SAP Q u a l i t y

Management:
Overview

SAP ERP Q u a l i t y M a n a g e m e n t : W h a t I t I s

Qua l i t y M an ag e m e n t
Staying Ahead of t h e Co m pet i t ion w it h Qualit y
Audit Management

Assessments
Supplier, Product, Process,
System and Environmental Audits

Qu a l i t y En g i n e e r i n g

Specifications and Sampling

Plans
Document Management
Stability Studies/Shelf Life
Studies
Advanced Product Quality
Planning

Qu a l i t y C o n t r o l a n d
A ss u r a n c e

Sample and Batch Management

Quality Inspections
Statistical Process Control (SPC)
Integrated Problem Management
Certificate of Analyses (CoA)
Gauge Calibration and Control

Qu a l i t y I m p r o ve m e n t

Corrective and Preventive Action

(CAPA)
Customer Complaint Management
Quality Analytics
Quality Manual

SAP ERP QM: A u d i t M a n a g e m e n t

K e y F u n c tio n a l i t y

Audit planning (different audit types)

Business partner management

Audit scheduling and execution

Audit valuation

Corrective and Preventive

Actions (CAPA) tracking

Documentation of audit results

Graphical evaluation of audit data

Offline audit result capturing

K e y Be ne f i t s

Standard compliance QS 9000; ISO 9000; ISO 19011; ISO14000,

Consistent and transparent data company-wide; easy communication of

quality information across company boundaries

Easy appraisal of quality performance through detailed documentation and

flexible reporting

Benchmarking quality performance

SAP ERP QM: Q u a l i t y E n g i n e e r i n g

K e y F u n c tio n a l i t y

Inspection Planning /
Specifications / Advanced Product
Quality Planning

Sampling Procedures (ISO 2859,

ISO 3951)

Recipe and Trial Management

Stability/Shelf Life Study

Integrated Document Management

Master Data and Change

Management

Supplier Management

K e y B e n e fi t s

Consistent master data (free of redundancies: High product quality

and compliance with standards

Inspection planning integrated with purchasing and production

Provides end users with direct access to relevant quality

documentation

SAP ERP QM: Q u a l i t y C o n t r o l a n d A s s u r a n c e

K e y Fu n c t i o n a l i t y

Events

Inspection Lot

Quality Inspections
Y Goods receipt inspection
Y In/post-process control
Y Inspections at goods
issue
Y Recurring inspections

Test equipment Interfacing

Usage Decision/Release

Certificate of Analysis

Statistical Process Control

Problem Management

Test Equipment Calibration

Quality Information System

Inspection

Decision

Quality
Inspection
stock

Goods movements

Orders

Samples

What are

Deadline

Skip lot

the

Monitoring

Shop papers

inspection
results ?

Supply Chain

K e y B e n e fi t s

Supports automatic or manual triggered inspections

Integrated tightly with supply chain and beyond (e.g. inventory)

Enables monitoring of critical product and process characteristics and

allows instantaneous intervention

Documents product quality to achieve regulatory compliance

Usage decision
What happens
with the product?

SAP ERP QM: Q u a l i t y I m p r o v e m e n t

K e y F u n c tio n a l i ty

Problem/Complain
t Management
Y Workflow
Y Quality-related
cost
Y Follow-up
Corrective
And
functions

Preventive Actions
(CAPA)

Procurement

Quality
Analytics
Y Predefined
queries

Production

Pr o b

Complaint
against
vendor

Sales

Service

lem

Notification
Defect
Damage

Customer complaint

Internal problem message

Y Early warning
system
Y Control charts
Y Supplier evaluation
Y Results history

K e y B e n e fi t s

Comprehensive problem handling for all types of complaints within mySAP

ERP

Efficient processing of quality issues using workflows

Higher quality performance, while lowering cost-of-quality delivery

Documentation and audit trails enable rapid root-cause analysis to

minimize cost of compliance and recalls

GMP/GL P Co m p l i a n c e Su p p o r t
Digital Signature in QM
Sample drawing
Results recording
Usage decision (release)

