Within the framework of the EN 31010 standard, we carry out a comprehensive risk assessment in order to determine the hazards and risks that exist in the workplace or may come from outside, and to determine the damages that may occur to employees, the workplace and its environment, and the measures to be taken against them. Failure mode and impact analysis (FMEA) is the analysis of elements, systems or processes. It is a technique used to identify issues where the company cannot achieve its planned goals.

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The FMEA method was developed for use in the aviation industry in the 60s. It is very popular in all technology-intensive sectors, as well as in the aerospace sector, chemical industry and automobile industry. The main reason why this method is popular is that it is easy to use and does not require extensive theoretical knowledge.

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Safety in workplaces is a fundamental requirement for the sustainability of employees and the workplace. For this purpose, a comprehensive risk assessment is required within the framework of the EN 31010 standard to identify existing or possible hazards and risks in the workplace, to determine the damages that may occur to employees, the workplace and its environment, and the measures to be taken against them.

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Reference Standard:

IEC 60812, Analysis techniques for system reliability – Procedures for failure mode and effect analysis (FMEA)

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Application Details:

The FMEA method generally focuses on the analysis of parts and equipment. This method analyzes each of the places and areas where failure may occur and evaluates it, taking into account personal opinions, and can be applied to each part of the system.

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• Failure Mode and Effect Analysis application;

• Determines the causes and factors of each error,

• Identifies potential errors,

• Reveals the priority of errors based on probability, severity and detectability,

• Ensures that problems are monitored and corrective actions are taken.

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FMEA has a number of applications: Design (or product) FMEA used for elements and products, System FMEA used for systems, Process FMEA used for production and assembly processes, Service FMEA and

 

Software FMEA. FMEA/FMECA can be applied during the design, production and operation of a physical system. However, changes to improve the system are generally more easily made at the design stage.

 

FMEA and FMECA can also be applied to processes and procedures. For example, it can also be used to identify medical errors and errors in care procedures in healthcare.

 

Failure Mode and Effect Analysis technique has a wide variety as listed below and its application areas cover all types of production and service:

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• Design FMEA: It is a method that identifies potential or known error types, ensuring that errors are identified and corrective actions are implemented before the first production occurs.

• Process FMEA: Design FMEA is a method that aims to produce engineering solutions to meet the quality, reliability, cost and efficiency criteria defined by the customer.

• Service FMEA: It is a method applied through production, quality assurance and marketing coordination in order to improve customer service.

• System FMEA: It is a method used to optimize the flow of systems such as production and quality assurance after the completion of all hardware and design.

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An FMEA technique application enables the realization of the functions summarized below;

• It systematically reviews error types to ensure that even the smallest damage caused by errors in the process or service is prevented,

• It identifies any errors that may affect the process or service or their functionality and the effects of this error,

• It determines which of these identified errors have more critical effects on process or service operations, therefore it defines the greatest damage that can occur and which type of error can produce this damage,

• Before assembly, assembly determines the possibility of errors occurring in the process and where they may originate (design, operation, etc.),

• It enables the establishment of necessary inspection programs by identifying error rates and types that cannot be obtained from other sources,

• Ensures the establishment of necessary inspection programs to test reliability experimentally,

• Identifies the possible effects of changes for a product,

• It defines how high-risk components can be made reliable,

• It defines how the negative effects of assembly errors can be eliminated.

 

Inputs:

FMEA and FMECA are used to analyze systems where each element, equipment, machine or process part fails. To perform this analysis, it requires detailed information about the system elements. While for a Detailed Design FMEA the element in question may be at the detailed independent component level; For high-level System FMEA, elements can be defined at a higher level. Information may include:

• A flow diagram or drawings containing the system being analyzed, its components or process stages,

• Understanding the function of each stage of a system component or process,

• Details of environmental and other parameters that may affect operation,

• Understanding the consequences for specific malfunctions,

• Historical information on failures, including data and failure rate where possible.

 

Period:

The FMEA process is shown below:

• The scope and objectives of the study are defined,

• Team members come together to work,

• The system/process subject to FMECA is tried to be understood,

• Errors that may occur in the components or stages of the system are identified,

• The function of each component and stage is defined,

• Identification is made for each listed component and phase,

• To eliminate the error, natural conditions in the design are identified,

• The following questions are discussed by team members;

o  Is it possible for each department to make mistakes?

o  What mechanisms can produce these modes of failure?

o  If an error occurs, what effects might occur?

o  Is the error harmful or harmless?

o  How to uncover the error?

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For FMECA, the working group proceeds to classify each of the identified failure modes according to their criticality. There are a number of methods to do this. General methods are presented below:

• Mode criticality index,

• risk level,

• Risk priority number.

 

Model criticality is a precaution against the possibility that the mode considered will result in failure of the system as a whole:

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Possibility of error impact * Mode failure rate * System operating time

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This is frequently applied to equipment failures where the aforementioned expressions describe it quantitatively and all failure modes have the same outcome.

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The risk level is obtained by combining the probability of failure and the consequences of a failure mode occurring. It is used when different failure modes are differentiated and applied to equipment systems or processes. The risk level is expressed quantitatively, semi-quantitatively or qualitatively.

Please review the Article and Blog section to get a detailed idea about our risk assessment studies.