Are you qualified to perform the calibration? This is the question I sometimes encounter during assessment or audits related to the competency of personnel.

Personnel competency is one of the main requirements in a calibration process where auditors are so motivated to assess for proper implementation.

And to be qualified is to provide evidence of our competency, which is usually satisfied by showing to the auditors our training records and other qualifications like education, skills, and experience.

But having a competency record as evidence for competent personnel is not enough, before we can finalize the competency record,  there are other competence requirements that we need to implement as per ISO 17025 Standards like evaluation and monitoring of competencies.

This is an ISO 17025 requirement for a calibration or testing lab but I believe it is also applicable to all industries implementing competency requirements of their personnel.

In this post, I will share with you a procedure based on my experience implementing the competence requirements of ISO 17025 Standard. This is not a perfect implementation but I hope it will provide guidance to those confused or starting to implement the competency requirements of ISO 17025:2017.

I will share with you the following topics:

1. Understanding The Meaning of Competency
2. Understanding ISO 17025:2017 Competence Requirements
3. Examples of Laboratory Activities that Need Competency Requirements
4. What Auditors May Ask – Audit Sequence to Determine Competency
5. Procedure to Determine Competency of Personnel
   • Identification of Personnel Competency
   • Initial Verification of competency
   • Training Program
   • Authorization
   • Monitoring competency
6. Records of Competency- Evidence of competency
7. Conclusion
8. References

Understanding The Meaning of Competency

ISO 17025 standards provide the requirements for the competency of personnel but these requirements are in general views. This means that there is no fixed procedure to meet the requirements.

Competency is the core requirement for personnel to allow the execution of important laboratory activities. It is also one of the reasons why customers pay for our service.

First, let us understand the meaning of competency.

I have taken this clear definition of competency from  two standards,

First, from ISO 19011 which defines competence as “demonstrated personal attributes and demonstrated ability to apply knowledge and skills“

Second,  ISO 17021  which states: “ability to apply knowledge and skills to achieve intended results

If you are a competent personnel, it means you are qualified to perform the specific job assigned to you. These qualifications are the knowledge, skills, experience, and behaviors necessary to complete a given laboratory task.

In other terms, competency is the demonstration of the qualifications you have that will produce the expected outcome for a given laboratory activity.

Understanding ISO 17025:2017 Competence Requirements 

ISO 17025 accreditation is one example of a competency evaluation. The whole standard itself is a competency evaluation guide during the assessment. You are a competent laboratory if you meet and satisfy all the requirements of the Standards.

As we can see, accreditation is all about competency evaluation which is why competency is a big part of the process implementation. 

But in this article, we will focus on the “competence requirements for personnel”, not the entire laboratory process.

To start, there are 3 main requirements for personnel under ISO 17025:2017 that we need to meet.. These are:

1. 1. 1. Impartiality
      2. Confidentiality
      3. Competency .

 (For impartiality, check out my separate posts in this link>> Risk to Impartiality)

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Competence requirements to determine the competency of personnel as per ISO 17025  are stated under Personnel, clause 6.2,  it states:

• All personnel of the laboratory that could influence the laboratory activities shall be competent.
• The laboratory shall ensure that the personnel have the competence to perform laboratory activities for which they are responsible.
• The laboratory shall document the competence requirements of each function influencing the results of laboratory activities,
• The laboratory shall have a procedure for determining the competence requirements:
• The laboratory shall have procedures for monitoring the competence of personnel.

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First, let us define the term ‘competence requirements’ further because at first, this was confusing for me. So I will define them as per my understanding during implementation.

Depending on how it is being used, 2 meanings are implied here:

1.    A competency requirement which is a requirement of ISO 17025  to ensure competency of personnel. Consists of procedures for competency evaluation, training, monitoring, and development (see clause 6.2).  Once completed, it will become a record or document as evidence of competency to be shown during audits or when requested.

2. Another meaning refers to personnel competency requirement, a requirement for qualifications, job description, performance criteria, training, and capabilities to show that a person is competent..

