Critical Supplier Initial evaluation for single purchases

jay747

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#1
We purchase raw materials (Critical products) from suppliers who are included in our Approved Vendor List. Under certain circumstances, we are forced to buy the RM from other unapproved Suppliers. Now should these suppliers be subjected to evaluation for these single purchases prior to the purchase and be added to the AVL or is there any way around it? (with reference to API Spec Q1)
 
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Sidney Vianna

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#2
Do you have a process to identify and mitigate risks for procuring critical products from unapproved sources? What additional checks and balances do you perform to ensure product conformity?
 

jay747

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#3
Do you have a process to identify and mitigate risks for procuring critical products from unapproved sources? What additional checks and balances do you perform to ensure product conformity?
As of now, there is no system in place to 'identify and mitigate risks for procuring critical products from unapproved sources'. The Approved Vendor list is in place just to please the auditors for now. I plan to improve the purchase process. But for the upcoming audit, the approved vendor list is vastly outdated. I plan to include the suppliers of the previous two years to exhibit during the Audit . It's a monumental task now, and I'm trying to minimize the task at hand.

"What additional checks and balances do you perform to ensure product conformity?" what can be included to ensure conformance at the product level? We have an effective incoming inspection process for all incoming critical products.
 

Sidney Vianna

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#4
what can be included to ensure conformance at the product level? We have an effective incoming inspection process for all incoming critical products.
How can I answer that, if I have no idea of the type of the raw material at hand? As an universal method, sending samples of the incoming material to independent test labs is an advisable step.

Do the unapproved suppliers have some form of quality system certification?

Can you reach out to customers of this unapproved supplier and ask for references and data on their quality performance?

I understand that your primary concern at this time is to "pass the audit", but, in theory, "passing audits" should be an outcome of having effective systems in place. If I were you, I wouldn't worry too much. The default value for nonconformities these days in CB audits is close to ZERO. Audits are less and less a good measure of system adequacy and effectiveness.

Good luck.
 

Rene Minassian

Do it right the first time....
#5
Straight answer, YES. Critical Purchase shall undergo the requirments of 5.6.1.2 it does no matter if one time or for general use.
Know it depens on how complicatde you have defined the requirments to collect the relevant information requied by 5.6.1.2. It should be a questionäre to the supplier for a) & b) and a first article inspecton (FAI) when receiving the product. to c), finished. It should not be usper complicated.

Example:
for a) the supplier should have a QMS at least for 9001 in place.
for b) the supplier should carry out a incomming good inspection for his purchases at least.
for c) FAI
BUT this neds o be in line with your procedure in compliance with API Q1.
 

jmech

Trusted Information Resource
#6
We purchase raw materials (Critical products) from suppliers who are included in our Approved Vendor List. Under certain circumstances, we are forced to buy the RM from other unapproved Suppliers. Now should these suppliers be subjected to evaluation for these single purchases prior to the purchase and be added to the AVL or is there any way around it? (with reference to API Spec Q1)
Q1 doesn't give any exemptions for single purchases, so they need to go through the approval process if you want to conform to Q1.

Q1 allows you to make the approval process fairly simple (as explained by Rene) but your procedure needs to conform to Q1 and your actions need to conform to your procedure.

The default value for nonconformities these days in CB audits is close to ZERO.
APIQR is still not shy about issuing nonconformities and they still cancel registrations if nonconformances are bad enough or don't get fixed to their satisfaction. APIQR is far from perfect, but they don't seem to be as slack as many other CBs.
 

Sidney Vianna

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#7
APIQR is still not shy about issuing nonconformities and they still cancel registrations if nonconformances are bad enough or don't get fixed to their satisfaction. APIQR is far from perfect, but they don't seem to be as slack as many other CBs.
Good to know that. I think that, when you have a monopoly, you can deliver the service any way you see fit, without a fear of losing the customer.
 

jay747

Starting to get Involved
#8
Straight answer, YES. Critical Purchase shall undergo the requirments of 5.6.1.2 it does no matter if one time or for general use.
Know it depens on how complicatde you have defined the requirments to collect the relevant information requied by 5.6.1.2. It should be a questionäre to the supplier for a) & b) and a first article inspecton (FAI) when receiving the product. to c), finished. It should not be usper complicated.

Example:
for a) the supplier should have a QMS at least for 9001 in place.
for b) the supplier should carry out a incomming good inspection for his purchases at least.
for c) FAI
BUT this neds o be in line with your procedure in compliance with API Q1.
Thanks Rene Minassian.

For Compliance to requirement 5.6.1.2 (c) would a routine internal incoming inspection be sufficient?

APIQR is still not shy about issuing nonconformities and they still cancel registrations if nonconformances are bad enough or don't get fixed to their satisfaction. APIQR is far from perfect, but they don't seem to be as slack as many other CBs.
This is my first API Q1 audit. I was previously working with ISO 13485 medical devices, so I'm working on my transition between the systems.
 
#9
I agree with Jmech.
In fact, it's a very simple question. Whether you procure raw materials from approved suppliers on the Critical Qualified Suppliers List or from other non-approved suppliers, you are fully responsible for the quality of the raw materials and products, and therefore you must have strict control over the procurement of critical raw materials because they are a matter of product quality and even safety. And, in 5.6.1.1 Procedures, it is clearly stated that the organization should establish documented procedures to ensure that the procured products, components or activities meet the specified requirements. Therefore, strict procurement control should also be carried out for the procurement of non-approved critical suppliers.
 
Last edited:

jay747

Starting to get Involved
#10
I agree with Jmech.
In fact, it's a very simple question. Whether you procure raw materials from approved suppliers on the Critical Qualified Suppliers List or from other non-approved suppliers, you are fully responsible for the quality of the raw materials and products, and therefore you must have strict control over the procurement of critical raw materials because they are a matter of product quality and even safety. And, in 5.6.1.1 Procedures, it is clearly stated that the organization should establish documented procedures to ensure that the procured products, components or activities meet the specified requirements. Therefore, strict procurement control should also be carried out for the procurement of non-approved critical suppliers.
Well, I understand what you are trying to say. We have clearly determined our requirements for what we are purchasing and have a proper incoming inspection procedure to ensure that requirements are met. if they are not being met the products are rejected.

Therefore, strict procurement control should also be carried out for the procurement of non-approved critical suppliers.
My question is - Am I allowed to procure critical products from non-approved critical suppliers without being non-compliance with the requirement?
 
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