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QMS Risk Management Date: MM/DD/YYYY
Revision History
Table of Contents
RISK
Occurrence Criteria
LEVEL
Remote Nonconformance relating to QMS processes has not occurred within last 5 years. 1
Low Nonconformance relating to QMS processes has not occurred within last 4 years. 2
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.
Risk Management {(sub) System – Name} Version: X.X
QMS Risk Management Date: MM/DD/YYYY
Increasing Severity
Severity Risk Level
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.
3. Risk Assessment
3.1 Risk Identification: Function / (sub) Process:
Identification of the process we are assessing and risk analysis of the potential hazards
that could occur.
Required Roles: Risk Analysis Team, Risk Management Report, Pre-defined Acceptance
Criteria, Authority to Change Plan & Resource Management
4. Risk Assessment
4.1 Risk Analysis: Hazard Identification
Additional numbering to be added as needed.
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Risk Management {(sub) System – Name} Version: X.X
QMS Risk Management Date: MM/DD/YYYY
Risk Assessment
Hazard Potential Failure Mode Potential Effects of Potential Causes of Assessment
Risk Control Method
ID (Hazard) Failure (Risk) Failure S O Overall
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Risk Management {(sub) System – Name} Version: X.X
QMS Risk Management Date: MM/DD/YYYY
5. Risk Control
5.1 Risk Reduction
Risk Reduction
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Risk Management {(sub) System – Name} Version: X.X
QMS Risk Management Date: MM/DD/YYYY
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
QMS Risk Management Date: MM/DD/YYYY
6. Risk Review
6.1 Completeness of Risk Assessment:
All hazards in Section 4.1 shall be reviewed for completeness of risk evaluation. Additional
risks identified will be documented below and added to Section 4.2.
ID # Review all hazards, list any risk (s) that have been omitted.
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Risk Management {(sub) System – Name} Version: X.X
QMS Risk Management Date: MM/DD/YYYY
The following agree that QMS Risk Management has been completed on identified (sub)
system. Action in this document (see below) are complete and correct.