ISO9001 GAP Analysis Question 61 - Documented Information on Non-Conforming Product Actions Taken, Concessions and Actions Taken.

To verify if there is evidence of documented information that describes the non-conformity, actions taken, concessions obtained, and the deciding authorities involved with actions taken, follow these steps:

Check for Records of Non-Conformities:

Review records related to non-conformities, such as non-conformance reports (NCRs), incident logs, or product/service deviation reports. These documents should clearly describe the nature of the non-conformity, including the specific requirements that were not met.

Review Documentation of Actions Taken:

Ensure that for each non-conformity, there is documented information outlining the actions taken. This could include corrective actions, containment procedures, rework instructions, or any other methods used to resolve the non-conformity. The documentation should specify how the non-conformity was addressed and prevented from affecting further operations.

Verify Concessions and Approvals:

Look for any records where the organization obtained customer or relevant authority approval for accepting the non-conformity under concession. These records should include the specific details of the concession, such as the agreed-upon terms, and any formal communication with the customer or authority.

Check for Documentation of Authority Involvement:

Ensure that the actions taken in response to non-conformities are authorized by the relevant individuals or authorities within the organization. There should be documented evidence of who decided the course of action for each non-conformity. This could be a signature, a formal approval, or a documented decision from the responsible authority.

By confirming that these elements are documented and traceable, you can determine whether the organization meets the requirement for retaining documented information on non-conformities, actions taken, concessions obtained, and the authorities involved in the decisions.