Manufacturing Process Controls

Aligned with BRCGS for Consumer Products – Section 4: Process Control

Requirement Overview

BRCGS for Consumer Products (Issue 4, applicable to both Personal Care and General Merchandise) requires that manufacturing operations are controlled to ensure that products consistently meet defined quality and safety standards.

Clause 4.1.1 (General): “The company shall identify the controls necessary for the manufacturing process and ensure these are implemented and maintained.”

Process control is essential for minimizing variability, preventing product defects, and ensuring conformance to customer and regulatory requirements.

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

  • ✓ Establish and maintain control over all critical manufacturing steps

    ✓ Ensure that operating parameters, equipment, and materials meet defined specifications

    ✓ Prevent the production of unsafe, non-conforming, or inconsistent consumer products

    ✓ Document evidence of ongoing process monitoring and corrective actions

Step-by-Step Compliance Implementation

1. Identify Key Process Control Points

  • Control Points May Include:

    • • Mixing, filling, assembly, packaging, and curing

      • Temperature, pressure, torque, weight, or pH (as applicable)

      • Automated equipment settings or operator-defined parameters

    Evidence to Maintain:

    • • Documented process maps or flow diagrams

      • Work instructions and process specifications

      • Defined tolerances and critical limits

2. Validate Equipment and Set-Up Procedures

  • Control Measures Include:

    • • Equipment calibration and qualification

      • Preventive maintenance schedules

      • Start-up and changeover checklists

    Evidence to Maintain:

    • • Calibration certificates and service logs

      • Set-up verification checklists

      • Pre-operational inspection records

3. Implement In-Process Monitoring

  • Monitoring Activities Should Include:

    • • Real-time checks during production

      • Verification of weights, dimensions, appearance, or function

      • Sampling and inspection frequency based on risk

    Evidence to Maintain:

    • • In-process inspection records

      • Non-conformance logs and deviation reports

      • Batch records with operator sign-offs

4. Establish Corrective Action Protocols

  • Required Actions:

    • • Define response procedures for out-of-spec conditions

      • Isolate, hold, and assess affected products

      • Conduct root cause analysis and implement corrective actions

    Evidence to Maintain:

    • • Hold and rework records

      • Corrective action reports (CARs)

      • Staff retraining documentation (if applicable)

Common Audit Findings & Recommended Fixes

Audit Finding Recommended Action
Lack of documented control parameters Define and document key process specs for each step
Inadequate in-process checks Introduce standardized monitoring procedures and frequencies
No evidence of corrective actions Record deviations and link to specific actions and resolutions
Equipment not calibrated Maintain calibration log and verify accuracy at defined intervals

Auditor Verification Checklist

During a BRCGS audit, expect to present:

  • • Defined process control parameters and critical limits

    • Work instructions and visual standards for operators

    • Monitoring and inspection records

    • Logs of non-conformance, corrective actions, and follow-up

    • Calibration and maintenance records

Implementation Roadmap

Build Your Program

  • ✓ Develop process flow diagrams and control point identification

    ✓ Define operating limits and tolerances

Train and Execute

  • ✓ Train operators on monitoring procedures and escalation steps

    ✓ Implement inspection checklists and sampling plans

Monitor and Validate

  • ✓ Record all monitoring results and equipment data

    ✓ Audit compliance to procedures regularly

Improve Continuously

  • ✓ Analyze process data to reduce variability

    ✓ Update procedures after non-conformances or changes

Why This Matters?

  • ✓ Reduces the risk of product defects and consumer complaints

    ✓ Ensures consistency in product appearance, performance, and safety

    ✓ Strengthens traceability and root cause investigations

    ✓ Demonstrates proactive compliance during audits

Support Tools Available

Food Safety Systems provides:

  • ✓ Process control SOP templates

    ✓ Visual inspection standards and operator guides

    ✓ In-process monitoring logs and checklists

    ✓ Corrective action tracking forms and root cause templates

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Food Safety Systems is an independent consulting provider. We offer support services to help businesses prepare for BRCGS certification but are not affiliated with, endorsed by, or certified by BRCGS, the British Retail Consortium, or any of its related entities. All trademarks, logos, and brand names are the property of their respective owners and are used for identification purposes only. Use of these names does not imply any official endorsement or partnership.

For official BRCGS requirements and guidance, visit www.brcgs.com.