Failure of Management with Executive Responsibility
19 July, 2016 Dr. Christopher Joseph Devine, President, Devine Guidance International Inc
Effective management teams should be fully engaged with their business operations.
|FDA says that management with executive
responsibility shall review the suitability
and effectiveness of the quality system at
For the second time in three weeks, Dr. D was able to quickly locate another rarely cited Form 483 observation: The failure of management with executive responsibility to actually review the quality management system they have been entrusted with managing. Now granted, from time-to-time it becomes a challenging task for the management representative to circle the wagons and corral all of the management-types into the executive conference room for a meeting focused on the performance of the quality management system (QMS). However, every Chief Jailable Officer (CJO) clearly understands the ramifications associated with not complying with the FDA’s sacred text, the quality system regulation (QSR). In fact, not being able to share at least documented evidence that a management review has occurred (agenda and sign-in sheet) is just not excusable. Heck, the agency even gives a ton of wiggle room with the “planned intervals” requirement, so holding at least one review annually should be a piece of cake. Right? Well, based on the performance of the device establishment targeted in this week’s guidance, the answer is a big “evidently not!” As many of the doctor’s friends and readers know, Dr. D is somewhat of a wisenheimer (look-it-up). However, when it comes entertaining the FDA during one of their friendly visits for a cup of coffee and an inspection, it is always Game On! Enjoy.
Warning Letter – March 17, 2016
Winning a prestigious warning letter award from the FDA should never be cause for a celebratory event. In fact, it should be quite the opposite. As the doctor has mentioned on many occasions, every device establishment on the planet receives a Form 483 observation from time-to-time. However, receiving an observation on a requirement where the results do not have to be shared with FDA (only evidence that the activity has occurred) is inexcusable. For the CJOs out there in quality and regulatory land, Dr. D knows that he is preaching to the proverbial choir. All Form 483 observations are preventable, and a handful of violations are seldom if ever seen (e.g., failing to hold management review meetings). Why, because it is not a particularly challenging task to actually hold a darn meeting. In QSR land, unlike ISO 13485, the FDA does not even provide a list of management review inputs, which simplifies the task. They leave the content up to the device establishment. How difficult can that requirement be to meet (content decided by management and evidence meeting actually occurred required by FDA)?
Warning Letter Excerpt
Observation Four (4) – “Failure of management with executive responsibility to review 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 Quality Manual, FSP-14, Revision A requires annual management reviews of the quality system. Your firm has not performed any management reviews.”
21 CFR, Part 820.20(c) – Management Review
“(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.”
820.180 (c) Exceptions.“This section does not apply to the reports required by 820.20(c) Management review, 820.22 Quality audits, and supplier audit reports used to meet the requirements of 820.50(a) Evaluation of suppliers, contractors, and consultants, but does apply to procedures established under these provisions. Upon request of a designated employee of FDA, an employee in management with executive responsibility shall certify in writing that the management reviews and quality audits required under this part, and supplier audits where applicable, have been performed and documented, the dates on which they were performed, and that any required corrective action has been undertaken.”
Compliance for Dummies
The doctor strongly believes that when the FDA identifies egregious violations such as not performing management reviews, management with executive responsibility should be banished to a local “B” school to re-learn the business 101 basics. Folks, you do not have to be in the device industry to realize that effective management teams are fully engaged with their business operations. In fact, every single industry on the planet (including bookmaking, just kidding) benefits from management reviews scheduled at a reasonable frequency. Dr. D would love to see establishments hold monthly reviews. However, the doctor also realizes the amount of work that goes into planning a good management review meeting. That being said, holding management reviews quarterly is considered a good practice.
Additionally, in accordance with §820.180(c), device establishments are not required to share the contents of management review with our dear friends from the agency. However, establishments do have to provide documented evidence that meetings are being held—for example, copies of the agenda and sign-in sheet will do. Make sure each management review meeting has a stand-alone agenda and a sign-in sheet. When FDA arrives for inspection fun and inquires about management review, share the agenda and sign-in sheet, nothing more. Now because medtech is truly a global endeavor, best practice (Dr. D’s opinion) is to align management review with review inputs and outputs delineated within ISO 13485.
For this week’s guidance, the doctor will leave the readers with two takeaways. One: remember, device establishments do not have to share management review content with FDA. Only documented evidence that meetings were held is required. Two: Dr. D strongly recommends holding management review meetings at least quarterly. Holding one meeting a year may be an acceptable practice, but the value of annual meetings is extremely limited. 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. (April 2015). 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. (March 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Grams Medical, Inc. Accessed May 04, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm497792.htm
A well-known and respected medical device industry quality and regulatory expert, Dr. Christopher Joseph Devine is the president and founder of Devine Guidance International, Inc., (DGII) a consulting firm providing regulatory and quality compliance support for the medical device industry. Prior to launching DGII, Dr. Devine spent 14-years with Boston Scientific Corporation working in a variety of quality and regulatory management roles. Additionally, Dr. Devine is the author of Devine Guidance, a weekly blog focusing on quality and regulatory compliance issues facing the medical device industry; and published by the MedTech Intelligence, an e-magazine. Furthermore, Dr. Devine has 35-years of combined experience in the fields of quality assurance and regulatory affairs; and is a senior member of the American Society of Quality (ASQ), a member of Regulatory Affairs Professionals Society (RAPS), a member of the Society of Manufacturing Engineers (SME), and a member of the Project Management Institute (PMI). Dr. Devine received his doctorate from Northcentral University, with his doctoral dissertation entitled, “Exploring the Effectiveness of Defensive-Receiving Inspection for Medical Device Manufacturers: A Mixed-Method Study. Finally, Dr. Devine is the author of six books on quality and regulatory compliance published by and available at Amazon.com. Prior to launching his commercial career, Dr. Devine served honorably as a member of the United States Marine Corps.