Clause 5 - Product Control - Global Standard Food Safety, Issue 9 Audit

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Site conducted
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Location

5.1 Product design/development

SOI Product design and development procedures shall be in place for new products or processes and any changes to product, packaging or manufacturing processes to ensure that safe and legal products are produced.

5.1.1

The company shall have a procedure for new product development and changes to existing product, packaging and manufacturing processes.
This procedure shall include any restrictions to the scope of new product development to control the introduction of hazards which would be unacceptable to the site or customers (e.g. the introduction of allergens, glass packaging, microbiological risks or the introduction of ingredients that may affect product claims).

5.1.2

All new products and changes to product formulation, packaging or methods of processing shall be formally approved by the HACCP team leader or an authorised HACCP team member. This shall ensure that hazards have been assessed and suitable controls, identified through the HACCP system, are implemented. This approval shall be granted before products are introduced into the factory environment.

5.1.3

Trials using production equipment shall be carried out where it is necessary to validate that product formulation and manufacturing processes are capable of producing a safe product of the required quality.

5.1.4

Initial shelf-life trials shall be undertaken using documented protocols that reflect conditions expected during manufacture, storage, transport/distribution, use and handling to determine product shelf life.
Results shall be recorded and retained and shall confirm compliance with the relevant microbiological, chemical and organoleptic criteria or sensory analysis. Where shelf-life trials prior to production are impractical, for instance for some long-life products, a documented science-based justification for the assigned shelf life shall be produced.

5.2 Product Labelling

SOI Product labelling shall comply with the appropriate legal requirements and contain information to enable the safe handling, display, storage and preparation of the product within the food supply chain or by the customer.

5.2.1

All products shall be labelled to meet legal requirements for the designated country of use and shall include information to allow the safe handling, display, storage, preparation and use of the product within the food supply chain or by the customer.
There shall be a process to verify that ingredient and allergen labelling is correct based on the product recipe and ingredient specifications.
The company shall have a procedure for artwork approval and sign-off.

5.2.2

There shall be effective processes in place to ensure that labelling information is reviewed whenever changes occur to:
• the product recipe
• raw materials
• the supplier of raw materials
• the country of origin of raw materials
• legislation.

5.2.3

Where the label information is the responsibility of a customer or a nominated second or third party, the company shall provide information:
• to enable the label to be accurately created
• whenever a change occurs which may affect the label information.

5.2.4

Where cooking instructions are provided to ensure product safety, they shall be fully validated to ensure that, when the product is cooked according to the instructions, a safe, ready-to-eat product is consistently produced.

5.3 Management of allergens

Pet food and animal feed manufacturers certificated to the Standard are required to meet the appropriate allergen management legislation in the country of intended sale of the products. Therefore, if there is no legislation relating to allergens in pet food/animal feed, this section of the Standard may be considered ‘not applicable’ for pet food or animal feed destined for those countries.
In some parts of the world, allergen claims (e g. gluten- or dairy-free) are made on pet food or animal feed products. Therefore, where a site makes an allergen claim on a pet food or animal feed, it is required to meet all of the requirements within section 5.3.
Fundamental SOI The site shall have a system for the management of allergenic materials which minimises the risk of allergen contamination (cross-contact) of products and meets legal requirements for labelling in the country of sale.

5.3.1

The site shall carry out an assessment of raw materials to establish the presence and likelihood of contamination (cross-contact) by allergens. This shall include a review of the raw material specifications and, where required, the acquisition of additional information from suppliers (e.g. through questionnaires to understand the allergen profile of the raw material, its ingredients and the factory in which it is produced).

5.3.2

The company shall identify and list allergen-containing materials handled on site. This shall include raw materials, processing aids, intermediate and finished products, and any new product development ingredients or products.

