Regulations (e.g., the U.S. FDA's QS Regulation, Europe's Regulation 2017/745, etc.) and standards (e.g., EN ISO 13485) don't typically prescribe what timelines are required for CAPAs, other than to say that the improvement action shall be taken without "undue delay" (e.g., EN ISO 13485). In fact, I can't think of a single regulation or standard that prescribes specific CAPA timelines.
Instead, we are allowed to establish whatever timeline makes sense to us provided that we are making a good faith effort to properly resolve and close the nonconformities (CA) or potential nonconformities (PA). Specifically, each CAPA's unique timelines need to be established commensurate with the risk, complexity, and practicality of the issues. For example, if the promised actions [be they within the correction, corrective action, or effectiveness verification aspects (for example, new regulatory authorizations could appear in any of these steps depending on the particular nature of the CAPA)] require 12 months to complete, then so be it as long as that date is established in good faith and doesn't involve undue delay.
By the way, you may get scolded by some (but hardly anyone) for using the "CAPA" acronym rather than just "CA" or "PA". This is in light of the GHTF's proper recognition about the pitfalls of the CAPA acronym. Thus, when using the CAPA acronym (just like regulatory agencies still do, and will continue to do, even in the most official ways), then just be sure to remember (officially, i.e., procedurally) that not every CA requires a PA even though either or both are most often, even by the governing authorities, colloquially called "CAPA".
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 01-May-2024 04:57
From: Martin Finnerty
Subject: CAPA - Including Regulatory Approval in CAPA Timelines
Hi, interested to find out common approach to establishing CAPA timelines where regulatory approvals (FDA, NB etc.) are required to fully implement changes resulting from a CAPA. Is regulatory approval which say for example could take up to 12 months in certain regions commonly incorporated into the CAPA timeline or is this considered outside the CAPA and monitored through some other QMS mechanism allowing the CAPA to close pending regulatory approval of the actions. If so, how does one go about verifying the effectiveness of actions if they have not been fully implemented yet due to been caught up in regulatory submissions.
Thanks!
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Martin Finnerty
Cook Medical - ENTERPRISE
Limerick
Ireland
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