Top 10 Non-Conformities in FSSC22000: Insights and Solutions for Food Businesses in the Middle East

FSSC 22000 Additional Requirement 2.5.15 | Equipment that is not properly specified, commissioned or managed introduces contamination risks and undermines the integrity of downstream food safety controls. This requirement is frequently underestimated, particularly by organizations outside direct manufacturing such as cold chain, storage and distribution operations.

Common Non-Conformities

• No documented purchase specification for equipment
• Specifications omit hygienic design, legal or customer requirements
• No supplier evidence confirming compliance prior to installation
• No change management process for new or modified equipment
• Changes made without a risk assessment or impact evaluation on the food safety management system (FSMS)
• Missing or inadequate commissioning records

Field Observation: Many facilities, particularly those in non-manufacturing segments of the food chain such as storage and distribution, lack documented procedures for equipment selection, maintenance and verification.

Recommended Actions

• Establish detailed equipment purchase specifications covering hygienic design, legal and operational requirements
• Obtain and retain supplier compliance evidence before installation (e.g., certificates and design drawings)
• Implement a risk-based change management procedure for all equipment modifications
• Conduct and document a risk assessment before any change is made
• Maintain commissioning and validation records to confirm equipment operates safely 

FSSC 22000 Additional Requirement 2.5.6 | Allergen management remains one of the highest-risk areas in food safety, with direct consequences for consumer health and regulatory compliance. Cross-contact from inadequate segregation, unvalidated cleaning procedures or unclear labeling continues to be a leading cause of product recalls across the region.

Common Non-Conformities

• No documented allergen management plan
• Incomplete or missing allergen register for raw materials and finished products
• No risk assessment for cross-contamination scenarios
• Ineffective or absent control measures such as segregation and validated cleaning
• No validation or verification program (e.g., swab tests, analytical testing)
• Precautionary allergen labeling applied without justification from risk assessment
• Personnel not trained on allergen awareness and control
• No annual review or update following product changes, incidents or recalls

Field Observation: In one case, shared preparation areas led to unintended nut residue in an allergen-free product, caused by the absence of a validated changeover procedure and defined allergen zoning.

Recommended Actions

• Establish and maintain a comprehensive allergen management plan
• Keep an updated allergen register for all raw materials and finished products
• Perform detailed risk assessments for all potential cross-contact points
• Implement validated control measures including segregation, scheduled cleaning and dedicated handling
• Conduct allergen-specific verification testing based on risk
• Apply precautionary labeling only when supported by documented risk assessment
• Provide allergen awareness training for all relevant personnel
• Conduct an annual review and update the plan following changes, incidents and trend analysis 

FSSC 22000 Additional Requirement 2.5.7  | A structured environmental monitoring program is the first line of defense against undetected microbiological contamination in food production environments. High-risk categories including dairy, ready-to-eat and chilled products are particularly exposed when this requirement is not systematically implemented.

Common Non-Conformities

• No risk-based environmental monitoring program
• Program does not cover relevant pathogens or indicator organisms
• No documented procedure for evaluating the effectiveness of controls
• Missing or inadequate microbiological verification
• No trend analysis of environmental monitoring results
• Program not reviewed regularly or following key triggers such as process changes or positive findings
• No defined corrective actions for positive or repeated contamination results

Field Observation: One food processing site had no microbiological swabbing of high-care zones, leaving the environment vulnerable to undetected contamination including Listeria or Salmonella.

Recommended Actions

• Establish a risk-based environmental monitoring program defining zones, target organisms and sampling frequency
• Document a procedure to evaluate the effectiveness of environmental controls
• Include regular microbiological testing aligned with legal and customer requirements
• Maintain records and perform trend analysis on all results
• Define and implement corrective actions for any positive findings
• Review the program at least annually and following triggers such as process changes, recalls or repeated positives

FSSC 22000 Additional Requirement 2.5.8 | Culture is often assumed rather than measured. FSSC 22000 V6 requires organizations to actively demonstrate, monitor and improve food safety and quality culture rather than treating it as an implied outcome of having a documented system in place.

