Clear Align Quality Note First Article
1. Clear Align First Article Inspection (FAI) Process
A First Article Inspection conforming to the requirements of AS9102 is required for items manufactured, assembled and tested to Clear Align controlled drawings and specifications unless otherwise specified in documentation attached to this Purchase Order. Common commercial (e.g. parts from distributors or catalogs) MIL-spec / DESC parts are exempt from this requirement.
A supplier that is unable to comply with the FAI requirements identified herein shall submit an alternative FAI plan to the Clear Align Buyer and obtain approval prior to beginning manufacture.
Note: If AS 9102 forms are not used, the fields of information from the AS 9102 forms must be in alignment (numbering) with the alternate form.
Note: As specified in AS9102 paragraph 5.3, items out of manufacture for a period of 2 years or as specified by Clear Align, based on the supplier’s records, shall receive a new FAI. Note: A Clear Align generated administrative drawing change (e.g. grammatical correction, typographical correction) that do not affect form, fit or function does not require a delta (“partial”) or Full FAI.
2. Standard approaches for Seller FAI are:
2.1 In the event Source Surveillance is not required by the contract, the seller notifies the Buyer that an FAI has been completed and provides a copy of the FAI package for Clear Align approval. The FAI or delta FAI package must be compliant to AS 9102 requirements. The Seller will be notified upon rejection of FAI. Seller has the right to request copy of FAI approval status (an approval copy (form 1) of the FAI) from the Buyer.
2.2 In the event that Source Surveillance is required or Clear Align participates, the Seller performs the complete FAI and subsequent delta FAIs. The Clear Align supplier quality representative may witness any FAI activity performed. Upon completion, Clear Align Source surveillance or supplier Quality representative verifies the completeness of FAI and delta FAI packages (measurements, test data, process documentation, material certifications, etc.) at the Seller's site and signs/stamps off accepted FAI and delta FAI packages in the Customer Approval field of the AS9102 Form 1. Seller ships a complete copy of the accepted FAI and delta FAI packages with the first shipment following package acceptance
Note: Subsequent shipments do not require submission of an FAI package unless a delta FAI or an additional full FAI is required per AS-9102 or customer request. Supplier will maintain a record of FAI completion status to support any future customer visit.
3. Requirements for FAI
3.1 INSPECTION AND TEST.
Seller shall conduct a complete First Article Inspection on one part chosen from the first deliverable lot of the initial purchase order. The part shall be a representative sample of the Seller’s manufacturing process. For parts that are the product of a die or mold, the First Article Inspection shall be performed on one piece per cavity. The First Article does not need to be performed multiple times, unless the Seller meets one or more of the change notification criterion identified in AS9102 paragraphs 5.3 – 5.3.4.
3.1.1 MINIMALLY DIMENSIONED DRAWINGS. When a Clear Align drawing has certain requirements defined in a model file, instead upon the face of the drawing, the resulting FAI must also address the compliance of the model file dimensions, as required by AS9102 paragraph 5.5.2
3.2 PRODUCTION RUN: Seller shall not commence production of units beyond the first production lot unless authorized by the Clear Align Buyer or designee. Hardware produced beyond the first production lot without the Clear Align Buyer’s approval shall be at the sole risk of the Seller.
3.3 NONCONFORMANCE HANDLING: The FAI is not complete until the Seller closes all non-conformances affecting the part/report.
3.4 OTHER OBLIGATIONS. Neither acceptance of first product, nor preproduction sample, nor Clear Align Buyer’s authorization to proceed with the manufacturing shall constitute acceptance on any subsequent items or a modification or limitation of any representation, warranty, or of any obligation of the Seller to perform strictly in accordance with the provisions of this purchase order. Clear Align Supplier Quality may at any time specifically request a new First Article Inspection because of quality concerns. If requested, formal direction shall be given through the Clear Align Buyer.