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Verification & Validation of HACCP Systems Flashcards

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  1. During a HACCP audit, the auditor finds that corrective action records indicate the same CCP deviation has recurred six times in three months. What does this MOST likely indicate?

    Answer: The critical limit or process needs revalidation and root cause analysis

    Recurring deviations at the same CCP signal that the current critical limit or process may not be adequate and that root cause analysis and revalidation are needed.

  2. Which element distinguishes an internal HACCP audit from a routine verification activity?

    Answer: Internal audits assess the overall HACCP system's implementation and effectiveness, not just individual CCP records

    Internal HACCP audits provide a comprehensive, system-level review of HACCP plan implementation and effectiveness beyond day-to-day monitoring record checks.

  3. A HACCP plan validation study must demonstrate that the process achieves at least what standard for a Listeria monocytogenes control CCP in ready-to-eat deli products under FDA guidance?

    Answer: 5-log reduction

    FDA and USDA/FSIS guidance for ready-to-eat deli meat products generally requires a minimum 5-log (100,000-fold) reduction of Listeria monocytogenes.

  4. What is the role of 'direct observation' as a HACCP verification tool?

    Answer: To confirm that monitoring personnel are performing procedures correctly as written

    Direct observation verifies that employees are actually following the monitoring procedures specified in the HACCP plan, ensuring system integrity.

  5. Which best describes 'system verification' compared to 'CCP verification' in a HACCP context?

    Answer: System verification evaluates the overall HACCP plan's effectiveness; CCP verification confirms individual CCPs function correctly

    CCP verification focuses on individual control points, while system verification is a broader assessment of whether the entire HACCP plan is functioning as intended.

  6. Under USDA FSIS regulations (9 CFR 417), how often must an establishment reassess its HACCP plan at a minimum?

    Answer: At least annually or whenever a change occurs that could affect the hazard analysis

    9 CFR 417.4 requires that the HACCP plan be reassessed at least annually or whenever there is a change that could affect the hazard analysis.

  7. A HACCP auditor discovers that the facility's HACCP plan lists water activity (aw) as a CCP for controlling Staphylococcus aureus but no validation records exist. What is the CORRECT auditor finding?

    Answer: Major non-conformance โ€” a CCP critical limit must be supported by validation evidence

    Every CCP critical limit must be supported by validation evidence; the absence of validation records for a CCP is a major non-conformance.

Verification & Validation of HACCP Systems Flashcards โ€” CHA Study Cards with Answers