What Is Process Failure Mode & Effects Analysis (PFMEA)?

Operating a business in any industry comes with a long list of risks. While many business owners can confidently manage their day-to-day business operations, taking preventative measures to improve the likelihood of long-term profitability is often overlooked. Precautionary measures may seem inconvenient, but analyzing potential failures takes much less time than dealing with them after they happen. Moreover, addressing identified risks is far less expensive than lengthy production delays and mechanical breakdowns. 

In other words, proactivity pays off. Using Process Failure Mode and Effects Analysis (Process FMEA or PFMEA) is a valuable tool to add to your risk management arsenal.

What Is PFMEA?

PFMEA is an analytical tool used to evaluate and identify potential failures related to operational processes. The ways in which a process may fail are referred to as failure modes. These include all vulnerabilities that may result in reduced productivity, worsened quality control and safety setbacks. 

PFMEA was first applied within the U.S. military, but since then, it has become useful in various industries and settings. It’s especially useful in the industrial manufacturing industry to help teams identify and address potential causes of failure modes throughout the manufacturing process.

FMEA vs. PFMEA

The PFMEA process falls under the larger umbrella of Failure Mode and Effects Analysis (FMEA). The main difference is FMEA takes a broad look at potential failure modes in systems, such as operations management and product development. 

PFMEA works in a similar way but exclusively encompasses the processes in a business. It examines identified failures within the production process, often conducted during the feasibility study phase.

Other Types of FMEAs

When the U.S. military started implementing FMEAs in the 1950s, it was used to create safer, more reliable and more efficient weapons. The method was swiftly adopted by NASA, followed by the civil aviation and automotive industries. FMEAs are not limited to process-oriented analyses. While the method of analysis is similar across the board, the following FMEAs have slightly different applications:

FFMEA (Functional FMEA)

Sometimes called System FMEA (or SFMEA), FFMEA analyzes the potential risks associated with how a system functions. It assumes that a system failure is rarely isolated and can occur between several assets and processes. By centering around system-level failures, it focuses on malfunctions like safety issues and interactions that may limit the viability of the end product or service.

DFMEA (Design FMEA)

DFMEA analyzes possible failures within the design phase of a product or service. Failure modes are identified and assessed before a product is even deployed. For example, an e-bike manufacturer could examine the safety impact of a hub motor failure during operation. 

When considering FMEA as a tool to find potential effects of failure within your operations, selecting which type of FMEA to use is dependent on the industry it’s being applied to as well as the size and complexity of the business.

Key Industries Using PFMEA

PFMEA should be a go-to strategy for any industry in which processes are critical . While this is not an exhaustive list, the following industries benefit greatly from PFMEA: 

• Agriculture: Helps to maintain product safety and quality management, providing protection against ethical and legal issues
• Automotive: Helps to avoid high-risk failures and ensuing recalls as well as to upgrade safety features
• Aerospace: Helps to mitigate potential component and system failures as well as to maintain quality and safety standards
• Manufacturing: Helps to both improve quality control plans and reduce unplanned downtime by mitigating mistakes
• Healthcare: Helps with accident prevention, particularly as it applies to power outages and the failure of medical equipment
• Software development: Helps to avoid unreliable user experience and prevent the need for costly corrections and minor failures from snowballing
• Transportation and logistics: Helps to optimize routes, improve speed of service and avoid bottlenecks in the global supply chain

When & How to Use PFMEA

Organizations often use PFMEA when new processes are introduced. When leadership performs the analysis prior to implementing new procedures, they’re able to establish training best practices to minimize human error and unexpected production needs down the line. PFMEA is valuable any time existing processes need to be modified as well.

Quality risk assessments allow businesses to design corrective protocols for scenarios in which quality has the potential to be compromised. Ultimately, this leads to fewer customer returns and complaints. Setting up processes in new environments is another excellent time to conduct a PFMEA. Even if you’re setting up an additional location using the same business model as your current location, it’s a valuable precaution that may help tie off loose ends that would have unraveled into larger problems over time.

