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User Manual - Olivia Solutions

1. 25 Preventive corrective actions cccccccssssccccsseccccssscccccsececeusececcessececeusececcuececseseseseusesecsunsess 26 CONEA O laeso E deus eU ieu td sra EN SUE UI PE EN 28 Practical usage SUCI es ossmietisohe eai dUPeniUeNEE Mal DENM E o UNE 32 Creatine a guality plan roni Scrateh aeree aE a NEEE 32 2 POM Adding a new version to an existing quality PlAN ccccceecccseecccesecceenseeeesceseueceseuecseeneeeeeness 37 Adding a plan version from another plan version cesses 40 Manufacturing cycle with quality iunii ier rover evi ent cux e so vare pra odo bed rv Es peES 42 Querying pending quality tasks ei sioi ie ot oro orba ia e akt O ed lsten busta 6 reae Ses ia aii 44 ASSIGNING Iegsuring InSEF ETTTES Saints i satur erts vas xar brute erac ELA RUE Le EU DI E RAE EU LERRA 45 Specifying instruments ina quality plan isses sciecs se vtces oe es so Co o Rue e er bee ve vecors aia 46 Instr mentsin a quality order analysiS io ree E oe aee UE be aD ever aniseed co vakt eins 48 Instruments in a quality order sample cccccesssccccesseccceesececeeeecceseuseceseuecesseeeceesauecessunesss 48 Instremnentswnhen adding individllals scsesdast te tete Lo S Ee Me Send Me Eel vestida Eco topo ai 49 Specibyinp egquipiient machiliesesec due tete dete e d bete DR Ue ete e nov bte eddie 50 Equipment machirnenialdseltief Tte dri it tol bs dete e vei du cibi tetotbu ui dec cn Ud bu A
2. Approved Implemented Closed Effective Closed Ineffective Cancelled The deadline can be changed up to five times requiring a signature in each case Once five changes have been reached the Renew action is necessary before the deadline can be extended again POM 27 Configuration PQM is designed in a modular way Businesses with very demanding regulations will use most of its functions Smaller businesses seeking maximum flexibility without compromising safety can disable some functions from the configuration page You access the configuration page from the options ribbon in the quality working area Aii Q9 ACTIONS Role Center Quality management I CRONUSEspafia S A Home gt Pa Quality Setup Ej Quality Areas es Ci Quality Analyses f3 Evaluation Schemas Intrumental Groups iq Quality Machines 8 Work Groups l1 Measurement Tools Quality Order Priority f Defect Codes Epigraphs Qualitative Specificz Evaluation Codes Reactives Group Role Center 4 Quality Plans Uncertified Quality Plans Certified Quality Plans b Quality Orders gt Preventive Corrective Actions Role Center Quality management QM Processor Activities Item Quality Plans gt ncidences Or from the Departments gt Quality menu Q T CRONUS Espa a S A Departments Quality Setup gt Departments Setup b Financial Management gt Cartera b Sales amp
3. GENERAL Plan Type Receipt Status New Quality Plan Subform Lines 98 Find Filter V Clear Filter Line No Measure Description eNo Quality Link WorkGroup Not Measure Limit Result Equipment Nominal Text Minimum Code Man Value Type Type Value Value 10000 TA 058 pH USP 1 QC Numeric 14 1 35 20000 DA IT 054 Viscosity USP 2 MCZ Numeric 0 0 LJ Signatures 6 Then proceed to modify the plan version Samples and analyses can be added changed or deleted Once the version is ready certify it so it can be used POM 39 Actions Navigate m m e Samples OneNote Notes Links Process Show Attached TSTO072 2 General Now TST0072 Modified by OLIVIA FELIP Version Code 2 Last Date Modified 05 11 2014 Description Hand made test plan Edition Description 2 Review Evaluation Schema GENERAL Plan Type Receipt Quality Plan Subforr Lines gt 9 Find le No Quality Link Work Group Not Measure Limit Result Equipment Nominal Text Minimum Code Man ValueType Type Value Value 10000 TA 058 HTTUSP ae Numeric 14 135 20000 DA IT 054 Viscosity USP 2 MCZ MCZ Numeric lt z Signatures Adding a plan version from another plan version This menu option makes it possible to construct a plan version based on any other one If it is applied to a ver
4. POM QUALITY MANAGEMENT for Microsoft Dynamics NAV201 3Rx User manual POM 1 Contents EEF ONG DION e e D E DET 4 MOE RS diBd iu esed pas cess aren MuR MM DUE EDM MUNDI E MM NM CHIMIE NM 5 eU Meli tms 7 PIA CAC i ERE 7 CEU TM Oo mem 7 SEI ec RENT 8 Pian what WHEN DUT WHO RE 9 VOSTO E 10 UTA OFCIBE eias mat RED asics DEMENS MEME EE MM MM MEE MM E EUM 11 Bec me T 12 BOT SW eS d NE 14 Related and additional Ordets TET E TTE EO 14 Cantcellihis OTCIGl S aestum na enn E dM M ee ee eee 14 Signatures security and the audit trail eee ceeeccccssececesececeeeceeeeeecceeeeseceseeneceeeeeceeseueeeetas 15 Va Ted dig A SS eds ster cosa ET Rm P 17 PU cM 19 Roco REND P 19 PCIE MING RR m 20 DEFICIENCIES CELECTSO T 20 CIBSUHg diltllb5 a Oe EIE HE S UI LED ELEM DM DEREN C IP ELM EE 20 PS VS A CS ceases es shee espa cee sas ert E E Epreuve EMI M MM NDS 22 NoHneobtroriltles ot sucsscnscnertencuentasestunsenrseuncscntcutsarsaynteonctenuuenanuscacnacdienannentenaiensanceumenenninccounes 23 Hel qe 23 HV SSC EIO ENTER OR RE RT 25 Bid e CC
5. q N A Do not apply Quality Instrumental Group Subform Instrument Code CALIBER MICROMETER STOPWATCH VIDEO Instrument Description CALIBER DIGIMATIC MICROMETER STOPWATCH Thousandths VIDEO MEASUREMENT MACHINE Sample Comments You can create as many groups as you like By sections by working groups or even by analyses a group to measure diameters a group to measure edges etc Specifying instruments in a quality plan Instruments can be specified in the quality plan This is done using the Instrument Group field of the plan lines The field displays a drop down arrow with an ellipsis alongside assistedit The drop down menu allows you to choose between predefined instrument groups Home Actions Navigate ES ES IN g e View X Delete Versions TSTO072 General No TST0072 Description Hand made test plan Description 2 Evaluation Schema DTR Modified by OLIVIA FELIP Last Date Modified 11 10 2014 Measures Lines Find Filter W Clear Filter Line No Measure Code 100 DA IT 054 Dimensional control 1 MCZ OLIVIALAB Numeric te Notes Links Status New Active Version Edition Review Plan Type Manufacturing Sample No Quality Link Work Group Not Code Man v M Instrumental Equipment Limit Result Nc Group Type Va 70 Description Do not apply WORKSHOP Workshop The choice of an instrument group assigns the instruments in the grou
6. Location Routing ManuM Pending Pending All Orders Inspect Orders Orders Samples Quality Pendin Item Quality Deviations Either of the queries can be filtered by working group warehouse or evaluation schema This is useful if the laboratory has enough volume to distribute tasks among staff t Microsoft Dynamics NAV g Actions E Related Information Home Pending Samples 2 Role Cent Sorting Table No Quality Order No Sample No Line No Type Entry Type No Columns v 2l Filter 7034951 Pending ole Center PB i Order Type Quali Item No Sample No Description Lot No SourceLot Destination Source Entry Type Decision Quality Plans yp ty P E Quality Plan Versi Order No No WIP Lot Docume Quality Plan Versions u 30 a od Routing OC000013 UM19710 1 Review and registration of MCZ self control AC00021 AC00021 Review Pending E Quality Orders oR RETA E Deviati Routing 0000014 UM19740 1 Review and registration of MCZ self control AC00022 AC00022 Review Pending Deviations E Vendor Evaluation D Routing OC000015 UM19750 1 Review and registration of MCZ self control AC00024 AC00024 Review Pending Vendor Evaluation Docs E Manufacturer Evaluation D Routing 0C000032 CI07300 2 Review and registration of CQ nitrured RPAC132 RPAC132 9 RPAC132 Review Pending Pending Samples Routing OC000066 1P23050 1 Review and registration of MCZ self control AC00144 AC00144 Review Pending E Pending Quality Orders Routing
7. Marketing gt Purchase Quality Setup ion Quality gt Warehouse b Manufacturing 4 Quality gt Third Party Evaluation gt Item Quality 0 Resource Planning gt Service Human Resources gt Administration A Home Kil Item Quality amp Incidences i Audits A Departments The module configuration page has two parts or tabs a general one and a more advanced one 28 POM me CRONUS Espa a S A Edit Quality Setup E View i e Notes Links be Goto 4 Previous Refresh Clear Filter P Next Quality Setup General Enable Quality Control Analysis Nos Evaluation Templates Nos Quality Plan Template Nos Receipt Plan Nos Manufacturing Plan Nos Purchase Q Order Nos Routing Q Order Nos Lot Q Order Nos Location Insp Q Order Nos Reanalysis Q Order Nos Advanced Lot Release Plan No Lot Release Plan Version Change Audits Status Role Change Incidences Status Role Change Actions Deadline Role Create Reanalysis Role Reanalysis Lead Time days Work Group Mandatory V CAL MEASUR QPFAB QPFAB QOPURCHASE QOROUTING QOLOT QOLOCATION QOREAN CAL AUDIT CAL INCID CAL FECHALIM CAL REANA Complementary Q Order Nos Audit Nos Preventive Actions Nos Corrective Actions Nos Incidence Nos Investigation Nos Deviation Nos Machine Nos Scrap Location Code Log Eleme
8. instrument or service must be notified and managed An analysis of how it has occurred its impact and seriousness and the actions to be taken to correct the situation is needed All these steps must be posted and documented Any restoration or incident prevention action must be stored in the system Extract from Managing corrective and preventive action CAPA in a life sciences environment IBM asset management solutions white paper POM has up to three levels of nonconformity management incident investigation and deviation Incident The incident is the entry point into the CAPA system It reflects only the detection of the problem with no conclusions for the moment Incidents can be created in the system from various origins e From a quality order when an out of range value is detected e From a sale delivery note when a customer complaint is received e Manually Whenever an anomaly is detected a problem is suspected or an improvement opportunity is seen The incident card has four parts e The header with descriptive data concerning the time and the origin of the incident e Ananalysis of the causes e Preventive actions e Corrective actions POM 23 Home Actions Navigate 3 9 amp e MB View Edit Change Create Print OneNote Notes Links Status Investigation Manage Process Show Attached INC0003 General Incidence No Creation Date 10 22 2014 12 12 45 857 Incidence Descrip
9. 51 Ehterine resus in Inalvididisa sus isi tope iret o Detur utes iebd eub mu pU ene roe omtUd UR Ute NU evens ceavane 52 WithobltAA Cause si rie E eae cer AER ane Conte ca NW broma ITI meds Les UM IM UTE 52 WERAQ NN PR EMT 52 Comments associated with plans samples and orders cccccceesecccceeecceeesececeeseceeeeeceeeeees 53 igiene HC 57 BO cs ossia rt Ata een ree thn errr rent eon erent ee ren ose testu er ine reenter ad cern ere eer cen inia reer ud 59 Assigning AQLs to quality Plans c cccscccccsssccccessececceseccceescceeeeseceseuecesseneceeseesecessuaecessenecss 64 Posting samples and decisions WIth AGL opacis o eg aei o qe pes deve E E Ea que Lo debo quos 66 POM 3 Introduction The quality control program provides the tools necessary for analysing and evaluating the quality of suppliers manufacturers and products Product quality is applied from the time when goods are received from a supplier or product manufacturing begins The processes involved are e Reception of raw materials purchased from other companies e Manufacture of finished and semi manufactured products e Subcontracting Checks not triggered by logistics processes are also applied such as warehouse inspections or periodic quality orders All posting actions are logged These actions normally require the signature of a user with the correct authorizations Security management in PQM is very flexible making it
