Raising a NC that has an action plan

Hello,

During internal audit, or auditing in general, and there is an open point not complying with a requirement but the team already have an action plan to close it in the future with evidence, should I raise it as a NC? or not consider it? or raise it in case of internal auditing and consider it as a Finding with an Action plan just for monitoring the due date in the QMS?

Thank you!

I think it's hard to say without more detail of the circumstances. You mention that there was a failure to meet a requirement. Was a nonconformance opened and if so was the investigation adequately documented? Was the requirement an actual documented requirements in the QMS? If there was a nonconformance, does the QMS require a CAPA? Not all NC's require a CAPA. but there should be criteria for when CAPA's are required.

Chrisx said:

I think it's hard to say without more detail of the circumstances. You mention that there was a failure to meet a requirement. Was a nonconformance opened and if so was the investigation adequately documented? Was the requirement an actual documented requirements in the QMS? If there was a nonconformance, does the QMS require a CAPA? Not all NC's require a CAPA. but there should be criteria for when CAPA's are required.

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The points to be raised are not a complete failure of complying to the requirements but rather an opportunity for improvement. example for one point is "There's no complete automation of the incoming material check" and the current status of the process is that there's a manual incoming material check, and there's a project to automate this process planned and has a due date.

Fatima97 said:

Hello,

During internal audit, or auditing in general, and there is an open point not complying with a requirement but the team already have an action plan to close it in the future with evidence, should I raise it as a NC? or not consider it? or raise it in case of internal auditing and consider it as a Finding with an Action plan just for monitoring the due date in the QMS?

Thank you!

Click to expand...

You would be surprised how many action plans are not completed. There is no harm in triggering a nonconformity if the auditee is already working on a corrective action because you have a mechanism to ensure completion and effectiveness of the actions taken.

In lieu of that, you might choose to report the issue as an observation in the audit report. In the auditing protocol you don’t have to report all findings as nonconformities.

Fatima97 said:

The points to be raised are not a complete failure of complying to the requirements but rather an opportunity for improvement. example for one point is "There's no complete automation of the incoming material check" and the current status of the process is that there's a manual incoming material check, and there's a project to automate this process planned and has a due date.

Click to expand...

I read this as there is no nonconformance to any external standard. (First sentence) It may be a nonconformance to an internal requirement - tho that is hard to imagine (a requirement to have fully automated incoming material check?). It may be an objective/goal to automate certain processes in which case there is an action plan. So what’s the nonconformance????? Should we issue NCs for every project that has not yet been completed?

I see this often. My own QMS had an action plan, signoffs, deliverables, budget, and deadlines for MDR in Europe. Then COVID happened and then MDR was "adjusted."

I then met with my CEO and I amended the entire plan with a memo stating "This plan has been suspended pending further MDR developments and COVID restrictions" Auditors saw this and accepted it. Not all plans are completed. As a company, we must address the objectives in this plan but not for several years. There is no requirement to complete this until 2028 so that's that.

And we don’t (yet) know that this action plan was in response to a real nonconformance or was just normal upgrading and/or improving projects. Usually covered with project plans and a budget for something like automation of a manual system. Nor do we know if the project is behind the original schedule…

Fatima97 said:

The points to be raised are not a complete failure of complying to the requirements but rather an opportunity for improvement. example for one point is "There's no complete automation of the incoming material check" and the current status of the process is that there's a manual incoming material check, and there's a project to automate this process planned and has a due date.

Click to expand...

In your first post, you stated that there is an open point not complying with a requirement. In this post, you state it is not a failure of complying, but an opportunity for improvement. Then further, that this is a project in work. Until it becomes "the process", there is not a nonconformance or an opportunity for improvement finding - it's already an improvement in the works - which is a good thing. Note it as a good finding in your internal audit records and maybe increase the audit frequency to evaluate the new process until it's proven to be fully implemented and effective/efficient.