Quality & Risk
Training Records
In one line
Documented evidence personnel have the education, training, and experience for assigned tasks.
Definition
21 CFR 820.25 and ISO 13485 clause 6.2 require establishing competency needs, providing training, and maintaining records that demonstrate personnel are qualified for their roles.
Effective training programs define competence requirements per role, train against current procedure revisions, evaluate whether training worked, and retrain when procedures change. Records typically show who was trained, on what revision, when and by what method. Inspectors often check that people performing a task were trained on the effective version, and that personnel understand the defects that can result from doing their job wrong.
Why it matters
Common audit gaps include missing read-and-understood records for new SOP versions and lack of effectiveness evaluation for safety-critical training.
Common pitfalls
- •A common pitfall is failing to document that personnel have read and understood new or revised Standard Operating Procedures (SOPs), particularly in electronic Quality Management Systems.
- •Another frequent mistake is neglecting to evaluate the effectiveness of training, especially for critical roles or tasks that directly impact product quality or patient safety.
- •Manufacturers often err by not conducting periodic refresher training or assessing ongoing competency, leading to skill degradation over time.
- •Inadequate training record retention, or records that do not clearly link training to specific job functions, can be a significant audit finding.
- •Failing to include specific cybersecurity training for personnel involved in the design, development, or maintenance of connected medical devices is a growing compliance issue.
Sources
- 21 CFR 820.25 · eCFR
- MDIC Case for Quality · MDIC
- FDA - Quality Systems · FDA