10. Clear Filter Description Damaged packing After the deadline Reference Classification Investigat The header contains different descriptive information about the origin of the audit The types of origin can be product management system supplier manufacturer and other As in the quality plan the Status field manages its lifecycle Being Prepared Implemented Entered Being Followed Up or Closed PQM 19 Audit lines The lines represent the items evaluated Lines can be added manually but normally an evaluation template is used It can be seen that the above audit is based on the AUTOOO1 template Each item can be assigned a score between 1 and 10 The meaning of this score is defined on the same line For example a score between 1 and 3 for packaging means fragile A score between 8 and 10 means robust The scores can be weighted using the weighting field Depending on the scores and the weighting of each one a final audit evaluation header field is calculated This is a field for information with no further implications Deficiencies detected As a result of the implementation of an audit deficiencies are detected and added at the bottom of the page The deficiencies are coded in an attached table When deficiencies are added to the audit existing codes can be reused or new ones created Once the deficiencies detected have been specified the next step is to create an investigation for each of
11. Filter Schema OLIVIA FELIP DT GROUP OLIVIAJAKUB LAB GROUP OLIVIAATONY LAB GROUP Decisions not assigned to a working group will be visible to all users It is possible to change this behaviour by enabling the Mandatory Working Group flag in the quality configuration When it is enabled the system requires that the working group is informed in all decisions A user without a working group will be able to see and manage all decisions This role is normally reserved for supervisor users The Working Group field also appears in the sample in both the plan and the quality order This field is not used for distributing tasks Here it operates in a way similar to the evaluation schema it makes it possible to establish different levels of requirements for signing actions So for example we might have a sample for which higher roles are required than for the others in order to post or change its results modification after posting A technical POM 17 management group will be assigned to this sample while a group with fewer restrictions will be assigned to the others mimgxmim JB WI sk New View Edit Delete Show Show as OneNote Notes Links Refresh Clear List List aslist Chart Filter New Manage View Show Attached Page Type to filter F3 Code v gt v Quality Work Group No filters applied Code a Description Blocked Certify Sample Review Sample Approve Review Approve Post Elements Approve Modify After Post Role Ro
12. No filters applied Lg d a Notes YE Clear Filter Line no View dit elete how Ow as ling Equipment Line Elements Out 1 19 11 2 19 11 List List astist Chat ljUnks iHi Find ency Co OfRange 1129 11 30 4 CORE G jew Manage View Show Attached rage 50 No 3 ASEH Quality Comments Type to filter F3 Comments v wv m No OK OK 13 Filter 7034761 QR00006 9 iii 7 4 2 1 4 43 8 coMMAE SER S21 9 A A 10 1 8 11 1 5 Line Information Lot Quantity Equipment Last user amp date Comments from Plan Check Mycrona calibration before measuring Firstly there is the possibility of entering comments linked to the quality order analysis These are comments on the specific measurement which are stored only in the quality order To enter the comment go to the analysis you want and click on HOME gt Line Comments Edit Result Input Matrix QR00006 sample 1 Ez HOME IONS NAVIGATE f ES A T a 2p S x it Sample bhow Show Only View Ed Post Show Showas Refresh Clear Find Comments amp Comments All Mandatory List Results Chart Filter Result Input Matrix Type to filter F3 Description gt No filters applied Line no Description Measure Nominal Minimum Valuf gm 1 2 19 11 Value Type Value 2 11 30 4 CORE 2 9 V 29 28 CRONUS Espa a S A o 5 91 52 H11 A 152 13 a X N Ey Lu 3 amp 3 Refresh OK 6 13
13. OC000067 1P23530 1 Review and registration of MCZ self control AC00145 AC00145 Review Pending 5 All Pending Tasks Routing 0000085 CI01440 2 Review and registration dimensional visual RPACO31 9 RPACO31 Z RPACO31 Review Pending i Routin OC000243 INPUOUO 1 Review and registration of the labelling RPAC163 1 RPAC163 Review Pendin Evaluation Templates g g Assigning measuring instruments In a heavily audited environment it must be possible to obtain information about the instruments used in each measurement The module supports this level of stringency but at the same time offers facilities so that entering this information is quick and convenient This is especially important when working by individuals as the number of times this information has to be entered many times One of these facilities is particularly useful entering the instruments once and offering the same one every time individuals are added All you need to do is enter the changes Throughout this section it is important to differentiate between measuring instrument and equipment machine The instrument is the class clock gauge etc The equipment machine is the instance IM 024 IM 029 etc The measuring instruments can be organized in instrument groups A instrument group represents a set of instruments to be used for a specific measurement POM 45 iments Administration Application Setup Intrumental Groups 4 Actions Code Description
14. The investigation card is almost identical to the incident card It has the same four parts As well as identifying the causes the investigation categorizes the nonconformity depending on the risk e Incident if it has occurred in non GPM critical processes The investigation is closed without further consequences e Minor Deviation when it occurs in GMP processes but does not affect product quality critical operations or instruments associated with the manufacturing process e Critical or Major Deviation in other cases If the investigation determines that the nonconformity is a deviation minor major or critical a deviation document is created This may be done in POM only from a closed investigation card GMP critical processes are those which have an impact on patient customer safety or on final product quality Deviation The deviation card is also similar to the incident and investigation cards It is possible that the investigation may have classed the nonconformity as a deviation but not been able to fully determine the causes For this reason a new investigation which will probably be referred to other people or departments can be created from the deviation card POM 25 Home Actions Navigate DA M kh w M Be Change Create Prnt OneNote Notes Links View Edit Status Investigation New Mana
15. a production order is launched As manufacturing continues and outputs of successive operations are posted related quality orders are created These are linked together In other words in the end a production order is associated with a set of quality orders e Lot Release orders These are linked to a physical lot already manufactured They are created automatically when a production order is closed one for each lot manufactured PQM 11 e Reception orders These are linked to a batch of raw material received from the supplier They are automatically created when the purchase order is posted Subcontracting is not covered here For that a routing order linked to the subcontracting operation is used e Warehouse inspection orders These are created manually from Navision s lot card The order is linked to the lot which goes into quarantine from then until the order decision It is not possible to create an inspection order on a lot in quarantine because that means there is already another quality order on the lot awaiting a decision e Reanalysis orders These are used for periodic quality and are generated from the reanalysis worksheet Actions F Ji N ee New Edit Delete Propose Create Show as Notes Links List Lines Reanalysis Chart Quality Templates Reanalysis Journal Type to filter F3 Item No ima VP Uncertified Quality Plans Sorting Enty No v r No filters applied Certified Quality Plans Cl
16. in some actions outside quality such as posting the production worksheet POM 15 Under no circumstances is it assumed that the action is carried out by the logged in user A dialog is shown describing why the signature is being given and prompting for a user name and password Validate Credentials Change condition Quality Plan 10 02 03 User Lf Password s The dialog forms part of an add in designed specifically for using Windows security APIs so the password is not saved in Navision nor does it travel between applications The add in merely checks the user name and password against the Active Directory and returns the OK to Navision Navision then checks whether the user name entered has the role required for the action assigned to it As well as the signature dialog a dialog is displayed so that the user can enter comments associated with the action This dialog is optional it can be disabled by configuration This differentiation between the session user and the signing user is a regular requirement of control authorities FDA EMA It also allows a user to complete a specific task requiring higher authorization getting his her superior to come and sign Once the action has been authorized a log is saved in the audit trail This uses the standard Navision change log function completed with additional information such as comments 16 PQM Working groups Using working groups we can divide tasks betwe
17. it is the first individual this suggestion comes from any of the three places explained above plan sample or quality order analysis If it is not the first individual the suggestion is the assignment made for the previous individual PQM 49 Specifying equipment machines The specific equipment or machine used in the measurements is given on the same page where the types of measurement instrument are entered in the Machine Code field It is not a free text field The drop down menu allows you to choose between registered equipment of the specific type of instrument Y A aic d c Xx ff Delete Show as Notes Links Refresh Clear Find Chart Filter Quality Instruments Entry Type to filter F3 Instrument Code gt Filter QR00006 1 Machine Code Instrument Instrument Description tarting Date Ending Date Comments Code MYCRONA MYCRONA v PALMER PALMER CORR MYCRONA MYCRONA E 493 MEASUREMENT MACHINE MYCRONA OK x CRONUS Espa a S A v Equipment machines must be entered on all existing lines If a particular type of instrument is not used for a measurement the whole line must be deleted Example there cannot be a CLOCK line with the Machine Code field empty As described above it is possible to enter the instrument types in different places in the plan in the quality order sample analysis or when adding individuals Equipment machines can also be specified in di
