GADV mbHSchafgasse 3

71032 BöblingenGermany

www.gadv.de

Phone +49 (0)7031 / 7196-0E-Mail i40-services@gadv.de

Improving the clarity of FMEA

Integration of FMEA-Tool intoIBM® Engineering Workflow Management (EWM/RTC)

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GADV mbH

DIGITALIZATION & CONNECTIVITY

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DIGITAL ASSISTENZ

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DIAGNOSIS & MONITORING TOOL FOR MEDTECH

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APPLICATION LIFECYCLE MANAGEMENT

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Expertise & Solution Focus

• Our industries is focused on Automotive, Manufacturing and MedTech

• Over 40 years of experience with Software and System Solutions in production and testing processes

• GADV is specialized in Digitalization & Interconnection of machines and processes and acts as a System Integrator

• We offer Consulting, Design, Integration, Education, Support and Maintenance Services and special automations and interfaces

www.gadv.de

Pain Points & FMEA-Requirements

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FMEA Usage of Failure Mode and Effects Analysis

• Higher product reliability & to lower product risk

• Easier handling of risk analysis for products with a high number of variants

Pain Points

• Product robustness / reliability

• High cost to develop new products

• Compliance efforts

• Quality issues

• Failure to meet timeline

• Causes of double effort

• Lack of transparency

• Difficult to collaborate across large or distributed teams

STEP 1 Planning & Preparation

STEP 2 Structure Analysis

STEP 3 Function Analysis

STEP 4

Failure Analysis

STEP 5

Risk Analysis

STEP 6 Optimization

STEP 7

Risk & Results Documentation

RiskSystem Analyse Failure Analysis and Risk Mitigation Communication

Automotive

FMEA Customer Requirements

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Some priorities of our Automotive Supplier

customer focus, excellent performance, efficient processes, lean structures . . .

FMEA Engineering Challenges and Requirements

• Representation of defined workflows including approval and release process

• Consistent treatment of the different FMEA types

• Various evaluation, search and filter functions across all FMEAs

• Monitoring of assigned actions/measures and all deadlines

• Access and modification protection of the entire FMEA

• Versioning of the complete status of each FMEA during the processing phase

• Archiving over a long period of time including the accompanying documents

• Variant management: grouping of FMEAs that differs only slightly for different products

• Number of active FMEAs: > 10k

• Number of Risk Analysis Version Work Items: > 45k

• Number of Risk Analysis Action Work Items: > 97k

• Number of Users: > 1k

Benefits for the use of IBM® Engineering Workflow Management (EWM)

• Standard functions out of the box (workflows, file handling, search, queries, plans, dashboards, reports)

• FMEA work items allow to integrate the FMEA directly into the development process of products or projects (planning, tracking, due dates, . . .)

• FMEA Action work items can be used like standard tasks to track effort, timelines/iterations and collaboration

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Key Points

• Representation of FMEA versions and FMEA actions as EWM work items

• Extensive use of the functions contained in EWM, e.g. search, analysis, workflows, dashboards, reports

• Initiating activities through status changes of the work items, e.g. start approval or release version

• Automated bi-directional connection of the FMEA tool

• Fully automated archiving of the associated documents on a secure archive network drive, with linking of the documents in the work item

• Automated evaluation and monitoring of FMEA actions

• Simple check-in and check-out process for important documents

• Interfaces to other applications such as product or project databases

Solution Benefits

Overview Integration FMEA into IBM® EWM - How it looks like

6www.gadv.de * functions deliverd by GADV

Jazz® Server

FMEA ServerUser PC

EWM Server

FMEA Application Server FMEA-Tool Server

Local File Storage

FMEA Frontend

EWM Frontend

Central File Storage

FMEA-Tool Client

• Request Approval

• Get new version and continue work

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• Edit work item attributes

• Edit files• Check-in,

check-out, retrieve file

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• Get new FMEA number

• Create from existing file

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• Document approval

• Long time archiving

• Dashboards with statistics and details

• Queries• Reports

• Quick search: work item or FMEA id or content

• Queries

• Project/ personal dashboards

• New/shared queries

search FMEA

create FMEA

release FMEA

Reportingapprove

FMEAupdate FMEA

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with *GADV function add-onsFunctionalities

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Risk Analysis Version Work Item represents FMEA Version

search FMEA

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One Risk Analysis Work Item for one FMEA version

Risk Analysis Action Work Item representsan Action / Measure Handling

One Risk Analysis Action Work Item for one Action / Measure

create FMEA

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Create new FMEA

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create FMEA

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1. Start new FMEA

2. Select Project Area, FMEA Type & Category

3. Request new Document (=FMEA) Number

4. System creates unique number and stores it in

a new, empty Risk Analysis Version work item.

Update FMEAupdate FMEA

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Check-In FMEA-file Check-Out FMEA-file

Test1524 1 0 test.fme 1252 In Work

Test1524 1 0 test.pdf 1252 In Work

Test1524 1 0 test.xml 1252 In Work

1. Add file as attachement

2. Select Work Item ID or FMEA

number

2. Set status to Checking In

3. System copies file to file share, add link, removes

attachment and sets status back to In Work

3. Checkout file

1. Select Tab File Action

4. Download of file is initiated; Status

of Work Item is set to Checked Out

Approve & Release FMEA

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release FMEA

approve FMEA

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Dashboards & Reports 1/3

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Reporting7

Dashboards & Reports 2/3

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Reporting7

Dashboards & Reports 3/3

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Reporting7

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Values & Your Questions

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• Complete integration of FMEA handling into the product/project developmentwith IBM® Engineering Workflow Management

• Optimization of time by -15% with faster and more agile processes due to reduction of duplicate work

• Higher productivity - fast execution & automated (FMEA) data exchange

• Transparency with reports/dashboards and control of FMEA deadlines

• Complete and quick evidence (current & historical)

GADV-Contacts

www.gadv.de

Ulrich SimonSenior Consultant & Architect

Application Lifecycle Management / IBM Engineering Lifecycle Management

Phone +49 (0)7031/71960

E-Mail: ulrich.simon@gadv.de

Dr. -Ing. Gregor Diehl

CEO

Phone +49 (0)7031/71960

E-Mail: i40-services@gadv.de