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PART I Quality Management Core Concepts
35
1 Quality Management in SAP ERP
37
1.1 Organizational Structures in SAP ERP
39
1.1.4 Storage Location
42
1.2 Quality Management in the SAP Landscape
42
1.3 Business Processes in QM
44
1.3.1 Quality Engineering
47
1.3.2 Quality Assurance and Control
49
1.3.3 Quality Improvement
51
1.3.4 Product Change Management
53
1.4 Integration with Other Components
54
1.4.1 Materials Management
54
1.4.2 Sales and Distribution
55
2.1 Quality Management View in Material Master
59
2.2.1 Change Master Record
70
2.2.5 Additional Master Record
72
2.3 Master Recipe or Routing
73
2.4 Reference Operation Set
74
2.7 Quality Agreements
78
2.7.1 Quality Assurance Agreement with Vendors
79
2.7.2 Quality Assurance Agreements with Customers
80
2.7.3 Technical Delivery Terms with Customers
80
2.8 Quality Information Record
80
2.9 Master Inspection Characteristic (MIC)
81
2.10 Sampling Procedure
91
2.11.1 Task List Header
96
2.11.2 Inspection Plan Header
97
2.11.3 Material Assignment
99
2.11.4 Test Equipment
100
2.11.5 Operations View
101
2.11.6 Long-Term Characteristic
102
2.11.7 Calculated Characteristic
103
2.11.8 Classed Characteristic
104
2.12 Material Specification
108
3.1 Business Processes in Quality Inspection
112
3.1.1 Inspection Lot Creation
112
3.1.2 Results Recording
116
3.1.5 Defect Recording
126
3.1.6 Inspection Report
128
3.2 Optimization Features of Inspection Planning and Quality Inspection
129
3.2.3 Results Recording
134
3.2.5 Engineering Workbench
149
3.3 Multiple Specifications
152
3.3.1 Configuration Settings
152
3.3.2 Master Data Settings for Multiple Specifications
154
3.3.3 Business Processes in Multiple Specifications
157
3.3.4 Example: Create and Integrate New Inspection Type in Business Process
160
3.4 Configuration Basics: Quality Planning and Quality Inspection
170
3.4.1 Client Settings
171
3.4.3 Quality Planning
179
3.4.4 Quality Inspection
203
PART II Quality Management Integration with Logistics Components
213
4 Integrating QM with Materials Management
215
4.1 Configuration Basics
216
4.1.1 Material Type: Task List Combination
216
4.1.2 Control Key for QM in Procurement
216
4.2 Procurement Business Processes
219
4.2.1 Goods Receipt in Procurement: Inspection Type 01
219
4.2.2 Source Inspection: Inspection Type 0101
226
4.3 Pilot Run Inspection: Inspection Type 0102
231
4.3.1 Configuration Basics
231
4.3.2 QM Master Data Checklist
233
4.3.3 Business Processes of Pilot Run Inspection
233
4.4 Subcontracting: Inspection Type 0130
236
4.4.1 QM Master Data Checklist
237
4.4.2 Subcontracting Purchase Order
237
4.4.3 Transfer Posting of Subcontracting Purchase Order
238
4.4.4 Goods Receipt for Subcontracting Purchase Order
239
4.4.5 Inspection Lot for Subcontracting Purchase Order
240
4.4.6 Invoice Receipt
241
4.5 Inventory Management Processes
241
4.5.1 Stock Transfer Inspection: Inspection Type 08
241
4.5.2 Other Goods Receipt: Inspection Type 05
246
4.6 Handling Inspection Stock at QM Activation: Inspection Type 0800
248
4.6.1 Configuration Settings
248
4.6.2 QM Stock at QM Activation
248
4.6.3 Inspection Lot on QM Activation
249
5 Integrating QM with Production Planning
253
5.1 Configuration Basics
254
5.1.1 Material Type–Task List Combination
254
5.1.2 Order Type Dependent Plant Parameters
254
5.1.3 Confirmation Parameters
256
5.2.1 PP and QM Master Data Checklist
260
5.2.2 QM Data in Master Recipe
260
5.3 Business Processes in Production Planning
263
5.3.1 Process Manufacturing and Discrete Manufacturing
263
5.3.2 Repetitive Manufacturing
274
6 Integrating QM with Sales and Distribution
283
6.1 Configuration Basics
284
6.3 Business Processes
287
6.3.1 Customer Delivery with Sales Order
287
6.3.2 Customer Delivery without Sales Order
291
6.3.4 General Delivery: Business Processes
294
7 Integrating QM with Plant Maintenance
297
7.1 Deciding Which SAP ERP Components to Implement
298
7.1.1 Scenario 1: PM Component without MM Component
