6.6.2c Product Conformance Verification

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. 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.

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Sean has a good start here. Even in a 17025 accredited lab not everything has to meet 17025 requirements - only the things that can affect your results.
Your organization need to develop and document a list of the products you purchase that can affect results. You need to document the critical qualities of these products to your products or processes. These are the items where you have to document a process on how to determine that the product is adequate. That could come down to checking whatever certification comes with the product to see if this is the correct product, correct strength, within expiry date, etc.
Retaining records for these checks can be as simple as having an authorized person review the documents and date and sign them as being reviewed and approved, then filing them.

Just knowing you received the correct goods in the correct quantity is a good start, but if you order something to meet a standard, then your purchasing document should specify that standard. You can then use the purchasing document to verify that the supplied goods meet the purchasing requirements. If it's not supplied to a standard then you will need to have a method to confirm it meets your requirements.

I'd suggest you publish the actual wording of the auditor's finding before we try any harder to answer your question

Rob_Kellock said:

I'd suggest you publish the actual wording of the auditor's finding before we try any harder to answer your question

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The auditor wrote "No records of reviews for externally provided products and services as required by clause 6.6.2c of the standard"

Could anyone provide some examples of methods used to determine that a product meets requirements?

DblHelixx said:

The auditor wrote "No records of reviews for externally provided products and services as required by clause 6.6.2c of the standard"

Could anyone provide some examples of methods used to determine that a product meets requirements?

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First step is to determine what your requirements are for the product. Since you are dealing with 17025 the no brainer is that you require accredited products with the 17025 logo, accredited datasheet, etc. You also need to document what you are purchasing. Let's say you are buying pH solutions. You need to set the requirements: pH value, accredited cert with uncertainties, container size, etc. You document that this is what you ordered by keeping a copy of the purchase order, initialed / signed / stamped to show that it was reviewed. Then when you receive the product you keep a copy of the documents provided as a record that you received what you ordered, within expiration date, etc. and keep a signed copy to indicate it was reviewed.

Tedious, but it satisfies 17025.

dwperron said:

You document that this is what you ordered by keeping a copy of the purchase order, initialed / signed / stamped to show that it was reviewed.

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All valid points from dwperron except the tiny point above. We, QA, do not control PO copies. Instead, we control all incoming materials with Packing slips.
But, btw, this makes little sense because errors are unfortunately quite often. Suppliers seems not treat their packing slip with due care and/or many do not contain necessitated contents such as lot#, item# etc. So, you may opt to skip this tiny point.

SeanN said:

All valid points from dwperron except the tiny point above. We, QA, do not control PO copies. Instead, we control all incoming materials with Packing slips.
But, btw, this makes little sense because errors are unfortunately quite often. Suppliers seems not treat their packing slip with due care and/or many do not contain necessitated contents such as lot#, item# etc. So, you may opt to skip this tiny point.

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6.6.2 states:
"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
c) ensuring that externally provided products and services conform to the laboratory’s established requirements"
You need a record of what you asked for, showing that it was reviewed.
Then you need a record of what you received and that this was also reviewed.
The OP asked for an example, I provided one.

dwperron said:

You need a record of what you asked for, showing that it was reviewed.

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This is the point I wanted to clarify. We do have defined/reviewed/approved laboratory’s requirements (a) and then check the incoming materials against these requirements (c). But I don't see the need to control purchase orders.

dwperron said:

You document that this is what you ordered by keeping a copy of the purchase order, initialed / signed / stamped to show that it was reviewed.

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I know some labs are doing this. It's a good practice to do so, but not a must in ISO 17025. Approved vendors list is another story.

SeanN said:

This is the point I wanted to clarify. We do have defined/reviewed/approved laboratory’s requirements (a) and then check the incoming materials against these requirements (c). But I don't see the need to control purchase orders.

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Nobody said you had to control purchase orders. I was offering a suggestion to the OP that he could use the reviewed PO as a record. What record do you retain to show that you reviewed the items to be purchased?

dwperron said:

What record do you retain to show that you reviewed the items to be purchased?

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All purchases are from an approved list (meaning anyone can place POs from this list). Then QA reviews packing slips and CoAs, approves or rejects.

Isn’t this really a matter of choice? In most manufacturing businesses, the purchasing function is controlled ‘by the QMS’ in several ways - some required by the ISO9000 standard and some not. Those that aren’t are typically employed because they work. Parts and materials are controlled on the drawing - listed and controlled on the BOM per the drawing and purchasing can only purchase what is on the BOM for released product. They can only purchases from approved vendors (on the approved vendor list). There are also certain other requirements that might be imposed to assure quality. fro example, in an organization where certain materials had similar part numbers and names and bottles etc. we only allowed a single PO per material; a PO could not include ordering both similar parts to avoid mislabeling and mis-receiving by entering the wrong lien item number on the PO. This was strictly enforced by our QMS).

Of course having the PO record of what was ordered doesn’t mean that the vendor actually sent what was ordered, but it does form a chain of evidence that what was ordered was correct. The thing is if we treat the Quality Management System as a System then we move beyond teh quality department as the police…and we have a more effective and involved organization.