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SAP Qual i ty
Management :
Overv iew
SAP ERP Qual i ty Management : What I t Is
Qual i t y Managem entStaying Ahead of the Compet i t ion w ith Quali ty
Aud i t Management• Assessments• Supplier, Product, Process,
System and Environmental Audits
Qual i t y Engineer ing• Specifications and Sampling
Plans• Document Management• Stability Studies/Shelf Life
Studies• Advanced Product Quality
Planning
Qual i t y Cont ro l and Assurance
• Sample and Batch Management• Quality Inspections• Statistical Process Control (SPC)• Integrated Problem Management• Certificate of Analyses (CoA)• Gauge Calibration and Control
Qual i t y Improvemen t• Corrective and Preventive Action
(CAPA)• Customer Complaint Management• Quality Analytics• Quality Manual
K ey Benef 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: Aud i t Management
Key Func tio na l i ty• 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
SAP ERP QM: Qual i ty Engineer ing
Key Func tio na l i ty
• 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
Key Benefi 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
• Supports product development process
SAP ERP QM: Qual i ty Contro l and Assurance
K ey Func t ional i t y• 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
Supply Chain
DecisionInspectionInspection LotQuality
Inspection stock
• Goods movements
• Orders
• Deadline
Monitoring
• Samples
• Skip lot
• Shop papers
Events
What are the
inspection
results ?
• Usage decision
What happens
with the product?
Key Benefi 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
Key Benefi 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
SAP ERP QM: Qual i ty Improvement
Key Func tio na l i ty• Problem/
Complaint ManagementY Workflow
Y Quality-related cost
Y Follow-up functions
• Corrective And Preventive Actions (CAPA)
• Quality AnalyticsY Predefined queries
Y Early warning system
Y Control charts
Y Supplier evaluation
Y Results history
Procurement Production Sales Service
Notification
Defect Damage
Complaint against vendor Customer complaint
Prob l e m
Internal problem message
GMP/GLP Com pl ianc e Support
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 egrat ed Ent erpr ise Qual i t y Managem ent
SalesP duct nProcurementResearch and development
Human resources
Logistics Finance and controlling
Enterprise asset
management
Enterprise Quality Management within SAP ERP
Stability studies, flexible
specifications, recipe
management APQP
Inspection planning, supplier release and COA, goods receipt inspection, sample management, audit
management
In-/post-process cont ol,test equ ment
interfacing deviamanagement, shop f oor
ntegration with MIxi
ntiopi
r
oior
,l
I
COA,quality
data exchange,
billing of analysis
Workflow, authorization
concept,QM manual
Inventory management, batch management,
change handling, CAPA, data warehouse, document management
Quality-related costs,
revenues
Test equipment management,
calibration planning and
execution
Plan t Floor In t eg ra t ion Using SAP x MII
Overview of SAP Quality Management
Plant Floor Integration: xMII and SAP QM
Customer Success Stories
Outlook
SAP Qua l i ty Manage m e n t: Overv ie w and
Manufac t ur ing Qual i t y Met r ic s Are Most Im port ant
Source: AMR Research, 08/2006
SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.11
SAP Qual i t y Managem entenables Shop Floor Managers and Operators to manage and assure product quality, monitor and improve quality standards and document quality compliance, for subsequent audit.
SAP Qual i t y Managem ent Is Par t o f SAP Manufa c t ur ing
K ey Benef 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
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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
Qual i t y Cont ro l in Manufac t ur ing – Bus iness Problem
Business problem
Manufacturing and quality management systems are often separated. Triggering preventive actions through statistical process control and trend analysis as well as tracking of material defects is difficult.SAP offers a powerful quality management solution as integral part of mySAP ERP, however, the user interface to record in-process quality data is not suitable foroperators or quality inspectors in the shop floor.
SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.13
SAP NETWEAVER
What is t he SAP x App Manuf . Int egrat ion and Int el l igenc e (x MII )?
MES – Manufacturing Execution Systems, EMI – Enterprise Manufacturing Intelligence, BW – Business Warehouse (from SAP)SFAC – Shop Floor Automation & Control, LIMS = Laboratory Information Management Systems
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AP
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mySAP ERPSAP Manufacturing
mySAP SCM
Manufac t ur ing Int e l l igenc e Dashboards
SAP xMII
The SAP x App Manufac t ur ing In t egrat ion and In t e l l igenc e (x MII ) is a pac k aged c omposi t e appl ic at ion t hat de l ivers:
Manufacturing Integration
Manufac t ur ing Int egrat ion: A single ISA-95 compliant layer enabling SAP ERP connectivity into real-time plant floor apps.(MES, SFA, LIMS,..) to drive plant-to-enterprisebusiness process interoperabilityManufacturing Intelligence
Manufac t ur ing Int el l igenc 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
SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.14
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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
C
SAP QM Produc t iv i t y Pac k for SAP x MII – Use Cases
ContentSAP will deliver generic templates for quality data entry and visualization that enable a state-of-the-art user interface for the operator who is responsible for in-process quality checks. A seamless integration between SAP xMII and the mySAP ERP QM backend will be provided.
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
SAP QM Produc t iv i t y Pac k for SAP x MII - Overv iew
(BAPIs or service-enabled)
mySAP ERP (SAP R/3)QM Master Data and Inspection Planning
SAP xMII (11.5)
Interface box(e.g. Steinwald)
QM Results Recording
QM Results Recording
„Heavy weight“ (for Power Users)
„Light weight“ for Operator on the Shop Floor
Exchange of Inspection resultsSAP QM Inspection lot data
Electronic test equipments
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.
