The External Provider Shall:

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 * Notify CEC on nonconforming product and obtain CEC's approval for disposition.

    In addition, any changes in product and/or process definition, change of suppliers, change of manufacturing facility and location (where required).   

 

 * Flow down to the supply chain the applicable customer requirements. 

 

 * Record retention of 7 years, or as customer directed.

 

 * Allow right of access by CEC, and regulatory authorities to areas of aII facilities, at any level of the supply chain, if required.

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The organization shall ensure the adequacy of requirements prior to their communication to the external provider. The organization shall communicate to external providers its requirements for:

 

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;

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g. test, inspection, and verification;

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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);

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    - notify the organization of nonconforming processes, products, or services and obtain approval for their disposition;

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    - prevent the use of suspected unapproved, and counterfeit parts;

 

    - notify the organization of changes to processes, products, or services, including changes of their external providers or location of manufacture; 

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    - flow down to external providers applicable requirements including customer requirements;

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    - provide a certificate of conformity, test reports, or authorized release certificate, as applicable;

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    - retain documented information, including retention periods and disposition requirements;

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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;

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k. ensuring that persons are aware of:

 

    - their contribution to product or service conformity;

 

    - their contribution to product safety;

 

    - the importance of ethical behavior.

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