FMEA on Product Development

Question: Discuss about the FMEA on Product Development. Answer: Introduction FMEA is a method or strategy used in product development to manage risks associated with the process. Generally, it will include four major steps which are: identifying and evaluating potential failures, techniques to reduce these potential failures, ranking the potential failures and finally, documenting the entire process [1]. From this general description, its clear to see the critical aspect of FMEA which is to anticipate a problem before it happens. In actual sense, anticipating problems is impossible but the development procedures used should have an extensive list of all the potential problems/failures associated with it. This list provides development teams with exact procedures to mitigate failure if they happen to occur. Furthermore, it reduces panic and instead facilitates a smooth follow of events. A consistent application of FMEA allows engineers to eliminate failures and instead produce safe and reliable products that meet the customers specifications. This outcome is achieved using the historical records kept by the consistent documentation of events. In a nutshell, engineers learn from past mistakes to produce better products [2]. Therefore, its through practice that FMEA is able to anticipate failures in product development and even in the product itself. Through such methods, a design team is able to deliberately reduce failures by eliminating past components that led to failures or had negative effects [3]. Implementing FMEA has many benefits, but none is as important as the outcome proposed by the Factor of 10 rule where good and early design improvements are known to reduce the expenditure costs used in product modification at later stages of product design. This benefit is especially important today where market competition is severe due to globalisation and market integration. Today, market winners are determined by the quality of products and more so, the business advantages they have in product development. Innovation and sustainable production are at the forefront of these business advantages that set aside successful companies and organisations [4]. Over the past few years, quality of products and services has been the focus of production where wastage is reduced while engaging high-speed production processes. These processes are facilitated by technological innovations implemented using FMEA outlines. This technological-FMEA integration helps reduce production cost by minimising the modifications costs and increases the number of products developed. Furthermore, innovation helps companies distinguish themselves from their rivals by having quality products with consistent standards. Again, this outcome increases the customer base and the overall profit margins [4]. Previously, FMEA was used as a support design tool where it facilitates the design process of product development. However, today FMEA is literally used as a design tool in itself. Its capabilities and most notably the ability to disclose failures qualify it for this role. Moreover, its able to quantify the elements of failure by varying the effects of the different chunks of product development. This procedure determines the overall list of preventable failures based on component prioritisation which reduces the overall failures [5]. Background FMEA was originally used by industrial pioneers particularly those in the automation and military industry. However, in the 1960s the aerospace industry started to emphasise on its capabilities and practicality in the industry which over the years transitioned to the modern application in product design and development. As its seen today, FMEA was used to prioritise quantitative and qualitative measures to meet the need of quality products and services. Consequently, owing to its success in the aerospace industry it was deployed in other diverse industries. However, different FMEA standards have been implemented in the various industries that have adopted it, for instance, the United States military has the MIL-P-1629 standards, while the International Organization for Standardization has the ISO/TS 16949 standard [6]. In academic research, a common direction is exhibited by all researchers who try to enhance the related features of FMEA particularly in risk management and failure analysis procedures. Consider the work done by Stone et al [7], where he proposed a design approach that would support FMEA in conceptual design procedures. In his approach, he utilises functions to define failures and assess risks in product design. Other researchers, such as Chao and Ishii advocated for error-proofing methods to mitigate failures. Moreover, these researchers classified their FMEA approach into six elements i.e.: knowledge, analysing, communication, execute, alterations and the organisation. Nevertheless, regardless of the approach or standard adopted a common component associated with FMEA is the evaluation index, which technically is known as the risk priority number (PRN). PRN is always established when executing a development process and will have three rating elements, the severity, occurrence and detection. These elements are then rated using a scale of ten and having different guidelines as shown below. No. Aspect 1 Rating value 10 1. Severity Insignificant Catastrophic 2. Occurrence Extremely unlikely Inevitable 3. Detection Absolutely certain to detect No control exists Rating Scale Guideline In research, establishing the accuracy of the RPN outline is important as it defines the accuracy of the FMEA process. Furthermore, the product of the three elements establishes the RPN which is used to predict failure of potential problems with the development process. However, this