Functional Safety Risk Management. Inside Polarion. Done Right.

Unify HARA and FMEA processes with complete traceability and enterprise-wide control. Achieve compliance with ISO 14971, ISO 26262, and automotive/industrial best practices.
Try with your data

Set Up Your Proof of Concept – With Your Sample Data

  • Validate the fit of Nextedy RISKSHEET while using your actual templates
  • Collaborate with our team to tailor templates and workflows
  • Experience full traceability, compliance, and user flow inside Polarion
  • Start small. Scale when you’re ready.

 

Please, let us know your name and we get in touch to setup a Proof of concept environment.


“Nextedy has truly exceeded our expectations with their exceptional service and innovative software solutions. “

Senior Manager
Advanced R&D-Digital Tooling 

 

Challenges in Regulated Environments

In safety-critical industries like automotive, medical devices, and industrial automation, 60-80% of system requirements are directly driven by Functional Safety analyses (HARA, FMEA). Yet, many organizations still face significant hurdles.

The result? Audit headaches, duplicated work, and unsafe products.

PROBLEM

Risk, Requirements & Verifications Disconnected

  • Fragmented Data & Tools: HARA and FMEA in isolated spreadsheets, detached from the core ALM.
  • Inconsistent Methodologies: Disparate templates and risk evaluation approaches hindering harmonization.
  • The Traceability Burden: Manual linking of safety artifacts is time-consuming and error-prone.

IMPACT

Disconnected Tools Create Silos and Inconsistencies

  • Siloed Tools & Workflows: Leading to fragmented safety analyses and miscommunication.
  • Compromised Data Integrity & Safety Case: Incoherent safety cases and potential compliance gaps.
  • Wasted Engineering Hours & Project Delays: Significant time lost searching for data and preparing for audits.

SOLUTION

Nextedy RISKSHEET Unifies Functional Safety Processes

  • A Single Source of Truth for Safety: Centralize all HARA and FMEA data within Polarion ALM.
  • Harmonized Safety Processes & Automated Traceability: Standardized templates, automated calculations, and live, auditable links.
  • Enterprise-Wide Control & Lifecycle Visibility: Track revisions and compare baselines of your safety analyses.

Unified, Intelligent Functional Safety in Polarion

Nextedy RISKSHEET elevates Siemens Polarion ALM into a robust, centralized platform specifically for your Functional Safety risk management needs. We provide the specialized capabilities to overcome the limitations of generic ALM tools, ensuring your HARA and FMEA processes are efficient, compliant, and fully integrated.

Capabilities Designed for Functional Safety Engineering

Nextedy RISKSHEET is deeply embedded within Polarion ALM. Hazards, failure modes, risks, and control measures are native Polarion Work Items, seamlessly connected to your safety requirements (FSR, TSR), architectural design, and test protocols.
  • Eliminate data exports & silos.
  • Accelerate collaboration between safety, design, and V&V teams.
  • Drive safety by design with direct links from HARA/FMEA to safety requirements.
Boost productivity and adoption with RISKSHEET’s familiar spreadsheet-style layout for your HARA and FMEA activities directly within Polarion LiveDocs.
  • Minimize learning curve for safety engineers.
  • Efficiently manage extensive HARA worksheets or detailed FMEAs.
  • Get instant feedback with real-time calculations of risk levels, ASILs, or RPNs/APs.
Whether you’re adhering to ISO 14971, ISO 26262, IEC 61508, or AIAG & VDA FMEA, RISKSHEET offers fully customizable templates.
  • Start with best-practice HARA/FMEA templates or configure to precisely match your internal processes and regulatory frameworks.
  • Ensure methodological consistency with standardized fields, enumerations, and evaluation logic.
Integrate your HARA/FMEA processes with Polarion’s workflow engine, enhanced by RISKSHEET, to reduce manual effort and errors.
  • Configure guided review and approval cycles for safety analysis stages.
  • Automate notifications to keep stakeholders informed.
  • Maintain rigorous, immutable audit trails for every change.
Managing the lifecycle of your safety analyses is critical. Nextedy RISKSHEET leverages Polarion’s versioning to provide complete insight:
  • Understand the “who, what, when, and why” of every change to your HARA or FMEA.
  • Formally baseline safety assessments at key milestones.

Visually compare different revisions or baselines directly within RISKSHEET. Instantly identify deltas in hazard ratings, control measures, or risk priorities – crucial for change impact analysis and justifying safety decisions.

Produce the necessary documentation for your safety case, assessments, and audits with confidence and ease.
  • Export comprehensive HARA worksheets, FMEA forms (e.g., AIAG & VDA), risk matrices, and detailed audit trails directly from RISKSHEET (e.g., to Excel, PDF).
  • Ensure reports are always accurate and up-to-date, generated from the live, authoritative safety data within Polarion.

Mastering FMEA in Polarion with Nextedy RISKSHEET: From Analysis to Actionable Improvement

Functional Safety Risk Management

HARA in Polarion with Nextedy RISKSHEET: Mastering ISO 14971 Compliance for Medical Devices

Functional Safety Risk Management

Built for Functional Safety Leaders and Practitioners:

  • Functional Safety Managers & Engineers (FSM, FSE)
  • HARA and FMEA Moderators & Participants
  • Quality Assurance & Regulatory Affairs in Safety-Critical Domains
  • Project Leaders overseeing safety-related product development

See Nextedy RISKSHEET in Action:
Full Webinar On-Demand

  • Discover how Nextedy RISKSHEET streamlines HARA (ISO 14971, ISO 26262) and FMEA (AIAG & VDA, IEC 60812) processes natively inside Polarion.
  • See how to transform Excel-based safety analyses into dynamic, traceable, and auditable models.
  • Learn to effectively link hazards, failure modes, safety goals, risk controls, and safety requirements.
  • Understand how to maintain continuous compliance with key functional safety standards.

Evaluate RISKSHEET With a Real Project

Quick and easy way to validate the fit of risk management discipline integrated into Polarion ALM.

Request Proof of Concept

Set Up Your Proof of Concept – With Your Sample Data

  • Validate the fit of Nextedy RISKSHEET while using your actual templates
  • Collaborate with our team to tailor templates and workflows
  • Experience full traceability, compliance, and user flow inside Polarion
  • Start small. Scale when you’re ready.

 

Please, let us know your name and we get in touch to setup a Proof of Concept environment.

Convert your Excel Template

We take your current Excel HARA or FMEA templates and convert them into Polarion data models.

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Review & Iterate with our Team

Review and provide feedback. After we help you tailor workflows, templates, and interfaces.

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Mature your workflow at your pace

Any time, even after the initial rollout, implement catalogs, reusable assets, and model-based approaches.

Industry Leaders Rely on Nextedy Products