What is Failure Mode and Effects Analysis (FMEA)?
A FMEA is pretty much what the letters spell out. A FMEA is a Failure Mode and their associated Effects Analysis.
FMEA is a step-by-step approach for identifying possible failures modes and can be applied to a wide variety of situations including:
- Identification of Reasonably Probable Failure Modes
- Elaboration of Implausible Failure Modes that may have an undesired Effect
- Manufacturing and Service industry process Failure Modes, and of course,
- Human Error Causes
These failures are studied in design/development, maintenance, manufacturing and operational processes, maintenance/service, as well as software phases and studies their consequences, to evaluate their effect – typically categorized by the immediate, next level and system level impacts. In a pure FMEA, Failures are not prioritized based on their severity and consequences of the failure modes.
When twisted a bit a “functionally focused” FMEA is a cornerstone step within any RCM analysis as well and has been traditionally used to improve system concept and design. The functional FMEA of RCM differs from a hierarchical FMEA sub-system division in that ift is based upon the functions, sub functions and functional failures.
When the FMEA concept is “extended” to evaluate criticality it then identifies highest priority tasks for mitigation based on criticality – hence the “C” in (FMECA). FMEA/FMECA approaches are not limited to production areas and can be utilized in administrative, maintenance and service departments as well to identify and eliminate loss and waste.
What is Failure Mode Effects and Criticality Analysis (FMECA)?
As noted above – the FMECA is an extension of FMEA that adds a criticality analysis to the basic FMEA to further prioritize failure modes for remediation. Its purpose is to help prioritize potential failures and allow organizations to proactively focus resources on critical issues before they impact reliability of operations, safety, or other critical aspects. In a qualitative construct, it typically charts the probability of failure modes against the severity of their failure consequences. In a quantitative construct – like those often associated with Mil-1629A approaches, the FMECA adopts failure rates, and failure mode apportioning concepts.
Failure Modes and Criticality Analysis (FMECA) to many is a process that operates off of 1 to 5 or 1 to 10 scales. It catalogues and helps to manage potential failure modes in systems, products, or processes. It also builds upon the principles of Failure Modes and Effects Analysis (FMEA). Not only failure modes, causes, and effects but also their criticality and consequences and at times – the failure rate and apportionment of failure modes to the overall failure rate. Irrespective of the qualitative or quantitative approach chosen, the FMECA analysis aims to focus on the most critical failure modes. It means those that the criticality could have severe impacts on safety, performance, or other aspects such as environmental harm. Besides, it evaluates factors such as likelihood of a failure mode, its severity, and detectability it is well positioned as an impressive methodology. By doing so, FMECA helps organizations assign more resources to address high-risk issues.
Why Launch a FMEA/FMECA Study?
FMEA/FMECAs are launched to proactively identify, assess, and mitigate potential failures in a system, process, concept, or product to help improve reliability, safety, and efficiency. The outcomes of deploying an FMEA/FMECA ultimately lead to better asset reliability, quality and a reduction in costs.
The Purpose of FMEA/FMECA
The FMEA/FMECA results define the system, identifying potential failure modes, analyzing their effects, assesses their criticality, and then developing and implementing corrective actions to proactively identify, evaluate, and mitigate potential failures in designs and processes before they occur.
In many ways – the FMECA is a one-dimensional risk assessment. When we choose to utilize 1 to 5 or 1 to 10 scales, we catalog the risk, and the artifact so we can calculate a Risk Priority Number (RPN).
The RPN helps to prioritize risks (based on criticality and consequences of failure)
Evaluate the severity of the effects, the likelihood of occurrence, and the ability to detect the failure (and its causes and effects), and then prioritize the failure modes based on risk (typically using a Risk Priority Number or Action Priority).
Develop and implement corrective and preventive actions
The natural extension of the FMECA RPN is to design and implement strategies to eliminate or reduce the likelihood or impact of the most critical failures.
Document findings and support continuous improvement
FMEA/FMECA’s of course serve a second purpose to record the analysis, recommended actions, and their effectiveness to inform future projects and drive ongoing improvement.
In essence, FMEA/FMECA aims to:
Improve product quality and asset reliability
By identifying and addressing potential failures early, manufacturers can create more reliable and higher-quality products.
Reduce costs
Preventing failures early avoids costly rework, scrap, warranty claims, and downtime.
Increase efficiency
By optimizing processes and reducing failures, manufacturing efficiency is enhanced.
Improve customer satisfaction
Delivering high-quality, reliable products leads to increased customer satisfaction.
