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Wednesday, 28 December 2011

Guidelines for Food/Product Operation Risk Assessment

The providers of food and health products must maintain full control of their operations at all times to ensure the protection of consumers. This means that every potential risk contributor must be prevented from causing harm to the consumer. Therefore, on-going risk assessment is inevitable for all product providers.

Risk assessment does not have to be arduous. In many instances, it is almost an imperceptible activity.  In fact almost everybody conducts risk assessment. Every time a situation is observed, if there is a decision to be made or an action to be taken, etc., risk assessment is done. Yes, we do need to learn how to properly conduct a risk assessment. Every effort must be made to ensure that the assessed risk is real, relevant and objective since unintended subjectivity tends to creep into the process.

Risk assessment is not to be confused with hazard analysis. They are related but different considerations. Whereas hazard analysis involves the identification of the types and sources of hazards, risk assessment is the determination of the actual harm that could be suffered due to the identified hazards. A detected hazard cannot be without the associated risk that must be assessed. On the other hand, a risk assessment may also be needed where a specific hazard has not been identified. For example, assessing the risks associated with buying ingredients from one supplier versus another. This may be done simply on the basis of projected vulnerabilities rather than due to any specific hazard that has been identified. The risk of using certain received materials may be assessed even when a specific hazard has not been identified. For example, if a company, with a preset meat cooking program for a particular size range for raw meat cuts, receives cuts of meat that fall outside of that range, a risk assessment is expected to be done. From that assessment, a decision to adjust the cooking program may be made to ensure the proper cooking of the received lot. Another decision may be to simply ship the meat to another operation with a system that is designed to properly cook any meat cut size. It is important to note with this example that raw meat or improperly cooked meat is not a hazard. The presence of pathogens in the meat is typically the likely hazard. This applies equally to raw, under-cooked and cross-contaminated cooked meat. Where the presence of pathogens is not confirmed, there is no pathogen hazard. Just as the presence of pathogens is possible, the raw meat or improperly cooked meat may also not have any pathogens present.

The Need for Proper Hazard Identification and Risk Assessment:

Where a hazard is not correctly identified and/or a risk assessment is not properly done, implemented risk mitigation measures are likely to be invalid, ineffective and inefficient. It is also worthy of note that a risk assessment that is based on commonsense is not sufficiently scientific and methodical. A risk assessment process must be methodical and must include the consideration of actual situations, circumstance and realities faced by an operation. Existing literature detailing the risks associated with similar operations are helpful. However, simply customizing such existing literature to suit your operation may not be sufficient. Each operation must also be independently examined. All identified risk mitigation measures must be properly challenged or tested and proven valid. The effectiveness of the mitigation measures must also be verified through actual utilization and evaluation in real operation situations before they are to be accepted as routine control measures.

As a food safety and quality systems auditor, I am always performing risk assessments. Every program is assessed to verify that all associated and likely risks are actually addressed. Every procedure is assessed. Every observation is assessed as to its possible contribution, and to what degree it may contribute to harming the consumer.

All identifiable hazards are considered critical by virtue of the description as hazards. Risks have varying degrees of significance (critical, high moderate and low) to consumers, to the business and to organization’s survival. Risks also have varying degrees of likelihood and severity. These should not be confused. Simply stated, likelihood deals with the question of the possibility of occurrence. Severity, on the other hand, deals with the question of how much a victim suffers the effects of an occurrence.

By all means, you need to conduct risk assessment of all contributors, situations, circumstances, observations and activities. You should conduct risk assessment on individual procedures, whole programs and whole systems – equipment, structures, personnel behavior, practices, etc. You need to conduct risk assessment in order to decide, determine and prioritize required actions.

An audit process is essentially a risk assessment process. It is not a corrective, preventive or control process. Although audit findings may lead to the implementation of such processes, the focus of all audits needs to be on risk assessment.

The audit process must look at all likely areas of flux – environment, pests, people, materials, equipment, methods, unacceptable practices, conditions, et cetera.

The scope of food/product risk assessment must include the identification of current Difficult to Manage Situations (DMS). This is in addition to the usual biological, physical, chemical, intrinsic risks and their sources, including known current developments.

How an organization identifies and addresses its DMS makes a great deal of difference in the effectiveness of established food safety assurance programs. All DMS are expected to be addressed through the implementation of well planned intervention measures. A detailed description of DMS-HACCP is provided in the SSQA Implementation Manual.

There are four possible risk contributors: Materials, People, Environment, Pests and Equipment. These also constitute the usual vectors.
The controls applied to assessed risks must address the contributors and vectors of risks: People, environment (air, building structures), pests, equipment and materials. On the basis of the assessed risks, mitigating or control measures are to be implemented. 

CONTROL simply means: The state and art of purposefully and effectively managing systems, processes, procedures, conditions, the environment and all actions with the goal of preventing real problems caused by potential risks.

A good risk assessment and control program must be supported with a good change management program.

Some of the material for this post was drawn from the SSQA Implementation Manual and some of the terms described such as "Difficult to Manage Situations (DMS)" as in DMS-HACCP are described in detail in this manual.
Posted By Felix Amiri
Felix Amiri is the current Food Sector Chair of GCSE-Food & Health Protection

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