Use of Certified Reference Materials for Quality Assurance

[ebrachhausen]

It seems that most Accrediting Bodies require Proficiency Testing to meet the quality assurance requirements of 5.9.1 for testing laboratories. Is testing using certified reference materials also required for 5.9.1? It seems that we hear a lot about PT, but not about the use of the other QA methods listed. Can anyone advise from experience? Thanks for any input you can give?

 

[Hershal]

Here is the real deal.

Clause 5.9.1 has the requirements. Sub-Clauses a through e hold examples. The one for PT/ILC is preferred for a singular reason: It has comparison to others. No other reason.

ALL the examples of a through e are acceptable - absent evidence of PT/ILC being available.

CRM makes things so much easier, as repeated comparisons to the CRM - where PT/ILC - do not exist, assure validity.

BUT, if PT/ILC truly does exist - AND - does NOT present undue burden on a lab.....you must comply.

Hope this helps.

 

[ebrachhausen]

Hershal, thank you very much for your reply. When you say that PT/ILC is preferred, or is acceptable, or that you must comply if it is available, I gather this is according to some rule of the Accrediting Body, is that right?
The language in the standard makes it sound as if they are all equally acceptable. It seems as if some things become ingrained practices, even if they are not explicitly written in the standard. I know you must have a reason for your explanation, and I hope you don't mind if I ask you what your response is based on?

As a separate question, have you ever run across the use of CRMs to support evaluation of the effectiveness of training (5.2.2)? Or if not, what is considered a best practice for evaluating the effectiveness of training?

 

[Hershal]

Hi, yes, and a well qualified - and now just former AB assessor (over 500 assessments) - I can stress the actual requirement, rather than parroting the ILAC/Region/AB position of the necessity of PT/ILC.

The ACTUAL requirement is in 5.9.1, NOT in the examples. Hence, if the examples do not apply and/or are not available, then bounce to one of the other examples as the method of meeting the requirement. But understand, you must have evidence that PT/ILC is either not available or presents and undue hardship on the lab. An undue hardship is not precisely defined but can be - roughly - interpreted - as if it equals or exceeds the cost of the accreditation, it is an undue hardship.

Yes, I have run across CRMs numerous times, as for testing at least, PT/ILC is limited. CRMs for several fields of testing are quite normal. And in some fields, even CRMs are not available, and so only consensus standards are available.

If you have detailed questions that may not be appropriate here, contact me off-line here.

Hope this helps.

 

[ebrachhausen]

Hi Hershal,

Thanks again for the added information. I would appreciate contacting you offline. How do I go about doing that? Telephone would be best for me.

 

[Hershal]

Hi Eric, I appreciated our conversation, subsequent to off-line messages.

 

[ebrachhausen]

Hi Hershal,

Likewise on my side. I appreciated your openness and insights helpful to the particular project I am working on.

Regards,
Eric