Supplier Evaluation - Is a supplier score card a requirement under ISO and QSR?

[snoopy2017]

Is a supplier score card a requirement under ISO and QSR? If so, does the supplier score card apply to critical suppliers only? When does a score card become necessary? How does this apply to suppliers from whom we make 1 or 2 transactions a year? Thanks.

 

[Russ]

ISO says we must evaluate but does not tell us how. We limit our evaluation to any supplier who provides service for "at least 5 lots per year" so this list is updated each year. Raw Material & incidental suppliers (nuts & bolts etc.) are not included.

 

[RoxaneB]

Is a supplier score card a requirement under ISO and QSR? If so, does the supplier score card apply to critical suppliers only? When does a score card become necessary? How does this apply to suppliers from whom we make 1 or 2 transactions a year? Thanks.

Unless a standard specifically says something to the effect of "The organization shall apply a scorecard methodology to the evaluation of suppliers", the approach your organization takes to demonstrating suitable, adequate control in supplier relationship is up to your organization.

Be careful, however, in determining a relationship between the "use of a scorecard" and the "number of transactions."

What if your organization buys critical components from that vendor, but only at a low frequency?

The evaluation of a supplier should be based on other criteria beyond the number of transactions, and might include (but is not limited to):

• Impact to final product
• Impact to process (to make product)
• Previous score
• Recent inspection results
• New vendor
• Location
• and so on...

 

[Sidney Vianna]

What if your organization buys critical components from that vendor, but only at a low frequency?

The evaluation of a supplier should be based on other criteria beyond the number of transactions, and might include (but is not limited to):

• Impact to final product
• Impact to process (to make product)
• Previous score
• Recent inspection results
• New vendor
• Location
• and so on...

Without using the dreaded R-word, you just laid down a risk-based supplier evaluation framework.

 

[Golfman25]

There is a difference between evaluation and monitoring. Monitoring suggests regularity and sufficient data points to monitor. 1 or 2 deliveries per year may not cut it. Evaluation would probably be done less often. As for the automotive guys, they will push for a scorecard approach as that is what they know. They have their "scorecard" criteria listed out. Not sure about medical. Good luck.

 

[Ronen E]

Is a supplier score card a requirement under ISO and QSR?

Where “ISO” means “ISO 13485” and “QSR” means “21 CFR 820”, the answer is categorically NO.

 

[locutus]

Agree that there is no requirement for a score card, but there are requirements for evaluation and monitoring. Evaluation to the 2016 version now should take a risk-based approach. Supplier performance is specified in the standard for monitoring your suppliers. Like most standards, statements of what the requirement is, but not how to do it. This is left up to each organisation based on the product and service, and (in the medical device field) risk of the device. Supplier score cards are just one method of supplier performance management. As you can imagine, whatever method you choose should be documented in the procedure and records maintained.

 

[Edward Reesor]

Another point that was brought up at our last audit was that the suppliers should be a line item on the Management Review along with a stated decision whether to keep them or move to another supplier (ensuring that any evaluation has been discussed by upper management).