Microbiological Risk Assessment

Product:
Micro-organism:
Updated:

Step Question

STEP 1 HAZARD IDENTIFICATION (Output from Questionnaire)

1. What is the name and type of product?
2. What is the name of the micro-organism realistically associated with the
product?
2.1 Is it toxiogenic or not?
STEP 2 HAZARD CHARACTERISATION
3.1 Who are the consumers of concern?
3.2 How many distinctive sub-groups are there in the population of
consumers?
3.3 What is the severity of the hazard (the sensitivity of each group should
be considered or that the most sensitive consumer should be used for a
single assessment?
3.4 What is the hazardous level of the micro-organism covered by this risk
assessment?
3.5 What is the uncertainty of this estimate?
STEP 3 EXPOSURE ASSESSMENT (E.A.)
E.A. - Occurrence of the hazardous micro-organism
4.1 What is the frequency of contamination of raw materials making up the
product?
4.2 What is the range of levels of contamination found in the raw
materials?
4.3 What is the uncertainty of this estimate?
E.A. – Effect of processing / decontamination
5.1 What is the effect of storage before processing on the level of the
hazard?
5.2 What is the intended effect of all processing and any decontamination
stages on the level of the micro-organism?
5.3 What is the uncertainty of this estimate?
E.A. - Occurrence of toxin (if the hazardous micro-organism is toxiogenic)

6.1 What is the likelihood of toxin presence if the micro-organism

contaminates the raw materials or product?
6.2 What is the uncertainty of this estimate?
E.A. – Re-contamination after processing or decontamination
7.1 What is the frequency of re-contamination of the product in the factory
after processing or decontamination, so that the hazard is present in the
final product?
7.2 What is the likely level of re-contamination after processing or
decontamination?
7.3 What is the uncertainty of this estimate?
E.A. - Packaging
8.1 Is the product put in its primary packaging before (Yes) or after (No) the
decontamination step?
8.2 If the answer to 8.1 is yes – what is the effectiveness of packaging at
preventing recontamination before consumption?
8.3 What is the frequency of recontamination after packaging?
8.4 What is the level of recontamination after packaging?
 8.8 What is the uncertainty of this estimate?
E.A. – Effect of product storage
9.1 How does the level of the micro-organism change during product
storage?
9.2 What is the uncertainty of this estimate?
9.3 What is the effect of storage on the final product (according to the
usage instructions) on the level of toxin?
9.4 What is the effect of storage conditions on toxigenesis (If the level of
the micro-organism changes and it is toxiogenic)
9.5 What is the likelihood of toxigenesis in the product?
9.6 What is the uncertainty of this estimate?
E.A. – Consumer Use
10.1 Is the product intended as single use (yes) or multi-use (no), with
storage after opening?
10.2 If the answer to 10.1 is No, this means that the product is multi-use
either in a domestic or food service application, and sections 11 & 12 must
be completed.
E.A. – The effect of open shelf-life on the microbial hazard
11.1 What is the effect of open shelf-life storage on the level of micro-
organisms?
11.2 What is the uncertainty of this estimate?
E.A. – The effect of open shelf-life on toxigenesis
12.1 What is the likelihood of growth and toxin production during open
shelf-life?
12.2 What is the uncertainty of this estimate?
E.A. – The effect of usage and preparation on the level of the hazardous
micro-organism
13.1 What is the effect of customer or food service preparation and usage
on the level of hazard?
13.2 What is the uncertainty of this estimate?
13.3 What is the effect of usage and preparation on toxin level and
production?

13.4 What is the probability of toxin presence at the point of consumption?

13.5 What is the uncertainty of this estimate?
E.A. – Food intake by a consumer
14.1 What is the likely quantity of the food consumed by a customer on a
specified occasion or over a period of time?
14.2 What is the uncertainty of this estimate?
STEP 4 RISK CHARACTERISATION
Risk Score - Total

Uncertainty Score - Total

RISK RANGE
High Risk
Medium Risk
Low Risk

Prepared and adapted from various sources including: Martyn Brown, Phil Voysey, R. Buchanan, M. Stringer, Notermans and Mead
Answers Options Score (Enter Score) Uncertainty of
Score

e.g. cooked ham

e.g. Listeria monocytogenes

No

e.g. families
e.g. pregnant women

e.g. yes or no…

details

0
0
 0

0
0

0
0

e.g. yes or no…

0
0

70-105
35-70
0-35

oysey, R. Buchanan, M. Stringer, Notermans and Mead

Notes and References
CCP determination required
CCP determination required
CCP determination not required
Prepared and adapted from various sources including:

Martyn Brown, Phil Voysey, R. Buchanan, M. Stringer, Notermans and Mead