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ISO 17025:2017 Clause 7.4.1 - Requirements for Procedures

fahimk

Starting to get Involved
#1
In ISO 17025:2017 clause 7.4.1 it is written that:

"The laboratory shall have a procedure for the transportation, receipt, handling, protection, storage, retention, and disposal or return of test or calibration items, including all provisions necessary to protect the integrity of the test or calibration item, and to protect the interests of the laboratory and the customer. Precautions shall be taken to avoid deterioration, contamination, loss or damage to the item during handling, transporting, storing/waiting, and preparation for testing or calibration. Handling instructions provided with the item shall be followed."

If i am not wrong, the author is asking for SEVEN (07) different procedures? How can i differentiate between the following terms: transportation, receipt, handling, protection, storage, retention, and disposal or return of test or calibration items?

Thanks and looking forward.
 

Benjamin Weber

Involved In Discussions
#2
I don't think, the author intended to require seven single procedures. The standard requires, that you have one or if necessary multiple procedures, how to deal with test/calibratoin items.

For example:
- Do you offer any transportation services or do the clients just send their stuff to your lab?
- You may have the rule for visual isnpection for any damages after arrival at your lab or do you always perform functional tests?
- What shall happen, if the item is damaged or non-functional?
- Are there special precautions your lab staff has to know with certain items?
- Where and how are the items stored? Just put them all together in a big box without any markings? Or maybe separate boxes, all marked with the corresponding client/order information?
- Are there special storage conditions (temperature, pressure, humidity...)?
- Do you need to retain samples for possible retesting or evidence later on? Maybe due to other obligations (directives, national laws or regulations....)
- What happens with the test items once the test/calibration is finsihed? Do you send them back to the client? Does the client pick it up at your lab? Do you hand it over personally? Do you throw it all just away?

Depending on how your lab internal rules are, write them down, train your people on the rules and make sure they work accordingly.

Maybe not all of the terms apply to your lab. We never dispose anything of the clients test items. Everything is shipped back to the client after the tests are finished. Hence we don't have disposal covered. (But we have written down, that everything is sent back).
 

fahimk

Starting to get Involved
#3
I think the following six processes are common to all labs:
transportation (how the lab receives?)
receipt (what between receiving and working on it?
handling (how the item is worked on?...forwarded to a particular section...then they assign workload to xyz...so team work...)
protection (from unauthorized use/ unfriendly environmental conditions?)
storage (so that to keep it for a long timer?)
return of test or calibration items


Only, the retention and disposal sub-parts are optional. Any comments?? Thanks.





I don't think, the author intended to require seven single procedures. The standard requires, that you have one or if necessary multiple procedures, how to deal with test/calibratoin items.

For example:
- Do you offer any transportation services or do the clients just send their stuff to your lab?
- You may have the rule for visual isnpection for any damages after arrival at your lab or do you always perform functional tests?
- What shall happen, if the item is damaged or non-functional?
- Are there special precautions your lab staff has to know with certain items?
- Where and how are the items stored? Just put them all together in a big box without any markings? Or maybe separate boxes, all marked with the corresponding client/order information?
- Are there special storage conditions (temperature, pressure, humidity...)?
- Do you need to retain samples for possible retesting or evidence later on? Maybe due to other obligations (directives, national laws or regulations....)
- What happens with the test items once the test/calibration is finsihed? Do you send them back to the client? Does the client pick it up at your lab? Do you hand it over personally? Do you throw it all just away?

Depending on how your lab internal rules are, write them down, train your people on the rules and make sure they work accordingly.

Maybe not all of the terms apply to your lab. We never dispose anything of the clients test items. Everything is shipped back to the client after the tests are finished. Hence we don't have disposal covered. (But we have written down, that everything is sent back).
 

Benjamin Weber

Involved In Discussions
#4
I don't think there are mandatory and optional parts. It just depends on the activities applicable to your lab!

What if your lab doesn't even receive test or calibration items, because you perform testing or calibration on-site at the client or maybe with a mobile lab? Than it would be weir to require a description of EUT reception.

Regarding your comments on the activities:
- Transportation may also apply, if you transport the test or calibration item. For instance, we receive items and some of the tests are performed at other labs. Then we have to take care of the transportation to and from this other lab.
- Storage does not onyl refer to longer periods. If you keep a test or cailbration item in your lab only for one day, you have to have rule for storage.

And I would not call these activities single "processes". I would rather call the combination of these activities a process named "DUT handling" (or similar). But how you structure your QM documentation and how you call different doc-types is totally up to you.
 
#5
An auditor is going to look at your handling processes and will compare them to your written procedure. As in all things 17025, the rigor of your process will depend on your lab's requirements. If you are doing biological or isotope testing your disposal process will be far more rigorous that an calibration lab that wants to dispose of a worn thread plug. Do you need to keep your test items in a specific environment or do you just need to keep them dry and out of the sun?
The auditor is going to be sure that you document how your lab needs to handle the items it normally works with, so that the process stays consistent and is repeatable with different staff members.
 
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