGMP s are regulatory requirements as such if you are regulated you must follow them To make it easier to incorpo
139. ve any glass in your facility ie it came from a supplier How do you know what supplier you used to make the bakery item It all comes back to being able to quickly and accurately track your production from your suppliers to your customers and vice versa A simple way of doing it is to create a record keeping system You assign a lot number to everything that you receive for example Flour 01012013a Flour 01012013b etc on a receiving log Figure 1 and then tag each product with that lot number Each of these lots is then correlated to the actual supplier of the product You can even use it as an inventory card and document what you used it in This helps you if your supplier calls and says they have a problem with the product it will help you to quickly figure out what products that you produced that may be contaminated see figure 1 for an example Page340f79 This material is protected by US and international Copyright laws All rights reserved e DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 You then maintain batch sheets of what you produce again tracking ingredients that are used See figure 2 for an example The next record you need is the shipping record On it you capture what you shipped and to whom See Figure 3 for an example The final record you need is a spillage waste record When something is thrown out you want to be able to show the regulator that your numbers match or they are go
140. ved the letter of guarantee from your supplier that the allergen component was made utilizing a food safety program that the product is safe for intended use Click Save amp Next If you don t have a letter of guarantee request form you can generate one by clicking the button You can also generate a request for third party audit findings Answer the three questions yes no or not applicable We recommend that you have a customer complaint GMP that includes reviewing complaints for potential allergen issues and that you also have a receiving GMP that includes reviewing labels to verify that the allergens coming into your establishment haven t changed without your knowledge During your pre shipment review process we recommend that review for potential issues with allergens specifically so that you don t inadvertently ship product with allergens How changes in production handled between allergen formulation and other production field are Give a detailed description of what sanitation and other measures you implement to preclude cross contamination Please remember to address airborne contaminates Letters of guarantee on file field Check the appropriate box if you have packaging letters of guarantee on file button it will open a pop up window Packaging Material Field Add the Packaging material Supplier Field Add the supplier Date of Letter Field Add the date of their letter of guarantee Remarks Field Add any remarks
141. veral resource folders that load with FSP L1 regulations and blank forms are things you will find very useful Please be aware that in L1 these folders are not updated if there are changes to regulations you will have to be aware of them and load them into your program as applicable On the main screen there are links to the FSIS export library the We R Food Safety web site the support site for FSP and scrolling links to our allied businesses and organizations this can be turned off FSP modules are integrated with each other the same as your food safety program For example you may have a pre requisite program for receiving raw material It s your own good manufacturing practice you use it for a lot of reasons to make sure your inventory is correct that you are receiving what you order etc FSP lets you link this program to others such as trace back recall management you hazard analysis etc When you are working in the HACCP module there are a couple of things to keep in mind Until you sign the HACCP Plan it is in draft mode When you sign a HACCP Plan it becomes active this is the plan you are using in the plant As soon as you modify an active plan a copy becomes a draft An additional copy is made and is moved into the Archive File and cannot be modified it is read only This helps you meet the record keeping requirements of the USDA and Title 11 requirements of the FDA You will be able to have a clear concise audit trail of y
142. ying to break into Food Safe Pro they will likely figure it out Using something like 05AbO1cD2013 creates a password that is very hard to break however it is sequence based so there is some vulnerability If you study it you will determine that it is a date May 1 2013 with the abcd used in a sequence starting and ending with capital letters One way to make it stronger is to add unique characters such as I 96 etc If you add them to the front and back the password becomes much stronger and still lets you have something you can remember for example if you set your password on the date you saw your first live concert and used this method you might have a password like this 07Ab23cD1973 9 Six months from now when you need to change your password you can pick the date of the next concert you saw and move everything else up so you end up with something like this 11eF14Gh19733 it s very hard to figure out however you as the owner of the password will always remember the dates July 23 1973 and November 14 1973 and you will also remember the sequences Again using anything that is not totally randomized creates vulnerabilities however whatever method you use needs to be 1 Strong and 2 easily remembered Page 120f79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Something to keep in mind is that if you u
143. ystem and it takes a variety of different kinds of knowledge and experience to develop a good system If your company has only a few people in it they may all need to be on the HACCP team because they all probably have multiple roles and responsibilities in the company s operations You should consider including on your HACCP team some resources which may be outside your company Describe the product and its method of production and distribution identify the intended use and consumers of the products The next preliminary step to take is to have the HACCP team describe the product s and their methods of production and distribution The important thing for them to keep in mind is that they need to include every step in the process The following questions should be answered when you describe the product What is the common name of the product 2 How is the product to be used 3 What type of packaging encloses the product 4 What is the length of shelf life of the product at what temperature 5 Where will the product be sold Who is the intended consumer and what is the intended use 6 What labeling instructions are needed 7 Is special distribution control needed Regulatory requirement for USDA FSIS inspected facilities After your team has described the products they can move on to the next preliminary step Develop and verify process flow diagram s Page 660f79 This material is protected by US and international Co
144. zards are living organisms that can make food unsafe to eat Biological hazards may be bacterial parasitic or viral Biological hazards are frequently associated with the raw materials from which meat and poultry products are made including the animals and birds which are primary components However biological hazards may be introduced during the processing of meat and poultry products from the people who are involved in the processing from the environment in which the foods are processed from other ingredients in the products or from the processes themselves Identifying the biological hazards to which your production processes might be subjected is clearly a difficult and important task one that requires all the expertise that your HACCP team can bring to it Currently there is a great deal of emphasis on microbial hazards associated with meat and poultry products Some of the major pathogens that may be associated with meat and poultry products are Salmonella Campylobacter jejuni Escherichia coli 0157 H7 Listeria monocytogenes Clostridium botulinum Staphylococcus aureus and Yersinia enterocoliticalfauy 2 Chemical Hazards Page 67 0f79 This material is protected by US and international Copyright laws All rights reserved DKM Integrated Software Solutions LLC 2015 Wilson Street DSDS Menomonie WI 54751 Chemical hazards may be the result of something naturally occurring in foods or added during the processing of foods Harmful ch

Food Safe Pro! L1 User Manual

Contents

Download Pdf Manuals

Related Search

Related Contents