Manufacturing Process Controls
Aligned with FSSC 22000 – ISO-Based Food Safety Management System (FSMS)
(Supports ISO 22000:2018 Clause 8.5 – Control of Production and Service Provision & Clause 8.9 – Control of Monitoring and Measuring)
Requirement Overview
Under FSSC 22000, manufacturing process control is a core requirement for maintaining product safety, legality, and quality. Specifically, Clause 8.5 of ISO 22000:2018 requires organizations to ensure that production and service processes are carried out under controlled conditions, including the monitoring of critical parameters, validation of equipment, and appropriate handling of non-conforming outputs.
Effective process control minimizes variability, ensures compliance with specifications, and protects consumers by preventing unsafe or inconsistent products from reaching the market.
Key Compliance Objectives
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✓ Identify and control key manufacturing steps critical to food safety
✓ Monitor operating parameters, equipment, and material specifications
✓ Prevent non-conforming, unsafe, or out-of-spec production
✓ Maintain documented evidence of process control and corrective actions
Step-by-Step Compliance Implementation
1. Identify Key Process Control Points
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Focus Areas May Include:
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• Mixing, cooking, chilling, filling, drying, or packaging steps
• Parameters such as temperature, time, pH, pressure, or weight
• CCPs and OPRPs defined during hazard analysis
Evidence to Maintain:
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• Process flow diagrams with control points (linked to PRPs and CCPs)
• Work instructions and operating procedures
• Defined limits, tolerances, and control measures
- • Mixing, cooking, chilling, filling, drying, or packaging steps • Parameters such as temperature, time, pH, pressure, or weight • CCPs and OPRPs defined during hazard analysis
- • Process flow diagrams with control points (linked to PRPs and CCPs) • Work instructions and operating procedures • Defined limits, tolerances, and control measures
2. Validate Equipment and Set-Up Procedures
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Control Measures:
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• Initial equipment qualification and periodic revalidation
• Calibration of instruments critical to food safety
• Routine and preventive maintenance
Evidence to Maintain:
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• Equipment validation and calibration certificates
• Maintenance logs and inspection checklists
• Pre-startup and changeover verification records
- • Initial equipment qualification and periodic revalidation • Calibration of instruments critical to food safety • Routine and preventive maintenance
- • Equipment validation and calibration certificates • Maintenance logs and inspection checklists • Pre-startup and changeover verification records
3. Implement In-Process Monitoring
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Monitoring Activities Should Include:
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• Continuous or batch-based monitoring of critical limits
• Sampling and inspection routines based on risk analysis
• Verification of key characteristics (e.g., temperature, weight, pH, label accuracy)
Evidence to Maintain:
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• Real-time process control logs
• In-process inspection reports and checklists
• Non-conformance and deviation records
- • Continuous or batch-based monitoring of critical limits • Sampling and inspection routines based on risk analysis • Verification of key characteristics (e.g., temperature, weight, pH, label accuracy)
- • Real-time process control logs • In-process inspection reports and checklists • Non-conformance and deviation records
4. Establish Corrective Action Protocols
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When Deviations Occur:
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• Define clear escalation procedures for non-conforming processes
• Isolate and evaluate affected products
• Conduct root cause analysis and implement preventive action
Evidence to Maintain:
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• Non-conforming product logs and hold/release records
• Corrective action reports (CARs)
• Employee retraining or procedural updates
- • Define clear escalation procedures for non-conforming processes • Isolate and evaluate affected products • Conduct root cause analysis and implement preventive action
- • Non-conforming product logs and hold/release records • Corrective action reports (CARs) • Employee retraining or procedural updates
Common Audit Findings & Recommended Fixes
| Audit Finding | Recommended Action |
|---|---|
| Lack of documented control parameters | Define, document, and communicate process specifications |
| Weak or inconsistent in-process monitoring | Introduce standardized forms, frequencies, and escalation steps |
| Missing corrective action records | Track all deviations with corresponding resolution actions |
| Uncalibrated or outdated equipment | Maintain an updated calibration and maintenance program |
