FMEA an its application in industries
Failure Mode and Effect Analysis (FMEA) is a strategic methodology employed in the early stages of product development to proactively identify and address potential issues, thereby enhancing the overall reliability of the design. Originally devised in 1949 by the US Armed Forces for mission-critical purposes, FMEA gained prominence during the Apollo space program and later found widespread adoption across diverse industries such as semiconductor processing, foodservice, plastics, software, and healthcare.
The primary objective of FMEA is to establish connections between process and product requirements, foresee unacceptable outputs, and understand their potential impacts. While time-consuming, a meticulously executed FMEA serves as a valuable tool to plan, detect, and react to challenges, ensuring a successful product life cycle. Its continuous utilization throughout the product life cycle significantly enhances safety, quality, delivery, and cost, with additional benefits achieved through cause chain analysis and mistake-proofing.
FMEA is integral to Six Sigma methodologies, aiding in the identification of controls required for continuous and specification-compliant product production. The tool is considered a living document, initiated prior to the launch of a new job or process and maintained throughout its life. It undergoes modifications with any changes to the design, product, or process, ensuring relevance in dynamic environments.
Various applications of FMEA include design, process, system, service functions, and software functions. This article delves into two primary formats: Design FMEA (DFMEA) and Process FMEA (PFMEA).
DFMEA (Design FMEA)
DFMEA focuses on components and subsystems during the conceptual phase of new product development. It provides an analytical analysis of potential failure modes and their causes, addressing aspects like safety, quality, cost, performance, and reliability. Critical characteristics, identified during design, highlight elements requiring special attention to prevent defects that could lead to severe consequences. For example, in the development of a new sensor, the DFMEA identifies critical characteristics such as dimensions or features crucial to personnel safety or mission success.
PFMEA (Process FMEA)
Following the completion of DFMEA, PFMEA is developed to control the production process. At Watlow, PFMEA documents are structured based on part numbers, outlining the steps from material receipt to shipping. However, a more efficient approach involves focusing on process structures rather than part numbers. For instance, a PFMEA developed for the induction braze process can be applied universally to all part numbers utilizing this process, streamlining updates and improvements.
Risk Priority Number (RPN)
A key outcome of FMEA is the calculation of a Risk Priority Number (RPN), derived from the severity, occurrence, and detection rankings. This numerical value highlights areas of concern, enabling prioritized corrective actions.
All companies will have to decide their risk appetite and from their Severity, Detection and Occurrence rating they can choose a Risk Priority Number that is acceptable to them. For instance, The Maximum number of RPN a failure mode can be assigned is 1000. The Management of a company or individual may decide that an RPN greater than 600 will be looked into and all risks will have a remediation plan.
Industries that FMEA could be applied to
While FMEA can be used for all industries, we have highlighted 10 industries that FMEA could be applied on:
1. Automotive Industry
Process: FMEA can be applied to manufacturing and assembly processes, identifying potential failure modes in components or subsystems. This ensures that the final automotive products meet quality standards and safety requirements.
2. Aerospace Industry
Process: FMEA helps in the development and manufacturing of critical components for aircraft, ensuring reliability, performance, and safety. It aids in detecting and mitigating potential issues early in the design and production phases.
3. Healthcare Industry
Process: In healthcare, FMEA can be employed in the design and production of medical devices, pharmaceuticals, and healthcare processes. It ensures adherence to regulatory standards and minimizes risks associated with product failure.
4. Electronics Industry
Process: FMEA is valuable in the electronics industry for the design and manufacturing of electronic components and devices. It helps identify potential failure modes that could impact the functionality and reliability of electronic products.
5. Food and Beverage Industry
Process: FMEA is applicable to food processing and packaging, ensuring the quality and safety of food products. It helps identify and address potential risks in the production process, preventing issues such as contamination or spoilage.
6. Energy Sector
Process: FMEA can be employed in power generation processes, ensuring the reliability and safety of energy production systems. It helps identify potential failure modes that could lead to downtime or safety hazards.
7. Chemical Industry
Process: In the chemical industry, FMEA assists in the design and production of chemicals and chemical processes. It helps identify potential hazards and ensures the safe and efficient production of chemical products.
8. Telecommunications Industry
Process: FMEA is valuable in the design and manufacturing of telecommunications equipment and networks. It helps identify and mitigate potential issues that could affect the performance and reliability of communication systems.
9. Construction Industry
Process: FMEA can be applied in construction processes, identifying potential failure modes in building materials, structural designs, and construction methods. This ensures the safety and durability of constructed infrastructure.
10. Software Development
Process: FMEA is beneficial in software development, helping identify potential failure modes in code, algorithms, and system architecture. It aids in delivering software products with high reliability, security, and performance.
In conclusion:FMEA an its application in industries
The interactive use of DFMEA and PFMEA aids in developing effective product designs, ensuring compliance with customer specifications, reducing design changes, minimizing scrap, improving delivery, and controlling costs.
