LOGO DOCUMENT: SUBJECT: DEPARTMENT: REVIEWED: 1.

XYZ (Pty) Ltd

Methodology for Determination of Hazard Control Measures, CCPs and oPRPs. Food Safety and Quality Management System Quality APPROVED: DOC NO: REV NO: PAGE: DATE: 00 Page 1 of 4

Purpose The purpose of this procedure is to describe the methodology based on risk assessment used to determine: - Significance and Acceptance of food safety hazards - Assessment of control measures - determination of oPRP and CCPs Application This procedure is applicable to the hazard analyis of the intake, blending and bottling processes of XYZ (Pty) Ltd.

2.

3. References 3.1 ISO 22000: 2005, 7.4.2, 7.4.3, 7.4.4 3.2 SANS 10330:2007 3.3 Risk assessment methodology 4 Abbreviations and Definitions 4.1 Risk (hazard) probability : Likelihood of a specific outcome. 4.2 Risk (hazard) impact: The value assigned to the consequence of failing to achieve control the hazard. 4.3 PRP Prerequisite programme: These are basically the generic controls in any type of food business operation. Mark the word GENERIC . These are to be applied in all types of food business so as to maintain a hygienic environment to reduce the risk to the Food Safety E.g. - Plant Layout or infrastructure control, pest control, personnel hygiene, sanitation, work environment, food handling and storage , transportation. 4.4 oPRP Operational prerequisite program: These differ from PRP in the sense that these are SPECIFIC to particular industry /food operations . And these are arrived only after doing the hazard analysis. So, oPRP wil differ within the food industry while PRP could be more or less similiar. Therefore, after you conduct hazard analysis for a specific food chain and there comes a requirement/step where control is required to prevent /reduce the hazard it becomes oPRP . 4.5 CCP: Critical Control Point: arise as a result of Hazard Analysis but difference b/w oPRP & CCP is the risk level of the identified hazard. If the hazard pose very high risk to food safety then it is CCP rather than oPRP(substantial risk) . Also, while doing hazard analysis some steps are required to control the hazard but since the hazard is reduced /eliminated in further step , it is not considered a CCP , so in such case it's an oPRP .

Responsibilities

LOGO DOCUMENT: SUBJECT: DEPARTMENT: REVIEWED: 5.1 -

XYZ (Pty) Ltd

Methodology for Determination of Hazard Control Measures, CCPs and oPRPs. Food Safety and Quality Management System Quality APPROVED: DOC NO: REV NO: PAGE: DATE: 00 Page 2 of 4

The Quality manager is responsible to assess and update the hazard assessment monthly based on the verification results obtained from: microbiological swabs taken at designated areas failure of filter integrity tests summary of foreign body control during bottling quality control If there is a change in the effectiveness of the control measure, the food safety tea must be informed and decision taken based on by following: FQ10 Non Conformance Procedure FQ08 Corrective and preventative action procedure FQ10 Product Recall and Withdrawal procedure

6 Procedure 6.1.1 Hazard Identification Methodology: Description of hazard: Define the process step or describe it. What will actually happen if the hazard occurs. The type of problems are defined in risk assessment. What kind of impact will arise? Types of impacts are described in the risk assessment. Probability : the probability of such an hazard occurring Measured : Low = 1; Medium Low = 2; Medium = 3; Medium High = 4; High = 5. Low 1 Medium Low 2 Medium 3 Medium High 4 High 5

Note: Consideration is given to the following when exposure is assigned: - steps of control preceding and following the specified operation - process equipment, utilities/service and surroundings - the precedings and following links in the food chain Impact: assess the impact using scale from 1 5 with Low = 1; Medium Low = 2; Medium = 3; Medium High = 4; High = 5. Low 1 Medium Low 2 Medium 3 Medium High 4 High 5

LOGO DOCUMENT: SUBJECT: DEPARTMENT: REVIEWED:

XYZ (Pty) Ltd

Methodology for Determination of Hazard Control Measures, CCPs and oPRPs. Food Safety and Quality Management System Quality APPROVED: DOC NO: REV NO: PAGE: DATE: 00 Page 3 of 4

6.1.2 Hazard Significance

Hazard Impact

High Med High Med Med Low Low

5 4 3 2 1

Quantifying Hazards 5 10 15 4 3 2 2 1 8 6 12 9

20 16 12

25 20 15 10 5 5 High

4 6 8 2 3 4 2 3 4 Med Med Low Med Low High Hazard Occurrence Probability

Significance Rating: (Exposure) 1-5 Low Med 6-10 Low 11-15 Med Med 16-20 High 21-25 High

6.1.3 Hazard Acceptance Level(Exposure level) The consequence of the hazard is accepted. There are two types of Acceptance: Passive Acceptance : Rating 1-10 Hazard is controlled by PRP Active Acceptance: Rating >10 Develop Control Measures in case hazard occurs. These would then either be controlled by CCP monitoring or oPRP monitoring. 6.1.4 Justification of determination of acceptable levels: 1-5 6-10 11-15 16-20 21-25 Significance Rating Low Med Low Med Med High High

Ratings <10 (i.e. significance levels Low and Med Low) are controlled by the PRP. Ratings > 10 are controlled by the CCPs or oPRP based on the assessment level of the control meaures/combinations of control measures.

LOGO DOCUMENT: SUBJECT: DEPARTMENT: REVIEWED:

XYZ (Pty) Ltd

Methodology for Determination of Hazard Control Measures, CCPs and oPRPs. Food Safety and Quality Management System Quality APPROVED: DOC NO: REV NO: PAGE: DATE: 00 Page 4 of 4

6.2.1 Methodology of Assessment of Control Measures: Rate effectivity of control measures from 1-3 based on the Criteria a) g), assigning a score to each criteria as detailed in Figure 1. Add the sum of the ratings; the control measures must now be categorized in terms of oPRP's and CCP. Assessment Criteria: a) Control measure effect on identified food safety hazards relative to the strictness applied b) Control measure feasibility for monitoring (e.g. ability to be monitored in a timely manner to enable immediate corrections) c) Control measure place within the system relative to other control measures d) the likelihood of failure in the funtioning of a control measure or significant processing variability e) the severity of the consequence (s) in the case of failure in its functioning f) whether the control measure is specifically estabished and applied to eliminate or significantly reduce the level of hazards(s) g) synergistic effects (i.e. interaction that occurs between two or more measures resulting in their combined effect being higher than the sum of their individual effects)
Assessment of Control Measures Assessment Criteria (Levels of effectiveness) Selected Combination of Control Measures 1: Low / 2: Medium / 3:High a b c d e f g 1 1 1 1 1 1 1 3 3 3 3 3 3 3 Total 7 21 Management HACCP OPRP Plan < 14 >14

Figure 1. 6.2.2 Justification of determining CCPs and oPRP By assigning the lowest possible level of effectivity rating and the highest level of effectivity that could be attained. It is clear that the ratings will be between 7-21. Extrapolated this means that: Values of < 14 rating of effectiveness will be controlled by the HACCP plan Values of > 14 rating of effectiveness will be controlled by the oPRPs 7 Records 7.1 Assessment records will be kept with the Quality manager and updated on monthly basis to be reviewed at the bi-month Food safety and Quality Management System Review. 7.2 Outdated records will be archived for a period of 5 years after which it will be destroyed. 8 Attachments 8.1 FQ01-03F/1 ISO 22000:2005 Decision Tree 8.2 FQ01-03F/2 Hazard Analysis