What is ISO 22000 Support Program?
ISO 22000 is one of
a family of standards focused on the development, implementation, and
improvement of a food safety management system for any organization in the food
supply chain. The ISO 22000 model is a systematic approach to developing,
planning, validating, establishing, implementing, monitoring, verifying and
improving the food safety management system. ISO 22000 can’t be operated alone
and that needs various support programs to operate it. ISO 22000 has been
developed by merging ISO 9001, Hazard Analysis Critical Control Point (HACCP)
system and Good Manufacturing (GMP) or Good Hygienic Practices (GHP) which are
necessary to support the controls for establishing food safety together. Accordingly,
good manufacturing practices lay the foundation for basic infrastructure while
HACCP control the food safety requirements and ISO 9001 manage the total
programs based on its management elements. The synchronization of these three
programs generally offers the better solution than handling three programs
separately and ISO 22000 support programs are the general food safety and
hygiene requirements which all food businesses must follow, where they are
basically included within these three programs. In addition to that, other main
program that can be included in to them is Japanese 5S which improve the
organized work environment and provide much easier working model with
harmonized work instructions within the food business.
Some of the typical
ISO 22000 support programs cover wide range of activities and programs
essential to ensure food safety, and may include:
- Maintenance – including design, construction and condition of premises, equipment, vessels or vehicles;
- Approved Supplier Program;
- Good Food Handling Practices;
- Cleaning and Sanitation;
- Pest Control Program;
- Personal Hygiene Program;
- Product Recall Program;
- Employee Training Program;
- Calibration Program;
- Internal Audit Program;
- Document and Data Control Program;
There may also be
support programs specific for your industry sectors. These have been included
in according to the place in the food chain as well as criticality of the
product manufactured. On the other hand, some of the ISO 22000 support programs
are depend on the buyer requirements, where certain buyers are requesting them
to follow some of the specific programs that are forced through various ways to
ensure their product integrity and customer satisfaction.
Maintenance Programs
All food processing
and associated organizations accredited to ISO 22000 standards must provide
documented evidence of service and maintenance for equipment and services used
upstream within the process to ensure that subsequent certificated inspections
are successful. In the standard it is explained as;
7.2.2
Infrastructure and Maintenance Programs
The organization
shall establish and maintain the infrastructure needed to achieve conformity to
the food safety needs including as applicable;
a) Lay-out, design and
construction of buildings and facilities, including workspace, employee
facilities, and associated utilities,
b) Supplies of air,
water, energy and other utilities,
c) Equipment including
its preventative maintenance, sanitary design and accessibility for maintenance
and cleaning for each unit, and
d) Supporting services
including waste and sewage disposal.
Verification of the fulfillment of these requirements shall be planned (see 7.8). The infrastructure shall be modified as necessary, taking into account the results of the hazard analysis (7.4) and the capability of the selected control measures to control the identified food safety hazards (see 7.5 and 7.6). Such modifications shall be recorded.
Maintenance of buildings and equipment is important to minimize the risk of
food contamination. Thus it is mandatory to follow the good
manufacturing practices which are applicable to food industry. The premises and
food handling equipment
should be designed, constructed
and maintained in a way that will reduce the
chance of food becoming contaminated.
Poorly maintained or damaged equipment and buildings may result in possible
physical, chemical and biological contamination
of food.
Maintenance
All production sites
must have an established Facility Preventive Maintenance Program. Each production
site must have an established preventive corrective maintenance program, temporary repairs procedure, reconciliation of tools/ utensils and release to production.
A maintenance program should
be established and should
include:
A system to regularly review
condition of building structure and equipment (eg monthly maintenance check by the manager or
delegated employee to ensure the integrity of the building and equipment
and daily checks prior
to work commencing in the premises and operation
of equipment to ensure it is
satisfactory to use. This information
is to be recorded).
Ensure that all
corrective action is documented,
Monthly maintenance
check,
Preventative
maintenance where machinery servicing is scheduled,
Ensure changes
made to buildings and equipment
that may impact food safety is documented. For
example: Building construction activities may increase the risk of contamination from bacteria,
pests or foreign matter.
Preventive Maintenance
A Preventive Maintenance
(PM) Program must be established for all equipment.