299
7.1.2 Scenario 2: PM Component with MM Component
299
7.1.3 Scenario 3: MM Component without PM Component
300
7.1.4 Scenario 4: No MM or PM Component
300
7.2 Defining Test Equipment
300
7.2.1 Test Equipment as Material
300
7.2.2 Test Equipment as PM Equipment
301
7.2.3 Test Equipment as Production Resource/Tool
301
7.2.4 Test Equipment as Document
302
7.3 Configuration Basics
302
7.3.1 Inspection Type Assignment to PM Order Type
303
7.3.2 Serial Number Profile
303
7.4 Test Equipment Master Data
305
7.4.1 Material Serial Number
307
7.4.2 Test Equipment and Serial Number Synchronization
308
7.4.4 General Task List
311
7.4.5 Maintenance Plan
316
7.4.6 Schedule Maintenance Plan
319
7.4.7 Deadline Monitoring
320
7.5 Business Processes in Test Equipment Management
322
7.5.1 Calibration Order
323
7.5.2 QM Inspection Lot for Test Equipment: Inspection Type 14
324
7.5.3 Results Recording
325
7.5.4 Calibration Orders Worklist
327
7.5.5 Calibration Orders Completion
327
8 Optimizing Quality Management
331
8.1 Dynamic Modification Rule (DMR)
332
8.1.1 QM Master Data Maintenance for DMR
333
8.1.2 Business Processes in DMR
344
8.2 Recurring Inspection, Best Before Date, and Shelf Life Expiration Date
346
8.2.1 QM Master Data Checklist
347
8.2.2 Business Processes in Recurring Inspection and BBD/SLED
350
8.3 Active Ingredient Management
354
8.3.1 Configuration Basics: Active Ingredient Management
354
8.3.2 Master Data: Active Ingredient Management
357
8.3.3 Business Processes in Active Ingredient Management
366
8.4.1 Configuration Basics: Batch Derivation
375
8.4.2 Classification in Material Master
375
8.4.3 Batch Derivation: Receiver Material
379
8.4.4 Business Processes in Batch Derivation
381
8.4.5 Process Order and Sender Material Assignment
382
PART III Quality Management Workflow Tools
387
9.1 Plant Settings: Sample Management
390
9.2.1 Sample-Drawing Procedure
391
9.2.2 Inspection Plan
395
9.2.3 QM Master Data Checklist
396
9.3 Business Processes in Sample Management
396
9.3.1 Goods Receipt for Purchase Order
397
9.3.2 Inspection Lot for Goods Receipt
397
9.3.3 Physical Samples for Goods Receipt
398
9.3.4 Label Printing for Physical Sample
399
9.3.5 Release Physical-Sample Drawing
399
9.3.6 Inspection Lots for Physical Samples
400
9.3.7 Results Recording for Pooled Samples (Goods Receipt Inspection)
402
9.3.8 QM Inspection Lot for Physical Sample: Inspection Type 15
403
9.3.9 Create Physical Sample (Manually)
404
9.4 Physical Sample Drawing with Reference: Production Processes
408
9.4.2 Physical-Sample Drawing with Reference
410
9.5 Configuration Basics
411
9.5.1 Physical-Sample Type Assignment to Inspection Type
411
9.5.2 Define Physical Sample Types
412
9.5.3 Define Physical Sample Container
413
9.5.4 Define Physical Sample Locations
413
10 Quality Certificates
415
10.1 Incoming Quality Certificates
415
10.1.1 Configuration Basics: Control Key
416
10.1.2 Define Control Functions for Certificate Processing
417
10.1.3 Master Data for Incoming Quality Certificates
419
10.1.4 Create a Purchase Order
420
10.1.5 Goods Receipt against the Purchase Order
421
10.1.6 Incoming Inspection Certificate
422
10.1.7 Incoming Certificate Worklist
424
10.2 Outgoing Quality Certificates
427
10.2.1 Define Keys for Certificate Processing
428
10.2.2 Master Data for Outgoing Quality Certificates
428
10.2.3 Business Processes in Outgoing Quality Certificates
433
11 Quality Notification
439
11.2 Quality Notification in Sales and Distribution
442
11.2.1 Creating Quality Notification: Customer Complaint
443
11.2.2 Correction Tasks
448
11.2.3 Changing the Activities Status and Completing the Notification
451
11.2.4 System Status and User Status
452
11.2.5 Follow-On Action
452
11.2.7 Partner Data of the Notification
453
11.3 Quality Notification in Production
457
11.4 Quality Notification in Procurement
460
11.4.1 Buyer’s Negotiation Sheet
462
11.5 Quality Notification Tools
464
11.5.1 Controlling Tasks Using Notification Worklist
464
11.5.2 Information System
