Rapid audit template for plastic parts manufacturing process

[zlcareer214]

Since you say "a rapid audit", I would focus your audit on your top priorities.

Think about: Why do you care? Why bother to audit them?

Something like:

1. Any regulatory/statutory requirements or concerns (e..g., are they subject to FDA? have they had an FDA audit recently?)
2. Any certification requirements (e..g., ISO 13485)
3. Any product safety concerns or product safety related processes
4. Validated (vs. verified) processes
5. Your documented supplier approval/supplier agreement criteria
6. Specific focus on areas related to recent quality trends, SCARs, etc.
7. Any other audit requirements placed on you by your QMS or external supplier audit requirements

Thanks Tagin, I copy your suggestions into my check list, maybe our action is more like a visit, however, I still need to get as much quality indicates as possible during this quick visit, that is also why I'm asking as much suggestions from all of you experienced experts as possible now.

 

[Mike S.]

I'm not going to define audit as this can be found several places.

But before I do a supplier audit, especially for a new supplier, I want to have goals, reasons for going, i.e. what do I hope to learn, what do I hope to accomplish? I think it is bass-ackward to say "I have 2 hours max, what can I do in that time?" instead of saying "I want to accomplish these things, how long do I think it is going to take to do that, and do it well?" Two man-hours just seems to me to be much less time than I typically would want to spend doing a first-visit supplier audit. If it is enough for you, okay.

 

[marystevens]

That sounds interesting.