Supplier Quality Clauses
1.0 PURPOSE
This document establishes the procurement Quality Assurance Requirements (Q Clauses), which are applicable to the extent specified in the procurement document.
2.0 DEFINITIONS
2.1 Buyer: Lenscan Medical Inc. procurement entity
2.2 Seller: The legal entity that is the contracting party with Buyer with respect to the procurement document.
2.3 Procurement Document: The purchase order or subcontract between the parties.
2.4 Item: The product or service contracted for by the procurement document.
3.0 PROCUREMENT QUALITY REQUIREMENTS
The following Q Clauses are a requirement of the procurement document when expressly specified by clause number.
Q-1 GENERAL QUALITY ASSURANCE REQUIREMENTS (A through K)
A. RIGHT OF ACCESS
The Buyer, the Buyers Customers and Regulatory Authorities have right of access to the facilities and records of the Seller and the Seller’s Sub-tier suppliers. Right of Access to be coordinated between the Buyer and Seller.
B. PROHIBITED PRACTICES
Unauthorized Repairs: Seller shall not repair any damaged item, nor any found to be faulty during manufacturing or that fails to meet Buyer specification/drawing requirements, without Buyer’s written approval. Change in Approval, Drawing, Processes, Materials, or Procedures: Seller shall not change any drawing, process, material (including sub- tier supplier parts), or procedure without prior Buyer written approval, if such drawing, process, material, or procedure was previously approved by Buyer as provided for in the procurement document.
Seller shall not change any process, material or procedure from that used to qualify any item or which was used by Seller to become a qualified source for Buyer specification/drawing, without Buyer written approval.
Re-submittal of Rejected Items: Any item rejected by Buyer and subsequently resubmitted to Buyer shall be clearly identified as a resubmitted item, indicating procurement document number and Buyer reject document number in Seller’s certificate of conformance.
Notification of Facility Change: Seller shall not use nor relocate any production, manufacturing, and/or processing facilities to differ from previous approval by Buyer, during performance of work specified in the procurement document, without previously notifying Buyer and affording Buyer an opportunity to examine such facilities for compliance with procurement Quality requirements.
Changing of Test Facility: Seller shall not change a test facility nor use another test facility to meet specification/drawing requirements without prior Buyer written approval, if a specific test facility was previously approved by the Buyer as provided for in the procurement document.
Change of Management/Owner: Seller shall notify Buyer when a significant change in management or ownership has occurred.
C. RESPONSIBILITY FOR CONFORMANCE
Neither surveillance, inspection and/or test made by Buyer or applicable Government Authority at either Seller’s or Buyer’s facility, nor Seller’s compliance with all applicable procurement quality requirements, shall relieve Seller of the responsibility to furnish an item that conforms to the requirements of the procurement document.
Seller shall control sub-tier supplier procurements and flow those requirements down to the extent necessary to ensure quality requirements specified in the procurement document are satisfied. Quality requirements shall include, but are not
limited to, the following: sub-tier supplier pre-award survey/evaluations, periodic auditing of supplier, implementing a sub-tier supplier rating system, ensuring adequate review of procurement documentation prior to procurements, controlling procurement of critical items for Seller product, inspection of procured items to documented procedures, and control of non-conforming material, including corrective action.
D. BUYER SURVEY, SURVEILLANCE, AUDITS AND INSPECTION
Buyer has the right to conduct surveys, audits and surveillance of Seller facilities, and those of Seller sub-tier suppliers with prior coordination with Seller, to determine capability to comply, and to verify continuing compliance, with the requirements of the procurement document.
Buyer has the right to perform inspection at Seller facilities and those of Seller sub-tier supplier with prior coordination with Seller, during the period of manufacturer and inspection prior to shipment. Final inspection, and acceptance, shall be performed at the Buyer facility, unless otherwise specified in the procurement document.
E. DOCUMENTATION
Buyer may refuse to accept item if Seller fails to submit certifications, documentation, test data or reports specified by the procurement document.
F. CORRECTIVE ACTION REQUEST
When a quality problem exists with any Seller item, Buyer may forward a “Corrective Action Request” to Seller, requiring timely response (as stated on the Corrective Action Request), that shall include the following information: containment action, analysis of the cause of the problem, statement of the action taken to prevent recurrence, and the effectively of the action.
G. MEASURING AND TEST EQUIPMENT
Seller shall be responsible for validating the accuracy and stability of tools, gages and test equipment used to demonstrate that any item conforms to the requirements specified by the procurement document. Documented schedules shall be maintained to provide for periodic calibration to adequate standards. Objective evidence of calibrations shall be recorded and made available for Buyer review.
H. NONCONFORMING MATERIAL
Any decision to accept any nonconformance (variance from Buyer drawings and specifications), detected at Seller facilities, must be made by Buyer unless otherwise specified by the procurement document.
Shipment of any non-conforming item shall be accompanied by Buyer approved document. Seller shall provide for identification, control and segregation of non-conforming material detected at Seller facilities.
I. INSPECTION RECORDS
Seller shall maintain records of all inspections and tests performed on any item delivered to Buyer. These records shall identify any non- conformance and shall be made available for Buyer review.
J. SAMPLE INSPECTION
Seller may use sample inspection plans, when tests are destructive, or when the records or inherent characteristics of the product indicate that a reduction in inspection/testing can be achieved without jeopardizing product quality. Sample inspection shall be in accordance with the applicable Buyer specification. When not specified by Buyer, military or a recognized standard sampling plan may be used. Buyer approval is required for sample inspection plans other than military or a recognized standard prior to their implementation.
K. SELLER’S BASIC CERTIFICATE OF CONFORMANCE
Seller shall provide a basic Certificate of Conformance providing a statement that the items furnished per the Buyer procurement document have been manufactured, tested and inspected in accordance with the requirements of the applicable specifications/drawings and the results of such tests and inspections meet the requirements.
The Certificate of Conformance shall include but is not limited to: Seller’s name, Sellers Address – Location where item was manufactured/tested/supplied from
Item name –Description, Seller’s Part Number, Lot Number, Serial Number, Process Number, Batch Number, etc… as applicable, Buyer’s Name, Buyer’s Part number, Specification/drawing number including applicable revision designation, Procurement document number/revision
Certificate of Conformance shall be signed by the Seller’s authorized representative and shall include title of signatory and date. Any certificate not meeting the above requirements is subject to rejection by Buyer upon receipt.
L. SELLER’S RISK BASED THINKING MANAGMENT
Seller shall provide a for a Risk Based Thinking process which identifies special requirements identified by the customer, or determined by the organization, manages and mitigates critical items, or key characteristics.
Q-2 CONTROL OF RECORDS
The Seller shall implement Control Records that provide evidence of product conformity to requirements according to procurement documentation. These records shall be made available to the Buyer upon request for up to seven (7) years from date of purchase order.
Q-3 PERSONNEL AWARENESS
Seller shall be responsible for ensuring competency of personnel, including necessary qualification they must possess and that their personnel are aware of their contribution to compliance and product safety and of the importance of ethical behavior
Q-4 DESIGN and DEVELOPMENT CONTROL
Seller shall establish, implement, and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services.