Define timeline for Major and Miner Audit finding

#1
Hi So currently we received finding on our internal audit process.. One of the audit finding (AF) was open over a year for miner corrective action.
So our new AF which is : Against FDA 21 CFR Part 820.22 Quality audit, and ISO 13485:2016 §8.2.4; regarding “undue delay of corrective actions” SOP**** did not describe the time limits nor the extension process of the identified corrective actions/audit findings from quality audits.

So our corrective action for this is: SOP shall update to - Duration of time as to when the audit findings should be closed.

I am not able to update that in procedure. What should be content. What will be the redline for this
How to define Major AF closure time
How to define Minor AF closure time
 
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Tagin

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#2
If I understand it correctly, the issue is not about predefining fixed closure times; instead, it is about the "undue delay".

There should be:
  • a plan for the corrective action completion, which includes projected target dates for completion of containment, correction, preventative action, effectiveness, etc.
  • those target dates should be realistic, and based on urgency of issue, resources available, etc.
  • if those target dates are being missed, and there is no justifiable reason for missing the target dates, then that is "undue delay".
So, if you had a minor corrective action open for over a year, and you had no justifiable reasons why it was still open, then that is 'undue delay'.

So, your SOP should probably include:
  • the planning of completion of corrective action steps with target dates
  • monitoring of target dates
  • escalation path if target dates are missed, so that management can take action
  • also, setting of target dates may be driven by external sources, such as the customer or auditing company, etc. So, your process should allow these externally-driven target dates to override (or at least, be considered) in place of internally-created target dates.
 
#3
If I understand it correctly, the issue is not about predefining fixed closure times; instead, it is about the "undue delay".

There should be:
  • a plan for the corrective action completion, which includes projected target dates for completion of containment, correction, preventative action, effectiveness, etc.
  • those target dates should be realistic, and based on urgency of issue, resources available, etc.
  • if those target dates are being missed, and there is no justifiable reason for missing the target dates, then that is "undue delay".
So, if you had a minor corrective action open for over a year, and you had no justifiable reasons why it was still open, then that is 'undue delay'.

So, your SOP should probably include:
  • the planning of completion of corrective action steps with target dates
  • monitoring of target dates
  • escalation path if target dates are missed, so that management can take action
  • also, setting of target dates may be driven by external sources, such as the customer or auditing company, etc. So, your process should allow these externally-driven target dates to override (or at least, be considered) in place of internally-created target dates.
Thank you for following up.

So how could you define the date in procedure. So request came from management that Minor AF corrective action should close in 90 days and Major should go to CAPA. But i am not sure how to add that verbiage in SOP.
 

Tagin

Trusted Information Resource
#4
So how could you define the date in procedure. So request came from management that Minor AF corrective action should close in 90 days and Major should go to CAPA. But i am not sure how to add that verbiage in SOP.

It depends alot on the structure and style of your SOP. But in general, maybe something like this:

Audit Findings
Audit findings shall be handled according to their severity:
  • Minor - corrective actions for minor audit findings shall be completed within 90 days of the final audit report. If the activities required to complete the corrective action are expected to exceed the 90 days, then <person-in-charge> should escalate the corrective action to management for how to proceed.
  • Major - corrective actions for major audit findings shall go into the CAPA system within 10 days of the final audit report.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
The issue has been discussed numerous times at the Cove and how unwise is to have pre-determined, fixed, cast-in-stone timeframes for "corrective actions". The treatment of the negative occurrence has to take into account the risks associated with the situation. Containment, correction and corrective actions must be commensurate (including timeframes) with the criticality and risks that are specific to the situation. Line stoppage and product recalls, for example, are extremely difficult to "proceduralize" but they should be available if and when necessary to mitigate nonconforming products multiplying and reaching end consumers.
 
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