HACCP Plan Review for Packaging

Inspection template for reviewing a packaging operation's HACCP plan, including hazard analysis, CCPs, OPRPs, validation status, and document control.

Review Scope and Document Control

• HACCP plan version is current and approved
  Verify the document revision matches the current approved master copy and shows formal approval by authorized personnel.
• Review date is within the required review cycle
  Confirm the HACCP plan has been reviewed within the organization-defined review interval and after significant process changes.
• Scope covers all packaging lines, products, and shifts
  Verify the plan includes all packaging operations, product types, line configurations, and operating shifts currently in use.
• Change control records are attached for recent process changes
  Confirm any changes to materials, equipment, layout, suppliers, or process parameters are documented and assessed for HACCP impact.
• Referenced SOPs and forms match current site practices
  Check that supporting procedures, monitoring forms, and work instructions referenced in the plan are current and in use.

Hazard Analysis and Risk Assessment

• Hazard analysis includes packaging-specific hazards
  Verify the analysis addresses hazards relevant to packaging materials, foreign material, lubricant contamination, allergen cross-contact, and mislabeling where applicable.
• All hazard categories are assessed
  Confirm biological, chemical, physical, and allergen hazards are considered where applicable to the packaging operation.
• Likelihood and severity ratings are defined and applied consistently
  Check that the risk matrix or scoring method is documented and used consistently across hazards.
• Reasoning for accepted hazards is documented
  Verify hazards not controlled by CCPs or OPRPs have documented rationale for acceptance or control by prerequisite programs.
• Hazard analysis reflects current raw materials and suppliers
  Confirm the analysis considers current packaging substrates, inks, adhesives, coatings, and supplier changes that may affect hazard status.

CCPs and OPRPs

• CCPs are clearly identified with critical limits
  Confirm each CCP has a documented critical limit, monitoring method, and responsible owner.
• OPRPs are defined with measurable control criteria
  Verify OPRPs have defined operating criteria, monitoring frequency, and escalation requirements.
• Control measures are appropriate for the identified hazard
  Check that each CCP or OPRP is logically linked to the hazard it is intended to control.
• Monitoring records show controls are performed at the required frequency
  Review recent records to confirm monitoring is completed as specified in the plan.
• Out-of-limit actions are documented and implemented
  Verify corrective actions, product disposition, and escalation steps are defined and used when CCP or OPRP limits are not met.

Validation, Verification, and Records

• Validation evidence supports the control measures
  Verify scientific, technical, or historical evidence demonstrates the selected controls are capable of managing the hazard.
• Verification activities are defined and current
  Confirm verification activities such as record review, internal audits, calibration checks, or challenge testing are documented and current.
• Calibration and measurement records are available for monitoring equipment
  Check that instruments used for monitoring are calibrated or verified according to schedule and records are retained.
• Records are complete, legible, and retained per procedure
  Review HACCP records for completeness, traceability, and retention in accordance with the site record control procedure.
• Internal review findings have been closed out
  Confirm prior non-conformances, deficiencies, and corrective actions related to the HACCP plan have been addressed and closed.

Approval and Follow-Up

• Review outcome is documented with pass/fail status
  Record whether the HACCP plan review passed, passed with deficiencies, or failed pending corrective action.
• Corrective action owner and due date assigned
  Identify the responsible person and target completion date for any open deficiencies or non-conformances.
• Inspector signature captured
  Capture the signature of the person completing the review.
• Management approval captured
  Capture approval from the responsible manager, quality lead, or designated authority.