By Alan P. Schwartz
The FDA cGMP under 820.25 Personnel (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."
This sounds pretty innocuous. As a matter of fact, the FDA's requirement for training is very close to the ISO 9000 Quality Standard 4.18 on training: "Training must be provided and documented for all personnel whose activities affect quality. Training must be documented."
So why then do so many medical device manufacturers get FDA 483s concerning training deficiencies during FDA inspections of their operations? Many companies understand that training is a requirement; however, they don't understand what constitutes training and how training should be documented. This is not a difficult process.
Initially, everyone thought all employees needed to be trained in the entire GMP requirements. In general, this is not a bad idea—but it has been my experience that unless the training can be accomplished in a manner that makes the GMPs entertaining, most production employees will find this very boring. While the knowledge and understanding of the GMP requirements and how to implement them is very important for a manufacturer, the full GMP spectrum does not pertain to the employee whose sole responsibility is receiving components. For this employee, the section on Acceptance Activities, 820.20 would apply and be most appropriate for his/her training.
So what training is necessary and appropriate for a manufacturing operation and how should this documented? The answer is as follows:
- Each employee should be trained in their job function by specifically using what is written in the Standard Operating Procedures (SOPs). The employee(s) should read the appropriate SOPs. Whenever possible, a review of the employee's work should be made to assure that the work is being performed properly, and this should be fully documented. Many companies will have the employee sign a copy of the SOPs. This is an acceptable means of documenting the training of that employee. Usually a sign-off sheet is prepared for each training session, and the employees who attended the training session are required to sign that they were there.
- If an employee is performing a specific task requiring outside training, i.e. soldering or welding, that training should be documented and a copy of the employee certification should be kept on file.
- Employees responsible for detecting defects should be trained in the defects that they are looking for to enable them to have a better understanding of the potential problems and how to look for them. This is very important for production line employees as well as for quality control/assurance employees. (It is a good idea to have examples of defects on hand, and as learning props, so that they are available whenever necessary to refresh the inspector's memory. For example: what constitutes a bad solder joint, a cold joint, and a good joint is critical to solder inspection training and to the job function, therefore many companies make these pictures a part of the SOP. The FDA would ask for this information as an overall part of their inspection for qualifying a soldering or welding process.)
Another area that creates deficiencies in a company's training documentation is when corrective actions are taken as a result of a product problem that may have resulted in a documentation change to a procedure or instruction. All changes that could affect the quality of the product should, by necessity, have as part of the change, a requirement that retraining of all employees involved in that process must be conducted. This training, or retaining, must be documented.
Additionally, another common deficiency that is noted on the FDA 483 or an FDA Warning Letter is when a company has a non-conforming product that was traced to an employee problem, the corrective action required retraining, but the retraining session was not documented.
And yet another common problem is that the retraining effort was not evaluated as part of the corrective action to determine if it was an effective means of eliminating the problem. You have to remember to "close the loop" and to not leave an auditor access to additional inquiries on how things were controlled.
A new area that you have to be aware of is the training of the employees who are responsible for the installation of medical devices. This is an area that is often overlooked. The GMPs require that installation of medical devices be part of the device master record and that it should be fully documented. Though companies train these installation personnel, they seem to forget to document that the training took place.
Do employees have to be trained in the full cGMPs? While the answer is "No," it is still a smart idea to provide employees with the understanding of the GMP requirements: what the GMPs stand for and that non-compliance to the GMPs could result in regulatory and legal problems. But, unless the employee is in middle or upper management or part of the quality assurance department, a full GMP training program would not serve any purpose. The part of the GMP that pertains to the employee's responsibility should be made part of the employee training requirements.
So it pays to remember that for both the FDA GMPs and the ISO standards, training is an integral part of compliance. The training is not the critical part, it is the monitoring of the training to make sure that the training was effective that takes precedence. Once you have been able to set up an effective monitoring system, you must not forget that documentation is the only way to prove that the training has been conducted and that it was effective.
It is unfortunate, but FDA will only accept the written word as the truth.
Alan P. Schwartz is senior partner of mdi Consultants, Inc., a management consulting firm that helps medical product manufacturers meet FDA requirements. Since 1978, mdi has provided such services as 510(k) submissions, GMP compliance, FDA strategic planning, ISO assistance, as well as market evaluations and strategic partnering. With more than 28 years in the device industry, Schwartz has authored many articles and been a guest speaker both nationally and internationally. He can be reached at firstname.lastname@example.org or through his website at http://www.mdiconsultants.com. Or visit the company's storefront on Medical Design Online.