The Human Side of Compliance
A quality management system is only as effective as the people running it. While QSR emphasizes procedures and records, QMSR emphasizes people—specifically, how well they understand and execute their responsibilities.
QMSR and ISO 13485 require manufacturers to establish competence, not just deliver training. That subtle word swap changes everything. The question is no longer “Did they attend?” but “Can they perform?”
What Competence Really Means
Under QMSR, competence combines three elements:
- Knowledge — Understanding of process, regulation, and risk.
- Skill — Ability to apply that knowledge effectively.
- Behavior — Consistency in following procedures and quality principles.
Training without follow-up assessment no longer satisfies FDA expectations. Each role must have a defined competence profile and evidence that those standards are met.
How to Redefine Training Programs for QMSR
- Map Competence to Roles
Identify which QMS processes each position touches and what knowledge or skill is essential. A production operator may need competence in equipment setup and visual inspection, while a supplier-quality engineer must master risk analysis and audit protocols. - Design Assessments That Prove Competence
Replace “sign-off after PowerPoint” with observation, tests, or demonstrations. Supervisors should record outcomes and corrective coaching. - Track Effectiveness
Auditors will ask: “How do you know training worked?”
Use CAPA trends, complaint reductions, or audit scores to demonstrate impact. - Refresh When Things Change
Process revisions, CAPAs, and new equipment require retraining. Document on who was affected and how competence was re-established.
Building a Culture of Accountability
Competence starts at the top. Leadership must allocate resources for meaningful learning and reinforce that compliance is part of professional excellence, not bureaucracy.
Quick Win: Tie training objectives to quality KPIs — link classroom outcomes to measurable business improvements.
Why It Matters
A workforce that “gets it” reduces deviations, improves audit outcomes, and drives continuous improvement. When the FDA asks about training under QMSR, your records should tell a story — not just list signatures.
Let Compliance Insight design a competence-based training framework that stands up to FDA review and builds long-term capability. Contact us today!