Posts in Validation and Verification

FMEA Risk management best practice (ISO 14971)

April 5th, 2011 Posted by ISO 14971, Risk Management, Validation and Verification 0 thoughts on “FMEA Risk management best practice (ISO 14971)”

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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IEC 62304 For Software Lifecycle In Medical Device

February 22nd, 2011 Posted by IEC 62304, Validation and Verification 0 thoughts on “IEC 62304 For Software Lifecycle In Medical Device”

IEC 62304 (and EN 62304) is the international standard for software life cycle for medical device. IEC 62304 specifies life cycle requirements for the development of medical software and software within medical devices. It is harmonized by the European Union and the United States. Compliance with this standard fulfills the FDA 21 CFR820 requirements as well as the Medical Device Directive 93/42/EEC.

Main activities described in IEC 62304 that are fully supported in QPack

  • Requirements traceability
  • Integrated risk management process
  • Test Management (Unit/Module/Integration/System)

See QPack main features

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