One of the most basic elements of any FDA-compliant quality management (QMS) system is training. It is absolutely imperative that device establishments train their employees, contractors, consultants, and in some cases their suppliers in the use of procedures, work instructions, forms and other relevant documentation needed to design, develop, validate, test, inspect, sterilize, distribute, and employ effective post-market surveillance activities for medical devices that are safe and effective in their intended use.

One of the concerns Dr. D frequently hears being raised by management, is absorbing the expense associated with training and then having key employees depart the organization for greener pastures after their training has been completed. However, the doctor always counters with the argument; “What about the costs associated with mistakes and errors employees make, when employees that are not properly trained and decide to stick around?” By the time FDA visits a device establishment for a cup of coffee and an inspection, it is too late. There is little chance of “blandishing” an investigator in an attempt to dissuade this individual from writing a From 483 observation against training. Enjoy!

FDA Warning Letter – 21 July 2014

For this week’s guidance, the doctor was able to quickly locate a manufacturer of misbranded product premised on all of the observations and subsections to observations noted in the warning letter. Dr. D was going to attempt to count all of the violations noted in this warning letter but was unable to do so as the doctor’s shoes were on; and Dr. D only have eight fingers and two thumbs, which equates to ten. Regardless, training observations always grab the doctor’s attention as training staff members, contractors, consultants, and occasionally suppliers is mandated by regulation. For those device establishments failing to comply with regulations, bad things happen. If you do not want to believe Dr. D, just ask your Chief Jailable Officer (CJO).

Observation Twelve (12):

Failure to establish procedures for identifying training needs, ensure that all personnel are trained to adequately perform their assigned responsibilities and that training is documented, as required by 21 CFR 820.25(b). For example:

a. Your firm does not maintain documentation that demonstrates the training needs of your employees have been identified.

b. Your firm does not maintain documentation demonstrating training has been given to meet the employees’ training needs.

c. Of eleven employees training records requested, no training records were available or provided by your firm’s officials.

Your firm’s response dated March 28, 2014 is not adequate as it did not include documentation or evidence of the corrections, corrective actions, or consideration of systemic corrective actions.

The QSR Requirement – 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

One of the biggest issues the doctor sees impacting training is the compilation and documentation associated with maintaining accurate training records. Well-established medical device manufacturers can afford document management systems capable of supporting the organization’s training requirements such as ZenDoc, CATSWeb, FileMaker Pro, QAD, TrackWise, EtQ, and way too many more to list. What about smaller entities and start-ups? How can they manage their training requirements?

Dr. D’s best advice is to create three documents: (a) a training SOP (required by regulation); (b) robust job descriptions; and (c) a training matrix. You can nestle basic training requirements into the job description and link the job description to the training matrix. However, there are going to be basic training requirements needed for all employees. For example:

• Training to the establishment’s quality policy;
• Training to the quality manual (50,000’);
• Training to a set of core QMS procedures that impact everyone’s job (e.g., training); and
• Training to generic safety procedures.

The type of training depicted in the bulleted points is typically performed during new employee orientation. For all other training, create specific requirements associated with the actual position; henceforth, the need for a job description. Some of the buckets that can be used are; quality engineer, inspector, manufacturing engineer, assembler, material handler, etc.

Additionally, contractors, consultants, and occasionally suppliers also require training to a device establishment’s procedures. For example, if the establishment employs a 3rd-party testing facility for monitoring a cleanroom or controlled environment room (CER) then employees of this 3rd-party contractor must be trained to gowning procedures, the procedure(s) for CER monitoring, and all other relevant procedures appropriate for the service they are providing. If an establishment is employing a metrology service for on-site calibration (including the CER) the same basic requirements apply. Furthermore, if a contract manufacturer is being employed and an establishment has very specific test requirements for the finished device or even subassemblies, it is incumbent upon the establishment to ensure these requirements make it into the contract manufacturer’s procedures. Finally, documented evidence is everything when placing the CJO in front of our friends from the agency. Without documented evidence, the CJO just has to grin and bear it as the investigator writes the Form 483 observation that will start with the infamous “Failure to establish” phrase.

Now Dr. D has seen a variety of different ways to control training documentation. After initial orientation training, the practice Dr. D prefers to see is training records being retained in each procedure folder or added as an attachment to a procedure or work instruction. By pursuing this approach, a CJO can quickly share a requested procedure or work instruction during an inspection and then provide the investigator with evidence of training. Is this approach simple? Yes, but it works. Regardless, documented evidence is everything during an agency inspection.

Takeaways

For this week’s guidance, the doctor will leave the readers with three takeaways. One – if your organization can afford an effective data/document management system, capable of supporting training, go for it; but choose wisely. Two – it is always better to invest in employee training versus expressing great remorse when bad things happen due to lack of training, like a RECALL (Dr. D’s favorite six-letter word). Three – regardless of your approach to training, make sure training activities are adequately documented. Your CJO will appreciate the effort when he or she has to defend training during an agency inspection.

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.

References

1. Code of Federal Regulation. (2013, April) 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’s enforcement page. (2014, August). FDA.gov Website. Retrieved August 4, 2014, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm406826.htm.