•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
3rd party LIMS
„SAP QM Productivity Pack for SAP xMII“
SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.16
Quality Planning
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Quality Inspector
Qual i t y Cont ro l in Manufac t ur ing: Proc ess
Roles
Measure and improve KPIs
Crea e Inspectiont
Approve Batch / Orders
Control Produced Batch / Orders
Plant ManagerAudit, on Demand and
Review Results
Quality Manager
SAP x MII
SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.17
St ep 1: Qual i t y Planning in my SAP ERP
• QM master data maintenance (characteristics, methods,… )
• Central inspection planningand 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
Demo Part 1
Role: Quality Planner
SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.18
St ep 2: Rec ord Qual i t y Dat a on Plant Floor Using SAP x MII
• 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
Demo Part 2
Roles: Quality Inspector or Operator
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.19
St ep 3: Qual i t y Dat a Analys is - Opt ions
Quality reporting in mySAP ERP:• Inspection Work lists and reports• Result histories and control charts• Supplier evaluation• QM Info System
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
Roles: Production Supervisor, Plant Manager or Quality Manager
SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.20
mySAP ERP
mySAP BI
xMII
SAP Manufacturing Intelligence Dashboards
© SAP AG 200G, SAP OM Overview and SAP xMII, Denver 200G p.21
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Par t ner x Apps based on SAP x MII t o Dr ive QM Int egrat ion (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 ner x Apps based on SAP x MII t o Dr ive QM Int egrat ion (2)
Partner xApp from IBM: SAP xLC (LIMS Connect)
SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.23
Plant Floor Int egrat ion Using SAP x MII
Overview on SAP Quality Management
Plant Floor Integration: xMII and SAP QM
Customer Success Stories
Outlook
SAP Qual i t y Managem ent : Overv iew and
Cust om er Suc c ess St ory
Driv ing Qual i t y Im provem ent t hru Higher Vis ib i l i t y and Responsiveness w i t h SAP x MII
Prat t and Whi t ney Canada
SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.25
SAP QM and SAP x MII a t Prat t & Whi t ney Canada
Results entry updates QM inspection lot
SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.26
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Prat t & Whi t ney CanadaDr iv ing Qual i t y Im provem ent t hru Higher Vis ibi l i t y & Responsiveness
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 floor productivity improvement.
Will reduce the probability of significant customer escapes*- major customer escape can cost in excess of $ 500K
he estimated annual savings are of $14MM per year at full plementation Claude Poliquin, Business Development Manager- Quality
Presentation at the SAP xMII User Group Conference, Philadelphia, October 2005
* Customer escape is a defective aircraft engine or component delivered to the customer
SAP’s xMII is a tool that will enable us to achieve roughly a $ 14 million saving 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 avoid, we cannot know. Statistically speaking, if we avoid one, it would pay for the system by itself.
“
SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.27
SAP® fo r Pharmaceu t ica ls : SAP QM U s e d a s L IMS
ROCHE DIAGNOSTICSRoche Diagnostics - based in Basel, Switzerland, and one of two divisions of the 100-year-old healthcare companyF. 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 Chal lenges• Manual, time-consuming, error-prone processes/ redundant data• Mounting regulatory pressures• Difficulty in managing growing product lines
Implementation HighlightImplemented solution as part of company-wide SAP® R/2® to SAP R/3® migration
Key Benefi ts• 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
"We now know we canrely on our Q M data andits documentation. Thismeans our customersand our employees areassured of continuing,top-level productquality."
Kai Rothermel. InformationManager SAP QM. RocheDiagnostics
USINESSES R U N S A P. .
1!'. ,© SAP AG 2006, SAP OM Overview and SAP xMII, Denver 2006 p.28 THE BEST-RUN
lJi,lgnu tics
Using SAP QM as In t egrat ed Ent erpr ise LIMS
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
More Than 4000 Cust om ers Use SAP QM Today!
“ Our efforts are focused on our customers and their demands for high quality.
The
quality of purchased parts plays a decisive role. Thanks to the transparency of data in mySAP PLM Quality Management our optimization process is supported and we are in a position to improve our quality and thereby lower costs.(Source: ZF Passau GmbH (Automotive Supplier), Germany)
“mySAP PLM QM accelerates the inspection processes up to 50%. Automation,bothwithin mySAP PLM QM and selected bolt-ons (LIMS and Auto Data 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 solveproblems that arise in the development phase.” (Source: Porsche AG, 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
Plant Floor Int egrat ion Using SAP x MII
Overview on SAP Quality Management
Plant Floor Integration: xMII and SAP QM
Customer Success Stories
Outlook
SAP Qual i t y Managem ent : Overv iew and
New in Qual i t y Managem ent w i t h my SAP ERP 2005
• 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 ey Objec t ives for Qual i t y Managem ent w i t h SAP
Quality Management with SAP
St ra t egic Theme s
K ey Headl ines • 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
Leverage SAP xMII for QM
Adopt Enterprise SOA for QM scenarios
Support improvement processes and compliance
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 ey Point s t o Tak e Home
Qual i t y Managem ent f rom SAP …
• 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
Thank you for your at t ent ion
Dr. Manfred Schulz Application Solution
Management Manufacturing
Compliance/QM & Six Sigma
SAP AG
Dietmar-Hopp-Allee
16 D-69190 Walldorf
Germany
www.sap.com
SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.35
Your Turn: Quest ions?
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SAP AG 2006, SAP QM Overview and SAP xMII, Denver 2006 p.36
The information in this document is proprietary to SAP. No part of this document may be reproduced, copied, or transmitted in any form or for any purpose without the express prior written permission of SAP AG.
This document is a preliminary version and not subject to your license agreement or any other agreement with SAP. This document contains only intended strategies, developments, and 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.
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