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PFMEA in manufacturing
PFMEA in manufacturing: How to Use it to Prevent Failures

Posted by Sadia Waseem

Process Failure Mode and Effects Analysis (PFMEA) is a systematic approach to evaluate and prevent process-related failures before they occur. It generally begins after design FMEA report is available. The corrective actions taken for each failure in the process FMEA prevents failure caused during the manufacturing or assembly process, increasing customer satisfaction, and further occurrence of failure.

According to a study,  PFMEA can help to avoid 80% of process problems during the simulation stage before the process is finalized. PFMEA not only highlights the failure of the process but continuously improves the process and products and increases a product’s reliability.

PFMEA has become an essential tool to optimize production, minimize waste, and consistently ensure high-quality products. In this article, we will discuss the components of PFMEA, and how you can easily conduct PFMEA with an AI-powered software.

What Does PFMEA Analyze?

PFMEA focuses on the manufacturing and assembly process rather than the product design. PFMEA evaluates each step of the process from stacking to raw material to shipment of the final product. There are two types of PFMEA: manufacturing FMEA and assembly FMEA. The key aspects of the PFMEA analysis include:

  1. Potential Failures:

PFMEA analyzes each step and identifies potential errors or failures that could during that step. This can include machine malfunction, material inconsistency, errors caused by operators, or external environmental factors.

  1. Failure Modes:

The analysis highlights the specific way in which the process failure would occur or become noticeable in the manufacturing process. These can be in the form of incorrect assembly, inaccurate dimensions, or wrong torque application.

 

  1. Effects of Failure:

PFMEA considers the potential effects of these failures on the quality of the product, the next manufacturing step, overall process efficiency, and customer satisfaction.

  1. Causes of Failure:

With the help of Root Causes Analysis (RCA) techniques like Pareto analysis or fishbone diagram, the causes of these failures are investigated. The causes might include improper training, poor material training, miscommunication among workers, wear out equipment, etc.

  1. Current Control:

PFMEA finally analyzes the current control of the process to prevent these failures. The control can be in the form of standard operating procedures, quality control, automated inspection checks, preventive maintenance schedules, etc.

The examples of the manufacturing process failures and their effects analyzed during the process FMEA may include:

S. No.

Process

Failure Example

Effect on Product

1

Metal Cutting

Cutting tool becomes dull

Incorrect final specification of the product

2

Plastic Molding

Mold temperature too high

Product has bubbles

3

Paint Spraying on Car

Spray nozzle clogged

Uneven paint coverage on car

4

Packaging of product

Sealing temperature too low

Package tears out or opens easily

5

Data entry

Typing mistake in customer information

Incorrect billing

By systematically analyzing these aspects, you can enhance process controls and improve product quality and manufacturing efficiency.

Common Challenges in Manufacturing Quality

Despite the importance of quality in manufacturing, many organizations face common challenges in achieving consistent quality. Some of the most common challenges include:

  1. Lack of quality control processes: Without well-established quality control processes, it can be difficult to ensure that products meet the desired quality standards.

  2. Inefficient production processes: Poorly designed production processes can result in defects and errors that impact product quality.

  3. Inadequate training and development: Employees who are not adequately trained in quality control processes and production techniques may struggle to consistently produce high-quality products.

  4. Limited resources: Lack of resources, including budget and personnel, can limit an organization’s ability to implement effective quality control measures and improve production processes.

FMEA vs. PFMEA: Key Differences

Failure Mode and Effects Analysis (FMEA) is a broader concept that focuses on evaluating potential errors that can occur from the design phase of the product to the delivery of the product. Process Failure Mode and Effects Analysis (PFMEA) focuses on the evaluation of the failures during the production stage. The key differences between FMEA and PFMEA are:

                                         FMEA

                                              PFMEA

                                                                             Scope of Application

It is broadly applicable to the design of the product, delivery, service development, and other areas

It is only applicable to the manufacturing process

                                                                              Types of Failures

It includes functional failures, issues with the performance of products, and safety issues related to product design

PFMEA focuses on process issues like equipment malfunctions, errors caused by operators, or issues with the material

                                                                          Outcomes and Actions

The actions included in FMEA can lead to changes in the design, selection of raw material or, system modifications

PFMEA actions result in process improvement, training of the operators, modification in the tools, etc.

                                                                   Timing in Product Lifecycle

It is performed before or during the design phase or during the development of system

It is performed when the production process is designed or refined

                                                                              Metrics or Goals

It prioritizes issues that can impact customer satisfaction or market competitiveness

It often prioritizes issues based on efficiency, quality of the product, and cost considerations

When to Use PFMEA?

PFMEA works the best in situation where there is a need for proactive risk management. Here’s a breakdown of key scenarios where PFMEA proves particularly valuable:

  • Introducing New Processes: Whenever you’re implementing a brand-new process, such as involve launching a new product line, adopting a different manufacturing technique, or even implementing a new software system for a critical task, PFMEA helps identify potential failure modes before they cause problems. Based on the results, you can develop robust controls and procedures to ensure smooth operation from the start.

