4.13. Control of Nonconforming Product


4.13.1. General

Upon identification of a nonconforming material or product, the item must be segregated, when possible, and identified as not suitable for use. All operations must have procedures in place to define the process that handles the nonconformance. When appropriate, the nonconformance must carry documentation that will support the evaluation of the product and disposition. A notification of the nonconformance and disposition shall be forwarded to all parties affected or involved in the nonconformance.

This clause requires that:

  • You must have procedures in place to handle all nonconformances such that the material/product is stopped from being dispatched to the customer.
  • Your nonconformance procedures address segregation, identification as nonconforming, and corrective methods.

4.13.2. Nonconforming product review and disposition

The evaluation of nonconforming material must be conducted by an authorized individual as defined by your documented procedures. If the authorized individual determines that the product is acceptable as is, or requires a regrade, a return, or is to be scrapped, the accompanying document will reflect this activity and only then may you proceed to process the material. Should the authorized agent determine that rework or repair is required, the original document outlining the nonconformance must remain active until a reinspection of the material is done and only then may the issue be closed. The documented prepared for the identification of the nonconforming product should include a description of the inadequacy, and a full description of the activities required for correction and disposition. If you determine that the product does not fully meet the specifications, but you still consider it acceptable from the customer's perspective, a full report of the material's condition must be made available to the customer and this condition must be recorded and retained.

Nonconforming product review and disposition requires that:

  • You will define who the responsible authority is for defining the disposition of nonconforming materials.
  • Disposition procedures should consider four possibilities with appropriately defined review procedures. They are; use as is, rework, regrade, and scrap.
  • Materials designated for rework must remain identified as nonconforming until a full reinspection of the nonconformance has been completed and found to meet specifications.