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Slide 82 of 262


7.4 Purchasing
7.4.1 Purchasing Process

This section is included to ensure that all purchased products, materials and services conform to purchaser requirements as well as any regulatory requirements. In effect, this section focuses on minimizing incoming non-conformances by the effective selection of suppliers, specifications / requirements and evaluation of performance.

Specifically, requirement 7.4.1 states that your company must control its purchasing processes to ensure purchased product conforms to the company’s requirements. The type and extent of the control over the subcontractor / supplier is dependent upon the type of the product or service and the impact of the sub-contracted product or service on the quality of the final product or service. Your company must also evaluate and select suppliers based on their ability to meet your requirements needs. And, as is most often the case, the results of the evaluations and follow-up actions must be recorded.

One suggestion for assessing suppliers is:

Supplier approval:

Suppliers are approved by one or more of the following methods:
Supplier Assessment Survey
On-site Audit / Review
Satisfactory History
Customer Specified
Specified by manufacturer (distributorships)

For supplier performance:

There may be suppliers that are sole source for supplies or services which have been below standard supplier rating. After all avenues of corrective action are exhausted we may revert to 100% inspection and corrective action measure may be suspended.

Potential Audit Questions

1) What approach does your company take to ensure that your supplied product conforms to your requirements?

2) What process is used to evaluate and select suppliers. Is this process used for All suppliers, and if not what criteria is used to identify applicable suppliers?

3) Are the results and follow-up actions of these evaluations documented and recorded? What is done when a key supplier does not meet your evaluation criteria (what are the follow-up actions?


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