ISO 13485 - Process validation at critical suppliers

#1
Hello,
We are a ISO 13485 certified company and are working with own production facilities as well as ISO 13485 certified sub-contractors.
Processes (primarily welding and injection moulding) are validated in our own facilities.
Our auditor requires us to perform process validations according to IQ/OQ/PQ also at the sub-contractors.
We argue that since they are ISO 13485 certified, it is covered in their QMS.
Any thoughts, remarks, guidance would be helpful.
Kind Regards,
T Verm
 
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William55401

Involved In Discussions
#2
Process that require validation in your own facility also need to be validated by your supplier if you choose to purchase the item instead. Yes, your supplier has a QMS. As a customer, you need to clearly communicate expectations and define how you will ensure oversight on the supplier's executed process validation. Your quality agreement is a great place to define validation expectations, roles, and responsibilities.
 

Philip B

Involved In Discussions
#3
Do you require your suppliers to follow IQ/OQ/PQ? If so, write it into your technical agreement and periodically audit compliance. If not, push back to your auditor with a documented rationale as to why it is not necessary.
 

William55401

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#4
PhilipB, I am good with your comment up to "if not.....". Can you share an example of a defendable rationale? Help me learn. Thank you.
 

Sidney Vianna

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Staff member
Admin
#5
We argue that since they are ISO 13485 certified, it is covered in their QMS.
Any thoughts, remarks, guidance would be helpful.
Just because you have a driver's license, it does not mean that you obey and follow the rules of the road all the time. You would be surprised how many certified systems have major violations. Have you asked to see copies of the supplier audit reports, issued by their CB? Who knows, maybe the CB found MAJOR nonconformities on the issue of the process validation subject and you are unaware of the fact?

As the process has been outsourced, YOUR ORGANIZATION is still responsible for the requirements. So, demand proof/evidence/records of process validation from your supplier. On top of that, you could demand that your supplier specifically requires their CB to assess the processes you are concerned with and the CB audit report sent to you during each and every surveillance? You can easily add that to your quality agreement with the supplier.

Good luck.
 

Philip B

Involved In Discussions
#6
PhilipB, I am good with your comment up to "if not.....". Can you share an example of a defendable rationale? Help me learn. Thank you.
I think you need to go back to your risk management for the device. What are the hazards and risks and how do you control these? Can they be adequately controlled by your own inspection and testing etc. If yes, there's your rationale. If not, what additional controls do you need over your sub-contractors, which might include IQ/OQ/PQ of equipment. Hope this helps.
 

William55401

Involved In Discussions
#7
Got it. Your rationale certainly applies to general processes but not special processes that require validation. (I know special is a dated term but I am old school).
 

Philip B

Involved In Discussions
#8
Another thought, IQ/OQ/PQ is normally used for equipment qualification, not for processes (the old pharmaceutical adage, equipment is qualified, processes are validated). So if you are looking to validate a process I'm not sure that IQ/OQ/PQ is the best approach (but of course it might be for the equipment used in the process). I'm sure there must be some process validation experts out there who can help?
 
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