ISO

There must be effective communication systems in place. This includes receiving information from external sources and feeding that information through the relevant internal channels.

Senior management must ensure that a Quality Policy is in place, along with the resources to achieve it. Roles, responsibilities and management are required and there must be a system of continuous improvement including management review.

Management must appoint a competent person to manage the management system and this role must have the required authority to lead its continuous improvement.

ISO

Before the management system is developed there are a number of pieces of work that are needed, to establish:

• What is the purpose of the management system.
• What the management system is expected to achieve.
• What the boundaries are to the system (scope).
• Identify the risks and opportunities that need addressing.

Once this is done, a plan must be put in place to:

• Ensure that all the above points are met.
• To develop and implement a change management system.
• To set, communicate and then monitor objectives to ensure that the management system is effective.
• Ensure that all the required resources are provided to achieve the above.

When the management system is developed or managed externally, the application and day-to-day management must remain the responsibility of the company.

There is a specific section for customer focus to ensure that customer requirements are met.

ISO

Non-conforming product process is required.

Internal audits are required.

Corrective and preventive actions are needed. Root cause analysis is not specifically mentioned but implied through the need to determine the cause of non-conformances to establish preventive actions.

Continuous improvement is a key focus and covers all aspects of the Standard.

Transport and storage technical specification

A non-conforming product procedure required.

ISO

Contingency plans for emergency situations and recall and withdrawal processes are required.

Transport and storage technical specification

Withdrawal procedures are required.

ISO

The hazard analysis system must include OPRP’s (operational prerequisites). Hazards do not highlight radiological specifically. Hazard analysis is required for food safety purposes only; quality does not require hazard analysis.

A process is required for handling products that are out of specification because they are unsafe.

Transport and storage technical specification

PRP’s (prerequisite procedures) must be implemented to protect the product and this includes from radiological contamination.

FSSC

An allergen risk management system is required.

Transport and storage technical specification

• Utilities must not pose a risk of contamination, including water, boiler chemicals, air and ventilation.
• Chemicals and processing aids must be identifiable, segregated and secure, and approved for use.
• Microbiological, allergenic, chemical, radiological and physical contamination controls must be in place.

FSSC

Labelling must meet the legal requirements for the country where the product will be sold.

ISO

A product development process is required which ensures that quality objectives and customer requirements are met, including:

• Planning
• Inputs and outputs of the system
• Review
• Verification and validation
• And change management

ISO

Where suppliers are used for systems, products or services which relate to the management system they must be selected based on set criteria and then monitored.

The system must verify that purchased materials comply with specification.

Transport and storage technical specification

• Supplier selection, approval and monitoring is required to ensure that materials meet specification.
• Materials must be covered by a certificate of conformance as a minimum.

FSSC

External labs used for product safety testing must comply with ISO17025 requirements.

A risk based environmental monitoring programme is required for food and packaging sites.

A system of monitoring, measuring and analysis needs to be implemented, which ensures that the product and process meets specification.

Monitoring equipment must be accurate.

Customer satisfaction must be measured.

Transport and storage technical specification

• Equipment must be of a hygienic design.
• Planned preventive maintenance is required.
• Corrective maintenance must be controlled.
• Product contact lubricants must be food grade.
• Hand back procedure needed.

FSSC

Both a threat assessment and also a vulnerability assessment is required. There is now a new FSSC guideline about how product defence should be handled, which is similar to an interpretation guide.

Transport and storage technical specification

There must be controls in place for food defence of the site, transport and distribution.

ISO

Personnel who work internally or who support externally, must be competent in their role. The company must set the competency required and then ensure that this is met.

Competency must include an understanding of:

• The food safety policy.
• Objectives application to their role.
• How they contribute to the management system.
• The benefits of getting it right and the consequences of getting it wrong.

ISO

There is a specific section of the Standard about resources. To ensure that the required resources are provided to meet the needs of the management system and in the case of personnel, they must be competent.

It also states that the work environment that is provided for personnel must be suitable.

This means it must be suitable from:

• An ethical perspective (e.g. regarding discrimination)
• A physiological perspective (e.g. mental health)
• A health and well being perspective (e.g. noise, temperature)

Transport and storage technical specification

• Hygienic staff facilities must be provided, including toilets, handwashing, changing facilities and staff eating areas.
• Rules must state how personal hygiene and behaviour is managed, including smoking, eating, personal items and medicines.
• Product contact equipment must not be lockers.
• Nail polish, false nails and eyelashes are not allowed, you’re not allowed to carry a pen behind your ear and lockers must be kept clean if you work in open product areas.
• Personnel who handle unpacked product must wear protective clothing, which is maintained and doesn’t have buttons or outside pockets above the waist.
• Personnel who work in food areas must wash their hands and keep fingernails short.
• Medical screening is required.

ISO

Also within the resources section, the company must provide the resources needed to ensure that the physical infrastructure of the site is fit for purpose and maintained.

Transport and storage technical specification

• Building construction must be fit for purpose and maintained.
• Assessment of the local area must be carried out.
• The site must be maintained.
• Layouts and flow must adhere to good hygiene practices.
• Internal fabrication must be fit for purpose and maintained.
• Equipment must be located so that it can be cleaned and maintained.
• Lighting must be adequate.

ISO

Customer property (product) that is unsuitable for use must be controlled.

Transport and storage technical specification

• Waste must be controlled; identified, segregated, located in a designated area, fit for purpose so they can be cleaned, closed when not in use and locked where needed.
• Drainage must be managed hygienically.
• A cleaning programme is required for facilities and equipment, including frequency, responsibility, method, tools, monitoring and inspection/verification.
• A pest management system is required.
• Canopies over loading areas are required for pest control and to protect the product from weather.

ISO

Operational processes are required, suitable to the operation. This includes traceability.

Transport and storage technical specification

Traceability is required throughout the process (They call this ‘product identification’ and they call the trace/batch code an ‘identifier’).

FSSC

Transport and system conditions must minimise the risk to product.

ISO

• A positive release process is required.
• The product must be preserved and protected.

Transport and storage technical specification

• Materials must be protected from contamination during storage and transport and cleaned inbetween loads where needed.
• Hygiene and integrity checks must be carried out before loading and unloading.
• Previous loads and cleaning of bulk container checks are required.
• Warehousing and transport environmental conditions, including temperature must be controlled.
• Stock rotation must be in place.
• Storage must be secure.
• Vehicle maintenance and emergency procedures are needed.
• Gasoline or diesel not to be used for equipment where product is stored.
• Cross-docking and transhipment must comply with the requirements listed.