Compass Health SOP: Competence and Training

Compass Health SOP: Competence and Training

• Document: This document is a Standard Operating Procedure (SOP) for Competence and Training at Compass Health.
• Date of Issue: 02 January 2024
• Version: 1.0
• Document Number: QMS-SOP-0005
• Authors: Tenzin Yangzom, Head of QA/RA, and James Baskin, COO
• Scope: Applies to all training programs for Compass Health personnel, whether regular, full-time, or part-time.
• Purpose: The SOP outlines processes and responsibilities for identifying employee training needs, providing required training, assessing competence, and maintaining training records.
• Quality Objectives: Employee training is linked to quality objectives.

Applicable and Reference Documents

• Standards: ISO 13485:2016 Section 6.2 Human Resources and TG(MD)R Sch3 P1 1.4(5)(b).
• Training Record Form: QMS-FRM-0011

Acronyms and Definitions

• CAPA: Corrective and Preventative Action
• HR: Human Resources
• QMS: Quality Management System

Process Roles

• Functional Managers: Determine additional training needs for employees and ensure training completion.
• QA/RA: Verify compliance with training procedures.
• New Employees: Participate in QMS orientation to understand quality policies and objectives.
• Current Employees: Ensure they have the training to perform their tasks effectively.

Competence and Awareness

• Hiring Process: Evaluates employee qualifications, experience, and competency.
• Documentation: Maintains records in the employee's personnel file.
• Job Description: Contracts are signed to acknowledge job responsibilities, including those affecting quality.
• QMS Orientation: All new employees must complete QMS orientation training which includes the company's quality policies.

Training Plans

• Training Matrix: QMS-LOG-0006 outlines mandatory QMS training and job-specific training for employees.
• Maintenance: Training Matrix is regularly updated for changes to QMS processes, organization, and materials used.
• Functional Manager Responsibility: Determines necessary training for team members.
• Training Completion: All training must be completed within the specified timeframe.

Training Effectiveness

• Evaluation: Training effectiveness is evaluated at least every 18 months during performance reviews.
• Ongoing Evaluation: Evaluated through different methods including written assessments, internal audits, etc..
• Retraining: Employees may need retraining for revised procedures or policies. Retraining is the responsibility of the functional manager.

Retraining

• Necessary Changes: Retraining is required when QMS/policy procedures change.
• Documentation: Retraining is documented in the SOP Impact Assessments Log.

Process Monitoring

• Training Requirements: QA-RA or HR personnel ensures all employees meet minimum training requirements.
• Personnel Files: Documents the training records and ensures sign-off and recording.
• Quarterly Report: A quarterly training report highlights the completed training.

Quality Records

• Training Records: Include internal forms (QMS-FRM-0011) and external course completion documentation.
• Training Matrix: Outlines training requirements for specific job roles.
• Waivers: There can be waivers if a manager determines that an employee already has the needed competencies.

SOP Impact Assessments Log

• SOP/QMS changes: Records impact on SOPs and any necessary updates.

This quiz focuses on the Standard Operating Procedure for Competence and Training at Compass Health, issued on January 2, 2024. It outlines processes for identifying training needs, assessing competence, and maintaining training records, while ensuring alignment with quality objectives. Participants will gain an understanding of relevant standards and definitions pertaining to employee training.