Training, or should the doctor say “lack of training”, is one of the areas that is growing in popularity during agency inspections. In fact, training issues are frequently documented in the audits performed by Dr. D. The doctor does not remember the author but one of the doctor’s favorite quality quotes has always been, “It is better to invest in your employees’ training and have them leave versus not training your employees and have them stay.” For some reason, a few device establishments tend to look at training as an afterthought, you have been trained now go assemble finished medical devices. Nugatory (look-it-up) requirements such as what constitutes the need for retraining or documentation of training are often overlooked. Unfortunately, the doctor has seen many a Chief Jailable Officer (CJO) sit across from an FDA investigator, during a friendly agency visit for coffee and an inspection, and pull their hair out when training records are requested and not forthcoming. If the CJO is follicle-challenged like Dr. D, the lack of training records can be downright painful. Enjoy!
Warning Letter – February 23, 2017
Thirteen is clearly an unlucky number for the device establishment referenced in this week’s DG. Twelve observations noted against Part 820 violations and one observation noted against Part 803 requirements (sounds like all of Part 803 – no MDR procedures) and the decision to move to a warning letter was pretty easy to make by the FDA. Couple the 13 observations with a deficient response in August of 2016 and the doctor is surprised that FDA took another six months to act. Regardless, when a device establishment racks up 13 observations during an agency inspection and provides the agency with a deficient response, a warning letter will be in the offending establishment’s future. One does not need to be clairvoyant or have Dr. D’s crystal ball to see the warning letter is in the offending establishment’s future.
Warning Letter Excerpt
Observation Eleven (11) – “Failure to adequately establish procedures for training and identify training needs as required by 21 CFR 820.25(b). For example, your (b)(4) requires that training needs be identified and that employees possess the required knowledge and skills for performing their jobs. You do not have records to demonstrate that training needs have been identified and that training has been conducted.”
21 CFR, Part 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.
Compliance for Dummies
Considering most state-of-the-art documentation systems link document control with training, the doctor struggles trying to understand why there continues to be a disconnect between training and documentation (i.e., standard operating procedures (SOP), work instructions (WI), inspection instructions (II), manufacturing process instructions (MPI), etc.). Yes, the doctor understands that smaller establishments have fiscal challenges when it comes to ERP, MRP and document management systems. However, the agency does not grant special dispensation based on financial balance sheets; they use the Quality System Regulation (QSR) for guidance. So what does the FDA expect to see in regards to training?
Not wanting to state the obvious but obliged to do so, the training program needs to be guided by a well-written procedure that clearly defines the establishment’s approach to training. Dr. D has always preferred the creation of a training matrix to provide guidance for the training of all staff members, including senior management. The doctor also likes to see well-written job descriptions with educational, experience and job-specific requirements clearly defined. A well-written job description can be linked to the training matrix when it comes to defining individual training requirements (i.e., training requirements for production operators, quality inspectors, engineers, etc. can be easily defined once the job requirements are understood). Remember, contractors and consultants also need to be trained, as appropriate.
The doctor also likes to see basic quality training for all employees, regardless of position. For example, everyone within an establishment should receive training to:
- The quality policy
- The quality manual
- Quality, regulatory, and statutory requirements (recommend annual training), as appropriate (i.e., 21 CFR, Part 820, ISO 13485, ISO 14971, etc.), and last but not least…
- Personnel shall be made aware of device defects, which may occur from the improper execution of their assigned duties, including verification and validation activities.
Finally, all training activities need to be documented—not only to protect the establishment from regulatory action, but protection from litigation should something really bad happen, such as employee injury, dismemberment or even death. Please remember my dear readers, if an event or activity is not documented in writing (or electronically with valid e-signatures), in the eyes of the FDA the event or activity never happened.
For this week’s guidance, the doctor will leave the readers with four takeaways. One: Create a training matrix and well-written job descriptions to help manage the training program. Two: Basic quality training to an establishment’s quality policy, quality manual or other high-level quality documents is extremely important. Dr. D recommends performing this training during employee orientation. Three: It is imperative that employees are trained to the importance of 21 CFR, Part 820, ISO 13485, and/or ISO 14971 (as appropriate). In fact, the doctor recommends holding refresher training for quality, regulatory and statutory requirements annually. Four: Employees must be trained in a manner that makes them aware of the impact the execution of their job functions has on device defects. Defect awareness should be deemed a mission critical training exercise for all establishments. In closing, thank you again for joining Dr. D., and I hope you found 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 2016). Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
- Code of Federal Regulation. (April 2016). Title 21 Part 803: Medical device reporting. 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. (February 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. Denttio, Inc.Accessed March 7, 2017. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm543694.htm.