Featured Article: Maintaining Hygienic Design
Maintaining Hygienic Design
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
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:
or oversee preparation of the food safety plan
of the preventive controls
review of the food safety plan
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.
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
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
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!
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.
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
Standards help processors identify and document the conformance with hygienic
design principles for equipment used in food processing:
of construction, whether metals or on-metals, must be inert, non-toxic,
non-corrosive, non-contaminating, and impervious to moisture.
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.
of various types must be cleanable, crevice-free and bacteria-tight.
– All surfaces must be free draining or drainable and properly pitched or
sloped to prevent any liquid pooling.
and Inspectability are fundamental to equipment design, manufacture and
installation. Many 3-A Sanitary
Standards include provisions for installation and inspectability.
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.
controls in your equipment maintenance program can help demonstrate that your
company goes beyond just the minimum and embraces a preventive control culture.