sap qm

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

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Human resources

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management

Enterprise Quality Management within SAP ERP

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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


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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 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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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


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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 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


•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“


Quality Planning

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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


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


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



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


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“.


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)


Plant Floor Int egrat ion Using SAP x MII

Overview on SAP Quality Management



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 QM and SAP x MII a t Prat t & Whi t ney Canada

Results entry updates QM inspection lot


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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® 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


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)

“


Plant Floor Int egrat ion Using SAP x MII

Overview on SAP Quality Management



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


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.


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


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

[email protected]

www.sap.com


Your Turn: Quest ions?

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