6.6.2c Product Conformance Verification

My laboratory recently had its annual surveillance assessment, and received a nonconformance because there were no records as required by clause 6.6.2c.
Could anyone provide some examples of how you fulfill the requirements of this clause? I'm drawing a blank on what these records should look like and what the procedure should be. Is it saying that every single thing I purchase for the lab has to be checked and marked as "approved"? What would this look like for something like... pipette tips??

Records are useful to show that "externally provided products and services conform to the laboratory’s established requirements, ... before they are used". So, basically you need to well define your "established requirements", then your vendors/purchased products will be checked/approved against these requirements. Who/What/How will be recorded/kept. It seems to me that you do not have such an SOP in place. Maybe not everything you purchase (paper towels?), but at least the materials that impact your test results (you may use risk-based approach to decide which ones need to be monitored). For pipette tips, are you using non-sterile or sterile? (what do you want?). How are your vendors evaluated/approved/rejected?
"If you don't know where you're going, any road will take you there." Alice in Wonderland.

SeanN said:

Records are useful to show that "externally provided products and services conform to the laboratory’s established requirements, ... before they are used". So, basically you need to well define your "established requirements", then your vendors/purchased products will be checked/approved against these requirements.

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So I have a procedure and established requirements for approving vendors, and I verify order fulfillment and sign off on the packing slips. This wasn't enough for the auditor...I was told that I somehow need to record that each individual product I receive conforms to requirements. There seems to be a bit of redundancy in validating vendors, and then validating the products from the already-approved vendors...

SeanN said:

How are your vendors evaluated/approved/rejected?

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Vendors are evaluated based on criteria such as certifications/registrations/accreditations, past performance, recommendations, customer service/responsiveness, and price.

Even with approved vendors, not all products/lots conform to your required/established requirements. Think about the possible risks that may impact your quality of tests.

DblHelixx said:

and I verify order fulfillment and sign off on the packing slips.

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How do you verify? count the quantity and then sign off packing slips? How do you know that lot # xxx of product# xxx received on date x/x/x meet your quality requirements? What happen if you need to investigate a deviation or OOS? (Traceability? Will you able to find the root cause?)

DblHelixx said:

somehow need to record that each individual product I receive conforms to requirements.

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This is a fair point.

DblHelixx said:

a bit of redundancy in validating vendors, and then validating the products from the already-approved vendors

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Multiple layers are usually required to ensure the quality. That's what we call a "SYSTEM".

Are these off the shelf parts made to teh manufacturer’s published specifications) or some custom parts made to our specifications for you?

How do you verify? count the quantity and then sign off packing slips? How do you know that lot # xxx of product# xxx received on date x/x/x meet your quality requirements? What happen if you need to investigate a deviation or OOS? (Traceability? Will you able to find the root cause?)

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Mostly the first point - quantity check and basic check that they sent me what I ordered. At some point I have to be able to trust my vendor, right? Take standard reference materials, for example. I have no way to verify that they are the concentration the CoA says. That's why I purchase them instead of make them myself. The vendor is approved based on ISO 17034 status, but how would I be able to verify their product?? Or with the pipette tip example - the vendor says they're sterile, so I trust that they're sterile.

Are these off the shelf parts made to teh manufacturer’s published specifications) or some custom parts made to our specifications for you?

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These are off-the shelf parts listed in a vendor's catalog and purchased online.

I am not familiar with 17025. Can you quote section 6.6.2? I am quite familiar with diagnostic laboratories for veterinary testing and they certainly don’t perform any testing of supplied ‘off the shelf’ products. That would defeat the purpose. I can’t see how a CofA isn’t sufficient or that suppliers of things like pipette tips can’t be trusted to ship to the contract…perhaps one of our auditing experts here can weigh in.

Bev D said:

I am not familiar with 17025. Can you quote section 6.6.2? I am quite familiar with diagnostic laboratories for veterinary testing and they certainly don’t perform any testing of supplied ‘off the shelf’ products. That would defeat the purpose. I can’t see how a CofA isn’t sufficient or that suppliers of things like pipette tips can’t be trusted to ship to the contract…perhaps one of our auditing experts here can weigh in.

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6.6.2 The laboratory shall have a procedure and retain records for: a) defining, reviewing and approving the laboratory’s requirements for externally provided products and services; b) defining the criteria for evaluation, selection, monitoring of performance and re-evaluation of the external providers; c) ensuring that externally provided products and services conform to the laboratory’s established requirements, or when applicable, to the relevant requirements of this document, before they are used or directly provided to the customer; d) taking any actions arising from evaluations, monitoring of performance and re-evaluations of the external providers.
In our ISO 17025 labs, we do perform testing of supplied ‘off the shelf’ products. Not all, but whatever we can. Personally, I see it's sometimes a bit too much and unnecessary (see my previous post, 166 views, no replies).

Anyhow, we have to monitor externally provided products because CoAs aren’t sufficient, in reality.

Bev D said:

... testing of supplied ‘off the shelf’ products. That would defeat the purpose. I can’t see how a CofA isn’t sufficient or that suppliers of things like pipette tips can’t be trusted to ship to the contract…

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This was my thought exactly, which is why I'm having such a hard time grasping how to meet this clause.

SeanN said:

In our ISO 17025 labs, we do perform testing of supplied ‘off the shelf’ products. Not all, but whatever we can. Personally, I see it's sometimes a bit too much and unnecessary

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Do you have a separate form you fill out for all products? Or do you just mark the product "approved" and that fulfills the recordkeeping requirement?

DblHelixx said:

This was my thought exactly, which is why I'm having such a hard time grasping how to meet this clause.

Do you have a separate form you fill out for all products? Or do you just mark the product "approved" and that fulfills the recordkeeping requirement?

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We do have separate forms to fill out for all (controlled) products. Hundreds forms in totel.