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sap pharma qm
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BB Installation Guide
EHP7 for SAP ERP 6.0February 2014March 2001EnglishEnglish
Pharma: QM Basics (P26)
SAP AGDietmar-Hopp-Allee 1669190 WalldorfGermanyBuilding Block Configuration Guide
Copyright
2013 SAP AG or an SAP affiliate company. All rights reserved.
No part of this publication may be reproduced or transmitted in any form or for any purpose without the express permission of SAP AG. The information contained herein may be changed without prior notice.
Some software products marketed by SAP AG and its distributors contain proprietary software components of other software vendors.
National product specifications may vary.
These materials are provided by SAP AG and its affiliated companies ("SAP Group") for informational purposes only, without representation or warranty of any kind, and SAP Group shall not be liable for errors or omissions with respect to the materials. The only warranties for SAP Group products and services are those that are set forth in the express warranty statements accompanying such products and services, if any. Nothing herein should be construed as constituting an additional warranty.
SAP and other SAP products and services mentioned herein as well as their respective logos are trademarks or registered trademarks of SAP AG in Germany and other countries. Please see http://www.sap.com/corporate-en/legal/copyright/index.epx#trademark for additional trademark information and notices.Icons
IconMeaning
Caution
Example
Note
Recommendation
Syntax
Typographic Conventions
Type StyleDescription
Example textWords or characters that appear on the screen. These include field names, screen titles, pushbuttons as well as menu names, paths and options.
Cross-references to other documentation.
Example textEmphasized words or phrases in body text, titles of graphics and tables.
EXAMPLE TEXTNames of elements in the system. These include report names, program names, transaction codes, table names, and individual key words of a programming language, when surrounded by body text, for example, SELECT and INCLUDE.
Example textScreen output. This includes file and directory names and their paths, messages, source code, names of variables and parameters as well as names of installation, upgrade and database tools.
EXAMPLE TEXTKeys on the keyboard, for example, function keys (such as F2) or the ENTER key.
Example textExact user entry. These are words or characters that you enter in the system exactly as they appear in the documentation.
Variable user entry. Pointed brackets indicate that you replace these words and characters with appropriate entries.
Contents
5Pharma: QM Basics: Configuration Guide
51Purpose
52Preparation
53Configuration
53.1Edit Catalogs (Maintain Code Groups and Codes)
133.2Edit Catalogs (Maintain Selected Sets)
263.3Define Inspector Qualifications
263.4Maintain Profiles for Default Values
273.5Define Identifier for Inspection Points
293.6Maintain Inspection Types
303.7Maintain Inspection Lot Origins and Assign Inspection Types
313.8Define Default Values for Inspection Type
323.9Defining Physical-Sample Container
323.10Define Qualifications
333.11Configure Planner Group
333.12Assign Material Types to Task List Types
343.13Specify Signature Method for Approval Using Simple Signature
343.14Maintain QM-Settings at Client Level
353.15Defining Object Type for Multiple Specifications
353.16Defining Objects for Multiple Specifications
363.17Maintain Qm Order Types
363.18Define Appraisal Cost Recording
373.19Maintaining Settings at Plant Level (Created in Base Line)
384Master Data
384.1Create Characteristics
384.2Create Inspection Method
394.3Create Master Inspection Characteristics (Qualitative)
394.4Create Master Inspection Characteristics (Quantitative)
404.5Define Sample Drawing Procedures
404.6Create Sampling Procedure
404.7Change Inspection Characteristic (Defects Recording)
414.8Create Work Center
414.9Change Material (Add QM View to Existing Materials)
414.10Change Classes, Add Characteristics
Pharma: QM Basics: Configuration Guide1 Purpose
This configuration guide provides the information you need to set up the configuration of this building block manually.
2 Preparation
Before you start installing this building block, you must install prerequisite building blocks. For more information, see the Building Block Prerequisite Matrix located on the documentation package on the Technical Content Library page.
3 Configuration
3.1 Edit Catalogs (Maintain Code Groups and Codes)Use
The purpose of this activity is to edit catalogs.Procedure
1. Access the activity using one of the following navigation options:
IMG MenuQuality Management ( Quality Planning ( Basic Data ( Catalog ( Edit Catalogs
Transaction CodeQS41
2. Choose activity Edit Code Groups and Codes.
Catalog 1
1. Choose catalog 1, Code group * and choose Enter.
2. Choose New Entries and make the following entries:Code groupShort Text
Code groupStatus
YPA01Appearancereleased
YPA02Colorreleased
YPA03Consistencyreleased
YPA04Sealingreleased
YPA05Packagingreleased
YPA06Documentsreleased
YPA07Friabilityreleased
YPA08Package contentreleased
YPA09Tablet printingreleased
YPA10Countriesreleased
YPA11Identityreleased
YPA12Equivalentreleased
YPA13Claerness / Opalescensereleased
YPA14Color of solutionreleased
3. Go back with F3.
4. Select the first new entry YPA01 and choose in the dialog structure the entry Codes.5. Select New entries:
CodeCode Short Text
01typical
02non typical
03clear
04cloudy
6. Go back with F3.
7. Select the second entry YPA02 and choose in the dialog structure the entry Codes.8. Select the button New entries:
CodeCode Short Text
01typical
02too dark
03too pale
9. Go back with F3.
10. Select entry YPA03 and choose in the dialog structure the entry Codes.11. Select New entries:
CodeCode Short Text
01conform to std.
