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Part Risk Analysis - Failure Mode and Effects Analysis FMEA

FMEA is essential to ensure the successful fabrication of molds for injection molding.

Failure Mode and Effects Analysis (FMEA) is a systematic method for evaluating and prioritizing potential failure modes in a process, product, or system, as well as their potential effects on performance or safety. It is commonly used in various industries, including manufacturing, automotive, aerospace, healthcare, and more.

Every business makes decisions based on the amount of risk they’re willing to take. In a perfect world, there would be no risk to consider, but that’s just not the reality.

The working methodology Failure Mode and Effects Analysis FMEA involves designing a mold for the component shown in figure 2 – polystyrene plastic anchor. After completing the design, the mold will be physically built, also a FMEA analysis will be done in parallel in order to verify whether the method can point out any problem that may arise from its use.

From the information-gathering stage through the process of setting up at a new molder, your current molds, processes, and products will be dissected and closely examined. Following these steps in of the mold tooling transfer process can often reveal potential risks in a plastic injection molding project that may have not been previous identified. However, the process can also help identify opportunities to make improvements, cut costs, and even extend the life of your mold(s).

Failure Mode and Effects Analysis FMEA steps
Mold Tooling design

Molds for plastic injection are complex products with many components that require careful design of the components of the sub-assemblies. The injection process of the plastic components is complex, with many variables that require adjustment of the process parameters in accordance with the mold and injected material. The paper proposes using Failure Mode and Effect Analysis in order to identify the situations in which a mold for plastic injection may produce scrap components.

Today’s competitive industrial environment continuously raises the expectations of customers and drives the development of highly complex products that meet end user requirements with minimum costs. The Failure Mode and Effect Analysis (FMEA) method provides a possible approach to tackle this issue because it helps to prevent defects that lead to nonconforming products, thus greater costs. By applying FMEA the defect identification is shifted from the product control phase to the product design phase, as it can be seen in the following figure:

Product manufacturing cycle
Product manufacturing cycle

Moreover,

alongside reducing defects after manufacturing and minimizing costs, FMEA can also be used as a risk assessment tool for facilitating decision making . Considering the above mentioned advantages and others that this method offers, its application ranges from the automotive industry , to the electronics industry , or even to the healthcare industry. The present paper aims to study the impact of applying FMEA to mold design by illustrating a case study for improving the functionality of an industrial mold used for plastic injection.

Failure Mode and Effects Analysis FMEA analysis were taken into account the following components of the mold:

The filling system – given that the design of the mold was made taking into account a series of simulations of the filling process, the analysis will take into account only those unpredictable situations that cannot be simulated.

The cooling system – the correct functionality of the cooling system leads to obtaining components at the desired quality standard, its dimensioning was made analytical, the results were verified using the Moldflow solution. Same as with the filling system only those situations that cannot be verified through calculus or simulation will be taken into account.

Failure Mode and Effects Analysis The closing system – will consider those elements that may prevent the correct closing of the mold.

The throw system – will consider situations that could lead to system blockage and the impossibility of removing the components from the mold.

Failure Mode and Effects Analysis Parameter – in this category will take into account the parameters that influence the cycle time.

Failure Mode and Effects Analysis Design – the designing of the mold was made taking into account all the recommendations and good practices in the field; will analyze possible defects that may occur because of design elements, nests and the filling system.

Here’s how Failure Mode and Effects Analysis FMEA typically works:

Identify Components, Processes, or Systems:

Determine the scope of the FMEA by identifying the components, processes, or systems to be analyzed. This could be a product, a manufacturing process, a service delivery process, or any other system of interest.

Assemble a Cross-Functional Team:

Form a team consisting of individuals with diverse expertise related to the system being analyzed. This might include engineers, designers, quality assurance specialists, technicians, operators, and other relevant stakeholders.

Brainstorm Potential Failure Modes:

Conduct brainstorming sessions to identify all possible failure modes that could occur within the scope of the analysis. A failure mode is a way in which a component, process, or system could fail to meet its intended function.

Identify Causes and Effects:

For each identified failure mode, determine the potential causes that could lead to the failure and the potential effects of the failure on the overall system performance or safety.

Assign Severity, Occurrence, and Detection Ratings:

Rate each failure mode based on its severity (S), occurrence likelihood (O), and detection ability (D). Severity indicates the seriousness of the consequences if the failure occurs, occurrence represents the likelihood of the failure happening, and detection reflects how easily the failure can be detected before it affects the system.

Calculate Risk Priority Number (RPN):

Calculate the Risk Priority Number (RPN) for each failure mode by multiplying the severity, occurrence, and detection ratings together (RPN = S × O × D). The RPN provides a numerical value that helps prioritize which failure modes should be addressed first.

Prioritize and Mitigate Risks:

Prioritize the failure modes based on their RPN values, focusing on those with the highest scores. Develop and implement risk mitigation strategies to reduce the likelihood or severity of these high-priority failure modes. This may involve design changes, process improvements, additional testing, or other corrective actions.

Failure Mode and Effects Analysis Review and Update:

Periodically review and update the FMEA to incorporate new information, changes in the system, or lessons learned from previous analyses. Continuous improvement is essential for maintaining the effectiveness of the risk management process.

By systematically analyzing potential failure modes and their effects, FMEA helps organizations identify and mitigate risks proactively, ultimately improving the reliability, safety, and performance of their products, processes, or systems.