Process Monitoring & Control
Aligned with BRCGS Food Safety Issue 9 – Clause 5.3
Requirement Overview
BRCGS Clause 5.3 requires that processes critical to food safety, legality, and quality are monitored and controlled to ensure products consistently meet defined specifications.
Clause 5.3.1: “The company shall ensure that the process is controlled to ensure that product conforms to specifications.”
Clause 5.3.2: “Process monitoring shall be carried out at a frequency based on risk and capable of detecting loss of control.”
Effective process control ensures consistency, reduces product variation, and protects the safety and integrity of food products throughout the manufacturing process.
Aligned with BRCGS for Storage & Distribution Issue 4 – Clause 4.3.1 & 4.3.3
Requirement Overview
BRCGS for Storage & Distribution requires that products moved via cross-docking are traceable and controlled at all times, even when they are not held in storage for extended periods.
Clause 4.3.1: “The company shall ensure that traceability is maintained at all stages, including during cross-docking operations.”
Clause 4.3.3: “Procedures shall be in place to ensure that all products handled, including those not stored on-site, remain under control and are not subject to contamination or substitution.”
Cross-docking operations must not compromise product traceability, safety, or integrity. Even with minimal handling and temporary presence, each product must be accurately identified, documented, and protected.
Key Compliance Objectives
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✓ Maintain process parameters that ensure product safety and quality
✓ Detect deviations quickly to prevent unsafe or non-compliant product
✓ Verify control measures are functioning effectively
✓ Document monitoring results and corrective actions
Step-by-Step Compliance Implementation
1. Identify Critical Process Parameters
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Parameters May Include:
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• Time, temperature, pH, weight, metal detection, flow rate
• CCPs (Critical Control Points) and OPRPs (Operational Prerequisite Programs)
• Defined process specifications or tolerances
Evidence to Maintain:
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• Process flow diagram with control points
• Product specification sheets
• Approved parameter limits and monitoring procedures
- • Time, temperature, pH, weight, metal detection, flow rate • CCPs (Critical Control Points) and OPRPs (Operational Prerequisite Programs) • Defined process specifications or tolerances
- • Process flow diagram with control points • Product specification sheets • Approved parameter limits and monitoring procedures
2. Monitor the Process Consistently
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Monitoring Requirements:
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• Use calibrated instruments and trained personnel
• Set frequency based on risk and process sensitivity
• Record each monitoring check clearly and completely
Evidence to Maintain:
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• Completed monitoring logs or digital records
• Calibration certificates of measurement tools
• Staff training records
- • Use calibrated instruments and trained personnel • Set frequency based on risk and process sensitivity • Record each monitoring check clearly and completely
- • Completed monitoring logs or digital records • Calibration certificates of measurement tools • Staff training records
3. Respond to Deviations Immediately
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Deviation Response Steps:
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• Identify the source and extent of deviation
• Quarantine or hold affected product
• Take corrective and preventive actions
• Investigate root cause and update procedures if needed
Evidence to Maintain:
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• Deviation and corrective action reports
• Product disposition records
• Updated process SOPs or monitoring protocols
- • Identify the source and extent of deviation • Quarantine or hold affected product • Take corrective and preventive actions • Investigate root cause and update procedures if needed
- • Deviation and corrective action reports • Product disposition records • Updated process SOPs or monitoring protocols
4. Validate and Verify Control Effectiveness
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Verification Activities Include:
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• Internal audits and supervisory checks
• Data trend analysis for process control
• Review of CCP verification logs
Evidence to Maintain:
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• Internal audit reports and checklists
• Process performance graphs or summaries
• CCP verification documentation
- • Internal audits and supervisory checks • Data trend analysis for process control • Review of CCP verification logs
- • Internal audit reports and checklists • Process performance graphs or summaries • CCP verification documentation
Common Audit Findings & Recommended Fixes
| Audit Finding | Recommended Action |
|---|---|
| Incomplete or missing monitoring logs | Train staff on proper record-keeping; use pre-approved templates |
| No defined limits for key parameters | Set clear specifications and justify scientifically |
| Delayed or undocumented corrective action | Implement immediate reporting protocol with CAPA documentation |
| Equipment not calibrated | Create and follow a calibration schedule for all instruments |