ISO9001 System Document Package (8) | Human Resource Management Procedure (7.1.2/7.2/7.3)

Document Description: This procedure corresponds to ISO 9001:2015 Clause 7.1.2 "People," Clause 7.2 "Competence," and Clause 7.3 "Awareness." It is a core procedure document under the "Resource Management" category of the quality management system (QMS) and is a second-level document. It incorporates the most critical process element, "people," into controlled management: through job position planning and personnel allocation, it ensures an adequate number of personnel who affect the conformity of products and services; through a closed-loop process of capability identification, evaluation, and training, it ensures that personnel have the necessary education, training, or experience to perform their jobs; through awareness education, it ensures that employees understand the quality policy, quality objectives, and their contributions to the effectiveness of the system. This procedure is applicable to all manufacturing, service, and small enterprises, especially those with high personnel turnover, key positions dependent on individual experience, and superficial training practices. It can be directly applied and then revised according to the actual conditions of the enterprise.

1. Purpose

To standardize the entire process of personnel allocation, capability management, and awareness management within the company, ensuring:

1. Adequate and competent personnel are provided for the operation of the QMS and product realization (7.1.2);
2. The capability requirements for positions that affect the conformity of products and services are determined, and measures such as training, reassignment, or other actions are taken to ensure personnel competence (7.2);
3. All employees establish a quality awareness, understand the quality policy, quality objectives, and their personal contributions, and are aware of the consequences of nonconformity (7.3);
4. Documented information on personnel capability, training, and evaluation is retained to provide evidence of the system's effectiveness.

2. Scope of Application

This procedure applies to all personnel within the company's QMS who affect the conformity of products and services, including:

1. Regular employees, probationary employees;
2. Temporary workers, seasonal workers, dispatched personnel;
3. Outsourced personnel and supplier on-site service personnel under the company's control;
4. Managers and operators involved in the planning, implementation, inspection, and disposition of the QMS.

This procedure does not apply to logistics support roles unrelated to product quality (such as cafeteria staff, cleaners, etc., who do not come into contact with products and do not affect quality). These roles are managed under the company's administrative regulations. However, if the results of their work directly impact product conformity (such as cleaners in a cleanroom), they should be included in the scope of this procedure.

3. Responsibilities

1. General Manager: Approves the company's organizational structure and staffing plan; approves the annual training plan and budget; approves the appointment and adjustment of key position personnel; provides necessary resources for personnel capability development; makes decisions on significant capability gaps.
2. Management Representative (System Manager): Reviews the list of job capability requirements and the capability evaluation plan; supervises the implementation of personnel capability management in various departments; organizes specialized quality awareness training; reports the status of human resource capabilities to the General Manager.
3. Human Resources Department (Lead Management Department): Compiles and revises this procedure; organizes the preparation and updating of job descriptions; implements recruitment, hiring, probation, reassignment, and resignation management; compiles and implements the annual training plan; organizes capability evaluations and training effectiveness assessments; establishes and maintains the "Personnel Capability Register"; retains records related to personnel management.
4. Quality Department: Participates in determining the capability requirements for key quality positions (inspection, internal audit, special process operation, etc.); cooperates in implementing quality awareness training; confirms and manages the authorization of quality specialists such as inspectors and internal auditors.
5. Department Heads: Propose personnel needs and allocation plans for their departments; organize the preparation of job descriptions; identify capability gaps and propose training needs; arrange for personnel to attend training and track training effectiveness; implement daily capability supervision and position evaluations.
6. All Employees: Fulfill their duties according to job descriptions; participate in required training and evaluations; proactively report personal capability gaps or issues discovered in work; understand and practice the quality policy and quality objectives.

