Hello Jennifer,
It sounds to me like your organization is in need of some Internal Audit(or) Training. The training should cover the various responsibilities and view points of the three parties to the audit.
The party at fault in your explanation is the Auditor, specifically, the Lead Auditor on that audit. It is the auditor’s responsibility (the Lead Auditor) to determine if enough objective evidence exists for the issuance of a request for corrective action. In this case, they stated the need for Corrective Action as part of the Audit Report, which might be correct with regard to how you structured your audit program. Traditionally, requests are treated separately, but in the case of Medical Device manufacturers, this is often not the case.
I disagree with allowing management (the client) the ability to issue corrective actions as part of the audit process. If they want to issue a request for CA outside of the audit process, that’s their prerogative, but they weren’t part of the auditing process whereby they lack the intimacy of details, conditions, and quite possibly, independence (the Client is sometimes the Auditee as well) at the time of the audit. I think that if you review a few resources on auditing, you’ll find that they’ll state that the responsibility for issuing CA requests rests with the Auditor.
I also get the impression that your audit program might be dysfunctional in that it might be used as a weapon of war. “CAR Wars” might pop up whereby the finger-pointing may take on a whole new look of ‘ugly’. An auditor one day may be an auditee another, and folks might be looking to get even rather than improve the QMS.
As I stated before, it looks like your organization does not understand well enough the audit process (i.e. parties, responsibilities, purpose, etc.). This is fundamental to a well running audit program. If nobody there is a resident authority, then you may need to get some outside resource in or attend some classes.
Keep posting here, though. There are many good auditors amongst the Covers who can offer good guidance.
Regards,
Kevin