18. letters corresponding to each lot size This page corresponds to table 1 of the example above Cae View List it Show as Chart Lot Size Letters Matrix 7 Type to filter F3 Lot Size Lot Size 1 00 A 151 00 B 281 00 C 501 00 AQL Master Table ATRPRINC And finally the acceptance level matrix which corresponds to table 2 of the example above As mentioned above this matrix offers two types of information sample size and acceptance level after how many bad units do we reject the whole batch To find out the sample size select it at the bottom below the AQL code and inspection type Each letter corresponds to a sample size To find out the acceptance level we also need the AQL column This value defines how strict we are For example for an AQL of 0 4 letter L we accept that there are 3 bad units within the sample of 200 62 POM Acceptance Levels Matrix LLLI COE Sorting AQL Master Table Inspection Type Letter v 2l No filters applied Letter Sample Size 0 01 0015 0025 0 04 SS S 3 00 4 00 8 00 13 00 20 00 eo OQ b Ww hh WM Boe r a WW N M We v B c D E F G H J K L M N AAL MaserTabie v mapeto POM 63 Assigning AQLs to quality plans The following AQL fields are assigned in the quality plan header AQL sampling table for example IMPCOMP100 I Inspection level code for example Inspection type for example Normal 4 Ed
19. or may not be by individuals HOME Gee A d s _ pt RA T ih New View Delete Notes Links Refresh Clear Find List Filter Quality Plan Sample Type to filter F3 Sample No gt v Filter PROD02 Sample Description Status Work Group Sample Size By Sample Type No Method Element 1 Raw material reception New GROPI v Percentage General Plan what when but who Going back to the standard definition above the analyses specify what procedures and associated resources must be applied When is defined using the samples there can be a sample for each operation or just one at the end of manufacturing The same thing happens with the receipt of raw materials there may be just one sample or the tasks can be divided into several document review identification purity analysis etc The question of who applies the procedures still needs to be answered To do this the quality plan offers two features the evaluation schema and working groups PQM 9 The evaluation schema is a plan header field establishing authorization requirements for the module s different actions There is a detailed description of the evaluation schema later in the section Signatures security and the audit trail The working groups allow tasks to be divided between laboratory staff There are also more details in the Working groups section Versions There is the possibility of creating diffe
20. possible to implement various access levels which can be changed in time The module has audit management allowing supplier evaluation both for initial approval and routine checks The scope of the audits has been expanded to also include the evaluation of manufacturers and internal management systems Finally a CAPA system is incorporated for managing nonconformities Its main feature is nonconformity management based on corrective and preventive action allowing the monitoring and assessment of compliance with regulations This area deserves its own chapter in this manual 4 PQM Working area PQM contains a specific working area for quality staff providing quick access to all the module s functions Aii Q v 5 CRONUSEspa a SA Home gt e s M ACTIONS 4f Quality Setup E Quality Areas iy Measurement Tools Quality Order Priority Defect Codes 4 Option Codes 333 Inspection Letter A Sam E Certification Authorities GQ Quality Analyses 4 Evaluation Schemas Qj Intrumental Groups Epigraphs t AQL Master Table Pk Inspection Level EA Acce Evaluation Codes ifs Quality Machines 8 Work Groups Reactives Group Qualitative Specifications E AQL Columns iiti Inspection Level Lot Size Navi Role Center Quality Plans Uncertified Quality Plans Certified Quality Plans Quality Orders Item Quality Plans Preventive Corrective Actions Role Center Quality management QM Processor Activities ncide
21. result is mandatory e The working group it will be assigned to e Additional information comments AQL information etc POM 7 The list of possible items to be measured analyses normally remains stable This list is loaded into the system on initial implementation but it is possible to extend it later Some properties can already be established in the analysis itself and these are transferred to the plan line They are as follows e The type of result expected numerical Boolean text value chosen from a list of options etc e Whether the entry of a result is mandatory e Working group HOME NAVIGATE OTE EA XX Mists Xk New View te Notes Links Refresh Clear Find List 3 t Filter Type to filter F3 Code v Quality Measures No filters applied Measure List Code Comments Instrumental Work Group Value Type Group Numeric No APPEARANCE External appearance Value List OKNOOK No PURITY Purity Numeric No Samples Not all the analyses are measured at the same time or by the same staff We group them into samples which means we can differentiate them There can be as many samples as needed Similarly within the sample there can be as many analyses as necessary There are three important characteristics defined in the sample how its size is calculated what type it is and whether or not it is by items In terms of size it can be a full sample the whole batch is analysed a percentage of the batch si
22. them There is an action to do this automatically the Create Investigations button Investigations follow an independent course and can result in associated preventive and or corrective actions Their operation is described later on in this manual Creating audits There are three different worksheets for creating audits automatically These worksheets suggest audits for suppliers manufacturers and management systems with assigned evaluation templates 20 POM Actions Z2AXxX SE x uu m og Edit Delete Propose Create i OneNote Notes Links List Lines Audits New Manage Process Show Attached LICLNMF C n Sorting Source Type Source No 2 l No filters applied Man System Audit Journal B E Source Type Source No Source Name Description Template Template Starti Hs Res apiid ate Eval No Eval Status Management System 2 AuT0002 Certified 10 13 2014 10 22 2014 The worksheet contains two buttons one to suggest audits to be created and the other to create the audit documents The worksheet s suggestion can be changed before being accepted E ga M d how Showas OneNote Notes Links Jastist Chart New Manage View Show Attached Evaluation Templates Man System Audit Journal Type to filter F3 SourceType gt Management Systems Sorting Source Type Source No 2l No filters applied Vendors a Source Type Source No Source Name Description Te
23. 8 V 138 13 3 b CD Y Clear Filter New Delete OneNote Notes Links 7 4 2 V 42 E i Find 43 8 32 V 32 3 Ne w Attached Page 9 HEX 3 G9 1 4 V 3 2 9 Quality Comments Type to filter F3 Comments v E 10 1 8 V 18 R Filter QROO006 9 11 15 V 1 5 1 4 Line Information b jo f pant LI Max Tol 2 95 3 02mm Su E Lot Quantity z meCommea M ETO A cee nes d J 3 02mm Equipment E 493 Last user amp date Comments from Plan Check Mycrona calibration before measuring Meanwhile there is also the possibility of adding comments associated with the sample and the quality order These are comments on the specific measurement which are stored only in the quality order 54 POM To add comments to the sample E ACTIONS NAVIGATE a o X E Sample Line Show Show Only Comments Komments All Mandatory Result Input Matrix Line no Description 4 CORE 92 9 5 91 52 H11 6 13 8 7 4 2 8 3 2 9 HEX 3 G9 1 4 10 1 8 11 15 Line Information Equipment E 493 Last user amp date E E m ce LA View Edit List List Manage Measure Value Type V c eE c x Line Comments Post Results Process Max 3 02 Edit Result Input Matrix QRO0006 sample 1 F Iis o9 Xd Show Show as Refresh Clear Find as List Chart Filter View Page Edt Delete Show as List list Chart New Manage View Quality Comments Comments P
24. 96514 Item uos 002 EC 222 2 0 2 00 2 200 00 0 00 0 00 On the right it does not fit into the screen shot information on users is shown along with the time when the posts were signed POM 57 Finally there are two special traceability functions for routing orders From the routing order card Forward Traceability shows later orders Backward Traceability shows earlier orders It is also possible to launch Backward Traceability from a lot release order lt HOME ACTIONS NAVIGATE S ER Fi Evaluation Schema Li my Tal 3 S d a Fa XY A l GA identification H wy X nh oA Show Show as OneNote Notes Links Refresh Clear Find t hart Filter Edit View General Post Navigate 9 P d G mples Sample Retention Analysis as List C cess Report View Show Attached Page Typetofilter F3 Level gt v No filters applied Quality Order Tracking Quality Quality Order No Order No QR00001 QR00001 QRO00001 QRO00001 Level No Entry Source Source Judgement Source Source Lot Destination Lot No Previous First Source Code Document Doc No IP Lot Type No Postin Routing LZ000002 LZ000002 Complies 1 28 2015 LZ000002 LZ000002 LZ000002 Complies 1 28 2015 LZ000002 LZ000002 LZ000002 LZ000002 QR00001 1 QR00001 2 QR00002 Routing 2 QR00003 Routing LZ000002 Complies 1 28 2015 58 POM AQL AQL means Acceptable Quality Level and represents the maximum percentage of
25. AQL we normally use the Frequency field to indicate to the worker how often or after how many parts the measurements must be made Without AQL EB ov ACTIONS NAVIGATE Edit Result Input Matrix QROO006 1 oE FEES mA fm 9 eo W gH LZ Oh ce xi Sample Line Show Show Only View Edit Post Show Showas Refresh Clear Find Comments Comments All Mandatory List List Results as List Chart Filter New Manage Process View Page Result Input Matrix Type to filter F3 Description gt No filters applied Line no Description Measure Nominal Minimum Value Maximum Value Sampling Line Elements Out 1 11 19 2 11 19 Value Type Value Frequency Co Of Range 11 29 11 30 4 CORE 692 9 V 29 2 85 29 1 50 No 5 91 52 H11 A 152 152 1 58 1 50 No OK OK 6 13 8 V 138 13 75 13 85 1 50 No 7 42 V 42 42 44 1 50 No 4 43 8 32 V 32 32 34 1 50 No 9 HEX 3 G9 1 4 V 3 2 973 2 998 PP Yes 10 1 8 V 18 175 18 1 50 No 11 1 5 V 15 1 45 1 55 1 50 No Line Information Lot Quantity 5 Line Comments Max Tol 2 95 3 02mm Equipment E 493 Last user amp date Comments from Plan Check Mycrona calibration before measuring With AQL iun r Actions Related Information v lt E ro T o Mark Unmark warning Sample Line Comments Comments Result Input Matrix Sorting Order No Line No v l Show All New Show Only Mandatory Show Only Selected Select all Post Result
26. CALIBER DIGIMATIC MICROMETER MICROMETER J 0000 Beeeesesee eene nnn nnne nennen nennen Mam E ue Result laid 95 95 96 Instruments in a quality order sample Another option that may be convenient is to specify the instrument group at quality order sample level When an instrument group is assigned to the sample all the analyses are given the same group This is only useful if the same types of instrument are used for all the analyses 48 PQM No 14QR00019 Entry Source Type Routing v Quality Order type First v Item No 0A08017 Description DOCETAXEL DILUENT Description 2 Samples Find Filter Clear Filter Sample No Description Co Sample Type 1 General sample No General Measures Actions Line Measure Limit Result Find Filter Clear Filter Nominal Minimum Value Value Type Type Value alue List Jalue List Plan Source Receipt Judgement 0 0 Lot Quantity Lot No Expiration Date Source Lot No Destination WIP Lot Quality Link Code Judgement Theoretical Sample Size Sample Size Sampling Date Maximum Value Instruments when adding individuals OPL 000070 LI 14 000170 QCL001 Sampling Comments Instrumental Not Sampk Group Instrumental Group ae r Code Descri N A Do not WORKSHOP Works The page for adding individuals suggests instruments to be assigned If