Electronic Batch Record (EBR)

Deviation Analysis
Audit Trail
Change Management
Batch Traceability
Tight integration between
QM and batch classification
Batch where-used-list
Batch Information Cockpit

In t e g r a t e d En t e r p r i s e Qu a l i t y Ma n a g e m e n t

Workflow,
authorization
concept,
QM manual

Human
resource
s

Inventory management,
batch management,
change handling, CAPA,
data warehouse,
document management

Logistics

Test equipment
management,
calibration
planning and
execution

Quality-related
costs,
revenues

Finance
and
controlling

Enterprise
asset
managemen
t

Enterprise Quality Management within SAP ERP

Research
and
development
Stability studies,
flexible
specifications,
recipe
management APQP

Procurement

Inspection planning,
supplier release and
COA, goods receipt
inspection, sample
management, audit
management

Production

In-/post-process control,
test equipment
interfacing, deviation
management, shop floor
integration with xMII

Sales

COA,
quality data
exchange,
billing of
analysis

SA P Qu a l i ty M a n a g e m e n t:
Ov e rv i e w a n d
Pl a n t Fl o o r In t e g ra ti o n
U s i n g SA P x M I I
Overview of SAP Quality Management
Plant Floor Integration: xMII and SAP QM
Customer Success Stories
Outlook

Ma n u f a c t u r i n g Qu a l i t y Me t r i c s A r e Mo s t I m p o r t a n t

Source: AMR Research, 08/2006

SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.

11

SA P Qu a l i t y Ma n a g e m e n t I s Pa r t o f SA P Ma n u fa c t u r i n g

SA P Qu a l i t y Ma n a g e m e n t
enables Shop Floor Managers and Operators
to manage and assure product quality, monitor
and improve quality standards and document
quality compliance, for subsequent audit.

K e y B e n e f i t s:

Higher product quality and customer satisfaction

Superior, cost-effective quality compliance
Exception based quality management
Continuous quality improvement

SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.

12

Qu a l i t y Co n t r o l i n Ma n u f a c t u r i n g B u s i n e s s Pr o b l e m
Businessproblem
problem
Business
Manufacturingand
andquality
qua ymanagement
manlit
agementsystems
systemsare
areoften
oftenseparated.
separatedTriggering
Tr gger. ingi
Manufacturing
preventiveactions
actionsthrough
throughstatistical
statist calprocess
processcontrol
controland
andtrend
trendanalysis
ai nalysisas
aswell
we
preventive
ll
astracking
track ngofofmaterial
mater aldefects
defectsissdifficult.
d ff cu .
as
i aapowerful
i ntisolution
i ution
lt as
SAPoffers
offers
powerfulquality
qualityimanagement
manageme
so
asintegral
integralpart
partofofmySAP
mySAP
SAP
ERP,however,
however,the
theuser
userinterface
in er acetoorecord
recordin-process
in-prolcessquality
qua tydata
dataisisnot
notsuitable
su ablefor
for
ERP,
tfloor.li
it lit
t
operatorsororquality
qua yinspectors
inspecttorsininfthe
heshop
shopfloor.
operators

Solution: Use SAP xMII to combine Manufacturing and

Quality Management Processes!
Value to Customer
Comprehensive view on quality and production data in SAP xMII

Easy user interface to access SAP QM results recording

Pre-built mySAP ERP integration
Process optimization in the laboratory and production area
Improved compliance through enhanced data visibility
Easier to connect electronic test devices
SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.
13

Wha t i s t he SA P x A pp Manu f . I nt eg r at i on an d I nt el l i gen c e (x M I I )?