02viscous
03liquid
04slimy
05free flow
06lumpy
12. Go back with F3.
13. Select entry YPA04 and choose in the dialog structure the entry Codes.14. Select New entries:
CodeCode Short Text
01okay
02tears
03wrinkles
04Holes
15. Go back with F3.
16. Select entry YPA05 and choose in the dialog structure the entry Codes.
17. Go on with New entries:
CodeCode Short Text
01okay
02damaged
03wet
18. Go back with F3.
19. Select entry YPA06 and choose in the dialog structure the entry Codes.
20. go on with New entries:
CodeCode Short Text
01complete
02not complete
03preliminary
21. Go back with F3.
22. Select entry YPA07 and choose in the dialog structure the entry Codes.
23. Go on with New entries:
CodeCode Short Text
01meets USP requirements
02does not meet USP requirements
24. Go back with F3.
25. Select entry YPA08 and choose in the dialog structure the entry Codes.
26. Go on with New entries.CodeCode Short Text
01complete
02leaflet missing
03imprint missing
27. Go back with F3.
28. Select entry YPA09 and choose in the dialog structure the entry Codes.29. Go on with New entries.CodeCode Short Text
01okay
02not okay
30. Go back with F3.
31. Select entry YPA10 and choose in the dialog structure the entry Codes.32. Go on with New entries.CodeCode Short Text
01Germany
02United States
03Great Britain
04Switzerland
05France
06Japan
33. Go back with F3.
34. Select entry YPA11 and choose in the dialog structure the entry Codes.35. Go on with New entries.CodeCode Short Text
01okay
02not okay
36. Go back with F3.
37. Select entry YPA12 and choose the entry Codes in the dialog structure.38. Choose New Entries, and enter the following values:
CodeCode Short Text
01complies
02doesn't comply
39. Choose F3 to go back.
40. Select entry YPA13 and choose the entry Codes in the dialog structure.41. Choose New Entries, and enter the following values:
CodeCode Short Text
01 Ref. II
42. Choose F3 to go back.
43. Select entry YPA14 and choose the entry Codes in the dialog structure.44. Choose New Entries, and enter the following values:
CodeCode Short Text
01 GG3
45. Choose F3 to go back.
46. Save your entries.Catalog 21. Choose catalog 2, Code group * and choose Enter.
2. Choose New Entries and make the following entries:
CodegroupShort Text CodegroupStatus
YP-TASKTasks Pharmareleased
3. Go back with F3.
4. Select the new entry YP-TASK and choose in the dialog structure the entry Codes.5. Go on with New entries:
CodeCode Short Text
01Receipt information Pharmacies
02Receipt information Hospitals
03Trigger recall
6. Go back with F3.
7. Save your entries.
Catalog 31. Choose catalog 3, Code group * and choose Enter.
2. Choose New Entries and make the following entries:
CodegroupShort Text CodegroupStatus
YP-SMUD for Sample Managementreleased
YPSTABIPharma: UD for Stability StudyReleased
3. Go back with F3.
4. Select the new entry YP-SM and choose in the dialog structure the entry Codes.5. Go on with New entries.
CodeCode Short Text
YP01released
YP02retest
YP03reject
YP04disposal
6. Go back with F3.
7. Select the new entry YPSTABI and choose in the dialog structure the entry Codes.8. Go on with New entries.
CodeCode Short Text
01Study Will Be Executed
02Continue Study
03Complete: Study Will Not Be Executed
04Cancel: Study Will Not Be Executed
05Complete Study
06Cancel Study
07No Follow-Up Actions
9. Save your entries.
Catalog 51. Choose catalog 5, Code group * and choose Enter.
2. Choose New Entries and make the following entries:
CodegroupShort Text CodegroupStatus
YPD01Defect causes syrupReleased
YPD02Defect causes tabletsReleased
3. Go back with F3.
4. Select the first new entry YPD01 and choose in the dialog structure the entry Codes.5. Go on with New entries:CodeCode Short Text
01low amount of active ingredient
02viscosity to low
03wrong packaging material
04Other
6. Go back with F3.
7. Select the second new entry YPD02 and choose in the dialog structure the entry Codes.
8. Go on with New entries:
CodeCode Short Text
01low amount of active ingredient
02weak compression
03wrong packaging material
04Other
9. Go back with F3.
10. Save your entries.
Catalog 81. Choose catalog 8, Code group * and choose Enter.
2. Choose New entries and make the following entries:
CodegroupShort Text CodegroupStatus
YP-ACTActivities PharmaReleased
3. Go back with F3.
4. Select the new entry YP-ACT and choose in the dialog structure the entry Codes.5. Go on with New entries:
CodeCode Short Text
01Check internal reports
02Inform responsible persons
03Trigger batch traceability
6. Go back with F3.
7. Save your entries.
Catalog 91. Choose catalog 9, Code group * and choose Enter.
2. Choose New Entries and make the following entries:
CodegroupShort Text CodegroupStatus
YP-PProduction tabletsReleased
YPP01Problems PharmacyReleased
YPP02Problems HospitalsReleased
YPP03Problems DoctorsReleased
3. Go back with F3.
4. Select the first new entry YP-P and choose in the dialog structure the entry Codes.5. Go on with New entries.CodeCode Short Text
01Impure raw material
02Water content too high
03Inhomogeneous raw material
6. Go back with F3.
7. Select the second new entry YPP01 and choose in the dialog structure the entry Codes.8. Go on with New entries:CodeCode Short Text
01Wrong amount delivered
02Wrong material
03Damaged packaging
04Other
9. Go back with F3.
10. Select the third new entry YPP02 and choose in the dialog structure the entry Codes.11. Go on with New entries:CodeCode Short Text
01Quality problems
02Missing documents
03Damaged packaging
04Other
12. Go back with F3.
13. Select the fourth new entry YPP03 and choose in the dialog structure the entry Codes.14. Go on with New entries:CodeCode Short Text
01Sample delivery missing
02Expiration date too low
03Damaged packaging
04Other
15. Go back with F3.
16. Save your entries.
Catalog E1 Choose catalog E, Code group * and choose Enter.
