ISO/IEC 17025:2017 Clause 6.2.4 to 6.2.5

 

 6.2.4

The management of the laboratory shall communicate to personnel their duties, responsibilities, and authorities" emphasizes the importance of clearly defining and communicating the roles and responsibilities of individuals within the laboratory. This communication is essential for establishing an effective quality management system and ensuring that personnel understand their contributions to maintaining the competence of the laboratory.

A. Duties:

Duties refer to the specific tasks or activities that individuals are expected to perform within the laboratory.

Implementation: The laboratory management must clearly define the duties of each position or role within the organization. This includes tasks related to testing, quality control, documentation, and any other relevant activities.

Communication: The defined duties should be communicated to the respective personnel through documents such as job descriptions, procedure manuals.

B. Responsibilities:

Responsibilities go beyond specific tasks and encompass the broader obligations and expectations associated with a particular role.

 Implementation: The laboratory management is responsible for outlining the general responsibilities of personnel, such as ensuring compliance with quality management system requirements, following established procedures, and contributing to the achievement of quality objectives.

 Communication: Responsibilities should be communicated clearly to individuals through written documentation,  and ongoing communication channels.

C. Authorities:

 Authorities refer to the level of decision making power and control that individuals have within the laboratory.

Implementation: The laboratory management must specify the authorities granted to each position or role. This includes the authority to make decisions related to testing methods, equipment usage, reporting results, and other relevant aspects.

Communication: Authorities should be clearly communicated to individuals, ensuring they understand the limits and extent of their decision making powers.

D. Communication:

Communication involves the exchange of information between management and personnel to ensure a common understanding of roles and expectations.

Implementation: The laboratory management is responsible for establishing effective communication channels to disseminate information regarding duties, responsibilities, and authorities.

Documentation: This communication can be achieved through documented procedures, manuals, job descriptions, training programs, and regular team meetings.

 

6.2.5

a)   Determining the Competence Requirements: 

The determination of competence requirements is a crucial aspect of ensuring that personnel in a laboratory are well-equipped to perform testing and calibration activities accurately and reliably. In this context, competence refers to the combination of knowledge, skills, and qualifications that individuals need to possess to fulfill their roles effectively.

Implementation:

Documented Procedure:  The laboratory is required to establish and maintain a documented procedure explicitly outlining how competence requirements for personnel are identified and defined.

Identification of Knowledge, Skills, and Qualifications:  The procedure should detail the methods used to identify the specific knowledge, skills, and qualifications required for personnel in different roles within the laboratory.

Role-Specific Requirements:  The procedure should address the diverse nature of tasks within the laboratory, tailoring competence requirements to the specific responsibilities associated with each role.

Involvement of Relevant Stakeholders:  The process should involve input from relevant stakeholders, including managers, subject matter experts, and individuals performing the tasks, to ensure a comprehensive understanding of the competence requirements.

Periodic Review and Update: The procedure should include provisions for periodic reviews and updates to ensure that competence requirements remain relevant and aligned with the evolving needs of the laboratory.

Documentation of Competence Criteria: The documented procedure should specify how the competence criteria are documented and maintained, creating a reference for personnel and auditors.

b)   Selection of Personnel: 

The selection of personnel is a critical component of ensuring that individuals assigned to specific roles within a laboratory possess the requisite qualifications, education, and experience. This process is essential for maintaining the competence needed to carry out testing and calibration activities accurately and reliably.

Implementation:

Documented Procedure:  A documented procedure should be established to outline the steps and criteria involved in the selection of personnel for various roles within the laboratory.

Qualifications, Education, and Experience: The procedure should clearly specify the necessary qualifications, educational background, and relevant experience required for each role. This ensures that individuals are well-suited for their assigned tasks.

Criteria for Hiring: The procedure may include specific criteria and guidelines for the hiring process, ensuring that it is conducted systematically and consistently.