outlook creates several challenges, for one, if a high number is obtained (the product of severity, occurrence and detection) then a high risk is imminent but of what component? A high RPN number does not indicate the actual risk, it does not highlight the exact aspect in question, either severity, occurrence or detection risk. Integration Framework From the previous section, RPN can be defined as a measurement tool used to assess and evaluate risk in the product development procedures. Generally, its values will range from 1 to 1000, where 1 is the absolute best (zero/minimal failures) and 1000 is the absolute worst scenario [8]. In terms of calculations the following procedure is used: Severity (S) Severity X Occurrence (S X-O) This is known as criticality Severity X Occurrence X Detection (S x O x D) This is the RPN Severity is critical and should always be treated as an independent variable regardless of the outcome. However, as highlighted before there still exists some significant gaps between the design platforms (product development) and the FMEA domains. These gaps as stated in the introductory part can only be met by developing an integrated framework that combines FMEA elements with design procedures. But before we do so lets first highlight the basic elements of product design and development. Basic elements of Product design/development Standardisation of design procedures is still a big problem among researchers and practitioners. In fact, no universal standards exist in design procedures which make it difficult to relate the work done by practitioners with that done by academic researchers [9]. However, regardless of this minor setbacks, the overall design/development process of any product can be classified in have the following format and having three elements: functions, requirements and components. Functions as a concept are derived from the how and what factor in product design. In true sense, its a philosophical term that engineers use to describe the basic purposes or use of a certain product [10]. Therefore, using the how and what distinction, a function is a process used to achieve a certain solution i.e. how. While the what identifies the solution itself. From this distinction, its clear to see that a common solution can be achieved using different functions and vice versa. Requirements, on the other hand, are the needs that gauge the usability of a certain product. Furthermore, these needs are mainly focused on the customers specifications which explain why most needs are associated with the customers. Moreover, it is the customer who pays for the product for his own use. Finally, the components are the subsequent solutions that meet the needs of certain functions [11]. Now, having defined the basic elements of product design, this paper now focuses on organising these factors to fit into the product development procedure. Note, in the past these elements are lately considered or even never considered in the development process. Similar to the RPN elements, these design elements must be itemised to fit the design procedure of a product. Therefore, the letters F, R and C are used to describe the design elements (F-Functions, R- Requirements and C-Components). Basic elements of FMEA procedure Several FMEA standards exist in the market as highlighted in the previous section of this report, however, at its core FMEA utilises some basic elements to characterise its operation procedures. These elements are modes of failure, effects and causes of these failures [12]. When a product fails to meet its original mandate or requirements, the mode(s) of failure are exhibited. Modes of failure are therefore the outcomes that cause a product to fails its originally set mandate. To satisfy the integration framework, the modes of failure must be defined according to the known design procedures, particularly the design elements identified above. This outlook enables a development team to prepare an accurate FMEA document having all the design procedures. On the other hand, cause and effects of failures are the reason behind the failure and the results of these failures respectively. For instance, consider a digital camera that is damaged after it falls on a concrete floor. As a failure m ode, the digital camera cannot execute its objective of taking pictures. The digital camera is damaged after the fall and therefore this is the cause of the failure. Finally, as an effect, the user or owner cannot take pictures. A good FMEA procedure concentrates on the direct outcomes of product failures i.e. the direct effects and causes of the failure. This practice establishes a guideline to resolve the actual problem. Now, applying the FMEA procedure, this report highlights these elements as components of the design/development process. This outlook is achieved by itemization of the said elements, in this case, CA, MF and EF are used to define the causes, failure modes and effects of product development [12]. Integration Procedure Most FMEA procedures will incorporate a method for risk control, this can either be the RPN method or the critical analysis method. As of now, the basic elements of the RPN method has been discussed, however, the discussion failed to highlight the actual design elements considered. To use the RPN method, a development team will analyse the following: 1.The severity of the effects of failure EF is the component considered when dealing with the severity element of the RPN procedure. 2.The occurrence of the cause of failure CA is the actual component where a team rates the likelihood of a certain cause of failure. 