BRCGS Packaging Hazard and Risk Analysis Annual Review
Annual review template for the BRCGS Packaging HARA, used to confirm the hazard analysis still matches current products, processes, suppliers, and control records. It helps you document Issue 7 review status, gaps, and follow-up actions in one audit-ready record.
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Overview
This template is an annual review record for a BRCGS Packaging Hazard and Risk Analysis (HARA). It is used to confirm that the hazard analysis still matches the site’s current product range, process flow, materials, suppliers, and control measures, and that the review was completed, approved, and supported by evidence.
Use it when you need a structured audit trail for the yearly HARA update, especially before certification audits, after significant process changes, or when supplier performance has raised questions about risk. The template walks through document control, hazard identification, supply chain risk, verification and monitoring, and the final review outcome so you can show that the HARA was not left static while the operation changed.
Do not use it as a substitute for the original hazard analysis or for day-to-day operational checks. It is not the right tool for a one-off incident investigation, a product release decision, or a detailed process validation study. It is also not enough on its own if the site has had major changes that require a full reassessment rather than a routine annual review. The value of this template is that it captures the annual confirmation step in a way that is specific, traceable, and easy to defend during an audit.
Standards & compliance context
- This template supports BRCGS Packaging Issue 7 expectations for maintaining a current, reviewed, and approved hazard and risk analysis with traceable evidence.
- It aligns with common quality management practice under ISO 9001 by documenting controlled changes, review outputs, and corrective action closure.
- Where packaging materials or services present contamination or food-contact risk, the review can support supplier and control expectations that are often assessed against food safety program requirements and the FDA Food Code context for downstream use.
- For sites with broader safety or process risk programs, the same review structure can complement ANSI/ASSP and internal management system practices for documented risk acceptance and verification.
- If the site handles regulated packaging inputs or outsourced processes, the annual review should reflect applicable supplier approval, traceability, and change-control obligations from the relevant standard family or customer specification.
General regulatory context for orientation only — verify current requirements with counsel or the relevant agency before relying on this template for compliance.
What's inside this template
Review Scope and Document Control
This section proves the review is current, controlled, and tied to the right version of the HARA before any hazard discussion starts.
- HARA document version, owner, and approval status are clearly identified
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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
This section checks whether the site has identified the right hazards and scored them using a consistent, defensible method.
- 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
This section matters because supplier changes, substitutions, and traceability gaps often create the biggest hidden risk in packaging operations.
- 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
This section shows whether the controls in the HARA actually worked in practice, not just on paper.
- 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
This section captures the decision, actions, and sign-off that turn the annual review into an auditable management record.
- Review conclusion
- Corrective actions identified during the review are assigned to an owner with due dates
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Supporting records reviewed
Select the records used to confirm the HARA review.
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Inspector comments
Summarize key findings, deficiencies, and required follow-up.
- Inspector signature
How to use this template
- 1. Open the current HARA, confirm the document owner and approval status, and record the latest revision, annual review date, and change summary.
- 2. Compare the HARA against the actual site product range, process flow, equipment, and activities, then note any changes that require reassessment.
- 3. Review each significant hazard, its severity and likelihood scoring, the existing controls, and the residual risk acceptance by an authorized competent person.
- 4. Check supplier approvals, incoming material controls, substitution and traceability risks, and any complaints or non-conformances that affect packaging materials or services.
- 5. Verify that monitoring, inspection, audit, and test records show the controls were performed at the required frequency and that any failures were closed with evidence.
- 6. Record the review conclusion, assign corrective actions with owners and due dates, attach supporting records, and obtain the final inspector signature.
Best practices
- Tie every annual review decision back to a specific change, record, or control evidence instead of relying on memory.
- Flag any material, supplier, equipment, or customer requirement change as a trigger for immediate HARA reassessment, not just the next annual cycle.
- Use the same severity and likelihood method consistently so year-over-year comparisons are meaningful.
- Photograph or attach objective evidence for control verification when the record alone does not clearly show effectiveness.
- Separate true hazard controls from housekeeping or cosmetic items so the review stays focused on risk reduction.
- Escalate recurring non-conformances or failed verification results into trend review, not just isolated corrective actions.
- Make sure the residual risk acceptance is signed by someone with authority and competence to approve the outcome.
What this template typically catches
Issues teams running this template most often surface in practice:
Common use cases
Frequently asked questions
What does this BRCGS Packaging HARA annual review template cover?
It covers the annual reassessment of your packaging hazard and risk analysis, including document control, hazard identification, supply chain risk, verification of controls, and final approval. The template is built to show whether the HARA still reflects current materials, process flow, site activities, and customer requirements. It also captures corrective actions and evidence reviewed during the annual update.
How often should this review be completed?
Use it at least once every 12 months, or sooner if there is a meaningful change to materials, equipment, process conditions, suppliers, or customer specifications. Annual review is the baseline, but change-driven updates should not wait for the calendar cycle. If your site has recurring non-conformances or supplier issues, it is smart to review the HARA earlier.
Who should run the annual HARA review?
A competent person who understands packaging operations, hazard controls, and the site’s risk assessment method should lead it. In practice, that is often quality, technical, or compliance staff with input from operations, procurement, and site leadership. Final acceptance should be signed by the person authorized to approve residual risk and corrective actions.
Does this template align with BRCGS Packaging Issue 7 expectations?
Yes, it is structured to support an annual review of the HARA under BRCGS Packaging Issue 7 expectations. It focuses on whether hazards, controls, supplier risks, and verification records remain current and effective. It is not a substitute for the standard, but it gives you a practical audit record that matches the way auditors typically test the system.
What are the most common mistakes this review catches?
Common gaps include outdated process flow diagrams, missing reassessment after a material or supplier change, weak justification for residual risk acceptance, and verification records that do not match the required frequency. Sites also miss single-source or high-risk material contingencies and fail to close corrective actions from failed checks. This template helps surface those issues before an audit does.
Can I customize this template for different packaging products or sites?
Yes, and you should. Add the specific packaging formats, lines, suppliers, and site activities in scope so the review reflects your actual operation rather than a generic model. If you run multiple sites, duplicate the template and tailor the hazard set, supplier list, and verification evidence for each location.
What records should be attached to support the review?
Attach the current HARA, revision history, process flow, supplier approvals, incoming inspection records, verification results, internal audit findings, complaint trends, and corrective action closure evidence. If a hazard or control changed during the year, include the change record or management review note that triggered the reassessment. The goal is to make the review traceable without hunting through separate systems.
How does this compare with doing the review ad hoc in email or spreadsheets?
Ad hoc reviews are harder to defend because they often leave gaps in ownership, timing, and evidence. This template gives you a repeatable structure for the annual check, so you can show what was reviewed, what changed, what failed, and what was approved. It also makes follow-up easier because actions, due dates, and supporting records stay in one place.
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