Support regulatory compliance
FMEA/FMECA helps meet quality and safety standards required in various industries.
Mantua’s FMEA/FMECA at a Glance: The 4 Phases
Phase 1: Cause and Effect Analysis
Step 1: Build a Team
Just like in an RCM engagement, we assemble a multidisciplinary/cross-functional team of personnel with diverse knowledge about the systems, processes, product, or service, and the customer needs/expectations. The team can consist of a cross-section of representatives from design, manufacturing, quality, testing, reliability, maintenance, purchasing (and vendor/suppliers), sales, marketing (and customers), and customer service.
Step 2: Define the Scope
Is it for concept, system, design, process, or service? What are the boundaries? How detailed should the scope be? Use flowcharts to identify the scope and make sure every team member understands it in detail.
Step 3: Identify Information
Fill in the identifying information regarding systems, processes, or products, etc. within the scope of work.
Step 4: Identify the Scope Functions
Identify the failure modes of your scope: In what ways can the system fail? What is the purpose of this concept, system, design, process, or service? What do our customers expect it to do? Usually, you can break the scope into separate subsystems, items, parts, assemblies, or process steps and identify the function of each.
Step 5: Identify the Failure
For each system, sub-system or component, identify the ways failures that could happen. This is a brainstorming session. These are failure modes.
Step 6: Identify Criticality/Consequence
For a FMECA – for each failure mode, identify the criticality and consequences on the system, related concepts, systems, process, secondary/tertiary processes, product, service, customer, or regulations. Assess the severity, occurrence probability, and detectability of each failure mode to prioritize them based on risk priority numbers (RPNs). Identifying critical failure modes that require immediate attention and mitigation. This is the most important activity in FMEA. These failure effects ranked by criticality (if performing a criticality analysis with FMECA).
Phase 2: Criticality Ranking
Step 7: Rate Severity
Determine how serious each effect is. This is the severity (S) rating. Severity usually is rated on a scale from 1 to 10: One being insignificant and 10 signaling catastrophic. If a failure mode has more than one effect, add only the highest severity rating for that failure mode.
Step 8: Determine Root Causes
For each failure mode, determine all the potential root causes. Use information from the Root Cause Analysis to inform the failure modes if you have one handy!
In summary, FMEA/FMECA while often confused as to which is which, are both essential in manufacturing and operations today and can assist organizations in achieving long-term success and improvements in quality, efficiency, and competitiveness by ensuring predictions of failure, criticality, consequence, and mitigation upon which decisions can be informed. Are you ready to start?
Phase 3: Risk Management
It does little to chalk up a win in the benefit column if you only assess the problem and do not recommend mitigation strategies.
Step 9: Mitigation Strategies
Developing risk mitigation strategies and controls to reduce the likelihood or impact of identified failure modes is essential. This may involve design improvements, process changes, redundancy measures, or enhancing monitoring and detection methods.
Step 10: Integration with Design and Process Improvement
Integrating FMEA/FMECA findings into design reviews, process improvement initiatives, and continuous improvement programs. Ensuring that lessons learned from FMEA/FMECA are applied to enhance reliability, safety, and performance.
Step 11: Verification and Validation
Verifying the effectiveness of mitigation actions through testing, validation, or simulation. Ensuring that implemented controls adequately reduce risk and meet desired performance criteria.
Step 12: Documentation and Reporting
Documenting the FMEA/FMECA process, results, and action plans in a structured format. Providing clear and concise reports to stakeholders, management, and regulatory bodies as required.
Phase 4: Continuous Improvement
Step 13: Follow-up and Review
Conducting periodic reviews and updates of FMEA/FMECA to reflect changes in processes, systems, or operating conditions. Continuously monitoring and reassessing risks to maintain proactive risk management practices.
Coupled with RCA, FMEA/FMECA are essential tools for identifying and addressing potential risks, failures, and inefficiencies in systems, processes, and products. They help organizations improve reliability, safety, and performance while supporting continuous improvement efforts.
Why Mantua Group?
- Independent Expertise: We apply structured, vendor-agnostic FMEA/FMECA methodology.
- Industry-Proven Tools: Digital scribing, logic trees, consequence ranking models.
- Cross-Sector Know-How: Clients in energy, mining, defense, and heavy industry.
- Execution Focus: We ensure FMEA/FMECA outputs are deployable in your CMMS with clear work instructions, frequency logic, and resource planning.
One-Page Visual Workflow
Download our FMEA/FMECA Project Infographic or connect with our team to learn how to apply Mantua’s pragmatic approach to your next critical asset.
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