Common Non-Conformities

• Culture program does not address the required elements: communication, training, employee engagement and performance measurement
• No documented culture plan with defined targets and timelines
• Culture objectives not recorded as a standing input to management review meetings
• Lack of evidence demonstrating implementation or monitoring of culture initiatives

Field Observation: Some facilities had food safety policies prominently displayed, yet a significant portion of staff could not describe basic concepts such as critical control points or the process for reporting concerns.

Recommended Actions

• Senior management to establish and visibly demonstrate commitment to food safety and quality culture
• Ensure the program addresses communication, training, employee engagement and performance measurement
• Develop a documented culture plan with specific, measurable targets and timelines
• Include the culture program as a standing agenda item at management review meetings
• Monitor, measure and record the progress and impact of culture initiatives
• Conduct annual food safety culture assessments using defined KPIs such as training completion rates and incident response times
• Create mechanisms for anonymous employee feedback and active leadership involvement 

FSSC 22000 Additional Requirement 2.5.2 | Errors in labeling, whether from outdated artwork, unvalidated claims or inadequate version control, can expose consumers to undeclared allergens and expose organizations to regulatory action and recall costs. This requirement demands a systematic approach to label governance throughout the product lifecycle.

Common Non-Conformities 

• Claims on labels (allergen, nutritional, origin) not validated or supported with evidence
• No verification system such as traceability or mass balance to confirm claim integrity
• Artwork and print control procedures for Category I packaging materials missing or incomplete
• No formal approval process for master samples or artwork
• No controls for managing artwork changes or retiring obsolete materials
• Inadequate print run approval and error detection processes
• No segregation of different print variants or controls for unused printed materials

Field Observation: One organization shipped products using outdated packaging that omitted key allergen declarations. Obsolete labels had not been securely destroyed and remained accessible on the production floor.

Recommended Actions

• Implement a label verification procedure at each stage of production
• Validate all packaging content against regulatory requirements before printing
• Establish version control and documented disposal procedures for obsolete labels
• Validate all claims on labels and retain supporting evidence
• Implement artwork management and print control procedures for Category I packaging, covering master sample approval, change management, print run approval, variant segregation and reconciliation of unused materials

FSSC 22000 Additional Requirements 2.5.3 and 2.5.4 | Food fraud and food defense represent two distinct but related vulnerabilities. Fraud addresses economically motivated adulteration of ingredients or materials, while defense addresses the intentional contamination of food for malicious purposes. Both require documented, risk-based assessments that are regularly reviewed and kept current with supply chain realities.

Common Non-Conformities

• No documented food fraud vulnerability assessment
• Threats not evaluated against all ingredients, processes and supply chain nodes
• Mitigation measures not defined or not aligned with identified vulnerabilities
• No food defense threat assessment covering intentional adulteration scenarios
• Procedures not reviewed following incidents, supply chain changes or regulatory updates
• Personnel not aware of their responsibilities under food fraud and food defense requirements

Field Observation: At one facility, a food fraud vulnerability assessment existed on paper but had not been updated in over two years, meaning recently onboarded high-risk ingredients had never been evaluated for fraudulent substitution risk.

Recommended Actions

• Conduct and document a formal food fraud vulnerability assessment covering all raw materials, ingredients and supply chain steps
• Define and implement specific mitigation measures for each identified vulnerability
• Complete a separate food defense threat assessment addressing intentional contamination or sabotage scenarios
• Review both assessments at least annually and following any relevant trigger (supplier change, recall or regulatory update)
• Assign clear responsibilities and provide training for relevant personnel 

ISO 22000 Clause 8.3 | An effective traceability system must be capable of rapidly linking raw materials to finished products and identifying the first point of delivery. Many facilities across the region still rely on fragmented, paper-based records that cannot support a timely and complete product recall when it matters most.

Common Non-Conformities

• Traceability system cannot link raw materials to finished products due to missing lot-level connections
• No controls or records for rework traceability
• Distribution records incomplete and unable to identify the first point of delivery
• Records not retained for the required period relative to product shelf life
• Legal and customer traceability requirements not identified or implemented
• Traceability testing (mock recall) not conducted or results are slow and incomplete

Field Observation: In one recall simulation exercise, the team was unable to identify all raw material lots used in a finished product within the required timeframe, exposing a critical gap in the lot-linkage system.

Recommended Actions

• Implement a full end-to-end traceability system covering supplier, production and first point of delivery
• Ensure clear lot and batch linkage for all materials, intermediates and finished products
• Control and document rework traceability at all stages
• Maintain accurate distribution records to enable rapid identification of affected product
• Define and follow a record retention policy aligned with product shelf life
• Conduct regular mock recall exercises and verify their speed and completeness against defined criteria 

ISO 22002-1 Clause 8.6 | Maintenance activities that are reactive, poorly documented or carried out without adequate hygiene controls create direct contamination risks. The release of equipment back into production without verification is one of the most commonly observed gaps during SGS audits in the region.

Common Non-Conformities

• No preventive maintenance program or incomplete coverage of critical equipment
• Monitoring and control devices such as metal detectors, filters and magnets not included
• Maintenance tasks not prioritized based on food safety risk
• Use of non-food-grade lubricants where contamination risk exists
• Temporary repairs left in place without permanent corrective action or tracking
• Equipment not cleaned, sanitized or inspected before being returned to production
• Maintenance activities creating cross-contamination risk to adjacent production areas
• Maintenance personnel not trained on food safety hazards

Field Observation: One facility routinely serviced slicing machines without confirming cleanliness afterward, which contributed to microbial findings in the finished product during environmental monitoring.

Recommended Actions

• Establish a comprehensive preventive maintenance program covering all food safety-related equipment
• Include and maintain monitoring and control devices such as metal detectors and filters
• Prioritize maintenance tasks based on the level of risk they present to product safety
• Use only food-grade lubricants where there is a risk of contact with product
• Replace temporary repairs with permanent fixes and track them through to closure
• Implement a formal equipment release procedure including cleaning, sanitation and documented inspection
• Train maintenance personnel on food safety risks and their responsibilities

ISO 22000 Clause 8.5.4 | The hazard control plan is the operational core of any FSMS. Gaps here, whether in hazard identification, critical limit setting or monitoring practice, directly compromise the ability to prevent or detect unsafe product. Staff understanding of the plan is as important as the document itself.

Common Non-Conformities

• No documented hazard control plan or plan is materially incomplete
• CCPs and OPRPs defined without clearly identified hazards
• Critical limits or action criteria missing, incorrect or not scientifically justified
• Monitoring procedures not defined or not followed consistently in practice
• No defined corrections or corrective actions when limits are exceeded
• Responsibilities and authorities for monitoring not assigned
• Monitoring records missing, incomplete or not retained

Field Observation: Staff at a beverage production line recorded pH values that were outside specification but took no corrective action. When questioned, they could not articulate the significance of the limit or their responsibility when it was breached.

Recommended Actions

• Establish a complete, documented hazard control plan for all CCPs and OPRPs
• Clearly define hazards, critical limits for CCPs and action criteria for OPRPs
• Implement and follow monitoring procedures specifying who monitors, how and at what frequency
• Define and apply corrections and corrective actions for all deviations
• Assign clear responsibilities and authorities for all monitoring activities
• Maintain accurate monitoring records as objective evidence of control 

FSSC 22000 Additional Requirement 2.5.16 | This requirement reflects the growing importance of sustainability within the food safety framework. Many food businesses in the region lack systems for measuring waste, managing surplus responsibly or ensuring that donated or redirected products are handled with the same food safety rigor as products entering normal trade channels.

Common Non-Conformities

• No documented policy or measurable objectives for reducing food loss and waste
• No controls for managing donated products including food safety verification
• Surplus products or by-products not properly managed, creating contamination or traceability risks

Field Observation: A food service operation was discarding large volumes of prepared meals daily without tracking quantities or investigating root causes for overproduction, generating both food safety risk and significant waste.

Recommended Actions

• Establish a documented food loss and waste policy with clear, measurable objectives
• Track food loss at each production stage and set quarterly reduction targets
• Implement controls for safe donation of surplus products, including food safety checks, labeling and traceability records
• Segregate and manage by-products to prevent contamination and maintain traceability
• Ensure all waste and reuse processes comply with applicable legislation
• Integrate food safety risk assessment into all food loss, reuse and donation processes