Additional Requirements FSSC 22000 V6

By Luciareli Garcia, Global Standards Auditor

The FSSC 22000 scheme is made up of three elements, the base standard of ISO 22000, the prerequisites for each category of the food chain (based on technical specifications for the sector e.g. ISO/TS 22002-x; PAS xyz); and additional requirements set by GFSI stakeholders.

The additional requirements are established by GFSI because the prerequisites lack some specific points that stakeholders consider important to maintain quality and safety in each category of the food chain.

In this blog, we will describe the additional requirements as well as changes that have been developed for FSSC 22000 V6.0.

2.5.1 Management of purchased services and materials (All categories)

Laboratories used for verification or validation must be able to ensure the accuracy and repeatability of tests using validated methods and good laboratory practices (e.g. ISO 17025).

Organizations with categories C, D, I, FII, G, and K, must document a procedure to make purchases in emergencies, to ensure safety and quality.

For food chain categories C0, CI, CIll, and CIV the organization shall have a policy for the procurement of animals, fish, and shellfish that are subject to the control of prohibited substances (e.g. pharmaceuticals, veterinary drugs, heavy metals, and pesticides).

Categories C, D, I, FI, G, and K must have a procedure to review raw materials, in compliance with the specifications of materials and finished products to ensure compliance with food safety, quality, legal, and customer requirements.

For Category I, the organization must establish criteria for the use of recycled packaging that will be used as raw material in the production of finished packaging material. These criteria must ensure that no F.Q.B. hazard is introduced and ensure quality compliance.

2.5.2 Labeling of products and printed materials (all categories).

Finished products must be labeled under all applicable legal and regulatory requirements in the country of sale ensuring allergen declarations and customer requirements.

Where a product is not labeled, all relevant product information should be available to ensure the safe use of the food by the customer or consumer.

Where a claim (e.g. allergen, nutritional, production method, etc.) is made on the product label or packaging, the organization shall maintain evidence of validation to support the claim and shall have verification systems in place, including traceability and mass balance, to ensure that product integrity is maintained.

For Category I, a procedure for graphic material management and print control, shall be established to ensure that printed material complies with legal and customer requirements. The procedure will address, at a minimum: the approval of standard samples or artwork; the process for changes in printing specifications and management of obsolete material; the process to ensure effective segregation of different print variants, and the handling of unused printed products.

2.5.3 Food defense (all categories)

The organization shall have a documented procedure to perform food defense threat assessment based on a defined methodology (e.g. TACCP (Threat Analysis and Critical Control Points; recommended by PAS96), CARVER + Shock, and FDA Food Defense Plan Builder), which can be used by organizations to identify potential threats linked to processes and products within the scope of the organization. The organization should implement appropriate mitigation measures for threats that prove to be significant, derived from the assessment.

The organization should document a mitigation plan and verification procedures covering processes and products within the scope of the food safety management system, this plan should conform to applicable legislation and be supported by the FSMS and senior management of the organization; it should contain elements such as verification activities, corrections and corrective actions, responsibilities, and continuous improvement, because it is information for management review.

For the FIl food chain category, in addition to the above, the organization must request that suppliers have a food defense plan.

2.5.4 Mitigation of food fraud (all categories)

Conduct a Food Fraud Vulnerability Analysis based on a methodology that identifies potential vulnerabilities such as substitution, unapproved improvements, misbranding, counterfeiting, stolen products, or others.

Identify and select proportionate control measures for significant vulnerabilities, including all processes, and products that are within the scope of the management system.

Document vulnerability analysis, control measures, verification, and incident management procedures in a Food Fraud Prevention Plan supported by the Food Safety Management System that should contain system elements such as training, internal audits, management review, etc., as well as operational control measures, verification activities, corrections and corrective actions, responsibilities, record keeping, verification activities, and continuous improvement.

For the FIl food chain category, in addition to the above, the organization must request that suppliers have a food fraud mitigation plan in place.

