API Q1 5.6.1.2 - Initial Supplier Evaluation

[Aussie99]

Hi,
API Q1 5.6.1.2 states:

"For purchase of critical products, components or activities, the criteria for the initial evaluation of suppliers by the organisation shall be site specific for each supplier and shall include the following:

(a) Verification that the supplier's quality management system conforms to the quality system requirements specified for suppliers by the organisation"

Can someone give me a couple of examples of what sort of quality system requirements we should be be specifying, or is it the norm to just say they must hold ISO 9001 or API Q1 for example.

A recent audit raised shortcomings in this area for us and I'm trying to find a realistic solution. Our auditor says it's not enough to just witness a certificate to show compliance with a quality management system spec............we actually have to verify their system. Does this mean an on site audit, or would a questionnaire suffice. (confident in the knowledge that the janitor could tick and flick any questionnaire).

We are a small company in a remote location, 3000kms plus from our critical suppliers, (and potential future suppliers). Our critical purchases are very minimal. Suppliers are certainly not going to bend over backwards to assist us when the value of our business to them is so small.

Any thoughts?

 

[lokeky1]

Re: Initial Supplier Evaluation

Hi Ausie99

When site audit is not cost effective, I use a combination of questionaire, relevant certificates for quality systems and product, email, website search and phone interview. I also provide history of supply and product quality.

I get as much information as I can about the Company, Quality System and the product until I am convinced and satisfied. Finally I write a report to say the reason I approve the supplier. I will also mentioned that this was a desktop audit.

Another way to justify the type of audits (site or desktop) is using risk assessment.


Hope this helps.

Loke

 

[Aussie99]

Re: Initial Supplier Evaluation

Thanks Lokeky,
I like your approach. We do have questionnaires we have sent out in the past, so I will brush them up a bit and utilise some of your other suggestions. Hopefully API will see it as being acceptable.

The suppliers we currently use for critical products are firmly entrenched and been in the system for many years, and as I stated previously, we are talking very minimal items. So it's not a process I'm likely to go through in the near future. Nonetheless, the process and associated documents need to be in place to satisfy the requirements of Q1.

Thanks for you help here.

Aussie

 

[bluepagen]

Re: Initial Supplier Evaluation

Hi Aussie99, we use questionnaires also, but require at a minimum that critical suppliers have a quality manual and a method in place to take actions whe NCR's or Trends are identified, and, an onsite assessment to ensure iit capability to meet purchasing requirements, or first article inspection to ensure confromance to stated requirments, or identifying how the supplied product conforms to stated requirements.

Hope this helps.

 

[Aussie99]

Re: Initial Supplier Evaluation

Hi Aussie99, we use questionnaires also, but require at a minimum that critical suppliers have a quality manual and a method in place to take actions whe NCR's or Trends are identified, and, an onsite assessment to ensure iit capability to meet purchasing requirements, or first article inspection to ensure confromance to stated requirments, or identifying how the supplied product conforms to stated requirements.

Hope this helps.

Thanks Bluepagen....................onsite assessments for us are out of the picture due to our location.

First article inspection is the major form of evaluation and re-evaluation for us. Big change in Q1 9th edition relative to suppliers of critical purchases is clause 5.6.1.2 where initial supplier evaluation must include both items (a) AND (b), as opposed to re-evaluation, (clause 5.6.1.3), where the "AND" is replaced by "OR" .
This is where I fell down................

 

[radica]

Please, what is meant by the "initial evaluation"? Does the initial evaluation is performed only at the beginning of cooperation with the supplier or refers to a periodic evaluation for example. once per a year? And if so what is the difference between the periodic evaluation and re-evaluation?

 

[Aussie99]

Please, what is meant by the "initial evaluation"? Does the initial evaluation is performed only at the beginning of cooperation with the supplier or refers to a periodic evaluation for example. once per a year? And if so what is the difference between the periodic evaluation and re-evaluation?

Hi Radica...........it is exactly as you describe.............initial evaluation is performed prior to the "beginning of cooperation" with a supplier. Periodic evaluations would be referred to as re-evaluations. Note that for "critical purchases" your initial valuation of a supplier contains an extra requirement (item (a) of clause 5.6.1.2) when compared to non-critical purchases, (clause 5.6.1.3).

 

[Suz10]

Hi All,
I have difficulties on b) item iii - identifying how the supplied product conforms to stated requirements when limited by proprietary, legal and/or contractual agreement. - how do we actually practice this?
Thanks in advance....

 

[samcanQA]

BUMP
Can anyone clarify 5.6.1.2, b) item iii)

 

[FaheemAhmadAnsari]

We got non-conformance during our API Re-audit kindly help to provide some supporting.NC- Procedure is not adequate to define the criteria for re- evaluation of non critical suppliers.