SCC QSP Control of Non Conforming Product

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Reference: ISO 9001:2008 Element 8.3 Control of non-conforming product or service

Purpose (1.)

To establish a procedure for the control and disposition of nonconforming products and materials, and to prevent unintentional use or shipment.

Scope (2.)

This procedure applies to all nonconforming products and materials detected within the SCC, whether obtained from a vendor or manufactured internally.

This procedure applies to all employees.

Responsibility and Authority (3.)

The Dir., Quality has responsibility and authority to ensure this procedure is followed. He may delegate tasks to qualified personnel as needed. All employees are responsible for knowing and following this procedure.

Procedure (4.)

Non-conforming material can be detected at an in-coming (or receiving) inspection, at an in-process inspection or other ad hoc inspection.

  • Nonconforming material, upon detection, shall be immediately removed and quarantined from any process flow. A senior manager shall be notified as soon as possible (either President, Director of Engineering, Director of Product Management, Director of Manufacturing, Directory of Quality, or Director of Sales and Marketing).
  • Nonconforming material shall be identified by attaching a correctly completed Nonconforming Material Tag to the affected item(s). The tag shall provide the part number, quantity, description, reason for quarantine, the name of the person reporting the non-compliance, and the date in yyyy-mm-dd format. TODO - add Non-Conforming Material Tag in Maestro Document Control.
  • An issue shall be logged in the SCC Corrective Action System, cross referenced to the part number and vendor.
  • The Quality Manager shall periodically review non-conforming material, and together with other management as appropriate, shall determine the appropriate course of action.
    • Only the Quality Manager or their delegate shall be permitted to removed non-conforming material from quarantine.
    • Any subsequent related decision or action shall be documented in the Corrective Action System, and cross-referenced to SCC part number and vendor.

Related and Support Documentation (5.)