Observational Audit of Contract Manufacturer Production

Ed Panek

Involved In Discussions
#1
I have production for a contract manufacturer we have not used in over a year. To reduce my interference but still audit them, we have agreed to an observational audit of their production next week. This will require no QA personnel from their team to be available as I will just observe production, note questions, and send the questions to them post production for their response. I will try to tie my questions into 13485:2016 standards focusing on the higher risk steps.

We have done in the past the standard sit down in a room ISO 13485 audit. They are 13485:2016 approved.


Does this method of audit seem legit?
 

bookish

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#3
If no QA personnel will be present, I don't think it's considered an audit. What are you hoping to achieve from this observation?
 

Sidney Vianna

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Staff member
Admin
#4
Does this method of audit seem legit?
Observation of a production process is a technique used as part of a system audit. It obviously has limitations on how much discovery you can really accomplish with this limited assessment.

I would say: it is better than nothing, but it does not raise to what I would consider a system audit.
 

Ed Panek

Involved In Discussions
#5
Well, we have done the standard ISO 13485 step by step of the regulation and objective evidence portion. We wanted a direct audit of production based on the overall risk of the device.
 

somashekar

Staff member
Super Moderator
#6
Hi e
I have production for a contract manufacturer we have not used in over a year. To reduce my interference but still audit them, we have agreed to an observational audit of their production next week. This will require no QA personnel from their team to be available as I will just observe production, note questions, and send the questions to them post production for their response. I will try to tie my questions into 13485:2016 standards focusing on the higher risk steps.

We have done in the past the standard sit down in a room ISO 13485 audit. They are 13485:2016 approved.


Does this method of audit seem legit?
Hi Ed..
This seems a 2nd party audit.
What is your expected outcome in this. Why do you mention that a QA personnel from their team would be otherwise required. You will be talking with the process owner when you audit a process.
You may observe and get answers or clarifications then and there from the responsible manager.
Otherwise this sounds just like a plant walk through visit, and you are masking it as an audit.
Since its a second party audit, it's legit or not is for you and your records as to what you are going to make out of it.
If its serving your purpose as a part of your control over the CM effectively, its fair enough.
 

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