1. © 2007 Wellesley Information Services. All rights reserved. SAP Quality Management (QM): When to Leverage It, How to Set It Up, and How to Integrate It with Your Current Production Planning Processes Isaac Mazliach S.D.M. Israel

2. 2 What This Session Will Cover, and Why! Due to regulations put forth by the Food & Drug Administration (FDA), the Federal Aviation Association (FAA), Sarbanes-Oxley (SOX), and others, SAP customers are compelled to use the Quality Management (QM) component more than ever

3. 3 QM is increasingly viewed as a business advantage (as with Motorola Six Sigma plan Statistical Process Control [SPC]) This session will introduce the Quality Management component (QM), and describe its main uses relevant to SAP Production Planning (PP) processes What This Session Will Cover, and Why! (cont.)

4. 4 What We’ll Cover … What is QM? How different manufacturing strategies — discrete, repetitive, and Process Industry (PP-PI) — change the ways to integrate QM What are the differences between QM during production and QM at the end of production? Main customizing tasks to integrate QM with PP Master data requirements to integrate QM with PP Demo: Process order with and without QM Wrap-up

5. 5 A Definition of QM Quality Management (QM) is a component of mySAP PLM used to plan, check, verify, and document the quality of products and processes Three main requirements for a QM system:  Total Quality Management (TQM)  Industry-specific standards: FDA and Good Manufacturing Practice (GMP)  Standards for QM systems (ISO 9000)

6. 6 Evolution of QM Let’s see a brief look at the history of software development in the quality management area  SAP R/3 – QM: Planned and event-controlled processes in quality management for purchasing and production, with little functionality (compared to today’s)  mySAP PLM – QM: Functional area of mySAP PLM, encompassing quality engineering, quality improvement, and quality assurance and control  mySAP ERP – QM: All QM-relevant processes (quality planning, quality inspection, quality certificate, quality notification, quality control, test equipment management, stability study)

7. 7 What Does QM Include? Quality Management is integrated in the SAP system and uses basic and cross-application functions, such as:  Document Management System (DMS)  Engineering Change Management (ECM)  Classification System  Audit Management  Workflow  ArchiveLink  SAPoffice  Example: QM documents may be managed with DMS (txn CC04) and/or SAPoffice (txn SBWP)

8. 8 Quality planning – create and manage the master data that is required to plan and execute quality inspections Quality inspection – identify whether the inspected units fulfill the predefined quality requirements Quality certificate – certify the quality of a material (contains texts, specification values, and inspection results) Quality notification – record and process internal and external problems that are primarily caused by poor-quality goods or services Functions of the Quality Management Area

9. 9 Functions of the Quality Management Area (cont.) Quality control – implement various preventive, monitoring, and corrective activities  Specifications from quality planning and evaluations from quality inspections and quality notifications, form the basis for quality control Test equipment management – manage master data, as well as plan and process calibration inspections for test equipment Stability study – manage basic data, as well as the planning and execution of stability studies

10. 10 Quality Management (QM) in Production Planning (PP) QM in PP covers the following areas:  Integrating inspection planning/production operations  Inspection operations can be directly included in routines (discrete manufacturing and repetitive manufacturing) or Master Recipes (process industry)  Controlling inspections during production  Inspection lot origin 03 (during production)  Inspection lot origin 04 (Goods Receipt [GR] from production)  Statistical Process Control (SPC)  For example, control chart with mean value and standard deviation for an inspection characteristic  Processing internal problem notifications – notification type Q3

11. 11 What is QM? How different manufacturing strategies — discrete, repetitive, and Process Industry (PP-PI) — change the ways to integrate QM What are the differences between QM during production and QM at the end of production? Main customizing tasks to integrate QM with PP Master data requirements to integrate QM with PP Demo: Process order with and without QM Wrap-up What We’ll Cover …

12. 12 Discrete Manufacturing These are the “normal” production orders  Each material is produced individually (i.e., an individual production order for each production lot) The work processes within a company are executed using production orders A production order defines which material is to be processed, at which location, at which time, and requiring how much work  It also defines which resources are to be used and how the order costs are to be settled As soon as a planned order is generated from Materials Requirement Planning (MRP), shop floor takes over the information available and adds the order- relevant data to it to guarantee complete order processing Production orders are used to control production within a company, and also to control cost accounting

