How should non-conforming products be handled?

• A. Return to process with no documentation.
• B. Segregate, label, and dispose or rework per approved procedures; prevent re-entry into the market.
• C. Rebrand the product and sell with warning.
• D. Ship to another market without review.

Answer: (B)

Non-conforming products must be controlled to prevent them from reaching customers, with quarantine, clear labeling, and a documented disposition according to approved procedures. This approach ensures that such items are separated from good stock, cannot accidentally re-enter production or distribution, and are only returned to market or disposed of after proper review and authorization. Doing the work per approved procedures—whether rework to bring them into compliance or disposal—provides traceability and accountability for every non-conforming item. Options that skip documentation, attempt to re-enter the market, or hide the issue do not provide the necessary controls or regulatory compliance.