Costly problems and defects can significantly impact a manufacturer or service provider’s reputation and financial bottom line. With customers expecting high levels of quality and reliability, it’s essential to address potential issues before they arise. However, identifying problems later in the development cycle can lead to increased costs and delays. To overcome this challenge, it’s critical to design quality and reliability into the process from the beginning and prevents defects from occurring.
Manufacturers and service providers can avoid costly delays and ensure customer satisfaction by evaluating and fixing potential issues early in the process by using failure mode and effects analysis (FMEA) as a method for recognizing potential problems and their impact. FMEA is an effective method for helping organizations design products and services that not only meet or exceed consumer expectations but also cut costs and boost efficiency.
What Is FMEA?
Failure Mode and Effects Analysis (FMEA) is a process for identifying all probable equipment failures and their influence on overall productivity. It creates an action plan from the bottom up by identifying the most vulnerable components. FMEA is critical in designing efficient preventive and predictive maintenance plans. FMEA explores the possible impact of unexpected equipment breakdowns on the entire facility by examining any materials, manufacturing processes, or systems that do not meet standard practices. By mapping out failure modes and their adverse effects, organizations can identify the root cause of failures more easily. This makes FMEA an essential tool for effective preventive and predictive maintenance strategies.
The Objective Of FMEA
FMEA is a data-collecting tool that helps in determining the impact of an asset failure on the manufacturing floor. Each failure mode is assigned a risk priority number based on its severity, and these modes are categorized based on criteria for full, partial, or degraded operation, which is especially important for special equipment such as hydraulic pumps. The effects portion discloses the repercussions of a failure event at increasing levels. You may find a local effect between two components or an end effect describing a compromised subsystem. The difficult part is formulating a strategy to overcome those effects.
Different Types of FMEA
There are four main types of failure mode and effects analysis.
FFMEA, or Functional Failure Mode and Effects Analysis, is a methodology used to identify potential failure modes and their impact on product performance. By using FFMEA, organizations can prioritize design changes and reduce the risk of failure. The primary objective of FFMEA is to identify all possible failure modes and their consequences in each system component or assembly, including human error or misuse, wear-out, and aging. Additionally, FFMEA involves estimating the probabilities of each failure mode and rating the severity level according to specific criteria, such as cost. Finally, FFMEA helps organizations prioritize corrective action by assessing the impact on customer satisfaction if a failure occurs.
Who uses FFMEA?
FMEA can be applied to software development. This approach is usually implemented when the team wants to improve software quality, reduce the Cost of Quality (CoQ), Cost of Poor Quality, (CoPQ), and defect density.
The manufacturing industry counts on FMEA to anticipate and eliminate potential assembly and product failures sooner, and prevent expensive corrective actions later. This results in reliably high-quality products that satisfy industry customers.
Transport and logistics
They also rely on FMEA to empower them to deliver products reliably. The industry uses FMEA to evaluate logistics and supply chains in order to ensure high-quality service to customers.
The healthcare industry counts on FMEA as an effective tool for identifying parts of processes that most need improvement. Working preventatively helps reduce risk to both patients and staff.
The agriculture industry also relies on FMEA. It is used to assess risk to the environment, to manufacturing and machinery, and to product quality. This is important for environmental, ethical, and legal considerations.
Design Failure Mode and Effects Analysis (DFMEA) is a risk assessment tool used during the design stage of an asset. Its purpose is to identify and mitigate potential issues with the asset to increase its reliability, reduce maintenance requirements, and extend its lifespan. By conducting a DFMEA, engineers can assess the risks associated with the design and develop strategies to address them before the asset is deployed.
Who Uses DFMEA?
Automotive Industry: DFMEA is used extensively in the automotive industry to identify potential design flaws in components, systems, and vehicles to ensure safety and reliability.
DFMEA is also used in the aerospace industry to assess the potential failure modes of designs for aircraft, spacecraft, and their systems.
Medical Device Industry
DFMEA is used in the medical device industry to identify and mitigate potential risks associated with design failures that could cause harm to patients. C
Consumer Products Industry
DFMEA is used in the consumer products industry to ensure that the design of products is safe and reliable for consumers.
DFMEA is used in the electronics industry to identify potential design flaws that could lead to failures in electronic components, circuits, and systems.