The standard has provided the competence requirements and the need to have a competent personnel, but does not explain or provide detailed information on the specific requirements for personnel competency, how to implement or what are the specific requirements for a personnel to be competent.

The reason is that competency requirements for personnel are based on the scope or capability of the laboratory and it differs for every lab. The important thing is that we should provide all the necessary competency documents as evidence to support the requirements of the standard.

Examples of Laboratory Activities that Need Competency Requirements 

Competency is demonstrated by performing specific lab activities effectively as per the Job description. And since it shows competency whenever it is performed as expected, it can now be used as a performance criterion to show that personnel is competent. See below examples:

1. Operates specific equipment or reference standards
2. Perform tests or calibrations
3. Record and review reports,
4. Evaluate and Interpret calibration or test results
5. Sign and/or  approve  calibration reports
6. Generate, develop or modify calibration procedures
7. Performing Internal Audit

What Auditors May Ask – Audit Sequence to Determine Competency

How do you show evidence for personnel competency?

Competency can be satisfied by training alone but it depends on the auditors or assessors. 

You only need to prove that they are competent. As an advice, just show only what is asked by the auditor. 

As per my observation, the way the auditors will assess are:

1. 1. They will sample a calibration certificate.
   2. Check the calibration procedure
   3. Check who performs the calibration 
   4. Then they will check the competency through the training records  and other certificates. For a deeper assessment, you may need to demonstrate a given procedure.
   5. They will check if the person is authorized to perform the procedure and generate the results

.Evidence of competency is simply the records of training supported by certificates, diploma and resume where records of qualifications like education, training, technical knowledge, skills and experience can be seen. (See more evidence examples at the bottom of this post.)

Procedure to Determine Competency of Personnel

To show the implementation and documentation of personnel competency, I will share with you a simple procedure that works with me that you can copy or provide a guide for your own implementation.

These are the 6 Steps To Determine the Technical Competency of Personnel. See below the step by step implementation of Competence Requirements.

1. Identification of Personnel Competency
2. Selection of Personnel
3. Training Program
4. Technical Competency Evaluation or Assessment
   • Evidence of qualifications
   • Performance evaluation
   • Evaluation based on competency level
5. Authorization
6. Monitoring competency

Step 1: Identification of  Personnel Competency

The initial step to determine the competency of personnel is to identify the competency that you require to do the laboratory activities within the lab. This will serve as the basis in finding the right candidate for the job.

Below are the Initial Competence Requirements for Personnel that we need to identify and consider:

1. Identify requirements for a Job Description. A job description is a list of laboratory activities that details all the necessary roles and responsibilities that is required to be accomplished for a given position.
   
   Job description will guide you on why you need the necessary competency of a specific personnel. Identify and list down all the possible job descriptions you need.
   
   A job description once demonstrated shows competency. It can be used as a performance criterion to determine that a personnel is competent. Therefore, it is important that a job description is already prepared for a specific position before hiring.
   
   See below examples of Calibration Job Descriptions:

• • • Operates specific equipment or reference standards and perform necessary maintenance;
    • Perform test or calibrations;
    • Record and review reports;
    • Evaluate and Interpret calibration or test results;
    • Sign and/or  approve  calibration reports;
    • Generate, develop or modify calibration procedures;
    • Perform Internal Audit of the quality management system

2. Identify Requirements for Personnel Qualifications like:
   1. Education
   2. Skills
   3. Experience
   4. Training
   5. Technical knowledge

List down all the qualities under each qualification that you need.

Step2: Selection of Personnel

Once we have identified the Job descriptions and competency requirements that we need for a laboratory personnel, it is now time for recruitment and selecting the best candidate to be hired.

During the selection of personnel, we determine the initial competency that we need through:

a. Review of submitted Resume showing its backgrounds and qualifications

b. Performance and background evaluation through Interview 

c. Review of provided Training certificates

Once a personnel is hired, make sure that he/she accepts and understand the calibration job description entitled to his position by signing a specific agreement or document. Once done, it is now time to implement the training program. 

Step 3: Training Program

Training and competency are linked to each other. Training is needed whether a personnel is already competent or not. It is a must activity to attain the required skills, knowledge, and capability, thus, becoming competent.

