DFMEA vs. PFMEA: Key Differences in Failure Mode and Effects Analysis

FMEA is a methodology that organizations use to pinpoint and prevent failures in their products and processes. Two of the most widely used types of FMEA are Design FMEA (DFMEA) and Process FMEA (PFMEA). Both of these significantly help with manufacturing quality and reliability, but companies use them in different ways for different reasons. We’ll cover the basics of each and help you determine which method is right for you and your company.

What is FMEA?

Failure Mode and Effects Analysis (FMEA) is the process of assessing and prioritizing the ways failure can occur in your product, process, or system. Teams typically approach it through a series of steps that can be grouped into three phases:

  1. Identifying failure scenarios: This initial phase entails brainstorming to compile a list of ways a new product, process, or system’s potential failure modes could prevent it from fulfilling its intended function. It requires an in-depth understanding of the system components and how they interact.
  2. Evaluating and prioritizing risks using the Risk Priority Number (RPN): Each identified failure scenario undergoes assessment based on its severity, likelihood of occurrence, and detectability. Teams assign values to these factors and multiply them to determine the RPN value. Higher RPN values signify critical failure modes that warrant attention.
  3. Taking action to fix the issue: For high-risk failure modes, teams must develop and implement corrective actions to reduce occurrence risk, improve detection capabilities, or minimize the negative outcomes of the failure. This proactive approach ensures effective failure prevention and minimizes potential impact on the system’s performance.

FMEA methodologies are employed by teams across various organizations at different stages of a product or process lifecycle. Depending on the context, teams may specialized types of FMEA such as: 

  • Design FMEA (DFMEA)
  • Process FMEA (PFMEA)
  • System FMEA 
  • Service FMEA 

Let’s examine the first two types of FMEA that are most often used in a manufacturing or production environment. 

What is DFMEA?

DFMEA, or Design Failure Mode and Effects Analysis, focuses on the problems that may occur as a result of a product’s design. Used effectively, you may discover potential issues before they actually show up in real life on the production line.

Applications and use cases

DFMEA is a valuable tool for:

  1. Discovering design flaws that make system failure or quality issues more likely
  2. Making the products you produce and sell more reliable 
  3. Helping you comply with regulations in your industry

For example, companies in the automotive industry use DFMEA to analyze the design of new brake systems. If analysis uncovers ways a new brake design could fail, such as brake pad wear or hydraulic fluid leaks, engineers are able to update the design to eliminate that specific safety problem, thereby creating higher-quality brakes and improving the reputation of the company.

Benefits and limitations

Using DFMEA has a lot of benefits, including early detection of potential causes of failure which can result in cost savings in the overall product development process. And of course, anything that results in a more reliable product also results in better brand reputation and market share.

DFMEA also has its limitations. In accounting for complex system interactions, you may have to use additional analysis techniques, like Event Tree Analysis (ETA) or Fault Tree Analysis (FTA), to eventually pin down the root cause of a potential failure. 

Despite these limitations, DFMEA remains an effective risk mitigation tool when used correctly and supplemented with other quality management practices.

What is PFMEA?

Process Failure Modes and Effects Analysis (PFMEA) examines issues in the process of production or fabrication of an item that could potentially lead to defects, production delays, or other issues in the actual end product. PFMEA happens a bit later in the product development process after much of the design work has been finalized.   

Applications and use cases

This methodology takes a microscope to each step in the manufacturing process to uncover possible failures and develop strategies to optimize production and minimize the risk of process-related malfunctions. 

For example, in a plastic injection molding process, PFMEA can help identify issues like improper mold temperature or insufficient cooling time, which could lead to defects in the resulting component.

Benefits and Limitations

PFMEA plays a crucial role in identifying bottlenecks, inefficiencies, and important improvements in whatever new process is being used. It helps organizations optimize procedures, reduce waste, improve productivity, and make more money. PFMEA also helps make processes more consistent and reliable over time by helping establish stronger standard operating procedures (SOPs) and monitoring systems.

One drawback of PFMEA is that it may not always easily identify or address the impact of human factors – like operator error or lack of training – on process performance. PFMEA may also struggle to account for external influences, such as supplier quality issues or environmental factors, which can affect process and product quality.

DFMEA vs. PFMEA: Key differences

Both of these are highly valuable tools in the FMEA methodology, but they differ in a lot of ways. Knowing the key differences is crucial for effectively analyzing how your product or processes can fall short of customer expectations.  

1. They have different scope and focus

DFMEA and PFMEA focus on two different things. DFMEA puts scrutiny on the actual product design in order to find and prevent flaws, while PFMEA examines the manufacturing process. This difference in scope and focus means that the stakeholders involved in each analysis, and the failure scenarios they discover, are totally different.

2. They have different inputs and outputs

DFMEA and PFMEA also differ in their inputs and outputs. DFMEA takes design requirements, product specifications, and component interactions as its primary inputs, aiming to produce a robust and reliable product design. On the other hand, PFMEA focuses on process steps, equipment capabilities, and process parameters, with the goal of establishing a stable and efficient manufacturing process.

