The foundation of a reliable testing laboratory rests upon the competence of its staff. ISO/IEC 17025:2017 outlines the necessity of ensuring personnel are capable of performing laboratory activities effectively. This article explores the importance of documenting competence requirements and methods for assessing staff competence in a testing laboratory environment.
Documenting Competence Requirements
According to clause 6.2.2 of ISO/IEC 17025:2017, a laboratory must have documented requirements for each role that influences the outcomes of its operations. These requirements span several facets:
- Education: The minimum academic credentials necessary for each position.
- Qualification: Professional certifications or registrations that validate expertise.
- Training: Specific courses or workshops completed relevant to the laboratory activities.
- Technical Knowledge: Understanding of laboratory techniques, equipment, and processes.
- Skills: Practical abilities to perform laboratory tasks efficiently and accurately.
- Experience: The amount and type of practical work experience required.
Documenting these parameters helps in establishing clear expectations for current and prospective employees and serves as a benchmark for assessing competence.
Assessing Competence
Clause 6.2.3 of ISO/IEC 17025:2017 requires laboratory personnel to not only perform activities competently but also to understand and evaluate deviations. Competence assessment can be conducted through various methods:
- Direct Observation: Supervisors can observe staff performing routine laboratory tasks, ensuring that operations are carried out according to standard protocols and safety guidelines.
- Proficiency Testing: Participation in proficiency testing or interlaboratory comparisons can provide objective evidence of a staff member’s capability to produce accurate results.
- Records Review: Evaluating records of tests and calibrations performed by the staff can reveal the quality and reliability of their work.
- Skill Tests: Practical examinations or skill tests designed to assess the ability to perform specific laboratory tasks.
- Performance Reviews: Regular performance reviews can assess not only technical abilities but also other aspects such as problem-solving and critical thinking.
Evaluating the Significance of Deviations
The ability to identify and evaluate the significance of deviations in laboratory results is a critical component of a staff member’s competence. This requires a deep understanding of the testing processes, quality control, and the potential impact of deviations on final results. Staff must be equipped with the knowledge to troubleshoot and take corrective actions when necessary.
Continuous Competence Development
Competence assessment is not a one-off activity but a continuous process. Laboratories must invest in ongoing training and professional development to keep pace with technological advancements, changes in standards, and evolving industry practices.
Conclusion
Adherence to the competence requirements of ISO/IEC 17025:2017 is essential for maintaining the integrity and credibility of a testing laboratory. By documenting the necessary competence requirements and regularly assessing the skills and knowledge of their staff, laboratories can ensure high-quality results and foster a culture of continuous improvement.
Below is an example of what such a format might look like:
Laboratory Competence Assessment Form
Assessment Date: [Insert Date]
Assessor: [Insert Assessor’s Name]
Employee: [Insert Employee’s Name]
Position: [Insert Position/Title]
Department: [Insert Department]
Scoring System:
1 – Poor: Does not meet expected competence levels
2 – Fair: Occasionally meets expected competence levels
3 – Good: Regularly meets expected competence levels
4 – Excellent: Consistently exceeds expected competence levels
N/A – Not Applicable
| Competency Area | Score (1-4) | Assessor’s Comments |
| Direct Observation of Routine Work | ||
| Adherence to Work Processes and Procedures | ||
| Compliance with Safety Practices | ||
| Equipment Maintenance and Checks | ||
| Accuracy in Equipment Maintenance | ||
| Proper Documentation of Equipment Checks | ||
| Monitoring of Results | ||
| Precision in Recording Examination Results | ||
| Timeliness in Reporting Results | ||
| Review of Work Records | ||
| Completeness of Work Records | ||
| Accuracy of Data Entry | ||
| Problem Solving Skills | ||
| Efficiency in Problem Identification | ||
| Effectiveness of Problem Resolution | ||
| Examination of Samples | ||
| Proficiency with Previously Examined Samples | ||
| Handling of Inter Laboratory Comparison Materials | ||
| Accuracy with Split Samples |
Overall Comments:
[Insert overall comments about the employee’s performance and areas of improvement]
Assessor’s Signature: ______________________
Employee’s Acknowledgement: ______________________ (Optional)
The form can be printed and used to assess laboratory staff during their routine duties. The assessor can score each area and provide comments to justify the scores. The overall comments section is for summarizing performance and suggesting improvements. The signatures at the bottom ensure that the assessment has been reviewed and acknowledged.
About the author
Dr. Sambhu Chakraborty is a distinguished consultant in quality accreditation for laboratories and hospitals. With a leadership portfolio that includes directorial roles in two laboratory organizations and a consulting firm, as well as chairmanship in a prominent laboratory organization, Dr. Chakraborty is a respected voice in the field. For further engagement or inquiries, Dr. Chakraborty can be contacted through email at director@iaqmconsultants.com and info@sambhuchakraborty.com. Additional resourcesand contact information are available on his websites, https://www.quality-pathshala.com and https://www.sambhuchakraborty.com, or via WhatsApp at +919830051583