T h e SAP x A p p M a n u f a c t u r i n g
I n t e g ra t i o n a n d I n t e l l i g e n c e (x MI I ) i s a
p a c k a g e d c o m p o s i t e a p p li c a t i o n t h a t
delivers:

Manufac t uring
Int elligenc e
Da s h b o a r d s

SAP BI

Other SAP Bus. Solu tions

SA P N ET WEA V ER

mySAP ERP
SAP Manufacturing
mySAP SCM

SAP xMII
Manufacturing
Intelligence
Manufacturing Integration

Man u fa c t ur i n g I n t e l l i ge n c e : Real-time
analytics engine that aggregates and delivers
unified visualization of events, alerts, KPIs and
decision support to production personnel thru
role-based dashboards

Ma nu f a c t u ri n g I n t egr a t i on: A single

ISA-95 compliant layer enabling SAP ERP
connectivity into real-time plant floor apps.
(MES, SFA, LIMS,..) to drive plant-to-enterprise
business process interoperability

MES Manufacturing Execution Systems, EMI Enterprise

Manufacturing Intelligence, BW Business Warehouse (from SAP)
SFAC Shop Floor Automation & Control, LIMS = Laboratory
Information Management Systems

SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.

14

SA P QM Pr o d u c t i v i t y Pa c k f o r SA P x MII U s e Ca s e s
Content
Content
SAP
SAPwill
willdeliver
delivergeneric
generictemplates
templatesfor
forquality
qualitydata
dataentry
entryand
andvisualization
visualizationthat
tha
enable
enab eaastate-of-the-art
s ate-of- he-ar user
userinterface
in erfacefor
forthe
theoperator
operatorwho
whois sresponsible
respons blefororin-nt quality
process
process
qual tychecks.
checks.AAseamless
seamlessintegration
integrat onbetween
be weenSAP
SAPxMII
xMIIand
andthe
hemySAP
mySAP
ERP
ERPQM
bactkendwill
w be
bt eprovided.
prov
lQMbackend
t ded.
t
i
i
f
ii
i
t
t
ill
i
Use Cases for the Operator/Quality Inspector
Retrieve a work list of QM inspection lot operations for his work center in SAP xMII
Record inspection results online (synchronized with mySAP ERP QM)
Display inspection results
Generate graphics for critical inspection characteristics (run chart, control chart,
results history) to perform trend analysis
Transfer results from electronic test devices
Trigger quality notifications in mySAP ERP QM

This slide contains only intended developments and/or functionalities of the SAP product and is not intended to be binding upon SAP to any particular course
of business, product strategy, and/or development. Please note that this document is subject to change and may be changed by SAP at any time without notice.

SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.

15

SA P QM Pr o d u c t i v i t y Pa c k f o r SA P x MI I - Ov e r v i e w
SAP QM Productivity Pack for SAP xMII

QM Results
Recording

SAP xMII (11.5)

Light weight for Operator on the Shop Floor

Exchange of
Inspection
results
(BAPIs
SAP
QMor service-enabled)
Inspection lot
data

Interface box
(e.g. Steinwald)

3rd party
LIMS

mySAP ERP (SAP R/3)

QM Master Data and Inspection Planning
QM Results
Recording

Electronic test equipments

Heavy weight (for Power Users)

mySAP ERP QM can be operated as a full-blown LIM-system

SAP xMII can integrate data from mySAP ERP QM (Rel. 4.6C and higher)
and from 3rd party LIM-systems to improve productivity on the shop floor
Planned Availability for SAP xMII 11.5: Q4 2006
This slide contains only intended developments and/or functionalities of the SAP product and is not intended to be binding upon SAP to any particular course
of business, product strategy, and/or development. Please note that this document is subject to change and may be changed by SAP at any time without notice.

SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.

16

Qu a l i t y Co n t r o l i n Ma n u f a c t u r i n g : Pr o c e s s
Roles

Quality Manager

Quality Planning

Measure and
improve
KPIs

SA P x MI I
Released
Production Order

Create Inspection
Lot (Automatically)

Operator

Record Quality Data

(Results/Defects/IPC)

Monitor Quality Data

(SPC / SQC)

Quality Inspector

Approve
Batch /
Orders

Control
Produced
Batch / Orders

Plant Manager

Audit, on Demand and

Review Results

SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.

