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Control of Nonconforming Materials is addressed in section 8.3 of the ISO 9001:2000 standard. The requirements are simple and addressing the requirements is also simple.

The ISO standard requires that:

  • Non-conforming materials be identified and controlled to prevent accidental use or delivery
  • There is a documented procedure for handling NCM
  • Responsibility and authority is assigned for the handling of NCM
  • Preventive and corrective actions are taken to eliminate the source of NCM
  • Records are maintained showing authorizing use of NCM (disposition), action taken to address NCM, and identifying the nature of the NCM
  • Corrected NCM are re-tested or re-confirmed
  • If NCM is detected after delivery or usage by customers, that appropriate action are taken to correct the NCM.

Addressing these points requires a non-conforming materials control procedure in addition to the procedure for preventive and corrective actions (engineering change request/orders).
A very simple way to meet the requirement is to write a procedure based on the use of NCM tags to identify the material. The procedure should address the titles of the personnel that are given the responsibility and authority to manage different part of the NCM process.

The procedure should also reference that NCM are used as input to the preventive and corrective actions system . This can be addressed by saying that trends in the NCM analysis are used to generate an Engineering Change Order (ECO). The ECO procedure should address field recalls to cover the requirement for correcting already shipped NCMs. The ECO procedure should also include requirements for re-testing and re-confirming materials.

I recommend this simple tagging system because the bright red tags:

  • Allow anyone in the organization to find and remove non-conforming materials from the production area
  • Assure that no known non-conforming materials in the facility will accidentally be used in production
  • Gather information about the NCM at the time the materials is found. This information is valuable at the time of disposition and will help with the creation of the ECR/ECO.

These tag can be printed on-demand using word or a simple label printing program. I made the tags 4.25 inches tall and 2.75 inches wide so that they could be printed 8 up on a standard 8-1/2 by 11 sheet of red cardstock.

The final part of the system requires the use of an excel spreadsheet, access database or other centralize software for collecting data about NCMs. This fulfills the requirement for record keeping and allows the creation of non-conforming materials summary reports These reports should be presented as part of the management review meetings.

Sample Non-Conforming Materials Procedure