Q.A. Clauses, Appendix B

Quality Assurance Clauses

REVISION – Date: 08/08/2014
Removed note Q.9

When any of the following clauses are noted on the purchase order, they are to be considered a line item of the purchase order:

Q.1

If any materials ordered are age sensitive, please include with the order, as applicable:

  1. Material name, lot number, cure date/date of manufacture.
  2. An expiration date or length of shelf life and what/how shelf life is initiated.
  3. Any special handling or storage requirements.

Q.2

Calibration Services – the supplier calibration system must conform to ANSI/NCSL Z540-1 or ISO 10012. The calibration report must contain, as a minimum. (7.4.2-a)

  1. Date of calibration
  2. Specification to which calibrated.
  3. Identification or serial number of the item(s) calibrated.
  4. Evidence of traceability of calibration(s) to the National Institute of Standards and Technology (NIST).
  5. Results of the calibrations performed, with a statement of uncertainties or accuracy of standards used, including data for any out-of-tolerance conditions found. The out-of-tolerance data should include the specific range that the instrument is out of tolerance.
  6. The signature of a responsible representative of the calibrating agency.

Q.3

Prior to the initiation of production for this purchase order, WFDC may conduct an audit of your facility to ensure compliance to and/or certification of:

  1. Quality management system requirements. (7.4.2-c)
  2. Personnel certification to specification(s). (7.4.2-b)
  3. Equipment certification to specifications(s). (7.4.2-a)
  4. Processes are compliant to specification(s). (7.4.2-a)
  5. Procedures are compliant to WFDC criteria. (7.4.2-a)

Q.4

When this clause is imposed, inspection instructions, technical data and test instructions will be included with the drawing package and must be complied with. (7.4.2-d,-e)

Q.5

In the event that nonconforming product is generated the following procedure shall be adhered to: (7.4.2-g)

  1. Immediately stop production and notify WFDC by phone of the specific problem.
  2. Segregate the nonconforming product from the acceptable product and positively identify the unacceptable product.
  3. If required, FAX a drawing with the nonconformance noted for WFDC review.
  4. No verbal approvals to continue production should be accepted by the supplier. (7.4.2-g)
  5. If acceptance or rework of nonconforming material is approved by WFDC, this variation will be in writing (including Faxes), and no other method should be accepted by the supplier. (7.4.2-g)

Q.6

Use of sub tier suppliers for production work is not authorized. Use of sub tier suppliers for required processes is limited to those listed on the WFDC Approved Supplier List. (ASL) (7.4.1-d; 7.4.2-j)

Q.7

The following documentation (as applicable) is required to be shipped with the completed product: (7.4.3)

  1. Test reports on the completed product.
  2. Test reports on the raw materials used in the manufacture of the product.
  3. Inspection reports, both in-process and final
  4. Statistical Process Control charts and reports.
  5. Non-destructive test (NDT) reports – with legible certifying stamp/signature.
  6. Certificate of Conformance – attesting to the complete and accurate manufacture of the components.
  7. If applicable, send appropriate test specimens, including the supplier test results, with the first shipment of product.

Q.8

The following inspections are to be performed at the supplier’s facility. Required Calibrated inspection tooling and associated inspection documentation is to be made available for the inspection. The personnel performing the inspection may include WFDC personnel, customer personnel and regulatory personnel. The method of product release should be stated in the P.O., whether at the supplier’s facility after the inspection or after receipt at WFDC. (7.4.2-i; 7.4.3)

Q.10

If the supplier wants to make any changes to the Product ordered or the processes utilized to manufacture the product, they will notify WFDC of their proposed changes prior to comensing fabrication of that part. This notification shall include the full extent of the changes and how these changes will affect the final configuration of the part. Only the CEO, Director of Operations, and/or the Director of Quality may okay these changes.