3. Finally, the detection component will have the cause of failure as well The development team will rate the possibility of identifying a certain cause of failure before it happens. This method seems too general to guarantee accurate results, for one, the design/development elements are not considered (Requirements, functions and components). Therefore, the entire assessment is based FMEA elements and past experiences. As a result of this assumption, it fails to highlight the product being developed despite the fact that it might be unique to each instance [13]. As a solution, this research/report processes the following integrated procedure as shown in the diagram below: Fig: Proposed Integration Model By integrating the various elements of FMEA and design/development process we are able to develop a holistic risk management procedure. In the model, the circular and oval shapes represent the FMEA elements. These elements are dependent on each other and thus have their corresponding relationship exhibited. However, their outcome is also dependent on the product in question i.e. the product being developed, which is the foundation of the assessment process thus the position and the box outline. Flow control is indicated by the arrows where the one-headed arrow indicates a continuous flow of events (to the next process). However, a double-headed arrow represents double dependency where each variable or element depends on the other. In this case, double headed arrow are shown between the design elements and MF, outlining the dependency between these production elements. Design and Development FMEA Design FMEA is the most common FMEA used in engineering and in product development. As the name suggest its used to analyse design procedures to identify risks and failures. Moreover, it utilises product functions and components as the risk assessment factors. For this method to work, researchers propose early inception so that the procedure can identify failure modes and mitigate them before they escalate to the product itself. However, having identified the benefits of FMEA i.e. risk reduction and improved quality of cost, it's normal for consumers to propose multiple FMEA procedures. However, the process is extensive, tedious and time-consuming which limits most development process to one assessment procedure. Therefore, there are no other risk assessment procedures used to assess the FMEA process, this outlines the importance of accuracy and consistency in the risk management process [14]. An integrated procedure helps to improve the accuracy and consistency of the FMEA procedure. For one, the proposed model can be applied at different stages of product development thus maintaining a high accuracy rate. Moreover, it can be used to counter check the results of the previous FMEA process. Therefore, a product development team can identify the risk assessments elements after obtaining the product requirements. After developing the product specifications, the team can then translate them to the functions and simultaneously transfer the FMEA elements from the requirements. Now, this transition can contain both the product requirements and the assessments made which are validated by the FMEA process conducted at the Function stage. Similarly, the process can be repeated again when executing the component level of product development procedure. In the end, the risk assessment procedure is executed multiple time (minimal 3 times) which can be used to cross check the final resul ts [12]. The FMEA procedure is a continuous process that starts at the customers specification and ends at the delivery of the product. Over this period, the risk assessment procedure must remain consistent especially when rating the risk numbers i.e. RPN which now has a better and accurate result because of the integrated system. Moreover, the important requirements must remain consistent throughout the process to satisfy the customer [15]. In addition to this, the critical elements that hold potential failures must be identified and highlighted throughout the production process. Functions, on the other hand, align with the requirements and are developed while observing the critical failures. Finally, the development procedure must prioritise the components it uses based on the risk analysis [16]. In the end, components with the least risk are selected as they hold the key to the function of the overall product (Sub-functions). As an added bonus, the integration model facilitates documentation of FMEA procedures more so, when you consider the logical flow of events and the overall selection of production elements. These accurate records are then modified to suit other subsequent products produced by an organisation or company [15]. Conclusion FMEA procedures have for many years been used to assess the risk associated with product development. However, different methods are used with varying results which conflict with the work done by researchers and practitioners. In practices, FMEA methods are supposed to help engineers and product developers in designing and eliminating failures in products/services. This research report highlights an integrated model that combines both design and FMEA elements to produce the best assessment results. However, the success of the procedure highlighted in this report depends on the work done by previous researchers and most importantly the documentation done by other development processes. Nevertheless, this outlook will allow product developers to borrow from past experiences and limit the critical factors that lead to product failures. As an objective, the research aimed to develop a holistic FMEA process that could integrate the various component of product development, from the cost of production (economy) to the technical requirements. This objective is easily met by the integrated model suggested in this report. 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