BRCGS Packaging Hazard and Risk Analysis Annual Review

Annual inspection template for reviewing the BRCGS Packaging Hazard and Risk Analysis (HARA), confirming it remains current under Issue 7 requirements and that supply chain risks, hazard controls, and supporting records are up to date.

Review Scope and Document Control

• HARA document version, owner, and approval status are clearly identified
• Annual review date is within the last 12 months
  Record the date of the most recent formal review.
• HARA reflects the current product range, process flow, and site activities
• Document control shows revision history and change summary for the latest update
• Obsolete versions are removed from use or clearly controlled

Hazard Identification and Risk Assessment

• Physical, chemical, and biological hazards are identified where applicable
• Risk assessment includes severity and likelihood scoring methodology
• Existing control measures are documented for each significant hazard
• Residual risk is reviewed and accepted by an authorized competent person
• Changes in materials, equipment, process conditions, or customer requirements have been reassessed

Supply Chain Risk Review

• Approved supplier list is current for packaging materials and services in scope
• Supplier risk assessment includes origin, substitution risk, and traceability exposure
• Incoming material controls address specification conformance and contamination risk
• Any high-risk or single-source materials have documented contingency controls
• Supplier performance issues, complaints, or non-conformances were reviewed in the annual HARA update

Verification, Monitoring, and Effectiveness

• Verification activities are defined for significant controls
• Monitoring records show controls were performed at the required frequency
• Internal audit, inspection, or test results support the effectiveness of the HARA controls
• Any failed verification results have documented corrective actions and closure evidence
• Trend analysis or management review has considered recurring hazards or control failures

Review Outcome and Approval

• Review conclusion
• Corrective actions identified during the review are assigned to an owner with due dates
• Supporting records reviewed
  Select the records used to confirm the HARA review.
• Inspector comments
  Summarize key findings, deficiencies, and required follow-up.
• Inspector signature