467
11.5.3 Solution Database
469
11.5.4 Quality Issue Management
473
11.6 Configuration Basics: Quality Notification
475
11.6.1 Overview of Notification Type
475
11.6.2 Notification Creation
475
11.6.3 Copy Screen Areas from the Standard System
478
11.6.4 Allocate Change of Notification Type
478
11.6.5 Notification Processing
478
11.6.6 Additional Notification Functions
480
11.6.7 Defects Recording
480
11.6.8 Nonconformity Costs for Vendor Evaluation
481
11.6.9 Define Confirmation Profile
481
12.1 Quality-Related Costs
484
12.1.1 Inspection Costs
484
12.1.2 Nonconformity Costs
484
12.1.3 Prevention Costs
486
12.2 Master Data Setup for Quality Costs
486
12.2.1 Inspection Setup Data
487
12.2.2 Activity Type/Price Planning
488
12.2.3 QM Work Center Setup
489
12.2.4 Control Key in Inspection Plan
489
12.2.5 QM Order Creation and Assignment to Inspection Types
490
12.3 Business Processes
493
12.3.1 Inspection Lot
493
12.4 Configuration Basics: Quality Costs
506
12.4.1 Maintain QM Order Type
506
12.4.2 Maintain Settings at the Plant Level
507
12.4.3 Maintain Settings for Inspection Type
507
13.1.1 Create Characteristics
510
13.1.2 Create a Class and Assign Characteristics
514
13.2 Assigning the Material Class to the Material Master
516
13.3 Finding Objects in Classes
518
14 Engineering Change Management
521
14.1 ECM Configuration
522
14.1.1 Control Data Overview
522
14.1.2 Statuses for Change Master Records
524
14.1.3 Revision Levels
525
14.1.4 Change Type: Approval with Digital Signature
525
14.1.5 Maintain Status Profile (User Status)
527
14.1.6 Change Type for Change Master Records
531
14.1.7 Change Type for Objects
532
14.1.8 Automated Transactions
533
14.1.9 Workflow for the ECR/ECO and Object Management Record
536
14.1.10 Maintain Profile
536
14.2.1 Change Master Creation
537
14.2.2 Changes in Inspection Plan with a Change Number
539
14.2.3 Engineering Change Management (ECM) Information System
540
14.3 Engineering Change Request/Engineering Change Order
542
14.3.2 Check ECR (Header)
545
14.3.3 Change Possible (Object) and Digital Signature
545
14.3.4 ECR Checked (Header) and Digital Signature
547
14.3.5 Automated Transactions and Convert ECR to ECO
547
14.3.6 Changes to the Master Data
548
14.3.7 Complete and Release Change (Object)
548
14.3.8 Close and Release ECO
549
14.4 ECR/ECO Step-by-Step Approach: At a Glance
550
15.1 Configuration Basics
555
15.1.1 Define Authorization Groups
555
15.1.2 Define Individual Signatures
556
15.1.3 Define a Signature Strategy
557
15.1.4 Authorization Groups for QM Master Data
561
15.1.5 Material Authorization Group, Inspection Lot Approval, Digital Signature
561
15.1.6 Signature Method
563
15.2 Digital Signature in QM Business Processes
564
15.2.1 Assigning the QM Material Authorization Group in the Material Master
564
15.2.2 Inspection Lot Creation
565
15.2.3 Digital Signature in Results Recording
565
15.2.4 Digital Signature in Usage Decision
566
15.3 Digital Signature Logs
566
16 Document Management System
569
16.1 Configuration Basics: Document Type
569
16.1.1 Define Number Ranges
570
16.1.2 Define the Document Type
571
16.1.3 Document Status
575
16.1.4 Document Browser and ACLs
578
16.2 Business Processes in DMS
581
16.2.1 Document Info Record (DIR)
582
16.2.2 Assign Originals to DIR
583
16.2.3 Document Hierarchy
584
16.2.4 Additional Data (Classification System)
585
16.2.6 New Version of DIR
588
16.2.7 Document Status
588
16.2.8 Digital Signature
589
16.2.9 Document Distribution
590
16.2.10 Distribution List
591
16.2.11 Search Functions
591
16.3 DMS Integration in QM Processes
594
PART IV Monitoring, Evaluation, and Control in Quality Management
599
17 Early Warning System
601
17.2.1 Create Exceptions
603
17.2.2 Group Exceptions
608
17.2.3 Set Up Periodic Analysis
609
17.5 Exception Analysis
615
18.1 The Basics of Reporting
618
18.1.1 Inspection Lot Selection
620
18.1.2 Multiple Selection
621
18.1.3 Maintain Selection
622
18.1.4 Maintain Variant
623
