FSSC 22000 Version 6 Gap Analysis

Use this FSSC Version 6 Gap Analysis checklist to determine which new Version 6 requirements you have met, and which ones need further attention.

FSSC 22000 Version 6 Gap Analysis



Management Of Services And Purchased Materials (All Food Chain Categories)

1. Has the organization established, implemented, and maintained a review process for raw material and finished product specifications to ensure continued compliance with food safety, quality, legal, and customer requirements for food chain categories C, D, I, FII, G, and K?


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2. Has the organization, for food chain category I, established criteria related to the use of recycled packaging as a raw material input into the production of finished packaging material and ensured that relevant legal and customer requirements are being met, in addition to clause 7.1.6 of ISO 22000:2018?


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Product Labeling And Printed Materials (All Food Chain Categories)

1. Does the organization, when a claim is made on the product label or packaging (e.g., allergen, nutritional, method of production, chain of custody, raw material status, etc.), maintain evidence of validation to support the claim and have verification systems in place, including traceability and mass balance, to ensure product integrity is maintained?


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2. Have artwork management and print control procedures been established and implemented for food chain category I to ensure that the printed material meets applicable customer and legal requirements, addressing elements such as: • approval of artwork standard or master sample • managing changes to artwork and print specifications and to manage obsolete artwork and printing materials • approval of each print run against the agreed standard or master sample • detecting and identifying printing errors • ensuring effective segregation of differing print variants • accounting for any unused printed product?


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Threat Assessment

1. Has the organization conducted and documented the food defense threat assessment, based on a defined methodology, to identify and evaluate potential threats linked to the processes and products within the scope of the organization?


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2. Has the organization developed and implemented appropriate mitigation measures for significant threats?


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Vulnerability Assessment

1. Has the organization conducted and documented the food fraud vulnerability assessment, based on a defined methodology, to identify and assess potential vulnerabilities


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2. Has the organization developed and implemented appropriate mitigation measures covering the processes and products within the scope of the organization?


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Logo Use (All Food Chain Categories)

1. Is the certified organization allowed to use the FSSC 22000 logo, any statement, or make reference to its certified status on certificates of analysis or certificates of conformance (CoAs or CoCs), and where exclusions to the scope of certification apply?


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Management Of Allergens (All Food Chain Categories)

1. Does the organization have a documented allergen management plan that includes a list of: all allergens handled on-site. validation and verification of control measures implemented and maintained as documented information. Where more than one product is produced in the same production area that has different allergen profiles, is verification testing conducted at a frequency based on risk, e.g. surface testing, air sampling, and/or product testing.


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2. Are precautionary or warning labels only used where the outcome of the risk assessment identifies allergen cross-contamination as a risk to the consumer, even though all the necessary control measures have been effectively implemented? Does applying warning labels not exempt the organization from implementing the necessary allergen control measures or undertaking verification testing?


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3. All personnel receive training in allergen awareness and specific training on allergen control measures associated with their area of work.


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4. Is the allergen management plan reviewed at least annually, and following any significant change that impacts food safety, a public recall, or a product withdrawal by the organization as a result of an allergen/s, or when trends in industry show contamination of similar products relating to allergens? Does the review include an evaluation of the effectiveness of existing control measures and the need for additional measures? Is the verification data trended and used as input for the review?


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5. For Food Chain Category D: Where there is no allergen-related legislation for the country of sale pertaining to animal feed, does this section of the Scheme requirements be indicated as ‘Not Applicable,’ unless a claim relating to an allergen status has been made on the animal feed?


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Environmental Monitoring (Food Chain Categories Biii, C, I & K)

1. Is there a risk-based environmental monitoring program for relevant pathogens, spoilage, and indicator organisms?


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2. Does the organization have a documented procedure for the evaluation of the effectiveness of all controls on preventing contamination from the manufacturing environment, and does this include, at a minimum, the evaluation of microbiological controls present; and shall comply with legal and customer requirements?


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3. Has the environmental monitoring program been reviewed for continued effectiveness and suitability, at least annually, and more often if required, including when the following triggers occur: • Significant changes related to products, processes, or legislation • When no positive testing results have been obtained over an extended period of time • Trend in out-of-specification microbiological results, related to both intermediate and finished products • environmental monitoring • A repeat detection of pathogens during routine environmental monitoring • When there are alerts, recalls, or withdrawals relating to product/s produced by the organization


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Food Safety And Quality Culture (All Food Chain Categories)

1. In accordance with and in addition to clause 5.1 of ISO 22000:2018, as part of the organization’s commitment to cultivating a positive food safety and quality culture, has senior management established, implemented, and maintained a food safety and quality culture objective(s) as part of the management system? Have the following elements been addressed as a minimum: • Communication • Training • Employee feedback and engagement • Performance measurement of defined activities covering all sections of the organization impacting on food safety and quality


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2. Have the objective(s) been supported by a documented food safety and quality culture plan, with targets and timelines, and included in the management review and continuous improvement processes of the management system?