4. Work Procedures

(1) Personnel Allocation Planning (7.1.2)

1. Allocation Principles: The basic starting point is to "meet the needs of the QMS operation and ensure the conformity of products and services." The principle of "setting positions based on tasks, staffing based on positions, and matching personnel to positions" should be followed to avoid quality risks such as missed inspections, non-compliance with operations, and missing records due to insufficient personnel.
2. Staffing and Position Setting: The Human Resources Department, in collaboration with various departments, compiles the annual "Staffing and Position Setting Plan" based on the company's business plan, production task volume, and process control requirements. This plan specifies the number of personnel required for each department and position and is approved by the General Manager. The plan is updated promptly if there are significant changes in production task volume or organizational structure.
3. Position Setting Review: An annual review of the suitability of position settings is conducted in conjunction with management review (9.3). The focus is on ensuring that sufficient inspection and monitoring personnel are assigned to key quality control points; that key equipment operation positions have backup personnel (A/B roles) to avoid production line stoppages or loss of control due to absenteeism; and that personnel configurations during night shifts, holidays, and other periods meet process control requirements.
4. Personnel Supplement: When a position is vacant, the department in need fills out the "Personnel Requirement Application Form," which is reviewed by the Human Resources Department and approved by the responsible leader before initiating recruitment. In cases of urgent personnel shortages, competent transferred or temporary personnel can be assigned to the position, but they must pass a capability confirmation before working independently.

(2) Determination of Job Capability Requirements (7.2 a)

1. Sources of Capability Requirements: For each job category, capability requirements should be clearly defined based on their responsibilities and impact on product quality. These requirements include four aspects: education (degree, major), training (onboarding training, specialized skill training, certification), experience (years of work, industry experience), and skills (operational skills, inspection skills, computer application).
2. Job Descriptions: The Human Resources Department organizes the preparation and updating of job descriptions for each position according to the "Guidelines for Compiling Job Descriptions and Qualification Requirements." The "Qualification Requirements" section should specify the minimum capability requirements for the position, which are reviewed by the department head, co-signed by the Human Resources Department, and approved by the Management Representative before publication.
3. Identification of Key Positions: The Quality Department, in collaboration with the Human Resources Department, identifies key positions that significantly impact product conformity. These typically include inspectors, metrologists, internal auditors, operators of special processes (welding, heat treatment, electroplating, injection molding, etc.), operators of key equipment, design and development personnel, procurement personnel, and after-sales service personnel. Key positions should be clearly marked in job descriptions and subject to certification or authorization management.

(3) Capability Evaluation and Gap Identification (7.2 b)

1. Initial Capability Evaluation: During the recruitment and hiring process, the department in need, in collaboration with the Human Resources Department, evaluates the capabilities of candidates based on the job description's qualification requirements through methods such as qualification review, written tests, practical assessments, and interviews. Only candidates who are confirmed to be competent are hired. At the end of the probationary period, a formal evaluation is conducted, and those who fail are either extended or not confirmed.
2. On-the-Job Capability Evaluation: The Human Resources Department organizes an annual capability evaluation for all employees. Evaluation methods include theoretical tests, practical assessments, performance reviews, on-site questioning, and 360-degree evaluations. Evaluation results are categorized into "Competent," "Basically Competent," and "Not Competent" and recorded in the "Personnel Capability Evaluation Form."
3. Capability Gap Analysis: The actual capabilities of personnel are compared with the job requirements to form a "Capability Gap Analysis Form." This identifies "capability gaps" (current personnel lack the required capabilities) and "potential gaps" (job requirements increase or personnel capabilities decline), which serve as the basis for formulating training plans and personnel adjustments.
4. Special Position Capability Confirmation: For positions requiring authorization, such as inspectors and internal auditors, the Quality Department organizes specialized assessments. Those who pass are issued a "Position Authorization Certificate" by the Management Representative. Specialized workers (electricians, forklift operators, welders, etc.) must hold valid certificates issued by government authorities to work. The Human Resources Department maintains a "Specialized Worker Register" and tracks the validity of these certificates, reminding personnel to renew them 1-2 months before expiration.