2.5.5 Use of logos (All categories)

The use of the FSSC 22000 logo image is for advertising purposes only, it should not be used on documents that infer that the product has been certified, such as COAs or quality certificates, on the label, on the product, on the primary or secondary packaging, or where exclusions to the scope of certification apply.

2.5.6 Allergen management (all categories)

A documented Allergen Management Plan should be in place, including a list of all allergens handled on-site (raw materials and finished products). A risk assessment should be performed covering all possible sources of allergen cross-contact contamination and derived from this assessment Identify and implement control measures to reduce or eliminate the risk of allergen cross-contact contamination.

The plan should include validation and verification of control measures and when more than one product is produced in the same production area that has different allergen profiles, allergen-free verification should be performed at a frequency based on the risk of allergen cross-contact contamination..

When an allergen warning is declared on the labels, it must be justified by the result of the risk assessment. The application of warning labels does not exempt the organization from implementing the necessary allergen control measures or verification testing.

The organization shall ensure that all personnel receive allergen awareness training and identification of control measures associated with their work area.

The allergen management plan shall be reviewed at least annually, and after any significant change affecting food safety, a public recall or product recall by the organization, or when industry trends show allergen contamination in products or processes similar or related to the organization.

The review of the plan should include an assessment of the effectiveness of existing control measures and the need for additional measures.

For Category D: When there is no allergen-related legislation for the country of sale for animal feed, this section of the scheme requirements may be indicated as “Not applicable”.

2.5.7 Environmental monitoring (categories BIII, C, I & K)

The organization should conduct a risk-based environmental monitoring program for relevant pathogens, spoilage, and indicators.

A procedure establishing microbiological controls should be documented and should comply with legal and customer requirements. These controls should be monitored and analyzed for trends.

At least once a year the program should be verified to ensure its effectiveness; or when any change occurs such as changes in products, processes, or legislation; when a prolonged period when there are no positive results for the sought microorganisms over a prolonged time when the trend of microbiological results is out of specification; when a pathogen is detected and when there are alerts, recalls or withdrawals related to the organization’s product/process.

2.5.8 Quality Culture and Food Safety (all categories)

Senior management should establish, implement, and maintain quality and food safety culture objectives, establishing a work plan that addresses communication, training, feedback, and employee engagement, as well as performance measurement. The objectives should be supported by the quality and food safety culture plan, should have measurable objectives, and established timelines for achieving them, and such information should be input for management review and continual improvement.

2.5.9 Quality Control (all categories)

The organization shall establish, implement, and maintain a quality policy and quality objectives and quality parameters for all products and/or product groups within the scope of the safety management system, including product launches addressing quality control and approvals.

An analysis and evaluation of the results of the quality control parameters (objectives, specifications, or quality parameters) should be carried out and reported for management review.

The audit scope shall include quality elements defined in this requirement.

The organization shall establish and implement quantity control procedures to ensure that products comply with applicable legal and customer requirements. This shall include a program for calibration and verification of equipment used for quality and weight control.

Start-up and line changeover procedures shall be established and implemented to ensure that products, including packaging and labeling, comply with applicable legal and customer requirements. This shall include the implementation of controls to ensure that labeling and packaging from the previous run have been removed from the line.

2.5.10 Transport and storage (all categories)

The organization should establish, implement, and maintain a procedure and specified stock rotation (FIFO, FEFO) in the warehouse.

For category C0, the organization must have specific requirements defining the post-slaughter storage time and temperature for chilling or freezing the products.

For the Fl food chain category, in addition to BSI/PAS 221:2013 clause 9.3, the organization shall ensure that the product is transported and delivered under conditions that minimize potential contamination.

Where transport tankers are used, a documented risk-based plan should be in place to address the cleanliness of transport tanks and should consider potential sources of cross-contamination and appropriate control measures, including validation of cleanliness. Measures should be implemented to assess tank truck cleanliness at the point of receipt of the empty tank truck, before loading. Request from the supplier as a minimum to ensure product safety and avoid cross-contamination: validation of tank truck cleanliness, restrictions linked to previous use, and applicable control measures relevant to the product being transported.

