Manufacturing is becoming more expensive. According to data from Deloitte, the cost of materials and employment is on the rise, while staffing availability continues to fall. The result is production processes with little room for error; even small amounts of unplanned downtime can negatively impact revenue and reputation.
Failure modes and effects analysis (FMEA) helps manufacturers proactively identify risk and prevent problems before failures occur, in turn boosting reliability, improving worker safety and minimizing unexpected costs.
Read on for an in-depth look at FMEA types, components, processes, benefits and practical implementation guidelines.
What is failure modes and effects analysis (FMEA)?
What is FMEA? It is a structured approach to identifying potential failures. It is designed to evaluate failure modes, causes and effects, and is applicable across manufacturing processes, equipment and systems.
The goal of FMEA frameworks is prevention rather than reaction. Consider a piece of equipment operating at the midpoint of a production line. If this equipment fails, bottlenecks occur behind it in the line, while downstream machines have nothing to process. The result is expensive machine downtime until the issue can be identified, addressed and resolved.
Reactive operations wait until failure occurs, then attempt to diagnose and solve issues ASAP. If failures are simple to find and easy to fix, downtime may only last an hour or two. If problems are more complex, machines could be offline for days or weeks if maintenance teams don’t have critical parts on hand.
FMEA processes identify potential failure conditions along with their causes and effects. This allows manufacturers to create targeted maintenance processes that proactively address these conditions and lower total failure rates.
Types of FMEA used in manufacturing
There are three common types of FMEA used in manufacturing:
- Design FMEA: Design FMEA, or DFMEA, is used for risk assessment in product or equipment design. For example, a manufacturing firm designing a new product might use DFMEA to pinpoint likely failure points, such as places where two or more parts join together, or where repeated motions may put stress on hinges or bearings.
- Process FMEA: Process FMEA, or PFMEA, evaluates risks in manufacturing processes and operations. Consider a piece of production line equipment that relies on the precisely calibrated use of compressed gas. PFMEA evaluates and ranks potential risks according to their likelihood and impact. Consider a simple process FMEA example. While it’s possible that the equipment could experience a power loss due to frayed cables or poor connections, the risk of this failure mode is low. It is far more likely that a pressurized line will fail due to repeated exposure to high-pressure gas distribution. Using PFMEA, companies can create targeted responses to high-risk events.
- Equipment or System FMEA: Equipment or system FMEA narrows the focus even further with an in-depth analysis of high-impact risks and outcomes. This criticality analysis is used to support both scheduled and proactive maintenance processes that address common failures before they occur.
While all types are beneficial, not all types apply to every situation. Aligning FMEA type with the intended use case is essential to maximize value.
Key components of FMEA
FMEA frameworks depend on five components. While each component offers insight on its own, they are most effective in combination. The five FMEA components are:
- Failure modes: Failure modes describe what went wrong. If a pipe bursts within equipment cooling systems, the burst is the failure mode.
- Failure effects: Failure effects are the potential impacts of failure mode. In the case of a burst coolant pipe, the effects could be machine overheating, lost production time or a factory fire.
- Failure causes: Failure causes speak to why failure modes happen. Burst pipes may be caused by simple wear and tear or because the wrong connectors were used. Unexpected coolant pressure or power fluctuations are also potential causes.
- Severity, occurrence and detection rankings: Severity (S) is a measure of failure effects. The worse the effect, the higher the severity. Occurrence (O) is the likelihood of a specific failure and its potential frequency. Detection (D) describes how easily failures can be detected when they occur.
- Risk Priority Number (RPN): RPNs are used to prioritize risk and assign resources.
To calculate the RPN, companies first assign values to the severity, occurrence and detection of an event. These values share a common scale, such as 1-10. Higher values are more worrisome—higher severity means greater impact, higher occurrence means more likely and higher failure detection means harder to pinpoint.
Next, teams multiply S, O and D values.
For example, if event X has an S value of 4, an O value of 7 and a D value of 5, then:
RPN = S x O x D = 4 x 7 x 5 = 140
Scores for multiple events are calculated and ranked, with higher-scoring events prioritized for maintenance.
How the FMEA process works
The FMEA process depends on a step-by-step approach. Each step builds on the next. Skipping steps for speed can lead to missed modes, causes or effects that may hamper FMEA analysis utility.
Step 1: Define the scope and process
The first step is clearly defining which events will be evaluated and how performance data will be collected. Are these events related to design? Processes? Equipment? Will they be measured using remote sensors, FMEA software tools, manual observation or some combination of each?
Step 2: Identify potential failure modes
Next is identifying what can go wrong. For a piece of production line machinery, this can include everything from power infrastructure to component connectors to PLCs, operating temperatures and regular wear and tear.
Step 3: Assess effects and causes
With failure modes compiled, teams must think forward and backwards: What could cause failure modes to occur, and what are the potential effects of these failures?
Step 4: Assign risk rankings
Once severity, occurrence and detection data are collected, the next step is calculating RPNs and assigning risk rankings to each event.
Step 5: Prioritize actions
RPN lists help identify which actions come first: What maintenance processes are a top priority, and where does it make the most sense to install IIoT sensors capable of detecting issues early?
Step 6: Review and update over time
Finally, it’s important to regularly review and update functional FMEA frameworks over time. As machines age, staff change and new processes are implemented, risk rankings change and FMEA must change in response.
