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P26 Pharma QM Basics

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EHP7 for SAP ERP 6.0 February 2014 English Pharma: QM Basics (P26) SAP AG Building Block Configuration Guide
Transcript

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

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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.

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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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