One main component of Training is to have a training program or procedure.

There are 2 reasons why we need to have a competent person training program. The first one, which is the obvious reason is to train ‘newbies’ to gain knowledge and skills for lab SOPs and the capability to  execute laboratory methods and procedures.

The second reason is for introduction purposes. At this stage, we already hired the best personnel that we need. Maybe you are thinking, why is there training if you already hired competent personnel in the initial stage? 

 As we see, the new hire needs an introduction because of exposure to: 

1. new  laboratory environment with  new equipment and procedures that are designed to the lab’s structure, 
2. new company policies,
3. the quality management system of the lab, 
4. documentation and reporting system of the lab
   

There are learning and development stages as part of the training program. Scheduled internal and external training are provided which are monitored and supervised.

A training program involves a training plan, training attendance, training evaluation, and finally authorization.

One part of the training is the performance evaluation, a process for verification of personnel competency. This is the most challenging part. After we already hired qualified personnel, the next is how to ensure and maintain their competency.

This is where competency evaluation and monitoring will be implemented.

Step 4: Technical Competency Evaluation: Competency Verification

The purpose of this step is to evaluate the competency after the training and during normal working routine or as per scheduled assessment.

During evaluation, we are also performing competency verification because we determine their performance by comparing it to defined criteria and laboratory activity.

There are 3 ways where you can evaluate the competency of personnel that you can implement.

1. 1. 1. 1. Evaluation through evidence of qualifications
         2. Evaluation based on performance criteria
         3. Evaluation based on competency level

1. Evaluation through Evidence of Qualifications

We gather evidence of qualifications based on the results of actual laboratory activities such as:

• Participation in Proficiency Test (PT) or Inter-lab Comparison (ILC)
• Actual demonstration of calibration procedures – witnessing activities during internal audits
• Practical exams and Q&A
• Statistical Analysis like Repeatability and Reproducibility
• Direct observation of specific Laboratory activities such as performing preventive maintenance.

These activities are scheduled depending on the discretion of the lab management or as by authorities like accreditation bodies.

2. Evaluation by basing it on Performance Criteria

The evaluation or assessment of personnel competency is also demonstrated according to a established performance criteria like:

• Does the technician perform the calibrations as per procedure without supervision
• Does the technician evaluate and calculate measurement uncertainty effectively
• Is the technician able to generate calibration procedures
• Can the technician perform preventive maintenance as per the procedure
• And other qualifications as per the Lab Manager

3. Evaluation based on Competency Level

Competency Evaluation can be shown based on a “competency level”. Providing a “level” is how you measure or evaluate their competency. 

During monitoring and evaluation, there should be a goal that you set. This goal will determine how competent a person is. 

To explain better, see below the EXAMPLE of competency evaluation. This will also be a part of competency monitoring.

(There are other ways to do it but I will be sharing a process that works with me.)

Example of Competency Evaluation Based on Competency Level

The FIRST step is to Set a goal,  the main goal is to reach a level 3 competency. The goal is to make all personnel to a ‘level 3’ or ‘superior’ level at a given period.

Competency Level could start from Level 1- entry level to Level 3. If they can do all the criteria you define, then they are level 3. 

level 3 – expert
level 2- needs supervision
level 1 – trainee

Again, “Your goal is to make all personnel to a level 3 rating”.

Next, define or use the performance criteria. Examples of performance criteria for level 3 are: (you can add more based on what you feel is needed)

• Able to perform calibration without supervision
• Can generate calibration procedure
• Estimate and calculate measurement uncertainty
• Can analyze and troubleshoot problems
• He can train others successfully
• Provide analysis and interpretations of results

Finally, assess the level of competency. If the personnel meets all the defined performance criteria, a competency level of ‘level 3’, will be given, then it’s done.

If they are not yet capable of some of the criteria, then they will fall to a lower level depending on your assessment. Then perform continuous monitoring until the goal is reached.

The results can be recorded in a competency form or Excel sheets for proper recording and reporting.

The next requirement is to monitor and maintain it with the records.