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Quality Control (All Food Chain Categories)

1. Has the organization: • In addition to, and aligned with, clauses 5.2 and 6.2 of ISO 22000:2018, established, implemented, and maintained a quality policy and quality objectives • established, implemented, and maintained quality parameters in line with finished product specifications, for all products and/or product groups within the scope of certification, including product release that addresses quality control and testing • In addition to, and aligned with, clauses 9.1 and 9.3 of ISO 22000:2018, undertake analysis and evaluation of the results of the quality control parameters, as defined under 2.5.9 (a)(ii) above, and include it as an input for the management review • In addition to, and aligned with, clause 9.2 of ISO 22000:2018, include quality elements as defined in this clause, within the scope of the internal audit


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2. Has the organization established, and implemented quantity control procedures, including for unit, weight, and volume to ensure products meet the applicable customer and legal requirements? Does this include a program for calibration and verification of equipment used for quality and quantity control?


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3. Are line start-up and change-over procedures established and implemented to ensure products, including packaging and labeling, meet applicable customer and legal requirements? Does this include having controls in place to ensure labeling and packaging from the previous run have been removed from the line?


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Transport, Storage And Warehousing (All Food Chain Categories)

1. Does the organization, for food chain category FI, ensure that the product is transported and delivered under conditions that minimize the potential for contamination?


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2. If organizations use tankers for the transportation of their final product, do they have a documented risk-based plan to address transport tank cleaning, considering potential sources of cross-contamination and appropriate control measures, including cleaning validation? Are measures in place to assess the cleanliness of the tanker at the point of reception of the empty tanker, prior to loading?


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3. For organizations receiving raw material in tankers, is there inclusion in the supplier agreement, as a minimum, to ensure product safety and prevent cross-contamination, with requirements such as tanker cleaning validation, restrictions linked to prior use, and applicable control measures relevant to the product being transported?


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Hazard Control And Measures For Preventing Cross Contamination (All Food Chain Categories, Excluding FII)

1. For all food chain categories, excluding FII, fo the following requirements relating to foreign matter management apply?


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2. Does the organization have a risk assessment in place to determine the need and type of foreign body detection equipment required? If the organization deems no foreign body detection equipment is necessary, is there justification maintained as documented information? Foreign body detection equipment includes equipment such as magnets, metal detectors, X-ray equipment, filters, and sieves.


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3. Are there documented procedures in place for the management and use of the selected equipment?


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4. Does the organization have controls in place for foreign matter management, including procedures for the management of all breakages linked to potential physical contamination (e.g., metal, ceramic, hard plastic)?


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Product Design And Development (Food Chain Categories BIII, C, D, E, F, I & K)

1. Is there a need to conduct production and shelf-life trials to validate product formulation and processes capable of producing a safe product and meeting customer requirements? Is there a process for ongoing shelf-life verification in place, at a frequency based on risk?


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2. If a ready-to-cook product is produced, are the cooking instructions provided on the product label or packaging validated to ensure food safety is maintained?


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Equipment Management (All Food Chain Categories, Excluding FII)

1. Does the organization have a documented purchase specification in place addressing hygienic design, applicable legal and customer requirements, and the intended use of the equipment, including the product handled? Does the supplier provide evidence of meeting the purchase specification prior to installation?


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2. Is there a risk-based change management process for new equipment and/or any changes to existing equipment, adequately documented, including evidence of successful commissioning? Are possible effects on existing systems assessed, and adequate control measures determined and implemented?


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Food Loss And Waste (All Food Chain Categories, Excluding I)

1. Does the organization have: A documented policy and objectives detailing the organization’s strategy to reduce food loss and waste within their organization and the related supply chain? Are controls in place to manage products donated to not-for-profit organizations, employees, and other organizations, ensuring that these products are safe to consume? Are surplus products or by-products intended as animal feed/food managed to prevent contamination of these products? Do these processes comply with applicable legislation, are they kept up to date, and do they not have a negative impact on food safety?


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Communication Requirements (All Food Chain Categories)

1. Does the organization inform the certification body within 3 working days of the commencement of the events or situations below and implement suitable measures as part of their emergency preparedness and response process: serious events impacting the FSMS, legality, and/or the integrity of the certification? Does this include situations that pose a threat to food safety or certification integrity as a result of force majeure, or natural or man-made disasters (e.g., war, strike, terrorism, crime, flood, earthquake, malicious computer hacking, etc.)?


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2. Serious situations where the integrity of the certification is at risk and/or where the foundation can be brought into disrepute? Does this include: • public food safety events (e.g., public recalls, withdrawals, calamities, food safety outbreaks, etc.) • where additional monitoring or forced shutdown of production is required • legal proceedings, prosecutions, malpractice, and negligence • fraudulent activities and corruption


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Checklist by GoAudits.com – Please note that this checklist is intended as an example. We do not guarantee compliance with the laws applicable to your territory or industry. You should seek professional advice to determine how this checklist should be adapted to your workplace or jurisdiction.

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