Dr. D has stated on multiple occasions that the greater the number of Form 483 observations received during an agency inspection, the greater the likelihood of regulatory action being pursued by FDA. Can you say warning letter? Obviously, there is no mystical mathematic equation or formula that provides the FDA with a surefire way of determining which establishments are on the receiving end of that dubious prize called a warning letter versus those that receive an acknowledgement that their corrections will be verified during the next inspection. However, receive a repeat violation and the chances are pretty darn good that the offending establishment will receive a warning letter. Dr. D cannot place enough emphasis on the importance of providing robust responses to Form 483 observations issued during an agency inspection. As most of the readers already know, an agency inspection can be mentally and physically exhausting. However, Chief Jailable Officers (CJOs) cannot not fall into the hebetude (look-it-up) of a lazy post-inspection afternoon and provide FDA with a less than stellar response to the inspectional observations. The results of poorly written responses can be devastating to the offending establishment. Seriously, can you say warning letter? Enjoy!
Warning Letter – July 12, 2017
The warning letter used to support this week’s Devine Guidance (DG) cited 12 observations noted during a March 2017 inspection. To make matters worse, the establishment provided FDA with less than stellar responses, including the complete failure to respond to one observation. In fact, eight of the 12 responses were identified as inadequate, two of the 12 responses were identified as incomplete, and one observation did not receive a response. Simply stated, only one response was deemed to be acceptable by FDA. Folks, one for 12 is always going to be problematic for offending establishments. One of the observations cited by FDA pertained to management review.
It is the doctor’s humble opinion that management review falls into the basic blocking and tackling category that football coaches have pounded into their player’s brains for decades. Dr. D is going out on a limb here and connecting the proverbial dots between the excessive number of inspectional observations and an establishment’s failure to conduct management reviews. Call the doctor crazy, but the link between Form 483 observations and the failure to conduct management reviews seems logical to the old doctor.
Warning Letter Excerpt
Observation Nine (9) – “Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency, as required by 21 CFR 820.20(c). For example, your procedure, QM-04, Management Review, Rev. B requires your firm to conduct management reviews at least once a year. Your firm failed to conduct management reviews in 2014 and 2015.
We reviewed (redacted name) response dated April 13, 2017, and find it inadequate. He referenced that the quality management system was the focus of discussions (b)(4), and that a formal management review was not conducted in 2014 or 2015. He did not reference whether a management review would be conducted for 2017.
21 CFR, Part 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
Please keep in mind, management review content is one of those items that device establishments do not have to share with our dear friends from the agency when an investigator magically appears in an establishment’s lobby for that friendly cup of coffee and an inspection (reference §820.80(c) – Exceptions). However, establishments still need to provide the FDA with documented evidence that reviews are occurring and with sufficient frequency to be effective. In lieu of sharing the results of management review reports or meeting minutes with FDA during an inspection, the CJO can certify (in writing) that the management reviews are occurring. Dr. D believes there is a better way of conveying compliance.
First and foremost, make sure you have a written procedure that clearly defines the frequency of management reviews. Most of the establishments that Dr. D has the pleasure of auditing during the course of a year default to the annual review. Although FDA, registrars and notified bodies typically deem this approach as acceptable, it really is not effective. The doctor prefers quarterly reviews. Monthly reviews would even be better but are much more difficult to manage.
Make sure management reviews are placed on your establishment’s annual schedule/calendar. Establishments typically include management review on the annual internal audit schedule. It has more visibility in this location, and it makes sense to hold management review meetings after an audit cycle has been completed.
Make sure each management review meeting has a written agenda and a signature (attendance) sheet. Instead of providing an FDA investigator with a certification statement, device establishments can share the signature sheet and agenda as documented evidence that reviews are occurring in accordance with the published schedule. However, if the meetings are lacking a quorum or lack being graced by the presence of the CJO, then sharing the signature sheet with the FDA is going to be a bad thing.
Finally, make sure one of the review attendees is taking meticulous notes. Review meeting minutes (report) will need to be scripted and assigned actions identified during the review, tracked to completion. It is imperative that individuals assigned action items be held accountable for the completion of these action items. It is called accountability. If there is no follow-up to assigned action items, what in the heck is the purpose of holding the management review? Drinking and thinking sessions can be held after hours at the local bar. Simply stated, management reviews can be an effective tool in helping device establishments remain in compliance with quality, regulatory and statutory requirements. Note: Without active involvement from management, device establishments are destined to struggle with sustaining compliance.
For this week’s guidance, the doctor will leave the readers with two takeaways. One: Management review, when employed properly, is a fabulous tool for keeping establishments on the straight and narrow path when it comes to compliance (quality, regulatory and statutory). Two: Contents of management review are never to be shared with FDA, only documented evidence that they are being held. Certification from the CJO or a management review sign-in sheet and agenda can be used to prove compliance with §820.20(c) to the FDA investigator(s). In closing, thank you again for joining Dr. D, and the doctor hopes you found value (and some humor) 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. (April 2016). 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. (July 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. Whitehall/Div of Acorn Engineering Co. Accessed August 21, 2017. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm567734.htm