2.5.11 Control of hazards and measures to prevent cross-contamination (all categories of the food chain, excluding FII).

For food chain categories BIII, C & I, specific requirements must be in place when packaging is used to impart or provide a functional effect on food (e.g. shelf-life extension).

As for food chain category C0, there must be specific requirements for an inspection process in the livestock breeding and/or evisceration process to ensure that the animals are fit for human consumption.

For category D, procedures must be in place to manage the use of additive ingredients containing component nutrients that may hurt animal health.

For all food chain categories except FII, it must meet the following requirements:

The organization should conduct a risk analysis to determine the need and type of foreign body detection equipment required (magnets, metal detectors, x-rays, filters, or sieves). Procedures for the use of such equipment should be documented.

If the organization considers that foreign body detection equipment is not necessary, it should be justified and maintained as documented information.

The organization should have an established control for the handling of foreign materials, including procedures for handling all breakage.

2.5.12 Verification of PRPs (Categories BIII, C, D, G, I & K).

Clause 8.8.1 of ISO 22000, verification of PRPs and hazard control plan, is reinforced in such a way that the organization shall verify the implementation of PRPs through periodic inspections, with a frequency justified by the level of risk. Inspections and verification sheets should be linked to relevant technical specifications (such as ISO/TS, Codex, or local regulations).

2.5.13 Product design and development (Categories BIII, C, D, E, F, I & K).

A design and development procedure should be established for new products and product or process changes.

The impact of the change on the safety management system and any introduction of new hazards (e.g. allergens) should be assessed. Consider all necessary resources and training, equipment, and maintenance requirements.

A process should be in place for ongoing verification of service life at a risk-based frequency.

For ready-to-cook (RTC) foods, cooking instructions should be validated to ensure that safety is preserved.

2.5.14 Health status (category D food chain)

The organization shall have a procedure to ensure that the health of personnel does not hurt food production operations. Employees shall undergo a medical examination before working in food contact operations unless the risk analysis or medical assessment indicates otherwise is not permitted by law.

2.5.15 Equipment management (all categories, except FII)

Organizations should have purchasing specifications that address the hygienic design of equipment, customer requirements, intended use of the equipment, and the type of product handled. Equipment suppliers should be able to provide evidence that equipment specifications are met before installation. Risk-based processes should be established and implemented to manage changes to new or existing equipment.

These processes shall be adequately documented, with evidence of their successful implementation.

2.5.16 Food waste (All categories, except I)

There should be a policy and measurable objectives detailing the strategy for reducing food waste both within the organization and throughout the supply chain.

This requirement will require controls to ensure the safety of donated food.

Surplus or by-products destined for animal feed should be managed in such a way as to prevent their contamination.

All these processes must comply with local regulations, be kept up to date, and not hurt safety.

2.5.17 Communication requirements (All categories)

Certified organizations must communicate to CBs, serious events that impact the FSMS, legality, and/or integrity of certification, including situations that pose a threat to food safety or certification integrity as a result of force majeure events, natural or man-made disasters (e.g. war, strike, terrorism, crime, flood, earthquake, malicious hacking, etc.), as well as serious situations where the integrity of certification is at risk and/or where the Foundation may be discredited.

2.5.18 2.5.18 Requirements for multisite certified organizations (categories E, F & G)

Central function management should ensure that sufficient resources are available, and that roles, responsibilities, and requirements are clearly defined for management, internal auditors, technical staff reviewing internal audits, and other key personnel involved in the FSMS.

For internal audits, in addition to clause 9.2 of ISO 22000-2018, the organization shall comply with the following requirements:

Corporate or head office, establish internal audit procedures and programs ensuring fairness at the sites. Ensure that all sites are audited at least annually or more frequently based on a risk assessment and demonstrate the effectiveness of corrective action.

FSSC 22000 in its constant updates seeks that organizations ensure safe and good quality food. In the FSSC 22000 V6.0 version, quality requirements have been added as a fundamental part of the scheme, covering points that perhaps were left aside, as well as importance so that in the end quality and safety are not different definitions, but elements that converge to ensure the health of the consumer.