The results of these evaluations are recorded as evidence of competency and used as one of the basis to give Authorization.

Step 5: Authorization

After all the evidence of competency was` generated, we are now ready to perform the review of personnel performance and issue an Authorization.

Authorization is usually issued by the General Manager or Lab Manager which is from a Top Management.

Evidence of authorizations can be shown by an accomplished authorization form or letter detailing that specific personnel is authorized to perform the laboratory activities where competency has been demonstrated and evaluated. 

See below clause from ISO 17025 for the example of specific laboratory activities where authorizations are given.

Clause 6.2.6 The laboratory shall authorize personnel to perform specific laboratory activities, including but not limited to, the following:

a) development, modification, verification and validation of methods;

b) analysis of results, including statements of conformity or opinions and interpretations;

c) report, review and authorization of results.

After the successful Authorizations, the personnel is now prepared and allowed to perform laboratory activities where he/she is authorized.

The next process now is the continuous evaluation of competency through monitoring and maintenance.

Step 6: Monitoring Competency – How to Monitor Competence of Personnel?

What is the purpose why we need to monitor competency? Once we determine the competency of our personnel, the next thing is to maintain, develop or extend their competency. 

To do this, we need to perform competency monitoring. Monitoring personnel competency can be achieved by continuous evaluation of their competency.

We can perform monitoring and maintenance of personnel competency by implementing below processes:

1. Identify possible improvements for training like:
   • providing continued education and development
   • Reassessment of training which is reviewed annually as an example. Reassessment will ensure that personnel stays familiar with the procedure or methods used.
2. Reviewing performance if it meets a (see example of implementation on number 3 of competency evaluation above):
   • defined performance criteria 
   • Set goals or objectives
3. Inclusion of competency check during internal audit- this is known as witnessing. 
4. Reviewing training records for any certifications or training that needs to be updated or to remain current. 
5. Evaluation of performance through the results of inter-comparison or Proficiency Test.

You can simplify all these by creating a monitoring program and competency matrix in an excel sheet.

Records of Competency- Evidence of Competency

How do you show evidence for the competency? This is one of the questions that we need to know perfectly. This is what we will use during audits or assessments.

The following are some examples of records used as evidence for competency:

1. educational and professional qualifications;
2. records of previous work experience;
3. job descriptions;
4. certifications;
5. training records;
6. reviews of personnel performance;
7. Authorization letter
8. Records of actual competency evaluation like witnessing or PT results.;
9. Records of continuing education and achievements;

Conclusion

Personnel competency is one of the main requirements of ISO 17025 that we need to meet.   

Competency is the demonstration of knowledge and abilities to attain the desired outcome of a specific laboratory activity. 

A competent person means qualified to perform a specific job to attain the intended results. These qualifications are the knowledge, skills, experience, and behaviors necessary to complete a given laboratory task.

In this post, I have discussed the procedure to determine the competence requirements that you can implement, this will also help you meet the competence requirements as per ISO 17025:2017.

I have discussed the following:

1. Understanding The Meaning of Competency
2. Understanding ISO 17025:2017 Competence Requirements
3. Examples of Laboratory Activities that Needs Competency Requirements
4. What Auditors May Ask – Audit Sequence to Determine Competency
5. Procedure to Determine Competency of Personnel
   • Identification of Personnel Competency
   • Initial Verification of competency
   • Training Program
   • Authorization
   • Monitoring competency
6. Records of Competency- Evidence of competency
7. Conclusion
   

Competence requirements is one of the most important requirements that a lab should meet for their personnel, all laboratory processes will be affected if competency is not properly implemented or maintained.

Thanks you for reading, please feel free to comment

For a small support fee, I created a ready-made Personnel Procedure with templates that demonstrates all the requirements that I presented, check it out here >> PERSONNEL COMPETENCY PROCEDURE

References:
1. Complying with ISO 17025: A practical guidebook for meeting the requirements of laboratory accreditation schemes based on ISO 17025:2005 or equivalent national standards
2. ISO 15189: Medical laboratories — Requirements for quality and competence

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Thank you.

Edwin