Auditing Internal Laboratory Personnel for Competence

sswaim

Registered
Hello, we are considering on having our own internal 17025 cal lab. One question that has come up and that I have not been able to locate is the amount of personnel that will be audited when the auditing body comes to do their audit. I once heard that 1/3 of the technicians will be audited/over the shoulder audits. I just cannot confirm. Please advise

Thanks
 

Marc

Fully vaccinated are you?
Leader
You can never tell who will be audited and there is no statistical method used so 1/3 of the personnel isn't relevant. In addition to interviews you have to be able to tell/show how you determine competence and any associated records (again a non-statistically derived sample).

A thing to think about is different personnel in a lab, or anywhere else for that matter, may have competence in different areas. A CMM is an example - If you have several people it may be that only one, maybe two, are qualified (competent) to use it.

You will not have any issues as long as each person is, in fact, competent in whatever their specific job duties are.
 

Hershal

Metrologist-Auditor
Trusted Information Resource
Here is the thing.

First, do NOT lock into any one AB! Talk to all and make them answer your question.

Now, as a former AB assessor (and former Metrologist), now no longer bound.....

When I did a Cal Lab, I spoke even to the receptionist and shipping person. Why? I learned so much more. I went on-site.

ISO/IEC17025 correctly done, is a MBA in a few pages for a lab.

Just my thoughts thus far.
 

dwperron

Trusted Information Resource
Throwing my 2 cents worth in here,

17025 5.2.5 states that management shall authorize specific personnel to perform particular types of calibrations. You shall document and maintain records about who is qualified and how you made that determination.

The labs I have worked in have maintained a "capabilities matrix" of some sort that lists the processes in your scope of accreditation and the personnel who are qualified to perform them. Auditors love to see these, it makes their work easier.

This leads to the amount of personnel to be observed. The auditor has a list of the processes in your scope and the people qualified. He can choose any of these (within reason, you are running a business) and ask them to demonstrate competency. Auditors don't want to observe the same few perform all of the work - they want it to represent your typical work situation, so if a person is listed as competent he may be called to demonstrate it. Based on the size of your work force and the size of your scope of accreditation this could be anywhere from a small percentage of your staff to 100%. The only rule involved is that all of the elements on your scope of accreditation should be observed.
 

Hershal

Metrologist-Auditor
Trusted Information Resource
dwperron is correct in terms of what an assessor can do. I typically would find out if there were other shifts and I would assess them as well. If that meant coming in late at night, so be it. But, that was me.
 
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