Regulatory Open Forum

I am part of a team that is working on improving our current CAPA system.  One of the things we're working on is creating a reasonable timeframe for closing CAPA's.  Our thoughts are CAPA's should not be open any longer than 90 days; however, there's been some talk that CAPA's can be closed within 30 days.  Can anyone share how their company approaches CAPA closures?

Thank you.

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Donna Elliott
Charlottesville VA
United States
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On more than one occasion I have heard FDA representatives say that they do not expect - indeed do not find logical - blanket time limitations on CAPA closure.  They recognize that some problems may be addressed by a thorough corrective action within 30 days, whereas others may take half a year or longer.  You may wish to place a time limit of some sort on how long it takes to analyze the problem and come up with a plan of action, but even there I would allow for extension of the time for particularly intractable problems.  Rather than requiring completion within even 90 days, I would suggest that you expect the team working on each problem to come up with a realistic estimate of the time required, and then as a metric look at how well you are doing at hitting your targets.

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William White
Senior Consultant
Quality System Strategies LLC
Elkhart IN
United States
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Original Message:
Sent: 05-17-2013 08:07
From: Donna Elliott
Subject: CAPA System

I am part of a team that is working on improving our current CAPA system.  One of the things we're working on is creating a reasonable timeframe for closing CAPA's.  Our thoughts are CAPA's should not be open any longer than 90 days; however, there's been some talk that CAPA's can be closed within 30 days.  Can anyone share how their company approaches CAPA closures?

Thank you.

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Donna Elliott
Charlottesville VA
United States
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I'm a consultant (devices) and often advise my clients on this issue.

I recommend that you don't set a specific time, because you will run into regulatory issues. Instead, recognize that that closure time, regardless of you define it, has an underlying skewed statistical distribution. It will have a long tail to the right. I recommend setting a target that utilizes this distribution; say 95% of CAs should close within 30 days. This now gives you a performance measure that you can monitor and discuss at Management Review. 

CAs need to be, in my opinion, on a short cycle. You need to prevent the problem from happening again by determining the cause. It is causing nonconformance material, waste of resources, and the potential for escape of a "bad" product.

PAs could have a different target, (95% within 60 days) because the problem has not happened.

(Be sure you understand the difference between CA and PA as defined in ISO 9000:2005!)

In either case, there is a psychological problem. If the CA or PA is open too long, nobody works it. Priorities change and other issues arise.

Part of your process should ensure that each open CA or PA is active. This means that somebody is actually doing work.

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Dan O'Leary
Swanzey NH
United States
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Original Message:
Sent: 05-17-2013 08:07
From: Donna Elliott
Subject: CAPA System

I am part of a team that is working on improving our current CAPA system.  One of the things we're working on is creating a reasonable timeframe for closing CAPA's.  Our thoughts are CAPA's should not be open any longer than 90 days; however, there's been some talk that CAPA's can be closed within 30 days.  Can anyone share how their company approaches CAPA closures?

Thank you.

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Donna Elliott
Charlottesville VA
United States
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Donna

I attended a training seminar on CAPA that was led by a former Director of Domestic Investigations for the Los Angeles District Office.  His recommendation was to set a "target date" for completion (typically 30 days).  If you cannot close it out in that time it should be because of the nature of the investigation (e.g. need for re-validation, communication with suppliers and sub-suppliers, etc).  He advised that during inspections it was not the fact that complaints were still open after 30 days that was an issue, it was the fact that there was no evidence that they were active (someone forgot about it or priorities changed).  As long as you are showing progress and not unduly delaying correction you should be fine.

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Jason Gumaer, MPH
Director, Quality Assurance
Therapak Corporation
Duarte CA
United States
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Original Message:
Sent: 05-17-2013 08:07
From: Donna Elliott
Subject: CAPA System

I am part of a team that is working on improving our current CAPA system.  One of the things we're working on is creating a reasonable timeframe for closing CAPA's.  Our thoughts are CAPA's should not be open any longer than 90 days; however, there's been some talk that CAPA's can be closed within 30 days.  Can anyone share how their company approaches CAPA closures?

