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QMS Risk Management Date: MM/DD/YYYY
Revision History
Table of Contents
Severity
1. Risk Control Charts Criteria Rating
Failure of the hazard could result in little to no effect on QMS sub-process, and
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Minor little to no effect on regulatory requirements.
Risk Management {(sub) System – Name} Version: X.X
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Failure of the hazard could result in only a slight effect to a QMS sub-process.
May result in a regulatory observation of a documented procedure indirectly 2
Low affecting a QMS sub-process.
Failure of the hazard could result in a noticeable deterioration to a QMS
sub-process. May result in a regulatory observation of a documented procedure 3
Moderate directly affecting QMS sub-process.
Failure of the hazard could result in a high degree of deterioration to a QMS
sub-process. May result in regulatory nonconformance directly affecting QMS 4
High sub-process.
Failure of the hazard could result in a very high degree of deterioration to a
QMS process. May result in regulatory nonconformance directly affecting 5
Very high complete systematic failure.
Occurrenc RISK
Criteria
e LEVEL
Nonconformance relating to QMS processes has not occurred within last 5
Remote 1
years.
Nonconformance relating to QMS processes has not occurred within last 4
Low 2
years.
Moderate Nonconformance relating to QMS process has not occurred within 2 years. 3
The above tables have been reviewed and accepted as the standard to be used for the risk analysis
of the quality management system.
2.1 Severity Risk Level x Occurrence Risk Level = Overall Risk Level of Hazard
Risk is intolerable, eliminate the hazard or build in controls to ensure the effects of the hazards are not
realized
Risk is tolerable. Risk mitigation measure documented to ensure risk is reduced as low as possible. All
risk control options will be implemented, unless the risk controls would not reduce risks further, or risk
controls are incompatible with other risk controls.
Required Roles: Risk Analysis Team, Risk Management Report, Pre-defined Acceptance
Criteria, Authority to Change Plan & Resource Management
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Risk Assessment
Hazar Potential Failure Mode Potential Effects of Potential Causes of Assessment
Risk Control Method
d ID (Hazard) Failure (Risk) Failure S O Overall
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5. Risk Control
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Risk control measures identified in Section 5.1 will be evaluated against risk
acceptability matrix. Justification of acceptability as well as residual risk is completed in
Section 5.2. Additional identified hazards from risk control measures (if any) shall be
transferred to Section 4.2 for risk evaluation.
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Risk Management {(sub) System – Name} Version: X.X
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ID # Review all hazards, list any risk (s) that have been omitted.
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The following agree that QMS Risk Management has been completed on identified (sub)
system. Action in this document (see below) are complete and correct.