IATF 16949 Clause 6.1.2.1 - Lessons Learned and Risk Analysis

[Retired Member 37256]

The clause 6.1.2.1:
The organization shall include in its risk analysis, at a minimum, lessons learned from product recalls, product audits, field returns and repairs, complaints, scrap, and rework.

This mean that we should include the lessons learned from product recalls, also lessons learned from product audits, also lessons learned from complaints, and so on?

Or the "lessons learned" is only referred to the "product recall"?

 

[Sidney Vianna]

Why would anyone limit the sources for lessons learned? Any successful organization wants to learn as much as possible from any problem, potential or real.

 

[SamuelB]

This mean that we should include the lessons learned from product recalls, also lessons learned from product audits, also lessons learned from complaints, and so on?

That would be the case. In our organization we have FMEAs and some of the risks got added as a result of customer complaint investigations and issues pointed out by internal or external auditors. It's difficult to determine every possible scenario the first time round.

 

[Retired Member 37256]

Uhmm I still don't understand how to satisfy this clause 6.1.2.1, what the auditor expect from our organization?..

Should I prepare a stand alone document where I list historical non conformances data (from product recalls, product audit, complaints, reworks, etc) as a risks and take actions to prevent happen again? If yes, is not this a PFMEA?

Hope anyone can address me with examples? thanks.

 

[AMIT BALLAL]

Uhmm I still don't understand how to satisfy this clause 6.1.2.1, what the auditor expect from our organization?..

Should I prepare a stand alone document where I list historical non conformances data (from product recalls, product audit, complaints, reworks, etc) as a risks and take actions to prevent happen again? If yes, is not this a PFMEA?

Hope anyone can address me with examples? thanks.

Assume you had to make product recall / observed NC during production /received customer complaint / any rejection/ rework occurred. You'll do analysis about what was the root cause and what could be / were risks during such cases. Based on this you'll identify actions to be taken and will include same as part of system.

Eg. If you receive a customer complaint, you'll do the problem solving and identify areas where there is a potential risk of occurring same problem and you'll horizontally deploy those actions. This can be used to fulfill requirements of this clause.

Intention and requirement is to learn from failures.

 

[jack770214]

Risks and opportunities, lessons learned are like improvement. It is rolled into each process not to be a single process or activity by itself. We have a corporate document that describes our R&O procedure and its sources just like continuous improvement. All of our process owners implement that document within the process they own. The only difficulty we may run into is keeping R&O at the level one process level and not forcing people to do this at the activity level 10 levels down.

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[Johnson]

Firstly the lessons learned should cover all the other items, if applicable.
Secondly you may use a different method for lessons learned, like a Lessons Learned database, a lessons learned list, or a combination of some individual lessons leared documents (like PPT), etc.