(4) Training Management

1. Training Needs Identification: Training needs arise from the results of capability gap analysis; the onboarding of new employees; the introduction of new equipment, new processes, and new standards; changes in laws, regulations, and standards; customer-specific requirements; improvement needs identified through internal and external audits and management reviews; and training needs related to corrective actions (10.2).
2. Training Plan Compilation: The Human Resources Department compiles the "Annual Training Plan" each December, summarizing the "Training Needs Application Forms" from various departments. The plan specifies training projects, participants, content, methods, time, instructors, assessment methods, and budget. It is reviewed by the Management Representative and approved by the General Manager before implementation. Any additional temporary training outside the annual plan is approved by the Human Resources Department and managed in the "Temporary Training Record."
3. Training Implementation: Training is implemented according to the "Employee Training Work Instruction." Training methods include classroom lectures, on-site practical training, mentorship, external training, online learning, and skill competitions. Before training, materials and sign-in sheets should be prepared, and the training process should retain the "Training Sign-In Sheet" and necessary audio-visual records.
4. New Employee Training: New employees must complete a three-level training program before starting work: company-level (corporate culture, quality policy, safety and environmental protection, rules and regulations), department-level (department responsibilities, job processes, quality objectives), and position-level (job description, operating procedures, equipment operation, quality record filling). Only after passing all training assessments can they work independently.
5. Training Effectiveness Evaluation (Four-Level Evaluation):
   • Reaction Level: After training, collect feedback from participants through questionnaires or verbal feedback to gauge their satisfaction.
   • Learning Level: Verify the mastery of knowledge and skills through written tests and practical assessments. The passing score is determined by the training organizing department (usually 80% or a single successful practical assessment).
   • Behavior Level: Within 1-3 months after training, the department head observes changes in participants' behavior at work (e.g., following procedures, correctly filling out records) and records these observations.
   • Result Level: Compare quality performance data before and after training (e.g., operation error rate, nonconforming product rate, customer complaint rate) to validate the actual impact of training. Evaluation results are recorded in the "Training Effectiveness Evaluation Form" and serve as the basis for training improvements and personnel capability confirmation. Those who fail the evaluation are scheduled for additional training or reassignment.

(5) Other Measures to Ensure Capability (7.2 c)

When training cannot eliminate capability gaps or when the cost-benefit of training is poor, the following measures can be taken and evidence retained:

1. Position Reassignment: Reassign personnel to positions that match their capabilities;
2. Mentorship: Arrange for experienced personnel to provide one-on-one mentoring, specifying the mentoring period and the criteria for completing the mentoring;
3. Simplification of Tasks: Reduce the capability requirements of positions through process improvements, the creation of visual work instructions, and the addition of poka-yoke devices;
4. Task Redistribution: Reassign tasks that exceed the capabilities of personnel to competent individuals;
5. External Support: Key capability shortages can be addressed by hiring external experts or commissioning professional institutions for testing;
6. Termination of Employment: For personnel who remain incompetent after training and cannot be reassigned, handle the situation legally and in accordance with regulations.

(6) Awareness Management (7.3)

1. Awareness Education Content: Ensure that all personnel under the company's control are aware and understand:
   • The quality policy and quality objectives (including specific targets for their positions);
   • The contribution of their job to the effectiveness of the QMS, including the benefits of improving quality performance;
   • The consequences of nonconformity (impact on customers, the company, and individuals);
   • Quality risks and prevention requirements related to their positions.
2. Education Methods: Incorporate quality awareness education into the mandatory training for new employees; conduct company-wide quality awareness campaigns annually during "Quality Month," management reviews, and quality incident case notifications; departments should regularly promote quality awareness through pre-shift meetings and quality meetings; post the quality policy and key quality requirements in workshops and office areas.
3. Awareness Verification: Verify the level of quality awareness through on-site questioning, exams, and daily inspections. Re-educate personnel with weak awareness. Encourage employees to proactively report quality issues and include this behavior in quality culture evaluations.

