Critical Supplier Initial evaluation for single purchases

[lanley liao]

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.


My question is - Am I allowed to procure critical products from non-approved critical suppliers without being non-compliance with the requirement?

I think you ask the question is really not the problem of the problem, although you purchase critical products from non-approved suppliers, but the auditor still need to be from the critical supplier requirements to audit your supplier, you can not give yourself that this situation does meet the requirements, the last is the need to come up with written evidence can prove that you are right; if you can not take a strong persuasive evidence, the non-conformity is established. In addition, from the point of view of enterprise management, no matter what form you take, first of all, whether the standard requirements are understand, whether the standard requirements and business processes are compatible, whether you can come up with strong and convincing written evidence to confirm that you do so to meet the standard and your management requirements, the ultimate decision to meet is the quality of your product.

 

[jmech]

My question is - Am I allowed to procure critical products from non-approved critical suppliers without being non-compliance with the requirement?

No.

 

[Sidney Vianna]

No.

In this day and age of dramatic supply chain disruptions, and if you think of business continuity and customer satisfaction, why wouldn't an organization be allowed to procure material from an "unqualified" source in an emergency situation? It is either that, or the total failure to supply customers with a product that will shut down their plants.

Most quality systems are designed for steady state conditions, but, from time to time, crap happens (like qualified suppliers being unable to fulfill orders) and there should be allowances for work arounds, PROVIDED risks are identified, managed and mitigated.

 

[jmech]

In this day and age of dramatic supply chain disruptions, and if you think of business continuity and customer satisfaction, why wouldn't an organization be allowed to procure material from an "unqualified" source in an emergency situation? It is either that, or the total failure to supply customers with a product that will shut down their plants.

Most quality systems are designed for steady state conditions, but, from time to time, crap happens (like qualified suppliers being unable to fulfill orders) and there should be allowances for work arounds, PROVIDED risks are identified, managed and mitigated.

There are some on the API Q1 committee who think that the critical supplier qualification process is vital for safety and quality. They don't want to allow work arounds to it because they are more concerned about a failure during operation than late product. The Deepwater Horizon / Macondo disaster is still very much on their minds.

Realistically, if an organization occasionally has to use not-yet-approved suppliers and they run it through a robust risk assessment and management of change procedure, APIQR probably won't get too upset with them (and might not even write a finding, depending on the auditor). However, the Q1 9th Edition supplier approval requirements are generally easy enough to meet so that you shouldn't need a workaround anyway.

 

[Sidney Vianna]

Thanks for the post. I find the two statements somewhat contradictory

There are some on the API Q1 committee who think that the critical supplier qualification process is vital for safety and quality. .......................................................................................... However, the Q1 9th Edition supplier approval requirements are generally easy enough to meet so that you shouldn't need a workaround anyway.

If a critical supplier qualification process is vital for safety and quality, it shouldn't be "easy". At the end of the day, supplier qualification process in itself is just a step to maximize the likelihood that the incoming product/service conforms to requirements. As long as the raw material (in this specific case) is verified to ensure conformity and adequacy to requirements, the intent of only allowing approved products to be processed, is being fulfilled.

 

[jmech]

Thanks for the post. I find the two statements somewhat contradictory
If a critical supplier qualification process is vital for safety and quality, it shouldn't be "easy". At the end of the day, supplier qualification process in itself is just a step to maximize the likelihood that the incoming product/service conforms to requirements. As long as the raw material (in this specific case) is verified to ensure conformity and adequacy to requirements, the intent of only allowing approved products to be processed, is being fulfilled.

I think you are correct. I think some on the API Q1 committee overestimate the value of supplier qualification (especially when it is done to the bare minimum API Q1 requirements).

 

[lanley liao]

I agree with Sindey and Jmech.
In fact, the management system standard has its limitations, and it is difficult to account for special circumstances beyond the management system's specified requirements.