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Internal Audits - Categories of non conformances

Jim Wynne

Super Moderator
#11
Hi Qualprod. I don't understand your question fully, but hope this helps.

If there is no objective evidence for a specific requirement called out in the SOP, that is an audit finding. In this case, an email is required. A printout of the email would provide objective evidence. A statement by the auditee that they always send the email would provide objective evidence. You instead have a statement by the auditee that they did not send the email. Therefore, this is a finding.

If there is no objective evidence that the requirements of ISO 13485 are fulfilled, that is an audit finding. But I don't know enough about the objective evidence you have gathered to make a determination on whether they are meeting the requirements of ISO 13485.
Everything that's "found" in an internal audit is a "finding." This doesn't necessarily mean that a "finding" is a nonconformity.

To answer the OP's questions:
  1. If the documented procedure says that the signal for release of product is an email message and there was no email message, there is a nonconformity. It doesn't matter whether the procedure says "must " or "shall." Presumably there's a reason for requiring the approval.
  2. If the person who released the product did so without the requisite email authorization, there is a second nonconformity. The email authorization and the actual release of the product are two different steps in the process, and both appear to have been violated. It's possible, of course, to write the nonconformity statement such that both infractions are addressed.
Whether or not any of the process makes sense is another matter. It seems to me, based on qualprod's previous posts on various issues, that the quality system in his company is not very well thought out and is a target-rich environment. This makes it impossible to offer specific advice on what should be done to remedy all of it.
 
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