17

St e p 1 : Qu a l i t y Pl a n n i n g i n m y SAP ERP
QM master data maintenance
(characteristics, methods, )
Central inspection planning
and distribution via ALE
possible
Engineering Workbench
(EWB)
for mass maintenance of
task lists
Inspection operations
integrated in
routings/master recipes or
as separate inspection plans
Release production order to
trigger in-process
inspection
SAP AG 2006, SAP
QM Overview
and 1
SAP xMII, Denver 2006 p.
Demo
Part
18

St e p 2 : Re c o r d Qu a l i t y Da t a o n Pl a n t Fl o o r U s i n g SA P x MI I
Work lists with inspection
lot operations (per work
center)
Display list of inspection
points
Select inspection
characteristics (from QM
inspection lot)
Record results for characteristic
Display run chart/control chart
Exception management
Automatic update of QM inspection
lot in mySAP ERP
This slide contains only intended developments and/or functionalities of the SAP product and is not intended to be binding upon SAP to any particular course
of business, product strategy, and/or development. Please note that this document is subject to change and may be changed by SAP at any time without notice.

Demo Part 2

SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.

19

St e p 3 : Qu a l i t y Da t a A n a l y s i s - Op t i o n s
Quality reporting in mySAP ERP:

Inspection Work lists and reports

Result histories and control charts
Supplier evaluation
QM Info System

mySAP ERP

mySAP BI

Analytics based on mySAP BI:

Predefined queries with aggregated data
from q-notifications and inspection lots
SAP Analytics Business Packages using
mySAp BI content or ERP reports

Quality Analytics with SAP xMII

xMII

Roles: Production Supervisor, Plant Manager or Quality Manager

SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.
20

SAP Manufacturing Intelligence

Dashboards

@ SAP EnteqHi se Pol'tal 6.0 Mic..osoft lntemet Explo..e.. p..ovided by

SAP
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Batch Area Production status

Packaging Area Production status

r l T

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Option
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Moisture Quality
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Actual Vs. Target Cost Analysis

Moleture Quality Analyels

Downloaded Order Display
SAP Control Recipe Monnor
SAP Notification & Maintenance
Orde
SAP stock Overview

xaAR

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SAP AG 200G, SAP OM Overview and SAP xMII, Denver 200G

p.21

Local
intranet

THE BESTRUN BUSINESSES R U N SAP

Par t ne r x A pps ba s ed on SA P x M I I t o Dr i v e QM I nt eg r a t i on (1)

Tata Consulting Services (TCS) is providing additional examples for dashboards
and composite applications based on SAP xMII, e.g. Rapid Sigma.

SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.

22

Par t ne r x A pps ba s ed on SA P x M I I t o Dr i v e QM I nt eg r at i on (2)

Partner xApp from IBM: SAP xLC (LIMS Connect)

SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.

23

SA P Qu a l i t y M a n a g e m e n t :
Ov e r v i e w a n d
Pl a n t Fl o o r I n t e g r a t i o n
U s i n g SA P x M I I
Overview on SAP Quality Management
Plant Floor Integration: xMII and SAP QM
Customer Success Stories
Outlook

Cu s t o m e r Su c c e s s St o r y

Pr a t t a n d Wh i t n e y
Ca n a d a
Dr i vi n g Qu al i t y I m p r o v e m e n t
t h r u H i g he r V i s i bi l i t y a nd
Re s p o n s i v e ne s s w i t h SA P x M I I

SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.

25

SA P QM a n d SAP x MI I a t Pr a t t & Wh i t n e y Ca n a d a

Results entry
updates QM
inspection lot

SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.