2 Choose New Entries and make the following entries:
CodegroupShort Text CodegroupStatus
YPE01Defect locations PharmaReleased
3 Go back with F3.
4 Select the new entry YPE01 and choose in the dialog structure the entry Codes.5 Go on with New entries:
CodeCode Short Text
01Production preparation
02Filling line
03Packaging line
04Final delivery
05Wholesaler
06Other
6 Go back with F3.
7 Choose Save.3.2 Edit Catalogs (Maintain Selected Sets)Use
The purpose of this activity is to edit catalogs/ to maintain selected sets for plant 1000Procedure1. Access the activity using one of the following navigation options:
IMG MenuQuality Management ( Quality Planning ( Basic Data ( ( Catalog ( Edit Catalogs
Transaction CodeQS51
2. Choose the activity Edit Selected Sets.
Catalog 11 Choose catalog 1, plant 1000, Code group * and choose Enter.
2 Choose New Entries and make the following entries:
Selected SetShort Text
Selected SetStatus
YP01Colour / Farbereleased
YP02Appearance general / Aussehenreleased
YP03Sealing / Siegelungreleased
YP04Packaging / Verpackungreleased
YP05Documents / Dokumentereleased
YP06Identity / Identittsprfungreleased
YP07Friabilityreleased
YP08Package content / Packungsinhaltreleased
YP09Tablet printing / Tablettenaufdruckreleased
YP10Countries / Lnderreleased
YP11Consistency / Konsistenzreleased
YP12Equivalentreleased
YP13Claerness/Opalescensereleased
YP14Color of solutionreleased
3 Go back with F3.
4 Select the first new entry YP01 and choose in the dialog structure the entry Selected Set Codes5 Go on with New entries:
Select. SetShort Text Selected SetCodegroupShort Text Codegr.CodeCode Short TextCode ValuationDefect Class
YP01Colour / FarbeYPA02Colour01typicalok
YP01Colour / FarbeYPA02Colour02too darkNot okMajor defect
YP01Colour / FarbeYPA02Colour03too paleNot okMajor defect
6 Go back with F3.
7 Select the second new entry YP02 and choose in the dialog structure the entry Selected Set Codes.8 Go on with New entries:Select. SetShort Text Selected SetCodegroupShort Text Codegr.CodeCode Short TextCode ValuationDefect Class
YP02Appearance general / AussehenYPA01Appearance01typicalOk
YP02Appearance general / AussehenYPA01Appearance02non typicalNot okCritical defect
YP02Appearance general / AussehenYPA01Appearance03clearOk
YP02Appearance general / AussehenYPA01Appearance04cloudyNot okMinor defect
9 Go back with F3.
10 Select the second new entry YP03 and choose in the dialog structure the entry Selected Set Codes.11 Go on with New entries.Select. SetShort Text Selected SetCodegroupShort Text Codegr.CodeCode Short TextCode ValuationDefect Class
YP03Sealing / SiegelungYPA04Sealing01okayok
YP03Sealing / SiegelungYPA04Sealing02tearsNot okCritical defect
YP03Sealing / SiegelungYPA04Sealing03wrinklesNot okMajor defect
YP03Sealing / SiegelungYPA04Sealing04HolesNot okCritical defect
12 Go back with F3.
13 Select the second new entry YP04 and choose in the dialog structure the entry Selected Set Codes.14 Go on with New entries.Select. SetShort Text Selected SetCodegroupShort Text Codegr.CodeCode Short TextCode ValuationDefect Class
YP04Packaging / VerpackungYPA05Packaging01okayOk
YP04Packaging / VerpackungYPA05Packaging02damagedNot okMajor defect
YP04Packaging / VerpackungYPA05Packaging03wetNot okMajor defect
15 Go back with F3.
16 Select the second new entry YP05 and choose in the dialog structure the entry Selected Set Codes.17 Go on with New entries.Select. SetShort Text Selected SetCodegroupShort Text Codegr.CodeCode Short TextCode ValuationDefect Class
YP05Documents / DokumenteYPA06Documents01completeOk
YP05Documents / DokumenteYPA06Documents02not completeNot okMajor defect
YP05Documents / DokumenteYPA06Documents03preliminaryOk
18 Go back with F3.
19 Select the second new entry YP06 and choose in the dialog structure the entry Selected Set Codes.20 Go on with New entries.Select. SetShort Text Selected SetCodegroupShort Text Codegr.CodeCode Short TextCode ValuationDefect Class
YP06Identity / IdentittsprfungYPA11Identity01okayok
02not okayNot okcriticaldefect
21 Go back with F3.
22 Select the second new entry YP07 and choose in the dialog structure the entry Selected Set Codes.23 Go on with New entries.Select. SetShort Text Selected SetCodegroupShort Text Codegr.CodeCode Short TextCode ValuationDefect Class
YP07
FriabilityYPA07Friability01meets USP requirementsok
YP07
FriabilityYPA07Friability02does not meet USP requirementsNot okMajor defect
24 Go back with F3.
25 Select the second new entry YP08 and choose in the dialog structure the entry Selected Set Codes.26 Go on with New entries:Select. SetShort Text Selected SetCodegroupShort Text Codegr.CodeCode Short TextCode ValuationDefect Class
YP08Package content / PackungsinhaltYPA08Package content01completeOk
YP08Package content / PackungsinhaltYPA08Package content02leaflet missingNot okMajor defect
YP08Package content / PackungsinhaltYPA08Package content03imprint missingNot okMajor defect
27 Go back with F3.
28 Select the second new entry YP09 and choose in the dialog structure the entry Selected Set Codes.29 Go on with New entries:Select. SetShort Text Selected SetCodegroupShort Text Codegr.CodeCode Short TextCode ValuationDefect Class
YP09Tablet printing / TablettenaufdruckYPA09Tablet printing01okayOk
YP09Tablet printing / TablettenaufdruckYPA09Tablet printing02not okayNot okMajor defect
