Competence, Training and Awareness Procedure

Procedure number	04
ISO/IEC 17025 reference	Clause 6.2
Revision	00
Effective date	[Enter date]
Approved by	[Quality Manager / Laboratory Director]

1. Purpose

To define the requirements for determining, providing, and evaluating the competence of all personnel whose activities affect the validity of laboratory results.

2. Scope

This procedure applies to all personnel working in or affecting the laboratory's QMS, including:

• Technical staff — Analysts performing testing and calibration
• Quality personnel — Quality Manager, supervisors, auditors
• Support staff — Equipment maintenance, sample handling, administrative
• Temporary staff — Contractors, students, visiting researchers

3. References

• ISO/IEC 17025:2017, Clause 6.2 — Personnel
• ISO/IEC 17025:2017, Clause 7.2.1 — Selection and verification of methods
• ISO/IEC 17025:2017, Clause 7.7 — Evaluation of measurement uncertainty (competence in uncertainty evaluation)

4. Definitions

Term	Definition
Competence	The demonstrated ability to perform activities according to procedures and to produce valid results. Includes knowledge, skills, experience, and qualifications.
Training	Structured activities designed to develop or maintain competence. Can be formal (courses, certifications) or on-the-job (mentoring, supervised practice).
Induction	Initial training provided to all new personnel covering safety, QMS overview, laboratory procedures, and role-specific requirements.
Qualification	Formal recognition of competence, such as a degree, diploma, or professional certification.
Competency assessment	Evaluation of whether a person can perform required tasks to the required standard. May be formal (exam, practical test) or informal (supervisor observation).
Continuing education	Ongoing training to maintain and update competence throughout employment.
Supervision	Oversight and mentoring of personnel by a qualified supervisor to ensure work is performed correctly.

5. Responsibilities

Role	Responsibility
Laboratory Director	Ensure sufficient resources (budget, time) are allocated for training. Approve major training initiatives and competence requirements.
Quality Manager	Maintain the Training Program (Appendix 04-App-01), coordinate training delivery, ensure records are complete and current, plan continuing education.
Technical Manager	Identify technical training needs, provide or arrange method-specific training, evaluate technical competence, supervise new analysts.
Supervisors	On-the-job supervision and mentoring, monitor work quality, identify competence gaps, document observations.
All personnel	Participate in required training, maintain awareness of QMS requirements, report any competence concerns to their supervisor.

6. Procedure — Competence Determination

6.1 Competence requirements

For each position, the Quality Manager (in consultation with the Technical Manager) defines required competence. For technical positions, competence requirements typically include:

Formal qualifications:

• Educational background (e.g., Bachelor's degree in chemistry or materials science)
• Professional certifications (where applicable)

Technical knowledge:

• Understanding of relevant test methods and theory
• Knowledge of equipment operation and limitations
• Familiarity with measurement uncertainty concepts
• Understanding of relevant standards and regulations

Skills:

• Practical ability to perform testing procedures
• Ability to identify and report anomalies
• Data recording and documentation skills
• Safety awareness and practices

Experience:

• Minimum years of experience in similar work
• Exposure to range of sample types
• Supervised practice on critical methods

For the battery materials laboratory example, an ICP-OES analyst should demonstrate competence in:

• Elemental analysis principles
• ICP-OES instrument operation and maintenance
• Sample preparation techniques
• Calibration and quality control procedures
• Result validation and uncertainty assessment

6.2 Competence verification at recruitment

When recruiting new personnel:

1. Technical Manager reviews résumé and qualifications against the competence requirements.
2. Interviews assess relevant knowledge and experience.
3. References are checked to verify previous relevant experience.
4. If qualifications are incomplete, Technical Manager identifies required training before the person can work independently.

6.3 Training needs analysis

The Quality Manager reviews training needs at least annually (or more frequently for new staff) by considering:

• Current competence of each person (from assessments and observations)
• Required competence for their current role
• Gaps identified through internal audits or quality issues
• Changes to procedures or equipment
• New methods or techniques to be introduced
• Regulatory or accreditation requirement changes
• Individual development goals and career progression

Results are documented in the Training Program (Appendix 04-App-01).

7. Procedure — Training Provision

7.1 Induction training

All new personnel receive induction training within their first month, covering:

• Laboratory safety — Emergency procedures, hazard identification, personal protective equipment (PPE)
• QMS overview — Key procedures, where to find documents, roles and responsibilities
• Laboratory procedures — Document control, record keeping, handling confidential information
• Ethical principles — Impartiality, conflicts of interest, professional conduct
• Role-specific orientation — Equipment locations, contact information, specific responsibilities

Induction is delivered by the Quality Manager or Technical Manager and documented in Appendix 04-App-03 — Record of Attendance.

