CAQN XD

General supplier quality requirements

1. GENERAL QUALITY REQUIREMENTS
   1.1 ORDER OF PRECEDENCE
   1.1.1 The requirements listed below are the minimum quality requirements.
   1.1.2 Additional and or conflicting requirements added through the application of another Quality Note (QNote), or described in an attached Statement of Work, will take precedence over these minimum requirements.
   1.1.3 Contact your buyer in writing if clarification is required.
   
   1.2 QUALITY MANAGMENT SYSTEM REQUIREMENTS
   1.2.1 Supplier shall implement and maintain a quality management system which complies with the applicable quality systems standard identified, by application of a QNote, on the Purchase Order. In the absence of a Quality Management System QNote the supplier shall implement and maintain a quality management system which complies with section 2 of this document “Basic Quality Management System”.
   1.2.2 Initial and subsequent periodic review of supplier’s quality system may be performed at the option of Clear Align. Objective evidence of supplier’s compliance, either by submittal of objective evidence, or evidence of a third party accreditation, may be acceptable, but will not preclude the use of on site evaluations or other review methods.
   1.2.3 Clear Align at its discretion may honor qualified second or third party audits, provided that the scope of the audit performed by the second or third party correlates with the type of product service being provided to Clear Align.
   
   1.3 QUALITY FLOWDOWN TO SUB-TIER SUPPLIERS
   1.3.1 The supplier's Quality System shall assure all relevant Purchase Order Requirements are flowed - down to their sub-tier suppliers. Suppliers will flow down all applicable requirements of the Purchase Order to their suppliers to insure conformance with all Specifications, Drawings, AS9100 or other Quality systems requirements, Regulations, Public Laws and other requirements as may be specified in the Purchase Order. The supplier's sub tier suppliers are responsible to comply with the same specifications and requirements specified on this Purchase Order.
   
   1.4 MATERIAL REVIEW AUTHORITY
   1.4.1 Material Review authority is not in effect unless specifically granted by QNote or through other Clear Align Quality Instructions. The supplier’s disposition authority is limited to rework to specification, return to supplier and scrap.
   
   1.5 CLEAR ALIGN SOURCE INSPECTION
   1.5.1 Deliverable products subject to Clear Align source inspection: Supplier shall notify Clear Align Purchasing Agent or Clear Align Field Representatives one week in advance of need to schedule “In-process” or “Final” source inspection. If contact cannot be made, call your buyer.
   
   1.6 CLEAR ALIGN FIRST ARTICLE INSPECTION
   1.6.1 CLEAR ALIGN VERIFICATION. Clear Align participation in completing or verification of a completed FAI may be required prior to shipment from the seller’s plant.
   1.6.2 The seller shall notify the Clear Align Buyer and/or Source Surveillance Control Point of their readiness to perform First Article Inspection/ Test (FAI/T) at least five (5) working days in advance of the required activity.
   1.6.3 CHANGE NOTIFICATION. The Seller is required to notify the Buyer of any change listed below that may require a complete, or partial, FAI/T to be conducted on the first production item manufactured after such change. The following definitions will be used by the Buyer to evaluate the type and significance of the change. Change in Design/Material. A design or raw material change that affects fit, form or function of the item. Change to Facility/Processing Equipment. A facility change is a change in, or to, tools, test equipment, measuring or aligning fixtures, processing tanks, or equipment, machinery, machine set-ups, other plant manufacturing equipment, etc., used to manufacture, process, assemble, inspect, and/or test the items. Change to Procedures. A change in or to the numerical control program or translation to another media, methods, procedures, planning and/or sequencing used in or applicable to the manufacturing, processing, assembly, inspection and/or test of an item.
   Change in Location. A change in the location of the site where some or all of the manufacturing is performed. This may include moving an assembly line, major change in facility procedures, significant personnel and/or processing changes.
   Change in Source or Processing. Such changes may be from an outside processing source to within the Seller’s facility, from within the Seller to an outside processing source, or from one outside processing source to another.
   Change in Production. When a lapse in production for two years or as specified by the customer has occurred.
   
   1.7 SHIPMENT OF NONCONFORMING MATERIAL
   1.7.1 Nonconforming material will not be accepted by Clear Align unless approved in advance in writing by the Buyer. Requests for authorization to ship nonconforming material will be addressed in writing to the appropriate Clear Align Buyer with full explanation of the nonconformance.
   
   1.8 SUPPLIER CORRECTIVE ACTION REQUEST (SCAR)
   1.8.1 The supplier shall respond to all requests for corrective action on or before the requested response due date. Supplier shall maintain a documented system for determining root causes of documented defects and obtaining corrective action both internally and from its suppliers. The supplier is responsible for effective corrective, preventive and containment action.
   1.8.2 Clear Align may grant the supplier an extension for their corrective action response on a case by case basis. Suppliers may formally request a time extensions at least forty-eight (48) hours in advance of the assigned corrective action response due date. Requests must be submitted in writing with adequate justification including a milestone plan documenting the actions, implementation dates and personnel responsible for root cause and corrective action implementation. Failure to respond to a corrective action request or allowing the response to become delinquent will negatively impact Supplier Rating System
   
   1.9 NOTIFICATION / DISCLOSURES
   1.9.1 The supplier system shall provide for timely reporting of nonconformities that may affect already delivered product. Notification to the buyer shall include a clear description of the discrepancy, which includes as necessary: parts affected, customer and/or supplier part numbers, quantities, and date(s) delivered.
   