30 Go back with F3.
31 Select the second new entry YP10 and choose in the dialog structure the entry Selected Set Codes.32 Go on with New entries:Select. SetShort Text Selected SetCodegroupShort Text Codegr.CodeCode Short TextCode ValuationDefect Class
YP10Countries / LnderYPA10Countries01Germanyok
YP10Countries / LnderYPA10Countries02United Statesok
YP10Countries / LnderYPA10Countries03Great Britainok
YP10Countries / LnderYPA10Countries04Switzerlandok
YP10Countries / LnderYPA10Countries05Franceok
YP10Countries / LnderYPA10Countries06Japanok
33 Go back with F3.
34 Select the second new entry YP11 and choose in the dialog structure the entry Selected Set Codes.35 Go on with New entries:Select. SetShort Text Selected SetCodegroupShort Text Codegr.CodeCode Short TextCode ValuationDefect Class
YP11Consistency / KonsistenzYPA01Consistency03clearok
YP11Consistency / KonsistenzYPA03Consistency02viscousok
YP11Consistency / KonsistenzYPA03Consistency03liquidNot okMajor defect B
YP11Consistency / KonsistenzYPA03Consistency04slimyNot okMajor defect A
36 Go back with F3.
37 Select the second new entry YP12 and choose in the dialog structure the entry Selected Set Codes.38 Go on with New entries:Select. SetShort Text Selected SetCodegroupShort Text Codegr.CodeCode Short TextCode ValuationDefect Class
YP12EquivalentYPA12Equivalent01Compliesok
YP12EquivalentYPA12Equivalent02doesn't complyNot okCritical defect
39 Go back with F3.
40 Select the second new entry YP13 and choose in the dialog structure the entry Selected Set Codes.41 Go on with New entries:Select. SetShort Text Selected SetCodegroupShort Text Codegr.CodeCode Short TextCode ValuationDefect Class
YP13Claerness/OpalescenseYPA13Claerness01 Ref. IINot okMajoy defect A
42 Go back with F3.
43 Select the second new entry YP14 and choose in the dialog structure the entry Selected Set Codes.44 Go on with New entries:Select. SetShort Text Selected SetCodegroupShort Text Codegr.CodeCode Short TextCode ValuationDefect Class
YP14Color of solutionYPA14Color of solution01 GG3Not okMajoy defect A
45 Go back with F3.
46 Select the second new entry YPCAL01 and choose in the dialog structure the entry Selected Set Codes.47 Go on with New entries:Select. SetShort Text Selected SetCodegroupShort Text Codegr.CodeCode Short TextCode ValuationDefect Class
YPCAL01Test Result / PrfergebnisYPCAL01Test Result01ok
YPCAL01Test Result / PrfergebnisYPCAL01Test Result05Not okMajoy defect A
48 Go back with F3.
49 Save your entries.Catalog 31 Choose catalog 3, plant 1000, Code group * and choose Enter.
2 Choose New Entries and make the following entries:
Selected SetShort Text
Selected SetStatus
YPVE-CAL Calibration / Kalibrierung Released
YPVE-GR Goods receipt / Wareneingang) Released
YPVE-REReturns inspection / RetourenprfungReleased
YPVE-SMSample management / ProbenverwaltungReleased
YPVE-IPCInprocess control/ In-Prozess-KontrolleReleased
YPST16Pharma: Stability Study (Follow-up test)Released
YPST1601Pharma: Stability Study (Initial Test)Released
YPST1602Pharma: St Study (Manual follow-up test)Released
3 Select the new entry YPVE-CAL and choose in the dialog structure the entry Selected Set Codes.4 Choose New Entries and make the following entries:
Select. SetShort Text Selected SetCode groupShort Text Code groupCodeCode Short TextCode
Val.Q-ScorePost. proposal UDFollow-up action
YPVE-CALCalibration / Kalibrierung14Usage decision for calibration inspect.ACan be usedok100NoneQM_PM
YPVE-CALCalibration / Kalibrierung14Usage decision for calibration inspect.R1Adjust-ment requiredNot ok50NoneQM_PM2
YPVE-CALCalibration / Kalibrierung14Usage decision for calibration inspect.R2Cannot be usedNot ok1NoneQM_PM2
5 Go back with F3.
6 Select the new entry YPVE-GR and choose in the dialog structure the entry Selected Set Codes.7 Make the following entries with New entries:Select. SetShort
Text
Selected SetCode groupShort Text Code groupCodeCode Short TextCode
Val.Q-
ScorePost. proposal UDFollow-up action
YPVE-GRGoods receipt / Wareneingang01UD for goods rec. from external deliveryA
Acceptok100Unrestr. Use, unrestr. Batch status
YPVE-GRGoods receipt / Wareneingang01UD for goods rec. from external deliveryAX
Other acceptance decision (see UD text)ok100
YPVE-GRGoods receipt / Wareneingang01UD for goods rec. from external deliveryAZ
Accept (Batch Revaluation)ok100Unrestr. Use, unrestr. Batch statusZ_ACTIVE
YPVE-GRGoods receipt / Wareneingang01UD for goods rec. from external deliveryR
RejectedNot ok1
YPVE-GRGoods receipt / Wareneingang01UD for goods rec. from external deliveryR11
Return delivery of defective quantityNot ok20
YPVE-GRGoods receipt / Wareneingang01UD for goods rec. from external deliveryR111
Return def. qty. with mailNot ok20Return delivery, blocked batch statusMAIL3
YPVE-GRGoods receipt / Wareneingang01UD for goods rec. from external deliveryR2
Rework the rejected quantityNot ok60
YPVE-GRGoods receipt / Wareneingang01UD for goods rec. from external deliveryR21
Rework the rej. qty. with mailNot ok60MAIL3
YPVE-GRGoods receipt / Wareneingang01UD for goods rec. from external deliveryR3
Scrapping of rejected quantityNot ok20
YPVE-GRGoods receipt / Wareneingang01UD for goods rec. from external deliveryRQ
Rejection with Q-activityNot ok1MAIL3
YPVE-GRGoods receipt / Wareneingang01UD for goods rec. from external deliveryRXOther rej. decision (see the UD text)Not ok1
