What are FMEA Methods The FMEA Process is carried out in 7 steps, these 7 steps provide a systematic approach in performing Failure Mode and Effects Analysis and assist in recording technical risk analysis records.
1. STEP :
Planning and Preparation The main purpose of planning in PFMEA is to determine which products/processes will or will not be covered. The main objectives of the Planning and Preparation Step are; Project definition - Project plan: In Tent, Timing, Team, Tasks, Tools (5T) - Boundary analysis: What will be included in the analysis and what will not - Creating the basis for the structure analysis step Some details must be considered to complete the preparations. These details will help the team to determine the main lines of Cyber-Physical System, meeting legal obligations, catalog and standard parts within the scope of innovation / improvement degree of technology, quality / reliability history, complexity of design, safety of people and systems, information reliability. existing information should be prepared and discussed with the team first. As a result of all these preliminary evaluations, the New Product Commissioning Plan and Process Flow Diagram should be prepared for use in the PFMEA.
STEP 2:
Structure Analysis The purpose of structure analysis is to decompose the production system into Process Parts, Process Steps and Process Work Elements. The main objectives of structural analysis; - Visualizing the analysis - Seeing the process flow - Identifying the process stages and sub-stages - Relationships between customer and supplier engineering - Forming the basis for function analysis The process flow diagram was prepared in step 1 to be an input to the structure analysis. If the customer does not have special requests for the symbols used in the flow chart, the symbols of the company can be used. The Structure Tree displays system elements hierarchically and with links. It enables the identification of the relationships of process parts, Process Steps and Process Work Elements and provides the basis for function analysis. The Process Work Element is the lowest level of the structure tree. Potential error causes occur here. Companies are not limited to the 4M method, 5M, 6M etc. can be applied.
6M Categories;
- Machine Production equipment,
poka-yoke details can be considered in this heading
- Man (Staff) - Material - EnvironMent (Environment)
- Method (Method)
- Measurement (Measurement and Quality Management)
Process Part : The highest level connection of the analysis objective Process Step : The focused element.
Error chain topic Process Work Element : Lower level of the focused element.(error causes topic)
STEP 3:
Functional Analysis The purpose of functional analysis is visual analysis of what the part or process steps should do. It's about requirements. It is the basis for the error analysis step. Outputs can have more than one function. Before starting the function analysis; Information on product and process functions, product and process requirements, environmental conditions, worker health and safety, environmental impacts, etc. should be collected. This information is necessary when identifying positive functions. The definition of function needs should be clear. - Negatives of parent (output) functions are Error Effects. - The downside of the functions of the process steps are the Failure Modes. - The negativities of the lowest level process elements are the Causes of Failure. It forms the basis for error analysis. Functions are made up of positive words, and errors are the opposite of negative.
STEP 4:
Error Analysis The purpose of error analysis; - To determine the error effect, error modes and error causes for each process function. In other words, the Error Chain is determined. Causes of errors are defined by 6M. - Working with the customer and supplier in terms of the impact of errors. - Error analysis provides the basic incentive for the risk analysis step. A specific Fault Chain is considered from 3 aspects: - Error Effect(HE) - Fault Mode(FM) - Cause of Fault(FC) Error Effect (FE): Error effects that affect safety or violate legal regulations must be clearly defined in FMEA. Error effects in order of severity; -In your company: The effect of the error assuming that the error was caught in your company -In the customer: The effect of assuming that the error was not caught before going to the customer- End User: The effect of the process part Error Mode (FM): Process error mode; It is the situation where the process may cause the product not to be delivered or not to provide the desired function. Failure modes should be determined in technical terms, not customer attention to detail. Errors due to design should also be taken into account. Cause of Fault (FC): Typical causes of failure can be addressed within the 6M Man: First adjuster, operator, assistant etc. Machine: machines, fixtures, fittings, etc. Material: washing, lubricating, grease etc. Environment: environmental conditions Once the fault analysis documentation structure analysis, function analysis, and fault analysis is complete, the structure tree or forms can have multiple views. Before starting the risk analysis, the outputs of the error analysis can be discussed with the relevant customer and/or supplier on the effects of the error. After the failure modes are completed, step 5, risk analysis can be done. Because severity, probability and detectability degrees are related to failure mode. The risk analysis may not be complete if the potential failure modes are too vague or incomplete
STEP 5:
Risk Analysis The purpose of the Process Risk analysis is to estimate the risks by evaluating Severity, Probability and Detectability in order to determine the priority order of the actions. The main objectives of Process Risk Analysis are; Identification of existing or planned checks and error rates. Preventive actions according to fault causes. Identification of controls to detect error causes or failure modes. Determination of Probability, Detectability and Severity values for each error chain. Priority assessment in activities. Working together and communicating with the customer and/or supplier about violence. Prepare the basis for the optimization step.
STEP 6:
OPTIMIZATION The purpose of the process optimization step is to determine the actions that will reduce the risks and to evaluate the effectiveness of these actions. Ultimately, it is to minimize the risk of producing and delivering faulty products that will not meet customer demands and expectations. Optimization is most effective in the following order; Process modification to reduce or avoid the error effect (FE). Process modification to reduce Probability (O) and Cause of Failure (FC). Increasing the ability (D) to detect the Cause of Fault (FC) or the Fault Mode (FM). In case of process modification, all affected process steps should be re-evaluated. In case of different production concept change, all affected FMEA steps should be re-evaluated. FMEAs can be used as a basis for the continuous improvement process.
STEP 7:
RESULT DOCUMENTATION The purpose of the results documentation is to communicate the summary and results of FMEA Activities. FMEA Report content may be as follows; FMEA Report; Comparison of the latest situation with the targets specified in the FMEA Project plan; Purpose of FMEAFMEA target dateList of participants FMEA coverageWhich methods we used Scope analysis summary, what's new Summary of how functions are created At a minimum, high-risk errors, S/O/D rating tables and action priorities table identified by the team Actions taken or planned for high-risk errors and their status Plan and commitments of ongoing FMEA improvement activities