3. They are used at different stages in product development

DFMEA is typically conducted earlier in the product development process than PFMEA, during the product development phase. Teams often conduct DFMEA at the same time as the actual design process, letting them figure out possible problems earlier. This risk assessment in turn minimizes the impact or damage from any required design changes.

After the design has been finalized, teams perform PFMEA, usually during the production planning phase. This allows teams to optimize the manufacturing process and ensure its reliability before full-scale production begins.

4. Stakeholder involvement

Both DFMEA and PFMEA require cross-functional team involvement, but the team members and stakeholders aren’t the same. DFMEA will rely heavily on the design team and include product designers, quality specialists, and reliability engineers. These workers know product design, which materials to select, and how different components interact. 

PFMEA typically involves manufacturing team members, including process engineers, production supervisors, and quality control specialists. They know how manufacturing processes work, the capabilities of different equipment, and process control strategies.

5. Integration with other methodologies

DFMEA and PFMEA can be integrated with other quality management and continuous improvement methodologies, such as Six Sigma and Advanced Product Quality Planning (APQP). Six Sigma, with its focus on lean principles and reducing process variation and defects, can leverage PFMEA to identify and prioritize process improvement opportunities. 

APQP, a structured approach to product development and launch, incorporates both DFMEA and PFMEA as key tools in its planning and risk management phases. By integrating DFMEA and PFMEA with these methodologies, organizations can achieve a more comprehensive and effective approach to quality management and risk mitigation.

Which failure mode analysis is appropriate for you?

So, how do you decide which FMEA to use? It depends on many possible factors, including your industry, the other processes you follow, and the product itself. All of these (and more below) help you determine which method can improve your product the most. 

Stage of the product lifecycle

This one may be obvious. If your product is in the design phase, DFMEA is the appropriate choice. However, if product design is finalized and you’re now focusing on optimizing the manufacturing process, use PFMEA.

Complexity of product design

Products with complex designs, multiple components, or intricate interactions will benefit more from DFMEA. That is because DFMEA allows for a thorough analysis of potential design failures inherent in the way complex systems and components impact one another.

Crucial aspects of the manufacturing process

If your manufacturing process involves critical steps (like heat treatment, welding or sterilization for example), specialized equipment, or strict process controls, PFMEA is the methodology to choose.

Combining DFMEA and PFMEA

In many cases, using both DFMEA and PFMEA (typically PFMEA comes after DFMEA) provides a comprehensive approach to failure mode analysis. By using both to identify potential failures, you can ensure a more robust and reliable product overall.

Tailoring to Industry Requirements

It’s essential to tailor your FMEA process to specific industry requirements and standards. For example, the automotive industry follows the AIAG-VDA FMEA guideline, which provides a harmonized approach to failure mode analysis. By aligning your FMEA process with industry-specific requirements, you can ensure compliance and bring better alignment with suppliers and customers.

The role of data in DFMEA and PFMEA

Reliable data is essential for identifying potential failure modes, assessing their risks, and guiding decision-making throughout the analysis process. The more experience and information your process is based on, the more effective your DFMEA and PFMEA will be.

Data sources for failure mode analysis

Just like most other forms of analysis, the more data you have available, the more accurate the outcome will be. Many data sources can contribute to your DFMEA and PFMEA analysis, such as:

  • Historical failure data: Records of past failures, warranty claims, and customer feedback offer valuable insights into potential failures and their consequences.
  • Simulation and testing results: Virtual simulations and physical testing can help identify potential failures and validate design or process improvements.
  • Expert knowledge and experience: The collective expertise of your cross-functional team is a valuable data source, providing insights into potential failure modes, their causes, and their real-life downstream effects.

Using data to prioritize risks

By leveraging data from these sources, you can prioritize risks more effectively and allocate resources to the most critical failure modes. Data-driven insights can help you make informed decisions about which failure modes to address first and which actions to take to lower their risks.

Every time you use DFMEA or PFMEA, you collect data that helps you improve. Check to see how well you succeeded (or didn’t) in order to refine your failure mode analysis and create better products.

Mastering failure mode analysis for optimal results

DFMEA and PFMEA are powerful tools that help you improve your product design and manufacturing processes. Applying the right analysis that truly meets your needs, puts your team on the path towards delivering better products and happier customers. 

A Computerized Maintenance Management System (CMMS) can streamline data collection and analysis, making it easier to track failures, prioritize risks, and deploy improvements throughout your analysis efforts. The journey to excellence in failure mode management is a work in progress, but with the right tools and mindset, the rewards are well worth the effort.

  • Good day,
    Kindly send me an example of completed PFMEA / FMEA for Harness build (new product) please and thanks.

  • Hi Marlen,

    We are offering a CMMS solution not engineering services 🙂 If you follow our guide, you should be able to execute a basic version yourself (even though this ought to be a team effort that includes someone who is experienced at performing DFMEA).

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