All products, systems or processes can fail. That is why pioneers of quality and reliability from various backgrounds such as statistics, mathematics, engineering, manufacturing, design, and art have developed various quality and reliability management tools over the past century for all industry verticals. Chief among them is the failure mode and effects analysis (FMEA) tool developed in the 1950s to help product designers and manufacturers identify and address failures in all phases of the product lifecycle.

There is one efficient and effective way to implement an FMEA program (notwithstanding the required human factors such as personality, cultural issues, and leadership), and that is through a robust software solution. There are two key areas of today’s software solutions worth exploring: business rules and business process requirements.

In the FMEA context, business rules refer to the FMEA parameters (the labels on FMEA forms and sheets) that help the organization comply with FMEA standards and reflect the company’s products design and production nuances. This aspect of the FMEA solution is best addressed in desktop software where, traditionally speaking, finer control of the user-interface is possible.

Business process requirements would refer to establishing FMEA in the right place in the company’s overall quality management framework, having role-based and secure availability across the organization for individual data entry and data mining, and having a centralized repository of FMEA data with cross-study reporting and dashboards. This aspect of the FMEA solution is best addressed through enterprise software accessed through web browsers.

FMEA desktop applications are usually great for business rules, but they do not address business process requirements well. Desktop users must implement manual procedures to work around these gaps, such as:

• Using file protection to prevent accidental or intentional study or template structure modifications so that the FMEA template in use can remain consistent
• Using shared directories on the network where users manually store their FMEA studies with restricted access
• Tracking FMEA actions manually through email or third-party action tracking applications
• Pulling study data manually into spreadsheets for cross-study reporting and dashboards.

Over time, as FMEA studies accumulate and the number of users increases, the deficiencies of the desktop FMEA software become more pronounced. Typically, the ideal solution will house and integrate the various FMEA types and related quality tools. Most users can create a basic FMEA solution in Microsoft Word or Excel, for example. However, there are inherent limitations with this option that can be alleviated via the use of specialized FMEA desktop software, which is designed to offer an intuitive user interface that is tailored for FMEA tasks. In addition, such software offers improved tie-in and integration of FMEA tools such as quality function deployment, process flow chart, process control plan, and action tracking.

Specialized FMEA software is designed to allow tailoring of the “low-level” business rules that would normally be onerous if not impossible to develop and maintain in spreadsheets or word processors. Desktop software lends itself to easy configuration and modifications; however, over time, as different facilitators and users edit the FMEA studies or create new ones, they tend to modify the template formatting and/or structure, causing deviations from a company’s risk procedure/standard.

Also, reporting on segregated studies is susceptible to errors because of manual operation: Collecting and compiling information from studies with different template solutions with potentially different risk matrices produces unreliable metrics. This defeats one of the purposes of an FMEA program, which is to continuously monitor and reduce or eliminate quality and safety risks across the organization.

Today, technology allows us to have a desktop-level, feature-rich user interface in the web browser. Some specific capabilities and features you should look for in a modern FMEA system include the following:

• Location on a centralized database platform with options for complex data manipulation, enforcement of relationships among parameters (database records), creation of specialized views, scalability as usage changes, and predefinition of highly tailored reports and dashboards.
• A default list of formatted FMEA templates that can be easily configured to meet industry standards and meet the company’s internal best practices.
• Tie-ins to FMEA libraries that subject-matter experts can review and edit and the ability for users to access the data from one or more sources simultaneously. Advanced library features such as advanced search, automatic filtering, and sub-item auto-population, also should be present. Users can then select a parent value and the child data will be automatically populated from an approved master library.
• The ability to configure complex risk matrices that are connected in intricate ways to perform specific risk calculations. This allows companies to update their FMEA approach to meet the evolving needs of their customers.
• Customizable markers for follow-up, notes, revalidation, high risk, etc., and automatic tracking of the markers in a central location with referenced hyperlinks.
• Active cross-referencing capability that allows many-to-one field relationships among worksheets. In a typical FMEA risk assessment, the list of controls has repeated values, as does the list of recommendations or corrective actions. Modern FMEA applications automatically compile a unique list of these values in a master “actions” worksheet with hyperlinked references back to the study. Action tracking can be performed from the actions worksheet.
• The ability to migrate data from your legacy studies to new and evolving versions of your FMEA solution.  

Ultimately, the quality of the FMEA content entered into the system will determine the success of your FMEA program. Software applications greatly enhance FMEA programs and help prevent incidents.