Vendor Flow Downs

External Provider Flow Down Requirements (As Applicable):

a. The processes, products, and services to be provided including the identification of relevant technical data (e.g., specifications, drawings, process requirements, work instructions).
b. The approval of:

1. products and services.

2. methods, processes, and equipment.

3. the release of products and services.

c. Competence, including any required qualification of persons.
d. The external providers’ interactions with the organization.
e. Control and monitoring of the external providers’ performance to be applied by the organization.
f. Verification or validation activities that the organization, or its customer, intends to perform at the external providers’ premises.
g. Test, inspection, and verification (including production process verification).
h. The use of statistical techniques for product acceptance and related instructions for acceptance by the organization.
i. The need to:

1. Implement a quality management system.

2. Use customer-designated or approved external providers, including process sources (e.g., special processes).

3. Notify the organization of nonconforming processes, products, or services and obtain approval for their disposition.

4. Prevent the use of suspect unapproved, unapproved and counterfeit parts (see 8.1.4).

5. Notify the organization of changes to processes, products, or services, including changes of their external providers or location of manufacture, and obtain the organization’s approval.

6. Flow down to external providers applicable requirements including customer requirements.

7. Provide test specimens for design approval, inspection/verification, investigation, or auditing.

8. Retain documented information, including retention periods and disposition requirements.

j. the right of access by the organization, their customer, and regulatory authorities to the applicable areas of facilities and to applicable documented information, at any level of the supply chain.
k. ensuring that persons are aware of:

1. Their contribution to product or service conformity.

2. Their contribution to product safety.

3. The importance of ethical behavior.