Training Management SOP

This procedure establishes the process for identifying training needs, planning and delivering training, assessing competency, and maintaining training records for all personnel whose work affects product quality. It ensures that personnel are qualified to perform their assigned tasks in compliance with ISO 13485:2016 and applicable regulatory requirements.

This procedure applies to all employees, contractors, and temporary personnel who perform work that affects product quality, including but not limited to: - Manufacturing and production personnel - Quality assurance and quality control staff - Engineering and design personnel - Regulatory affairs personnel - Purchasing and supply chain staff - Management and supervisory personnel - Temporary or contract workers performing quality-affecting activities

Department Managers: Identify training needs for their staff, ensure training is completed within required timeframes, and evaluate competency of their direct reports. Human Resources / Training Coordinator: Maintain the Training Matrix, coordinate training delivery, maintain training records, and generate training compliance reports. Quality Manager: Approve the annual Training Plan, ensure GMP and quality system training is included, and review training effectiveness during Management Review. All Employees: Complete assigned training within specified timeframes and acknowledge understanding of trained materials.

4.1 Training Needs Identification - For new hires: Training needs are identified based on the job description and the Training Matrix (FRM-TM-001) - For existing employees: Training needs are triggered by: - New or revised SOPs, work instructions, or forms - New equipment or process introduction - CAPA-driven retraining requirements - Job role changes or promotions - Audit findings indicating competency gaps - Annual training needs assessment 4.2 Training Matrix - The Training Matrix maps each job role to required training documents and competencies - The matrix shall be reviewed and updated at least annually and whenever job roles change - Minimum training for all employees: Quality Policy, Quality Manual awareness, GMP/GDP fundamentals, complaint and adverse event reporting awareness 4.3 Training Delivery Methods - Read and Understand: Employee reads the document and signs acknowledgment - Instructor-Led Training: Classroom or virtual session with qualified trainer; attendance documented - On-the-Job Training (OJT): Hands-on demonstration with qualified trainer observation; OJT checklist completed - External Training: Seminars, courses, or certifications from third-party providers; certificate of completion retained - Computer-Based Training: Self-paced modules with quiz or assessment; passing score required 4.4 Competency Assessment - All training must include a competency assessment appropriate to the criticality of the task: - Written quiz (minimum passing score: 80%) - Practical demonstration observed by a qualified trainer - OJT checklist sign-off by trainer and trainee - Personnel who fail a competency assessment must be retrained and reassessed before performing the task independently 4.5 Training Records - Individual Training Records (FRM-TM-002) shall document: employee name, training topic, training method, date completed, trainer name, competency assessment result - Records shall be maintained for the duration of employment plus [X] years per the Record Retention Schedule - The Training Coordinator shall generate a Training Compliance Report monthly and flag overdue training 4.6 Retraining Triggers - Document revision (SOP, WI, or Form) - CAPA requiring retraining as a corrective action - Failed competency assessment or observed non-compliance - Extended absence from a role (greater than 6 months) - Audit finding related to competency

- Training Matrix (FRM-TM-001) - Individual Training Records (FRM-TM-002) - Training Plan (annual) - Competency assessment results - External training certificates - Training Compliance Reports

- ISO 13485:2016 Clause 6.2 Human Resources - FDA 21 CFR 820.25 Personnel - Quality Manual (QM-001) - Document Control SOP (SOP-DC-001)