The FDA’s requirements for personnel are delineated within Section 820.25. In fact, Section 820.25 appears to be one of the more innocuous requirements and in the opinion of Dr. D, one of the most important. Can you say training, training, and more training?
Regardless, compliance to the requirement is mandated by the regulation. That said, Dr. D would probably suffer from some compunction if I failed to cover all aspects of the regulations as part of this current series. As always, my goal is to enlighten, entertain, and educate the readers while limiting the Doctor’s pontification episodes. In reality, training is that low hanging fruit where compliance can be achieved, as the output of an effective training program having a positive influence on manufacturing operations.
Warning letter violations and regulations
For this week’s edition of Devine Guidance (DG), it was a real stretch for me to find an abundance of warning letter violations. I had to search FDA’s warning letter database, back to July of last year (2009) to find three events. However, please do not let the absence of documented events steer you into a false sense of security. Fact: FDA did identify violations of Section 820.25. Fact: three medical device manufacturers were identified as having inadequate systems in support of the QSR. Fact: three device manufacturers were cited specifically for training related issues. And fact: the three observations could have been avoided through the implementation of a robust quality system with an emphasis on documented training.
Warning Letter One (February 2010): Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, and training shall be documented as required by 21 CFR § 820.25 (b). Specifically, your firm has failed to establish procedures for identifying training needs and has also failed to record personnel training so that records can be updated and gaps in training can readily be identified and filed.
We have reviewed your response and have concluded that it is inadequate because your firm has failed to establish a training procedure that would ensure personnel adequately performed their assigned responsibilities, and were provided with information about the cGMP requirements and how their particular job functions relate to the overall quality system.
Warning Letter Two (September 2009): Failure to adequately establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented, as required by 21 CFR 820.25(b). For example, there is no documentation of employee training for your firm’s numerous procedures and work instructions that are necessary for your employees to perform their assigned responsibilities.
Warning Letter Three (July 2009): Failure to establish procedures for identifying training needs and ensure all personnel are trained to adequately perform their assigned responsibilities and failure to document the training [21 CFR. 820.25(b)]. There are no procedures for identifying training needs, and company employees who are responsible for medical device manufacturing and complaint, CAPA, and Medical Device Report (MDR) handling are not adequately trained to ensure those duties are performed correctly.
The Quality System Regulation – 21 CFR, Part 820, is crystal clear as it delineates the requirements for personnel training.
1. QSR – Subpart B – Quality System Requirements: Section 820.25 Personnel
(a) General: Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.
(b) Training: Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.
(1) As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs.
(2) Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.
Training – a ‘no-brainer’
From Dr. D’s perspective, the guidance provided in this week’s edition falls into the category of the proverbial “no-brainer.” Why – because the QSR is crystal clear as it delineates the requirements namely, (a) a sufficient number of personnel; (b) that possess the education, experience, background, and training to ensure work is performed correctly; (c) training procedures are established; and (d) the training is documented.
Additionally, when device defects, non-conformances, and associated anomalies are the result of the improper execution of a specific job task, the individuals performing these tasks, shall be made aware of their errors. Years ago, as a young U.S. Marine, Dr. D. would use a 30-day assignment to the mess hall to reinforce training issues; however, this would not be practical in today’s medical device industry. That said, documented retraining with a follow-up evaluation and a supervisor’s additional oversight of the offending individual’s work should suffice. Furthermore, the same basic requirement is applicable to individuals tasked with executing verification and validation protocols. These individuals must also remain informed in regards to defects and errors.
Finally, one tool that Dr. D. found particularly effective was public flogging in the back parking lot (just kidding). It was in the front parking lot. Ok, seriously, I found a weekly review of complaint data, mixed with some good-natured needling of the offending/ responsible R&D, quality, and manufacturing engineers, on a Friday afternoon, to be a nice proactive approach for identifying real product issues. The information gleaned from these brainstorming sessions can be shared with the operators, technicians, and inspectors.
The result is a cohesive team approach to manufacturing medical devices that are safe and effective. Additionally, Dr. D is a believer of a simple rule (probably would qualify for a DG rule): All managers and above, regardless of responsibility, should walk the manufacturing floor at least once each week. If you are a manager tasked with overseeing production, quality, engineering, etc., the walk needs to be daily. Furthermore, trust your employees and staff. My 30-plus years of experience (yes Dr. D is old) tells me that if an assembler or inspector identifies ways to improve a process, you should listen to them as they live and breathe manufacturing day in and day out.
Conclusion: Ensure adequate training
In wrapping up this week’s edition of DG, the key takeaway needs to be the training piece. Ensuring adequate training cascades through all levels of the organization is of significant importance. Documented evidence of training to ensure employees, contractors, consultants, etc. can adequately execute assigned tasks associated with medical device manufacturing is a prerequisite. The expectation is that all individuals associated with device manufacturing understand the QSR, as it influences their particular job function. Remember, the agency can and will issue Form 483s for all noted violations.
In closing, thank you again for joining Dr. D and I hope you find value in the guidance provided. Until the next installment, when I begin discussing Section 820.30 Design Controls, cheers from Dr. D. and best wishes for continued professional success.
- Code of Federal Regulation. (2008, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
- Devine. C. (2009, July). Exploring the effectiveness of defensive-receiving inspection for medical device manufacturers: a mixed method study. Published doctoral dissertation. Northcentral University. Prescott Valley, AZ.
- FDA – U.S. Food and Drug Administration Website. (2010). Warning letters. Retrieved April 14, 2010, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/