We operate a small commercial cal lab in the western U.S.

A client of ours recently performed an audit on our Quality System, which is compliant to ISO 17025. This client manufactures medical products and follows FDA requirements.

The auditor would like to see our calibration technicians qualified on each calibration procedure in our technical library (about 4,000 documents). Each technician would not need to be qualified 4,000 times but they may have to be qualified in the 100's or 1000's of times.

Let's say a Dimensional Calibration Technician needs to be qualified to do calipers. Our library might have 15 different calibration procedures to do vernier, dial, digital, etc. Now multiply this by the many different types of instruments he may calibrate times the many calibration procedures for each "Model" and the task is dauntingly huge.

We see the proposed training as being non-affordable, non-necessary and most of all nearly impossible.

A2LA, an accreditation body, expects training by "Type" of tool (i.e. calipers). Two resources exist on their site a Q&A document titled Understanding ISO/IEC 17025: A2LA Specific Applications of the Standard and a FAQs document.

Although they clarify A2LA's expectation of our quality system in regards to training procedures, they do not state, "Training by Type of Instruments is acceptable".

And, on the other hand: The FDA website offered CFR 820, a sample Quality Manual and a sample Personnel Training Procedure, etc.

The FDA seems to side with A2LA and I am not finding the expectation our client has of training on each procedure.

It would be great if a reader replies with clarification from a recognized "authority" for us to pose our reply to the "Major" corrective action, which is headed our way.

Welcome to the posting side of the Cove.

I don't have the authoritative answer you are looking for but I am a 2pCP auditor for AIAG laboratory recognition. I know of no requirement for any lab technician to be qualified on any test method/procedure he/she is not actually using. The requirement is the use of qualified lab personnel. If your training accomplishes the level of competency required by using a "type of equipment" method then referring to specific documents for "model" differences, I see nothing wrong with that as far as compliance with the requirements.

Always remember, when an auditor writes a nonconformance, he/she writes it against a specific requirement. If the auditor can show you a specific clause relating to the nonconformance, you will have to accept it and correct it. If it is just a matter of auditor interpretation, the most he/she can do is offer it as an opportunity for improvement. I understand it is sometimes difficult to "argue" with a customer but in a case where "what they would like" is too costly or is of no service to your company, you should take a stand. Don't be bullied by the auditor. This has almost become a war cry around here --- Have him/her show you the shall.

Dave

I know of no requirement for any lab technician to be qualified on any test method/procedure he/she is not actually using.

That has been my experience as well.

During the accreditation audits, they wanted to see how we controlled the training of the employees and how we know who is responsible for what and is allowed to conduct certain procedures.

We do this using a number of documents and procedures:

We have a master list of all procedures cross referenced to employees. If employees get the written procedures, they can conduct the procedure.

We also have a Responsibilities and Authority Form signed by management which is essentially a job description that lists the procedures employees can perform.

Then we have a Equipment and Procedures Verification form that records and evaluates the employee's expertise for the activity.

And we have a form that lists all the formal internal and external training that the employees have had that shows they have been trained and that our own experts have evaluated and verified their understanding of what they supposidly learned.

So, there are many documents used as controls to ensure who can do what with which equipment based on training and internal verifications.

Kind of complicated, but pretty easy after you think about it.

DaveSoutham,

The training and qualification depends on what one is doing.....if you have several thousand procedures (not terribly unusual, BTW), then training/qualification by type of measurement or parameter is much more common.

I can't speak to A2LA's position as they are colleagues, they will have to clarify that.....but I can suggest that you may chat with the other four recognized accrediting bodies operating in North America.....IAS, L-A-B, NVLAP, and SCC/CLAS.....never ever ask only the one.....after all, your clients shop several providers.....whether you are seeking an answer or accreditation or both, ask all the ABs.

Hershal