   1.10 QUALITY RECORD RETENTION
   1.10.1 Supplier's Process Control and Quality Records shall be retained at the Supplier’s location a minimum of five years, or as specified in the Purchase Order. The records shall be adequate to ascertain the quality level of production processes. This includes chemical and physical test results of Raw Material used in the manufacture of the item on this Purchase Order. Quality records shall be provided to Clear Align upon request.
   
   1.11 FOREIGN OBJECT ELIMINATION
   1.11.1 The Seller shall establish and maintain an effective Foreign Object Damage (FOD) Prevention Program to reduce FOD using NAS412 as a guideline.
   1.11.2 The seller’s program shall utilize effective FOD prevention practices. The program shall be proportional to the sensitivity of the design of the products(s) to FOD, as well as, to the FOD generating potential of the manufacturing methods.
   1.11.3 The written procedures or policies developed by the seller shall be subject to review and audit by the Buyer and /or government representative, and shall be disapproved when the Seller’s procedures or polices do not accomplish their objectives.
   
   1.12 . SUPPLIER RATING SYSTEM
   1.12.1 Clear Align uses the Supplier Rating System to measure both on time delivery and quality performance and response to request for corrective action. The web based system grants supplier’s access to a Supplier Performance Relationship Reports. Reports should be periodically reviewed and when necessary corrective actions implemented. Please contact your Clear Align Buyer should you have any question regarding the reports.
2. BASIC QUALITY MANAGEMENT SYSTEM , Supplier’s Inspection System Requirements
   2.1 Scope
   2.1.1 Scope. This specification establishes requirements for suppliers' and their sub-contractors inspection systems. These requirements pertain to the inspections and tests necessary to substantiate product conformance to drawings, specifications and contract requirements and to all inspections and tests required by the purchase order. These requirements are in addition to those inspections and tests set forth in applicable specifications and other contractual documents.
   
   2.2 Applicability
   2.2.1 In the absence of higher level requirements applied by QNote on the PO, the following default inspection system specification shall be imposed. This specification shall apply to all suppliers, their sub-contactors or service providers when referenced in the item specification or purchase order.
   
   2.3 Relation to Other Purchase Order.
   2.3.1 The inspection system requirements set forth in this specification shall be satisfied in addition to all detail requirements contained in the statement of work or in other parts of the contract. The Supplier is responsible for compliance with all provisions of the contract and for furnishing specified articles which meet all requirements of the contract. To the extent of any inconsistency between the contract schedule or its general provisions and this specification the contract schedule and the general provisions shall control.
   
   2.4 Right of Access
   2.4.1 The Supplier shall provide Clear Align, our customers, and regulatory authority access to all facilities involved in the order and to all applicable records.
   
   2.5 Supplier Responsibilities.
   2.5.1 The Supplier shall provide and maintain an inspection system which will assure that all supplies and services submitted to Clear Align for acceptance conform to purchase order requirements whether manufactured, processed or procured from subcontractors or vendors.
   2.5.2 It is the Suppliers responsibility to notify the Clear Align Buyer about any conditions of nonconformity and to secure written authorization from the buyer to proceed with shipment /presentation of the nonconforming supplies/services to Clear Align.
   2.5.3 The Supplier's inspection system shall be documented.
   
   2.6 Supplier Procurement Documents.
   2.6.1 Supplier's procurement documents shall describe technical, inspection, and other requirements necessary to assure the Supplier's procured items conform to Clear Align technical and purchase order requirements.
   
   2.7 Receiving Inspection.
   2.7.1 Purchased supplies shall be subjected to inspection after receipt, as necessary, to assure conformance to purchase order requirements
   
   2.8 Inspection and Testing Documentation.
   2.8.1 Inspection and testing shall be prescribed by clear, complete and current instructions. The instructions shall assure inspection and test of materials, work in process and completed articles, as required, by the item specification and the purchase order. In addition, criteria for approval and rejection of product shall be included.
   
   2.9 Records.
   2.9.1 The contractor shall maintain adequate records of all inspections and tests. The records shall indicate the nature and number of observations made the number and type of deficiencies found, the quantities approved and rejected and the nature of corrective action taken, as appropriate. All applicable records shall be available for review by Clear Align.
   
   2.10 Clear Align Furnished Material
   2.10.1 When material is furnished by Clear Align, the supplier's procedures shall include, as a minimum:
   1. Examination upon receipt, consistent with practicality, to detect damage in transit
   2. Inspection for completeness and proper type
   3. Periodic inspection and precautions to assure adequate storage conditions and to safeguard against damage 4. Functional testing either prior to or after installation, or both, as required by the purchase order; to determine satisfactory operation
   5. Identification and protection from improper use or disposition
   6. Verification of quantity
   
   2.11 Nonconforming Material.
   2.11.1 The Supplier shall establish and maintain an effective and positive system for controlling nonconforming material, including procedures for the identification, segregation, presentation and disposition of reworked or repaired supplies.
   
   2.12 Corrective Action.

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