One of the most basic fundamentals associated with any quality management system (QMS) is the need to train the individuals that are required to operate within the boundaries of the QMS. Unfortunately, throughout the year Dr. D continues to write a large number of non-conformances during the execution of audits due to issues associated with the execution of training programs. However, if an establishment has failed to script and launch a training program for their employees, the doctor guarantees that organizational performance issues will frequent the offending establishment. We all know that Mr. Murphy is alive and well; and loves to frequent device establishments, especially those without a robust training program. For those Chief Jailable Officers (CJOs) out there that occasionally enjoy to reading Dr. D’s fine prose, understanding the meaning of the following quote is of the utmost importance to device establishments. “It is better to invest and train your employees and have them leave versus not investing (time and money) in your employees and have them stay” (Dr. D is unsure of the author and made some minor tweaks to the quote). If CJOs dream of the instauration (look-it-up) of a utopian QMS then training needs to part of the foundation. Enjoy!

Warning Letter – January 12, 2018

The warning letter referenced in this week’s guidance contained five violations of the quality system regulation (QSR), a failure to establish a procedure for MDRs, and an issue referenced in the previous Devine Guidance (DG) article, a failure to respond to inspectional observations. Unfortunately, the failure to respond resulted in the automatic issuance of a warning letter. However, the five QSR violations were from critical areas associated with an effective QMS: (a) design control, (b) CAPA, (c) complaints, (d) document control, and (e) the topic of this week’s DG, training. Considering the agency typically enters an establishment’s QMS through either CAPA or complaints, problems noted within these areas usually results in an inspection moving downhill quickly. No CJO wants to sit across from and investigator from the FDA attempting to defend the un-defendable, missing or a lack of documentation.

Warning Letter Excerpt

Observation Five (5) “Failure to establish procedures for identifying training needs as required by 21 CFR 820.25(b). Specifically, your firm lacks written training procedures.”

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 the availability of QMS software that links procedures directly to training requirements, Dr. D struggles to understand why training continues to be problematic for device establishments. Products such as Qualio, Master Control, Pilgrim, and CATSWeb (n,o Dr. D is not a paid spokesperson for these companies) are examples of the plethora of software products available to assist in the management of training. However, even if establishments decide to manage training the old-fashion way, through the use of paper, the FDA requires that a system still be established. In the eyes of FDA, the term “ESTABLISH” means to: “define, document (in writing or electronically), and implement.” Can you say, written procedure?

For starters, device establishments need to ensure they have adequate headcount to ensure all tasks associated with entering their finished devices into commerce receive the appropriate amount of attention. Note: It is acceptable to use contract labor and hired guns (a.k.a., consultants) to ensure resource needs are achieved. However, contract labor and hired guns must still be trained. Additionally, employees must have the appropriate education, background, training and experience to ensure they are capable of executing their assigned job tasks. For example, if a medical background is necessary to ensure complaints are appropriately reviewed for the need to report as an adverse event, having a mechanical engineer reviewing the complaints for potential medical issues is going to be problematic. In fact, the FDA just might find Dr. D’s example as form 483 observation worthy.

Furthermore, device establishments are required to establish procedures to govern their approach to training. It is imperative that all employees, contractors and hired guns receive the appropriate level of training. For example, if you have service personnel that require access to your controlled environment room (CER), these individuals need to be trained to your gowning procedure. The doctor would like to remind the readers that all training activities shall be documented. Why? Because, if a training activity is not documented, in the eyes of FDA, it never happened. Can you say, documented evidence of compliance? Dr. D knew you could.

Finally, employees working directly with the manufacture, inspection or test of finished devices “shall be made aware of device defects, which may occur from the improper performance of their specific jobs.” This requirement is not a nice-to-have or optional. It is a requirement. Similarly, staff members involved with the execution of verification and validation activities “shall be made aware of defects and errors that may be encountered” during the execution of verification and validation testing activities.

Takeaways

For this week’s guidance, the doctor will leave the readers with three takeaways. One: Devices establishments are required to ESTABLISH written procedures for training. Two: Employees, contractors and hired guns are required to be trained. Three: Training shall be documented. Why? Again, in the eyes of FDA, if training is not documented, it never happened. 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.

References

1. Code of Federal Regulation. (April 2017). Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
2. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation –21 CFR, Part 820. Charleston, SC: Amazon.
3. Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
4. FDA. (January 2018). Inspections, Compliance, Enforcement, and Criminal Investigations. Biomodeling Solutions, Inc. Accessed January 27, 2018. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm592704.htm