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Food Safety Enhancement Program Manual

Printer-friendly PDF version - Appendix III

Appendix III - Guidelines for use of the Health Risk Assessment Model

Introduction

The Health Risk Assessment Model is a tool which may be used by the inspector/auditor as guidance when evaluating the health risk of a product.

The model uses Severity of Consequences (horizontal axis) and Likelihood of Occurrence (vertical axis) to determine the rating for deficiencies which impact on health and safety.

The Severity of Consequences for an identified hazard is set based on the health outcome. (Subclinical = low, temporary disability = medium, permanent disability/death = high). As well, severity of consequences is based on the worst case scenario as it relates to the health of the end user e.g., microbiological pathogens will always be categorized as high whereas physical hazards will usually be categorized as low or medium.

The Likelihood of Occurrence is the vertical axis which relates strictly to the hazard likelihood that it will appear in the product (i.e. likelihood that the end user will be exposed to the hazard identified). This will be influenced by items such as in-plant process controls, type and use of product, target group, regulatory requirements, complaint file, plant history and other relevant information e.g., a metal hazard due to defective equipment prior to a metal detector will be categorized as low, whereas without a metal detector it will be categorized as high.

The following definitions apply to the model:

A)	Satisfactory (Sa)	-	No deficiencies noted which would result in a health risk or risk of contamination or adulteration.
B)	Nonsatisfactory	-	If deficiencies are noted which would result in a health risk of contamination or adulteration, they are to be assessed using the following criteria:
	Minor Deficiency (Mi)	-	Deficiencies which could result in a low health risk or a low to moderate risk of contamination or adulteration.
	Major Deficiency (Ma)	-	Deficiencies which could result in a moderate health risk or a high risk of contamination or adulteration.
	Critical Deficiency (Cr)	-	Deficiencies (including contamination) which could result in a high health risk.

Figure I - Health Risk Assessment Model

Likelihood of Occurence	High	Sa	Mi	Ma	Cr
	Medium	Sa	Mi	Ma	Ma
	Low	Sa	Mi	Mi	Mi
	Remote	Sa	Sa	Sa	Sa
			Low	Medium	high
		Severity of Consequences

Likelihood of Occurrence
Based on:

control at the subitem
frequency of deficiency
controls at other sub items
other relevant information

Severity of Consequences
Based on:

type of hazard involved
health outcome (low = subclinical, medium = temporary disability, high = permanent disability or death

Exception - Population at risk is considered for sensitive populations such as infants, immunocompromised, or individuals using products as a sole source of nutrition are involved.

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