Varian Supplier Quality Requirements
The Supplier identified on the purchase order (“Seller”) agrees to incorporate the quality requirements outlined below and implement where appropriate in accordance with the Supplier’s business and the Products and Services being provided to Varian as identified in the purchase order.
These requirements will be implemented for all Suppliers that provide goods or services that impact the quality, performance, safety and/or efficacy of Varian finished Products or the Quality Management System. This will be done through a hyperlink to the URL, https://www.varian.com/about-varian/supplier-quality-requirements in Purchase Orders (PO’s) which will take the Supplier to the page that defines the following the Quality Requirements.
- The Supplier agrees to ensure that Products/Services meet Varian requirements and specifications.
- The Supplier agrees to notify Varian of any changes in the product, service, processes, or manufacturing location(s) so that Varian may determine whether the changes will affect the quality of a finished device. The Supplier shall notify the buyer of any change in design and obtain Varian approval prior to delivery of any product which includes the changed design.
- The Supplier agrees to maintain a documented quality management system that contains at a minimum the following key elements.
- Manufacturing controls, i.e., Job Orders/Travelers, Training, Calibration, etc.
- Control of records (Job orders, material records, training, etc.)
- Control of documents including Varian Specified requirements
- Receiving, In- process and Final Inspection and Test
- Control of Non-Conforming Product and Corrective Action Program
- The Supplier agrees to notify Varian of any changes to the quality management system including certification, recertification, or withdrawals.
- Supplier agrees to sign and provide a certificate of conformance (the “Certificate of Conformance”) for each shipment of product confirming that all the materials, processes, and/or finished product supplied under that order are specified and conform to the specifications as well as the applicable product environmental compliance standards (RoHS/REACH). Supplier shall deliver the signed Certificate of Conformance to Varian with the product or electronically at Supplier.Cert@Varian.com for Palo Alto and SupplierCN.Cert@varian.com for Beijing. Supplier may use its own template which must include the part number, revision, purchase order, lot #, serial #, quantity, etc. or Supplier has the option of using the Varian Supplier Certificate of Conformance. An example of a Varian Supplier Certificate of Conformance form is provided in Appendix A - Supplier Certificate of Conformance. Upon request Supplier will provide applicable signed certificates, examples of which include but are not limited to, material certificates, special processing, and product environmental compliance specification such as RoHS/REACH.
Raw Materials Suppliers shall ONLY use the material specified on the drawing or purchase order to fabricate components.
Material Certifications shall be maintained on file at the supplier’s facility and made available upon request to Varian.
- All raw materials shall be identified and directly traceable to the certifications that demonstrate the material's conformance to stated requirements.
- Raw materials shall be stored and handled in such a way that it will not degrade or become contaminated. Storage and handling shall not result in the raw material no longer conforming to material certifications, material standards, or acceptance specifications.
- Surplus materials, including remnants, coverage, and scrap, that cannot be traced directly to its certification shall not be used
Alternate forms of raw materials (e.g. plate, bar, sheet, etc.) that are not specified on the drawing shall not be substituted.
Sourcing and purchasing of raw OFE (Oxygen Free Electrolytic Copper) shall comply with Varian, P1-1 "Approved Sources for OFE Copper" (non-QSD reference).
Varian reserves the right to test raw material or require that a supplier test raw material at a Varian approved independent lab to confirm that the material is conforming to stated standards, acceptance specifications, or material certifications.
Special process certifications shall be maintained on file at supplier's facility and made available upon request to Varian.
- Special processing requirements that are required by the specified requirements (e.g. heat treatment, chemical treatment, painting, cleaning, etc.) must be certified by the supplier.
- The Supplier agrees to make their facility available for Varian supplier audits at a mutually agreed upon time and date.
- Varian may issue Supplier Corrective Action Requests (SCARs) or Audit Observations. The Supplier shall investigate the cause of the product/process nonconformity and provide to Varian, a corrective action plan no later than thirty (30) calendar days of receipt of a SCAR. Supplier shall implement the agreed corrective actions and effectiveness check within the agreed timeframe and provide the records to Varian.
- Supplier shall notify Varian within five (5) business days of the notification or first day (whichever is earlier) of a regulatory inspection or audit, announced or unannounced (such as by a EU notified body, FDA, Japanese PAL or ANVISA), where such inspection or audit applies to a Supplier facility where the Products are manufactured. Supplier shall cooperate fully with any such inspections or audits. Supplier shall provide to Varian, within five (5) days of its submission or receipt by Supplier, copies of the inspection or audit observations and copies of responses to regulatory observations pertaining to Varian Product (For example: FDA 483 Form). Supplier shall immediately correct any deficiencies identified in the regulatory inspection.
- If the Supplier receives any complaints related to the product, or any similar product or becomes aware of potential deficiencies or defects the Supplier will promptly notify Varian. If Varian receives a complaint related to the Supplier’s product, Supplier will fully co-operate with the investigation, inspection, or inquiry regarding the Products.
- Varian shall have the sole authority to declare a recall of any Products if Varian believes there is or may be a potential significant health hazard or non-compliance with applicable government regulations.