Have you ever thought about the possible ways in which a product can fail? Or have you ever considered the consequences of a product failure? Well, that’s what failure modes and effects analysis (FMEA) is all about. Many CMMS systems have FMEA capabilities that help facility managers or technicians identify potential causes of equipment failure.

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What This Article Covers:

• What Is Failure Mode and Effects Analysis?
• Importance
• Process
• Design FMEA vs. Process FMEA
• Steps
• Primary Benefits
• Limitations
• Next Steps

What Is Failure Mode and Effects Analysis?

Failure mode and effects analysis (FMEA) is a systematic approach used to identify and analyze potential failures or problems that can occur in a product or process. The primary objective of FMEA is to identify potential failures before they occur and take proactive steps to mitigate or prevent them from happening.

You typically perform FMEA during a product or process’ design or planning stage. It involves a team of experts who analyze a product or process’ various components or subsystems and identify potential failure modes. Failure modes are the ways in which a component or system can fail or malfunction.

Once your team identifies the potential failure modes, they then evaluate the failure’s severity, the likelihood of the failure occurring and the ability to detect the failure. You can use this information to assign a risk priority number (RPN) to each potential failure mode. The RPN is a numerical value that indicates the severity, likelihood and detectability of a potential failure.

Based on the RPN, your team can then prioritize the potential failure modes and develop mitigation strategies to reduce the risk of the failure occurring. This may involve redesigning the product or process, addressing redundancies, improving quality control processes, or other corrective actions.

Importance

FMEA is a critical tool for businesses that want to ensure their products are reliable and safe. By identifying potential failure modes and developing mitigation strategies, FMEA helps minimize the risk of failures during product development and manufacturing processes.

In industries where product failure can have severe consequences, such as automotive, aerospace and health care, failure modes and effects analysis is essential.

For example, in the automotive industry, FMEA can help ensure that vehicles meet safety standards and don’t pose a risk to drivers or passengers. In the health care industry, FMEA can identify potential medical device and treatment risks, which can have life-or-death consequences.

Moreover, FMEA can reduce costs associated with product development and manufacturing. By identifying potential problems early in the process, you can avoid costly mistakes that could require expensive reworks or even result in a product recall.

Process

Before beginning the FMEA process, it’s important to clearly define the system or process you want to analyze and its functions. This involves identifying the inputs, outputs and processes involved in the system. The system can be a product, product component or process used in manufacturing.

Defining the system and its functions is important because it helps the FMEA team identify all potential failure modes and their effects. It also helps to ensure that the FMEA focuses on the most critical aspects of the system rather than irrelevant or less important features.

The process of defining the system and its functions involves several steps, including:

1. Identifying Boundaries: Identifying boundaries involves determining the included and excluded elements in the system you’re analyzing. It’s important to consider upstream and downstream processes and their interaction with the system.
2. Defining Inputs and Outputs: This step involves identifying the inputs and outputs of the system, including any intermediate processes or components. This helps the FMEA team to understand the flow of materials or information through the system.
3. Determining Functions: Here, you’ll determine the system’s primary functions and the requirements it must meet. This helps the FMEA team understand the purpose of the system and the critical aspects they must analyze.
4. Documenting Functions: This involves creating a detailed diagram or document plainly outlining the system and its functions. This helps you ensure that all team members clearly understand the system they’re analyzing.

Following the process will help you lay out a clear FMEA approach and help get your team up to speed.

But before you start, take a look at the differences between design and process FMEA, so you know when and how to perform each.

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Design FMEA vs. Process FMEA

Design failure modes and effects analysis (DFMEA) and process failure modes and effects analysis (PFMEA) are two types of FMEA that are commonly used in product development and manufacturing.

While both DFMEA and PFMEA serve the same purpose of identifying potential failure modes and developing mitigation strategies, there are several key differences between the two:

• Timing: You typically conduct DFMEA during the product design phase, while you conduct PFMEA during the manufacturing or production process. DFMEA focuses on identifying potential failures in the design of the product, while PFMEA focuses on identifying potential failures in the manufacturing or production process.
• Scope: DFMEA analyzes how the design of the product can impact its functionality, reliability and safety. PFMEA analyzes how the manufacturing or production process can impact the quality and reliability of the product.
• Inputs: The inputs for DFMEA include product requirements, specifications and design documents. The inputs for PFMEA include manufacturing process flow diagrams, process control plans and work instructions.
• Outputs: The outputs of DFMEA include a list of potential failure modes, their effects and mitigation strategies, and design changes to improve product reliability and safety. The outputs of PFMEA include a list of potential failure modes, their effects and mitigation strategies, and process changes to improve product quality and reliability.
• Team Composition: The DFMEA team typically includes design engineers, product managers and quality engineers. The PFMEA team typically includes manufacturing engineers, quality engineers and production personnel.

DFMEA and PFMEA are both important tools for ensuring product reliability and safety, but they’re conducted at different stages of the product development and manufacturing processes. They focus on different aspects of the product and involve different inputs and outputs.

Understanding these differences is crucial if you want to use failure modes and effects analysis effectively in your product development and manufacturing processes.

