Abstract:
For medical device manufacturers, a robust Hazard Analysis and Risk Assessment (HARA) process compliant with ISO 14971 is not just a regulatory mandate but a cornerstone of patient safety. While Siemens Polarion ALM provides a strong foundational platform, realizing the full potential of an efficient, traceable, and user-friendly HARA process often requires specialized enhancements. This whitepaper, authored by Nextedy, details how Nextedy RISKSHEET revolutionizes HARA within Polarion. We explore how RISKSHEET’s intuitive, Excel-like interface, powerful configuration capabilities, and seamless integration transform Polarion LiveDocs into dynamic HARA workbenches, enabling organizations to meet ISO 14971 requirements with unprecedented efficiency and clarity, ensuring comprehensive risk management from hazard identification through to verified control measures.
Introduction:
The Imperative of HARA in Medical Device Development – And the Nextedy Solution
In the safety-critical domain of medical device development, the Hazard Analysis and Risk Assessment (HARA) process, as mandated by ISO 14971, is fundamental. It demands a systematic approach to identifying hazards, estimating and evaluating associated risks, defining control measures, and monitoring their effectiveness.
Siemens Polarion ALM offers a comprehensive application lifecycle management environment. However, to truly master the complexities of HARA and unlock significant efficiency gains, Nextedy RISKSHEET provides the crucial a specialized layer of functionality. This whitepaper, based on the proven principles embedded in our HARA Demo Template, demonstrates how Nextedy RISKSHEET empowers organizations to implement a fully compliant and highly efficient ISO 14971 HARA process directly within Polarion. (We invite you to evaluate this firsthand with a live demonstration on Nextedy’s hosted Testdrive server, available upon request.)
Why Polarion ALM for HARA?
The Foundation Nextedy Builds Upon
Polarion ALM offers inherent strengths that make it a suitable foundation for HARA:
- Integrated Lifecycle Management: It unifies requirements, design, risk, and V&V.
- End-to-End Traceability: Essential for ISO 14971 audits, connecting all artifacts.
- Configurability: Allows tailoring of Work Items, fields, and link roles.
- Collaborative Environment: Supports cross-functional team involvement.
- Document-Centric & Data-Driven: LiveDocs provide a unique framework for risk files.
While Polarion provides these foundational capabilities, Nextedy RISKSHEET is the catalyst that transforms this potential into a streamlined, intuitive, and powerful HARA solution. Without RISKSHEET, users might still grapple with less interactive views or more cumbersome data entry for the detailed matrix work inherent in HARA.
Terminology Mapping:
ISO 14971 Concepts & the Nextedy-Enhanced Polarion Context
Effectively implementing HARA involves mapping ISO 14971 terms to Polarion artifacts. Nextedy RISKSHEET interacts seamlessly with these configurations, making them accessible and manageable.
| ISO 14971 Concept | Polarion Equivalent (Enhanced by Nextedy RISKSHEET) |
| Hazard | Work Item (Type: Hazard). RISKSHEET allows easy linking and viewing of related Hazards. |
| Foreseeable Sequence of Events / Hazardous Situation | Textual description in the Risk Work Item. RISKSHEET provides a clear column for its input and review. |
| Harm | Work Item (Type: Harm). RISKSHEET facilitates linking Harms and their severities to Risks. |
| Risk | Work Item (Type: Risk). Central artifact. RISKSHEET presents Risks in a structured table, enabling efficient assessment. |
| Severity | Custom Field (e.g., harmSeverity). RISKSHEET allows direct selection from configured enumerations. |
| Probability of Occurrence of Harm | Custom Fields (e.g., pHazardBefore, pOverallAfter). RISKSHEET enables intuitive selection and powers automated risk calculations. |
| Risk Evaluation | Driven by Nextedy RISKSHEET’s visualization of configurable risk matrices and support for documented rationale. |
| Risk Control Measure | Work Item (Type: RiskControl). RISKSHEET streamlines the definition, linking, and status tracking of controls. |
| Residual Risk | Calculated and displayed dynamically within Nextedy RISKSHEET based on post-mitigation inputs. |
| Risk Management File / Risk Management Report | Polarion LiveDocument(s). Nextedy RISKSHEET views are embedded directly, providing live, interactive risk tables instead of static exports. |
HARA Implementation Structure:
Optimized by Nextedy RISKSHEET
While Polarion allows for the setup of Work Items, custom fields, and link roles, Nextedy RISKSHEET brings these static configurations to life, making them part of an interactive and efficient HARA workflow:
- Work Item Types (Hazard, Harm, Risk, RiskControl): Configured in Polarion, but managed and interconnected with ease through the RISKSHEET interface.
- Custom Fields (Severity, Probabilities, Risk Indices): Defined in Polarion, but RISKSHEET enables direct, user-friendly input and leverages them for real-time calculations (e.g., Risk Index) without needing complex Polarion scripting for immediate visual feedback in the table.