Verification of Credentials: The procedure should outline the steps for verifying the credentials of potential candidates. This may include checking educational degrees, certifications, and other qualifications to ensure their accuracy and validity.

Matching Qualifications with Laboratory Requirements: There should be a defined process for matching the qualifications of candidates with the specific requirements of the laboratory. This ensures that individuals are assigned roles that align with their skills and expertise.

c)   Training of Personnel: 

Ensuring that personnel in a testing laboratory are well-trained is essential for maintaining and enhancing the competence required to perform testing activities accurately and consistently. The training of personnel involves systematic processes to equip individuals with the necessary knowledge, skills, and competence for their assigned tasks.

Implementation: 

Documented Procedure: A comprehensive documented procedure should be established to govern the training of personnel within the laboratory. This procedure serves as a guide for planning, implementing, and assessing training activities.

Identification of Training Needs:  The procedure should outline mechanisms for identifying training needs, considering factors such as changes in technology, new testing methods, and evolving standards. This ensures that training programs address relevant and current requirements.

Initial Training: The procedure may include details on the initial training provided to new personnel, covering fundamental aspects related to laboratory operations, safety protocols, and specific testing methodologies.

Ongoing Professional Development: Recognizing that competence is dynamic, the procedure should address ongoing professional development. This involves periodic training to enhance and update the skills of personnel as technologies and methodologies evolve.

Training Program Design:  The procedure should detail how training programs are designed, specifying learning objectives, content, and methods of delivery. This ensures that the training is structured, effective, and tailored to the needs of the laboratory.

 Verification of Training Effectiveness: Methods for verifying the effectiveness of training programs should be included in the procedure. This may involve assessments, practical demonstrations, or other evaluation tools to ensure that personnel have acquired the necessary competence.

Documentation of Training Records:  The procedure should emphasize the importance of maintaining comprehensive training records for each individual. These records should include details such as the type of training, dates attended, and any assessments or certifications obtained.

Responsibility for Training: Clearly define responsibilities for coordinating and delivering training. Designate individuals or departments responsible for overseeing the training process, including assessing the ongoing competence of personnel.

 Feedback and Continuous Improvement: Encourage feedback from personnel regarding the effectiveness of training programs. Use this feedback to continuously improve and refine the training process.

 

 d)   Supervision of Personnel: 

Supervision of personnel in a testing laboratory is crucial to ensure that individuals receive adequate guidance, support, and monitoring in their work. This process is designed to maintain and enhance the quality of testing activities by overseeing the performance of laboratory staff.

Implementation:  

Documented Procedure:  Establish a documented procedure outlining the supervision process for personnel within the laboratory. This procedure serves as a guide for supervisors and employees, ensuring consistency and effectiveness.

Guidance and Support: Define the role of supervisors in providing guidance and support to personnel. This involves helping employees understand their tasks, offering clarification on procedures, and addressing any challenges they may encounter.

Monitoring Work: Specify how the supervision process includes the monitoring of personnel's work. This may involve periodic reviews of testing procedures, data records, and adherence to quality management system requirements.

Frequency of Supervision:  Detail how often supervision should occur. This could be on a regular schedule or as needed based on the complexity of tasks and the experience level of the personnel.

Methods of Supervision:  Describe the methods used for supervision. This may include direct observation of work, review of documentation, and discussions with personnel to ensure that testing activities align with established procedures.

Performance Feedback:  Include provisions for providing feedback on personnel performance during supervision. Positive feedback reinforces good practices, while constructive feedback addresses areas for improvement.

 Addressing Performance Issues: Outline mechanisms for addressing performance issues. This may involve corrective actions, additional training, or other measures to ensure that personnel meet the required standards.

Documentation of Supervision Activities:  Emphasize the importance of documenting supervision activities. This includes records of discussions, feedback provided, and any corrective actions taken. Documentation serves as evidence of compliance and helps in performance reviews.

