IEC 60601-1 3rd Edition Requires Risk Management

July 18th, 2011 Posted by ISO 14971, Risk Management 0 thoughts on “IEC 60601-1 3rd Edition Requires Risk Management”
IEC 60601-1 3rd Edition Mandatory Adoption Dates:
– Europe: June 1, 2012
– Canada: June 1, 2012
– USA: July 1, 2013
IEC 60601-1 3rd Edition requires Risk Management process in accordance to ISO 14971
Please note clause 4.2 of the IEC 60601-1 3rd Edition that states:
“A risk management process complying with ISO 14971 shall be performed”.

Severity and detectable control in risk management

July 15th, 2011 Posted by ISO 14971, Risk Management 0 thoughts on “Severity and detectable control in risk management”

A dispute we encounter in many organizations.

Can the risk mitigation reduce the severity, or just the probability?

Another issue:

RPN is calculated by Severity * Probability

In some cases, companies use Detectable with is another factor used to calculate the RPN.

Is it relevant just in software risk management?

We will be happy to hear your input

Can we link test case to hazard for mitigation?

June 28th, 2011 Posted by ISO 14971, Risk Management, Test Management 0 thoughts on “Can we link test case to hazard for mitigation?”

In some occasions, test case is traced to a risk in order to assure mitigation. I believe this traceability used for risk mitigation is wrong.

The correct flow is adding a risk control, and then add traceability from the test case to the risk control (can be software requirement, user manual reference, etc.)

The test case will be used to verify that the control implemented is actually reduce the risk

So the test case is used for verification of the risk control and NOT as risk mitigation.

Software Validation and Verification

June 22nd, 2011 Posted by Validation and Verification 0 thoughts on “Software Validation and Verification”

Software Verification

The Goal is to provide objective evidence that the software meets all the specified requirements

> building the thing right

Software Validation

The Goal is to confirm that the software meets the user needs and intended uses

> building the right thing

Manage risk mitigation types

April 13th, 2011 Posted by Software Lifecycle Management 0 thoughts on “Manage risk mitigation types”

You can add custom field “Required Mitigation” in order to indicate which mitigations are required for a specific risk:

Risk mitigation types

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Risk and software requirements traceability

April 12th, 2011 Posted by ISO 14971, Risk Management 0 thoughts on “Risk and software requirements traceability”

I have encountered the following question more than once:

Do we manage traceability from risk to software requirement (saying: this risk is derived from the linked software requirement) or do we link software requirement to risk (saying: this software requireemnt is used as risk control (mitigation) for the linked risk)?

The regulation requires management of the following traceability: Software requirement -> risk

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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Wireless medicine and mobile health

April 4th, 2011 Posted by Software Lifecycle Management 0 thoughts on “Wireless medicine and mobile health”

Some links on this subject:
http://mobihealthnews.com/10495/fda-promises-regulatory-guidance-this-year

The wireless future of medicine: http://www.ted.com/talks/eric_topol_the_wireless_future_of_medicine.html

Risk Management, FMEA and ISO 14971

April 3rd, 2011 Posted by ISO 14971, Risk Management 0 thoughts on “Risk Management, FMEA and ISO 14971”

The risk management standard required by medical device manufacturers is ISO 14971.

The ISO14971 talks about risk management plan, risk management file, risk analysis, risk evaluation, risk control, production and post production, verification methods and more.

The FMEA (Failure Mode Effect Analysis) or FMECA (Failure Mode Effect Cause Analysis) is an acceptable risk management application that supports some parts described in ISO 14971.

Safety classification and level of concern

March 15th, 2011 Posted by FDA, Medical Device Directive 93/42/EEC 0 thoughts on “Safety classification and level of concern”

Software safety classification required by the CE (According to IEC 62304) is based on the product type. The classification is 1, 2a, 2b, 3 (major).

The FDA safety classification is called level of concern, and it talks about the potential harm to the patient/user. There is Class I, II, III.

There is a list of questions to ask in order to determine the safety classification, such as “Is the software part of a product with high risk”

The risk management is on system level and is not related to the level of concern

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