DFMEA is used in the manufacturing industry to assess the design of manufacturing processes, equipment, and tools to identify potential failure modes and effects that could affect product quality and reliability.
Overall, any industry that involves the design of products or systems can benefit from using DFMEA to ensure that potential failure modes are identified and mitigated early in the design process.
Process failure mode and effects analysis (PFMEA) is a type of FMEA that aims to identify potential failures within a process. Unlike other FMEAs, PFMEA concentrates on identifying failure modes that may occur during the operation and maintenance of a system. The primary goal of PFMEA is to improve the process by anticipating potential failures, assessing their impact, and implementing preventive measures to reduce the risks associated with process failures.
Who uses PFMEA?
PFMEA is used extensively in the automotive industry to identify and mitigate potential risks associated with manufacturing processes to ensure that the final product is safe and reliable.
PFMEA is also used in the aerospace industry to assess the potential failure modes of manufacturing processes for aircraft, spacecraft, and their components.
Medical Device Industry
PFMEA is used in the medical device industry to identify potential risks associated with manufacturing processes that could affect the quality and safety of medical devices.
PFMEA is used in the electronics industry to identify potential failure modes in the manufacturing processes for electronic components, circuits, and systems.
Food and Beverage Industry
PFMEA is used in the food and beverage industry to assess the potential risks associated with manufacturing processes that could affect product quality and safety.
PFMEA is used in the chemical industry to identify potential hazards associated with manufacturing processes that could pose a risk to employees or the environment.
Overall, any industry that involves manufacturing processes can benefit from using PFMEA to identify potential failure modes and effects early in the process to ensure that the final product is safe, reliable, and of high quality.
FMECA (Failure Mode, Effects & Criticality Analysis)
FMECA is an analytical technique employed to evaluate the potential risks linked to assets. The methodology involves identifying possible failure modes and their corresponding effects, as well as determining their degree of severity. By utilizing FMECA, the underlying cause of a failure can be pinpointed, and the likelihood of each failure mode can be assessed. This process enables an evaluation of the reliability of maintenance for assets, giving valuable insights into the reasons for any incidents and aiding the allocation of resources toward avoiding future failures.
Who uses FMECA?
FMECA is used in the aerospace industry to evaluate the criticality of aircraft components and systems and to ensure their safety and reliability.
FMECA is used in the defense industry to identify potential failure modes and the criticality of military equipment and systems.
FMECA is used in the automotive industry to assess the potential failure modes and criticality of components and systems in vehicles to ensure safety and reliability.
FMECA is used in the healthcare industry to assess the potential risks associated with medical devices and equipment and to ensure their safety and effectiveness.
FMECA is used in the energy industry to identify and mitigate potential risks associated with equipment and systems in power plants, refineries, and other facilities.
FMECA is used in the manufacturing industry to assess the potential failure modes and criticality of equipment and systems used in the production process.
Overall, any industry that involves assets with critical functions can benefit from using FMECA to identify potential failure modes, their consequences, and criticality, and to allocate resources to prevent future failures. FMECA is particularly useful in industries where safety, reliability, and high performance are paramount.
Integration Of FMEA Into Maintenance And CMMS
CMMS (Computerized Maintenance Management System) plays an important part in FMEA (Failure Mode and Effects Analysis) by providing a centralized platform for collecting, storing, and analyzing data on equipment failures and maintenance activities. FMEAs (Failure Mode and Effects Analysis) can be a valuable tool in maintenance operations. By identifying potential failures and their impacts, FMEAs can help organizations reduce costs, improve quality, and increase customer satisfaction. Here are some ways to integrate FMEAs into your maintenance operations:
Preventive Maintenance Work Orders
FMEAs can be used to create preventive maintenance work orders that address potential failure modes. By scheduling maintenance tasks based on FMEA results, you can reduce the likelihood of failures occurring and extend the lifespan of the equipment.
Maintenance Backlog FMEAs can also be used to create a maintenance backlog that prioritizes tasks based on the risk of failure. This ensures that maintenance efforts are focused on the most critical equipment and processes first, reducing the risk of downtime and improving overall reliability.
Conducting a cost-benefit analysis can provide insights into the criticality of the plant and help prioritize maintenance efforts. This involves identifying the potential cost of a failure and weighing it against the cost of preventive maintenance.
