Timeframe to resolve Corrective Actions (Undue Delay)

Q

QAMTY

#1
Hi everybody

How do you set timeframe to resolve Corrective actions?

in order to evaluate how a company is resolving the internal CA´s
in my opinion, it is needed to set a timeframe to be resolved, for example
date CA was issued, when was attended with actions plans, when
action plans are verified and closure date. All of them fit into the timeframe.
what do you consider practical to monitor how the employees are attending the CA´s.? in order to evaluate if they are ok or delayed.

Additional to this, a Kpi may be set as well.

Maybe closure within 60 days,30 days.
or maximum days to attend them = 15 days.


Is it possibe to set this allowed time but only internally, not into the Management system? this way is not an argument for an auditor to check when are resolved with due dates.

I assume, the auditor will check this issue against the standard "resolve
without undue delay" which in my opinion is less restrictive.

Please share your opinion.

Thanks
 
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Sam Lazzara

Trusted Information Resource
#2
The amount of time it can take to implement effective corrective actions can vary considerably. You can break the timeline into 2 segments:
1. Time until you get to the "Original Planned Completion Date" (OPCD).
2. Action completion delays beyond the OPCD.

The OPCD should be based on the risk of the situation, balanced (somewhat) by the available resources. And there should be a procedural allowance to assign a "Revised Planned Completion Date" with appropriate justification (via a CAPA Extension Memo, or the like). Also a good idea to report accomplishments-to-date in such memos, to show progress.

See attached example for addressing timeliness in a CAPA procedure. While the "undue delay" requirement (in ISO 13485:2016 at least) only applies to corrective actions, I prefer to apply the same guidelines to preventive actions.

Finally, it is important to have a quality objective (KPI) associated with CAPA timeliness. Example: 80% of all CAPA actions completed by original planned completion date. (The "action" completion date, not the date of completing verification/validation of effectiveness).
 

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QAMTY

#3
Thanks Sam
But how do you measure the 80%?
Do you evaluate at the end of month and check the status? But based on what ?for the last month,or the total in the year?
Please explain.
 

Sam Lazzara

Trusted Information Resource
#4
Thanks Sam
But how do you measure the 80%?
Do you evaluate at the end of month and check the status? But based on what ?for the last month, or the total in the year? Please explain.
The source of the data is my CAPA Log (see attached).

You can base the percentage calculation based on whatever time interval you wish. You count the number of CAPAs that had actions fully completed in the time interval - that is your denominator. Then you count number of those CAPAs for which the actions were fully completed by/before the Original Expected Completion Date - that is your numerator.

For me, I recast Quality Objectives on an annual basis (in January) and after each quarter I report accomplishments, year to date. In January of the next year, I would report results for all CAPAs with actions completed in the entire prior year.
 

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QAMTY

#5
Hey Sam
Two questions
1 How convenient is to check AC quarterly? Is it not better each month? This way if something is wrong, you do something immediately to fix the problem.
2 what do you monitor monthly? And is this reviewed in the Mgmt. Review meetings.
thanks for your time.
 

Sam Lazzara

Trusted Information Resource
#6
Hey Sam
Two questions
1 How convenient is to check AC quarterly? Is it not better each month? This way if something is wrong, you do something immediately to fix the problem.
2 what do you monitor monthly? And is this reviewed in the Mgmt. Review meetings.
thanks for your time.
1. Frequency is up to you. My clients are mostly small companies that do not have a large quantity of CAPAs at any given time, so quarterly reporting is fine.

2. Managers should continually monitor their processes, with formal review results reported at Management Reviews. And yes it would be reviewed at Management Reviews since the progress towards Quality Objectives is one of the agenda topics.
 
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