QUESTION / EVIDENCE / FOLLOW-UP
REQUIRED? / CAR #, IF
APPLICABLE
Control of externally provided products and services—Clause 8.4 (this checklist is to be used in conjunction with the “All Processes” checklist)
1. Describe the purchasing process. How are suppliers of quality-related goods and services evaluated and approved? (Note: ‘Suppliers’ here can mean a provider of goods and services used by the organization, a provider of goods and services provided by the organization directly to the customer, or a contractor performing a process or a part of a process.)
2. Are evaluation and selection criteria for new suppliers and contractors clearly defined? May I see them please? (Pull X current supplier records and verify that they provide evidence of conformance to requirements. If any suppliers have been approved in the past year, review their records to verify that they met requirements.)
3. How are suppliers and contractors re-evaluated? (Review records to verify conformance to specified requirements. Where records show evidence of poor performance, follow through to ensure that corrective action has been initiated.)
4. How is supplier and contractor performance monitored? Who is responsible for gathering and analyzing this information? What actions are taken based on these data? How is performance information communicated to the supplier? (Review records and verify conformance.)
5. (Review X purchase orders—or the organization’s purchasing documents—and verify the following:)
a. Were they issued to suppliers and/or contractors that have met the selection and evaluation criteria?
b. Were the products or services being ordered clearly defined in purchasing documents along with, as applicable, required delivery dates, any required quality system standards, applicable approval requirements, personnel qualifications, and any verification or validation activities that the organization or its customer plans to perform at the supplier’s facilities?
6. How does the organization define the level of supplier/contractor control? May I see it? (Verify that the decision considers the potential impact of the process, product, or service provided as well as the effectiveness of controls provided by the supplier.)
7. (Using samples reviewed in Question 5, verify that defined controls were implemented. These controls may be those applied to the supplier or those applied to the process, product, or service provided.
Control of Externally Provided Products and Services