FMEA Development Workshop
Our Failure Mode and Effects Analysis (FMEA) Development Workshop is designed to help engineering and quality teams master the structured process of identifying, prioritizing, and mitigating risk within product and process design. Whether your organization is new to FMEA or looking to strengthen existing frameworks, this workshop provides a deep, hands-on understanding of both Design FMEA (DFMEA) and Process FMEA (PFMEA) development in alignment with ISO 14971, AIAG-VDA, and ISO 13485 expectations.
Participants will learn not only how to construct and maintain FMEAs effectively, but also why this process is integral to safety, reliability, and regulatory compliance. Through a mix of guided instruction, practical exercises, and real-world examples, teams leave with the tools and confidence to implement robust risk management systems that prevent failures before they occur.
Customizable Options
We tailor the workshop to meet your company’s needs and experience level. You may select from three engagement types:
Training Session (Foundational)
Ideal for teams seeking a strong theoretical and procedural understanding of FMEA.
Covers FMEA principles, terminology, scoring methodology, and integration into the risk management file.
Includes sample exercises and templates for internal use.
Sample Walkthrough (Applied Learning)
Perfect for organizations looking to see FMEA methods applied to an industry-relevant example.
The session uses a sample product or process from a similar field to illustrate best practices and common pitfalls.
Interactive group discussion enhances understanding of scoring consistency and mitigation prioritization.
Real Guided Walkthrough (Company-Specific Implementation)
A hands-on, collaborative session where we develop or refine your company’s own FMEA in real time.
Facilitated by our expert consultant to ensure alignment with your internal processes, design history file, and quality objectives.
Participants leave with a completed or near-complete FMEA ready for use in ongoing risk reviews or design control documentation.
Session Length Options
While we are flexible and can customize your session lengths, here are the most popular formats, catered to your team’s needs and depth of exploration:​
Format | Duration | Ideal For | Focus |
|---|---|---|---|
Two-Day Intensive | 16 hours | Teams seeking to create or overhaul their FMEA library | Comprehensive FMEA development, review, and integration with CAPA, design controls, and risk files |
Full-Day Workshop | 8 hours | Balanced blend of instruction and hands-on application | Team-based FMEA build with facilitation |
Half-Day Workshop | 4 hours | Quick introduction or refresher training | Theory, structure, and guided example |
What Will Participants Learn?
Participants will learn how to:
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Structure and maintain effective DFMEAs and PFMEAs aligned with current standards.
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Identify and evaluate potential failure modes, effects, and causes with clear traceability.
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Calculate Risk Priority Numbers (RPN) and determine optimized corrective actions.
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Integrate FMEA outcomes into design verification, process validation, and risk management plans.
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Facilitate multidisciplinary collaboration and maintain living FMEA documents throughout the product lifecycle.
Get a Quote
Every organization's compliance journey is different — your quote should be too.
Share a few details about your project at contact@heurnova.com, and we'll prepare a customized quote.
Alternatively, you can drop your information below, and we will reach out to you: