FMEA training teaches you the concepts, tools, techniques, and applications of failure modes effect analysis (FMEA). FMEA Training will help you mitigate the risks in your organization that are originated from avoidable mistakes and train you to determine all the latent modes of failure prior to delivering a new product.
Brief History of FMEA
The US Armed Forces validated FMEA in 1949 by introducing of Mil-P 1629 Procedure to execute a failure mode effect and criticality analysis. The goal was to categorize failures based on their effects on the safety of personnel and equipment.
Later, NASA used FMEA in the Apollo space program to reduce risk. The employment of FMEA speeded up during the 1960s, after landing on the moon and coming back to earth safely. It was in the late 1970s, when Ford started using FMEA for safety and regulatory consideration after the Pinto situation. Ford also used FMEA to enhance the manufacturing and design. Then in the 1980s, the entire automotive industry started executing and establishing FMEA by standardizing the framework and techniques cross the Automotive Industry Action Group (AIAG). Initially developed by the military, the FMEA methodology is now being widely applied in a range of industries including semiconductor processing, foodservice, plastics, software, aeronautics, automotive, and healthcare, to name a few.
Common FMEA Standards
- SAE J1739, Potential Failure Mode and Effects Analysis in Design (Design FMEA), Potential Failure Mode and Effects Analysis in Manufacturing and Assembly Processes (Process FMEA)
- AIAG, Potential Failure Mode and Effects Analysis (FMEA) Reference Manual Fourth Edition
- MIL-STD-1629A, Procedures for Performing a Failure Mode Effects and Criticality Analysis (Cited for cancelation in 1994, but still used in some military and other applications)
- SAE ARP5580, Recommended Failure Modes and Effects Analysis (FMEA) Practices for Non-Automobile Applications
- IEC 60812, Analysis techniques for system reliability – Procedure for failure mode and effects analysis (FMEA)
Why Do We Need FMEA?
- FMEA is a confirmed technique to cut down life cycle warranty costs.
- FMEA can reduce mistakes during product development.
- It is way less expensive to inhibit problems in the early stages of the product development rather than fixing problems later on after the product is made
- FMEA can determine and anticipate potential safety issues before an actual catastrophe happens
FMEA Definition and Purposes
FMEA, Failure Mode and Effects Analysis, is a methodology designed to:
- Determine and completely comprehend possible failure modes and their causes, and the effects of failure on the system or customers, for a certain product or process.
- Analyze the risk related to the identified failure modes, effects and causes, and put the issues in order based on their importance for corrective action.
- Determine and perform corrective actions to consider the most serious issues.
An effective FMEA is the one inclusively analyzed by a multidisciplinary engineering team in regards to product designs or manufacturing processes, preferably in the early stages of the product development process. FMEA intends to discover and correct flaws before the product is out in the market. Other objectives are:
- Identifying and inhibiting safety hazards
- Reducing the loss of product performance or performance degradation
- Enhancing test and verification plans (in the case of System or Design FMEAs)
- Enhancing Process Control Plans (in the case of Process FMEAs)
- Applying modifications in the product design or manufacturing process
- Determining substantial product or process specifications
- Creating Preventive Maintenance plans for operating machinery and equipment
- Creating online analytical approaches
Various Types of FMEAs
The greatest level of analysis performed on the whole system, constructed of multiple subsystems. The concentration is on deficiencies associated with system, including safety, integration, interfaces or interactions between subsystems or with other systems, interactions with the surrounding environment, human interaction, service, and other issues that could lead to failure of the overall system. In System FMEAs, the emphasis is on roles and interactions specific to the system as a whole.
Design FMEA (DFMEA)
DFMEA emphasizes on product design, usually at the smaller level of subsystem or component. As the name indicates, DFMEA focuses on design- associated defects, to enhance the design and ensure the product operation is safe and reliable during the useful life of the equipment. The scope of the DFMEA contains the subsystem or element itself, as well as the boundaries between adjacent components.
Process FMEA (PFMEA)
PFMEA focuses on the process of manufacturing or assembly, with the emphasis on how the production process can be enhanced to confirm that a product is made to design specifications in a safe way, with negligible downtime, scrap and rework. The scope of a PFMEA includes manufacturing and assembly operations, shipping, parts, storage, conveyors, maintenance, and even labeling.
