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Regulatory Risk Assessment Overview

This document outlines a risk assessment matrix for evaluating potential risks from international policy changes. It assesses the probability and consequences of risks across different scenarios based on the number and type of products affected and the magnitude of required changes. The matrix assigns numerical scores to determine the overall level of risk, from very low to very high.

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Armand Liviu
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41 views2 pages

Regulatory Risk Assessment Overview

This document outlines a risk assessment matrix for evaluating potential risks from international policy changes. It assesses the probability and consequences of risks across different scenarios based on the number and type of products affected and the magnitude of required changes. The matrix assigns numerical scores to determine the overall level of risk, from very low to very high.

Uploaded by

Armand Liviu
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLS, PDF, TXT or read online on Scribd
  • Risk Assessment Overview
  • Risk Impact Analysis

PROBABILITY OF RISK PRODUCTS AFFECTED

One or two non-critical Several non-critical


products affected products affected

1 2

International policy change 1


Very low Very low
TYPE OF CHANGE

Minor changes to legislation/directives (already


compliant) 2 Very low Low
Major changes to legislation/directives (already
compliant) 3 Low Low
Minor changes to legislation/directives where changes
will be needed 4 Medium Medium
New or major changes to legislation/directives where
changes will be needed 5 Medium Medium

POTENTIAL IMPACT CONSEQUENCES OF RIS


Changes to internal policies
Minor changes to internal or procedures with minor
policies or procedures investment

1 2

Very low 1 1 2
PROBABILITY OF RISK

Low 2 2 4

Medium 3 3 6

High 4 4 8

Very high 5 5 10
PRODUCTS AFFECTED
One or 2 critical products
One or 2 critical products Several critical and non-
affected along with non-
affected only critical products affected
critical products

3 4 5

Low Low Medium

Low Medium Medium

Medium Medium High

Medium High Very high

High Very high Very high

CONSEQUENCES OF RISK
Participation on Significant investment Major change of strategy
committees/review boards, needed or alter strategic
needed (product banned)
etc. needed course

3 4 5

3 4 5

6 8 10

9 12 15

12 16 20

15 20 25

PROBABILITY OF RISK PRODUCTS AFFECTED 1 2 TYPE OF CHANGE International policy change 1 Very low Very low 2 Very low Low 3 Low
PRODUCTS AFFECTED 3 4 5 Low Low Medium Low Medium Medium Medium Medium High Medium High Very high High Very high Very high CO

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