The following process is based on QPack FMEA Risk Management Module.
Phase 1: Risk Assessment – Intended use and safety related characteristics
You can build a risk assessment document in QPack and add the safety related questions.
Example: Add risk assessment document and add safety related questions by category
Set the paragraph to be of type “Safety Question”
The paragraph has a short and simple workflow:
Open - new safety question was added
Estimated - the safety related question was responded by risk object
NA - safety question is not applicable for this product.
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Now start identifying risks to your product. Each risk is linked to the safety question so can verify that every question was addressed by risk.
Example: Safety questions traceability
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The outcome of this phase is the risk category (failure mode) as shown here:
Example: Risk category list (failure mode)
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Phase 2: Hazard Identification
Setup risk status to “Identify Hazard”
Use QPack to add new risk object.
Setup risk name, and failure mode.
Example: Setup new risk
Risk name: Failure in power supply
Failure mode: Energy Electromagnetic
Cause of failure: Short circuit
Effect of failure: Shock to patient
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Phase 3: Risk estimation
change risk status to “Estimation”
Use QPack Risk estimation form in order to calculate the RPN
Set the RPN parameters in order to calculate the risk zone (Acceptable/Alarp/ Unacceptable):
Example: Calculate RPN before mitigation
- Probability (P1)
- Detectability (D1)
- Severity (S1)
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Phase 4: Identify and setup risk control
Change risk status to “Identify Controls”
Identify preventive actions in order to reduce risk severity/probability, or improve detectability.
Example: Risk recommended actions
Risk reduction: Front panel lights will not be off indicating power supply fault.
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At this phase, or in later phases, we will setup risk estimated cost, assign to the relevant person and setup due date
Example: Risk cost, due date and assignment
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In case a software requirement is used as a recommended actions – add a software requirement in your SRS
Setup requirement “Risk Mitigation” indication to “Yes”
Example: Add software requirement for mitigation
Software requirement: Use the alert mechanism to control warning lights in front panel
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Link the software requirement to the relevant risk for mitigation traceability. Use the “Risk Mitigation” link type.
Example: Software requirement is linked to the risk
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Based on the risk mitigation – setup the new RPN value
Example: Revised RPN is automatically calculated
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Phase 5: Completeness of risk control
Software team will develop the software requirement
Once software requirement is finished, the software requirement status is changed to “Done”
Example: software requirement is implemented
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Show a filter of all software requirements that are used for risk mitigation, in status “Done”
Example: report of implemented software requirements used for mitigation
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Open the related risk of each requirement and change the risk status to “Control Implemented”
Example: risk controls are implemented
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Phase 6: Risk verification
Add a software test case to the STD and link it to the software requirement in the SRS
Example: traceability of test case to software requirement used for mitigation
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SQA team execute the tests, and when test passes its status is set to “Pass”
Example: Get all requirements that are used for risk mitigation and trace their verification status (derived from test execution status)
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When all tests were passed for the software requirement – open the related risk and change the risk status to “Verified”
Example: risk is set to “Verified”
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Phase 7: Risk management report
Create a filter that retrieves all risk items
Example: risks report
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Build the risk management document in QPack based on your template and embed the risk report filter in the relevant chapter.
Example: risk management document in QPack
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Generate the risk management document and save it as attachment
Example: Generated risk and hazards document
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