The problem originates with the author of 820.100 who, in my opinion, didn't understand the difference between corrective action and preventive action. This leads to the abomination "CAPA" in which two different processes CA and PA are jammed together as if they were one. Eventually the GHTF disavowed this approach in GHTF/SG3/N18:2010 Quality Management System –Medical Devices – Guidance on Corrective Action and Preventive Action and Related QMS Processes with the statement, "The acronym 'CAPA' will not be used in this document because the concept of corrective action and preventive action has been incorrectly interpreted to assume that a preventive action is required for every corrective action."
I parse 820.100(a)(3) (Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems) into four constituent parts:
Identify action to correct nonconforming product
Identify action to correct other quality problems
Identifying action to prevent recurrence of nonconforming product
Identifying action to prevent recurrence of other quality problems
The concern is that there should have been a different set of constituent parts. The first two are misplaced. The missing ones are:
Identifying action to prevent occurrence of nonconforming product
Identifying action to prevent occurrence of other quality problems
The wording in 820.100(a)(3) appears to cover correction and corrective action and doesn't include preventive action. I believe, in the context of the misunderstanding, "correct" was incorrectly used for corrective action and "prevent recurrence" was incorrectly used for preventive action. (This is the warning from the GHTF.)
There are three process to consider.
Correction eliminates a detected non-conformity
Corrective action eliminates the cause of a detected nonconformity
Preventive action eliminates the cause of a potential nonconformity
We also need to eliminate terms such as "root cause" (the worst instance is the "true root cause", implying we have been finding false root causes all this time) and "CAPA".
My hope is that the plan from FDA-CDRH that QSR "revisions will supplant the existing requirements with the specifications of an international consensus standard for medical device manufacture, ISO 13485:2016" will address the issue.
Unfortunately, I'm not confident that the plan to supplant (to eradicate and supply a substitute for – Merriam-Webster) QSR with ISO 13485:2016 will resolve the problem.
------------------------------
Dan O'Leary
Swanzey NH
United States
------------------------------
Original Message:
Sent: 27-Oct-2018 16:10
From: Kevin Randall
Subject: Definition of Correction
Remember that the U.S. FDA uses the term "correction" in two different ways depending on the context. But because there is somewhat of a Venn diagram relationship between the two ways (more about that in a moment), the issue can become confusing. Therefore, it is important that you keep these distinctions clear in your QMS and thus in your dealings with FDA investigators (and ISO assessors).
Also noteworthy is that in the various FDA inspections I've overseen in the last couple years, I'm seeing more young new investigators at FDA rather than the more tenured pillars that have been fixtures in times past. So be patient with your FDA investigators, and diplomatically explain the differences in the way "correction" is used in your QMS. In doing so, also be prepared to show the FDA that the way you're doing it is in fact based on the FDA's own long-standing precedents. Then in addition, be ready to leverage the close overlaps that now exist between FDA's 21 CFR concepts/definitions vs. ISO 13485:2016.
Given below is some additional commentary expanding on my preceding points.
The Venn-type diagram provided below (and/or attached) illustrates FDA's two-fold usage of the term "correction":
Remember that FDA's original intent for 21 CFR Part 820 was to model it and its terminology after the essence of ISO 9001 and ISO 13485. For example, in the Part 820 preambles, FDA states, "…it would be beneficial…for the CGMP regulation to be consistent, to the extent possible, with…ISO 9001:1994…and the ISO committee draft (CD) revision of ISO/CD 13485…" FDA also stated, "…the most appropriate approach to developing device CGMP regulations equivalent to the quality system specifications in ISO 9001 is to…use similar terminology where appropriate…" Although the aforesaid versions of ISO 9001 and ISO 13485 are superseded by later versions, the essence of FDA's intentions for synergy between ISO 9001/13485 and 21 CFR 820 still remain; especially as evidenced by ISO 13485:2016 (now more similar than ever to 21 CFR 820).
The term "correction" used in the context of FDA 21 CFR 820.100(a)(3) (general corrective/preventive action) is a great example of where FDA uses "similar terminology [to ISO] where appropriate". There is copious evidence of FDA doing this with the term "correction". For example, FDA's public QSIT workshops for industry for the CAPA subsystem defined "correction" as repair, rework, or adjustment relating to the disposition of an existing nonconformity. This is the identical definition from ISO (by original way of ISO 8402 now replaced by ISO 9000 and its synonymous definition "action to eliminate a detected nonconformity" recited above by Melinda). This same definition was also used in this context by FDA in its c. 2012 CAPA overview presentation by Kimberly Lewandowski-Walker. And in Joe Tartal's FDA CAPA presentation from 2014, FDA defined correction using the aforesaid updated ISO 9000 definition. Also noteworthy is that the IMDRF (GHTF) defines correction in this way too, and the GHTF has for some time been a favorite resource and venue for FDA to assert its perspectives. So we use this form of "correction" when correcting nonconforming product, processes, or quality systems. As a side note, the term "correction" does not appear in 21 CFR 820.90 (nonconformity product), which instead only refers to "disposition" where one type of disposition could be a correction (such as rework) taken under 21 CFR 820.100. To avoid additional confusion, it is important that these demarcations between adjacent quality subsystems be clearly delineated in your QMS.
In contrast to the 21 CFR 820.100 / ISO 9000 versions of correction, when FDA instead uses the term "correction" in the context of 21 CFR Parts 7 and 806 (i.e., in the context of recalls and recall reports), then FDA applies the definition from 7.3(h) and 806.2(d). This type of correction is specifically intended to address corrections of marketed products that are in violation of FDA law to such a degree that FDA would take legal action if needed to resolve the issue. This is the reason for FDA's sensitivity about this term in the context of recalls and the consequent need for firms to use and define it appropriately, including proper distinction from the aforementioned more general type of correction in the larger context of 820.100.
But remember once again the Venn-type diagram relationship between the two types of correction. The key to avoiding confusion and keeping FDA and your ISO registrars happy is by clearly showing this relationship in your QMS documentation and also being able to articulate that your approach is based on long-standing harmonized precedent. Such an approach tends to keep your newer/younger FDA investigators in check and in sync with your logic. And once you've properly articulated the foregoing relationship between FDA and ISO terminology, your ISO assessors should also be satisfied. Therefore Sam Lazzara's comments are wise indeed about handling the different definitions pursuant to ISO 13485:2016 clause 0.1 (and clauses 2 and 3).
Hope this helps.
------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com
© Copyright 2018 by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 24-Oct-2018 11:40
From: Melinda Smith
Subject: Definition of Correction
I'd like to get some opinions of how to address the FDA versus ISO definition of correction. FDA defines correction as "the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without its physical removal from its point of use to some other location". ISO defines a correction as "an action to eliminate a detected non-conformity". During an FDA inspection, the FDA made a big deal about the definition of correction not being the exact FDA definition, however, during an ISO registrar audit, they want to see the ISO definition. How do you make both organizations happy?
Hoping to start a conversation about this here. Thanks!
------------------------------
Melinda
------------------------------