27. E ACETATE GELATIN Order Due Date Sample No Description Co Theoretical Sample Size Sample By Sampling Analysis Starting Sample Size Location Ele Date Date 1 Sample 1 No 3 11 7 2014 11 7 2014 9 33 13 lt gt Measures Home Line 9 Find Filter Clear Filter Measure Description Measure Va Limit Result Result Nominal Va M DA IT 1088 Water KF USP Numeric 1 0 5 DA IT 054 Viscosity USP Numeric 2 1 MAIT 1117AN Aa names Bee abat ELF n ALES dE ID To post the sample you must first have created at least one individual and entered results for it 11 Quality order decision A check is made that the samples are posted Querying pending quality tasks There are queries providing quick access to the list of samples waiting to be posted and the list of quality orders awaiting decisions A third query shows the two things together 44 POM Microsoft Dynamics NAV Actions FR Reports Home Role Center Role Center Activities gt Ej Quality Plans Item Quality Plans m Quality Plan Versions Quality Orders fi E Deviations 916 D Vendor Evaluation Docs Uncerti Certified Manufacturer Evaluation D Quality Quality Pending Samples Item Quality Plan Versions E Pending Quality Orders All Pending Tasks Evaluation emplates 1 837 19 Uncerti Certified PlanVe Plan Ve Item Quality Orders 25 0 257 283 282 565 Recepti
28. INE TARTRATE EP Receipt ai AE PE FQ 020 MELPHALAN USP Receipt T PE FQ 022 VINORELBINE TARTRATE EDOM Receipt Gj Departments PE IR 002 ANHYDRO VINBLASITINE Receipt a2 Item Quality PE IR 003 TOTAL VINCA ALKALOIDS Receipt mm aum ccc Xam mmm mis ra mscr 3 The quality plan card appears Fill in the N9 field on the plan manually there is no automatic numbering The description and plan type reception manufacturing fields are for information 4 Click the Versions button 32 POM Process Show Attached Quality Plan Card stood Description Hand made test plan Evaluation Schema v Modified by OLIVIA FELIP Last Date Modified 05 11 2014 Measures Description 2 Lines 9 Find Filter W Clear Filter Line No Measure Code Description 0 Status New Active Version ane Edition Review Plan Type Receipt v Sample No Quality Link Work Group Not Measure Code Mandatory Value Type E L Limit Result Type Equip 5 The version list appears empty Click the New button Manage dNJOneNote Notes eo Links Show Attached Quality Plan Version List Typetofiter F3 aussi ghe Version Code Description 6 The plan version card appears empty Description 2 Status Fill in the Version Code field on the plan manually there is no automatic numbering Also fil
29. O mW OneNote Notes Links CRONUS Espa a S A Refresh Y Clear Filter MM Find Show Attached Page Type to filter F3 Comments v gt Filter QRO0006 PQM 55 To add comments to the quality order di Edit Quality Order Card QR00006 oa X ROME ACTIONS NAVIGATE CRONUS Espa a S A S H2 f Jhb Show Incidences E E E i 2 Show Forward Tracking p Comments Evaluation Show Identification Retention General Schema Change Log 4 Show Backward Tracking Samples Samples Order Samples QRO00006 General AC Entry Source Type Routing uro M Lot No Quality Order type First ws sedan Item No SK2 3812 Description Description 2 EN eax m EZ New View Edt Delete Samples List List dM Find Filter Clear Fit New Manage Comments i ommen E Quality Comments ado No Comments lt Measures Actions Line 4d Find Measure C Description P03406 94 2 P00745 03 85 1 4 1 Plan 56 POM Source Lot No 1700000 CRONUS Espa a S A mg Sea z LUSA li amp Clear Filter Show Showas OneNote Notes Links aslist Chart 3 n View Show Attached Type to filter F3 Comments gt roup No filters applied gt Minimum Va 42 Numeric 3 85 3 85 v Traceability The module has various ways of checking traceability Firstly the Browse function launched from a quality order shows all related documents and it is possible to follow the link
30. TST0072 sme Status New E Description Hand made test plan Active Version Edition Description 2 Review Evaluation Schema v Modified by OLIVIA FELIP Last Date Modified 05 11 2014 Measures Lines 99 Find Filter Clear Filter Measure Code Line No Description 0 Manufacturing v Plan Type Sample No Quality Link Work Group Not Measure Code Mandatory Value Type 0 o 4 The version list appears there must be at least one 38 POM Limit Result Type Equip Click the New button Home Actions Navigate X xa me Edit View Delete Show Show as OneNote Notes Links as List Chart Manage View Show Attached Quality Plan Version List Typeto filter F3 Mow a ifa i v Sorting No Version Code v Sly Filter TSTOO72 Version Code Description Description 2 Status ITSTOO2 Hand made test plan New 5 The plan version card appears empty Fill in the Version code field At that point the data copied from the previous version appears on the screen samples analyses description and evaluation schema Actions Navigate 58 EBge OneNote Notes Links TSTO072 2 General No TST0072 Modified by OLIVIA FELIP 2 Last Date Modified 05 11 2014 Description Hand made test plan Description 2 Review Evaluation Schema
31. about periodic quality and the orders are created in the future The decision on a reanalysis order checks whether the lot is still in stock if it is not in quarantine it could have been dispatched or consumed Decision The decision on a quality order represents its closure It is a prerequisite for the samples to be posted There are three types of decision e Conforming a good quantity and various rejection quantities with different reasons for rejection can be specified e Non conforming the whole quantity will be rejected No good quantity is allowed 12 POM Partial decision a good quantity and various quantities for rejection can be specified The total quantity specified must be less than the quantity on the quality order The quality order is decided and a related order is created with the quantity remaining to be decided on in future Compliant Non Compliant Partial Report Manage Process 14QR00012 Details No 14QR00012 Source Lot No OPL 000063 Item No 0A08017 Destination WIP Lot OPL 000063 Description CHLOROFORM Solvent Lot Quantity Lot No Quantities to Post Good Quantity 3 Quantities to Scrapping X Find Quantity to Scr Scrap Code Fault Opera Entry comments 0 POM 13 Lot statuses As explained above reception inspection and lot release quality orders are linked to a lot code As soon as the order is creat
32. bled results are not required The following fields are optional e Standard For information e Minimum Value Maximum Value If these are not present the system will allow results to be entered without checking the range e Sample Size Method If its value is established as AQL the fields AQL Sample Table Inspection Level Code Inspection Type and AQL Column must be filled in 10 Optional If the analysis does not exist in the drop down menu it can be added by clicking on the New label POM 35 Quality Plan Subform Lines v Find Filter Clear Filter Line Measure Description Sample No No Code 10000 TA 058 pH USP 20000 v Viscosity USP T Code Description DA IT 045 PLA Characterization GPC M DA IT 054 Viscosity USP DA IT 1088 Water KF USP DA IT 1090 Uniformity of dosage units Signatures DA IT 1100 Lyophilized appearance DA IT 1101 Crew The list of analyses appears with a blank line All fields must be filled in Solution appearance dvanced Y Set as default filter column The code must contain letters and numbers When templates were imported analyses were created with a counter It is recommended that the same criterion should be followed Fill in the Measurement Value Type field Numerical Boolean Value List etc If it is Value List fill in the List Code field Finally exit the page with the OK but
33. defects that can be considered satisfactory for a chosen sample AQL also makes it possible to determine the sample size for inspection depending on the total quantity of the order and the level of strictness It is possible to choose between levels I Il and IIl where level IIl is the strictest and level the least strict Two types of table are used for the calculations for which there are various standards Example AQL table code GENERAL level Il normal inspection TABLE SAMPLE SIZE CODE LETTERS TABLE Il SINGLE SAMPLING FOR NORMAL INSPECTION MASTER TABLE Use first sampling plan below arrow If sample size is equals or batch size do 100 inspection Use first sampling plan above arrow Ac Acceptance number Re Rejection number PQM 59 The procedure to be followed is to look for the letter corresponding to the lot size in the first table with inspection level Il For example for a batch of 5 000 we obtain the letter L With the letter L we go to the second table and obtain two things e The size the sample should be 200 e The acceptance level In this example for an AQL column of 2 5 it tells us that we accept up to 10 defective units out of a sample of 200 To define an AQL like the one above in the module we need to go to the AQL section by either of the following two paths e From the quality Role Centre working area Start gt Administration menu e Departments gt Quality cont
34. e effort in posting the production worksheet and managing quality orders because there are more of them This flag releases you from the need to use different WIP lots in each operation When enabled when the production worksheet is opened it suggests the production order code as the WIP lot in all operations There is no need to change the WIP lot although this can be done sporadically PQM 31 Practical usage guide Creating a quality plan from scratch By from scratch we mean a new plan code to which new samples and decisions will be added manually 1 From the Start button go to the quality plan list 2 Click the New button Search Ctrl F3 4 7 7 x3 Ni E Sha Show as OneNote Notes Links sList Chart TE Quality Plans Type to filter F3 No x v 4 Quality Plans Sorting No l No filters applied Uncertified Quality Plans m Certified Quality Plans No Description Description 2 Plan Type gt Quality Orders PE FQ 004 VINORELBINE TARTRATE USP EP Receipt ncidences PE FQ 010 VINORELBINE TARTRATE USP Receipt Investigations PE FQ 011 VINORELBINE TARTRATE USP EP Receipt bein PE FQ 012 VINORELBINE TARTRATE USP Receipt Audits PE FQ 013 VINORELBINE TARTRATE USP Receipt Evaluation Templates PE FQ 014 OXALIPLATIN EP Receipt AP Home PE FQ 015 MELPHALAN BULK Receipt o PE FQ 016 VINORELBINE TARTRATE Receipt PE FQ 017 VINORELBINE TARTRATE Receipt p Incidences PE FQ 018 VINORELB
35. ed the lot goes into quarantine status In this status the product cannot be sold or consumed The order decision alters this status to Conforming or Non conforming There is another possible status for lots expired The expiry of a lot is not automatic When it reaches its expiry date its status does not change Lots expire under a manual process there is a worksheet that checks the expiry date and suggests moving lots to Expired status In this status they cannot be dispatched or consumed In routing quality orders linked to WIP lots the operation is different There is no physical stock that can be kept in quarantine Instead there is a check in the production worksheet that does not allow an operation to be posted if the quality decision for the previous operation is missing In the same way to make a decision on a routing order the operation first needs to have been registered in the production worksheet Otherwise the order has no destination WIP lots assigned and the decision shows an error Related and additional orders In the Decision section we have seen that a related order can be generated in the case of partial release This is an identical order with the quantity remaining outstanding from the decision on the first order There is another type of related order additional orders The normal use of additional orders is to collect information or apply additional procedures not established in the quality p
