Timothy R. Rugh
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Featured Article: Maintaining Hygienic Design

Maintaining Hygienic Design

Congratulations if your company has attained compliance to the Preventive Controls rules under the Food Safety Modernization Act (FSMA)! 

To the credit of FDA, a wealth of resources have been assembled to help processors develop and implement a plan to come into compliance with the Preventive Controls rules. For example, the Agency has created a Food Safety Plan Builder to assist owners/operators of food facilities with the development of food safety plans that are specific to their facilities and has published several guidance documents related to implementing FSMA.  The FDA has also partnered with numerous authorities through the Food Safety Preventive Controls Alliance (FSPCA) to provide the required training for Preventive Controls Qualified Individuals or (PCQIs) under a standardized curriculum.

The real work of compliance begins with the completion of your Food Safety Plan (FSP) and the training of your PCQI.  However, it does not end there.  The responsibilities of a PCQI include:

  • Developing or oversee preparation of the food safety plan

  • Validation of the preventive controls

  • Review of records

  • Periodic review of the food safety plan

The FSP includes a thorough hazard analysis which leads to implementing effective preventive controls, and it must be reanalyzed at least once every three years. But the facility must also review portions of the FSP under certain circumstances, such as when a preventive control is found to be ineffective.

So what are some of the key considerations to help you identify and control equipment related food safety hazards, particularly during maintenance operations?

Maintenance and Repair = Facts of Life

Every type of equipment is subject to wear and tear over time, requiring regular maintenance.  This needs to be taken into account when making an assessment of the overall equipment condition. This should include inspections for lost, worn, broken or loose parts on equipment. Special attention is required for microorganism harborage sites, such as worn or frayed hoses, gaskets, belts, porous welds or pitted, cracked, or damaged product contact surfaces.

Any materials used during maintenance and repair must be safe and suitable for food processing and equivalent to the original component.  Your site’s plan should guide you on proper repair and maintenance components to be used.

Know Your Preventive Maintenance Schedule

Your FSP must reflect your knowledge of the operating characteristics of the equipment and which parts of the system are scheduled for periodic maintenance or replacement.  Do you know the expected life for replaceable parts such as O-rings, gaskets, etc.? Is preventive maintenance written into your FSP?

Re-think Your Hygienic Design, Installation and Working Practices

Does the layout, configuration and installation of your food processing and handling equipment allow for adequate inspection and maintenance of a hygienic processing environment? Do you have enough space and clearance so that all equipment parts and components are readily and easily accessible for inspection, maintenance and troubleshooting? 

Who Maintains Your Equipment?

Be sure that you have requirements that are written and appropriate for personal hygiene for those who conduct maintenance and repairs in any part of your operation.  Your maintenance staff or contractors must follow your procedures with regard to personal safety and hygiene.  Food safety training should be tailored for personnel that perform maintenance in and around food processing with special emphasis on protecting product zones, tool sanitation, and accounting for all parts and materials.

Trust and Verify!

Review the completed maintenance operations before production resumes.  Have technical problems been resolved? Are the repairs completed in a way that your equipment will produce safe foods when production resumes.  Keep comprehensive records to verify that the repair and maintenance program is operating as it should.

The identification and control of equipment-related food safety hazards begins with the selection of food processing equipment which is fabricated and designed to be cleanable, and conforms to appropriate hygienic design principles.  3-A Sanitary Standards for equipment and 3-A Accepted Practices for processing systems are designed to help food processors, audit professionals and regulatory sanitarians assure the integrity of the food processing system and the safety of food. The standards embody objective, verifiable baseline criteria and they are designed to be compatible with U.S. regulatory criteria and guidelines such as the European Hygienic Engineering & Design Group (EHEDG). The 3-A Symbol is available to equipment fabricators on a voluntary basis to signify the equipment was designed, manufactured and verified by independent inspection to conform to a 3-A Sanitary Standard.

3-A Sanitary Standards help processors identify and document the conformance with hygienic design principles for equipment used in food processing:

  • Materials of construction, whether metals or on-metals, must be inert, non-toxic, non-corrosive, non-contaminating, and impervious to moisture.

  • Surface finishes must be durable, free of cracks and crevices and smooth to a minimum measure of 32 microinch Ra (roughness average) for a product contact surface.

  • Joints of various types must be cleanable, crevice-free and bacteria-tight.

  • Drainability – All surfaces must be free draining or drainable and properly pitched or sloped to prevent any liquid pooling.

  • Cleaning and Inspectability are fundamental to equipment design, manufacture and installation.  Many 3-A Sanitary Standards include provisions for installation and inspectability.

  • Construction Elements such as dead ends, gaskets, gasket retaining grooves, O-rings and seals, threads, springs, shafts and bearings must be bacteria-tight and accessible for cleaning, sanitizing and inspection.

 

Documenting the controls in your equipment maintenance program can help demonstrate that your company goes beyond just the minimum and embraces a preventive control culture.
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