Continuous Improvement: Encourage a culture of continuous improvement in the supervision process. Regularly review the effectiveness of supervision procedures and make adjustments as needed to enhance the overall quality of laboratory operations.

 

 e)   Authorization of Personnel: 

In a testing laboratory, it is essential to have a documented procedure for authorizing personnel to perform specific tasks. This process ensures that individuals are granted the necessary authority based on their demonstrated competence, contributing to the reliability and accuracy of testing activities.

Implementation:   

Documented Procedure:  Establish a documented procedure that outlines the steps and criteria for authorizing personnel to undertake specific tasks within the laboratory. This procedure serves as a systematic guide for the authorization process.

Criteria for Authorization: Clearly define the criteria that individuals must meet to be authorized for specific tasks. This includes considerations such as education, training, experience, and demonstrated competence in the relevant areas.

Documentation Requirements: Specify the documentation required for the authorization process. This may include certificates, training records, or other evidence of competence that supports the individual's eligibility for task authorization.

Review Process: Define a review process for authorizations, ensuring that they are periodically assessed and updated as needed. This could involve regular reviews by supervisors, management, or designated personnel responsible for overseeing the authorization process.

Authority Levels:  Clearly outline the levels of authority associated with different tasks or roles within the laboratory. This ensures that personnel are authorized only for tasks that align with their demonstrated competence.

Training and Competence Assessment:  Include provisions for training and competence assessments as part of the authorization process. This ensures that individuals not only meet initial criteria but also continue to maintain the required competence for authorized tasks.

Record Keeping:  Emphasize the importance of maintaining accurate and up-to-date records of personnel authorizations. This documentation serves as evidence of compliance during internal and external audits.

 Communication of Authorizations: Communicate authorized personnel and their assigned tasks to relevant stakeholders within the laboratory. This ensures transparency and awareness of who is authorized to perform specific activities.

 Feedback Mechanism:  Establish a feedback mechanism that allows authorized personnel to provide input on the authorization process. This can help identify areas for improvement and contribute to the overall effectiveness of the system.

f)   Monitoring Competence of Personnel: 

 In a testing laboratory, it is crucial to have a documented procedure for monitoring the ongoing competence of personnel. This process ensures that individuals remain proficient in their assigned roles, contributing to the consistent quality of testing activities.

Implementation:    

 Documented Procedure: Develop a documented procedure outlining how the laboratory will monitor the ongoing competence of its personnel. This procedure provides a structured approach to assessing and confirming the proficiency of individuals in their roles.

Periodic Assessments: Include provisions for periodic assessments of personnel competence. These assessments may cover a range of factors, including knowledge of testing methodologies, adherence to quality standards, and compliance with laboratory procedures.

Performance Reviews:  Implement a system of performance reviews as part of the monitoring process. Regular evaluations allow supervisors to provide feedback, recognize strengths, and address any areas where improvement may be needed.

Training and Development Opportunities:  Integrate opportunities for training and development within the monitoring procedure. This ensures that personnel have access to resources that support continuous learning and skill enhancement.

 Documentation of Competence:  Emphasize the importance of maintaining comprehensive records documenting the competence of each individual. These records should include evidence of completed training, certifications, and any relevant qualifications.

Feedback Mechanism: Establish a feedback mechanism that encourages open communication between supervisors and personnel. This can include discussions on performance, identification of areas for improvement, and setting goals for ongoing professional development.

Verification of Continued Competence:    Define methods for verifying the continued competence of personnel over time. This may involve regular competency assessments, participation in proficiency testing programs, or other means to confirm that individuals remain proficient in their roles.

Adaptation to Changes: Incorporate flexibility in the procedure to adapt to changes in technology, methodologies, or standards. Ensure that ongoing competence monitoring remains aligned with evolving requirements within the laboratory and the industry.

Clear Communication: Clearly communicate the results of competence assessments to personnel. This transparency fosters a culture of continuous improvement and ensures that individuals are aware of their strengths and areas for development.

 

 

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