(7) Retention of Capability Evidence (7.2 d)

1. Record Requirements: The Human Resources Department maintains a personnel file for each employee, retaining copies of educational certificates, qualification certificates, job descriptions, training records, capability evaluation records, authorization records, and performance evaluation records as documented information evidence of personnel capability.
2. Personnel Capability Register: The Human Resources Department establishes and dynamically maintains the "Personnel Capability Register," which includes the name, position, start date, education, major training experiences, certificate status and validity, capability evaluation results, and authorization status. This ensures that key position personnel information can be quickly accessed.
3. Record Management: Personnel capability-related records are managed according to the "Record Control Procedure" for identification, storage, protection, retrieval, retention, and disposal. Personnel files are retained for at least 3 years after an employee leaves, in accordance with regulations and company policies.

(8) Flowchart (Text Version)

Start
  │
  ▼
Staffing and Position Setting (based on business plan and process control requirements) → General Manager Approval
  │
  ▼
Compiling Job Descriptions (education/training/experience/skills qualification requirements)
  │
  ▼
Identifying Key Positions (inspection, internal audit, special processes, specialized operations, etc.)
  │
  ▼
Recruitment and Hiring/Reassignment → Initial Capability Evaluation (qualification review + written test/practical assessment/interview)
  │
  ▼
Three-Level Training for New Employees (company-level → department-level → position-level) → Passing Evaluation
  │
  ▼
Independent Work (key positions require certification/authorization)
  │
  ▼
Annual On-the-Job Capability Evaluation → Capability Gap Analysis
  │
  ├──── Competent ────► Continuous Monitoring, Enter Next Cycle
  │
  └──── Gaps ──► Training/Reassignment/Mentorship/External Support, etc.
                          │
                          ▼
                    Four-Level Training Effectiveness Evaluation (reaction/learning/behavior/result)
                          │
                          ▼
                    Passing Evaluation → Update the "Personnel Capability Register"
                    Failing Evaluation → Additional Training or Reassignment
  │
  ▼
Quality Awareness Education (policy and objectives dissemination, Quality Month, case notifications) → Awareness Verification
  │
  ▼
Retaining Capability and Training Records (7.2 d documented information)
  │
  ▼
End

5. Related Records

Record Form Filling Instructions:

• Job Description: One form per position, including the position name, department, direct supervisor, job responsibilities, qualification requirements (education/training/experience/skills), work interfaces, and evaluation indicators. Qualification requirements must be specific and evaluable, avoiding vague statements like "strong sense of responsibility" or "hardworking."
• Personnel Capability Evaluation Form: List capability requirements for each position and fill in the evaluation methods (theoretical/practical/performance review/on-site questioning) and results (competent/basically competent/not competent). Attach evaluation bases and signatures from evaluators, and include a comprehensive evaluation opinion from the department head.
• Capability Gap Analysis Form: Horizontally list capability items (education, training, experience, skills), and vertically list personnel names. Mark each cell with "met," "gap," or "serious gap." Summarize training needs and adjustment suggestions.
• Annual Training Plan: List the sequence number, training project, participants, content, method, time, instructors/institutions, assessment method, budget, and responsible department. The plan is executed according to the approved schedule, and completion is reviewed at the end of the year.
• Training Effectiveness Evaluation Form: One form covers four levels of evaluation—reaction (participant satisfaction score), learning (assessment results), behavior (department head's observation of behavior changes 1-3 months after training), and result (changes in related quality performance indicators). All four levels are required.
• Personnel Capability Register: One row per person, dynamically updated, with a focus on certificate validity and authorization status. This serves as a quick reference for capability evidence during management reviews and internal audits.

6. Related Documents

1. Quality Manual (QM-01) Chapters 7.1.2, 7.2, 7.3;
2. Document Control Procedure (QP-3);
3. Record Control Procedure (QP-4);
4. Quality Policy and Quality Objectives Management Procedure (QP-7);
5. Guidelines for Compiling Job Descriptions and Qualification Requirements (WI-30);
6. Employee Training Work Instruction (WI-31);
7. Nonconforming Product and Corrective Action Procedure (QP-27);
8. Management Review Procedure (QP-26).