10-Step Process to Perform PFMEAs

Performing PFMEAs is straightforward once you understand the methodology. Like FMEA, PFMEA involves assigning a 0-10 score to determine the severity, frequency and detectability of a failure mode, with 0 being that the failure has no measurable impact and 10 being that the failure is hazardous and requires immediate attention. To brainstorm all potential failure modes off the top of your head can become too disorganized to be effective. Instead, start by following these 10 process steps:

1. Define and review your process: Use flowcharts to illustrate all process tasks, and prioritize those that impact your operational functionality the most. These reviews are intended to get all team members, particularly those who aren’t involved in day-to-day operations, to have a solid understanding of all process components.
   
2. Identify the possible failure modes: Analyze historical data to estimate the likely ways processes may fail. These include full failures, partial failures, intermittent failures, failures due to degrading parts and unintentional failures in which external factors are at fault.
   
3. Name the potential effects each failure mode could have on your operational processes: Establish what may occur if a failure mode happens. Be as detailed as possible to inform the following step.
   
4. Analyze the impacts of each failure mode: Give it a severity ranking on the 0-10 scale. A 10 implies the impact is immediate and severe and, therefore, should be addressed first. A low score indicates a failure mode that can fall lower on your priority list.
   
5. Determine the failure’s expected frequency ranking: Give it a similar 0-10 score. Historical data helps here, but establishing the root cause of the failure mode is useful, too. Estimate how often a failure mode is likely to occur. Those with a high occurrence ranking should take priority.
   
6. Assess how easy or difficult it will be to detect this failure: Give it a 0-10 detection ranking. Lower scores mean the risk is easy to identify and can be avoided in advance, while a score of 10 implies the failure is almost impossible to recognize before it happens.
   
7. Calculate a risk priority number (RPN): This is done by multiplying the severity score, the frequency score and the detection score. Maintenance efforts should focus on failure modes with high RPNs.
   
8. Create a recommended action plan: This plan should have a primary goal of reducing the likelihood of failure. The higher the number, the more resources you should invest in that action plan.
   
9. Implement the plan: Provide standard operating procedures to help all cross-functional teams involved stay on track.
   
10. Run another RPN calculation: Continuous improvement is key to make this work, so run another calculation after operational changes have been made.

An Example of PFMEA in Action

Let’s take the example of how PFMEA could help the operational processes in Toyota’s automotive manufacturing plants. To ensure the company’s production line processes remain efficient while producing high-quality vehicles, Toyota would want to proactively identify any potential problems with its manufacturing process.

By applying PFMEA to its current process, Toyota can:
●  Reduce defects: Improve product quality and reliability by identifying and addressing potential problems before they occur.
●  Increase efficiency and cost savings: Streamline production process flows and minimize downtime caused by unexpected failures, resulting in current process improvements and production outputs as well as cost savings.
●  Maintain customer satisfaction: Deliver high-quality vehicles consistently, which supports Toyota’s strong reputation and customer loyalty.

Benefits of PFMEA

As you can see, the benefits of PFMEA are widespread. By performing a PFMEA, both potential and current process issues can be identified and addressed, improving outcomes on several fronts. 

Firstly, PFMEA may prevent costly failures. While failure modes are inevitable, performing PFMEA lowers the likelihood that process errors will result in expensive setbacks. Doing so also allows businesses to continually improve, implementing updated procedures to lower risk and improve outcomes. Development and production costs are lower as a result. 

Additionally, PFMEA reduces customer exposure to failure risks. Simply lowering the number of warranty claims filed may improve your bottom line significantly, and it aids in customer satisfaction, too. By reducing customer-facing problems — including safety, reliability and quality — customer retention gets a push in the right direction. 

Performing PFMEAs Is Easier With CMMS Help

It’s possible to tackle PFMEAs manually, but using a computerized maintenance management system (CMMS) streamlines your efforts drastically. 

To get ahead of process breakdowns and take your preventive maintenance tactics to a new level of efficiency, sign up for a free Coast account today.