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

S

snoopy2017

#1
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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mihzago

Trusted Information Resource
#3
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

Trusted Information Resource
#5
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.
 

Wolf.K

Quite Involved in Discussions
#6
Re: Supplier Classifications - Please give me a good definition of the following term

We have/had a similar discussion:

ISO 13485:2016 Clause 7.4.2 regarding Supplier Quality Agreements

As I have stated above (link), we have different categories for our suppliers. Some we deem critical, others not. Depends on your decision, and how much work do you want to have (e.g. requirement of on-site audits of supplier).
 
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