26

Pr a t t & Wh i t n e y Ca n a d a
Dr i v i ng Qua li t y I m p r ov em e nt t hr u H i gh er V i s i bi l i t y & Res pons i v en es s

Value from the SAP xMII Solution:

Savings from Quality Cost Avoidance will be realized in six major areas:
internal scrap rework & repair
lower supplier scrap resulting in lower material prices
reduction in QN (quality notification) items
reduction in warranty expense caused by manufacturing escapes
improvement in engine retest ratio, and
shop
productivity
improvement.
SAPsfloor
xMII is
a tool that will
enable us to achieve roughly a $ 14 million saving

Will reduce the probability of significant customer

per year in quality cost avoidance. In addition, we will avoid costly engine
escapes at the end each of which could potentially cost us half a million
dollars. How
many
are we going
to can
avoid,
we cannot
know.
a escapes*major
customer
escape
cost
in excess
of Statistically
$
speaking, if we avoid one, it would pay for the system by itself.

500K

T
Claude Poliquin, Business Development Manager- Quality
im he estimated annual savings
are of at$14MM
per
year
Presentation
the SAP xMII
User
Groupat full
Conference, Philadelphia, October 2005
plementation
* Customer escape is a defective aircraft engine or component delivered to the
customer
SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.
27

SAP f o r P h a r m a c e u t i c a l s : SAP QM U s e d a s L I M S

ROCHE DIAGNOSTICS
Roche Diagnostics - based in Basel, Switzerland , and one
of two divisions of the 100-year-old healthcare company
F. Hoffmann-La Roche Ltd. - invents and manufactures reagents
for medical diagnostics. Roche chose the quality management
capabilities of mySAP"' Product Lifecycle Management (mySAP
PLM) to improve and automate lab and production processes.

Key C h a l l e n g e s
Manual, time-consuming, error-prone processes/ redundant data
Mounting regulatory pressures
Difficulty in managing growing product lines

"We now know we can

rely on our Q M data and
its documentation. This
means our customers
and our employees are
assured of continuing,
top-level product
quality."
Kai Rothermel. Information
Manager SAP QM. Roche
Diagnostics

Implementation Highlight
Implemented solution as part of company-wide SAP R/2
to SAP R/3 migration

Key Benefits
Transparent laboratory processes/accurate documentation
to ensure compliance with regulatory requirements
Automated , streamlined processes - from laboratory to
production
Reduced IT complexity
Increased quality of data in highly integrated system
landscape

lJi,lgnu tics
USINESSES R UN S AP..

SAP AG 2006, SAP OM Overview and SAP xMII, Denver 2006 p.28

T H E B E S T-R U N

1!'.,

U s i n g SA P QM a s I n t e g r a t e d En t e r p r i s e L I MS
The Solution
LIMS is not a separate product but based on SAP Quality
Management Application integrated in mySAP ERP
Main focus is on In-Process and Quality Assurance &
Control labs

Selected Reference Customers:

BASF, Germany
Roche Diagnostics, Germany
Clariant, Switzerland
DSM Fine Chemicals, Austria
Olin Corporation, USA
Dow Corning, USA

SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.

29

Mo r e T h a n 4 0 0 0 Cu s t o m e r s U s e SA P QM T o d a y !

bothwithin
PLM QM and
selected bolt-ons
(LIMS
AutoAutomation,
Data
PLMmySAP
QM accelerates
the inspection
processes
upand
to 50%.
mySAP
Collection), reduces our inspection costs by approximately $750,000 (USD)
annually in our global labs, and assists in ISO, GMP, and legal compliance efforts.
(Source: Dow Corning, Midland, Michigan, U.S.A.)

mySAP PLM offers a flexible and open solution for our quality management.
We are using quality notifications to improve our company-specific
development processes. The associated workflow functions enable us to
efficiently solve
problems that arise in the development phase. (Source: Porsche AG, Germany)

of purchased
parts
a decisiveand
role.their
Thanks
to thefor
transparency
of
Our efforts
are focused
onplays
our customers
demands
high quality.
quality
data in mySAP PLM Quality Management our optimization process is supported
Theand we are in a position to improve our quality and thereby lower costs.
(Source: ZF Passau GmbH (Automotive Supplier), Germany)

Using Quality Management with mySAP PLM as our Enterprise Laboratory

Information Management System (LIMS), we were able to accelerate our inspection
processes, reduce costs and fulfill legal requirements.
(Source B.Braun Melsungen AG (Life Sciences), Germany)

SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.

