Leveraging Audit Report from Previous Job

[quality-man]

Hi all, I have a question for everyone and I'm just wondering what other professionals think about it. For anyone who thinks this question is crazy - I'm almost certainly going to just do the audit - but I was curious if anyone has thought about this before or if there is some precedent for doing this.

I have recently joined a new company who will be qualifying a supplier I have used in the past at other companies. Typically I would go do a qualification audit, but it's a little annoying because I was at this supplier for a qualification audit three months ago in my last role. It seems like a very silly use of my time and the suppliers time to go basically repeat what I did three months ago. I still have copies of my audit report and their audit responses, and the use case for the supplier is the same for both my previous employer and current employer.

Does anyone here think there is a path forward for leveraging this audit report? I'm not particularly concerned from a confidentiality perspective as my previous employer went out of business and the CEO signed off on quality folks taking records with them.

 

[Wearerofmanyhats]

I'd say it sounds like a fine day or so of vacation and beers with an old pal to me!

 

[Golfman25]

If there is no conflict, then I don't see a problem with it.

 

[John C. Abnet]

Maybe @Wearerofmanyhats , an opportunity to simply visit and introduce your new role/new company to the supplier. This time, instead of an audit or review of their processes, how about simply buying your counterparts lunch or grabbing a coffee. It's ALL about the relationship

Be well.

 

[LUFAN]

Just make sure whatever qualification path you decide is in alignment with your procedure. Don't give yourself a nonconformance as result of something that might make logical sense.

 

[Wearerofmanyhats]

Maybe @Wearerofmanyhats , an opportunity to simply visit and introduce your new role/new company to the supplier. This time, instead of an audit or review of their processes, how about simply buying your counterparts lunch or grabbing a coffee. It's ALL about the relationship

Be well.

Exactly! What he said! You're a pretty smart person, John.

Just make sure whatever qualification path you decide is in alignment with your procedure. Don't give yourself a nonconformance as result of something that might make logical sense.

Really great point here though, I think what the consensus says is: make it out to be a good trip. A lot can change in three months, heck, its amazing what can change in 30 minutes. I have great relationships with almost all of my suppliers and if not usually there's someone (e.g. CSR, Assistant, rubber meets road people) I could buy lunch for.

 

[I_Moy]

This is a very interesting question and I can see myself ending up in similar situations - of course as others have said if you can go - do, but I have also been in the position of having to justify all audit trip spending in a company tight on money so will add my perspective to the discussion:
1. Your supplier audit isnt just of their QMS its also of their processes specifically for your company, so you should be reviewing records related to the manufacture of your specific product (or lot numbers you received if its the exact same product) for your current company.
2. Personally, I would use your personal recent knowledge of the supplier QMS to justify doing a half day remote audit of just what I talked about in point 1 and a review of any changes made to their QMS since you last visited. You get a fresh new audit report, get to touch base with them and pivot that connection on behalf of your new company while saving time and money for both parties. That's a win in my books!

 

[d_addams]

There is no way you should be using that as evidence your new company has audited this supplier. I had to double check that this was still in the Medical Device section of the forums because this is so far out of compliance acceptability and unethical I'm shocked someone is suggesting this.

Imagine you showed up at a supplier for an audit and they said no thanks, we were just audited by customer X last month, here is a copy of their report, we're all good, see you in 2 years. Good luck showing a regulatory body a copy of your prior employers audit report as evidence you audited this supplier to your new companies requirements.

 

[Golfman25]

There is no way you should be using that as evidence your new company has audited this supplier. I had to double check that this was still in the Medical Device section of the forums because this is so far out of compliance acceptability and unethical I'm shocked someone is suggesting this.

Imagine you showed up at a supplier for an audit and they said no thanks, we were just audited by customer X last month, here is a copy of their report, we're all good, see you in 2 years. Good luck showing a regulatory body a copy of your prior employers audit report as evidence you audited this supplier to your new companies requirements.

What the difference between that and showing them a third party audit? I find customer audits much more substantive As they tend to focus on real issues. Op was talking about a suppler qualification via an audit. Is that even required under 13485?

 

[chris1price]

In complete agreement with d_addams, , the previous qualification/audit report belongs to the previous company not the OP. Unless he has a written agreement with his previous employer, he should not even have a copy of the report and I can't see how it can be shared with a new company, he doesn't own it. Additionally, his new company may have different processes, audit standards and requirements, also a different quality agreement with the supplier. To me, both legally and regulatory, this would be a very bad practice.