From Risk Assessment to Prevention: Managing Physical Contamination Under FSSC 22000

Risk assessment drives every effective physical contamination control program. Without understanding where contamination can enter your process, prevention measures may fall short.

Kelly Mulholland, Technical Manager for Safety and Quality at Foundation FSSC, highlighted a critical trend identified at the time of her webinar hosted by Vikan Ltd: Physical contamination has become the number one nonconformity in FSSC 22000 Version 6 audits.

She outlined how a proper risk assessment paired with targeted prevention strategies can help food manufacturers stay compliant and protect consumers.

This represents a significant shift. Physical contamination was the second most common nonconformity based on data from Version 6 audits conducted between April and December 2024. This upward trend demonstrates why effective foreign matter management has become critical for food manufacturers.

How FSSC 22000 Addresses Physical Contamination

FSSC 22000 builds its requirements through three distinct document layers that add specificity to how organizations must manage physical contamination in their operations.

To start with, ISO 22000 provides requirements on hazard analysis and control, whilst sector-specific prerequisite programs add more detailed requirements, and FSSC 22000 Additional Requirements add further requirements for foreign matter management.

ISO 22000: The Food Safety Management System (FSMS) Requirements

ISO 22000 provides the normative standard for food safety management systems incorporated within FSSC 22000. Clause 8.2.4 requires organizations to implement prerequisite programs, including cross-contamination prevention measures. Clause 8 further requires that organizations conduct a hazard analysis and implement suitable control measures for significant hazards to ensure food safety, part of which is the consideration of physical hazards within their hazard analysis. 

ISO/TS 22002-1: Detailed Pre-requisite Program (PRP) Requirements for Food Manufacturers

ISO/TS22002-1:2009 provides detailed PRP requirements for food manufacturers.

Clause 10.4 in the technical specification specifically addresses measures for the prevention of physical contamination. This is where the detailed requirements come into play.

Keep in mind that whilst ISO/TS 22002-1 applies for food manufacturing, there are other sector specific PRP standards for other sectors, so make sure to check which applies to your organization in the food chain, to identify what requirements are relevant to your specific industry.

FSSC 22000 Additional Requirement 2.5.11(d): Foreign Matter Management

FSSC 22000 Additional Requirement 2.5.11(d), found in Part 2 of the Scheme document, adds specific requirements for foreign matter management beyond the ISO standards. This additional requirement works in conjunction with clause 8.2.4 (h) of ISO 22000:2018.

Organizations shall also refer to the Board of Stakeholders decision list, available on our website. This document contains decisions applicable to FSSC 22000 that overrule or provide further clarification on existing Scheme requirements.  Make sure to keep up to date with the latest version of thesis document.

The Mandatory Risk Assessment Requirement

Additional Requirement 2.5.11 (d) makes risk assessment mandatory. Organizations must conduct a risk assessment to determine both the need for, and type of foreign body detection equipment required.

Detection equipment options: This includes, and is not limited to magnets, metal detectors, X-ray equipment, filters, and sieves. Which equipment your organization needs depends entirely on your specific operation and the outcome of the risk assessment.

No detection equipment needed: If your risk assessment concludes that no foreign body detection equipment is necessary, the decision must be justified and supported with documented information. Auditors will review this justification during FSSC 22000 audits.

Equipment management procedures: Organizations must establish procedures for the management and use of selected equipment. These procedures ensure adequate equipment management and effective use.

What Are Some Common Sources of Physical Contamination

Understanding potential contamination sources is the first step in building an effective prevention strategy.

Brittle materials: Glass and hard plastics can break, chip, or shatter, introducing fragments into food products. These materials require specific controls under Clause 10.4 of ISO/TS 22002-1, and FSSC 22000 Additional Requirement 2.5.11 (d).

Metal contamination: A major hazard addressed through detection equipment like metal detectors and magnets. Sources of metal contamination can be from equipment such as blenders, blades on equipment, knives, and utensils, for example.

Often-overlooked sources include:

• Wooden pallets that can introduce splinters

• Maintenance or production tools

• Rubber seals on equipment that may degrade and release small pieces

• Personal protective clothing and equipment that can shed fibers or components

Each source requires consideration in your risk assessment. Prevention strategies shall address the specific hazards present in your facility.

Prevention Measures Under Clause 10.4

Clause 10.4 of ISO/TS 22002-1 provides specific requirements for preventing physical contamination.

Managing Brittle Materials

Periodic inspection: When your organization uses brittle materials like glass or hard plastic, you must implement regular inspections. These ensure items remain intact without chips or damage, and when damage occurs that it is identified and actions taken.

Breakage procedures: Defined procedures are mandatory. Your procedures must explain how to deal with breakages, how to manage them, and how to prevent product contamination when incidents occur.

Record retention: Organizations must retain records of glass or hard plastic breakage for traceability purposes. These records become essential when conducting contamination incident investigations.

Avoid where possible: Organizations should therefore minimize the use of brittle materials in equipment components to the extent possible, to lower the risk of potential product contamination.

Risk-Based Controls

Organizations must implement measures based on risk assessment to prevent, control, or detect potential contamination, such as:

Physical barriers: Adequate covers over equipment or containers to protect exposed materials and products. Screens separate products from potential contaminants. Sieves filter out physical particles. Filters remove contamination from liquids or air.

Proactive controls: In-process magnets remove metal contaminants before they reach final products.

Detection devices: Metal detectors and X-ray machines detect foreign bodies.

Your risk assessment determines which combination of measures is appropriate. Not all organizations need all measures, but selection must be justified based on the risk assessment.

Documentation Requirements

Proper documentation supports both effective implementation and successful audit outcomes.

Breakage records: Must be retained for traceability purposes.

Risk assessment documentation: Document both the methodology followed and the outcomes reached.

Equipment selection justification: Whether you select specific detection equipment or determine none is necessary, your justification must be documented and clearly linked to your risk assessment.

Procedures: Breakage incident procedures and equipment management procedures must be written, accessible, and followed.

Further details on additional requirements can be found in the FSSC 22000 Scheme document, Board of Stakeholders decision list, and scheme interpretation articles.

Key Takeaways for FSSC 22000 Compliance

The rise of nonconformities related to physical contamination sends a clear message: food manufacturers must review and keep their foreign matter management systems up to date to ensure proper controls are in place

Risk assessment is mandatory: It must be specific to your organization and drives decisions about detection equipment and preventive controls.

Prevention before detection: Implement measures that prevent contamination from entering products first. Use risk-based controls like covers, screens, magnets, sieves, and filters.

Multiple standards work together:  FSSC 22000 has an unique approach whereby the power of multiple standards are combined, namely ISO 22000 that provides the FSMS framework, the ISO Technical Specifications that provide detailed PRP requirements including on measures for the prevention of cross contamination, plus the FSSC 22000 Additional Requirement 2.5.11 that adds specific foreign matter management requirements. All must be considered together for full compliance.

Documentation is critical: Without proper records, risk assessments, justifications, and procedures, you cannot demonstrate compliance during audits.

Foundation FSSC acknowledges that useful guidance exists beyond Scheme requirements. Organizations should seek out and utilize available resources to strengthen their foreign matter management programs.

Effective foreign matter management is essential to ensure food safety and to protect both your certification status and the consumers who trust your products.

This article is based on a webinar presentation by Kelly Mulholland, Technical Manager for Safety and Quality at Foundation FSSC.