8 Go back with F3.
9 Select the new entry YPVE-IPC and choose in the dialog structure the entry Selected Set Codes.10 Make the following entries with the button New entries:Select. SetShort Text Selected SetCode groupShort Text Code groupCodeCode Short TextCode
Val.Q-ScorePost. proposal UDFollow-up action
YPVE-IPCInprocess control/ In-Prozess-Kontrolle3UD for inspection lots in productionAAccept
ok100nonemanual
YPVE-IPCInprocess control/ In-Prozess-Kontrolle3UD for inspection lots in productionA1Other batch
ok100nonemanual
YPVE-IPCInprocess control/ In-Prozess-Kontrolle3UD for inspection lots in productionA2Other material
ok80nonemanual
YPVE-IPCInprocess control/ In-Prozess-Kontrolle3UD for inspection lots in productionRRejected
Not ok1nonemanual
YPVE-IPCInprocess control/ In-Prozess-Kontrolle3UD for inspection lots in productionR1Return delivery
Not ok20nonemanual
YPVE-IPCInprocess control/ In-Prozess-Kontrolle3UD for inspection lots in productionR2Rework
Not ok40nonemanual
YPVE-IPCInprocess control/ In-Prozess-Kontrolle3UD for inspection lots in productionR3Scrapping
Not ok1nonemanual
YPVE-IPCInprocess control/ In-Prozess-Kontrolle3UD for inspection lots in productionR4Start 100% inspection
Not ok60nonemanual
YPVE-IPCInprocess control/ In-Prozess-Kontrolle3UD for inspection lots in productionRQReject and start Q-activity
Not ok1nonemanual
YPVE-IPCInprocess control/ In-Prozess-Kontrolle3UD for inspection lots in productionXOther usage decision (see the UD text)Not ok50nonemanual
11 Go back with F3.
12 Select the new entry YPVE-RE and choose in the dialog structure the entry Selected Set Codes.13 Go on with New entries:Select. SetShort Text Selected SetCode groupShort Text Code groupCodeCode Short TextCode
ValQ-ScorePost. proposal UDFollow-up action
YPVE-REReturns inspection / Retourenprfung02UD for goods issueAAcceptok100NoneNone
YPVE-REReturns inspection / Retourenprfung02UD for goods issueR2ReworkNot ok10NoneNone
YPVE-REReturns inspection / Retourenprfung02UD for goods issueR3ScrappingNot ok1NoneNone
YPVE-REReturns inspection / Retourenprfung02UD for goods issueXOther usage decision (see the UD text)Not ok1noneNone
14 Go back with F3.
15 Select the entry YPVE-SM and choose in the dialog structure the entry Selected Set Codes.16 Go on with New entries.Select. SetShort Text Selected SetCode groupShort Text Code groupCodeCode Short TextCode
Val.Q-ScorePost. proposal UDFollow-up action
YPVE-SMSample management / ProbenverwaltungYP-SMUD for Sample ManagementYP01releasedOk100NoneNone
YPVE-SMSample management / ProbenverwaltungYP-SMUD for Sample ManagementYP02retestNot ok50NoneNone
YPVE-SMSample management / ProbenverwaltungYP-SMUD for Sample ManagementYP03rejectNot ok1NoneNone
YPVE-SMSample management / ProbenverwaltungYP-SMUD for Sample ManagementYP04disposalNot ok1noneNone
17 Go back with F3.
18 Select the entry YPST16 and choose in the dialog structure the entry Selected Set Codes.19 Go on with New entries.Select. SetShort Text Selected SetCode groupShort Text Code groupCodeCode Short TextCode
Val.Q-ScorePost. proposal UDFollow-up action
YPST16Pharma: Stability Study (Follow-up test)YPSTABIPharma: UD for Stability Study02Continue StudyAccepted100NoneNone
YPST16Pharma: Stability Study (Follow-up test)YPSTABIPharma: UD for Stability Study05Complete StudyAccepted100NoneNone
YPST16Pharma: Stability Study (Follow-up test)YPSTABIPharma: UD for Stability Study06Cancel StudyAccepted100NoneNone
20 Go back with F3.
21 Select the entry YPST1601 and choose in the dialog structure the entry Selected Set Codes.22 Go on with New entries.Select. SetShort Text Selected SetCode groupShort Text Code groupCodeCode Short TextCode
Val.Q-ScorePost. proposal UDFollow-up action
YPST1601 Pharma: Stability Study (Initial Test)YPSTABIPharma: UD for Stability Study01Study Will Be ExecutedAccepted100NoneNone
YPST1601 Pharma: Stability Study (Initial Test)YPSTABIPharma: UD for Stability Study03Complete: Study Will Not Be ExecutedAccepted100NoneNone
23 Go back with F3.
24 Select the entry YPST1602 and choose in the dialog structure the entry Selected Set Codes.25 Go on with New entries.Select. SetShort Text Selected SetCode groupShort Text Code groupCodeCode Short TextCode
Val.Q-ScorePost. proposal UDFollow-up action
YPST1602 Pharma: St Study (Manual follow-up test)YPSTABIPharma: UD for Stability Study05Complete StudyAccepted100NoneNone
YPST1602Pharma: St Study (Manual follow-up test)YPSTABIPharma: UD for Stability Study06Cancel StudyAccepted100NoneNone
YPST1602Pharma: St Study (Manual follow-up test)YPSTABIPharma: UD for Stability Study07No Follow-Up ActionsAccepted100NoneNone
