We all know that, for any organization to be successful in the market, identification of risk and eliminating the same is very important. The process of identifying and assessing risks and its various impacts followed by actions to minimize and control the impact of unfortunate events is called risk management. These risks can come from any field of business like uncertainty in finance, failure in projects, accidents, legal liabilities, etc. Various organizations follow different methods to find out the risks involved in a process.
Failure Mode and Effects Analysis (FMEA) is an analysis technique that facilitates the identification of potential issues in a design by examining the effects of lower-level failures. The objective of FMEA activities is clearly to prevent failures that lead to incidents and accidents. Note that with this system the focus is on complete prevention, it is not Corrective Action following the event.
Why is FMEA Important?
Reasons why this analysis technique is so valuable. Here are just a few:
1) FMEA provides a basis for identifying root failure causes and developing effective corrective actions.
2) The FMEA identifies reliability and safety-critical components.
3) It facilitates the investigation of alternatives at all stages of the design or process.
4) FMEA provides a foundation for maintainability, safety, testability, and logistics analyses.
Conducting an FMEA is not an especially difficult task, but requires the establishment of a team with appropriate skills, including interpersonal skills. In many situations, the analysis process will challenge some earlier judgment of one or more team members, and this cannot be avoided since their expertise is essential to the effectiveness of the process.
Design FMEA has proven its worth with time again and again throughout several industries. It is often used in the defense, automotive, telecommunications, and medical industries along with many others. There are many good resources where you can find out more about FMEA design. Both large and small type of company benefited from making FMEA an integral part of their quality programs.
Orcanos Software was come into existence in the year 2005 by Zohar Peretz and Rami Azulay. Orcanos is the only company that provides integrated software for ALM (Design Control) and quality management (QMS), combined with regulations compliance, and specializes in the FMEA medical device industry.
The unique thing about us is our years of proven experience in a regulated hi-tech industry, working with medical device manufacturers and other high-tech companies, and assisting them in building their operational excellence.
Moreover, to keep your organization safe, Orcanos FMEA Risk Management System has scheduled alerts that will notify you continuously regarding anomalies within the process, and also impact analysis information.
From the above discussion, we can conclude that an FMEA is, therefore, a thorough assessment of the potential for failure of a product, along with an estimate of the percentage chance of each failure happening, and a decision on the actions to come from the acquisition of that information.
To know more about Orcanos or more please, call us at 3-5372561 or visit our website HERE; https://www.orcanos.com/compliance
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