In most compliance training programs, employees are taught what to do: follow SOPs, complete forms, maintain cleanliness, and document deviations. The instructions are explicit and the expectations are clear. What is often left unspoken is the “why” that is attached to each step of a training program, meaning “what happens when those steps aren’t followed?”
A recent FDA 483-observation from a medical device inspection highlights the failure of a firm to explain “why” following procedures is paramount:
“…..Procedures for training and identifying training needs have not been established…
Specifically, your firm’s Quality Manager does not have any documented training to indicate that he was made aware of defects which may occur from the improper performance of his job.”
This isn’t a routine training citation. It signals that consequence awareness, understanding the downstream risks of doing the job improperly, is now firmly within the scope of FDA expectations. FDA’s implicit message here is powerful: it’s not enough to teach the process; firms must also train on the stakes.
This 483 aligns with a broader regulatory trend that encourages not just rote compliance, but critical thinking and risk awareness at all levels of an organization. When it comes to the Quality Manager, the person tasked with overseeing product integrity, awareness of failure modes and their consequences is critical and essential. When a Quality Manager doesn’t understand potential defects, root causes are likely to be missed along with preventive actions.
This observation suggests firms must foster a culture of accountability. Quality management is a mindset that must be prevalent throughout all functions of a pharmaceutical or medical device firm. (Subscribing to GMP Trends will support the mission for team members to develop a quality mindset at all levels of your organization. Schedule a call to view the GMP Trends platform and learn how our reports will empower your quality team)
Under 21 CFR §820.25(b), manufacturers must ensure that “personnel are aware of device defects that may occur from the improper performance of their specific jobs.”
This observation calls out that obligation, specifically for a Quality Manager, and suggests the firm fell short on both training content and documentation.
FDA is not just auditing your systems; they’re auditing your awareness. In the case of this particular 483-observation, FDA made it clear that training must cover not just how to do the job, but what happens if you don’t. The consequences of non-compliance are not just theoretical; failures of a quality system are very much real and severe.
