Externally developed combinations of control measures are
being created for many segments of the food chain in a wide variety of
countries. This work has been done by industry associations, colleges and
universities or in some cases, by governments as an aid to small food
businesses where industry needs expert knowledge which is lacking in their
organizations. Intergovernmental
organizations such as the Food and Agriculture Organization of the United
Nations (FAO) have also done some work in this area. There are many examples of
such programmes for primary production and some for small processors, packers
and distributors, truckers, retailers and food service operators.
In this regard, ISO 22000 allows a small and/or less
developed organization at any stage of the supply chain (e.g. a farm, a
packer-distributor, a processor, a transporter, a retail or food service
outlet) to implement an externally developed combination of control measures.
This permits an organization to choose between developing its own control
measures or using one of the developed food safety system by an industry
association, government agency, university, etc., while customizing it
according to the requirements of the company. The option of using an externally
developed combination of control measures is important for a small and/or less
developed organization, because small organizations may not have the scale or
the resources required to undertake the hazard assessment and hazard analysis
required by ISO 22000 to develop a site-specific food safety management system
which basically affect their business if the organization mostly depends on the
export market or with few specific buyers or a buyer. In such instances, it is
much easier for a company to look out to get a consultant’s help as well as to
use externally developed food safety measures to control the food safety. ISO 22000 states that externally developed
combinations of control measures must have been developed as specified. Not all
the currently available programmes will meet this requirement, nor have all of
them been developed using HACCP principles.
An externally developed combination of control measures to meet the requirements of ISO 22000 must be developed in compliance with exact requirements in the given food business. In
particular, the external body must demonstrate that it has followed the steps
set out in respecting the hazard assessment, hazard analysis and selection of
control measures outlined in the standard.
ISO 22000 sets out the steps for the development of a food safety management system. Those dealing with the development of control
measures are detailed in Clause 7 of ISO 22000. They are particularly rigorous.
Organizations that seek to provide generic combinations of control measures for
specific segments of the supply chain (e.g. vegetable farmers or truckers or
small poultry processing facilities, black tea manufacturers) must show that
they have complied with these requirements.
These organizations need to make available to other organization,
and to any third-party auditors, detailed information about:
- The food safety
team and the competence of team members;
- The scope of the combination of control measures;
- Product characteristics (e.g. raw materials, ingredients and product contact materials) as well as the end product characteristics and intended use;
- Generic flow diagrams and site schematics;
- Descriptions of process steps and control measures;
- Details of the hazards identified and their acceptable limits;
- Hazard assessment;
- Selection of the control measures;
- Prerequisite programes, including both those -initially selected and those determined by the hazard analysis;
- Operational prerequisite programes;
- Critical control points and their critical limits, etc.;
- Program elements concerning control of non-conformist, verification, etc.;
- Results of validations
An external organization providing a commodity or
segment-specific combination of control measures is taking on a long-term
obligation. Just as an organization developing its own control measures which must
have in place a process for evaluating effectiveness and updating the system, whereas
the external organization must have same specific controls.
Externally developed combinations of control measures will
have been established using a generic model (e.g. a set of facilities,
processes, operational circumstances, etc.) which reflects the most likely
situations for a small organization producing the specified products. As a
result, the control measures will require adaptation to your organization and
its operations.
Small organization must adapt any externally developed
combination of control measures to the specific processes in the given
organization. The control measures will have been developed based on certain
assumptions which should be clearly stated in the material provided to that
organization. The organization’s food safety team needs to review these control
measures in detail to determine whether or not they correspond to the
circumstances within organization. For example, the team must review the
process flow diagram and conduct an on-site verification to identify any
significant differences that might result in new hazards entering generic
system or require changes to control measures (PRPs, operational PRPs and
CCPs). The organization also need to take into account the differences between regulatory
or customer requirements in the generic model and the requirements applicable
to company’s operation. The process of adopting and then adapting an externally
developed combination of control measures is not simply one of following the
“guide”. Company’s food safety team needs to assure itself that the guide’s
recommendations fit to the organization’s circumstances. Company’s food safety
team should document the review and provide records that demonstrate it has
undertaken the required comparisons, made the necessary changes, etc. If the
company uses an externally developed combination of control measures, the
organization will have to demonstrate that such measures have been implemented
and are being operated in accordance with all the other requirements of ISO
22000.
The implementation of an externally developed combination
of control measures is in principle and practice no different than implementing
a set of control measures developed internally. For example, the organization
needs to undertake training, monitoring and verification activities, as well as
engage in the evaluation and updating of the food safety management system. An
externally developed combination of control measures reduces the burden of the
development phase but does not limit the given organization’s responsibility
and accountability for implementation of the food safety management system.
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