36. en quality staff A working group can be associated with each individual decision This can be done in the quality order or previously in the plan HOME NAVIGATE N pe HS ty ra Go to Q PIN H ae N X L New 4 Previous View Versions Notes Links Refresh Clear X Delete Filter Next PROOO2 General No PROOO2 t Status Under Development v Description Generic plan Active Version Description 2 Edition Evaluation Schema GENERAL v Review Modified by OLIVIA FELIP Plan Type Manufacturing v Last Date Modified 10 21 2014 Measures F4 Lines dM Find Filter Clear Filter Line No Measure Code Description Sample No Quality Link Work Group Not Measure Limit Result Equipment Nominal Text Minimum Text Maximum Code Man Value Type Type Value Value Value 10000 PURITY Purity 1 QUALITY LAB GROUP Numeric 4 3 5 pom 20000 ACIDITY Acidity 1 QUALITY LaBGROUP Numeric 2 15 6 30000 APPEARANCE External appearance 1 QUALITY DT GROUP ValueList In an equivalent way working groups can be assigned to a user on the User Configuration page Once this has been done the user will see and can manage only the decisions corresponding to his her group User Setup ype to filter F3 User ID gt v No filters applied UserID Allow Allow Register Sales Resp Purchase Resp Service Resp Time Sheet Quality Work Quality Evaluation Posting From Posting To Time Ctr Filter Ctr Filter Ctr Filter Admin Group Location
37. es HOME NAVIGATE N rs Goto a ge Bias k 1 New r G 4 Previous View Versions Notes Links Refresh Clear XX Delete Filter P Next PROOO2 General No PR0002 Status Under Development v Description Generic plan Active Version Description 2 Edition Evaluation Schema GENERAL v Review Modified by OLIVIA FELIP Plan Type Manufacturing v Last Date Modified 21 10 2014 Measures r Clear Filter Lines dM Find Filter Line No Measure Code Description Sample No Quality Link Work Group Not Measure Limit Result Equipment Nominal Text Minimum Text Maximum Cod e Man Value Type Type Value Value Value m 10000 PURITY Purity 1 QUALITY C Numeric 4 3 5 20000 ACIDITY Acidity 1 QUALITY Numeric 2 15 6 30000 APPEARANCE External appearance 1 QUALITY Value List Plan header This contains descriptive general details and also the Status field which manages its lifecycle The status of a plan is similar to the status of a routing or list of materials Changes are allowed if the status is New or Under Development They are not allowed in Certified or Closed status Plan lines Each plan line includes among other things e The concept to be measured also called analysis e The instrument or instrument group that must be used e The type of result expected numerical Boolean text value chosen from a list of options etc e The acceptable range of values e Whether the entry of a
38. esult Equipment Nominal Text Minimum Text Coc Code Value Type Type Value Value Value 10000 TA 0 p 1 QC Numeric 1 4 1 35 1 45 20000 DA IT 054 Viscosity USP 2 MCZ Numeric 121 115 125 0 0 lt Signatures Manufacturing cycle with quality The first three actions are carried out from the manufacturing side The others come on the quality side 1 Creating a planned confirmed production order 2 Launching a production order If the first operation in the routing has quality linked to it the Quality link code field is filled in the quality order is created automatically 3 Posting production The production worksheet gives information about parts manufactured together with the original and destination WIP lot 4 Entering results in quality order This action can be done before step 3 Posting production That is it would be possible to first enter results and then post the production worksheet 5 From Quality order gt General samples post start of analysis 42 PQM Nj Be View Edit Element Posti Started OneNote Notes Links Management Manage Process Show Attached 14QR000 21 1 Order Order No 14QR00021 Location Code item No 0A08001 Lot No Priority F Lot Quantity 0 Description LEUPROLIDE ACETATE GELATIN Order Due Date Sample No Description Co Theoretical Sample Size Sample By Sampling Analys
39. fferent places The different possibilities are detailed here Equipment machines cannot be specified in the quality plan only instrument types But they can be specified in the quality order sample and analysis The system takes this information as a template Individual n9 O appears in the assignments When the first individual is added this assignment is shown so the user can change it if required When adding individuals The first individual suggests the assignment of the instrument types and equipment given in the plan or in the order sample analysis For each new individual to be added the last assignment made is offered That means if a piece of equipment is changed for the second individual this assignment suggestion is maintained for the third and successive individuals 50 POM Example of equipment assignment in the sample A Edit General Sample Card 14QR00019 1 EF BERE Home Actions Navigate E e DZIE gt MA View Edit Element Post Started OneNote Notes Links Management Analysis Manage Process Show Attached 14QR00019 1 Order Priority 4 Lot Quantity 1 Description DOCETAXEL DILUENT Order Due Date Theoretical Sample Size Sample By Sampling Analysis Starting Sample Size Location Ele Date Date 1 General sample No 1 m OCHEM Sample No Description Work Group Instrumental Group WO Home Actions MT Baxi pms ge View Ed
40. fied This should be much quicker than doing it from scratch However it is possible to delete the lines and leave it blank if you prefer 1 From the Start button go to the quality plan list 2 Choose the existing plan to which you a new version will be added Double click on it POM 37 SJON E Eriochem Desarrollo Home Quality Plans gt Search Ctrl F3 Home Ed Mi ge Show Show as OneNote Notes Links asList Chart View PX Edit View Delete New Manage Show Attached Quality Plans Sorting Noy y Role Center 4 Quality Plans Uncertified Quality Plans Type to filter F3 Ne gt No filters applied No Description PE ST 118 SULFURIC ACID PE ST 119 SULFURIC ACID PE ST 120 ACETYLSALICYLIC ACID PE ST 121 ACETYLSALICYLIC ACID PE ST 122 ACETYLSALICYLIC ACID PE ST 123 LYOPHILIZED PEMETREXED PE ST 124 ASCORBIC ACID PE ST 132 LYOPHILIZED PEMETREXED PE ST 133 ASCORBIC ACID TST0072 Hand made test plan Certified Quality Plans Quality Orders Preventive Corrective Actions Incidences Investigations Deviations Audits Evaluation Templates p Incidences al Audits 3 The plan card appears Click the Versions button N Description 2 Plan Type A Receipt Receipt Receipt Receipt Receipt Receipt Receipt Receipt Receipt Receipt A Edit Nj S co View X Delete ions OneNote Notes Links Manage Show Attached
41. ge Process Show Attached DEVO0001 General Deviation No DEVO001 Ree Creation Date 10 08 2014 12 334 DeviationDescripti Jih Creation User OLIVIATONY Extended Descripti No Source Type Manual v Item No 0A00006 v Source Document Item Description MELPHALAN BULK USP API HOSPI Source No Lot No RT 54 y Source Description l Location Code FAR027A v Initial Classification Critical v Area v Final Classification Major v Status In Progress v From Incidence No Planned Closing Date 10 24 2014 v From Investigation Reason Analysis v Preventice Actions To Take v Corrective Actions To Take v Preventive corrective actions Preventive and corrective actions have their own identity and their own card They have their own status and implementation deadlines They are assigned to incidents investigations or deviations or the same action is assigned to several of them at the same time An incident investigation or deviation cannot be closed if it has preventive corrective actions assigned and they are still in their initial status Planned 26 POM DEA N Aa View XD SR Change OneNote Notes Links Process Show Attached Preventive PRE0004 General Type Deadline 10 23 2014 v Action Code PRE0004 l o Creation Date 10 22 2014 13 38 Description Calibrate pycnometer Closing Due Date 10 22 2015 Status Approved Planned
42. gn it the ID 7035200 Q09 Im CRONUS Espa a S A Departments Administration Application Setup RoleTailored Client Profiles HOME ACTIONS AN 46xK Bm EMACS New Edit View Delete Show Show as OneNote Notes Links Refresh Clear Find as List Chart Filter New Manage View Show Attached Page Departments A b Financial Management Profiles b Cartera v A Home Profile ID 4 Description Role Cent Defa Disa a Sea RRL XS Ki Item Quality QUALTYMNGMNT NONEM L O as RAPIDSTART SERVICES RapidStart Services Implementer 9021 LJ Incidences SMALL BUSINESS Small Business 9022 O i Audits Departments e Assign the profile created to module users in User customization HOME ACTIONS NAVIGATE BUD 4 Previous View OneNote Notes Links Refresh Clear 7X Delete Filter P Next Manage Show Attached Page OLIVIA FELIP General User ID OLIVIAVFELIP Language ID 1033 v Profile ID es 2 NR M ELE Company CRONUS Espafia S A v 6 POM Quality plan The standard definition of a quality plan is as follows a document that specifies the procedures and associated resources which must be applied who must apply them and when they must be applied to a project product process or specific contract UNE EN ISO 9000 2005 quality management systems fundamentals and vocabulary In PQM a quality plan is a three level structure It consists of a header samples and lin
43. hey have been deleted Home Es 2 Edit AH New V ew X Delete Manage Process Show Attached TST0072 3 General No TST0072 Version Code 3 Modified by OLIVIA FELIP Last Date Modified 05 11 2014 Description Hand made test plan Edition Description 2 Review Evaluation Schema GENERAL Plan Type Receipt Status New Quality Plan Subform Lines 9 amp Find Filter Clear Filter Line No Measure Description e 10000 TA 058 pH USP 20000 DA IT 054 Viscosity USP 0 Sample No Quality Link Work Group Not Code Man 1 QC 2 MCZ 0 Measure Value Type Numeric Numeric B Limit Result Equipment _ Type Nominal Text Minimum Value Value 14 135 121 115 Text Value 145 E 3 Signatures Proceed to modify the plan version Samples and analyses can be added changed or deleted Once the version is ready certify it so it can be used POM 41 Navigate IN 4 TSTO072 3 General No TST0072 Modified by OLIVIA FELIP Version Code 3 Last Date Modified 05 11 2014 Description Hand made test plan Edition Description 2 Review Evaluation Schema GENERAL Plan Type Receipt uu ve New Quality Plan Subfo Certified Lines 9 amp Find Wunder p amp elopment Line No Mei Closed le No Quality Link Work Group Measure Limit R
44. igured internally as Full Inspection These theoretical sample sizes also appear on the results entry page so the user can find out how many individuals must be measured in each case POM 65 Posting samples and decisions with AQL As explained above the system makes various checks on the sample post One of these is that for each decision there are as many measurements as indicated by the line AQL If there are none it does not allow the sample to be posted In the decision there are no checks at all on the number of individuals This has already been done in the sample post As for the acceptance threshold the system merely offers information It does not prohibit a Conforming decision when there are rejectable individuals above the acceptance threshold set by the AQL 66 PQM Written by Toni Martinez 22 October 2014 Reviewed by Frederic Barbera 18 November 2014 Doc version V06 2 Add on version V6 0 NAV version 2013Rx All rights reserved in favour of Olivia Sistemas s l Barcelona Olivia SOLUTIONS 34 932 380 132 olivia olivia es www olivia es POM 6 7
