Risk Management {(sub) System – Name} Version: X.

X
QMS Risk Management Date: MM/DD/YYYY

Risk Management {(sub) System – Name}

QMS Risk Management

Version Number: X.X

Version Date: DDMMMYYYY
Risk Management {(sub) System – Name} Version: X.X
QMS Risk Management Date: MM/DD/YYYY

Revision History

Date Version Description Author

MM/DD/YYYY 0.1 Initial draft document Author
 Risk Management {(sub) System – Name} Version: X.X
QMS Risk Management Date: MM/DD/YYYY

Table of Contents

1. Risk Control Charts .................................................................................................................4

1.2 Severity: Severity of the failure ............................................................................................4
1.2 Occurrence: Occurrence of the Failure ..................................................................................4
2. Risk Acceptability Matrix ..........................................................................................................5
2.1 Severity Risk Level x Occurrence Risk Level = Overall Risk Level of Hazard ..........................5
3. Risk Assessment .......................................................................................................................6
3.1 Risk Identification: Function / (sub) Process: ......................................................................6
3.2 Risk Management Responsibilities ......................................................................................6
4. Risk Assessment ......................................................................................................................7
4.1 Risk Analysis: Hazard Identification ....................................................................................7
4.2 Risk Evaluation .................................................................................................................8
5. Risk Control ..............................................................................................................................9
5.1 Risk Reduction ..................................................................................................................9
5.2 Residual Risk and Acceptability: ....................................................................................... 10
6. Risk Review ............................................................................................................................ 11
6.1 Completeness of Risk Assessment: .................................................................................. 11
7. Risk Management Report Approval .......................................................................................... 12
 Risk Management {(sub) System – Name} Version: X.X
QMS Risk Management Date: MM/DD/YYYY

1. Risk Control Charts

1.2 Severity: Severity of the failure

Severity Criteria Rating

Failure of the hazard could result in little to no effect on QMS sub-process, and
1
Minor little to no effect on regulatory requirements.
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 complete 5
Very high systematic failure.

1.2 Occurrence: Occurrence of the Failure

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

High Nonconformance has occurred within the last 12 months. 4

Nonconformance relating to QMS processes is currently open or has occurred

Very high 5
within 6 months.

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
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2. Risk Acceptability Matrix

2.1 Severity Risk Level x Occurrence Risk Level = Overall Risk Level of Hazard

Risk Acceptability Matrix

Risk Acceptability Matrix

severity RL x Occurrence RL = Overall RL of Hazard
Very High (5) Acceptable Tolerable Intolerable Intolerable Intolerable
Occurrence Risk Level

High (4) Acceptable Tolerable Intolerable Intolerable Intolerable

Inc. occurrence

Moderate (3) Acceptable Acceptable Tolerable Intolerable Intolerable

Low (2) Acceptable Acceptable Tolerable Tolerable Intolerable
Remote (1) Acceptable Acceptable Acceptable Acceptable Tolerable
Minor (1) Low (2) Moderate (3) High (4) Very High (5)

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.

Broadly acceptable Risk. No reduction or new controls are required.

 Risk Management {(sub) System – Name} Version: X.X
QMS Risk Management Date: MM/DD/YYYY

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.

3.2 Risk Management Responsibilities

Required Roles: Risk Analysis Team, Risk Management Report, Pre-defined Acceptance
Criteria, Authority to Change Plan & Resource Management

Name Title / Role Contact

Department
 Risk Management {(sub) System – Name} Version: X.X
QMS Risk Management Date: MM/DD/YYYY

4. Risk Assessment
4.1 Risk Analysis: Hazard Identification
Additional numbering to be added as needed.

ID # List all foreseeable hazards in both normal and fault conditions

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4.2 Risk Evaluation

Risk Assessment
Hazard Potential Failure Mode Potential Effects of Potential Causes of Assessment
Risk Control Method
ID (Hazard) Failure (Risk) Failure S O Overall

10

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5. Risk Control
5.1 Risk Reduction
Risk Reduction

Assessment After Mitigation: Action results

Hazard Risk Mitigation Responsibility & Target Completion
ID Measures Date Action Taken & Verification
S O Overall Completion Date
Reference
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Risk Management {(sub) System – Name} Version: X.X
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5.2 Residual Risk and Acceptability:

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.

ID # Identify Risk and Justify Acceptability, where applicable.

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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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7. Risk Management Report Approval

Risks identified have been completed and judged to be acceptable.

The following agree that QMS Risk Management has been completed on identified (sub)
system. Action in this document (see below) are complete and correct.

 Function / Purpose of (sub) System Identified

 Identification of potential or known hazards

 Risk Evaluation of identified (sub) System

 Risk Reduction of identified (sub) System

 Residual Risk identified, acceptability of risk justified

 Completeness of Risk Assessment

Approvers can be added as necessary.

 Risk Management {(sub) System – Name} Version: X.X
QMS Risk Management Date: MM/DD/YYYY

Role Title Signature

Risk Management Report

Author

Risk Analysis Team Member

Approver

Risk Analysis Team Member

Approver

Regulatory Affairs & Quality

Management Manager

Director of Quality Management

& Regulatory Affairs