13. 13 Repetitive Manufacturing A component in the SAP system for planning and controlling repetitive manufacturing and flow manufacturing It enables the period- dependent and quantity- dependent planning of production lines, reduces the work involved in production control, and simplifies backflushing (confirmation, Goods Receipt posting) Implement repetitive manufacturing if the following is true of your production process:  You produce the same or similar products over a lengthy period of time  You do not manufacture in individually defined lots. Instead, a total quantity is produced over a certain period at a certain rate per part-period.  Your products always follow the same sequence through the machines and work centers in production  Routings tend to be simple and do not vary much

14. 14 Process Industry Manufacturing (PP-PI) With PP-PI, SAP provides an integrated planning tool for batch-oriented process manufacturing It is primarily designed for the chemical, pharmaceutical, food, and beverage industries, as well as the batch-oriented electronics industries PP-PI uses terms such as:  Master Recipes – the processes to be used for producing materials in your plant, as well as the resources and ingredients required for production  Process Orders – copy a process described in a Master Recipe and adjust it to the actual production run  Process Management – coordinate the communication between PP-PI and the process control during the execution of a process order

15. 15 QM Changes According to Production Method QM uses different blocks (customizing, master data, etc.) according to the production method (discrete, process, and repetitive). Here are some examples:  When process order is used – inspection planning may reside in the Master Recipe  When production order is used – inspection planning may reside in the routine (txn CA03)  When PP-PI is used – inspection results shall be recorded in the PI sheet (txn CO60)  When discrete or repetitive is used – inspection results shall be recorded in the inspection lot (txn QE51N)

16. 16 What We’ll Cover … What is QM? How different manufacturing strategies — discrete, repetitive, and Process Industry (PP-PI) — change the ways to integrate QM What are the differences between QM during production and QM at the end of production? Main customizing tasks to integrate QM with PP Master data requirements to integrate QM with PP Demo: Process order with and without QM Wrap-up

17. 17 Production Planning Order release Inspection during production Order confirmation Goods movement Sample calculation Inspection lot creation Approval procedure Recording of scrap Partial lot creation Valuation Batch classification GR in warehouse Batch proposal Batch classification Release of batch record Operations + inspection characteristics Inspection points Measured value and defects recording SPC control chart Externally processed operations Production Chain

18. 18 QM During Production Inspection lot origin = 03 Inspection lot is created at the PP order release At Goods Receipt, material immediately entered into unrestricted-use stock Control is less strict  Materials with “bad” inspection may enter the “good” stock If better control is required, production reporting should be on the operation level  In this case, it should be forbidden to move to the next operation if the previous one was not accepted

19. 19 QM at the End of Production Inspection lot origin = 04 Inspection lot is created at Goods Receipt At Goods Received, the produced material is received into QI-Stock  Only usage-decision may move it to unrestricted-use stock Control is more strict  If material did not pass inspection, it cannot be used Production reporting may be on operation level or on order level

20. 20 What We’ll Cover … What is QM? How different manufacturing strategies — discrete, repetitive, and Process Industry (PP-PI) — change the ways to integrate QM What are the differences between QM during production and QM at the end of production? Main customizing tasks to integrate QM with PP Master data requirements to integrate QM with PP Demo: Process order with and without QM Wrap-up

21. 21 Customization Tasks to Integrate QM with PP Separate transaction for QM customization: QCC0 Quality planning  Inspection characteristics, inspection methods  Sample determination  Define task list types, usage, and status  Define control key for inspection operations  The required Task List Usages can be created in customizing  The Task List Usage is entered in the headers of the task lists and in customizing of the inspection types

22. 22 Assign Task List Type to Material Types

23. 23 Quality Inspection Inspection types Inspection for goods movements Assign inspection type for manufacturing order (per production order type or process order type) Maintain usage decision for catalog type = 3 Define physical sample type, container, and locations Important:  The meaning of the catalogs 0 to 9 Z and A to O is defined by SAP  The other catalogs (P to Z) can be defined by the customer

24. 24 Define Control Keys for Inspection Operations

25. 25 Quality Certificates Certificate profile Maintain form Output determination

26. 26 Quality Notifications Notification types and content Additional notification functions (action box and follow-up actions) Q: What are Quality Notifications? A: Quality Notifications are the central medium in QM for processing problems and unplanned events

27. 27 Quality Control In Materials Management (MM): Vendor evaluation In Logistics Information System (LIS): Quality Management Information System (QMIS) In QM: Definition and evaluation of original documents Control Chart: Form for the graphical display of characteristics values that occur during an inspection. The control chart compares the displayed values with the action limits and, in this way, supports the quality-related control of the process. The run-chart is a graphical display of the single values of a quantitative characteristic in a run time. You cannot valuate inspection results using the run-chart.

