📺 Watch the Nextedy Webinar on Integrated Risk Management. By Jiri Walek
Prefer to read? Dive into the key insights below:
In today’s complex product development, from automotive to medical devices, a critical disconnect often exists: while sophisticated ALM tools like Polarion manage requirements and tests, crucial risk management frequently defaults to isolated Excel spreadsheets. This isn’t just inefficient; it’s a fundamental flaw that compromises quality, delays projects, and obscures true enterprise-wide risk exposure.
Smart leaders know that robust risk management is non-negotiable, especially when 60-80% of system requirements in regulated industries are driven by it. The question is: why do so many organizations struggle to move beyond the limitations of disconnected tools?
The Systemic Flaw: Why Current Approaches Break at Scale
Consider an organization developing multiple complex products, with shared components, and teams needing to collaborate on functional safety (FMEA, HARA) and cybersecurity (CVSS, TARA) assessments.
Here’s why common, isolated approaches fall short:
- The Traceability Black Hole: Rows in Excel are data islands. Linking risks to specific requirements, system elements, or mitigation measures becomes a manual, error-prone nightmare, crippling impact analysis and auditability.
- Inconsistency & Redundant Effort: Different teams, departments, or projects often use disparate templates and terminology. This prevents leveraging shared knowledge (e.g., common hazards, failure modes) and leads to duplicated effort in assessing similar risks or meeting regulatory demands.
- Compromised Data Integrity & Siloed Communication: When risk data lives outside the core engineering platform, it’s perpetually out of sync. Requirements acting as control measures in Polarion might not match what’s documented in a risk spreadsheet, leading to fragmented communication and, critically, compromised safety or security.
- Isolated Collaboration & Lack of Holistic View: The “risk management silo” prevents a comprehensive understanding of risk across the organization. Decisions are made with incomplete information, hindering proactive mitigation and strategic oversight.
A New Paradigm: Integrated Risk Intelligence Natively in Polarion
At Nextedy, we leverage Siemens Polarion ALM’s strength as a single source of engineering truth to deliver integrated, enterprise-scale risk management with Nextedy RISKSHEET. Polarion already excels at managing traceability and collaboration. We extend this power directly to your risk processes.
Our approach centers on three core principles:
I. Unified Risk Workspace in a Familiar Format:
Nextedy RISKSHEET provides an Excel-like, highly interactive interface directly within Polarion. Users work in a familiar sheet view, performing FMEA, HARA, or cybersecurity assessments.
Crucially, all data – every risk, hazard, harm, failure mode, control measure – is a native Polarion work item. No external databases, no complex synchronizations.
II. True Risk Intelligence Through Structure & Catalogs:
We enable the move from free-text entries to structured, reusable risk components.
- Define catalogs of standard hazards, harms, failure modes, or threats as reusable Polarion work items.
- Users select from these catalogs, ensuring consistency and enabling powerful querying (e.g., “Show all risks related to ‘Hazard X'”).
- This structured data is vital for consistent assessment and for building a reusable knowledge base. This depth of data interconnectedness is where a written explanation highlights strategic value beyond a simple demo.
III. End-to-End Lifecycle Integration & Collaboration:
By managing risks within Polarion, you unlock its full potential for the risk discipline:
- Seamless Traceability: Directly link risks to system elements, requirements (as inputs or mitigation outputs), and test cases.
- Robust Versioning & Baselining: Every risk assessment, every change, is versioned. Create immutable baselines for audits or historical comparison.
- Streamlined Collaboration & Workflows: Utilize Polarion’s approval workflows and access controls for your risk management processes, ensuring rigor and auditability. Explaining the benefits of harmonizing these workflows with existing requirement management practices is a key point better articulated in writing.
Strategic Outcomes for Enterprise Leaders
By adopting this integrated approach with Nextedy RISKSHEET in Polarion, organizations achieve:
- A Single Source of Truth for Risk: Eliminate spreadsheet chaos. All risk data is centralized, auditable, and connected.
- Harmonized & Consistent Processes: Standardize risk assessments (FMEA, HARA, CVSS, etc.) across teams and projects.
- Enhanced Data Integrity & Unbroken Traceability: Ensure risk mitigations are directly tied to verifiable requirements and tests.
- Improved Efficiency & Reduced Redundancy: Leverage reusable catalogs and a familiar interface to streamline assessments.
- Informed, Data-Driven Decisions: Gain a holistic view of risk, enabling proactive management and strategic resource allocation.
- Simplified Regulatory Compliance & Auditability: Easily generate reports and demonstrate compliance with standards like ISO 14971.
This isn’t about digitizing spreadsheets; it’s about transforming risk management from an isolated chore into an integrated, strategic enabler of quality and safety.
Rethink Your Enterprise Risk Management.
Discover how leading organizations are achieving truly integrated, auditable, and efficient risk management within Polarion.
Who Should Watch?
– Functional Safety & Risk Managers
– Cybersecurity Experts
– Engineers & QA Teams
– Project Managers in regulated industries (Automotive, MedTech, Pharma)