The doctor’s dear friend and evil twin, James Twitchell (a well-known and respected quality system expert) was trolling through the FDA warning letters over the holidays and recommended that Dr. D take a look at a tersely-worded warning letter issued by the agency back in November. Thanks Twitch!
Typically, when the number of Form 483 observations reaches nine or moves into double digits, the warning letter warrants some attention from industry, so establishments do not make the same mistakes. That being said, this warning letter will probably result in the old doctor visiting this warning letter a few times over the next few weeks. However, at this very moment the doctor is reading, typing, and listening to the Ohio State and Oregon National Title Game, so this week’s guidance will be brief. Now Dr. recognizes that all device establishments may suffer from the occasional “solecism” (look-it-up) or inaccuracies associated with managing a dynamic quality management system (QMS); however, when nine Form 483 observations are documented in an agency warning letter, the QA and RA folks are more than likely fast asleep at the proverbial wheel. Enjoy!
Warning letter – 05 November 2014
One of the most basic elements associated with any QMS is management review. Heck, in accordance with 21 CFR, Part 820, device establishments do not even need to share the content of management review with our friends from the agency, only evidence that such reviews are occurring. How difficult is it to meet this requirement? Ask a caveman, he might know. Seriously folks; holding a management review meeting is simply a basic management task. A task that Dr. D finds incredibly difficult to screw up, but the doctor guesses anything is possible when Mr. Murphy is alive and well in the device industry. Additionally, when an establishment provides the FDA with a deficient response, bad things are about to happen. A crystal ball is not needed to look into the future and ascertain the level of regulatory pain the FDA is about to unleash on this noncompliant establishment. In fact, for this establishment, the FDA clearly states in the warning letter that corrections should occur prior to manufacturing products. Duh! You think?
Warning Letter Excerpt
Observation Eight: “Failure to establish procedures for management reviews required by 21 CFR 820.20(c). Specifically, your firm has not established procedures for conducting management reviews.”
“We received a response letter dated September 17, 2014 from your Vice President and CEO. Our review found the response was inadequate. Although you indicate you will correct the deviations through the generation of new procedures, you did not provide copies of the procedures or sufficient detail of the content of the procedures for our review. We acknowledge in your firm’s response you indicate you will not be (b)(4); however, corrections to the deficiencies identified above should be completed prior to manufacturing the products”.
Subpart B – Quality System requirement
Section 820.20 – Management responsibility
“(c) Management review. Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer’s established quality policy and objectives. The dates and results of quality system reviews shall be documented.”
Compliance for Dummies
The doctor is a big proponent of the ISO 13485 (Clause 5.6) requirement for management review. In fact, review input (Clause 5.6.2) and review output (Clause 5.6.3) clearly delineate what requirements need to be assessed as part of the management review process. All establishments really needs to do is create a template that incorporates these requirements and plan to hold management reviews at defined intervals. Although the rule-of-thumb for many establishments is the annual default for a management review, that is not a realistic approach for holding these reviews. As a minimum, Dr. D recommends holding a quarterly review. Best practice would be considered monthly; but that really is a ton of work to put together, especially for larger entities.
The doctor also recommends a stand-alone agenda and sign-in sheet. Why? Because the agenda and sign-in sheet becomes a Chief Jailable officer’s (CJO) documented evidence of compliance. Upon request, give FDA a copy of the agenda and the sign-in sheet, but never share the content of management review with the agency.
For this week’s brief guidance, Dr. D will leave the readers with four takeaways.
- Establishments do not have to share management review content with FDA, only evidence that the review(s) are occurring at defined intervals.
- Use the ISO 13485 (Clause 5.6) blueprint for management review meetings, it works.
- Always have a stand-alone agenda and sign-in sheet.
- Annual management reviews are not really effective, shoot for quarterly reviews.
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.
- Code of Federal Regulation. (2014, April) Title 21 Part 820: Quality system regulation.Washington, D.C.: U.S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon. Devine, C. (2013).
- Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
- FDA’s enforcement page. (2014, November). FDA.gov Website. Retrieved January 12, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm426559.htm.