Differences between High, Medium, Low Risk Suppliers

M

MEDQA

#1
#1
Hello -

In Reference to ISO 9001.

I'm looking for suggestions on supplier management / controls that are dependent upon the risk associated with what they supplier or other factors i.e. sole supplier.

This is what I have in mind so far.

  • Inspections - (Increased, Reduce inspections, Accept on Cert /no inspection)
  • Reporting - Monthly, Quarterly, Annual
  • Review -Quarterly, Annual, Bi-Annual
  • On Site Audits
Right now, there is no difference in our controls for High Risk vs Medium Risk Suppliers....

thanks
 
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#2
#2
MEDQA said:
Hello -

In Reference to ISO 9001.

I'm looking for suggestions on supplier management / controls that are dependent upon the risk associated with what they supplier or other factors i.e. sole supplier.

This is what I have in mind so far.

  • Inspections - (Increased, Reduce inspections, Accept on Cert /no inspection)
  • Reporting - Monthly, Quarterly, Annual
  • Review -Quarterly, Annual, Bi-Annual
  • On Site Audits
Right now, there is no difference in our controls for High Risk vs Medium Risk Suppliers....

thanks
Click to expand...
How do you quantify the risk?
 
D

db

#3
#3
MEDQA said:
Hello -

In Reference to ISO 9001.

I'm looking for suggestions on supplier management / controls that are dependent upon the risk associated with what they supplier or other factors i.e. sole supplier.

This is what I have in mind so far.

  • Inspections - (Increased, Reduce inspections, Accept on Cert /no inspection)
  • Reporting - Monthly, Quarterly, Annual
  • Review -Quarterly, Annual, Bi-Annual
  • On Site Audits
Right now, there is no difference in our controls for High Risk vs Medium Risk Suppliers....

thanks
Click to expand...
In reference to ISO 9001, there is no requirement to determine risks of suppliers. You do have to evaluate and select suppliers based on their ability to supply product in accordance to your requirements, and risk could be part of that, but it doesn't have to be.

I think looking at risks (including timing and financial) is important, and you need to determine what those requirements would be, but there is no ISO 9001 mandate.
 
D

db

#4
#4
If I may add...

ISO 9001 does say that the amount of control over the product or supplier will be dependent on the impact of the purchased product. So, again, looking at risks is not a bad idea.

I am attaching a sample procedure that might show one way to look at risks from that standpoint.
 

Attachments

M

MEDQA

#5
#5
Supplier Grades (high / medium / low) are based on a point system.
0-20 (low), 21-60 (medium), 61-100 (high)

Answers
High = 25 points
Med = 15 points
Low = 5 points

1. Impact on Quality Management System (QMS) / business, product safety or company performance should supplier fail to deliver as required.

  • High - Significant
  • Med - Potential
  • Low - Minimal
2. availability

  • High - Single source provider of a critical component.

  • Medium - One of only a few vendors who offers the components / service.
  • Low - One vendor of several who offers the components / service on short lead times.
3.Custom vs stock

  • High - Customized or one of a kind component
  • Med - Customized part from a standard array of products
  • Low - Vendor of stock items
4. History

  • High - 0-10 consecutive acceptable lots
  • Med - 11-20 consecutive acceptable lots
  • low - 21+ consecutive acceptable lots
 
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