Qualification and re-qualification of all personnel involved in laboratory activities are critical aspects, which contribute to ensuring the validity of results.
This article describes how to manage the qualification of new personnel in the different phases as well ensuring maintenance of competences and the steps to be undertaken to re-qualify personnel after e.g. long absence.
This document covers not only the technical qualification of permanent and contractual personnel, which is working in the laboratory, but also qualification of all personnel involved in activities that can have influence on the validity of results.
The ISO/IEC 17025 standard includes several requirements concerning this issue. The main reference chapters are 6.2.1, 6.2.2, 6.2.3, 6.2.4 and 6.2.5.
The ISO/IEC 17025:2017 claims:
All personnel of the laboratory, either internal or external, that could influence the laboratory activities shall act impartially, be competent and work in accordance with the laboratory’s management system.
Furthermore,
The laboratory shall document the competence requirements for each function influencing the results of laboratory activities, including requirements for education, qualification, training, technical knowledge, skills and experience.
Functions influencing the results of laboratory activities can be included in the following groups:
Group 1: Analyst, laboratory technician – responsible for performance of the tests and involved in other laboratory activities such as e.g. monitoring of environmental conditions, qualification of pipettes etc.
Group 2: Supervisor of analysts, Deputy of Supervisor of analysts – responsible for review and/or approval of results, calculation/recalculation, approval of reports/ certificates, monitoring the validity of results etc.
Group 3: Head of the laboratory, other personnel whose activities can influence validity of results – metrologist, function responsible for the management of the quality system of the laboratory (e.g. qualitymanager), inspector, IT personnel.
Group 4: Supporting personnel – e.g. animal keeper; personnel involved in reception of samples, reference materials and reagents; personnel in wash-rooms; personnel involved in cleaning activities etc.
The competence requirements shall be established and documented for each function in the lab, influencing the results of the lab activities. A list of competences in relation to the functions can be helpful.
According to ISO/IEC 17025, the laboratory shall ensure that the personnel have the competence to perform laboratory activities for which they are responsible and to evaluate the significance of deviations.
The effectiveness of training can be considered in the evaluation of the training plan. Principally, there are four types of situations where qualification or re-qualification can be
needed:
1) New personnel
After the new staff member has entered the organisation, a personal training plan can be determined based on the employee’s skills, knowledge and experience.
The training could be divided in two parts:
- First part: covering general training issues in relation to laboratory activities
- Second part: covering specific requirements for the post in relation to the function and involvement in laboratory activities (e.g. technical).
After the proof of competence the employee shall be informed about the new competence and responsibilities, this can be done in a documented way.
2) Personnel who change or enlarge duties
A personal training plan is established, and is based on the past experience and competencies necessary of the employee to carry out a new duty.
3) Qualified personnel who needs re-qualification based on the result of the monitoring
If the qualification of the employee was not verified during monitoring, re- qualification should be considered concerning the activity for which the qualification was not maintained. In this case, only specific parts of the training could be included in the plan and have to be successfully completed.
4) Loss of qualification
If the qualification is lost, a new qualification plan and process shall be established and the qualification has to be successfully passed. Under special circumstances, the qualification process can be shortened, if justified.
A risk-based approach should be defined to establish criteria (e.g. period of time, unsuccessful performance of testing etc.) to evaluate the cases when a staff member has lost the qualification.
Monitoring the qualification of personnel means to verify and maintain the qualification for particular competence on regular basis and it should cover monitoring of:
a. Quality management system qualification (applicable to the entire personnel)
- System for nonconforming work
- Successful completion of trainings related to laboratory activities in connection with QMS (management of documents, changes…)
b. Technical qualification
Regarding the technical personnel, the laboratory shall have a procedure, which defines the need for requalification and the minimal intervals depending on the complexity of the individual technique to keep the particular staff member qualified.
All qualification activities shall be planned and monitored which can also be based on the results of risk assessment. The documentation of the qualification activities shall be retained (e.g. in the personnel file of the employee).
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Resource Person: BARBARA PIROLA