  • Modifying Existing Processes: Even seemingly minor changes to existing processes such as integrating new machinery or automation technologies can introduce unforeseen risks. PFMEA can help analyze the impact of these changes on potential failure modes beforehand.

  • Addressing Recurring Manufacturing Defects: In cases where you experience persistent quality problems with specific components or finished products, PFMEA can be a powerful tool for getting to the root cause. It can systematically analyze each step in the production process and its potential failure modes, to identify weaknesses in your current controls, pinpoint the source of the defects, and help develop targeted solutions to prevent them from recurring.

  • Supplier Quality Management: PFMEA isn’t limited to your internal manufacturing processes. You can also leverage it to evaluate the potential risks associated with your suppliers’ processes. You can understand their potential failure modes in areas like material sourcing or component manufacturing, you can assess your suppliers’ reliability and take steps to mitigate any risks that could impact your own production schedule or final product quality.

Benefits of Using PFMEA in Manufacturing

A research was conducted with 150 quality-approved automotive suppliers across various sectors to judge the usage of PFMEA. The research concluded that PFMEA is widely used in the automotive industry as a problem-prevention tool. And it should be considering that it offers a host of benefits such as:

  1. Reduction in Defects: PFMEA highlights failure in the process beforehand, which prevents defective products and improves quality of products. In this way, product reliability is also increased leading to customer satisfaction.

  2. Increased Productivity: Less defective products yield more output within the same input, which increases overall productivity of the process. It also reduces downtime caused by equipment failures.

  3. Proactive Identification of Risk: PFMEA allows manufacturers manufacturing process to shift from a reactive problem-solving approach to preventive risk management.

  4. Cost Reduction: PFMEA analysis reduces and sometimes even eliminates rework costs. It also helps to reduce the cost of quality by preventing cost rather than detecting it.

  5. Improved Customer Satisfaction: One intangible or indirect benefit of PFMEA that it increases customer satisfaction because the products have less defects and so there are less complaints.

  6. Improved Safety: PFMEA also identifies any potential hazards during the manufacturing process. It reduces the risk of incidents and implements safety measures that could affect the process or workers.

Conduct PFMEA with Kaizen Copilot

You can always conduct PFMEA manually. However, it is feasible for small processes only. When it comes to complex processes of today, manually conducting PFMEA could be time-consuming, and prone to errors. Moreover, it is difficult to track revisions and maintain version and there is limited data analysis and reporting capabilities available.

A better way to conduct PFMEA is through an AI-powered software such as Kaizen Copilot. Powered by computer vision and advanced AI algorithms, Kaizen Copilot addresses all the issues associated with manual PFMEA process. The software digitalizes PFMWA and processes your historical data to give you the most optimum recommendations based on what it learned from user entries in more detail.

Here is how you can perform PFMEA using wave soldering example through Kaizen Copilot:

  • Just enter your task along with the requirements of your task. Make sure you input all the requirements that are necessary to complete a task.
  • Kaizen copilot then shows potential failures along with their effects and severity that can occur during the completion of the task based on your input. You can also re-generate the failures till you are satisfied with the results to insert them in your PFMEA list.
Figure 1: An example of Failure Analysis in Kaizen Copilot
  • For each failure, Kaizen Copilot suggests a list of causes that can contribute to this failure. You have to select the causes that seem the most relevant to you.
Figure 2: Suggested Causes Example in Kaizen Copilot
  • As the goal of the PFMEA is to identify the mitigate the risk, after identifying the causes of the failures Kaizen Copilot recommends actions to prevent these failures.
Figure 3: Recommended Actions Example in Kaizen Copilot
  • After entering all the parameters, the software generates a risk matrix to identify the frequency of high risk, medium risk, and low risk.
Figure 4: An example of Risk Matrix in Kaizen Copilot
  • Lastly, you have a recommended action list. Someone can take responsibility to implement the recommendations and write down the actual action taken to prevent the failure. All the changes recorded will visible to everyone on the team and can be tracked down for analysis purposes.

You can also download the results in Excel format to easily edit and adjust it accordingly. The user-friendly interface in PFMEA allows for assessing risk and developing strategies in real-time. The AI-based system ensures that the severity, occurrence, and detection ratings are consistent, and automatic RPN calculations help to prioritize actions effectively.

Conclusion

The benefits of PFMEA extend far beyond simply identifying risks. It fosters a culture of preventive maintenance, improves communication and collaboration across teams, and ultimately leads to higher quality products and processes. Combined with an AI-powered software, PFMEA can become a powerful tool to continuously strengthen your operations and achieve long-term success.

Want to see how Kaizen Copilot makes PFMEA easier? Schedule a free demo today!

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