Key Steps

The following are the typical steps involved in conducting failure modes and effects analysis:

1. Define the Scope: The first step is to define the scope of the FMEA. This includes identifying the system, process or product that you’ll analyze and determining the purpose and objectives of the FMEA.
2. Form the FMEA Team: The FMEA team should include cross-functional members who have a good understanding of the system, process or product they’ll analyze. The team should include members from different disciplines such as design, engineering, quality and manufacturing.
3. Identify Failure Modes: The team should identify all possible failure modes that could occur in the system, process or product they’re analyzing. This is typically done through brainstorming, historical data analysis and industry experience.
4. Identify Failure Effects: For each failure analysis, the team should determine the effects of failure on the system, process or product. This includes the impact on safety, performance, quality and customer satisfaction.
5. Assign a Severity Ranking: The team should assign a severity ranking to each failure mode based on the severity of its effects. Severity rankings are typically assigned on a numerical scale from 1 to 10, with 1 being the lowest severity and 10 being the highest severity.
6. Identify Failure Causes: The team should identify the causes of each failure mode. This involves determining the root cause of the failure and identifying the factors that contribute to the failure.
7. Assign a Probability Ranking: The team should assign a probability ranking to each failure mode based on the likelihood of its occurrence. Probability rankings are typically assigned on a numerical scale from 1 to 10, with 1 being the lowest probability and 10 being the highest probability.
8. Identify Current Controls: The team should identify the current controls in place to prevent or detect the failure mode. This includes quality control measures, testing and inspection procedures.
9. Assign a Detection Ranking: The team should assign a detection ranking to each failure mode based on the ability of the current controls to detect the failure mode. Detection rankings are typically assigned on a numerical scale from 1 to 10, with 1 being the lowest detection capability and 10 being the highest detection capability.
10. Calculate the Risk Priority Number: The team should calculate the RPN for each failure mode by multiplying the assigned severity, probability and detection rankings. The RPN is used to prioritize failure modes and determine which ones require the most attention.
11. Develop and Implement Mitigation Strategies: The team should develop and implement mitigation strategies to address the high-risk failure modes. This includes redesigning the system, improving quality control measures, and enhancing testing and inspection procedures.
12. Monitor and Review Strategies: The team should monitor the effectiveness of the mitigation strategies and periodically review and update the FMEA as needed.

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Primary Benefits

Failure modes and effects analysis is a valuable tool that can help your organization improve their products and processes, enhance customer satisfaction, and stay competitive in the market. Here are some of the process’ primary benefits:

Identify Potential Problems

One of the significant advantages of FMEA is that it helps identify potential problems before they occur. This early identification of potential problems can save significant time, money and resources that you’d otherwise spend addressing the issues after they occur.

Reduce Product Development Costs

FMEA can help reduce product development costs by identifying potential issues during the design phase.

By catching problems early, the FMEA team can avoid costly redesigns and reworks later in the development process. This can help streamline the product development process and ultimately reduce the overall cost of bringing the product to market.

Improve Product Quality and Reliability

FMEA helps you improve product quality and reliability by identifying potential failure modes and their effects.

By addressing these issues early in the development process, the team can implement mitigation strategies that improve the product’s quality and reliability. This can result in fewer warranty claims, fewer product recalls and improved customer satisfaction.

Facilitate Continuous Improvement

FMEA can help facilitate continuous improvement by identifying areas for improvement in the system, process or product you’re analyzing. By identifying potential failure modes and their causes, the FMEA team can implement changes to the system, process or product that improve its performance, reliability and quality.

This continuous improvement cycle can help your organization stay competitive in the market and meet the evolving needs of your customers.

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Limitations

Organizations should carefully consider these limitations when deciding to use failure modes and effects analysis and supplement it with other quality control tools to ensure comprehensive analysis and risk mitigation:

Extended Time and Resources

One of the primary limitations of FMEA is that it requires a significant amount of time and resources to complete. The process involves multiple stakeholders, including subject matter experts, designers, engineers and other members of the product development team.

It can be time-consuming, especially when analyzing complex systems or products. Additionally, FMEA requires a thorough understanding of the system or product you’re analyzing, which can also add to the time and resource requirements.

Missed Identification

Despite the thorough analysis provided by FMEA, it may not identify all potential failure modes. This is because it relies on the expertise and knowledge of ‌FMEA team members.

If team members lack sufficient knowledge or experience in a particular area, they may miss certain failure modes. Additionally, new failure modes may emerge during the product’s use that weren’t identified during the FMEA process.

Limited Accuracy

FMEA assumes that failure modes can be predicted accurately, which may not always be the case. The analysis is based on historical data, experience and expertise, and it’s subject to uncertainties and errors.

Additionally, it assumes that the system or product you’re analyzing operates under stable conditions, which may not always be the case. External factors, such as changes in environmental conditions or user behavior, can impact the system’s or product’s performance and introduce new failure modes.

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Next Steps

In today’s competitive business environment, it’s more critical than ever to produce high-quality products that meet customer needs and expectations. Adopting failure modes and effects analysis in product development and manufacturing processes can help your organization achieve these goals and gain a competitive advantage.

By doing so, you can identify potential problems early, reduce costs, and improve product quality and reliability. With FMEA, your organization can remain competitive, meet customer expectations and stay ahead in the market.

As you move forward, consider how you can implement FMEA in your organization. CMMS systems can be useful in this case. Check out our comparison report to evaluate top CMMS vendors and products.

How can you leverage the power of FMEA to improve your products or services? What’re some potential areas of risk that your team can identify and mitigate using FMEA? Let us know in the comments!