30

SA P Qu a l i t y M a n a g e m e n t :
Ov e r v i e w a n d
Pl a n t Fl o o r I n t e g r a t i o n
U s i n g SA P x M I I
Overview on SAP Quality Management
Plant Floor Integration: xMII and SAP QM
Customer Success Stories
Outlook

N e w i n Qua l i t y Ma n a g e m e n t w i t h m y SA P ERP 2 0 0 5
Multiple Specifications
Plan, test, and classify batches according
to different characteristics
Operation Completion Function
Indicate when inspections are complete
in one work center/laboratory and
trigger follow-up actions
Flexible Reporting Capabilities
Create analytical online reports on quality

data combined with graphical

representation
Enhancements to Audit Management

Function
Link corrective actions to ERP QM notifications

and evaluate audit data with mySAP BI

Quality Inspection Engine (QIE)
QIE is delivered with mySAP SCM 5.0/SAP NetWeaver 2004s to support
service-based quality inspections in a heterogeneous system
landscape

SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.

32

K e y Ob j e c t i v e s f o r Qu a l i t y Ma n a g e m e n t w i t h SA P
Quality Management with SAP
St r a t e g i c T h e m e s

Leverage SAP xMII for QM

Adopt Enterprise SOA for QM scenarios
Support improvement processes and
compliance

K ey Headlines

Deliver QM content for SAP xMII

Enable test equipments/interface box connectivity using SAP xMII
Provide dashboard for Six Sigma Project Lead and Quality Inspector
Provide Failure Mode and Effect Analysis (FMEA) tool to enable Design
for Six Sigma and support NPDI process
Enhance product compliance
Continuous improvements for QM as LIMS/CAQ
Develop enterprise services to enable new QM scenarios

Note: The information in this Roadmap is proprietary of SAP. This document contains only intended strategies, developments, and/or functionalities of the SAP
product and is not intended to be binding upon SAP to any particular course of business, product strategy, and/or development. Please note that this document is
subject to change and may be changed by SAP at any time without notice.

SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.

33

7 K e y Po i n t s t o T a k e H o m e
Qu a l i t y Ma n a g e m e n t f r o m SA P
Offers a solution seamlessly integrated with the supply chain
with various control options at every stage
Supports Good Manufacturing Practices (GMP)
and other legal requirements
Offers an end-to-end solution for QM and lowers Total Cost
of Ownership (TCO)
Provides consolidated and predefined quality key figures
they can be analyzed and drilled down to any detail
Enables proactive tracking of Corrective And
Preventive Actions (CAPA)
Drives decision-making to the shop floor through integration
with SAP xMII
Is a flexible and scalable solution built on
latest SAP NetWeaver technology

SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.

34

Y o u r T u r n : Qu e s t i o n s ?

Thank you for your at t ent ion

Dr. Manfred Schulz
Application Solution
Management Manufacturing
Compliance/QM & Six Sigma
SA P A G
Dietmar-Hopp-Allee
16 D-69190 Walldorf
Germany
man.schulz@sap.com
www.sap.com

SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.

35

Co p y r i g h t 2 0 0 6 SA P A G. Al l Ri g h t s Re s e r v e d
No part of this publication may be reproduced or transmitted in any form or for any purpose without the express permission of SAP AG. The information
contained herein may be changed without prior notice.
Some software products marketed by SAP AG and its distributors contain proprietary software components of other software
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