Process Failure Mode and Effects Analysis (PFMEA)

Process Failure Mode and Effects Analysis (PFMEA) is a methodology used to systematically identify potential causes of failure in the manufacturing process and to prioritize these issues as part of a broader preventive maintenance strategy. A robust PFMEA strategy is essential to preventive maintenance, providing the assessment and insight required to ensure maximum reliability, safety, and operational continuity.

The importance of effective Process Failure Mode Effects Analysis (PFMEA)

In essence, PFMEA is a risk assessment and mitigation strategy specific to industrial processes such as production and assembly. In addition to anticipating possible failure, PFMEA also provides an understanding of the potential effects of failure on your overall operation as well as strategies for mitigating this impact.

In the discussion that follows, we’ll explore the role that PFMEA plays in helping maintenance team members anticipate, prepare for, and prevent equipment failures. We’ll also discuss the importance of PFMEA to the long-term viability of your equipment, your product quality, and your organization’s capacity for process optimization. 

What is PFMEA

In short, PFMEA is an analytical process that manufacturing-industry organizations use to evaluate the potential for failure in their current production processes and to initiate efforts to prevent these failures. 

Practical implementation of PFMEA

In a practical sense, PFMEA is meant to enhance preventive maintenance efforts and reduce the likelihood of operational disruption by anticipating the root cause of various failure modes. This analytical process typically requires the practitioner to:

  • Identify where and how a process might fail
  • Assess the risks associated with process failure
  • Determine the criticality of these risks
  • Prioritize certain physical assets based on this determination
  • Implement solutions to limit the likelihood and mitigate the potential impact of process failure

Goals of PFMEA

The overarching objective of PFMEA is to identify and correct points of potential failure before they can manifest as actual failures. Effective analysis should advance several key organizational goals by helping your organization to: 

  • Minimize the risk of product defects
  • Improve regulatory compliance
  • Adhere to safety standards for both products and processes 
  • Improve the consistency, quality, and on-time delivery of products 
  • Enhance customer satisfaction.

Benefits of PFMEA

There are several valuable benefits to PFMEA, particularly in the areas of asset management and facilities maintenance. Effective PFMEA implementation can help your organization:

  • Reduce maintenance costs by repairing defects, preventing failures, and avoiding  unplanned downtime
  • Improve quality assurance by making proactive improvements to the production process and the equipment used in that process
  • Create a safer workplace, yield safer products, and ensure compliance with industry standards
  • Protect your organization’s reputation, improve public trust, raise customer satisfaction, and pass audits with ease

How does PFMEA work?

PFMEA is a structured process aimed at identifying and mitigating potential points of failure along production lines. PFMEA works by first conducting a process review, subsequently identifying potential failure modes, and ultimately using these stages to develop control plans for failure mitigation

This analytical tool is commonly used in a range of scenarios, including: 

  • New product launches
  • Implementation of new processes
  • Introduction of new production techniques and/or equipment
  • Adoption of initiatives aimed at quality improvements or improved regulatory compliance 
  • Correction of existing processes 


Process Failure Mode and Effects Analysis (PFMEA) and Failure Mode and Effects Analysis (FMEA) are closely related concepts. The primary difference is their scope. In short, PFMEA is one type of FMEA. FMEA is an umbrella term that encompasses PFMEA as well as System FMEA (SFMEA) and Design FMEA (DFMEA). Each of these analytical methods focuses on a different stage in the product life cycle

System FMEA

Whereas PFMEA is focused on the risk of failure in the manufacturing or production process, System FMEA is concerned with the potential for systemwide failure and how this might impact product development. SFMEA examines interactions between components in a connected system (i.e. equipment, technology platforms, subsystems) to identify and prevent system-level failures. This mode of analysis is particularly valuable at the early stages of product development and can help illuminate systemic issues that might impede the viability or quality of end products. 


Design FMEA focuses on product design. This analysis must typically be conducted before manufacturing begins and is meant to identify potential design flaws that might ultimately prevent optimal product performance. 


Failure Mode Effects Analysis (FMEA) is a multi-stage process. Each of the analytical modes included under the FMEA umbrella is critical to a different stage of the product life cycle, with System FMEA ensuring the functionality, reliability, and interconnectivity of the overall system; Design FMEA ensuring optimal product design; and Process FMEA minimizing the risk of failures in the manufacturing process.

Which industries use PFMEA?

Process Failure Mode Effects Analysis (PFMEA) is used in a wide range of industries and plays a particularly important role in sectors that rely on manufacturing processes. This is especially true of industries where the cost of process failure may be high. 

