During the course of a year, Dr. D has the opportunity to visit between 50 and 100 device establishments scattered around the globe. For most of these establishments, CAPA is an integral component of the quality management system (QMS).

However, for a handful of these establishments, CAPA is treated like a four-letter expletive and shunned. In fact, recipients of CAPAs, within these organizations, are often treated as lepers. Unfortunately, these establishments have not learned the true value of CAPA, as a tool to correct organizational deficiencies in support of driving quality and regulatory compliance within their organizations.

People, CAPAs are good things and necessary tools to keep device manufacturers out of the often treacherous regulatory waters associated with a heavily regulated industry. These days there is an “infinitesimal” (look-it-up) line between compliance with the QSR and when the agency decides to pursue a warning letter because of a Form 483 observation or multiple Form 483 observations noted when FDA appears on your doorstep for a cup of coffee and an inspection. Enjoy.

Warning Letter – 26 September 2014

This week’s winner of the agency’s prize for stellar organizations received the award premised on eight Form 483 observations, including two for CAPA (or lack of). In fact, CAPAs opened to correct inspectional deficiencies in 2008 were opened and closed with no evidence of corrections occurring. Folks, this equates to an automatic warning letter being awarded by FDA; and reinforces the title of this week’s guidance; “What is the point of CAPA if the establishment fails to fix problems?”

Warning Letter Excerpt – Observation 1: Corrective and preventive action activities and/or results have not been adequately documented, as required by 21 CFR 820.100(b).

Specifically, your Corrective and Preventative Action (CAPA) SOP #J-001, Rev A, dated 10/11/06, references as data sources the deficiencies identified during internal audits and regulatory inspections. Your firm was issued a Notice of Violation from the CA DPH on 05/17/08 and a FDA-483 Inspectional Observations from the FDA on 12/10/2008. CAPA actions identified as #1 and #2 were initiated to address the deficiencies identified during the subject regulatory inspections. Our inspection found the status of those CAPA actions listed as completed. However, your firm does not have documentation demonstrating that the deficiencies were corrected. Furthermore, our current inspection found many previous deficiencies were not corrected. For example, deficiencies were found with receiving inspection procedures, component identification and traceability, acceptance activities, CAPA activities and trending/analysis of data sources, device history records, and employee training.

The adequacy of your firm’s response cannot be determined at this time. Your response includes a log of CAPAs opened on 07/22/14 to address deficiencies found during the current inspection, and records of some corrective actions that have been initiated. However, activities associated with CAPAs # 2014-001 – 2014-009 are in progress with a target completion date of 10/31/2014. We will assess your corrective actions and documentation of those actions during the next inspection of your firm.”

Observation 2: “Procedures for corrective and preventive action have not been established, as required by 21 CFR 820.100(a).

Specifically, your Corrective and Preventative Action SOP #J-001, Rev A, dated 10/11/06, was not implemented. Section 4.1.4 requires devices reported or returned from the field as defective or malfunctioning to be investigated in accordance with SOP #M-005, Customer Complaint Investigation (also referred to as Customer Experience Investigation). However, there is no documentation that a failure investigation of reported and returned devices included a review to identify potential trends, as required by SOP M-005, Rev A, Section 3.12; nor is there documentation of trending analysis of Customer Experience Reports (CERs), as required by Section 3.17. For example, the subject documentation is missing for CER # 12-004 , 12-006, 12-008, 13-006, 14-003, 14-007 and 13-004 concerning device malfunctions of the low tone or low output or low DB level.

The adequacy of your firm’s response cannot be determined at this time. Your response states “A new CAPA procedure is in the process of being revised” and “we… will immediately begin analyzing all sources of quality data dating back to the previous 2008 inspection.” We will assess your corrective actions and documentation of those actions during the next inspection of your firm.”

21 CFR, Part 820.100 – Corrective and Preventive Action

(a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for:

1. Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems;
2. Investigating the cause of nonconformities relating to product, processes, and the quality system;
3. Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems;
4. Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device;
5. Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;
6. Ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems; and
7. Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.

(b) All activities required under this section, and their results, shall be documented.

Compliance for Dummies

Now my dear readers, Dr. D is going to let you in on a little secret, pursuing effective corrective action and preventive action is not rocket science. Yes, there are tons of training materials, seminars, even books that can help bring novices up to speed on effective CAPA activities or even reinforce what experienced industry professionals already know. However, CAPA is actually an extremely simple process that can be broken down into seven steps:

1. Script a procedure and create a CAPA form that captures FDA requirements. If you need a procedure and a form, contact Dr. D and he will provide them per gratis.
2. Once a CAPA opportunity has been identified, investigate the cause of the issue. Remember the issue could be related to product non-conformances; ineffective processes, or a QMS issue requiring a correction. Make sure the investigative process gets you to root-cause. If the non-conformance is device related, you will need to pursue containment activities ASAP!
3. Identify potential actions required to correct/mitigate the issue (nonconformance).
4. Implement the actions identified for resolving the issue (nonconformance).
5. Verify the effectiveness (VOE) of the actions taken. Folks, the doctor recommends waiting up to 90-days to determine if the actions pursued are effective. For some corrections, such as a minor tweak to a procedure, implementing the procedure may suffice for VOE. However, for process-related changes, time will be needed for executing an effective VOE.
6. Make sure information associated with the CAPA, especially if it pertains to product and processes, is disseminated to the appropriate personnel, i.e., engineers, inspectors, operators, assemblers, etc.
7. Make sure all CAPAs: (a) opened; (b) closed; (c) delinquent; (d) cancelled; or (e) determined to be ineffective; find their way into management review.

Finally, it is important to remember, FDA’s primary point of entry into your QMS, during an inspection, will be the CAPA system. You see, the agency really does not want to waste time searching for the proverbial skeletons in the closets of establishments when the CAPA system can provide the roadmap as to where the skeletons can be quickly located.

Takeaways

For this week’s guidance the doctor will leave the readers with just one takeaway. “CAPA is our friend!” Device establishments that manage to navigate the often treacherous waters associated with our heavily regulated industry manage to do so through an effective CAPA system. Remember, CAPAs should always be viewed as proactive tools needed to drive quality and regulatory compliance in support of an effective QMS.

In closing, thank you again for joining Dr. D and I hope you find value in the guidance provided. Until the next installment of DG – cheers from Dr. D. and best wishes for continued professional success.

References:

1. Code of Federal Regulation. (2013, April) Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
2. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon. Devine, C. (2013).
3. Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
4. FDA’s enforcement page. (2014, September). FDA.gov Website. Retrieved October 13, 2014, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm416625.htm.