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Reverse PFMEA

An Iterative Approach to FMEA: Since a process FMEA is a preventive analysis, it is conducted prior at the advanced product quality planning (APQP) phase and conducted prior to actual process development and implementation of machines or infrastructure. The ideal FMEA process starts, identifying the elements that are critical to quality (CTQ) for the customer. Once the initial FMEA is complete, these documents need to be updated for opportunities to update the document during: Defects and complaints Changes in Product and process design Issues related to Mass production and issues those were not anticipated earlier Necessary adjustments may include identifying new failure modes, or updating severity, occurrence and detection data for a more accurate RPN calculation, Linkage between PFD, PFMEA and Control Plan

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Santosh Ballal
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100% found this document useful (3 votes)
1K views5 pages

Reverse PFMEA

An Iterative Approach to FMEA: Since a process FMEA is a preventive analysis, it is conducted prior at the advanced product quality planning (APQP) phase and conducted prior to actual process development and implementation of machines or infrastructure. The ideal FMEA process starts, identifying the elements that are critical to quality (CTQ) for the customer. Once the initial FMEA is complete, these documents need to be updated for opportunities to update the document during: Defects and complaints Changes in Product and process design Issues related to Mass production and issues those were not anticipated earlier Necessary adjustments may include identifying new failure modes, or updating severity, occurrence and detection data for a more accurate RPN calculation, Linkage between PFD, PFMEA and Control Plan

Uploaded by

Santosh Ballal
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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PFMEA Review Process

PFMEA DWM – Reverse PFMEA


An Iterative Approach to FMEA:
Since a process FMEA is a preventive analysis, it is conducted prior at the advanced product quality planning (APQP) phase
and conducted prior to actual process development and implementation of machines or infrastructure. The ideal FMEA
process starts, identifying the elements that are critical to quality (CTQ) for the customer.
Once the initial FMEA is complete, these documents need to be updated for opportunities to update the document during:
 Defects and complaints
 Changes in Product and process design
 Issues related to Mass production and issues those were not anticipated earlier
Necessary adjustments may include identifying new failure modes, or updating severity, occurrence and detection data for a
more accurate RPN calculation, Linkage between PFD, PFMEA and Control Plan
Benefits:
The FMEA DWM will be carried out for the operational processes .
The systematic application of the FMEA DWM is planned to brings many benefits to the company, such as:
 Get experience and knowledge of the operations teams.
 Maintain, review and systematically improve the FMEAs
 Reduce risks and costs of non-quality
 Build a structured knowledge base
 Improve production processes.
Method Description
What
A tool for continuous improvement based on on-site review and observation.
Why
To improve production robustness (to reduce and anticipate quality issues)
Who
A Cross Functional Team with:
• A method leader from TS (a trained and skilled person responsible for process development)
• Participants (e.g.: Quality, Production, Maintenance, SQ)
Where
On-site: Production line or workstation (incoming, production, dispatch).
When
During mass production
How often
As per the schedule made by TS after taking inputs from different departments like Quality, Manufacturing,
Maintenance, etc.
How
By identifying new quality related risks associated with real-life production situations, in order to enhance and
update all the relevant process documents ( PFD/ FMEA/Control Plan)
New failure modes observed during day to day production, field failures. Re-rating of SOD rating after checking
consistency with data gathered and IATF recommendations.
Refer Management System Chart for the review process
Activities to do
1) Form CFT shop wise
A CFT led by TS and having members from Quality, Production, Maintenance and SQ should be formed.
Nominations to be given by all heads.

2) Build database of issues and keep it centrally for CFT review


 Station wise failure modes – Operations Quality . Already being done for Zero Defect Station Tracking
 Process Rejection from SAP

3) Prepare schedule
TS to prepare shop wise schedule based on database of issues prioritizing the stations with issue frequency (of
occurrence) , severity of issues

4) TS to keep current process documents and drawings on central location (one drive ) and read
only access to CFT members

5) Explain the methodology to CFT members and kick start the process
Thanks

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