A concrete example of linking risk management using a preliminary hazard analysis approach with the software architecture when applying IEC 62304 in a medical device ALM.
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Applying IEC 62304 Risk Management in Aligned Elements - the medical device ALM
1. Risk Management and IEC 62304
Applying IEC 62304 Risk Management in Aligned Elements
February 2015
2. Elements
Medical Devices and Risk Management
Workflows and functions drives
Risk Management
Risk Management drives Design
Design and Risk Management
are interdependent
Traceability connects Design and
Risk Management
Workflows
&
Functions
Hazardous
Situation
Risk
Risk
Control
Design
3. Elements
Risk Management and Regulations
ISO 13485
QMS
ISO 14971
Risk
Management
IEC 62304
Software
Lifecycle
IEC 60601-1
Security in
Electromedical
devices
IEC 62366
Usability
Refers to
Refers to
Refers to
4. Elements
Risk Management and Regulations
ISO 13485
QMS
ISO 14971
Risk
Management
IEC 62304
Software
Lifecycle
Design &
Maintenance of
software in MD
IEC 60601-1
Security in
Electromedical
devices
IEC 62366
Usability
Affects
Affects
Affects
5. Elements
General Concepts of Risk Assessments
Identify Hazards
Evaluate Risks (likelihood &
consequences)
Perform Risk Reduction
Evaluate residual Risks
6. Elements
Risk Management in IEC 62304
Risk drives the level of
documentation required
Software Safety Classification of
architectural artifacts
Risk inheritance in architecture
Systematic risks => 100% probability
of occurrence
Affects not only development, also
affects maintenance
Software System
Class C
Software Item
Class C
Software Unit
Class C
Software Unit
Class B
Software Item
Class A
Software Item
Class A
7. Elements
Documenting Medical Device Development
Increasing number of regulations
Development documentation is difficult,
complex and resource intensive to manage
Aligned Elements helps you “build” a
consistent and complete documentation
Free up valuable resources from
cumbersome administrative tasks
8. Elements
Aligned Elements – a medical device ALM
Manages the DHF Design Control Items
Version Control + Traceability + Documents
Integrated Risk Management
Real-time quality checks on content
Ensures completeness and consistency
9. Elements
FMEA
Concerns Safety & “Business”
Widely adopted technique
Versatile usage
Probability x Severity x
Visibility
Preliminary Hazard Analysis
Concerns Safety / Harm only
In the early design phase
Full device implementation is
not required
Aligned with ISO 14971
Risk Assessments in Aligned Elements
10. Elements
Preliminary Hazard Analysis (PHA) Overview
Cause
(with probability)
Harm
(with severity)
Hazardous
Situation
Risk Control
Measure
Hazard
11. Elements
Risk Analysis Element
PHA in Aligned Elements
Cause
Harm
(with severity)
Hazardous
Situation
Risk Control
Measure
Reusable Elements
Probability of
Harm
Potential
Hazard
14. Elements
Risk Analysis
PHA and Traceability
Cause 1
Measure 1
Cause 2
Cause 3
Measure 2
Measure 3
SW Use Case
HW Function
SW Item
SW
Requirement
Instructions
For Use
HW
Specification
Potential
Hazards
15. Elements
Aligned Elements as Risk Management Tool
Automatic calculation of RPN
Automatic checks of RPN against
thresholds
Reuse of Harms, Causes and Measures
Measures grouped and sorted according
to Risk Reduction Type
Highlighting of insufficiently controlled
risks
Highlighting of unimplemented Measures
Risk elements integrated with Design
trace landscape
16. Elements
Risk Management in IEC 62304
Cause
Hazardous
Situation
Risk Reduction
Measure
Hazard Software Item
Software
Requirement
Verification
IEC 62304 – 7.3.3 Document Traceability
17. Elements
Risk Analysis
IEC 62304 PHA in Aligned Elements
Cause
Measure
Software Item
(with classification)
SW
Requirement
Verification
Harm
Does classification
match Harms in the
Risk Analysis?
Hazardous
Situation
Are Risk Control
Measures implemented
and verified?
18. Elements
Software Safety Classification (SSC) in Aligned
Automatic Rule Checks:
Is SSC consistent with severity of
(implicitly) linked Harms?
Is SSC consistent with classification
of dependent Software Items?
Specify Rules:
SSC inheritance of Software Items
Software Item must trace to Cause
Connect Severity of Harm with SSC
Severity of Harm Classification
5 or 4 C
3 or 2 B
1 A
19. Elements
Risk Analysis
SSC example in Aligned Elements
Cause
Software Item
(Class B)
SW Unit
(Class C)
Harm
Severity: 5
Not OK!
Not OK!
Severity of Harm Classification
5 or 4 C
3 or 2 B
1 A
20. Elements
IEC 62304 and Probability in Risk Management
Software error probability is difficult
to estimate
Software errors are systematic
IEC 62304 claims that Software
Safety Classification shall not
depend on probability, only on harm
Assume Probability of software
error = 100% (section 4.3. a)
Can we reduce the probability with
our Risk Control Measures?
21. Elements
Use two probabilities:
Probability of Hazardous Situation (P1)
Probability of Harm (P2)
Usage:
P2 can be estimated by professional (e.g.
a Medical Doctor)
Adapt risk policy and thresholds
Risk Control Measures affect P1 and P2
Using two probabilities
Software
Error
Hazardous
Situation
Harm
P1
P2
24. Elements
Architecture vs. Functional Usage
Architecture: Hierarchical
decomposition of Software
into Items and Units
Software risk emanates from
how we use the software
i.e. in which functional
context we use the software
items
Functional use cuts across
the architecture
Use Case
1
(high risk)
Use Case
2
(mid risk)
Use Case
3
(low risk)
SW Item 1
SW Item
2
SW Item 4
SW Item
3
SW Unit
1
SW Unit
2
SW Unit
3
26. Elements
Matrix Model in Aligned Elements
Write Use Cases from SW Reqs
Perform Risk Analysis on Use Cases
Generate Causes from Use Cases
where applicable
Create Architecture
Map Use Cases to Software Items by
connecting Software Items to existing
Causes
If applicable, generate new Causes
from Software Items and map back to
User CasesRisk Analysis
Causes
Software
Requirements
Harm
Hazardous
Situation
Software
Items
27. Elements
Software Problem Resolution Process
Record Problem Report
Identify Causes and perform risk
analysis
Evaluate Risk
Create Change Request (if
applicable)
Verify Change
Risk AnalysisCause
Measure
Problem
Report
Change
Request
Verification
Harm Hazardous
Situation
28. Elements
Aligned Elements IEC 62304 Package
Full template set for all IEC 62304 Artifacts
Includes clear references to applicable sections in IEC 62304
Full usage of Aligned Elements automatic consistency checks
Integrated Checklists and Review Generators
Preconfigured Word reports
Preconfigured Trace Tables
Preconfigured Queries