Supplier Classifications - Please give me a good definition of the following terms

Hi everyone,

Can somebody give me a good definition of the following terms?

1- Critical Supplier
2- Moderately-Critical Supplier
3- Non-critical supplier

My group is trying to decide whether we should cut out the second category and define suppliers as either Critical or Non-Critical.

I look forward to your responses.


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Re: Supplier Classifications - Please give me a good definition of the following term

Each company should develop their own supplier classification and definitions.
Using only two levels, critical and non-critical is too simplistic, in my opinion, and results in very inflexible system. I typically recommend to have 4 categories/levels based on risk (critical, major, minor, trivial) and apply various controls to each supplier category, with increasing scrutiny for higher risk suppliers.

As far as I know, only Health Canada provides a definition of their meaning of a critical supplier.

From GD211 Guidance on the Content of Quality Management System audit reports:
"Supplier, Critical

A supplier delivering materials, components, or services, that may influence the safety and performance of the product.

Note: In the context of the audit of medical device manufacturers, a critical supplier is a supplier of a product or service, the failure of which to meet specified requirements could cause unreasonable risk to the patient, clinician or others, or could cause a significant degradation in performance. This can include suppliers of services which are needed for compliance with QMS or regulatory requirements. (SG4N84:2010).

In addition to the definitions above, the definitions found in the following documents applies:

ISO 9000:2005 Quality management systems - Fundamentals and vocabulary
ISO/IEC 17000:2004 - Conformity assessment - Vocabulary and general principles

Similar discussion of significant suppliers (in particular on page 12) is provided in GD210: ISO 13485:2003 Quality Management System Audits Performed by Health Canada Recognized Registrars.

Edward Reesor

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Re: Supplier Classifications - Please give me a good definition of the following term

Another way of looking at it would be to weigh the value of the supplier against your risk assessment and if there is a reasonable mitigation strategy if things go sideways. Those who have a serious impact on your final product without any quick substitutes would (IMHO) critical whereas if Staples ran out of paper I could go to Walmart (i.e. not so much critical)...and everything in between.
Labeling a supplier critical or not is just a tag. How you plan on dealing with issues arising from them is the real work.

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