45. is Starting Sample Size Location Ele Date Date 1 Sample 1 No 7 3 1 09 2014 11 09 2014 lt gt Measures Home Line Find Filter Clear Filter Measure Description Measure Va Limit Result Result Nominal Va M DA IT 1088 Water KF USP Numeric 1 0 5 DA IT 054 Viscosity USP Numeric 2 1 mea rr o 44nn a or 6 Goto Manage individuals and create as many as are going to be entered They can be created one by one or using the Add Remove Individuals action to create them in bulk i Actions T gs E Q Previous Set ao Eg 7 6 7 D Next Set Add1 Delete 1 Add Delete ement Element Element mu Print 7 BSS Order No Sample No Description Instrumental Group 1j Dimensional control WORKSHOP Sample Size 7 This page specifies the instruments used in the analysis See the Assigning measuring instruments section for more details POM 43 8 Finally go to Show matrix Go to the Entering results in individuals section for more information about the results entry page 9 Optional Post the results on the results entry page If they are posted they are frozen Special permission will be required to change them afterwards 10 Posting the sample Home Actions le N amp Se a View Elemen lote Notes Links Manageme 14QR00021 1 Order Order No 14QR00021 Location Code 01 Item No 0A08001 Lot No Priority Lot Quantity 8 Description LEUPROLID
46. it Quality Plan Version Card IP22510 BRI g Actions B Related Information fej Samples Process IP22510 BRI General No AQL Master Table IMPCOMP100 Version Code Inspection Level Code Il Description Implant TINY 2 5 x 8 5 Inspection Type Normal Description 2 Active Drawing No IP 225 1 0 8 Evaluation Schema BBIB Edition Status Certified Review Modified by ANTONIO Last Date Modified 08 08 2014 Plan Type Manufacturing Quality Plan Subform Line No Analysis Code Description Quality Link Work Group Code 10000 CD1787 Visual inspection CQ 10010 CD2069 Total Long cQ 10020 CD2071 Metrics amp Deep cQ 10030 CD2072 Diameter amp Deep CQ 10040 CD2342 Width Across Flats cQ Li m Signatures This field is assigned in the plan samples Samples button e Sample Size Method This indicates how the system should calculate the theoretical sample size fixed quantity percentage ACL etc To enable calculation by AQL you need to select AQL here These four fields move from the plan to the quality order When the lot quantity is confirmed in the quality order the sample size is calculated according to AQL for samples configured as AQL This theoretical size can be seen in the AQL Sample Size field of the sample It represents the quantity of parts that should be samples 64 POM Alongside this field is another called Sample Size This is the actual sample size When w
47. ity order is required to release the lot In this case the lot is in Conforming status from the time it is registered in stock Change Audit Status Role Only users with the role specified here can manage audits Change Incident Status Role Only users with the role specified here can manage incidents investigations and deviations Change Action Deadline Role Only users with the role specified here can change the deadline for preventive and corrective actions Create Reanalysis Role Only users with the role specified here can create reanalysis orders Reanalysis Lead Time Days Corresponds to the estimated lead time for a reanalysis It is used to plan reanalysis quality orders Mandatory Working Group If enabled each analysis must be assigned to a working group If this not enabled it may be assigned or left blank The working groups function allows tasks to be distributed between different people A user assigned to a working group can see and manage only its tasks Confirm Password Ask for Observations These two flags enable the signature function The first should always be enabled If it is disabled the dialog prompting for a user name password when posting actions is not displayed It is assumed that the user posting is the logged in user and the action can only be completed if this user has the required role Automatic Incident Creation If enabled incidents are created for out of
48. l in the Evaluation Schema field POM 33 7 Click the Samples button Navigate Pe D N E View X Delete Manage TSTO072 General No TST0072 Modified by OLIVIA FELIP 1 Last Date Modified 05 11 2014 Description Hand made test plan Edition Description 2 Review Evaluation Schema GENERAL Plan Type Receipt Status New Quality Plan Subform Lines 68 Find Filter V Clear Filter Line Measure Description Sample No Quality Link Work Group Not Measure Limit Result Equipment Nominal Text Minimum Text Maximur No Code Code Man Value Type Type Value Value Value 0 0 Signatures 8 The sample list appears initially empty Add the samples required In each one as well as the sample number you need to fill in the following fields e Working Group e Sample Size Method e By Individual Yes No Actio jons zx edu mg Show Show as OneNote Notes Links aslist Chart View Show Attached Quality Plan Sample Type to filter F3 SampeNo gt v se Sorting Plan No Version Code Sample No aly Filter TSTOO72 1 Sample No Description Status ESSE ample Size By Method Elem ent 1 Self control workshop New OLIVIALAB 2 Dimensional control New OLIVIALAB AQL 9 Exit the page with the OK button The plan version card appears again Enter the analyses at the botto
49. lan Instead of amending the original order to add or modify samples and analyses one or more additional ones can be created In this way what was established is better differentiated from what was not An additional order can be created from the quality order card associated to a lot To put it another way additional orders cannot be created from routing orders They can be created at any time unless the original order is already closed The quality plan on which an additional order is based is the warehouse inspection plan To be able to make a decision on the original order all the additional ones must be decided Cancelling orders Quality orders cannot just be deleted Under certain conditions they can be cancelled remaining in the system in Cancelled status In this way an order ceases to be pending and any lot associated with it will cease to be in quarantine 14 POM Cancellation conditions e The order must not be decided e The user must have the role specified in the order evaluation schema It is important that the number of people who belong to that role is restricted The cancellation of a quality order without another one being created as a result allows the product to be used without quality control e Routing orders may be cancelled as long as the Destination WIP Lot is not filled in If this field has a value the operation already has at least one production output posted There is an exception to this f
50. le Sample Role Analysis Role Analysis Role Role Elements Role Role Q IND Q IND Q SAMPLESPOST GROUP1 Global group 01 Q SAMPLES Q SAMPLES O 18 PQM Audits An audit is the systematic critical examination carried out of an organization system process project or product In PQM audits are documents structured in three parts the header lines and deficiencies HOME ACTIONS ash 6 h Change View Edit New NAVIGATE OneNote Notes Create Status Investigations Manage Audit Card General No Source Type Source No Source Name Description Starting Date Ending Date Lead Auditor Ready To Close Lines Line dM Find Filter Code PACKING DTIME lt Concept Packing appearance Delivery ime Process Show 1 50P00002 hol Vendor v 01863656 v American Wood Exports Y Clear Filter Links Asl ml Attached BI c Refresh Clear Filter Goto 4 Previous b Next Page Status Last Date Modified Modified by Creation Date Creation User Template Eval No Template Name Evaluation 4 7 Acceptable 1 week In Progress 05 11 2014 OLIVIAVFELIP 05 11 2014 11 21 39 983 OLIVIA FELIP AUTOO001 Supplier evaluation Deficiencies d amp Find Filtre Line No Header Deficiency 10000 PACKAG 20000 DEADLINE
51. m of the page To choose analyses select from the drop down menu 34 POM Actions Navigate P NS g s New DA View Samples i i f Delete te Notes TSTO072 General No TST0072 Modified by OLIVIA FELIP Version Code 1 Last Date Modified 05 11 2014 Description Hand made test plan Edition Description 2 Review Evaluation Schema Plan Type Receipt Status New Quality Plan Subform Lines 9 amp Find Filter W Clear Filter Line Measure Description Sample No Quality Link Work Group Not Measure Limit Result Equipment Nominal Text Minimum Text Maximu No Code Code Man f Value Type Type Value Value Value 10000 TA 058 pH USP 1 MCZ 4 Numeric 14 1 35 1 45 2008 DA IT 054 Wiscosity USP 2 CQ Numeric Signatures The following fields are required e Sample N2 Each analysis must be assigned to one of the samples created in the previous step e Quality Link Code e Not Mandatory flag If an analysis is mandatory a result will be required for the sample to be posted And if the sample is by individuals as many results will be required as the number in the sample size Examples e Sample X Batch of 100 units Sample size method 1096 10 results are required e Sample Y Batch of 100 units Sample size method AQL The sample size is calculated according to AQL and comes out as 7 7 results are required If the Not Mandatory flag is ena
52. mplate Template Starting Ending 4 Home Eval No Eval Status Date Date 5 item Quali Management System 2 Sistema gesti n 2 AUT0002 Certified 10 13 2014 10 22 2014 Audits can also be created manually at any time and for any item POM 21 Closing audits Audits can be closed only when one of these circumstances occurs e They have no deficiencies e They have no investigations associated with the deficiencies detected e The preventive and corrective actions associated with the investigation of deficiencies have been closed successfully see the following section on investigations and preventive corrective actions To help with closure there is the Ready for Closure field in the audit header It also appears in the list of audits in progress 22 POM Nonconformities Paper based or partially computerized nonconformity management can slow down the lifecycle of the nonconformity and the resolution of the defect Manual monitoring of nonconformities based on unrelated sources can take a great deal of time It is very difficult to monitor the different circumstances that can potentially end in a preventive or corrective action A nonconformity management system based on activities to be carried out is necessary allowing the monitoring and evaluation of conformity with the regulations This system is called CAPA Any problem identified as a deviation from standard procedure linked to an asset tool piece of equipment
53. mples and lines 4 Actions IE Related Information v E NES FS Navigate Print Certificate G oe Evaluation Schema enera Samples Process OC001003 General AU 2 No SIS Lot No Quality Order type First y Lot Quantity 24 Item No CI00813 Description PORT IMPLANT C U L 6 Source Lot No AD00006 Description 2 Destination WIP Lot AD00006 1 Judgement Complies v Quality Link Code MCZ Samples ga Sample No Description Co Sample Type Sample Size Sample Size Sampling Date Sampling Comments Instr 1 Self control workshop No General 4 05 27 2014 TALI 2 Dimensional analysis CQ No General 24 lt gt Analysis Analysis Code Description Sample No Quality Link Work Group Measure Val Nominal Val Minimum Value Maximum Val CD0519 Live edge appearance Burr Br 1 MCZ Value List 0 CD0520 M1 8x0 35 6H Inner thread 1 MCZ Value List 0 CD0050 Outside diameter 1 MCZ Numeric 41 405 4 CD1757 Spanner outside 1 MCZ Numeric 44 43 sv lt gt Plan v Source v There are different types of order depending on their origin e Routing orders These are linked to a manufacturing process operation There is no physical lot yet so we use WIP Lots for monitoring These are internal identifiers different from the Lot No used by Navision An order of this kind is created automatically when
