What questions to ask in annual supplier evaluation?

[snoopy2017]

In an annual evaluation of critical suppliers, what type of questions can we ask?They provide critical parts for the devices we build.
So far, the procedure in our company is a questionnaire. But the questions are very high level like "has the supplier's performance been satisfactory?". What kind of questions can we ask in the annual monitoring of that supplier?

When is it necessary to perform a supplier audit? Does 13485:2016 require that we audit all of our critical suppliers?

Thank you.

 

[EthanLoh]

Hi snoopy2017,

Normally, for supplier audit it is a coffee drinking session if there is no issue with the product. Everybody is happy.

If there are issues or the audit is a CAPA response for a delivery failure, I would dig up all their production and QA records. Check process validation, training, environment, etc.... Just make their life difficult.

In a nutshell, depend on the performance of the supplier.

 

[Golfman25]

First I would prefer an onsite meeting. It's good to meet face to face every so often.

Second I would focus on anything relevant to there ability to continue to supply you. Machine maintenance and redundancy. Their supply base. Risk and Contingency, stuff like that.

Third, obviously address any part specific issues.

 

[AndyN]

Hi snoopy2017,

Normally, for supplier audit it is a coffee drinking session if there is no issue with the product. Everybody is happy.

Not if you are professional and know what you are doing!

Supplier evaluation isn't synonymous with auditing. You can do a supplier evaluation based on their performance: Delivery, quality and cost.