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

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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
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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

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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

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)

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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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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

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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 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

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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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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

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Production Chain

Inspection
Production Order Order Goods
during
Planning release production
confirmation movement

Sample Operations + Recording GR in

calculation inspection of scrap warehouse
characteristics
Inspection Partial lot Batch
lot creation Inspection creation proposal
points
Approval Valuation Batch
procedure Measured classification
value and Batch
defects classification Release of
recording batch record

SPC control
chart
Externally
processed
operations

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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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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

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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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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

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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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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

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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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DEMO Process Order with QM

Enter QM
data here!

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DEMO Process Order with QM (cont.)

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DEMO Process Order with QM (cont.)

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DEMO Process Order with QM (cont.)

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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

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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 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

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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
ISAAC@SDM-C.COM
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