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Evidence of Contract Review for External Calibration Laboratory

ScottBP

Involved In Discussions
#1
This question has to do with the paper shuffle end of ISO 17025. On one of our audits we got hit up for this: "Calibration work order #{such and such} is an accredited calibration performed by the laboratory, but the laboratory could not show evidence of the contract review for this calibration." The reference is 17025:2005 section 4.4.2, "Review request tenders & contracts". Normally, we just give an informal verbal or email response to a customer as in "Yeah, we can do that calibration accredited", but it looks like the auditor is looking for something more formal. How does everybody else deal with this situation? How can we make it more formal? :confused:
 
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R

RMain

#2
Re: Evidence of contract review?

This question has to do with the paper shuffle end of ISO 17025. On one of our audits we got hit up for this: "Calibration work order #{such and such} is an accredited calibration performed by the laboratory, but the laboratory could not show evidence of the contract review for this calibration." The reference is 17025:2005 section 4.4.2, "Review request tenders & contracts". Normally, we just give an informal verbal or email response to a customer as in "Yeah, we can do that calibration accredited", but it looks like the auditor is looking for something more formal. How does everybody else deal with this situation? How can we make it more formal? :confused:
If I read the posting correctly, a response in the form of an “Order Acknowledgement” which would include wording along the lines of “Upon review of your requirements we have deemed our accredited scope of competency capable of fulfilling your request”, please see the details/costing included herein” would be sufficient proof of a review, agreement in the scope of supply and acceptance based on your capabilities.
My Two Cents
 
J

JodiB

#3
Re: Evidence of contract review?

We have testing labs (not cal). Requests are received on a specific order form that only includes tests that we are capable of performing. We process the request into a database for tracking each sample. If there is a special request, such as Rush, that is noted on the order form and tracked also.

The original hard copy order form accompanies the sample to the testing station. It will eventually be discarded after the test is run and results are entered into the database. (it is not necessary to maintain paper doc if the information has been transferred to electronic media).

Our contract review is therefore conducted passively (the order form only lists what we're capable of doing) as well as conducted actively twice (the analyst enters the request into the database if the work is accepted, and the test analyst reviews the request before conducting the test).

My understanding is that this is enough. What were you specifically lacking to demonstrate that you performed a contract review?
 
R

RMain

#4
Re: Evidence of contract review?

We have testing labs (not cal). Requests are received on a specific order form that only includes tests that we are capable of performing. We process the request into a database for tracking each sample. If there is a special request, such as Rush, that is noted on the order form and tracked also.

The original hard copy order form accompanies the sample to the testing station. It will eventually be discarded after the test is run and results are entered into the database. (it is not necessary to maintain paper doc if the information has been transferred to electronic media).

Our contract review is therefore conducted passively (the order form only lists what we're capable of doing) as well as conducted actively twice (the analyst enters the request into the database if the work is accepted, and the test analyst reviews the request before conducting the test).

My understanding is that this is enough. What were you specifically lacking to demonstrate that you performed a contract review?
Contract Review, in your example where is the meeting of the minds between you the disciplines within your company accepting the work to be done and the customer accepting the requirements/conditions of the Order/Contract and the Authorization /Acceptance by the Customer etc…, to move forward /fulfill the order?
 
J

JodiB

#5
Re: Evidence of contract review?

Contract Review, in your example where is the meeting of the minds between you the disciplines within your company accepting the work to be done and the customer accepting the requirements/conditions of the Order/Contract and the Authorization /Acceptance by the Customer etc…, to move forward /fulfill the order?
Our customer is internal only. The meeting of the minds is contained on what we call a Service Level Agreement where we list the tests we perform, as well as our requirements for the sample amount, packaging, accompanying documentation, etc. We state that we will reject any samples sent for testing that do not conform and will inform the customer of rejected samples.

Customer acceptance of these terms is demonstrated by upper management approval /signatures of the SLA and by the individual customer submitting the sample to us. There is no back-and-forth discussion/agreement needed.

I think our approach could be adapted for providing services to 3rd parties with inclusion of Terms and Conditions specifically outlined on an Order Form, Order Page, etc. couldn't it?
 
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Hershal

Metrologist-Auditor
Staff member
Super Moderator
#6
ScottBP, the Clause that likely should have been cited is 4.4.1.a as that is where we learn that contract review has some responsibility for both lab and customer (you).

That is, the lab needs to understand your needs and requirements, which means you get to communicate the same to the lab. There are several ways to have the evidence such as email or similar. The cal labs' AB assessor in turn should review to make sure they have documented the requirements on their end.

Hope this helps.
 

ScottBP

Involved In Discussions
#7
What our quality manager ended up doing is to create a sticker that gets affixed to the cover sheet of the work order for every accredited calibration we're asked to do. (It's on a sticker until we get a chance to revamp our work order cover sheet. We're in the process of writing a better database to keep track of our work orders.)

The sticker has a blank for the date, and a short checklist with blanks to sign off on:

1. Customer requirements reviewed- We'll print the email, customer purchase order, or special requirements form and attach it to the work order.

2. Accredited standards available- Here we will list the asset #s of the proper lab equipment for the technician to use.

3. Proper Method available- Here we will list the proper calibration procedure to use.

4. Calibration data from technician is correct- This is a QA check to make sure they captured everything required by 17025 for the calibration.

5. Verified uncertainty is within lab CMC- We've been hit up before for reporting an uncertainty that's tighter than what we have listed on our scope of accreditation, so this is here as a reminder to go back and check.

(For items 2 and 3, we may sometimes use different equipment and procedures for accredited vs. non-accredited calibrations; this is to make sure the technicians are aware of the fact.)
 
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