Supplier’s inspection system requirements
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, contract requirements, inspections and tests required by the purchase order. These requirements are in addition to inspections and tests set forth in applicable specifications and other contractual documents. (ie- Statements of Work, Drawings, Buyer/Seller approved Test Procedures)
1.2.1 Applicability. This specification shall apply to all suppliers, their sub-contactors or services when referenced in the item specification or purchase order.
1.2.2 Relation to Other Purchase Order. 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 artifacts, which meet all requirements of the contract. Any inconsistency(s) between the contract schedule or its general provisions and this specification, the contract schedule and the general provisions shall control.
2 2.0 APPLICABLE DOCUMENT
2.1 The following documents of the issue in effect on date of invitations for bids form a part of this specification to the extent specified herein.
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION INTERNATIONAL STANDARD, ISO 10012:2003 Measurement Management Systems - Requirements for Measurement Processes and Measuring Equipment
2.2 Amendments and Revisions. Whenever this specification is amended or revised subsequent to its contractually effective date, the Supplier may follow or authorize sub-contractors to follow the amended or revised document provided no increase in price or fee is required. The sub-contractor shall not be required to follow the amended or revised document except as a change in contract. If the sub-contractor elects to follow the amended or revised document, the Clear Align Buyer shall be notified in writing of this election. When the Supplier elects to follow the provisions of an amendment or revision, all amendments or revisions must be followed in full.
2.3 Ordering Clear Align Documents. Copies of specifications, standards and drawings required by suppliers and sub-contractors in connection with specific procurements may be obtained from the Clear Align Buyer.
3 RIGHT OF ACCESS
3.1 Access. The Supplier shall provide Clear Align, our customers and regulatory authorities’ access to all facilities involved in this purchase order and to all applicable artifacts.
4.1 Contractor Responsibilities. 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 the purchase order requirements whether manufactured, processed, or procured from sub-contractors or sub tier suppliers, unless the Clear Align buyer is notified about the condition of a nonconformity and the buyer provides authorization to proceed with shipment/presentation of the nonconforming supplies/services to Clear Align. The Supplier’s inspection system shall be documented and evidence to indicate approval by suppliers senior management is required.
4.2 Supplier Procurement Documents. Supplier’s procurement documents shall describe technical, inspection and other methods to flow down requirements necessary to assure the Supplier’s procured items conform to Clear Align technical and purchase order requirements.
4.3 Receiving Inspection. Purchased supplies shall be subjected to inspection after receipt, as necessary, to assure conformance to purchase order requirements. The Supplier shall report to the Clear Align buyer any nonconformance found on supplies and shall require any sub-contractor or sub tier supplier or provide corrective action(s) or replacements, as necessary.
4.4 Inspection and Testing Documentation. Inspection and testing shall be prescribed with 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.
4.5 Records. The subcontractor 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.
4.6 Clear Align Furnished Material. When material is furnished by Clear Align, the supplier’s procedures shall include, as a minimum:
4.7 Nonconforming Material. The Supplier shall establish and maintain an effective system for controlling all nonconforming material, including procedures for the identification, segregation, presentation and disposition of reworked, scrapped or repaired supplies.
4.8 Root Cause and Corrective Action. The Supplier shall take prompt action to correct assignable conditions which have resulted or could result in the submission to Clear Align of supplies and services which do not conform to
4.8.1 The quality assurance provisions of the item specification
4.8.2 Inspections and tests required by the purchase order (contract)
4.8.3 Other inspections and tests required to substantiate product conformance. When it is determined that the supplier is responsible for the nonconformance of material, the supplier shall respond to Clear Align’s request for a supplier’s corrective action plan. Failure to respond within the time frame requested may affect supplier’s status as an approved supplier.
4.9 Drawings and Changes. The supplier’s or sub-contractor’s inspection system shall provide for procedures which will assure that the latest applicable drawings, specifications and instructions required by the purchase order, as well as authorized changes thereto, are used for procurements, fabrication, inspection and testing. The revision in effect at the time the purchase order was placed applies.
4.10 Measuring and Test Equipment. The Supplier shall provide and maintain gages and other measuring and testing devices necessary to assure that supplies conform to the technical requirements. In order to assure continued accuracy, these devices shall be calibrated at established intervals against certified standards considering areas of uncertainty which have known valid relationships to national standards. If production tooling, such as jigs, fixtures, templates and patterns used as a media of inspection, such devices shall also be proved for accuracy at established intervals. Calibration of inspection and test equipment shall be in accordance with ISO 10012:2003.
4.11 Process Controls. Process control procedures shall be an integral part of the inspection system when such inspections are a part of the specification or the contract. The Supplier shall notify Clear Align of changes in product and/or process definition and where required, obtain Clear Align’s approval. Statistical Process Control (SPC) is the preferred method of validating these areas.
4.12 Electrostatic Control Plan (ESD). The Supplier must take necessary precautions to ensure static sensitive items or repair services to static sensitive items are protected from electrostatic discharge events. Additionally, the supplier is required to have an ESD Control Program Plan and artifacts 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”.
4.13 Indication of Inspection Status. The Supplier shall maintain a positive system for identifying the inspection status of supplies. Identification may be accomplished by means of stamps, tags, routing cards, move tickets, tote box cards or other control devices. Artifacts conveying the control of this process shall be available for review.
4.14 Sampling Inspection. Sampling inspection procedures used by the Supplier to determine quality conformance of supplies shall be described in the Supplier’s inspection system and shall comply with industry sampling practices. If supplier’s sampling process is internally developed they must demonstrate their ability to comply with industry statistical methods proven over time. If sampling instructions are described in the Clear Align purchase order or technical documents within the purchase order, the Supplier shall assure that the purchase order requirements are complied with.