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
2007 Wellesley Information Services. All rights reserved.

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

What This Session Will Cover, and Why! (cont.)

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
3

What Well 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
4

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)

Evolution of QM
Lets 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 todays) 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)

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)

Functions of the Quality Management Area

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 (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

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
10

What Well 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
11

Discrete Manufacturing
These are the normal As soon as a planned

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

order is generated from Materials Requirement Planning (MRP), shop floor takes over the information available and adds the orderrelevant data to it to guarantee complete order processing Production orders are used to control production within a company, and also to control cost accounting
12

Repetitive Manufacturing
A component in the SAP Implement repetitive

system for planning and controlling repetitive manufacturing and flow manufacturing It enables the perioddependent and quantitydependent planning of production lines, reduces the work involved in production control, and simplifies backflushing (confirmation, Goods Receipt posting)

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
13

Process Industry Manufacturing (PP-PI)

With PP-PI, SAP provides an PP-PI uses terms such as:
Master Recipes the processes

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

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

14

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)

15

What Well 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
16

Production Chain
Production Planning Order release
Sample calculation
Inspection during production Order confirmation Goods movement

Inspection lot creation

Approval procedure

Operations + Recording inspection of scrap characteristics Partial lot Inspection creation points Valuation Measured Batch value and classification defects recording SPC control chart Externally processed operations

GR in warehouse Batch proposal Batch classification Release of batch record

17

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

18

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

19

What Well 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
20

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

21

Assign Task List Type to Material Types

22

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
23

Define Control Keys for Inspection Operations

24

Quality Certificates
Certificate profile Maintain form Output determination

25

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

26

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.
27

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
28

What Well 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
29

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

30

Master Data: Material Master QM View

31

Master Data: Routine View

32

Master Data: Routine View (cont.)

33

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

34

Quality Planning and Inspection Planning Data

Quality planning uses inspection planning data such as: Inspection plans PP-PI: Master Recipe, Resource Routing Material specifications

35

What Well 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
36

Process Order Without QM

When production is complete, enter a Goods Receipt of

the material into stock The Transaction is CO60 maintain PI sheet

37

DEMO Process Order Without QM

No QM data!

38

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

39

DEMO Process Order with QM

Enter QM data here!

40

DEMO Process Order with QM (cont.)

41

DEMO Process Order with QM (cont.)

42

DEMO Process Order with QM (cont.)

43

What Well 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
44

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 45

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 companys 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

46

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

47

Your Turn!

How to contact me: Isaac Mazliach ISAAC@SDM-C.COM

48