Usage Instructions

1. How to Modify According to the Actual Situation of the Enterprise

• Organizational Structure Adaptation: Medium-sized enterprises can set up a dedicated Human Resources Department; small enterprises can have an administrative personnel specialist take on this role, but the four-step closed loop of "planning—implementation—evaluation—recording" must not be omitted. The responsibilities of the Management Representative can be combined with those of the General Manager or Quality Manager, with the authorization certificate issued by the General Manager.
• Job Scope Adaptation: Manufacturing enterprises should focus on front-line operators, inspectors, equipment operators, and specialized workers, emphasizing practical assessments and certification management. Service enterprises should focus on customer service, technical engineers, and project delivery personnel, emphasizing communication skills and professional qualification evaluations. Research and development enterprises should add capability evaluations for design personnel (project experience, standard knowledge, tool application).
• Key Position Definition Adaptation: Define key positions based on the product risks of the enterprise. For example, food enterprises should add "Critical Control Point (CCP) Operators," and medical device enterprises should add "Sterile Inspection Personnel." Do not copy lists from other industries.
• Training Management Adaptation: Enterprises with fewer personnel can simplify the annual training plan to a quarterly rolling plan. Seasonal production enterprises (such as agricultural product processing) should complete onboarding training and capability confirmation before the peak season to avoid uncontrolled temporary employment during the peak season.
• Outsourced Personnel Management Adaptation: For enterprises using dispatched or outsourced personnel, capability requirements must be specified in contracts or agreements, and the supplier must provide proof of personnel capabilities. Outsourced personnel for key positions must pass the same assessment as internal personnel before starting work.

2. Audit Focus Points (Certification Auditors Typically Check)

• Whether Capability Requirements are Documented: Randomly check 3-5 positions to verify if the qualification requirements in job descriptions cover education, training, experience, and skills, and if they align with actual job responsibilities.
• Whether Capability Evidence is Sufficient: Randomly select front-line operators and inspectors to request their training records, assessment results, and authorization certificates. Lack of evidence or mismatched evidence constitutes a typical nonconformity.
• Whether Training Effectiveness is Evaluated: Only sign-in sheets without effectiveness evaluations, or evaluations that only focus on satisfaction scores (lacking learning, behavior, and result evidence), will result in nonconformities.
• Special Position Qualifications: Verify if specialized workers' certificates are valid and if the certificate holders match the personnel. Ensure that inspector authorizations are documented and that the scope of authorization is clearly defined.
• Awareness Clause (7.3): Auditors may randomly ask employees, "What is the company's quality policy? How does your work affect quality? What are the consequences of nonconformity?" Failure to answer or irrelevant answers constitute nonconformities.
• Temporary and Outsourced Personnel: Auditors often check if temporary and dispatched personnel have undergone the same training and capability confirmation as regular employees, which is a frequent nonconformity under Clause 7.2.

3. Common Errors

• Disconnection Between Training and Capability: Only tracking training hours without verifying capability outcomes, having the same training plan year after year, and training content unrelated to actual job skills.
• Superficial Capability Evaluation: All personnel are marked as "competent" without evaluation bases or signatures, which fails to identify gaps.
• Lack of Backup for Key Positions: Only one person is certified for key equipment operation or inspection, leading to the risk of unqualified personnel working when the certified person is absent.
• Expired Certificates: Continuing to assign tasks to personnel with expired specialized worker certificates or metrologist certificates, which violates regulations and constitutes a serious nonconformity.
• Formalistic Awareness Dissemination: Posting the quality policy on walls without regular dissemination, leading to employees being unaware of objectives, personal contribution points, and the consequences of nonconformity.
• Missing or Dispersed Records: Training records scattered across various departments, unarchived records of resigned personnel, and lack of capability proof for outsourced personnel, making it difficult to provide an evidence chain during audits.
• Training Without Improvement: Repeated occurrence of the same quality issues (such as incorrect record filling) indicates that training has not been effective or has not addressed the root cause. Training needs should be assessed in conjunction with corrective actions (10.2).

Matching personnel to positions ensures adequate capability, training and evaluation form a closed loop, and full awareness maintains quality.

Knowledge code: 2.3.1

Version: v20260809

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