ISO 17025 Documented Procedure for 6.2.5 - Determining competency

#1
Was recently audited and was given a non-conformity for clause 6.2.5 in particular.

Auditor stated that " though the lab has records of experience and competency of individual personnel it does not have a procedure for determining competency requirements, training and supervision.

I have been trying to wrap my head around the requirements part and how to place it in the procedural format.

Any suggestions?
 
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dwperron

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#2
This is a new area in 17025, and as such there isn't a lot of precedence as to what an assessor should expect.

Basically, you are already doing these functions. You know who is competent for a job, you select that person, you train that person, you authorize that person, you supervise that person.
17025 now wants you to document how you make these decisions.
Do you have your technical lead determine qualifications? Or lab manager? Or Quality Manager? Document the process.
Who determines what training is required for someone to do the job? Document that process.
Do you have a way of knowing that a person is good at the job? Document that process.

And keep records of this for each technician.

This can be like the old qualification card system. You can create a form for each class of instrument, and fill it out for each competent technician.
 
#3
Thank you for the input.

If the lab manager determines the qualifications can a document stating experience/education needed for the job be used as a part of the procedure?
I think I have a grasp of how to handle it. Its hard to document processes that are determined verbally or innately.
 

dwperron

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#4
Thank you for the input.

If the lab manager determines the qualifications can a document stating experience/education needed for the job be used as a part of the procedure?
I think I have a grasp of how to handle it. Its hard to document processes that are determined verbally or innately.
You hit the issue. It's hard to define what you are doing, but you know when it is right or wrong.
I suggest keeping it simple. If your lab manager determines the qualifications, write that down as part of the procedure. Don't get specific about rules for experience or education, just state that they will be taken into consideration. Maybe state some general minimum requirements.

Monitoring competence is the challenging one. It's not just documenting training any more, you need to show the technician is competent. There are a few articles out there you can Google about determining competence. Some suggestions might be observation by a subject matter expert, review of calibration reports for accuracy and completeness, having a second technician duplicate their results, lack of complaints from customers, etc.
 
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