Leveraging Audit Report from Previous Job

[Golfman25]

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.

Maybe read the last sentence of OPs post. He has permission from previous company.

 

[John C. Abnet]

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



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.

...my reference was meant to be back to the OP ...i.e. comment was intended for @quality-man .

Be well.

 

[Ampein]

Relax. Be professional. Go through the audit like going to a new supplier.
You may same time by going quickly through some same areas and go for new areas where you think you had no time to do in the last audit.

Do not skip the audit and use the last audit results. That's unethical and unprofessional.

Good luck.

 

[d_addams]

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?

qualification or audit, in a Medical Device company, you still need to follow your policy and procedures. The entities auditing you expect to see evidence you followed your procedures in qualifying a supplier. Showing them a report done by someone else as justification you didn't need to follow your process would be an immediate finding.

 

[Golfman25]

qualification or audit, in a Medical Device company, you still need to follow your policy and procedures. The entities auditing you expect to see evidence you followed your procedures in qualifying a supplier. Showing them a report done by someone else as justification you didn't need to follow your process would be an immediate finding.

Right, but unless 13485 specifically required a supplier audit, then you can do what your procedures say to do. Most that I am familiar with leave supplier audits up to the organization's discretion -- so not every supplier is audited, which could be a real waste a resources. This report was done by the OP. He knows the supplier's capabilities and performance. It would be like someone telling me I couldn't take the suppliers I have been using for 30 years to my next job. A 30 year history of performance or a 1 day "audit" -- which is better?