FMEA RISK MANAGEMENT And How It Helps In Managing Risk?

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. FMEA (Failure mode and effects analysis) is a step-by-step approach for identifying all possible failures in a design, a producing or assembly process, or a product or service.


identify the probable risk involved in a process. Now it has become essential for organizations to identify the risk and manage suitably to avoid huge financial losses.

Five ways FMEAs help manage risk

  1. They start by providing a framework to develop a comprehensive identification of potential risks.
  2. They assist with the evaluation of those risks in terms of how severe they could be, their likelihood of occurring, and the chance the potential failure has to be detected before failure.
  3. They are a tool to decide which are the most serious risks.
  4. They help point to ways to reduce the most serious risks.
  5. They enable reevaluation to determine if the risk has been sufficiently reduced or if more work needs to be done.


To achieve an appropriate level, the session takes a broad view of the end-to-end supply chain - how to map it and identify the typical 'pressure points' where issues and risks are likely to occur. The focus is on identifying the risks from multiple perspectives by achieving true cross-functional and cross-company involvement and buy-in. The output from this becomes the input to a risk assessment exercise such as FMEA, the construction of which is explored.


So why should you use it?

FMEA is a tool to ensure that you have captured all possible causes and failure modes of your system. Ultimately, this system is effective at identifying and correcting process failures early on so that you'll avoid the nasty consequences of poor performance.


In the year 2005, the company named Orcanos comes into existence by Zohar Peretz and Rami Azulay. The one and the only company that provides integrated software for quality management (QMS) and ALM (Design Control) combined with regulations compliance. Orcanos Risk Management is meant to help medical device manufacturers to identify, track, and mitigate potential risks before they happen.. By using one system that connects design control, risk, and Quality Management, you'll reduce risk of failure, ensures hazards are mitigated, and prevents failure from happening .With years of proven experience in a regulated hi-tech industry, operating with medical device manufacturers makes Orcanos unique from others.


For more details and to know about FMEA Risk Management Tool or more please, call us at +972- 3-5372561 or visit our website HERE;


FMEA Risk Management Tool


Orcanos provides an cloud ALM system that combines quality (QMS) and regulations into the R&D process, thus assuring better FDA, ISO, CE compliance.

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