Facility Preventive Maintenance
A Facility Preventive
Maintenance (FPM) Program must be established for the maintenance of the building,
exterior and interior, at a required frequency based on the facility, age and environmental
conditions. A facility inspection must be conducted at least annually and corrective
actions must be documented to support the FPM Program and food safety requirements.
Equipment Preventative Maintenance
An Equipment Preventive
Maintenance (EPM) Program must be established for all food contact, monitoring and
measuring equipment. An EPM Program, as defined by the manufacturer or maintenance/engineering
department, must be established for all product related equipment that may have
an impact on quality and food safety. The program must include frequency, replacement
inventory requirements, release requirements for preventive and corrective maintenance
and allowable temporary repairs based on the EPM criteria per equipment. The release
must include a reconciliation of tools used for the EPM.
Reconciliation of tools:
The maintenance responsible must account for all tools used during the PM or temporary
repair of equipment, assure that no tools remain behind and all tools are returned
to the appropriate maintenance storage location.
Temporary Repairs
Temporary repairs must
follow release-to-production criteria per equipment.
Temporary repairs of
the facility must follow release criteria. A description of the repair, a risk assessment
and corrective action must be documented. The release must include a reconciliation
of tools used for the repair.
Maintenance Personnel Training
Authorized maintenance
personnel must be trained or licensed to perform in the maintenance and technical areas. Training
records must be documented and available for review.
Layout of Premises and Workspace
Each production site
must establish a program that monitors the external and internal building structure
including floors, walls and ceilings.
The program must include
environment/vegetation controls, perimeter restrictions, parking lot maintenance,
control of standing water and potential contamination from the local environment
(air, water, chemicals). The program must include temporary structures.
Exterior Controls
Each facility must maintain
the building and building perimeter to avoid any potential for product contamination
from the local environment.
Interior Layout
Each facility must maintain
the walls, ceilings and floors to prevent potential contamination. Each facility
must establish traffic patterns for product and personnel to minimize the potential
for product contamination.
Laboratory Layout
All laboratories must
be separated from production and must have restricted access. Microbiology laboratories
must not open directly into production.
Temporary Structures
Prior to release for
use, a risk assessment must be conducted, appropriate controls identified and applied.
Utilities
All production sites
must have an established program for the handling and use of water, electricity/lighting,
boilers/steam, gas and compressed air.
The program must include
the monitoring, maintenance and documentation.
Air Handling
Heating, ventilation
and air conditioning, positive/negative pressure rooms, clean rooms, filters, ventilation,
testing of air, exterior air intake, etc. if applicable, must be monitored and recorded.
All clean rooms where open product is handled must have positive pressure to avoid
airborne contamination.
Water Usage
Potable and non-potable
water usage must be monitored to minimize contamination risk. Potable water must
be tested annually and comply with local regulation or WHO. Treated, chlorinated
and de-ionized water must comply with local regulations regarding quality and microbiological
requirements. Where applicable, back-flow preventers must be in place. Dead-end
piping should be avoided, if in use, must be cleaned and monitored and must be included
in the environmental program. Steam (culinary water) supply used for products or
product surfaces must be potable and comply with local regulations regarding quality
and micro-biological requirements.
Lighting
The lighting must be
sufficient enough to maintain hygienic conditions. Fixtures must be protected to
prevent breakage. Bulbs must be safety coated or non-breakable. Each facility must
have a glass breakage procedure.
Gas/Compressed Air
Oil free compressors
are preferred; if not applicable oil must be food grade or oil should not come in
contact with the air. The compressor systems must be maintained to prevent contamination
per the Preventive Maintenance (PM) Program.
Boiler Chemicals
Boiler chemicals must
be approved food-grade chemicals per local regulation.
New Equipment
All new equipment must
be selected based on food grade requirements and performance. Validated sanitation
procedures, preventive/corrective maintenance must be established for all new equipment
prior to release to production. This includes measuring and monitoring equipment.
NOTE: New equipment
or changes to existing equipment may require new verification studies, such as re-evaluating
temperature controls.
Equipment Design
Equipment must be of
hygienic design with approved food contact surfaces.
Sanitation
Sanitation procedures
must be defined by either the manufacturer or per a sanitation validation program.
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