Compass Health Training and Competence SOP

Study Notes

This SOP outlines a procedure for identifying employee training needs, providing necessary training, assessing competence, ensuring awareness of quality, and maintaining training records.
The SOP is applicable to all Compass Health personnel, including regular, full-time, and part-time employees.
Applicable standards include ISO 13485:2016 Section 6.2 Human Resources and TG(MD)R Sch3 P1 1.4(5)(b) – Requirements of the Quality Management System.
Key documents referenced include a Training Record Form (QMS-FRM-0011).

The procedure provides a process and assigns responsibilities for employee training.
It ensures employees are competent for their job roles.
It covers awareness of product quality and quality objectives.
It outlines assessment of training effectiveness and maintaining training records.

Functional managers: Determine any additional training required for individual team members, ensuring timely completion as per the Training Plan.
QA/RA: Verify compliance with this procedure.
New employees: Required to participate in mandatory orientation training to understand quality policy, quality objectives, and their role's impact on product quality.
Current employees: Maintain required training and competency for their respective tasks.

Employees are assessed for qualifications, experience, and competency for their roles.
Objective evidence is documented in employee personnel files.
Job descriptions include employee responsibilities regarding quality.
New employees receive QMS orientation, outlining quality policy, quality objectives, and job function's impact on product quality.

The Personnel Training Matrix (QMS-LOG-0006) outlines mandatory QMS and job-specific training.
QA/RA and People Managers determine appropriate training.
The matrix is maintained and updated with organizational changes and new materials.
All employees receive training based on their job function requirements, outlined in the training plan.
Functional Managers determine supplementary training necessary for team members.
Training is assigned within one month of document approval and completed within specified timeframes.

Training effectiveness is evaluated every 18 months, or through performance reviews, written assessments, quizzes, Internal Audits, and CAPA investigations.
If retraining is needed, the Functional Manager is responsible for its completion and documentation.

QA-RA or HR personnel ensure all employees receive minimum training requirements.
Employee personnel files track training records.
A Quarterly Personnel Training Report details training completed and ensures no training is missed.
Retraining records are updated before effective date changes.

Training Records: A signed Training Record Form (QMS-FRM-0011) documents completed training.
Training Records (External): Supports external training courses and seminars with written proof of attendance.
Personnel Training Matrix (QMS-LOG-0006): Documents required training for each job title.
Training Waiver Memo: Documentation justifying waivers of mandatory training for any employee for whom the training is not relevant.
SOP Impact Assessments Log (QMS-LOG-0006): Records changes in SOPs and outlines requirements for re-training.