External Provider Flow Down Requirements

DOWNLOAD PDF

 

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:

• Implement a quality management system;
• Use customer-designated or approved external providers, including process sources (e.g., special
  processes);
• Notify the organization of nonconforming processes, products, or services and obtain approval for their
  disposition;
• Prevent the use of suspect unapproved, unapproved and counterfeit parts (see 8.1.4);
• 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;
• Flow down to external providers applicable requirements including customer requirements;
• Provide test specimens for design approval, inspection/verification, investigation, or auditing;
• 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:

• Their contribution to product or service conformity;
• Their contribution to product safety;
• The importance of ethical behavior.