Introduction
In modern food safety and quality management systems, the reassessment document plays a critical role in ensuring that processes remain current, effective, and compliant with evolving regulations and standards. The reassessment document is not merely a formality but a structured mechanism to evaluate whether procedures, policies, or records still serve their intended purpose, meet regulatory obligations, and address new risks or operational realities. By serving as a formal record of review and justification for changes, the reassessment document provides transparency, accountability, and evidence during regulatory inspections and third-party audits.
This article explores the role of a reassessment document in document change management. It addresses requirements across Code of Federal Regulations (CFR), Safe Quality Food (SQF) certification, International Organization for Standardization (ISO 9001 and ISO 22000), and the British Retail Consortium (BRCGS) Global Standards.
1. The Purpose of Reassessment in Document Control
Document control is fundamental to any effective management system, particularly in industries where food safety, quality, and regulatory compliance are paramount. The reassessment document is designed to:
- Ensure policies and procedures remain relevant.
- Confirm that hazards, controls, and corrective actions reflect current operations.
- Provide traceability for why a document was revised.
- Demonstrate compliance with regulatory or certification standards.
- Maintain consistency and reduce risk of non-conformity.
Without reassessment, organizations risk operating under outdated assumptions, ineffective practices, or non-compliant documentation.
2. Regulatory Framework: CFR Requirements
Under U.S. federal law, reassessment is explicitly required for food safety plans. For example:
- 21 CFR Part 117.170 (Food Safety Modernization Act, Hazard Analysis and Risk-Based Preventive Controls for Human Food – HARPC): Requires that the written food safety plan be reassessed at least once every three years, or whenever significant changes occur that could affect food safety.
- 9 CFR 417.4(a)(3) (FSIS – USDA HACCP Systems): Requires establishments to conduct a reassessment of their Hazard Analysis and Critical Control Point (HACCP) plan at least annually and whenever changes occur that could affect hazard analysis or alter the HACCP plan.
Both provisions emphasize that reassessment is not optional—it is a mandatory safeguard to keep hazard management aligned with actual conditions.
The reassessment document, therefore, acts as the evidence file demonstrating compliance with these CFR requirements.
3. SQF System Requirements for Reassessment
The SQF Food Safety Code requires routine review and validation of policies and procedures, including:
- SQF Code, Edition 9, Module 2, 2.1.3 (Management Review): Senior site management must review the SQF system at least annually to ensure continuing suitability, adequacy, and effectiveness.
- SQF Code 2.4.3 (Food Safety Plan): The food safety plan shall be reviewed and validated at least annually, and whenever changes occur that could affect food safety.
Here, the reassessment document serves as the formal record of the review and validation process. It provides an auditor with evidence that the facility did not merely conduct a paper exercise but engaged in critical analysis of potential risks, updates, and improvements.
4. ISO Standards and Reassessment in Document Management
ISO management systems are built on the principle of continual improvement. Reassessment plays a direct role in this cycle:
- ISO 9001:2015 (Quality Management Systems) Clause 7.5: Requires organizations to control documents and ensure that changes are identified, reviewed, and approved.
- ISO 22000:2018 (Food Safety Management Systems) Clause 8.5.2: Requires the food safety team to verify and, if necessary, update the hazard analysis and control measures at planned intervals, as well as when changes occur.
In ISO-based systems, the reassessment document supports the Plan-Do-Check-Act (PDCA) cycle by functioning as the “Check” stage in document control. It ensures that corrective measures and updates are systematically introduced, rather than reactively or inconsistently.
5. BRCGS Standards and Reassessment Practices
The BRCGS Global Standard for Food Safety, Issue 9, also emphasizes reassessment:
- Clause 3.2.1: Management review meetings must be held at appropriate intervals, with review inputs including results from audits, incidents, and changes that could affect the management system.
- Clause 2.7.1 (HACCP / Food Safety Plan): The HACCP plan must be reviewed at least annually and whenever changes occur, ensuring its continued effectiveness.
Reassessment documents are a direct tool to demonstrate conformity with these requirements. They provide auditable proof that reviews were conducted and decisions documented, creating a defensible compliance record.
6. Structure of a Reassessment Document
A well-structured reassessment document typically includes:
- Document ID and Title: Links the reassessment to the specific SOP or policy.
- Reason for Reassessment: Change in regulation, process modification, incident, audit finding, or scheduled annual review.
- Scope of Review: What parts of the document or process are being reviewed.
- Risk Assessment: Evaluation of new or existing risks, including physical, chemical, and biological hazards.
- Decision: Whether to maintain, revise, or replace the document.
- Approval Signatures: Demonstrating accountability and management oversight.
- Revision History: Providing traceability of document changes.
7. The Role of Reassessment in Document Change Management
Document change management involves not just updating documents but ensuring that updates are justified, reviewed, and controlled. The reassessment document acts as the evidence trail for this process. Its roles include:
- Compliance Assurance: Demonstrates adherence to CFR, ISO, SQF, and BRCGS.
- Risk Mitigation: Ensures new risks are identified and controlled.
- Audit Readiness: Provides records during inspections and audits.
- Knowledge Retention: Ensures rationale for changes is preserved, even if staff turnover occurs.
- System Integrity: Prevents uncontrolled or unauthorized changes that could weaken the system.
8. Frequency and Triggers for Reassessment
While annual review is a common requirement, reassessment must also be triggered by:
- New regulations or customer requirements.
- New products, processes, or equipment.
- Changes in suppliers or raw materials.
- Corrective actions from audit findings or incidents.
- Deviations, complaints, or recalls.
Thus, the reassessment document is not static but dynamic—reflecting both planned and event-driven reviews.
9. Challenges and Best Practices
Challenges:
- Ensuring timely reassessments.
- Engaging cross-functional teams.
- Documenting rationales clearly.
- Preventing reassessment from becoming a “check-the-box” task.
Best Practices:
- Establish a master reassessment schedule linked to the document control index.
- Use standardized templates to ensure consistency.
- Train staff in both regulatory drivers and organizational needs.
- Integrate reassessment into management review and internal audit cycles.
10. Conclusion
The reassessment document is a vital instrument in document change management. By providing a structured and auditable record of review, it ensures compliance with regulatory requirements (CFR), certification standards (SQF, ISO, BRCGS), and internal policies. More importantly, it drives continual improvement, strengthens risk management, and sustains confidence in the organization’s ability to manage food safety and quality effectively.
In an environment where regulators, certifiers, and customers demand robust evidence of control, the reassessment document stands as the written proof that the organization is not only compliant but proactive in safeguarding its processes, products, and reputation.
References
- U.S. Food and Drug Administration, 21 CFR Part 117 – Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.
- U.S. Department of Agriculture, Food Safety and Inspection Service, 9 CFR Part 417 – Hazard Analysis and Critical Control Point (HACCP) Systems.
- SQF Code, Edition 9. Safe Quality Food Institute, 2021.
- ISO 9001:2015 – Quality Management Systems. International Organization for Standardization.
- ISO 22000:2018 – Food Safety Management Systems. International Organization for Standardization.
- BRCGS Global Standard for Food Safety, Issue 9. BRCGS, 2022.