The New Requirements for Equipment Management in FSSC 22000 V.6
The latest version of the FSSC 22000 - Version 6, has introduced a new guidance document on Equipment Management. This new requirement is included in the FSSC 22000 V.6 scheme to ensure that hygienic design is considered at the purchasing stage. This is crucial to minimize the risk of microbiological, chemical, and physical contamination of food.
Principles of Hygienic Design
The principles of hygienic design play a crucial role in ensuring the safety of food products. Here are some key principles:
- Accessibility: Equipment should be designed in a way that allows easy access for cleaning, maintenance, and inspection. This helps in ensuring that no food residues or microorganisms are left behind.
- Cleanability: The equipment should be easy to clean. This means that the materials used should be able to withstand the cleaning processes and chemicals used in the industry.
- Drainability: Good design ensures that after cleaning, water and cleaning agents can be easily drained from the equipment, preventing the growth of microorganisms.
- Material Compatibility: The materials used in the construction of the equipment should be compatible with the food product, the cleaning agents used, and the operating conditions of the process.
- Segregation: There should be proper segregation between clean and unclean areas to prevent cross-contamination.
- Surface and Geometry: The surfaces of the equipment that come into contact with food should be smooth and free from cracks, crevices, or roughness. The geometry of the equipment should facilitate self-draining to prevent liquid accumulation.
By adhering to these principles, we can significantly enhance food safety and protect consumers as well as brand integrity.
Impact on Existing Equipment
The organization is not required to assess its current existing equipment against this requirement, unless existing equipment undergoes significant change; however, it is important to note that hazards and associated risks relating to current equipment would still need to be addressed within the hazard analysis under clause 8.5 of ISO 22000:2018.
In accordance with 2.5.15 (a), an organization shall have a documented purchase specification in place that addresses the hygienic design, applicable legal and customer requirements, and the intended use of the equipment, including the product handled.
Organizations should also include a requirement in the purchase specification that the equipment manufacturers have the responsibility of informing the organization of any food safety risks that could not be eliminated by hygienic design and also of providing the organization with an instruction manual covering information needed for hygienic safe operation within the limits of use of the respective equipment.
Factory Acceptance Test (FAT)
When purchasing machinery and equipment, it’s crucial to ensure that the supplier meets the purchase specifications prior to installation. This is where the Factory Acceptance Test (FAT) comes into play.
The FAT is designed to confirm that the machinery works as intended under conditions that simulate its intended operation. A FAT aims to validate that the equipment or system meets the pre-defined specifications and requirements as agreed upon in the purchase contract.
After accepting a FAT, here’s what you should expect:
- Full FAT Protocol: Outlines the procedures and results of each test.
- User’s Manuals and Maintenance Guides: Detailed instructions on operation and maintenance.
- Training Materials: Easy-to-use One Point Lessons (OPLs) and videos.
- Standard Work Procedures: Outlines standard operating procedures.
- Standard Maintenance Procedures: Outlines standard maintenance procedures.
- Recommended List of Spare Parts: Recommendations for spare parts to keep on hand.
- Certificates of Conformity: Confirm compliance with all relevant standards and regulations.
- As-Built Technical Drawings: Includes electrical, pneumatic, mechanical, and process designs.
- Datasheets and Materials Certificates: Detailed information about materials used.
- Main Equipment Data Sheets: Detailed specifications for each piece of main equipment.
- Certificates of Calibration for Instruments: Confirm that all instruments have been properly calibrated.
- Welding Processes Qualifications: Confirm that all welding processes have been carried out correctly.
By ensuring these elements are in place, you can have confidence in your new machinery or equipment. Remember, it’s not just about buying a machine - it’s about ensuring it will meet your needs and operate safely and efficiently.
Change Control
Change control consists of the organization undertaking a risk assessment, determining risk mitigation based on hygienic design principles as well as documenting changes. The Food Safety Team should ensure that relevant managers are aware of these requirements in order to ensure that change management process is followed.
Installation and Commissioning Phase
During installation, check that the correct equipment has been received and has been installed according to the approved specification. For equipment that has been prefabricated (assembled and/or assigned) at the equipment suppliers’ site, a factory acceptance test (FAT) should be performed by the purchasing organization at the supplier’s site prior to delivery at the purchasing organization.
After installation and before use at the organization’s premises, it should be verified that all functional (operational) parameters and specifications, limits, and tolerances detailed in the purchase specification and user manual/guide can be met to achieve the required hygienic performance. A site-acceptance test (SAT) should be done after the equipment components are installed and commissioned at the organization and typically includes functional testing.
The organization should conduct a validation study to confirm that newly installed equipment functions as designed according to the manual/guide. This should include food safety, quality, cleanability aspects, and cleaning validation activities. The validation, which may have been initiated and planned prior to equipment being built, should be completed as part of the process qualification, taking into consideration the planned or projected usage in production.
Risk-based Change Management Process
This systematic approach assesses the risks associated with introducing new equipment or making changes to existing ones. The process is based on the level of risk associated with the change.
Documentation
All changes, including new equipment introductions and modifications to existing equipment, must be adequately documented. This includes evidence that the equipment has been successfully commissioned - that is, properly installed, tested, and operational.
Assessment of Effects on Existing Systems
Before implementing any changes, it’s crucial to evaluate how they might impact current systems. This could include anything from production processes to quality control measures.
Control Measures
Based on the risk assessment and potential impact on existing systems, appropriate control measures should be determined and implemented. These could include new procedures, additional training for staff, or increased monitoring and inspection activities.
This clause emphasizes the importance of careful planning and risk management when making changes to equipment to maintain food safety standards.
In conclusion, these new requirements for equipment management in FSSC 22000 V.6 are a step forward in ensuring food safety by emphasizing hygienic design from the purchasing stage itself.
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