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食品安全指挥中心 14 项

Preventive Controls Qualified Individual (PCQI) Records Checklist

此检查清单为英文版。

Verify that PCQI qualifications, training records, and oversight activities meet the Preventive Controls for Human Food requirements.

21 CFR 117FSPCA

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PCQI Qualification

  • Has each PCQI completed training equivalent to the FSPCA standardized curriculum or is otherwise qualified through job experience? *
  • Is documentation of PCQI training retained, including course completion certificates? *
  • Where qualification is based on experience, is that experience documented as sufficient to perform the activities?
  • PCQI name

Oversight Duties

  • Did the PCQI prepare or oversee preparation of the food safety plan? *
  • Did the PCQI validate the preventive controls? *
  • Did the PCQI review records for monitoring, corrective actions, and verification? *
  • Did the PCQI conduct or oversee the reanalysis of the food safety plan? *

Qualified Individual Training (General Workforce)

  • Are all individuals engaged in manufacturing, processing, packing, or holding trained in food hygiene and food safety appropriate to their duties? *
  • Is training documentation maintained for each qualified individual? *
  • Are supervisors responsible for ensuring compliance identified and trained?

Records Retention

  • Are PCQI and training records retained for at least two years? *
  • Are records signed and dated by the responsible individual? *
  • Are records available for FDA review within 24 hours of request?

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