THE ORGANIZATION SHALL:
a) Maintain a register of its suppliers that includes approval status (e.g., approved, conditional, disapproved) and the scope of the approval (e.g., product type, process family);
b) Periodically review suppler performance; the results of these review shall be used as a basis for establishing the level of controls to be implemented;
c) Define the necessary actions to take when dealing with suppliers that do not meet requirements;
d) Ensure where required that both the organization and all suppliers use customer approved special process sources;
1. The seller shall ensure that only new and authentic materials are used in products delivered to HILTRONICS. The Seller may only purchase parts directly from Original Component Manufacturers (OCMs), OCM franchised distributors, or authorized aftermarket manufacturers. Use of product that was not provided by these sources is not authorized unless first approved in writing by HILTRONICS. The seller must present compelling support for its request (e.g., OCM documentation that authenticates traceability of the parts to the OCM), and include in its request all actions to ensure the parts thus procured are authentic/conforming parts IAW AS5553.
e) prevent the use of counterfeit products (see 8.1.4)
f) Define the process, responsibility, and authority for the approval status decision, changes of the approval status and conditions for a controlled use of suppliers depending on the supplier’s approval status, and;
g) Determine and manage the risk when selecting and using suppliers (see 7.1.2)
h) the external providers' interactions with Hiltronics
7.4.2 PURCHASING INFORMATION
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 specifications, drawings, process requirements, instructions and other relevant technical data;
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) design and development control;
h) critical items, including key characteristics;
i) test, inspection and verification (including production process verification);
j) the use of statistical techniques for product acceptance and related instructions for acceptance by the organization;
k) 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 counterfeit products (see 8.1.4);
notify the organization of changes to processes, products or services, including changes of external providers or location of manufacture, and obtain their approval;
flow down to their external providers applicable requirements including customer requirements;
provide test specimens (e.g., production method, number, storage conditions) for design approval, inspection/verification, investigation or auditing;
retain documented information, including retention periods and disposition requirements (minimum 7 years)
l) the right of access by the organization, their customer and regulatory authorities to the applicable areas of facilities and to applicable documented information;
m) ensuring persons are aware of their contribution to compliance and product safety and of the importance of ethical behavior.
n) Quality management system requirements, at a minimum, compliant with ISO9001 or an equivalent quality management system standard
o) in the event any parts are purchased from non-authorized distributors, traceability to the original component manufacturer (OCM) must be provided.
CERTIFICATE OF CONFORMANCE
The seller shall approve, retain, and provide copies of Electrical, Electronic, and Electromechanical (EEE) part Manufacture Certificates of Conformance (CoC). Manufactures CoCs shall, at minimum, include the following:
a. Manufacture name and address
b. Manufacturer and/or buyer’s part number and dash number
c. Batch identification for the item(s) such as date codes, lot codes, serializations, or other batch identifications
d. Signature or stamp with title of seller’s authorized personnel signing the certificate.
NOTE: Distributors shall, in addition to the above, include their name for each part shipped.