© 2007 wellesley information services. all rights reserved. sap quality management (qm): when to...

© 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 MazliachS.D.M. Israel

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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

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• 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.)

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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

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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)

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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)

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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)

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• 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

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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

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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

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• What is QM? • How different manufacturing strategies — discrete,





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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

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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

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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

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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)

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ProductionPlanning

Orderrelease

Inspectionduring

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

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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

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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

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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

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Assign Task List Type to Material Types

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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

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Define Control Keys for Inspection Operations

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Quality Certificates

• Certificate profile• Maintain form• Output determination

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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

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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.

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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

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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

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Master Data: Material Master QM View

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Master Data: Routine View

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Master Data: Routine View (cont.)

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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

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Quality Planning and Inspection Planning Data

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

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Process Order Without QM

• When production is complete, enter a Goods Receipt of the material into stock

• The Transaction is CO60 – maintain PI sheet

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DEMO – Process Order Without QM

No QM data!

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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

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Enter QM data here!

DEMO – Process Order with QM

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DEMO – Process Order with QM (cont.)

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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

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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

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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

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Your Turn!

How to contact me:Isaac Mazliach

[email protected]

© 2007 wellesley information services. all rights reserved. sap quality management (qm): when to...

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