What are Validation Requirements for Vendor (Supplier) Processes

E

ElmerF

Hello,

I have a question with regard to the level of validation required from vendors. My understanding of validation is you either 100% inspect or you validate.

With off the shelf items from vendors, they are not likely to supply a validation of their process. Is it sufficient that they provide a COC saying that their product meets their specification. What incoming ispection must be conducted thereafter. Is an AQL depending on criticality sufficient? Typically Z1.4 or Z1.9 as applicable?

What about a component made to our specification? Must we get an IQ, OQ, PQ from the vendor or have them conduct 100% inspection or is an AQL sufficient? Will a COC suffice in place of a validation? If in turn that vendor receives a sub-component from a sub-supplier do they need to do the same (validate or 100% inspect) and are we responsible for ensuring our vendor has completed this or again rely on their certification (COC).

Thanks for the help.

Elmer
 
somashekar

somashekar

Leader
Admin
Re: What are validation requirements for vendor processes

Hi Elmer.
The simple bottom line is that if x process needs a validation for quality assurance, it must be so identified, planned and validated before the run, so that consistency and quality assurance is maintained and traceable.
Nothing can replace validation.
It is for this as one of the understanding that an organization selects a supplier who has implemented a QMS.
COC is meaningful only when the conformance comes from validated process runs.
Ex: Painting
1. Color match to spec comes out from validation but a 100% inspect may do the same, but only after the painting is done and cured.
2. Paint thickness assurance comes out from validation, and can be verified in samples
3. Paint adhesion strength assurance comes out from validation, and can be verified in samples.
Remember that operator qualification is a part of process validation.
 
E

ElmerF

Thanks Somashekar,

With regard to off the shelf items, for example, suture, what level of assurance do I need from the vendor. It is an ISO 13485 certified vendor and the suture is CE marked. Therefore it will have been validated. However, being an off the shelf item the validation data is not available to customers. As it is being incorporated into another medical device it will be validated but the process can only be validated by the vendor.

I am trying to write a Master validation plan that addresses all critical vendor components. Just wondering how to handle off the shelf components. Is it sufficient to ask for a COC that states it has been validated under ISO 13485? If not what else can be done?
 
somashekar

somashekar

Leader
Admin
ElmerF said:
Thanks Somashekar,

With regard to off the shelf items, for example, suture, what level of assurance do I need from the vendor. It is an ISO 13485 certified vendor and the suture is CE marked. Therefore it will have been validated. However, being an off the shelf item the validation data is not available to customers. As it is being incorporated into another medical device it will be validated but the process can only be validated by the vendor.

I am trying to write a Master validation plan that addresses all critical vendor components. Just wondering how to handle off the shelf components. Is it sufficient to ask for a COC that states it has been validated under ISO 13485? If not what else can be done?
Click to expand...
When you are buying an off the shelf item like a suture in your case, you are selecting this item based on the manufacturers specs after you test and agree that it meets your requirements.
The supplier being ISO 13485 certified is your added criteria providing assurance to your selection.
As a customer you can get (or ask and be provided) the COC for the batch you purchase which shows evidence that the suture has met the manufacturer's own specs that are claimed, and based on which you have decided to buy and use that suture.
Here you are not having any control directly over his process and so you have no scope in this activity. This is purchasing and not outsourced process.
On the other hand, if you draw up specs for a suture, and this manufacturer agrees to make and supply to you, you can (before ordering) chart out your controls for this purchasing activity which is outsourcing and must include validation.
When you buy product off the shelf, you can:
1. Base your acceptance on the supplier's COC +
2. Conduct your own sampling tests to assure the supply meets your requirements +
3. Seek a 3rd party lab to test the product against the supplier's specs
However these are your own inspection and assurance activities and are not any controls over the supplier's off the shelf products.
 
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