28. 28 Stability Study Define physical sample types Define testing schedule category Notification types Catalogs Inspection types Stability Studies are performed in the chemical, pharmaceutical, and food industries to examine how different conditions affect a product over a specified period of time

29. 29 What We’ll Cover … What is QM? How different manufacturing strategies — discrete, repetitive, and Process Industry (PP-PI) — change the ways to integrate QM What are the differences between QM during production and QM at the end of production? Main customizing tasks to integrate QM with PP Master data requirements to integrate QM with PP Demo: Process order with and without QM Wrap-up

30. 30 Quality Planning as a Foundation for Master Data In quality planning, you define information and processes on a long-term basis as Master Records Quality planning provides the basis for inspection processing To do that, quality planning uses cross-application data, such as:  Material Master  Batch classification  Quality documents  Work center  Serial numbers

31. 31 Master Data: Material Master QM View

32. 32 Master Data: Routine View

33. 33 Master Data: Routine View (cont.)

34. 34 Quality Planning as Part of QM Quality planning uses QM-specific basic data such as:  Master inspection characteristics  Inspection methods  Sampling procedures  QM work center (with its capacity)  Catalog

35. 35 Quality Planning and Inspection Planning Data Quality planning uses inspection planning data such as:  Inspection plans  PP-PI: Master Recipe, Resource  Routing  Material specifications

36. 36 What We’ll Cover … What is QM? How different manufacturing strategies — discrete, repetitive, and Process Industry (PP-PI) — change the ways to integrate QM What are the differences between QM during production and QM at the end of production? Main customizing tasks to integrate QM with PP Master data requirements to integrate QM with PP Demo: Process order with and without QM Wrap-up

37. 37 Process Order Without QM When production is complete, enter a Goods Receipt of the material into stock The Transaction is CO60 – maintain PI sheet

38. 38 DEMO – Process Order Without QM No QM data!

39. 39 Process Order with QM When production is complete, enter the following:  Inspection results (through characteristics)  Usage decision  Only then, enter Goods Receipt of the material into stock The transactions:  CO60 – maintain PI sheet  QE51N – find inspection lot per material  QA11 – enter usage decision

40. 40 Enter QM data here! DEMO – Process Order with QM

41. 41 DEMO – Process Order with QM (cont.)

42. 42 DEMO – Process Order with QM (cont.)

43. 43 DEMO – Process Order with QM (cont.)

44. 44 What We’ll Cover … What is QM? How different manufacturing strategies — discrete, repetitive, and Process Industry (PP-PI) — change the ways to integrate QM What are the differences between QM during production and QM at the end of production? Main customizing tasks to integrate QM with PP Master data requirements to integrate QM with PP Demo: Process order with and without QM Wrap-up

45. 45 Resources Product information:  www.sap.com/plm Product documentation:  http://help.sap.com For customers and partners:  http://service.sap.com/qm * Information about courses:  www.sap.com/education *Requires login credentials to the SAP Service Marketplace

46. 46 7 Key Points to Take Home QM became crucial in recent years  Now, more than ever, it is important to implement it in PP Before starting the QM project, make sure your implementation complies to the rules and regulations of your company’s business (SOX, FDA, etc.) To allow the QM process to work, allocate the necessary resources to ensure that master data is correct If a more strict control is required, you may consider inspecting the material at the end of production  If the production process is long or divided into many processes, you may consider inspecting during production, also

47. 47 7 Key Points to Take Home (cont.) Focus on the main customizing and master data tasks  Do not try to achieve everything right at the beginning Use notification wisely. It is very powerful. Make sure you allow production to continue working after QM implementation  Do not sacrifice production on the altar of QM

48. 48 Your Turn! How to contact me: Isaac Mazliach ISAAC@SDM-C.COM