Preventing failure is always more cost-effective than correcting it after the fact.
Failure mode and effects analysis (FMEA) helps manufacturers identify and mitigate risk. Two subsets of this approach are design failure mode and effects analysis (DFMEA) and process failure mode and effects analysis (PFMEA).
While they share the same foundational methodology, they serve different purposes and are applied at different stages during the product lifecycle. Knowing which one to choose and how to use it effectively helps manufacturers reduce defects, improve reliability and protect profitability.
Below, we break down where DFMEA and PFMEA fit in the product lifecycle, when each should be used and best practices to effectively use them.
Design failure mode and effects analysis
Design FMEA identifies failures caused by design. It is conducted during the product development phase and aims to reduce design flaws before manufacturing begins.
Process failure mode and effects analysis
Process FMEA pinpoints failures tied to processes. It is carried out before and during process launches, and looks to reduce scrap and rework volumes, product defects and unplanned downtime.
PFMEA vs. DFMEA—Key differences
PFMEA and DFMEA share a common goal but occur at different stages in the manufacturing lifecycle. Here’s a quick visual comparison:
Category | DFMEA | PFMEA |
Primary focus | Product design risks | Manufacturing process risks |
Lifecycle stage | Product development phase | Pre-production and ongoing production |
Main objective | Prevent design flaws | Prevent process defects |
Scope | Materials, tolerances, geometry and functionality | Equipment, workflow, operator actions and tooling |
Team involvement | Design engineers, R&D and product teams | Manufacturing, maintenance and product quality teams |
Failure types addressed | Structural failure, performance issues and safety risks | Assembly errors, machine faults and human errors |
Impact areas | Product reliability & warranty risks | Scrap, reworks, defects and unplanned downtime |
Timing of use | Before manufacturing begins | Before and during production |
Documentation output | Design control updates | Control plans and process flow diagrams |
How DFMEA and PFMEA work together
DFMEA identifies inherent product risks, while PFMEA identifies risk in how products are assembled. The result is a cyclical relationship that can be leveraged to identify issues, limit downtime and improve profitability.
Consider an example. Mike’s Manufacturing has designed a new and improved version of its best-selling product. Just an hour into the first production run, however, something goes wrong.
Warning lights blaze, alarm bells ring and critical machinery goes offline. The result is two days of unplanned downtime before teams find and resolve the issue—a small measurement mistake during the design phase.
Applying DFMEA and PFMEA could have prevented this problem. Here’s how.
FMEA focuses on pinpointing the way a design or process fails—the “mode.” In the example above, the mode is an incorrect measurement, which resulted in the failure of both product and process.
Finding and correcting this issue starts with DFMEA. During the design process, teams document and review product specifications such as weights, materials and measurements. In addition to physical analysis, DFMEA often includes digital modeling to assess the real-world impact of design. By looking for risks rather than assuming accuracy, Mike’s Manufacturing could have spotted and corrected the measurement error before production began.
PFMEA offers another line of defense by evaluating the likelihood and impact of assembly errors, machine faults and design issues. Even if DFMEA missed the measurement issue, pre-production PFMEA analysis could pinpoint potential failure modes.
Put simply, design flaws can increase process complexity, while process analysis can reveal feedback that leads to improved design. By using DFMEA and PFMEA in tandem, companies can reduce warranty risk and improve operational efficiency in manufacturing.
Teams can also leverage system FMEA to help streamline the integration of assets, services and software at scale.
Common mistakes in PFMEA and DFMEA implementation
PFMEA and DFMEA are ongoing analyses that require time and effort to deliver actionable results. If failure analysis programs aren’t delivering on their potential, evaluate them for these common mistakes.
- Treating failure analysis as a paperwork exercise: Documentation isn’t enough to improve designs and processes. While accurately calculating and recording data such as risk priority numbers (RPNs) is critical for effective PFMEA and DFMEA, it’s the first step.
- Forgetting to update models after changes: Once changes are implemented, models must be updated to reflect new specifications. Failure to do so can create visibility gaps.
- Limiting cross-functional participation: Multiple teams contribute to the success of DFMEA and PFMEA. Limiting participation reduces the amount of data available for impact, outcome and criticality analysis.
- Overlooking maintenance and reliability inputs: Even if designs and processes are optimized, maintenance or reliability issues can derail productivity. As a result, they are a key component of effective failure mode analysis.
- Ignoring detection and prevention controls: Detection and prevention controls provide context for design and process actions. Ignoring them puts operations at risk.
- Failing to prioritize and address high-risk issues: Once issues are identified, teams must create and follow priority lists to ensure timely resolution. Skip this step, and any design or process fixes will be temporary.
To eliminate these risks and improve FMEA efficacy, it’s worth scheduling regular PFMEA and DFMEA evaluations. These evaluations should include analysis of failure identification rates, the effectiveness of design or process resolutions, and the accuracy of failure and resolution documentation.
Benefits of using FMEA in manufacturing
Using FMEA in manufacturing offers measurable benefits such as:
- Reduced defects and scrap
- Improved first-pass yield
- Higher product reliability
- Lower warranty costs
- Increased equipment uptime
- Better cross-department communication
- Stronger compliance documentation
In addition, solid DFMEA and PFMEA programs set the stage for continuous, data-driven improvement.
How outsourced maintenance supports risk reduction & process reliability
While DFMEA is often carried out in-house, PFMEA benefits from the expertise of outsourced maintenance experts. This is because preventive maintenance programs play a key role in process reliability. If critical equipment is poorly maintained, manufacturers may experience unexpected downtime that causes them to miss production targets and spend days or weeks identifying root causes.
By partnering with outsourced experts, businesses gain:
- Maintenance strategy alignment with PFMEA
- Reliability-centered maintenance integration
- Data-driven insights from predictive technologies
- Cross-functional collaboration
- Continuous improvement expertise
- Access to predictive maintenance solutions
Bottom line? Consistent application of PFMEA and DFMEA processes contributes to improved production, reduced downtime and increased profitability.
Support risk reduction and improve process reliability with outsourced maintenance services from ATS. Let’s talk.
