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The FDA requires medical device manufacturers to have the appropriate personnel and training in place. According to 21 CFR 820, “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.” Employees need to be trained so they can adequately perform responsibilities based on their job descriptions. It is also essential that all employees are aware of any potential defects that may arise if their job is not performed correctly. There is an expectation that companies will establish comprehensive procedures that detail how employees will be trained, and how this information will be captured.
ISO 9001’s requirements are very similar to those the FDA. According to section 6.2.2, a manufacturer is required to:
- Define the knowledge and skill needed for each employee to conduct their job (job descriptions)
- Deliver training to develop the required knowledge and skill
- Provide a way to prove the training was effective
- Ensure employees are aware of how their activities contribute to the quality objectives
- Keep training records, as well as records of employee education, skill and experience
One area where manufacturers are typically deficient is when corrective actions are taken and result in a documentation change to a procedure. All changes that could affect the quality of the product should have a requirement that retraining of employees involved in the process should be conducted. This is also true for non-conforming product that is traced to an employee issue.
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