5.3.3

A documented risk assessment shall be carried out to identify routes of contamination (cross-contact) and establish documented policies, and procedures for handling raw materials and intermediate and finished products, to ensure cross-contamination (cross-contact) is avoided. This assessment shall include:
• consideration of the physical state of the allergenic material (e.g. powder, liquid, particulate)
• identification of potential points of cross-contamination (cross-contact) through the process flow
• assessment of the risk of allergen cross-contamination (cross-contact) at each process step
• identification of suitable controls to reduce or eliminate the risk of cross-contamination (cross-contact).

5.3.4

Procedures shall be established to ensure the effective management of allergenic materials to prevent cross-contamination (cross-contact) of products not containing the allergen. These shall include, as appropriate:
• physical or time segregation while allergen-containing materials are being stored, processed or packed
• the use of separate or additional protective overclothing when handling allergenic materials
• use of identified, dedicated equipment and utensils for processing
• scheduling of production to reduce changes between products containing an allergen and products not containing the allergen
• systems to restrict the movement of airborne dust containing allergenic material
• waste handling and spillage controls
• restrictions on food brought onto site by staff, visitors and contractors and for catering purposes.

5.3.5

Where rework is used, or reworking operations are carried out, procedures shall be implemented to ensure rework containing allergens is not used in products that do not already contain the allergen.

5.3.6

Where a justified, risk-based assessment demonstrates that the nature of the production process is such that cross-contamination (cross-contact) from an allergen cannot be prevented, a warning should be included on the label. Legislation, national guidelines or codes of practice shall be used when making such a warning statement.

5.3.7

Where a claim is made regarding the suitability of a food for individuals with a food allergy or food sensitivity (sometimes referred to as a ‘food hyper-sensitivity’), the site shall ensure that the production process is fully validated to meet the stated claim and the effectiveness of the process is routinely verified. This shall be documented.

5.3.8

Equipment or area-cleaning procedures shall be designed to remove or reduce to acceptable levels any potential cross-contamination (cross-contact) by allergens. The cleaning methods shall be validated to ensure that they are effective and the effectiveness of the procedure routinely verified. Cleaning equipment used to clean allergenic materials shall either be:
• identifiable and specific for allergen use
• single use
• effectively cleaned after use.

5.4 Product authenticity, claims and chain of custody

SOI Systems shall be in place to minimise the risk of purchasing fraudulent or adulterated food raw materials and to ensure that all product descriptions and claims are legal, accurate and verified.

5.4.1

Where personnel are engaged in vulnerability assessments, the individual or team responsible shall understand potential food fraud risks. This shall include knowledge of raw materials used by the site and the principles of vulnerability assessment.

5.4.2

The company shall have processes in place to access information on historical and developing threats to the supply chain which may present a risk of adulteration or substitution of raw materials (i.e. fraudulent raw materials). Such information may come from, for example:
• trade associations
• government sources
• private resource centres
• activities completed for clause 1.1.8.

5.4.3

A documented vulnerability assessment shall be carried out on all food raw materials or groups of raw materials to assess the potential risk of adulteration or substitution. This shall take into account:
• historical evidence of substitution or adulteration
• economic factors which may make adulteration or substitution more attractive
• ease of access to raw materials through the supply chain
• sophistication of routine testing to identify adulterants
• the nature of the raw material.
The output from this assessment shall be a documented vulnerability assessment plan.
This plan shall be kept under review to reflect changing economic circumstances and market intelligence which may alter the potential risks. It shall be reviewed annually and whenever there is:
• a change in raw materials or a supplier of raw materials
• emergence of a new risk (e.g. known adulteration of an ingredient or developments in scientific information associated with authenticity of the site’s products or raw materials, for example, information obtained as part of clause 1.1.8)
• following a significant product safety incident (e.g. a product recall) where the authenticity of the site’s products or raw materials is implicated.

5.4.4

Where raw materials are identified as being at particular risk of adulteration or substitution, the vulnerability assessment plan shall include appropriate assurance and/or testing processes to mitigate the identified risks.