Qualitative and Quantitative Parameters
FMEAs require defining both qualitative and quantitative parameters. Severity and occurrence frequency should be labeled on a scale of 1 to 10, and formulas can be used to calculate failure modes in real time.
Redundancies Implementing redundancies, such as backup systems or alternative routes, can increase security and reduce the impact of failures.
Use the RPN (Risk Priority Number) to create a criticality table that plots the values. This table can be used to prioritize maintenance efforts and ensure that resources are allocated to the most critical equipment and processes.
CMMS can gather data on the equipment and its maintenance history, which can be used to identify potential failure modes and determine their risks.
CMMS can keep a detailed record of maintenance activities, including what was done when it was done, and by whom, which can be used to analyze past failures and identify potential risks.
CMMS can schedule and track preventive maintenance procedures, lowering the chance of failure.
Resource Allocation CMMS can assist in more efficiently allocating resources such as personnel and materials, reducing downtime, and minimizing the impact of failures.
CMMS may produce reports on equipment failures and maintenance activities that can be used to identify trends and patterns and guide future maintenance decisions.
How To Conduct A Failure Modes And Effects Analysis (FMEA)
Performing an FMEA early in a system or product’s lifecycle helps reduce costs, improve quality, and increase customer satisfaction by identifying potential failures. This powerful tool fosters active problem-solving by identifying high-risk areas through data collection from OEM guidelines, discussions with operators, and work order forms. To initiate the process, it is important to collect accurate data on all staff actions and use an FMEA flow diagram or worksheet. Overall, FMEA improves reliability and prevents or mitigates failures and their impact on systems, processes, or products. Here are the 10 steps to completing an FMEA:
- Identify the process, system, or product to be analyzed.
Determine what needs to be analyzed in order to understand its potential failure modes and associated risks.
- Create a team of cross-functional members with expertise in the process.
Assemble a team with members who have a diverse set of skills and expertise in the process being analyzed.
- List all potential failure modes for each step in the process.
Identify all possible ways in which the process could fail and create a list of them.
- Determine the severity, occurrence, and detection of each failure mode.
For each failure mode identified, determine how severe the consequences would be, how likely it is to occur, and how easy it would be to detect.
- Calculate the Risk Priority Number (RPN) for each failure mode.
Calculate the RPN for each failure mode by multiplying the severity, occurrence, and detection scores.
- Prioritize the highest RPNs for corrective action.
Identify the failure modes with the highest RPNs and prioritize them for corrective action.
- Develop and implement a plan for corrective action.
Create a plan to address the identified failure modes and implement it.
- Verify the effectiveness of corrective action.
Determine if the corrective action plan was effective in addressing the identified failure modes.
- Update the FMEA with any new data and continually monitor and reassess the process.
Update the FMEA with any new data as it becomes available and continually monitor and reassess the process to ensure it remains effective.
- Communicate the findings and results to all stakeholders involved.
Share the findings and results with all stakeholders involved in the process being analyzed to ensure that everyone is informed and on the same page.
Benefits Of FMEA
FMEA is designed to assist the engineer to improve the quality and reliability of the design. Properly used FMEA provides the engineer with several benefits. Among others, these benefits include:
Documentation of maintenance knowledge
FMEA documents maintenance knowledge, making it available for future use and enabling knowledge sharing across teams. Emphasis on problem prevention FMEA helps identify potential issues before they occur, emphasizing problem prevention rather than just problem-solving. Risk reduction FMEA documents risks and actions taken to reduce those risks, providing a record of the steps taken to mitigate potential failures and improve safety. Teamwork and collaboration FMEA can act as a catalyst for teamwork and collaboration between maintenance teams and other functions, helping to break down silos and improve communication.
Failure Mode and Effects Analysis (FMEA) is a crucial tool in identifying potential failures and their impact on processes, products, or systems. It helps organizations to mitigate high-risk failure modes, improve reliability, reduce costs, and enhance customer satisfaction. The benefits of FMEA include improved quality, increased customer satisfaction, better risk management, and compliance with industry standards. Additionally, Computerized Maintenance Management Systems (CMMS) can support the FMEA process by centralizing maintenance data, automating scheduling, tracking activities, providing real-time reporting, and integrating with FMEA software. Through the FMEA process, supported by CMMS, organizations can achieve operational excellence and continuous improvement.
Manufacturing Glossary of Terms and Definitions