7.2 Technical training

Internal training

• Delivered by the Technical Manager or an experienced analyst acting as mentor
• Covers method theory, equipment operation, sample handling, quality control
• Includes supervised practice (on-the-job training) with gradual increase in responsibility
• Example: A new ICP-OES analyst receives training on instrument startup, sample introduction, calibration verification, and troubleshooting

External training

• Arranged by Quality Manager when expertise is unavailable internally
• Examples: Manufacturer training for new equipment, advanced courses in measurement uncertainty, regulatory or compliance updates
• Attendance and outcomes are recorded

7.3 Competence evaluation

Initial evaluation

• Conducted by Technical Manager after supervised practice period (typically 4–12 weeks depending on complexity)
• Evaluation methods may include:
  • Practical demonstration (e.g., analyst performs complete analysis under observation)
  • Written or oral examination
  • Review of initial results for quality and correctness
  • Supervisor sign-off on competence
• Documented in Appendix 04-App-02 — Training Record and Performance Monitoring
• Only when competence is confirmed can the person work independently

Continuing evaluation

• Supervisors observe work quality during routine operations
• Results are monitored for consistency and validity
• Annual review of competence through supervisor assessment
• Any concerns trigger refresher training or further evaluation

7.4 Continuing education and updates

All personnel receive:

• Annual awareness training on QMS changes, safety updates, regulatory changes (minimum 2 hours per year)
• Method-specific updates when procedures change or new methods are introduced
• Equipment updates when new equipment is installed or modified
• Competence refresher if a person has not performed a critical method for >6 months

Continuing education is tracked in Appendix 04-App-02 and is a factor in the annual competence review.

8. Procedure — Competence Records

8.1 Training records

Training records are maintained by the Quality Manager and include:

• Transcript of qualifications and certifications
• Record of all formal training (courses, seminars, certifications)
• Records of on-the-job training with supervisor notes
• Competence assessment results
• Continuing education participation

Records are kept in a secure, centralized location ([specify location/system]).

8.2 Competence authorization

When a person is determined to be competent for a specific method or role, the Technical Manager (or Quality Manager for QMS competence) signs Appendix 04-App-04 — Competence Approval and Authorization Record. This record includes:

• Name and position
• Method(s) or areas of competence
• Date of authorization
• Supervisor signature
• Any limitations or conditions (e.g., "requires supervision for complex samples")

Authorization is reviewed annually and renewed.

9. Procedure — Supervision

9.1 Initial supervision

New personnel work under direct or periodic supervision until competence is confirmed. The Technical Manager or a designated supervisor:

• Observes work quality and technique
• Reviews results for accuracy and completeness
• Provides feedback and correction
• Documents observations in Appendix 04-App-02

9.2 Ongoing supervision

Even after competence is confirmed, supervision continues through:

• Regular review of results
• Periodic observation of work
• Feedback from quality control checks
• Discussion during team meetings or performance reviews

10. Procedure — Competence Monitoring and Review

10.1 Annual competence review

The Technical Manager conducts an annual review of each technical person's competence, considering:

• Quality of results produced
• Ability to identify and report problems
• Adherence to procedures
• Safety record
• Professional development
• Any incidents or complaints

Results are documented and may lead to:

• Continued authorization (no changes)
• Conditions on continued work (e.g., additional supervision)
• Requirement for refresher training
• Recommendation for advanced training or specialization

10.2 Competence concerns

If competence concerns arise at any time:

1. Supervisor documents the specific concerns and discusses with the person
2. Technical Manager assesses whether refresher training or evaluation is needed
3. If significant concerns exist, the person's authorization may be suspended pending retraining and re-evaluation
4. Quality Manager documents the concern and outcome in Appendix 04-App-02

11. Related documents

Document	Reference
Appendix 1 — Training Program	04-App-01
Appendix 2 — Training Record and Performance Monitoring	04-App-02
Appendix 3 — Record of Attendance	04-App-03
Appendix 4 — Competence Approval and Authorization Record	04-App-04
Procedure 00 — Document and Record Control	Procedure 00
Procedure 02 — Quality Policy	Procedure 02
Procedure 18 — Internal Audit	Procedure 18

12. Revision history

Revision	Date	Description	Approved by
00	[Date]	Initial issue	[Name]

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Why this section exists

Section 04 answers a question that every other section in the QMS silently assumes: is the person doing this work actually qualified to do it?

Every procedure in this system assumes a competent operator. The SOP for equipment maintenance assumes the person reading it understands the instrument. The method validation procedure assumes the analyst can evaluate the data. The uncertainty budget assumes the person completing it understands measurement statistics. Section 04 is what makes those assumptions defensible.

The difference between training and authorization

These are not the same thing, and confusing them is one of the most common mistakes in competence management.

A training record documents that a person participated in a learning activity. It says: this happened. Authorisation says something different: this person is currently permitted to perform this task independently. Someone can have a training record for a method they are no longer authorized to use — because the method changed significantly, because they had a long gap in practice, or because a competence concern was identified. The training record is history. The authorization register is the current operational state.

Appendix 04-App-04 — the Competence Approval and Authorization Record — is the document that carries that operational weight. It is the single source of truth that an auditor will go to when they ask: who is authorized to sign off results for this method, and what is the basis for that authorization?

Why withdrawn authorizations must be preserved

Most competence registers only show current authorizations. This is a mistake. When an auditor asks why a person who was previously authorized is no longer on the list — or when a historical result needs to be defended and the question arises of who was authorized at that time — the register must have the answer.

Never delete a withdrawn authorization. Mark it as withdrawn, record the date and reason, and retain it. The history of who was authorized and when is as important to traceability as the current state.

The upstream and downstream connections

Section 04 does not operate alone. It is fed by every training pathway associated with a specific task — SOPs, risk assessments, practical assessments — and it feeds forward into every section that depends on qualified personnel to function.

When something goes wrong and section 14 investigates a nonconformity, one of the first questions is whether the person performing the task was authorized to do so. If section 04 is complete, that question has a clear answer. If it is not, the investigation stalls — and the nonconformity potentially becomes a systemic finding rather than an isolated one.

Section 04 is not overhead. It is the foundation that makes every other section defensible.