Failure Mode Effects and Criticality Analysis (FMECA)
FMECA is very similar to FMEA, only supplemented with one step of a more formal Criticality Analysis. Such extra step usually needs objective data to assist the criticality calculation. It is important for those individuals who are required to carry out a FMECA to learn the fundamentals of FMEA deeply, and then to learn the FMECA procedure.
- Concept FMEA, a short form of FMEA to assist in choosing optimum concept alternatives or to identify changes to system design specifications
- Maintenance FMEA, in support of Reliability Centered Maintenance projects
- Hazard Analysis, which concentrates on determining and addressing potential hazards related to the use of a product
- Software FMEA, which determines system deficiencies, and analyses the efficiency of the software architecture and software requirements
FMEA Success Elements
There are six broad success factors that are crucial to consistency of success in the use of FMEA in any field and organization:
- Understanding all the bases and procedures of FMEAs, including the concepts and definitions.
- Choosing the appropriate FMEA
- Research thoroughly for each FMEA project
- Using the lessons learned and quality purposes
- Offering excellent assistance
- Executing an efficient FMEA process
- Effect(s) of Failure
- Cause(s) of Failure
- Current Control(s)
- Recommended Action(s)
- Plus other relevant details
FMEA Risk Analysis Methods
- Risk Priority Numbers (RPNs)
- Criticality Analysis (FMEA with Criticality Analysis = FMECA)
In order to evaluate risks via the Risk Priority Number (RPN) method:
- Rate the severity of each effect of failure
- Rate the possibilities of occurrence for each cause of failure
- Rate the possibilities of previous determination for each cause of failure
- Calculate the RPN by obtaining the product of the three ratings:
RPN = Severity x Occurrence x Detection
- It is subjective, not objective
- The potential values of RPN are not continuous
- The detection scale has its own limitations
- There are many duplicate RPN values, demonstrating various mixes of severity, occurrence and detection rankings
- The practice of using RPN thresholds is not advised
- When RPN is applied, high severity must be considered regardless of RPN value.
The MIL-STD-1629A document explains two different forms of criticality analysis: quantitative and qualitative.
To use the quantitative criticality analysis method:
- Define the reliability/unreliability for each item and apply it to approximate the expected number of failures at a certain operating time
- Determine the ratio of the item’s unreliability that can be qualified to each potential failure mode
- Rate the probability of loss (or severity) that will result from each failure mode that may occur.
- Calculate the criticality for each potential failure mode by obtaining the product of the three factors:
Mode Criticality = Expected Failures x Mode Ratio of Unreliability x Probability of Loss
- Measure the criticality for each item by acquiring the sum of the criticalities for each failure mode that has been determined for the item.
Item Criticality = SUM of Mode Criticalities
To apply the qualitative criticality analysis method to analyze the risk and prioritize corrective actions, the analysis team must:
- Rate the severity of the potential effects of failure
- Rate the possibilities of occurrence for each potential failure mode.
- Compare failure modes via a Criticality Matrix, which determines severity on the horizontal axis and occurrence on the vertical axis.
- Determine effects for every single failure mode
- Rating the severity level for each effect
- Determining possible causes of each failure mode
- Ranking the occurrence level of each cause
- Outlining the already existing controls for each cause
- Rating the detection level of each cause
- Calculating the RPN
- Recommending corrective actions
- Allocating responsible people
- Executing the actions plan
- Prioritizing based on the RPNs
- MUST look at severities rated a 10
- Allocating the anticipated severity, occurrence, and detection levels and compare the RPNs
Common FMEA Selection Criteria
- New technology
- New designs where risk is a concern
- New applications of existing technology
- Potential for safety issues
- History of significant field problems
- Potential for important regulation issues
- Mission Critical applications
- Supplier Capability
How Can You Learn About FMEAs?
TONEX is offering a number of comprehensive, hands-on training courses. Each training is a combination of interactive lectures and hands-on activities, including practical exercises, individual/group activities, and hands-on workshops. To explore which course serves you the best, click on the course name below:
- DFMEA Training, Design FMEA Training
- DRBFM Training, Design Review Based on Failure Modes Training
- FMEA Training, Failure Modes Effects Analysis
- FMECA Training, Failure Modes Effects Critical Analysis
- FRACAS Training, Failure Reporting Analysis and Corrective Actions Systems
- PFMEA Training, Process FMEA Training
- SFMEA, Software Failure Modes Effects Analysis Training