It’s important to note that each step in the process benefits from a cross-functional approach. This is because failure modes may be tied to one manufacturing function but manifest in another. For example, an issue with manufacturing execution software (MES) could lead to invalid equipment inputs that cause unplanned stoppages. If these stoppages are treated as independent actions with no connection to software inputs, maintenance operations will solve symptoms rather than address root causes.
Benefits of using FMEA in manufacturing
Developing and applying an effective FMEA framework in manufacturing offers multiple benefits, including:
- Reduced unplanned downtime: By understanding the causes and likely frequency of failure modes, teams can take steps to prevent them, in turn reducing unplanned downtime.
- Improved product and process quality: Fewer failures reduce quality issues across both product development and operational processes. This leads to less reworks, reduced material waste and stronger support for zero defect manufacturing initiatives.
- Enhanced safety and compliance: Many manufacturers are subject to strict compliance rules, especially those in pharmaceutical and food manufacturing. FMEA processes limit reactive risk, in turn reducing the risk of process noncompliance.
- More effective maintenance planning: Maintenance is necessary to ensure asset health. Over-maintenance, however, leads to cost without benefit, while reactive maintenance is expensive and time-consuming. FMEA helps align maintenance efforts with measurable risk.
- Lower total cost of ownership: The more companies spend on maintenance and emergency repairs, the higher their total cost of ownership (TCO). FMEA helps reduce this cost by aligning recommended actions with data-driven root cause analysis.
FMEA’s role in maintenance and reliability programs
FMEA plays a key role in developing a reliability-centered maintenance strategy. It also sets the stage for manufacturers to build preventive and predictive maintenance programs that focus on proactively reducing risk.
The primary role of FMEA in maintenance is identifying high-risk assets and failure modes. Consider a piece of equipment used in food manufacturing. While minor clogs or misalignments can lead to moderate downtime, they pale in comparison to issues such as cross-contamination or improper storage. FMEA practices identify and rank both assets and failure modes to ensure high-risk modes are minimized.
FMEA also helps inform industrial preventive maintenance schedules and the use of predictive maintenance tools. Consider the example above. If FMEA data shows that clogs are happening more frequently, teams can schedule regular evaluations and repairs to limit their impact. Leaders can also carry out root cause failure analysis (RCFA) to pinpoint the origin of the issue.
Finally, FMEA improves resource prioritization. These resources include physical parts, digital systems and employee labor. By determining which failure modes are most likely and which have the largest impact on operations, manufacturers can assign resources where they are needed most.
Applied effectively, FMEA both reduces the risk of short-term failures and supports the development of long-term reliability initiatives.
Common challenges when implementing FMEA
Not all FMEA efforts are successful. In some cases, inexperience contributes to FMEA failures. In others, companies fail to lay the groundwork required for reliable FMEA results. In practice, five challenges are common:
- Treating FMEA as a one-time exercise
- Using overly complex scoring systems
- Lack of accurate failure data
- Poor follow-through on action items
- Limited cross-functional participation
FMEA and continuous improvement
FMEA sets the stage for continuous improvement, but this doesn’t happen automatically. Instead, failure modes and effects analysis practices must be regularly revisited and reevaluated to ensure it meets current needs.
This starts with the understanding that FMEA processes form a living document, one that must be regularly updated based on new modes, failures and effects data. It’s also important to connect FMEA efforts with key performance indicators (KPIs) and RCFA. This helps teams better understand what’s driving operational failure and how multiple components interact to produce failure results.
Regularly evaluated and updated FMEA frameworks support both lean manufacturing processes and underpin enterprise-wide reliability initiatives.
Using data and technology to strengthen FMEA
FMEA outputs depend on data. How often does X machine fail? What causes (A, B, C or D) are most common? What impacts (X, Y and Z) the results?
Using data helps improve the accuracy of risk analysis and provides better visibility into asset performance. It also underpins the development of predictive maintenance efforts and condition-based approaches that leverage observed events along with scheduled repairs to reduce overall failure risk.
Data required for improved FMEA includes historical failure and maintenance records, along with recent and real-time performance data. Technologies that enable the application of this data include enterprise resource planning (ERP) tools, computerized maintenance management systems (CMMS) and MES.
When and where manufacturers should apply FMEA
When does it make sense to apply FMEA, and which processes should be prioritized? Five use cases are common:
- New equipment or process deployments
- Persistent reliability issues
- Safety-critical operations
- High-cost or high-impact assets
- Major operational changes
FMEA is essential for proactive manufacturing operations
Prevention is more effective and cost-effective than reaction. Even when companies respond quickly to address production line issues, they face significant downtime losses and may spend more time solving symptoms rather than resolving root causes.
FMEA frameworks are proactive risk management tools that enable manufacturers to identify common failure points, address common causes and limit negative impacts. The result is a maintenance strategy that focuses on building long-term operational excellence tied to reliability, safety and cost control.
Strengthen your FMEA framework with data-driven industrial maintenance services from ATS. Let’s talk.
References
Shepley, S., Hardin, K., Morehouse, J., & Dwivedi, K. (2025, November 13). 2026 manufacturing industry outlook. Deloitte Insights.
https://www.deloitte.com/us/en/insights/industry/manufacturing-industrial-products/manufacturing-industry-outlook.html
