Design 2 Manufacture
Flats and Windows
Free-forms and Custom Designs
Thin Film Coatings
Manufacturers standard commercial quality management system
Seller shall maintain and, on request, make available to Buyer, adequate records of calibrations, measurements, tests, inspections, and other objective evidence necessary to assure the Buyer that the raw materials and/or electronic components used in the manufacture of items on this order and other supplies/services supplies meet the specification and quality requirements of this order.
Seller certifies that all parts and materials obtained to satisfy the requirements of this order shall be procured from original equipment manufacturers (OEM) distributors who are authorized franchised distributors for the manufactured items involved, or subcontractors to whom the requirements of this attachment are made applicable. Where the Seller is not an OEM distributor (surplus, obsolete parts, etc.), the Seller shall inform the Buyer and provide any information that will allow validation of the manufacturer and source of the procured part/assembly prior to shipment.
Seller shall maintain data required for A-1 above for a period of five (5) years or as specified in the purchase order. Upon completion of all deliveries, the data shall be made available for inspection by, or copies supplied to the Clear Align Buyer upon request.
Seller assures that the revision levels of the specifications as denoted on the purchase order are used in manufacture and inspection.
Seller shall provide for adequate final and pre-shipment inspection to assure product conformance including required certification, and adequate packaging that meets the requirement of the purchase order.
Tools, gauges and test equipment employed to meet the above requirements shall be calibrated at established intervals, acceptable to Buyer, against standards with calibration traceable to the National Institute of Standards & Technology (NIST).
ELECTROSTATIC CONTROL PLAN
Seller must take necessary precautions to ensure static sensitive items or repair services to static sensitive items are protected from electrostatic discharges. Additionally, the seller is required to have an ESD Control Program Plan available for review. It is recommended the ESD Control Program Plan follow the guidelines of MIL-HDBK-263, titled “ESD Control Handbook for Protection of Parts, Assemblies and Equipments”. ESD control manual is required when the supplier is providing static sensitive devices.
Buyer and authorized Customer Representative reserve the right to enter Seller’s plant(s) or those of Seller’s suppliers, at every tier, or such parts thereof as may be engaged in work relating to this order, at all reasonable times, for the purpose of surveillance inspection of Seller’s processes, controls, quality records, and systems as well as supplies/services procured under this order. This inspection of Seller’s processes and controls will not constitute acceptance of the supplies/services being procured.
When Seller’s quality personnel determine that supplies/services to be submitted for Buyer’s acceptance depart from the specified requirements of this order and that rework to specifications is not practical, the items in question shall be identified as discrepant and withheld pending Buyer’s disposition. Seller is required to submit detailed description of discrepancies to Buyer for disposition instructions.
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