Thank you.

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Donna Elliott
Charlottesville VA
United States
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We have just updated our CAPA SOP.  We define 30 days for completion of the CAPA and if it cannot be completed in this time frame, it is rolled over into a long term CAPA.  This ensures that we follow the CAPA and that it does not get lost in bureaucracy.

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Alice M Varga, MS, MA
VP, Regulatory Affairs and Quality Assurance
OXiGENE, Inc.
South San Francisco, CA 94080
USA
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Original Message:
Sent: 05-20-2013 16:56
From: Jason Gumaer, MPH
Subject: CAPA System

Donna

I attended a training seminar on CAPA that was led by a former Director of Domestic Investigations for the Los Angeles District Office.  His recommendation was to set a "target date" for completion (typically 30 days).  If you cannot close it out in that time it should be because of the nature of the investigation (e.g. need for re-validation, communication with suppliers and sub-suppliers, etc).  He advised that during inspections it was not the fact that complaints were still open after 30 days that was an issue, it was the fact that there was no evidence that they were active (someone forgot about it or priorities changed).  As long as you are showing progress and not unduly delaying correction you should be fine.

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Jason Gumaer, MPH
Director, Quality Assurance
Therapak Corporation
Duarte CA
United States
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Original Message:
Sent: 05-17-2013 08:07
From: Donna Elliott
Subject: CAPA System

I am part of a team that is working on improving our current CAPA system.  One of the things we're working on is creating a reasonable timeframe for closing CAPA's.  Our thoughts are CAPA's should not be open any longer than 90 days; however, there's been some talk that CAPA's can be closed within 30 days.  Can anyone share how their company approaches CAPA closures?

Thank you.

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Donna Elliott
Charlottesville VA
United States
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I agree with the not setting hard deadlines as then you come across the issue of not meeting them consistently. In a previous company we had broken the CAPA system into 4 parts:
Base investigation - something simple in nature should be able to completed in 30 days or less
Post Investigation - something a little more involved, usually cross functional -target was to complete in 90 days
Corrections - the implementer defined how long this would take but was required to justify to QA the timeframe
CA/PA - same as the correction, the implementer sets the timeframe for completion but must justify to QA

All dates are targets and are listed as such in the procedures and if those targets dates are exceeded then justification is required as to why and a new target date is set.

As for showing that progress is happening for everything other than the 30 day ones, monthly updates are asked for and in the case of a CA/PA (the actual action) interim checks were asked for at defined intervals to show that progress was happening.

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Keri Froese RAC
Quality Assurance Specialist
Ottawa ON
Canada
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Original Message:
Sent: 05-17-2013 08:07
From: Donna Elliott
Subject: CAPA System

I am part of a team that is working on improving our current CAPA system.  One of the things we're working on is creating a reasonable timeframe for closing CAPA's.  Our thoughts are CAPA's should not be open any longer than 90 days; however, there's been some talk that CAPA's can be closed within 30 days.  Can anyone share how their company approaches CAPA closures?

Thank you.

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Donna Elliott
Charlottesville VA
United States
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Hi Donna,

In addition to all the above comments which are very helpful, you may also consider to factor in the time required to review the CA/PA taken and its effectiveness as per ISO 13485:2003.

Hope this helps.

Regards
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Romit Singh
Regulatory Affairs Associate
Device Technologies Pty Ltd
Frenchs Forest
Australia
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Original Message:
Sent: 05-17-2013 08:07
From: Donna Elliott
Subject: CAPA System

I am part of a team that is working on improving our current CAPA system.  One of the things we're working on is creating a reasonable timeframe for closing CAPA's.  Our thoughts are CAPA's should not be open any longer than 90 days; however, there's been some talk that CAPA's can be closed within 30 days.  Can anyone share how their company approaches CAPA closures?

Thank you.

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Donna Elliott
Charlottesville VA
United States
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