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December 19, 2023     RELIASOFT

The evolving landscape of Failure Modes and Effects Analysis (FMEA) has meant saying farewell to traditional spreadsheet methods.

Industries, particularly the automotive sector with key players like Ford, have ushered in new FMEA approaches, influenced by standards such as AIAG & VDA and SAE handbooks. This has impacted not only how FMEAs are conducted but also the tools used to perform them.

In this article, we will explore some of the major changes emerging from the evolving FMEA requirements – inside and outside the FMEA handbooks – as well as the benefits of embracing dedicated software solutions like XFMEA to be prepared for changes.

The changing face of FMEA

Representation of a car in 3D with the wheel and parts of the engine with OEM and tier suppliers highlighted

The world of FMEA is no stranger to change, with evolving standards and customer-specific requirements (CSRs) steering the way. Leading the shifts today are industry giants like Ford, who have made dedicated FMEA software a necessity, replacing traditional spreadsheet methods like Excel. This shift is not about investing in something extravagant – it's about intelligent data management and traceability throughout the FMEA process.

To navigate these changes, ReliaSoft's XFMEA emerges as a pivotal solution, offering support for various FMEA guidelines, including:

  • AIAG & VDA 1st Edition: Complying with the latest standards.
  • SAE J1739 (2021): Staying up to date with the most recent SAE guidelines.
  • Legacy FMEA forms: Retaining compatibility with previous FMEA methodologies, such as J1739, AIAG, Simplified VDA, and more.
  • Configurability: XFMEA's flexibility allows for customization, including risk ranking methods such as Action Priority, ensuring it adapts to your unique needs.

In recent times, the AIAG & VDA FMEA Handbook and SAE’s response to FMEA methodology have caused significant upheavals in the automotive FMEA domain. Several fundamental changes have occurred, such as the removal of Risk Priority Numbers (RPNs) and the shift toward Action Priority.

XFMEA was well prepared for this transition, having supported similar approaches since XFMEA version 5; it is now advancing to version 23. Whether it’s industry guidelines or internal protocols, XFMEA stands ready to assist, ensuring you're always in compliance.

Understanding the significance of linkages

Linkages between the FMEA steps form the backbone of an effective FMEA process. These links ensure the seamless flow of critical information from one stage to another, maintaining consistency and traceability throughout the FMEA journey.

XFMEA recognizes the paramount importance of these linkages and comprehensively supports them. It enables the reuse of information from various FMEA types, such as:

  • Design FMEA into Process FMEA
  • Process FMEA into Control Plans
  • Process FMEA to Reverse FMEA

The key is not just establishing these linkages, but also updating them when modifications occur behind the scenes.

In short, XFMEA supports a multitude of connections, ensuring that data flows smoothly, shows traceability, and adapts to changes as they happen.
It's especially crucial when transitioning from a generic FMEA to a product-specific one or when transferring information from a Design FMEA to a DVP&R or Test Plan, a DFMEA to a PFMEA, or a PFMEA to a Process Control Plan.

This traceability safeguards against any overlooked assumptions or modifications.

XFMEA also aligns with the requirements of many Original Equipment Manufacturers' (OEMs’) CSRs by supporting direct integrations with XFRACAS for 8D, Corrective and Preventive Action (CAPA), and Root Cause Analysis (RCA) solutions.
By integrating XFMEA and XFRACAS, you gain a seamless connection between your system hierarchy, failure modes, and causes to track the performance of your FMEA and its associated processes.

What are reference or family FMEAs?

Various names exist for the fundamental FMEAs – generic, family, core, master, template, reference, and more.

Regardless of what they’re called, the concept remains the same.

These master FMEAs serve as repositories for validated lessons learned. They are the cornerstone of well-managed FMEA processes, subject to strict revision control to ensure their accuracy and relevance.

What makes these master FMEAs truly invaluable is their reusability. They serve as initial baselines for redesigns, new models, or analogous processes.

This reuse practice is instrumental in maintaining consistency and predictability in FMEA methodologies and outcomes.

A generic FMEA captures standard approaches and common lessons learned, applicable to multiple product lines. These FMEAs become repositories that eliminate the need to reinvent the FMEA with every new project.

XFMEA supports this concept by offering a reference FMEA that allows controlled access for viewing, reuse, and management. This makes it easy to use, while still being controlled to prevent unauthorized updates.