54. nces Investigations p P Q Deviations New Quality Plan Audits Uncertified Certified Quality Quality Plans In Progress Audits gt In Progress Investigations Item Quality Orders Evaluation Templates Manufacturing Orders Reanalysis Orders New Prev Corrective Action aum New Incidence Gem In Progress In Progress n Progress In Progress itum Quality Prev Corrective incidences tigation Deviations cs amp Incidences i Audits New Evaluation Template New Audit 4 Departments Evaluation The following parts of the working area can be distinguished 1 Action ribbon with configuration accesses 2 Exploration panel Five buttons appear at the bottom When you click on each of them different options appear above them The buttons are a Home When you click here Working Area appears as the first option This makes the central activity panel appear number 3 in the image b Product quality Contains the accesses for managing plans and quality orders c Incidents for managing nonconformities d Audits Audit documents and worksheets for creating them POM 5 e Departments for accessing the whole application s menu tree purchases sales manufacture etc 3 Activity panel including a Stacks of tasks b Stack of tasks actions To allocate this working area to users two steps need to be followed e Create a new profile for example Basic quality and assi
55. nt Insertion Deletion Log Element Post Verify Password Ask For Reason Automatic Creation Of Deviations Post Results Before Exit Order Post Causes Review Sample Post Causes Review Optional Sample Post Lot Order Positive Adjustments Don t Create QO Ask For Confirmation To Close PO w o Lot Release Plan Use Unique WIP Lot Use Item Versions QOCOMPL QAUDIT QPREVACT QCORRACT QINCID QINVES QDEVIAT RECHAZOS The general tab contains the series that are going to be used for the module documents It also contains a general flag for enabling or disabling the module If Enable Quality Control is not enabled quality orders are not generated and the batches going into stock never go into quarantine The Advanced tab contains more critical fields e Lot Release Plan and Lot Release Plan Version Lot release quality orders are created when production orders are closed one for each lot manufactured The plan used for these quality orders is the one specified on the product card However it is possible to use a general plan instead of a different release plan for POM 29 each product To work in this way the lot release plan on the product card needs to be left blank and a plan must be specified here in configuration If there is no release plan assigned either on the product card or in setup it is assumed that no qual
56. orking by individuals as you are working with complete plans the actual sample size is the number of individuals created It is also possible to calculate the AQL by analysis For example the maximum diameter can be measured in 5 parts and the threaded hole in 8 To enable this option you need to use the AQL fields of the analysis 4M Edit General Samples OC001015 2 g Actions 8l Related Information Fr E Started Analysis Element Post Management Process OC001015 2 Order Order No OC001015 Location Code 01 Item No IP22510 Lot No Priority Lot Quantity Description IMPLANT 2 5 X8 5 TINY Order Due Date Sample No Description z Sample Size Sample Size B Sampling Date Analysis Starting Date Work Group Instrumen 2 Dimensional An lisis QC 45 2 V BTI 4 l Analysis Nominal Value Minimum Maximum N Instrumental Sampling Observations AQL Master Table Inspection Inspection Type AQL Column Sample Size Value Value M Group Level Code 0 0 V 10096 II Normal 0 01 45 9 52 9 6 v IMPCOMP100 Normal 0 01 45 0 0 v IMPCOMP100 Normal 0 01 45 2 05 2 05 2 05 Vv IMPCOMP100 Normal 0 01 45 2 5 2 5 25 v CRITICV Normal 0 01 45 2 87 R0 05 2 87 2 87 7 IMPCOMP100 Normal 0 01 AQL Scrap level In this example you can see the theoretical sample sizes according to AQL calculated for each analysis The first line Visual Inspection has an AQL of 100 assigned This AQL is conf
57. osed Quality Plans Item No Lot No Lot Status Description Reanalysis Reanalysis Reanalysis Last Plan No Plan Vers Frecuency Reanalys Reception Orders 0400001 LI 13 000010 SOLVENT ENDROLIN LEUPRORELIN ACETATE 3 75 PE CE 008 3M 04 06 2014 Location Inspection Orders Routing Orders 0A00001 LI 13 000036 Doesn t co SOLVENT ENDROLIN LEUPRORELIN ACETATE 3 75 PE CE 008 3M Manufacturing Orders 0A00001 LI 13 000037 Complies SOLVENT ENDROLIN LEUPRORELIN ACETATE 3 75 PE CE 008 3M 01 02 2014 Reanalysis Orders 0A00001 LI 13 000038 Complies SOLVENT ENDROLIN LEUPRORELIN ACETATE 3 75 PE CE 008 3M Posted Quality Order 0A00001 LI 13 000041 Quarantine SOLVENT ENDROLIN LEUPRORELIN ACETATE 3 75 PE CE 008 3M Reanalysis Joumal V 0A00001 LI 14 000002 Quarantine SOLVENT ENDROLIN LEUPRORELIN ACETATE 3 75 PE CE 008 3M Pig Home 0A00001 LI 14 000015 Quarantine SOLVENT ENDROLIN LEUPRORELIN ACETATE 3 75 3M 0A00001 LI 14 000016 Complies SOLVENT ENDROLIN LEUPRORELIN ACETATE 3 75 3M 2 ltem Quali dia ty 0A00001 LI 14 000017 Quarantine SOLVENT ENDROLIN LEUPRORELIN ACETATE 3 75 3M The product has a field called Reanalysis Frequency on the card The creation of an order is suggested depending on the date of the last lot reanalysis this date is on its card Reanalysis orders have an established start and end date Unlike other orders when a new one is created the lot does not go into quarantine This makes sense because we are talking
58. p to the plan line These can be consulted by clicking on the ellipsis 46 POM Instrumental Equipment Limit Result Nominal Text Minimum Te Group Type Value Value Ve WO 70 57 96 Home Actions d e j Bx eA Se AD NE 44 PB New View Edit Delete Show Show as OneNote Notes Links List List as List Chart Quality Instruments Line Type to filter F3 Instrument Code 3 v Instrument Instrument Description Sample Comme SINUS v CALIBER DIGIMATIC MICROMETER MICROMETER STOPWATCH STOPWATCH Thousandths VIDEO VIDEO MEASUREMENT MACHINE In the same way it is possible to leave the instrument group empty and specify the instruments manually It is important to bear in mind that only instrument types are defined here Actual equipment or machines are not specified PQM 47 Instruments in a quality order analysis The instruments specified in the plan are automatically included in the quality order Once there they can be changed E Started Analysis Element Post Management OC000265 1 Order Order No 000026 7 A Item No IIPS4510 Priority pmi Description Quality Instruments Entry Type tofilter e Element Nov st Sorting Order No Line No Element No Line Sequence Filter OC000265 1 Element No Instrument Instrument Description Machine Code Starting Date Ending Date C 4s CALIBER
59. range values in the quality order decision A dialog is displayed to ask for confirmation Sample Posting Causes Review Posting is always mandatory but does not require a user role By enabling this flag we post and review the sample in a single step It requires a role specified in the evaluation schema d Sample Release Order Posting Optiona 30 POM If enabled lot release orders may be decided without the need to post the samples It makes sense to enable it when the release order has a single sample of the Release Yes No type Ask For Confirmation To Close PO w o Lot Release Plan When enabled if a production order is closed without the product having a release plan assigned to it a dialog is displayed asking for confirmation This is an attempt to prevent the lot carelessly being made available without having been released Positive Adjustments Do Not Generate QO This flag should only be enabled when the system starts up for initial stock loading It avoids the creation of quality orders for all the stock transferred Use Single WIP Lot Affects only routing quality orders The normal way of working consists of using different WIP lots in each operation And also using different WIP lots at each shift change component lot change or change in any circumstances that could affect the quality of the manufactured product This is the way of ensuring full traceability in exchange for a little mor
60. rent versions of the same quality plan Like the plan each version contains a header samples and analyses Versions are used for two different things as a development of the plan over time history and as an alternative There are facilities for creating versions Details can be seen later on in the manual 4 5 Actions del Related Information 7 Quality Plan Version Card E View Ctrl Mayus V Edit Ctrl Mayus E fj New Ctrl N A Delete Ctrl Del Notes Links Ctrl L Copy from Quality Plan Version Quality Plan VEPSrOm care vita fessus AQL Master Table ATRCRITIC J Refresh F5 Inspection Level Code if v WZ ClearFilter Ctrl Mayus A a m Reduced yl Send To gt i Active Drawing No G Previ Ctrl PgU 4 gu ore idi Edition D gt Next Ctrl PgDn 4 Review E Print Page Ctrl P Plan Type Manufacturing v Last Date Modified 10 10 2014 l E Quality Plan Subform Line No Analysis Code Description Sample No Quality Link Work Group N Measure Val Equipment 100000 CD1787 Visual inspection 11 Value List Microscope 100010 CD1792 Total Quantity 11 Value List Visual 10 POM Quality order A quality order is the application of a quality plan to a batch or manufacturing operation The quality order is not created from scratch it is based on a plan associated with the product with the same structure of header sa
61. rol gt Administration gt AQL Q v CRONUS Espa a S A Departments Quality Item b Purchase A gt Warehouse AQL b Manufacturing 4 Quality Administration gt Third Party Evaluation AQL Master Table d AQL Columns 4 hem Quality Inspection Letter Design Inspection Level Execution Inspection Level Lot Size Hi Lot Size Letters Matrix istory S Acceptance Quality Levels Reports 4 Setup Organization Trace Presentation AGL Setup v FN Home lxi Item Quality Incidences i Audits Ji Departments The tables AQL Columns and Inspection Letter contain additional data the letters of the alphabet and the numerical columns of the latter 0 10 0 25 0 40 Additional inspection levels can be inserted on the Inspection Level page 60 POM HOME o t Cea View List MA Show as List Ait OneNote 3 Ez Edit Lit N ShowasChart Notes Y gt Delete 3 Links d New Manage View Show Attached Page New Inspection Level Type to filter F3 AQL Master Table v gt v AQL Master Code a Description Table 100 I Level Il VARPRINC Level v HOME o View List TA St S Ep Edit lit m S X New X lt Delete ai i New Manage View Show Attached Page Inspection Level Lot Size ATRPRINC AQL Master Table v V AQL Inspection Lot Size Master Level Table ATRPRINC ATRPRINC ATRPRINC ATRPRINC POM 61 Lot Size Letter Matrix defines the
62. rom the production module it is possible to delete a production order if it has no movements If it has an associated quality order the deletion of the production order will lead to the deletion of the quality order without a trace oignatures security and the audit trail Security management in POM is very flexible making it possible to implement various access levels which can be changed in time The basic element that manages security is the evaluation schema which is associated with the quality plan From there it is transferred to the order The schema contains two types of information e How many signatures are required for the acceptance of samples analyses and the quality order The following may be required e Posting only e Posting and review e Posting review and approval e The simplest implementation requires only posting the samples and the quality order decision The most complex requires posting review and separate approval different people for each thing e Which user role is required for each module action e To post results and to post the sample e To change results already posted e To make a decision on the order when there are no values outside tolerance e To make a decision on the order when there are values outside tolerance e To make a decision on a release order Lot Release type order e Etc An electronic user signature is required in all quality module posting actions A signature is also required
63. s Process Type to filter gt Selected an 9 No filters applied Lineno S Description C Visual inspection C Total Long C Diameter amp Deep Width Across Flats Measure Value Type A A iA A A Nominal Value 96 M2X0 4 2 05 25 Minimum Value 9 52 2 05 25 Maximum Value 9 6 2 05 23 Sample Siz 4 4 5 Equipment Additional Info Notes Microscopio Calibre TM2 Assembly tool TM2 Assembly tool Hexagonal Ring Line Plan Elements Out 1 Co Co Of Range No No No No No No No No No No Line Information Drawing No IP 225 1 0 B Lot Quantity 45 Equipment IM 42 IM 74 Last user amp date Line Comments Comments from Plan Comments associated with plans samples and orders The results matrix shows comments from the plan and it is also possible to add comments associated with the quality order to the measurement being made First we will see how the comments from the plan are displayed In the case of automatic monitoring the comments from the imported templates were overall ones for the whole plan They are displayed at the bottom of the page Comments field Edit Result Input Matrix QROO006 sample 1 eri HOME ACTIONS NAVIGATE s B EM 3 WX gm 2 d o X d Sample Line Show Show Only View Post Show as Refresh Clear Find Commen
64. s to see each of them HOME ACTIONS la Show Related Entries il Find wt Print Selected Production Order Document Document LZ000003 Posting D 10 09 14 Bill No Related Entries No of Entries Production Order 1 Capacity Ledger Entry 8 Quality Order 3 Source Document T Source No Source Type Source N The same thing can be done by asking about a lot instead of an order no This Browse function includes quality measurements When this link is followed you can check the results list entered for this code including the user date and time Another available function is Lot Traceability available only in release orders It shows all the information from the different operations and components involved in manufacturing the lot in the form of a drop down tree Sorting User id Entry No Y jb No fiters applied No Description Lot No Type Document Unt Measure Item Version Item Drawing Quality Plan Quality Plan Consumed OK Scrap Good Prod Scrap Prod Quality Qty ersion Consumed HV1400957 ID CT0020 Quasity Control Hv14009357 XB W C MANUFACT 001 2 00 0 00 CTOO10 Machining Hv 1400957 XB we 2 00 0 00 0 00 COCR X13 5 COBALT CHROME H 13 5MM LOH140003 Item HV1400957 UDS 002 EC 233 1 1 0 03 0 00 0 00 0 00 COCR X13 5 COCR BIOSTAR D98 5MM H 13 5MM LOH140003 Item ACI400064 UOS 002 EC 2331 1 RECEIPT 001 10 00 0 00 0 00 LB TRIPLEX STD LABEL ER 56X28 TRIPLEX RED 11
65. sion containing samples and analyses these are deleted before the process 1 From a plan version card go to Actions Copy from quality plan version 5 Actions HS Related Information 7 Ctrl Mayuis V 2 Edit Ctrl Mayus E Ctrl N Ctrl Del Links Ctrl L x Copy from Quality Plan Version Quality Plan VEPSrOmeare wide memet AQL Master Table ATRCRITIC v 2 F5 Inspection Level Code u v Z Clear Filter Ctrl Mayus A a a ee R Dd v Send To Active Drawing No Previ Ctrl PgU m eee mre V Edition gt Next Ctrl PgDn x Review Print Page Ctrl P Plan Type Manufacturing v Last Date Modified 10 10 2014 Quality Plan Subform goa Line No Analysis Code Description Sample No Quality Link Work Group N Measure Val Equipment 100000 CD1787 Visual inspection 11 Value List Microscope 100010 CD1792 Total Quantity 11 Value List Visual 2 Thelist of quality plan versions appears Select one and click on OK 40 POM Manage Quality Plan Version List Sorting No Version Code No Version Code ipE SE 016 02 2t Description CONTROL IN THE COOLING PROCESS Hand made test plan Hand made test plan wee ers Msn No filters applied Description 2 The version card appears again with samples and analyses copied from the chosen version If there were previous samples and analyses t
66. t Delete Show Show as OneNote Notes Links List List as List Chart Measure i Description New Manage View Show Attached TA 485 Turbidity pEr Biani sieniin i Sorting Order No Line No LineSequence 2l Filter 14QR00019 10000 Density USP ne Instrument Instrument Description Machine C Starting Date Ending Date Comments x STOPWATCH STOPWATCH Thousandths VIDEO VIDEO MEASUREMENT MA DENSITY MTR DENSITY METER METTLER Equipment machine management The equipment is managed on the Quality machines page There it can be registered modified or deleted 7 Actions f Related Information v New New Quality Machine Center List Sorting No fr No filters applied No Name Quality Location Instruments Code 4M 10 WATCH THOUSANDTHS COMPARATOR 254B MITUTOYO WATCH IM 102 VIDEO MEASURING MACHINE TESA VISIO 200 VIDEO IM 104 CALIPER DIGIMATIC ABS 500 181 MITUTOYO CALIPER IM 113 THIN CONTACT MICROMETER 0 30mm TESA MICROMETER IM 116 CALIPER DIGIMATIC DATA OUTPUT 500 161 CALIPER IM 119 CALIPER DIGIMATIC DATA OUTPUT 500 203 CALIPER OUTPUT PQM 51 Entering results in individuals The results entry page is adapted depending on whether the sample uses AQL This difference is due to the fact that different fields are needed For example AQL has already calculated the sample size and therefore the number of values that must be entered in the mandatory analyses Without
67. tion s Creation User OLIVIAYTONY Extended Description Review Date Item No 0A08017 v Review User Item Description DOCETAXEL DILUENT Lot No Planned Closing Date Source Type Location Code Source Document No 14QR00012 Area Source No TA 488 Application Scope Source Description Density wih pycnometer USP Status In Progress v Reason Analysis y Find Filter Clear Filter Comments Density higher than the maximum value 5 The analysis was repeated two times Is recommended to check the pycnometer calibraton Nae r Preventice Actions To Take p Show Comments Find Filter Clear Filter Action Code Description Status Deadline PREO004 v Recalibrate the pycnometer Approved 10 23 2014 PREO0005 Again measure densify in the today s producsons Implemented 10 22 2014 Corrective Actions To Take C5 Show Comments Find Filter W Clear Filter Action Code Description Status Deadline CORO0004 Mix with sample of lower density Planned 10 24 2014 Planned Sometimes the conclusion that it has been a false alarm can be reached or the causes of the problem may be perfectly identified In this case the incident is closed with no further consequences If on the other hand the causes are unknown an investigation is opened to clarify them This is done in POM from the incident card itself 24 POM Investigation
68. ton Home Actions Navigate Bax ew Mi e View Edt Delete Show Show as OneNote Notes Links List List as List Chart New Manage View Show Attached Quality Measures Type to filter F3 Gode xo Sorting Code v 2l No filters applied Code Description Measure List Code Comments Value Type No DA IT 054 Viscosity USP Numeric DA IT 1088 Water KF USP Numeric IE C CEA GERE OUS REA es CSS A A s a v A 11 Once all analyses have been added certify the version so it can be used POM Actions Navigate N eb x New aw amp v gt View r te Notes Links f Delete TSTO072 General No TST0072 Version Code 1 Description Hand made test plan Description 2 Evaluation Schema GENERAL Me New Quality Plan Subforn c c a Lines Find Under Development Line Measure Closed No Code 20000 DA IT v Signatures Adding a new version to an existing quality plan This will be the option most often used once the module is up and running Modified by OLIVIA FELIP Last Date Modified 05 11 2014 Edition Review Plan Type Receipt Work Group Not Measure Man Value Type Numeric Tex Minimum Text Maximur Starting with an existing plan and version when you add a new version the system copies the old version to the new one samples and analyses In this way only the changes have to be modi
69. ts Comments All Mandatory List Results Chart Filter Result Input Matrix Line no Description Measure Nominal Minimum Value Maximum Value Sampling Equipment Value Type Value Frequency 4 CORE 2 9 V 2 9 2 85 2 9 1 50 5 1 52 H11 A 1 52 1 52 1 58 1 50 6 13 8 V 13 8 13 75 13 85 1 50 7 4 2 V 42 42 44 1 50 8 3 2 V 3 2 3 2 34 1 50 9 HEX 3 G9 1 4 V 3 2 973 2 998 PP 10 1 8 V 18 1 75 1 8 1 50 11 1 5 V 1 5 1 45 1 55 1 50 Line Information Line Comments Max Tol 2 95 3 02mm Lot Quantity 5 Equipment E 493 Last user amp date Comments from Plan Check Mycrona calibration before measuring By contrast on the laboratory templates there are no overall comments but there were some associated with each analysis The Comment field shows the comments associated with the analysis selected on the screen In addition the Comment column indicates whether there are comments associated with the line If you click on a cell a page opens allowing you to add or modify the comments Modifying these comments affects the plan and not just the quality order PQM 53 ES HOME ACTIONS E b Show Show Only All 3 NAVIGATE Sample Line Comments Comments Show Show as Edit Result Input Matrix QR00006 sample 1 el we X Refresh Clear Find hart Filter CRONUS Espa a S A Type to filter F3 Description d Result Input Matri P FF x Tal JltOneNote KJ Refresh
70. ze or a fixed quantity It may have an AQL associated with it There are four different types of sample depending on what we are trying to achieve e Identification Typically this allows us to identify check the raw material we have received e Sample library This is used to send a sample of manufactured product or raw material to a special location where it will be stored in case a problem is detected in the future and has to be analysed 8 PQM e Documentation Sample for storing information or a checklist of things to be confirmed e General These are normal quality samples They contain measurement results resulting in the conformity or nonconformity of the batch Depending on how the results are managed the sample may or may not be by items In a sample managed by items measurements are made for every part manufactured or received Each measurement therefore has N results instead of just one Example diameter of an implant If you measure 10 parts you have 10 diameters A sample not managed by individuals has a single result For example richness of mixture 97 This is a single result for the whole sample Although there is a flag to establish whether or not the sample is by items it is important to know that there are two restrictions e An identification sample must be by individuals although it is possible to have just one individual e Asample library sample cannot be by items The other two types may

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