  • Automotive industry: PFMEA is used to minimize risks associated with the manufacture of vehicles and vehicle components. For instance, analysis might be used to identify potential failures in assembly line procedures, flaws in the design of tools used during assembly, or shortcomings in the training curriculum for technicians
  • Pharmaceutical industry: PFMEA can help ensure consistency and regulatory compliance in the process of drug production. For instance, PFMEA might be used to identify risks of cross-contamination in the production process and to mitigate these risks through better equipment cleaning and stricter quality control measures. 
  • Electronics industry: PFMEA may be used to pinpoint potential failures in the functionality or safety of electronics products. For instance, PFMEA might be used to identify the potential for errors in the assembly of circuit boards. This might consequently prompt improved training, more sophisticated production equipment, or the implementation of preventive maintenance techniques. 
  • Food and beverage industry: PFMEA may be used to ensure that processes comply with food safety standards. For instance, PFMEA may help to identify risks of contamination during a beverage bottling process and prompt heightened sanitation procedures.
  • Medical devices industry: PFMEA is used to mitigate the serious health risks that can be caused by failures in the medical device manufacturing process. For instance, PFMEA can help to identify and address the potential of electronic malfunctions in life-saving medical devices such as pacemakers and insulin pumps.

Benefits of PFMEA in preventive maintenance programs

PFMEA is a particularly valuable process for organizations that employ preventive maintenance programs. This is because this mode of strategic analysis can help maintenance teams hone their focus on equipment in need of proactive calibration, repairs, parts replacement, and other corrective actions. Below, we identify some of the key benefits of PFMEA for your preventive maintenance program.

  • Enhanced process reliability, with greater precision in identifying and correcting potential equipment failures, breakdowns, and production stoppages before they can occur. 
  • Improved quality control, with the identification of potential failures ultimately helping to eliminate the causes of possible product defects or inconsistencies.
  • Reduced operational costs, with a lower frequency and severity of failure, ultimately lowering the costs associated with asset repair and replacement, as well as reducing the occurrence of costly unplanned downtime.
  • Heightened regulatory compliance, with PFMEA reducing the risks of equipment malfunction, and ultimately contributing directly to the creation of production environments that are at once safer and more compliant with industry standards and regulatory requirements. 
  • Refined maintenance planning, with effective process analysis providing the data and insights needed to plan maintenance activities at predetermined intervals, allocate resources more effectively, and schedule interventions that minimize operational disruptions.

6 steps for running a PFMEA

Below, we highlight some of the most important steps in the PFMEA process.

Step 1–Conduct a process review

Begin by documenting the full production process in detail, outlining each step in the manufacture and assembly of products. Details should include an overarching description of the process, delineation of the sequence of operations, identification of equipment used, and listing of the personnel involved in both the upkeep and use of this equipment. This review and the resulting documentation should provide a primary source of information for the subsequent analysis. 

Step 2–Identify potential failure modes

Narrow your view to each manufacturing process step, and determine all potential causes for failure (i.e. defects, delays, breakdowns, etc.) at each step in the process. Such causes may include human error, equipment failure, procedural flaws, environmental factors, and more. 

Step 3–Analyze business impact

Determine the possible impact of each failure mode including its potential to impede the quality of your output, endanger your customers, or disrupt your production process altogether. 

Step 4–Assign Severity, Occurrence, and Detection Rankings

Once you’ve identified the potential impact of each failure mode, use these findings to assign a Severity Ranking to each potential effect, as well as rankings indicating both the likelihood of each effect (Occurrence Ranking) and the ability of your system to detect each failure mode before it can occur (Detection Ranking). It is common to use a scale of 1-10 to rank all three of these indicators.

Step 5—Calculate the Risk Priority Number (RPN)

Prioritize the failure modes that will require the most urgent attention by calculating a Risk Priority Number (RPN). This figure can be calculated by multiplying the three scores above (i.e. RPN = Severity Ranking x Occurrence Ranking x Detection Ranking). Those failure modes with the highest RPN will present a high risk to your processes and products, and will therefore demand the most urgent attention.

Step 6–Develop and implement an action plan

Use the resulting RPN to inform your action plan and prioritize specific activities. These activities may include a shift in production procedures, the introduction of new quality control protocols, upgraded materials, additional training, and more. Use this stage in the process to assign maintenance personnel to specific responsibilities, and to implement a corresponding preventive maintenance schedule. 

Asset and risk management with Limble

Computerized Maintenance Management Systems (CMMS) like Limble can play a pivotal role in supporting the successful implementation of PFMEA

Among the key benefits of an effective CMMS are: 

  • Centralized asset information
  • Streamlined maintenance scheduling
  • Real-time monitoring and alerts
  • Risk management tools
  • Documentation and compliance
  • Enhanced communication and collaboration
  • Continuous improvement

CMMS platforms like Limble can be instrumental in ensuring the effectiveness of Process Failure Mode Effects Analysis by helping your maintenance team prioritize tasks, monitor assets, maintain compliance, and ultimately mitigate the risks that can lead to process failure.  

Learn more about the role of maintenance technology in addressing the root causes of failure in this webinar recording. 


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