26 Go back with F3.
27 Save your entries.3.3 Define Inspector QualificationsUse
The purpose of this activity is to define inspector qualifications.Procedure
1. Access the activity using one of the following navigation options:
IMG MenuQuality Management ( Quality Planning ( Basic Data ( Inspection Characteristic, Inspection Method ( Define Inspector Qualifications
Transaction CodeSPRO
2. Choose New entries and make the following entries:
Inspection QualificationShort Text Qualification
YP001Head of quality control
YP002PTA
3. Save your entries.
3.4 Maintain Profiles for Default ValuesUse
The purpose of this activity is to maintain profiles for default values.Procedure
1. Access the activity using one of the following navigation options:
IMG MenuQuality Management ( Quality Planning ( Inspection Planning ( General ( Maintain Profiles for Default Values
Transaction CodeOQ84
2. Choose the activity Profile: default values plan/general3. Choose New entries and make the following entries:
PlantUsageStatus
100054
4. Save your entries.3.5 Define Identifier for Inspection PointsUse
The purpose of this activity is to define identifier for inspection points.Procedure
1. Access the activity using one of the following navigation options:
IMG MenuQuality Management ( Quality Planning ( Inspection Planning ( General ( Define Identifier for Inspection Points
Transaction CodeSPRO
2. Select field combination 200 and go to details:
3. Select the tab page Valuation and make the following entries:
Field CombinationInspection Plan TypeShort TextDefault for Valuation Inspection PointDefault when all chars are acceptedDefault when at least one char. is rejected
PlantSelected SetCodegroupCodeCodegroupCode
200
3=Inspection point for phys. sampleInspection point for phys. sample1000YPVE-SMYP01YP-SMYP03YP-SM
4. Choose New entries and make the first new entry YP1:
Field nameDescriptionUser action and valuesNote
Field combinat:YP1
Description for YP1Insp.point for phys. samples
InspPt type: 3
5. Select tab page Fields:Field Combination: YP1 Field ActionKeyword
Physical sample1Physical sample
Text length 18
2Sampling location
Text length 10
Number length 10
Number length 3
Date3Sampling date
TimeTime4Sampling time
6. Select tab page Valuation:
Field CombinationInspection Plan TypeShort TextDefault for Valuation Inspection PointDefault when all chars are acceptedDefault when at least one char. is rejected
PlantSelected SetCodegroupCodeCodegroupCode
YP13=Inspection point for phys. sampleInsp.point for phys. samples with loc.1000YPVE-SMYP01YP-SMYP03YP-SM
7. Go back with F3.
8. Choose New entries and make the second new entry YP2:
Field nameDescriptionUser action and valuesNote
Field combinat:YP2
Description for YP2Generated insp. points; shift-ID
InspPt type:
9. Select tab page Fields:Field Combination: YP2 Field ActionKeyword
Text length 18
3Shift-ID
Text length 10
Number length 10
Number length 3
Date
1Drawing Date
Time
2Drawing Time
10. Select tab page Valuation:
Field CombinationInspection Plan TypeShort TextDefault for Valuation Inspection PointDefault when all chars are acceptedDefault when at least one char. is rejected
PlantSelected SetCodegroupCodeCodegroupCode
YP2Freely-defined inspection pointGenerated insp. points, shift-ID1000YPVE-IPC03A03R
11. Select tab page Function modules:
The function module that is defined for automatic creation of inspection points is "QAPP_CUST_IP_CREATE".
12. Save your entries.
3.6 Maintain Inspection TypesUse
The purpose of this activity is to maintain inspection types.
Procedure
1. Access the activity using one of the following navigation options:
IMG MenuQuality Management ( Quality Inspection ( Inspection Lot creation ( Maintain Inspection Types
Transaction CodeSPRO
2. Change the settings for the following inspection types as described in the table:
YP01YP0101YP03YP04YP06YP15YP16YP1601YP1602YP89
Phys.-sample type01010202050808
UD selected setYPVE-GRYPVE-GRIPVE-IPCYPVE-GRYPVE-REYPVE-SMYPST16YPST1601YPST1602YPVE-GR
Sel. Set in the same plantXXXXXXXXXX
Notification typeQ2F2F3F3F1F3F3F3F3Q3
Task list usage551-5699995
3. Save your entries.3.7 Maintain Inspection Lot Origins and Assign Inspection TypesUse
The purpose of this activity is to maintain Inspection Lot Origins and Assign Inspection Types
Procedure
1. Access the activity using one of the following navigation options:
IMG MenuQuality Management ( Quality Inspection ( Inspection Lot creation ( Maintain Inspection Lot Origins and Assign Inspection Types
Transaction CodeSPRO
2. Select all inspection types and check against the following settings:
LOVarInspType
010101
020101
030130
04YP01
05YP0101
030103
02YP03
040104
02YP04
050105
060106
02YP06
090109
150115
02YP15
160116
021601
031602
04YP16
05YP1601
06YP1602
890189
02YP89
3. Save your entries.3.8 Define Default Values for Inspection TypeUse
The purpose of this activity is to define default values for inspection type
Procedure1. Access the activity using one of the following navigation options:
IMG MenuQuality Management ( Quality Inspection ( Inspection Lot Creation ( Define Default Values for Inspection Type
Transaction CodeSPRO
2. Maintain the default values for the inspection types as shown in the following table:
YP01YP0101YP03YP04YP06YP15YP16YP1601YP1602YP89
Insp. By task listXXXXXXXXXX
Insp by spec.
Insp. Acc. To conf.
Assign rqmts. Automat.XXXXXXXXX
Rec. charact. ResultsXXXXXXXXXX
Serial no. possibleXXXXXX
100% inspectionXX
Skips allowedXXXXX
Post to insp. StockXXX
Control Insp. Lot222111
Automat. Usage decision
Q score procedure06060606060606060606
3. This table contains only the most important parameters. The ones which are not listed here must be deactivated.
4. Save your entries.3.9 Defining Physical-Sample ContainerUse
The purpose of this activity is to define physical-sample container.Procedure1. Access the activity using one of the following navigation options:
IMG MenuQuality Management ( Quality Inspection ( Sample Management ( Define Physical-Sample Container
Transaction CodeSPRO
2. Choose New Entries and make the following entries:
Physical Sample ContainerShort Text
YP0001Sample container PE brown
YP0002Sample container PE clear
YP0003Sample container glass brown
YP0004Sample container glass clear
3. Save your entries.
3.10 Define QualificationsUse
The purpose of this activity is to define work center qualification.
Procedure
1. Access the activity using one of the following navigation options:
IMG MenuQuality Management ( Quality Planning ( Inspection Planning ( Operation ( Work Center ( Define Qualifications
Transaction CodeSPRO
2. Select plant 1000 in determine work area entry and choose Enter.3. Make the following entries:
SuitabilityText
QMQuality Control
4. Save your entries.3.11 Configure Planner GroupUse
The purpose of this activity is to define the Planner Group.Procedure
1. Access the activity using one of the following navigation options:
IMG MenuQuality Management ( Quality Planning ( Inspection Planning ( General ( Define Planner Group
Transaction CodeSPRO
2. Choose New entries and make the following entries:
PlantPlanner GroupDescription
1000QQuality Assurance
3. Save your entries.3.12 Assign Material Types to Task List TypesUse
The purpose of this activity is to assign task list type to material type.Procedure
1. Access the activity using one of the following navigation options:
IMG MenuQuality Management ( Quality Planning ( Inspection Planning ( General ( Assign Task List Type to Material Type
Transaction CodeSPRO
2. Choose New Entries and enter the following values:
TL TypeDescriptionMTypMType Description
QInspection PlanVERPPackaging
3. Save and go back.3.13 Specify Signature Method for Approval Using Simple SignatureUse
The purpose of this activity is to specify signature for simple signature.Procedure
1. Access the activity using one of the following navigation options:
IMG MenuProduction Planning for Process Industries ( Process Management ( Control Recipes / PI Sheets ( Digital Signatures ( Specify Signature Method for Approval Using Simple Signature
Transaction CodeSPRO
2. Choose New Entries and enter the following values:
Sign. obj.Sign. meth.
20 - Inspection lot: results recordingR System signature with authorization by R/3 user ID/password
21 - Inspection lot: usage decisionR System signature with authorization by R/3 user ID/password
22 - Sample drawingR System signature with authorization by R/3 user ID/password
3. Save and go back.3.14 Maintain QM-Settings at Client LevelUse
The purpose of this activity is to maintain QM-settings at client level.Procedure
1. Access the activity using one of the following navigation options:
IMG MenuQuality management (Basic Settings ( Maintain Settings at Client Level
Transaction CodeSPRO
2. Enter the following values:
Field nameUser action
Replace master insp. Charac.Select
Replace inspection methodSelect
Unplanned characteristics8000
Chars from spec/config/batch9000
Multiple specsSelect
Value rule for lot-based dyn. Mod.QDQL_U_D_WORST_CASE
Bom usagePP01
3. Save and go back to configuration menu.
3.15 Defining Object Type for Multiple SpecificationsUse
The purpose of this activity is to define Object Types for Multiple Specifications.
Procedure1. Access the activity using one of the following navigation options:
IMG MenuQuality management ( Quality Planning ( Inspection Planning ( General ( Multiple Specifications ( Define Object Types for Multiple Specifications
Transaction CodeSPRO
2. Enter the following entries:
Type of Object for Multiple SpecificationsShort TextClass Characteristic (Valuation "Suitable For")Class Characteristic (Valuation "Not Suitable for")
01Country
LOBM_COUNTRY_OKLOBM_COUNTRY_NOK
02CustomerLOBM_CUSTOMER_OKLOBM_CUSTOMER_NOK
3. Save your entries.3.16 Defining Objects for Multiple SpecificationsUse
The purpose of this activity is to define objects for multiple specifications
Procedure1. Access the activity using one of the following navigation options:
IMG MenuQuality management ( Quality Planning Inspection Planning -( General ( Multiple Specifications ( Define Objects for Multiple Specifications
Transaction CodeSPRO
2. Make the following entries:
Object for Multiple SpecificationsText for Key of Object for Multiple SpecificationType of Object for Multiple SpecificationsCountry Key
DEGermany01DE
FRFrance01FR
USAUSA01US
3. Save your entries.3.17 Maintain Qm Order TypesUse
The purpose of this activity is to maintain QM order types.
Procedure1. Access the activity using one of the following navigation options:
IMG MenuQuality Management ( Environment ( Central Functions ( Maintain QM Order Types
Transaction CodeSPRO
2. Choose the activity Maintain Costing Parameter for Q-Costs-Order Types by Plant3. Select the first entry (QL01) and go on with copy as (F6).
4. Overwrite plant 0001 with 1000.
5. Go back with F3.
6. Select the second entry (QL02) and go on with copy as (F6)
7. Overwrite plant 0001 with 1000
8. Go back with F3
9. Select the first entry (QN01) and go on with copy as (F6)
10. Overwrite plant 0001 with 1000
11. Go back with F3.
12. Save your entries.
3.18 Define Appraisal Cost RecordingUse
The purpose of this activity is to define Appraisal Cost Recording.
