FAILURE MODE AND EFFECT ANALYSIS (FMEA)
The methods of Failure Mode and Effects Analysis (FMEA) is beneficial for the evaluation of any process for determination of the avenues that have the potential to make it failure along with the assessment of the associated outcomes of various kinds of failure, for identification of the parts in the process that required the change. Failure Mode and Effect Analysis include the review of the following:-
- Adequacy of steps and procedures of the relevant process.
- Potential avenues that may lead to failure.
- Reason behind the occurrence of failure.
- Impacts of the failure with ability to demonstrate the consequences of that failure(“FMEA”, 2019).
FMEA helps in evaluation of the failure and to prevent them by making the corrections to the processes instead of reacting to the adverse events after the occurrence of the failure. There are certain advantages to Failure Mode and Effect Analysis (FMEA).
- It helps regarding improvement of the quality and safety of the process.
- It provides a structured format for identifying the area of concern.
- It helps in providing historical records(“FMEA”, 2019).
- It creates satisfaction to customers.
- It saves time focusing on failure(“FMEA | Failure Mode and Effects Analysis | Quality-One”, 2019).
“Failure Modesare defined as various avenues or ways in which sometimes processes might fail. Failure may be errors or effects that may cause an issue to the process. Failure mode and effect analysis is an comprehensive approach for the determination of possible failures that may exist within the design of the product(“What is FMEA? Failure Mode & Effects Analysis | ASQ”, 2019). The modes are the way that may fail the entire process if not check carefully(“What is a failure mode? – Minitab”, 2019).
In the year 1940, the US Military wanted to change the approach from “find the failure and fix it” to “found the failure and prevent it”, it is a method which helps in critically analyses the quantitative failure analysis. FMEA is hardware and or functional approach for the risk assessment(“FMECA | Failure Mode, Effects & Criticality Analysis | Quality-One”, 2019). It is an analytical or data-driven element of failure chain as follows: possible impacts of failure, mode of failure and the causes of such failure(“FMEA | Introduction to Failure Mode and Effects Analysis”, 2019). These elements realtely estimate the modern 5 why techniques in Root Causes Analysis(“What is FMEA and how is it different from Hazard Analysis? – SoftComply”, 2019). The failure then describes the question “WHY”, causes that result in a mode of failure. Each failure has the assigned probability and every failure has a rate allotted to it. In case the data is not available, the probability shall be given for its occurrence. This analysis shall be done before the occurrence of actual failure. There shall be 2 activities to perform FMEA:-
- Creation of FMEA
- Performance of the Analysis
The Failure may be measured critically depending upon the cause, probability, ranking and the interaction of the severity. Analysis should be done to determine the product or process design weakness. Two Quantitative options for the FMEA (Herman, 2019). The intent of the failure mode, effect, and analysis of the whole methods to determine the knowledge of risk which helps in preventing the failure. There are certain benefits of FMEA, which are explained in the following category:
- Design and Development Benefits
- It helps in increasing the Reliability(Mikulak, 2019).
- It provides better quality.
- It gives higher safety margins.
- It helps in redesigning the process, without any error.
- Operational Benefit
- It helps in controlling the plan more effectively.
- It helps in improving the verification and validation testing requirement
The FMEA is done by utilizing a more multi-functional team to set the severity and the occurrence. Risk is a kind of substitute for the failure of any process, there may be a failure in case, the risk is not identified properly. This is the main goal that the risk shall be identified before the acquisition of tooling. Removing of identified risk before process approval shall increase the performance of the process in a superior manner(“NEED FOR FMEA”, 2019). Generally, the risk is identified in the new process or technology. The PMEA is applied, in case the new process or technology is applied, there is any kind of changes in the current process or for continuous improvement in the process or for exposing to a new environment. The process of FMEA is required to be completed in the following sequence:-
- Process Name/ function – It helps in describing the process of technology that is being analyzed. The process could be a manufacturing operation or an assembly. There may be various functions for the process operation(Publishing, 2019).
- Requirements- The requirement of the process function shall be mentioned in various sections.. The requirement may be assisted by the way of drawing or a list of some special characters. A character matrix in the form of Quality Function Deployment is used to link the various characters to the process(“Quick Guide to Failure Mode and Effects Analysis – iSixSigma”, 2019).
