The Purchasing Agent, or designees (typically the Inspection department), control the purchasing process to ensure purchased product or services conform to the customer requirements. The type and extent of the control exercised over the supplier shall be based on the effect of the subsequent product or service and their output and, where applicable, on the quality audit reports and/or quality records of previously demonstrated capability and performance of suppliers.
The Purchaser controls the purchasing process of Outside Processing to ensure purchased processes conform to customer requirements.
Xact Tech Inc. dba Comstock Industries (Xact Tech) evaluates and selects suppliers based on their ability to supply product/ service in accordance with the organization’s requirements. Criteria for selection, evaluation and re-evaluation are established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained in the company’s information systems.
The Purchaser or his/her designee:
- maintains 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),
- periodically reviews supplier performance; the results of these reviews shall be used as basis for establishing the level of controls to be implemented,
- defines the necessary actions to take when dealing with suppliers that do not meet requirements,
- ensures, where required, that both the organization and all suppliers use customer approved special process sources, with concurrence of Director of QMS
- defines the process, responsibilities and authority for the approval status decision, changes of the approval status and conditions for a controlled use of suppliers depending on their approval status, and;
- determine and manage the risk when selecting and using suppliers.
The acceptance of a Purchase Order from Xact Tech shall include the following provisions from the accepting party providing the provisions are appropriate for the goods or services provided:
- the processes, products or services to be provided including the identification of relevant technical data (e.g., specifications, drawings, process requirements, work instructions);
- requirements for approval or qualification of:
- product/services
- methods, processes and equipment
- the release of products and services
- proof of competence, including any required qualifications of persons;
- the external providers’ interactions with the organization upon request;
- exceed minimum threshold or supplier quality rating as defined by the purchaser;
- verification or validation of all activities related to the Xact Tech order
- acknowledgement of special requirements, critical items, or key characteristics;
- provide results of test, inspection, and verification (including production process verification);
- the use of statistical techniques for product acceptance and related instructions for acceptance by Xact Tech;
- Suppliers shall:
- maintain a recognized quality management system;
- use Xact Tech-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 parts (see 8.1.4 of the AS9100 standard);
- 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 all Xact Tech requirements;
- provide test specimens for approval by the Xact Tech upon request, inspection/verification, investigation, or auditing results;
- retain documented information, including retention periods and disposition requirements to be surrendered upon request;
- the right of access by Xact Tech and regulatory authorities to the applicable areas of facilities and to applicable documented information, at any level of the suppliers organization;
- ensuring that the suppliers employees are aware of:
- Their contribution to product or service conformity;
- Their contribution to product safety;
- The importance of ethical behavior.
The supplier shall ensure the adequacy of specified purchase requirements prior to their acceptance of orders from Xact Tech.