T-005-012

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Employee Information

Employee name: Job description: Department: Manager: Evaluation period: Evaluation date:

T-005-012 Annual performance and competency evaluation

Employee information

Employee name	_______________
Job description	_______________
Department	_______________
Manager	_______________
Evaluation period	_______________
Evaluation date	_______________

Part 1: Competency evaluation

Competency assessment against job description requirements

Edit competencies

Education: Gap

Experience: Gap

Technical skills: Gap

QMS knowledge: Gap

Regulatory knowledge: Gap

Other: Gap

Competency area	Required (per JD)	Current level	Gap identified	Comments
Education			☐ No
Experience			☐ No
Technical skills			☐ No
QMS knowledge			☐ No
Regulatory knowledge			☐ No
Other			☐ No

Overall competency status

Fully competent for current roleCompetent with minor gaps (action plan required)Significant gaps identified (immediate action required)

• ☑ Fully competent for current role
• ☐ Competent with minor gaps (action plan required)
• ☐ Significant gaps identified (immediate action required)

Part 2: QMS procedures competency verification

This section evaluates the employee's competence in applying the QMS procedures applicable to their job description.

Edit applicable procedures

GP-001 Control of documents

GP-002 Quality planning

GP-003 Audits

GP-004 Vigilance system

GP-005 Human resources and training

GP-006 Non-conformity, CAPA

GP-007 Post-market surveillance

GP-009 Sales

GP-010 Purchases and suppliers

GP-011 Provision of service

GP-012 Design and development

GP-013 Risk management

GP-014 Feedback and complaints

GP-015 Clinical evaluation

GP-016 Traceability and identification

GP-017 Technical Assistance Service

GP-018 Infrastructure and facilities

GP-019 Non-product software validation

GP-020 QMS Data analysis

GP-021 Communications

GP-022 Document translation

GP-023 Change control management

GP-024 Predetermined Change Control Plan

GP-025 Usability and Human Factors

GP-026 Market-specific requirements

GP-027 Corporate Governance

GP-028 AI Development

GP-029 Software Delivery and Commissioning

GP-030 Cyber Security Management

GP-050 Data protection

GP-051 Security violations

GP-052 DPIA

GP-100 Business continuity

GP-101 Information security

GP-110 Esquema Nacional de Seguridad

GP-200 Remote Data Acquisition

Procedure	Applicable	Competency demonstrated	Evidence/Observations
No procedures marked as applicable

Overall QMS procedures competency status

Pass - Employee demonstrates competence in all applicable proceduresFail - Employee requires re-training on specific procedures

• ☑ Pass: Employee demonstrates competence in all applicable procedures
• ☐ Fail: Employee requires re-training on specific procedures

Part 3: Performance review

Review of previous period objectives

Edit objectives

1.Rating⭐⭐⭐⭐ Exceeded⭐⭐⭐ Met⭐⭐ Partially met⭐ Did not meet

2.Rating⭐⭐⭐⭐ Exceeded⭐⭐⭐ Met⭐⭐ Partially met⭐ Did not meet

3.Rating⭐⭐⭐⭐ Exceeded⭐⭐⭐ Met⭐⭐ Partially met⭐ Did not meet

4.Rating⭐⭐⭐⭐ Exceeded⭐⭐⭐ Met⭐⭐ Partially met⭐ Did not meet

5.Rating⭐⭐⭐⭐ Exceeded⭐⭐⭐ Met⭐⭐ Partially met⭐ Did not meet

Objective	Target	Result	Rating	Comments
1.
2.
3.
4.
5.

Rating scale: ⭐⭐⭐⭐ Exceeded expectations | ⭐⭐⭐ Met expectations | ⭐⭐ Partially met | ⭐ Did not meet

Overall performance rating

Exceeded expectationsMet expectationsPartially met expectationsDid not meet expectations

• ☐ Exceeded expectations
• ☑ Met expectations
• ☐ Partially met expectations
• ☐ Did not meet expectations

Performance comments

Strengths	Areas for improvement

Part 4: Action plan for identified gaps

Edit action plan

Gap identified	Action required	Responsible	Target date	Status

Part 5: Objectives for next period

Edit next period objectives

1.

2.

3.

4.

5.

#	Objective (SMART)	Target/KPI	Timeline
1
2
3
4
5

Part 6: Training and development

Training completed during evaluation period

Edit completed training

YesNoN/A

YesNoN/A

YesNoN/A

Training	Date	Certificate obtained
		N/A
		N/A
		N/A

Training needs identified for next period

Edit training needs

HighMediumLow

HighMediumLow

HighMediumLow

Training need	Priority	Justification
	☑ Medium
	☑ Medium
	☑ Medium

Part 7: Employee feedback

Work environment and resources

Edit employee feedback

Adequate resources to perform my job:

Clear understanding of my responsibilities:

Adequate training and support received:

Effective communication with my manager:

Positive work environment:

Question	Rating (1-5)	Comments
Adequate resources to perform my job
Clear understanding of my responsibilities
Adequate training and support received
Effective communication with my manager
Positive work environment

Employee comments and suggestions

Career development interests

Part 8: CV update confirmation

CV has been updated Updated CV has been signed and dated Updated CV has been uploaded to FactorialHR

• ☐ CV has been updated to reflect current education, training, and experience
• ☐ Updated CV has been signed and dated
• ☐ Updated CV has been uploaded to FactorialHR

Signatures

Role	Name	Signature	Date
Employee	_______________
Manager	_______________

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info

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• Author: JD-004
• Review: JD-003
• Approval: JD-001 ㅤㅤ ㅤ