- Failure Mode- These are the various modes of failures that occur due to non-compliance of the requirements. The failure may be of any kind such as Full failure, partial failure, Degraded Failure, Unintentional failure.
- Effects of Failure- the various outcomes of failure are due to the impact on the mechanism. Many effects can happen due to many failures. Many customers may be affected, the customers may be internal or external(“Research fmea and fmea Essay Example | Topics and Well Written Essays – 250 words”, 2019).
- Severity- The determination of severity of any process depends upon the process or design effect to a great extent. The ranking of severity shall be between 1 through 10. The highest-ranking shall be based on different potential effects. Actions are to be determined in order to apply the alternate design directions.
Proper Method for the process FMEA
- Choose a Process to analyze- Select that process that have some issues in the faculty.
- Select the team Members and the Facilitator- The facilitator shall be appointed by the leadership. Team members are the persons who are involved in project analyses.
- Description of Project- Define the steps of the process.
- Identify what may go wrong during the process- It helps in defing that what might go wrong in the entire process.
- Choose the Problem
- Design and Implement Changes- Change the process to reduce the risk.
- Evaluate the success of process change- In this the improvements are
Recommendation – The recommended action is the location within the process of FMEA that all potential improvements are placed. To complete the actions are the purpose of FEMA. The actions shall be complete to make some sense in case it is alone in the risk register or action.
Eliminate the modes of failure with severity list with ranking 0 to 9, lower detection on specific test improvements.
FMEA. (2019). Retrieved 16 September 2019, from https://polarion.plm.automation.siemens.com/hubfs/Docs/Guides_and_Manuals/Siemens-PLM-Polarion-How-to-conduct-a-failure-modes-and-effects-analysis-FMEA-wp-60071-A3.pdf
FMEA. (2019). Retrieved 16 September 2019, from https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/QAPI/downloads/GuidanceForFMEA.pdf
FMEA | Failure Mode and Effects Analysis | Quality-One. (2019). Retrieved 16 September 2019, from https://quality-one.com/FMEA/
FMEA | Introduction to Failure Mode and Effects Analysis. (2019). Retrieved 16 September 2019, from https://www.datalyzer.com/knowledge/fmea/
FMECA | Failure Mode, Effects & Criticality Analysis | Quality-One. (2019). Retrieved 16 September 2019, from https://quality-one.com/fmeca/
Herman, M. (2019). FMEA – Failure Mode and Effects Analysis, FMECA. Retrieved 16 September 2019, from http://fmea-fmeca.com/
Mikulak, R. (2019). Seven Things You Need to Know About How FMEAs Work. Retrieved 16 September 2019, from https://fmea-training.com/seven-things-fmeas/
NEED FOR FMEA. (2019). Retrieved 16 September 2019, from http://www.johanyak.hu/files/u1/segedlet/problemamegoldo_modszerek/fmea_angol.pdf
Publishing, R. (2019). Basic Concepts of FMEA and FMECA. Retrieved 16 September 2019, from https://www.weibull.com/hotwire/issue46/relbasics46.htm
Quick Guide to Failure Mode and Effects Analysis – iSixSigma. (2019). Retrieved 16 September 2019, from https://www.isixsigma.com/tools-templates/fmea/fmea-quick-guide/
Research fmea and hfmea Essay Example | Topics and Well Written Essays – 250 words. (2019). Retrieved 16 September 2019, from https://studentshare.org/nursing/1699525-research-fmea-and-hfmea
Top 10 FMEA Mistakes – Harpco Systems. (2019). Retrieved 16 September 2019, from https://www.harpcosystems.com/articles/top-10-fmea-mistakes
What is a failure mode? – Minitab. (2019). Retrieved 16 September 2019, from https://support.minitab.com/en-us/minitab/18/help-and-how-to/modeling-statistics/reliability/supporting-topics/basics/what-is-a-failure-mode/
What is FMEA and how is it different from Hazard Analysis? – SoftComply. (2019). Retrieved 16 September 2019, from https://softcomply.com/what-is-fmea-and-how-is-it-different-from-hazard-analysis/
What is FMEA? Failure Mode & Effects Analysis | ASQ. (2019). Retrieved 16 September 2019, from https://asq.org/quality-resources/fmea