Introduction

For plant managers, the main goal that they aim to achieve is a manufacturing process that is fully error-free. However, that is one of the optimum scenarios and is difficult to implement. This is because mistakes, particularly those perpetuated when others are present, can be disastrous.

Process Failure Mode and Effects Analysis (PFMEA) is extremely important in such a scenario. This primarily examines each process step to detect risks and potential mistakes from various sources. As a result, the manufacturing process is enhanced, producing a high-quality product. In this article, we will go through the details of this procedure and how it can be implemented in simple steps.

What is PFMEA?

Process Failure Mode Effects Analysis (PFMEA) is one of the most important processes used in manufacturing. This method is mostly implemented in plants to ensure that product quality is improved during the manufacturing process. Manufacturers can readily uncover possible faults that are found in the physical process of making a product using this approach. Each stage of the process is meticulously examined to discover any potential flaws.

The PFMEA method incorporates some of the most basic elements and follows a very similar procedure to that of DFMEA but looks at failures resulting only from the process rather than design. Planning for potential production disasters enables all-around preparation. Planning for potential production disasters provides for readiness for all eventualities. Process Failure Mode Effects Analysis (PFMEA) allows producers to incorporate process controls to prevent possible failures.

PFMEA template

For a better process, it is always suggested that the plant managers use a structured excel sheet to analyze the steps involved.  The Process Failure Mode Effects Analysis (PFMEA) template is an effective defect prevention tool because it anticipates defects and implements countermeasures before they occur. Each process step’s risk level is assessed using a Risk Priority Number (RPN), which normally runs from 1 to 1,000, with 1,000 representing the greatest potential risk level.

In the first column, add information about the process, as well as the Potential Failure Mode, which specifies how the Process Step, Variable, or Key Input might fail. This also mentions the Potential Customer Impact Due to Defects. After a thorough examination, you may also determine the Potential Causes from the table. In one of the columns, you should additionally describe what existing controls are in place to either prevent the failure mode from occurring or identify it if it does occur. Measures suggested, response and target date, and what actions were taken? must be provided as well Include the completion month/year in the table as well.

How to conduct the process of PFMEA?

Step 1: Examine the procedure

The first step is to examine the manufacturing process. A flowchart is used to identify each process component in this procedure. Then, using a thorough diagram, identify the process and the intermediate phases. Determine what each step is meant to accomplish. All key aims are decided at this step, and the main goal to be achieved is also set.

Step 2: Possible modes for failures

After you have determined the goals, it is time to identify all potential failure(s) for each phase of the process. This procedure should be carried out thoroughly. Brainstorm all of the pertinent topics and then make an informed decision.

Step 3: Consequences for potential failures

If the indicated failure(s) occurred, describe the impact on production capacity, the next sequential phase, or the completed product.

Step 4: Assign Severity Levels

It is now time to allocate the severity ranks. Now, in case you’re wondering, what precisely are they? The severity rankings are determined by the gravity of the consequences of failure: If the potential danger is minimal, values close to one are assigned; if the potential risk is high, numbers such as ten are assigned.

Step 5: Determine Occurrence ranks

Assessing the extent of the danger is no longer sufficient. Instead, we must assess how often such a potential risk failure can occur. The occurrence rankings are based on how frequently the failure’s cause is expected to occur: 1 (least likely) – 10 (extremely likely).

Step 6: Determine Detection ranks

Assign detection rankings in this step. Based on the likelihood that the issue will be noticed before the client discovers it. In this phase, a unity value is assigned if the deduction is simple, while a number closer to ten is assigned if it is extremely difficult.

Step 7: Determine the RPN

Now you must assess whether the number calculated in the previous step is appropriate for the failure being investigated.

Severity X Occurrence X Detection = RPN

Step 8: Create an action plan

Now, that you know all the details about potential failures, it’s time to determine how you can improve the scenario. In case of difficulty, you can get help from established professional organizations.

Step 9: Take action

Implement the changes recommended by your Process Failure Mode Effects Analysis (PFMEA) team.

Step 10:  Determine the resultant RPN

Once changes have been made, re-evaluate each possible failure and identify the effect of the improvements.

PFMEA vs FMEA

You could believe that FMEA and PFMEA are the same, but they aren’t. So, let’s see what the distinction is between them. The FMEA aims to eliminate or decrease failures by starting with the most critical failures. As well as chronicling current knowledge about failure risks, failure modes and effects analysis can be used to develop a continuous improvement process. FMEA is used to prevent failures throughout the design process. As the process continues, it is used as a control device, both before and during the continuous operation of the process. It is best to start the FMEA process at the early conceptual stages of the design and continue it throughout the product’s lifecycle.

Many sectors, particularly those where risk reduction and failure prevention are critical, can benefit from employing FMEA, including:

• Business Processes
• Manufacturing
• Software
• Hospitality and healthcare service
• Cosmetics
• Medicines

This FMEA may now be divided into two types: DFMEA and PFMEA. The distinction between the two is seen in the sorts of failures examined – design (product) vs process. But, again, just because two processes have different names doesn’t imply they aren’t related. If the design of an established product is changed, the process must be re-evaluated, and vice versa.

Conclusion

Using Process Failure Mode Effects Analysis (PFMEA) is a proven systematic and qualitative technique that offers genuine results if you want to reduce the likelihood of an error or defect ever reaching your consumer. So, follow this procedure and incorporate all processes correctly and methodically. Then you will be able to improve the product quality.

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