Demystifying reverse FMEAs

One term that’s been generating curiosity is RFMEA – the reverse FMEA. But what is it?
A reverse FMEA is a review of the process FMEA, verifying the process, data, and underlying assumptions.
Different organizations often have their own approaches, as the process has not been standardized yet. But for XFMEA users, conducting an RFMEA is quite straightforward, while also providing:

  • Action notifications: Receive email notifications and overdue notices, and close the loop on completion activities.
  • Maintaining relationships: Keep your entire PFMEA > RFMEA > P/D FMEA relationship intact within a single software package.
  • Revision control: Ensure consistency and security in your RFMEA.

So, what’s the process of conducting an RFMEA?

  1. Identify scope: Is your RFMEA for a specific station, production line, or machine?
  2. Validate failure modes and causes: Are they realistic, relevant, and based in reality?
  3. Audit: Ensure that all failure modes and causes in your PFMEA are present. Use the insights from operators who can identify missing or unconsidered factors.
  4. Validate scoring: Verify the detectability and frequency scores in the PFMEA with known data on how often issues are detected before release.
  5. Validate controls: Check that all prevention and detection controls are effective, followed, and documented in the PFMEA.
  6. Review and update: Review all steps in the PFMEA and documentation, including work instructions, Control Plans, and Process Flow Diagrams (PFDs). Update them as needed.
  7. Close the loop: Update the PFMEA and relevant documents with your insights from the RFMEA.
  8. Document the entire process: Record every step, review, and correction for an effective RFMEA
  9. Repeat as needed: An RFMEA is not a one-time activity; it may be done on a regular basis: semi-annually, upon encountering major issues, or at every revision step. This keeps your PFMEA aligned with real-world experiences.
engineer touching a desktop screen in a 3D image of a car during the development phase in the Automotive industry

The vital role of revision control in FMEA

Revision control comes in various forms and serves different essential functions.
XFMEA offers two primary approaches to manage the integrity of your FMEAs over time:

Change logs

These empower FMEA managers to track and audit changes to an FMEA, providing a transparent mechanism for approving or rejecting FMEAs upon completion.
This helps FMEA managers keep a close eye on every modification, ensuring the FMEA stays accurate, up-to-date, and aligned with the project or process.

References and permissions

By establishing your generic FMEAs as reference FMEAs, users can view and reuse templated FMEAs, streamlining the process.
However, this method restricts the ability to modify the generic FMEAs to a select group of power users or managers. This keeps generic FMEAs consistent, serving as solid foundations for various projects and processes.
Effective revision control is particularly vital when dealing with reference projects. Any revisions or updates to reference FMEAs need to be carefully tracked to maintain the integrity of the FMEA process.

What XFMEA can do for you

ReliaSoft’s XFMEA software does it all – whether you're navigating the intricacies of design, system, or process FMEAs, or delving into the depths of FMECA.
The “X” in XFMEA signifies its universal nature – it doesn't limit itself to a specific type of FMEA or industry.
XFMEA goes one step further by providing support for various related analyses, including:

  • P-Diagrams: For comprehensive Process Diagrams
  • DVP&Rs (Test Plans): Allowing you to create Detailed Verification Plans and reports
  • Design Reviews Based on Failure Mode (DRBFMs): A crucial tool for design-focused evaluations
  • Process Flow Diagrams: Simplifying the representation of your processes
  • Process Control Plans: Streamlining your process control strategies

XFMEA provides extensive reporting capabilities, allowing you to generate detailed reports – invaluable for effective communication and decision-making within your organization.
In addition, XFMEA is hugely customizable and adaptable, with seamless desktop FMEA tools designed to cater to a wide spectrum of FMEA types and industries.

Empower your analysis with XFMEA

As the requirements of the FMEA world expand and adapt, XFMEA is the ideal tool to achieve your goals:

  1. Versatile to meet different requirements: Navigate the vast web of requirements from multiple OEMs and customers within a single software package. For suppliers, XFMEA supports multiple profiles, allowing you to accommodate both internal templates and those from external stakeholders.
  2. Configurable for data accessibility: Tailor the software to your specific needs and preferences. If you’re transitioning from an Excel-based environment, import your existing data easily with XFMEA. Or set up templates to bring in data and ensure a smooth transition to the software.
  3. Seamlessly integrate into reliability disciplines: More than just an FMEA tool, XFMEA is a gateway to the wider world of reliability disciplines. Expand your reliability portfolio with direct integration into different reliability processes.

In this ever-changing FMEA landscape, XFMEA provides the flexibility and functionality you need to tackle evolving requirements – whether it’s from the latest handbooks or your customers and OEMs.

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