18.1.5 Inspection Lot Selection Worklist
623
18.1.6 Filter Settings
626
18.1.9 Copy Selective Data to Microsoft Excel
628
18.2 Standard Analyses
628
18.2.1 Standard Analyses in QM
629
18.2.2 Standard Analysis: Material Overview
630
18.2.4 Other Info Structures
634
18.2.5 Standard Analysis: ABC Analysis
635
18.2.6 Standard Analysis: Time Series
637
18.3 QM Cockpit for Evaluations
638
18.5.1 Maintain InfoSet
643
18.5.2 Create User Groups
646
18.5.3 Create a Query
647
18.5.4 Adding Local Field to SAP Query
652
18.7 Assign a Transaction Code to a Query
654
18.8 Flexible Evaluation
655
18.8.1 Evaluation Structure
656
18.8.3 Execute Evaluation
658
18.9 Batch Information Cockpit
659
19.1 Vendor Evaluation
664
19.1.1 Configuration Basics
665
19.1.2 Master Data Maintenance
671
19.1.3 Business Processes
673
19.1.4 Calculate Score
673
19.1.5 Additional Functions
677
19.2.1 Updating the Quality Level during Inspection Lot Creation
681
19.2.2 Manual Creation of the Quality Level
681
19.2.3 Evaluating Quality Level
681
19.3 Statistical Process Control (SPC)
683
19.3.1 Analyzing Data using Control Chart
684
19.3.3 QM Master Data Checklist
686
19.3.4 Process Capability
691
19.3.5 History of Quality Scores
692
PART V Continuous Business Process Improvements with Quality Management
695
20 Audit Management with SAP ERP
697
20.2 Setting Up Audit Management
700
20.2.1 Set Up Audit Plan
700
20.2.3 Set Up Question List/Question
706
20.3 Business Processes in Audit Management
708
20.3.1 Release Audit Plan
710
20.3.3 Valuate Question
710
20.3.4 Create Corrective/Preventive Action
711
20.4 Productivity Tools and Audit Monitor
717
20.4.1 Productivity Tools in Audit Management: Audit Plan in MS Project
717
20.4.2 Productivity Tools in Audit Management: Import and Export Audits
718
20.5 Audit Inspection: Inspection Type 17
721
20.6 Configuration Basics: Audit Management
722
20.6.3 Digital Signature
725
21.1 Integration Aspects
728
21.2 Master Data in Stability Study
729
21.3 Business Processes in Stability Study
730
21.3.1 Create Stability Study with Material
730
21.3.2 Initial Sample
732
21.3.3 Bill of Material
735
21.3.4 Initial Test Inspection Lot: Inspection Type 1601
736
21.3.5 Inspection Lot for Initial Test Inspection: Results Recording and Usage Decision
738
21.3.6 Change Notification
741
21.3.7 Complete Initial Test
741
21.3.8 Storage Conditions
741
21.3.9 Testing Schedule
745
21.3.10 Business Processes of Storage Conditions in Stability Study
748
21.4 Configuration Basics: Stability Study
758
21.4.1 Primary Packaging
759
21.4.2 Physical-Sample Container
759
21.4.3 Storage Conditions
759
21.4.4 Storage Locations
760
21.4.5 Bill of Material Usage
760
21.4.6 Samples for Stability Study
760
21.4.7 Testing Schedule Category
760
21.4.8 Maintenance Strategy
761
21.4.9 Notification Type
763
21.4.10 Priority Type
764
22 Failure Mode and Effects Analysis (FMEA) and Control Plan
769
22.1 FMEA Process Overview
770
22.1.2 Failure Across Categories
772
22.1.3 Closed-Loop Quality Approach
773
22.2.1 Create Function List (Functions)
780
22.2.2 Create Function
783
22.2.3 Create Prerequisite
784
22.2.4 Creating a Characteristic
785
22.2.7 Create Preventive Action
791
22.2.8 Create Detection Action
793
22.2.9 Create an Effect
793
22.3 Business Processes in FMEA
796
22.3.1 Valuation of Detection Action
797
22.3.2 Valuation of Preventive Action
799
22.3.3 Valuation of Effect
800
22.3.4 Calculation of Risk Priority Number (RPN)
801
22.3.5 Additional FMEA Features
804
22.4.1 Create Questions in the Question List
809
22.4.2 Approval and Release of a Question List
810
22.6.1 Create a Control Plan
814
22.6.2 Control Plan Integration with FMEA
821
22.7 Configuration Basics: FMEA and Control Plan
822
22.7.1 Field Selection
822
22.7.2 Valuation Specification
823
22.7.3 Structure of Question List
824
22.7.5 List Structure
825
22.7.6 Rating Profile
827
22.7.8 Objects, Properties, Forms
829
22.7.9 Control Plan Type
830
22.7.10 Structure Type in Control Plan
831
B Movement Type Mapping
843