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ATTACHMENT 28

Example: There have been numerous letters of concern identifying tools that were not calibrated or stored in accordance with the repair station’s maintenance program procedures.  The tools were either being used or were lying around the facilities in various locations instead of being stored with the other tools.  This problem has been noted over the past two years.

Section 2. Risk Analysis and Assessment

The purpose of risk analysis is to determine, “Why are things going wrong” with the certificate holder’s operation, especially its systems.  To complete the risk assessment step, certificate management members must identify the potential consequences that could result if the hazard were not addressed and the factors that are causing or contributing to the hazard’s occurrence.  The risk factors identify what must later be fixed or controlled in order to reduce the level of risk.

Risk assessment answers the question, “How bad might it get?”  That is, what is the level of risk?  To complete the risk assessment step, certificate management members use the information from the risk analysis to determine the overall level of risk.  The overall level of risk is one consideration in determining how much of a priority should be placed on ensuring the certificate holder addresses the hazard and its risk factors.

Section 2: Risk Analysis (What could happen and why?)

Risk Assessment (How likely is it to happen and how bad would it be?)

Potential Consequence Description

6

5

Risk Factors

7

Choose Likelihood Value (Place where appropriate)

Frequent

Probable

Occasional

Remote

8

Choose Severity Value (Place where appropriate)

High

Medium

Low

Overall Risk Assessment Value (Red, Yellow, Blue) from Risk Assessment Matrix

9

5.  Potential Consequence Description:  A potential consequence is defined as an equipment failure, process breakdown, human error, injury/death to persons, damage to equipment, non-compliance with regulations, or non-conformance with procedures.  The PI or designated person will describe the maximum credible potential consequence (in other words, the most believable worst case scenario that could occur as a direct result of the hazard).

Example of Potential Consequence Description:  If the tool calibration and storage issue is not corrected, this could result in many unwanted consequences such as equipment failure, damage to equipment, and injury to persons.

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