5.4.5

Where products are labelled or claims are made on finished packs which are dependent on the status of a raw material, the status of each batch of the raw material shall be verified. These claims include:
• specific provenance or origin
• breed/varietal claims
• assured status (e.g. GLOBALG.A.P.)
• genetically modified organism (GMO) status
• identity preserved
• named specific trademarked ingredients.
The facility shall maintain purchasing records, traceability of raw material usage and final product packing records to substantiate claims. The site shall undertake documented mass balance tests at a frequency to meet the particular requirements of any scheme it is certificated to, or in the absence of a scheme-specific requirement, at least one mass balance test every 6 months.

5.4.6

Where claims are made about the methods of production (e.g. organic, halal, kosher), the site shall maintain the necessary certification status in order to make such a claim.

5.4.7

Where a product is designed to enable a claim to be made, the company shall ensure that all claims are substantiated, and product formulation and the production process are fully validated to meet the stated claim and any legal requirements (in the country of intended sale) relating to the claim.
The process flow (see clause 2.5.1) for the production of products where claims are made shall be documented and potential areas for contamination or loss of identity identified.
Appropriate controls shall be established to ensure the integrity of the product claims.

5.5 Product Packaging

SOI Product packaging and processes for the purchase of product packaging shall be appropriate for the intended use. Packaging shall be stored under conditions to prevent contamination and minimise deterioration.

5.5.1

When purchasing or specifying primary packaging, the supplier of packaging materials shall be made aware of any particular characteristics of the food or existing packaging (e.g. high fat content, pH, usage conditions such as microwaving, other packaging used on the product, use of recyclable or reusable packaging materials) which may affect packaging suitability.
Certificates of conformity or other evidence shall be available for primary packaging to confirm it complies with applicable food safety legislation and is suitable for its intended use.

5.5.2

Product liners and bags purchased by the company for use in direct contact with ingredients, or work in process, shall be appropriately coloured (e.g. contrasting colour to the product) and resistant to tearing to prevent accidental contamination.

5.5.3

The company shall have a procedure to manage obsolete packaging (including labels). This shall include:
• mechanisms to prevent accidental use of obsolete packaging
• control and disposal of obsolete packaging
• appropriate procedures for the disposal of obsolete printed materials (e.g. rendering trademarked materials unusable).

5.6 Product inspection, on-site product testing and laboratory analysis

SOI The company shall undertake or subcontract inspection and analyses which are critical to confirm product safety, authenticity, legality and quality, using appropriate procedures, facilities and standards.

5.6.1

There shall be a scheduled programme of product testing which may include microbiological, chemical, physical and organoleptic testing according to risk. The methods, processes for obtaining product samples (including, where appropriate, their delivery to a laboratory), frequency and specified limits shall be documented.

5.6.2

Test and inspection results shall be recorded and reviewed regularly to identify trends.
The significance of on-site and laboratory results shall be understood and acted upon accordingly. Appropriate actions shall be implemented promptly to address any unsatisfactory results or trends.
Where legal limits apply, these shall be understood and appropriate action taken promptly to address any exceedance of these limits.
Where applicable, the measurement uncertainty associated with laboratory test results shall be considered.

5.6.3

The site shall ensure that a system of validation and ongoing verification of the shelf life is in place. This shall be based on risk and shall include sensory analysis and, as applicable, microbiological testing and relevant chemical factors such as pH and aw. Records and results from shelf-life tests shall verify the shelf-life period indicated on the product.

5.6.4

The site shall ensure that a system of validation and ongoing verification of the shelf life is in place. This shall be based on risk and shall include sensory analysis and, as applicable, microbiological testing and relevant chemical factors such as pH and aw. Records and results from shelf-life tests shall verify the shelf-life period indicated on the product.

5.6.5

Where testing laboratories are present on a manufacturing site, they shall be located, designed and operated to eliminate potential risks to product safety. Controls shall be documented and implemented, and include consideration of:
• operating procedures to contain laboratory activities, including the design and operation of drainage and ventilation systems
• access and security of the facility
• movement of laboratory personnel
• hygiene and protective clothing arrangements
• movement of materials that may pose a risk to products, raw materials or the production area, into and out of the laboratory, including the disposal of laboratory waste
• the management and monitoring of laboratory equipment.
Where testing activities are performed in production or storage areas (e.g. at the line tests or rapid tests), these shall be located, designed and operated to prevent product contamination.