Procedure1. Access the activity using one of the following navigation options:
IMG MenuQuality management Quality Inspection Define Appraisal Cost Recording(
Transaction CodeSPRO
2. Choose the activity Maintain Parameters of Order Confirmation3. Choose the entry with plant 0001 and Order Types (QL01 and QL02) and choose Copy as (F6).
4. Overwrite plant 0001 with 1000.
5. Save your entries.
6. Choose the activity Maintain Additional Confirmation Parameters7. Choose the entry with plant 0001 and Order Types (QL01 and QL02) and choose Copy as (F6).
8. Overwrite plant 0001 with 1000.
9. Save your entries.3.19 Maintaining Settings at Plant Level (Created in Base Line)Use
The purpose of this activity is to maintain settings at plant levelProcedure
1. Access the activity using one of the following navigation options:
IMG MenuQuality Management ( Basic Settings ( Maintain Settings at Plant Level
Transaction CodeSPRO
2. Choose Change View Plant-Dependent QM Settings
3. Select plant 1000.
4. Choose the Basic data tab.
5. Set Change with history' for master inspection characteristics and methods
6. Choose the Insp. lot creation tab.
7. Enter Recording of number of container possible for field Enter container at GR
8. Choose the Results Recording tab.
9. From the menu, choose Recording configuration ( Automatic close.10. Choose the InsLot completion tab.
11. Select Batch valuation without material specification.12. Save your entries.
4 Master DataThe following activities describe the master data required for this Building Block. The steps do not describe the transactions in detail but list the relevant transaction and the corresponding master data file. For more details on using the individual transactions please refer to the Online Help in the system.4.1 Create CharacteristicsUse
The purpose of this activity is to create a characteristic to describe the properties of objects.
Procedure
1. Access the activity using one of the following navigation options:
SAP MenuCross-Application Components ( Classification System ( Master Data ( Characteristics
Transaction CodeCT04
2. Refer to the following file for details of the master data required: SMB99_CHARACTERISTIC_O209_J01_P26.TXT.4.2 Create Inspection MethodUse
The purpose of this activity is to create inspection methods to describe how to carry out an inspection for an inspection characteristic. Procedure
1. Access the activity using one of the following navigation options:
SAP MenuQuality Management ( Quality Planning ( Basic Data ( Inspection Method ( Create
Transaction CodeQS31
2. Refer to the following file for details of the master data required: SMB10_QS31_O001_P26.TXT.4.3 Create Master Inspection Characteristics (Qualitative)Use
The purpose of this activity is to create qualitative master inspection characteristics for stability studies.
Procedure
1. Access the activity using one of the following navigation options:
SAP MenuQuality Management ( Quality Planning ( Basic Data ( Inspection Characteristic ( Create
Transaction CodeQS21
2. Refer to the following file for details of the master data required: SMB10_QS21_O002_P26.TXT.4.4 Create Master Inspection Characteristics (Quantitative)Use
The purpose of this activity is to create quantitative master inspection characteristics for stability studies.
Procedure
1. Access the activity using one of the following navigation options:
SAP MenuQuality Management ( Quality Planning ( Basic Data ( Inspection Characteristic ( Create
Transaction CodeQS21
2. Refer to the following file for details of the master data required: SMB10_QS21_O003_P26.TXT.4.5 Define Sample Drawing ProceduresUse
The purpose of this activity is to define sample drawing procedure in which you plan the drawing of physical samples.
Procedure
1. Access the activity using one of the following navigation options:
SAP MenuQuality Management ( Quality Planning ( Basic Data ( Sample ( Sample-Drawing Procedure ( Edit
Transaction CodeQPV2
2. Refer to the following file for details of the master data required: SMB10_QPV2_O005_P26.TXT .4.6 Create Sampling ProcedureUse
The purpose of this activity is to create sampling procedures. A sampling procedure defines the rules that specify how the system calculates the sample size and it contains information about the valuation of an inspection characteristic during results recording (attributive, variable, manual, etc.).Procedure
1. Access the activity using one of the following navigation options:
SAP MenuQuality Management ( Quality Planning ( Basic Data ( Sample ( Sampling Procedure ( Create
Transaction CodeQDV1
2. Refer to the following file for details of the master data required: SMB10_QDV1_O006_P34.TXT.4.7 Change Inspection Characteristic (Defects Recording)Use
The purpose of this activity is to change a master inspection characteristic for defects recording.
Procedure
1.Access the activity using one of the following navigation options:
SAP MenuQuality Management ( Quality Planning ( Basic Data ( Inspection Characteristic ( Create
Transaction CodeQS23
2. Refer to the following file for details of the master data required: SMB10_QS23_O009_P34.TXT.4.8 Create Work CenterUse
The purpose of this activity is to create work centers for quality inspections.
Procedure
1.Access the activity using one of the following navigation options:
SAP MenuQuality Management ( Quality Planning ( Basic Data ( Work Center ( QM Work Center ( Work Cente r( Create
Transaction CodeCR01
2. Refer to the following file for details of the master data required: SMB10_WORK_CENTER_O999_P09_P34.TXT.4.9 Change Material (Add QM View to Existing Materials)Use
The purpose of this activity is to create change master for inspection plans.
Procedure
1.Access the activity using one of the following navigation options:
SAP MenuMaterials Management ( Material Master ( Material ( Change ( Immediately
Transaction CodeMM02
2. Refer to the following file for details of the master data required: SMB10_MM02_O001_P04_P26_01.TXT and SMB10_MM02_O001_P04_P26_02.TXT.4.10 Change Classes, Add CharacteristicsUse
The purpose of this activity is to change classes and add characteristics.
Procedure
1.Access the activity using one of the following navigation options:
SAP MenuCross-Application Components ( Classification System ( Master Data ( CL02 - Classes
Transaction CodeCL02
2. Refer to the following file for details of the master data required: SMBUSE_CL02_O014_P02_P26.TXT.
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