- Link Roles (e.g., assessesHazard, mitigates): Polarion provides the linking mechanism, but RISKSHEET often provides more intuitive ways to create and visualize these critical relationships directly within the risk assessment context.
- LiveDocs for Risk Management File: Polarion LiveDocs serve as the container. Nextedy RISKSHEET elevates them from static documents to dynamic risk workbenches by embedding live, editable, and calculative risk tables. This means the “Risk File” is always up-to-date and interactive.
The Nextedy RISKSHEET Advantage:
Revolutionizing Risk Assessment in Polarion
The core risk assessment activities – identification, analysis, and evaluation – are where Nextedy RISKSHEET delivers transformative value within the Polarion LiveDoc environment.
Nextedy RISKSHEET is not just a viewer; it’s an interactive HARA workspace offering:
- The Familiarity of Excel, The Power of Polarion: Users immediately grasp the spreadsheet-style interface, drastically reducing training needs and boosting adoption. All data, however, remains natively within Polarion, ensuring integrity and traceability.
- Dynamic, Real-Time Risk Calculations: As users select Severity and Probability from dropdowns, RISKSHEET instantly calculates the Risk Index and displays the corresponding risk level (e.g., color-coding) based on your configured risk matrix. This immediate feedback is crucial for efficient decision-making and eliminates manual lookups or external calculations.
- Integrated Traceability at Your Fingertips: RISKSHEET allows users to directly create or link Hazards, Harms, and Risk Controls within the context of the risk being assessed. This visual and direct linking strengthens compliance and simplifies audit preparation immeasurably compared to navigating standard Polarion linking dialogues for each relationship.
- Configurable & Purpose-Built HARA Views: RISKSHEET enables tailored views for each step of the HARA process. Columns can be precisely arranged for initial hazard identification, pre-mitigation assessment, risk control planning, and residual risk evaluation, guiding users through a structured workflow.
- Making Risk Controls Truly Actionable: Within RISKSHEET, identified Risk Control measures are not just text. They are linked to (or can initiate the creation of) actual RiskControl Work Items in Polarion. This unique Nextedy capability ensures a seamless transition from risk assessment to actionable task management, where controls can be assigned, tracked, and directly linked to the implementation of Safety Requirements and subsequent V&V activities.
- Enhanced Collaboration & Centralized Truth: By making HARA data accessible and editable through an intuitive interface within Polarion, RISKSHEET facilitates better collaboration among stakeholders. Everyone works on the same, up-to-date dataset, eliminating the versioning chaos of offline spreadsheets.
- Unparalleled Adaptability: While this whitepaper focuses on ISO 14971, Nextedy RISKSHEET’s flexible configuration engine means it can be readily adapted for other HARA/risk assessment standards (e.g., ISO 26262, FMEA/IEC 60812), making it a versatile solution for diverse regulated industries.
Risk Evaluation:
Powered by Nextedy RISKSHEET’s Visual Logic
ISO 14971’s risk evaluation, based on Severity and Probability, comes alive with Nextedy RISKSHEET.
- Intuitive Input: Severity and Probability levels are selected from dropdowns directly in the RISKSHEET cells.
- Automated Risk Matrix Application: RISKSHEET applies your organization’s pre-configured risk matrix logic in real-time. As inputs change, the calculated risk level (e.g., “Acceptable,” “Not Acceptable”) and its visual representation (e.g., cell color) update instantly. This provides immediate, clear feedback on risk acceptability without manual cross-referencing.
The HARA flow within RISKSHEET typically involves:
- Initial Risk Assessment: Input pre-mitigation Severity/Probability; RISKSHEET displays the initial risk.
- Risk Control Definition: If unacceptable, define/link Risk Controls directly in relevant RISKSHEET columns.
- Residual Risk Assessment: Input post-mitigation Severity/Probability; RISKSHEET displays the residual risk.
This dynamic feedback loop significantly accelerates the risk evaluation and iteration process.
Conclusion:
Nextedy RISKSHEET – The Key to Mastering HARA in Polarion
While Siemens Polarion ALM provides a robust platform for integrated lifecycle management, Nextedy RISKSHEET is the essential enhancement that unlocks true efficiency, usability, and power for ISO 14971 HARA processes.
By transforming Polarion LiveDocs into dynamic, interactive risk assessment workbenches, Nextedy RISKSHEET empowers medical device manufacturers to:
- Dramatically streamline HARA with an intuitive, universally understood Excel-like interface.
- Guarantee real-time, end-to-end traceability that simplifies audits and ensures data integrity.
- Automate risk calculations and visual risk level indicators, enabling faster, more informed decisions.
- Make risk control measures genuinely actionable by seamlessly integrating them into Polarion’s task and requirement management.
- Foster superior collaboration by providing a clear, accessible, and centralized HARA environment.
Nextedy is committed to providing solutions that augment Polarion’s capabilities, making complex regulatory processes like HARA more manageable and effective. With Nextedy RISKSHEET, organizations can confidently navigate ISO 14971 requirements, build safer medical devices, and bring them to market more efficiently.