5.6.6

Where the company undertakes or subcontracts analyses which are critical to product safety, authenticity or legality, the laboratory or subcontractors shall have gained recognised laboratory accreditation or operate in accordance with the requirements and principles of ISO/IEC 17025, including proficiency testing where applicable. Documented justification shall be available where accredited methods are not undertaken.

5.6.7

Procedures shall be in place to ensure reliability of laboratory results, other than those critical to safety and legality specified in clause 5.6.6. These shall include:
• use of recognised test methods, where available
• documented testing procedures
• ensuring staff are suitably qualified and/or trained and competent to carry out the analysis required
• use of a system to verify the accuracy of test results (e.g. proficiency testing where applicable)
• use of appropriately calibrated and maintained equipment.

5.7 Product Release

SOI The site shall ensure that finished product is not released unless all agreed procedures have been followed.

5.7.1

Where products require positive release, procedures shall be in place to ensure that release does not occur until all release criteria have been completed and the release has been authorised.

5.8 Pet food and animal feed

Where a site produces pet food or animal feed, all the relevant requirements from sections 1–7 of the Standard must be fulfilled in addition to the requirements in this section.
SOI The site shall ensure that pet food and animal feed products are safe and fit for intended use.

5.8.1

The site shall ensure that pet food and animal feed is formulated/designed for the intended use (e.g. where products are designed for complete diet or as a complementary product).

5.8.2

The site shall ensure that pet food and animal feed is formulated/designed for the intended use (e.g. where products are designed for complete diet or as a complementary product).

5.8.3

5.8.3 Where the site manufactures, processes or packs pet food or animal feed products that contain medicinal substances, the site shall have specific procedures for the management of the medicated raw materials and finished products. At a minimum, these procedures shall include:
• identification of medication-containing materials handled on site. These can be raw materials, processing aids, intermediate and finished products, rework or any new product or product development ingredients
• supplier approval equivalent to section 3.5.1 for all medicated raw materials
• specific staff training on the correct handling of medicated materials
• mechanisms to ensure the correct concentrations of medicinal substances in finished products
• procedures (e.g. cleaning procedures) to prevent contamination of non-medicated pet food or animal feed with materials containing medicinal substances
• specific procedures to ensure the correct labelling of medicated pet food or animal feed
• waste disposal mechanisms (see section 4.12) that include the safe and legal disposal of medicated raw materials and products.

5.8.4

Site procedures shall be designed and implemented to meet the relevant pet food and animal feed product safety legislation (both in the country of production and in the country of sale).

5.9 Animal primary conversion

Where a site completes animal primary conversion (e.g. for red meat, poultry or fish), the following requirements apply, in addition to those within the rest of the Standard.
SOI For animal primary conversion, the site shall operate controlled processes that ensure products are safe and fit for intended use.

5.9.1

The company shall undertake a risk assessment for potential prohibited substances (i.e. those prohibited by legislation in the country of operation or intended country of sale). Example substances include pharmaceuticals, veterinary medicines (e.g. growth hormones), heavy metals and pesticides.
The risk assessment may be completed as part of clause 3.5.1.1 or as a separate activity.
The results of the risk assessment shall be included in raw material acceptance and testing procedures and in the processes adopted for supplier approval and monitoring (see clauses 3.5.1.2–3.5.2.2).

5.9.2

Where the site is in receipt of live animals, there shall be an inspection by a suitably competent individual at lairage and post-mortem to ensure that the animals are fit for human consumption.

5.9.3

The site shall operate procedures to ensure that the traceability of all edible parts of the carcass (i.e. all parts that are intended for the human food supply chain) is maintained.

5.9.4

The site shall establish defined time and temperature requirements for all post-slaughter processes (for example, post-slaughter cooling, processing, storage and distribution). These requirements shall be defined for all chilled or frozen, edible parts of the carcass.

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