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AS9100C. 7.1.2 Risk Management - Interpretations

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AlexanderS

#1
Good day everybody,
My company is planning certification for AS9100, and I am looking for piece of advice on this Forum.

7.1.2 Risk Management.
My interpretation is as follows.
We are Contract Manufacturer and produce PCBs (no design work). We should manage risks of being non-compliant to industry/customer/regulatory requirements on quality/delivery/and safety.

a) To satisfy industry requirements I have written PFMEA to manage quality related production risks. Our main source of requirements is IPC-A-600 standard (Acceptance of PCBs) and my PFMEA is based on Control Plan. (Evidence - Record)

b) To satisfy customer requirements we manage risks by identifying Customer Critical Items during Job Planing, such as Key Dimensions, special requirements for raw materials, etc. (Evidence - specific Travelers with identified Critical Items)

c) To satisfy Customer requirements for Delivery we have Job Planning procedure where we manage Delivery risks. (Evidence - no record :( just procedure)

d) Compliance people make sure that we have all necessary safety related documents (WHIMIS, MSDS). Procedures are in place. (Evidence - records)

e) Risk of loosing important Customer. Decided to conduct Reviews bi-annualy based on Customer Satisfaction Surveys. (Evidence - records)

Further have outlined all these risks above in one document, called it Risk Matrix, assigned RPN numbers, and put together future Action plan to reduce RPN. (Evidence - Record)

Am I missing anything?
What is your understanding of the Risk Management?


Your comments would be greatly appreciated.



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Alexander
 
Last edited by a moderator:
#2
Re: AS9100C. 7.1.2 Risk Management.

Am I missing anything?
What is your understanding of the Risk Management?

Alexander
There is a concept of mitigation that could be written into what you have, if you have not. Something like 'Critical Item Review - Risk - Long Lead Time purchased good - Mitigation - stock some or re-negotiate ship date.'

Also, while not expressly written, I was asked for records of the Risk Management during an audit. I believe it is allowable to say that the Risk Management Process is employed during Quote Review, and that blanket or bulk purchase orders that have been accepted are exempt from the process.

I added the record of the Risk Assessment to a Quote Review checklist and that seemed to pass muster.

Good luck!

Eric
 
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