Appendix 4 — Competence Approval and Authorization Record
Parent procedure: 04 – Competence, Training and Awareness
Purpose
To formally authorize qualified personnel to work independently on specific test methods, equipment, or QMS functions. This document serves as official evidence that a person has demonstrated the required competence and has been approved to perform their assigned role.
Instructions
When a person completes training, supervised practice, and competence evaluation, the Technical Manager (or Quality Manager for QMS roles) completes this authorization form. The form is reviewed annually. Any conditions or limitations on authorization are clearly stated.
Competence Approval and Authorization Record
Employee Name (print): [Name]
Position/Role: [e.g., ICP-OES Analyst, Quality Inspector, Sample Preparation Technician]
Employment Start Date: [Date] | Current Authorization Date: [Date]
Methods/Equipment Authorized
| Method/Equipment | Authorization Date | Authorization Valid Until | Supervisor Signature | Limitations or Conditions | Notes |
|---|---|---|---|---|---|
| [e.g., ICP-OES Elemental Analysis] | [Date] | [Date, typically +1 year] | [Signature] | [e.g., None / Requires supervision for samples >10 elements / Requires annual refresher calibration training] | [e.g., Includes sample preparation, calibration, data reporting] |
| [e.g., Karl Fischer Titration] | [Date] | [Date] | [Signature] | ||
| [e.g., Laser Diffraction Particle Sizing] | [Date] | [Date] | [Signature] | ||
QMS Functions Authorized (if applicable)
| QMS Function/Responsibility | Authorization Date | Valid Until | Supervisor Signature | Conditions | Notes |
|---|---|---|---|---|---|
| [e.g., Internal Auditor] | [Date] | [Date] | [Signature] | [e.g., None / Audit planning and reporting only, not sampling procedures] | [Qualifications: 40-hour auditor training, [date]] |
| [e.g., Competence Evaluator for New Analysts] | [Date] | [Date] | [Signature] | ||
Summary of Competence Demonstrated
Training Completed:
- Formal qualifications: [e.g., B.S. Chemistry]
- Internal method training: [Date]
- Supervised practice period: [Date] to [Date] ([# weeks])
- External courses (if applicable): [List with dates]
Competence Evaluation Results:
- Practical demonstration: ☐ Pass ☐ Conditional
- Written/oral examination (if required): ☐ Pass ☐ Conditional ☐ N/A
- Review of initial results: ☐ Satisfactory ☐ Conditional ☐ N/A
- Supervisor sign-off: ☐ Approved ☐ Conditional
Evaluation Summary: [Brief description, e.g., "Employee demonstrated thorough understanding of ICP-OES operation, proper calibration procedures, and quality control requirements. All standards and regulations were correctly applied. Approved for independent operation."]
Conditions or Limitations
Check if applicable:
☐ No conditions. Employee is authorized for full, independent operation of the assigned method(s) or role.
☐ Conditional authorization. Employee may perform the method/role subject to the following conditions:
- [e.g., Supervisor review of results for first 20 analyses]
- [e.g., Does not include complex matrix samples — complex samples require supervisor approval]
- [e.g., May perform routine calibration checks only; major troubleshooting requires Technical Manager involvement]
- [e.g., Required to attend annual advanced training on measurement uncertainty]
Authorization Approval
Technical Manager / Quality Manager Name (print): [Name]
Title: [Technical Manager / Quality Manager]
Signature: [Signature] | Date: [Date]
Laboratory Director Review (if required): [Signature] | Date: [Date]
Annual Review and Renewal
Year 1 Review
Review Date: [Date] | Reviewed by: [Name]
Competence Status: ☐ Competent — Approved for continued authorization | ☐ Competent with conditions — See below | ☐ Not competent — Authorization suspended pending retraining
Reviewer Comments: [e.g., "Employee continues to produce quality results with no deviations. All procedures followed correctly. Approved for renewal for one additional year."]
Signature: [Signature] | Date: [Date]
Authorization Valid Until: [New expiry date]
Year 2 Review (if applicable)
Review Date: [Date] | Reviewed by: [Name]
Competence Status: ☐ Competent — Approved | ☐ Competent with conditions | ☐ Not competent — Authorization suspended
Reviewer Comments:
Signature: [Signature] | Date: [Date]
Authorization Valid Until: [New expiry date]
Suspension or Withdrawal of Authorization
If at any time an employee's competence is questioned, authorization may be suspended pending further evaluation.
Date of Suspension: [Date] | Reason: [e.g., "Results outside control limits; refresher training required"]
Supervisor/Manager Name: [Name] | Signature: [Signature]
Reauthorization after Retraining:
Date Reauthorized: [Date] | Evaluator: [Name]
Approved: ☐ Yes, full authorization restored | ☐ Yes, conditional authorization | ☐ No, further training needed
Signature: [Signature] | Date: [Date]
Some laboratories maintain a master "Competency Matrix" listing all authorized personnel and methods in one table, with links to individual authorization records. This provides a quick reference for supervisors and auditors. Consider including specific procedure numbers, equipment serial numbers, or version dates of SOPs under which the person was trained.