Introducing a new product or a new process is always exciting. It could potentially solve problems, capture new markets, increase revenue and much more. But, there’s also a risk. From automotives to healthcare, there are countless stories of manufacturing recalling products. Often, this is because of manufacturing or safety issues. So, how do you lower this risk – with a Failure Mode and Effect Analysis (FMEA). FMEA helps you assess what could go wrong, how serious the impact would be and ideally, how to fix it. Let’s learn more.
What is FMEA (Failure Mode and Effect Analysis)?
The concept of FMEA dates back to the mid-1900s. It was developed by the US Military as a way to deal with malfunctioning ammunition. Today, it is a popular practice with brands manufacturing everything from toys to cars and rockets.
Definition of FMEA
FMEA is a systematic, proactive measure to identify the potential failures in any new design or process. Broadly speaking, FMEA has 2 parts.
- Failure Mode
This focuses on identifying potential problems, failures or errors.
- Effects Analysis
This focuses on understanding the consequences of the potential failure and finding ways to lower their impact.
Discovering potential problems with FMEA before they occur can help businesses in many ways.
- It reduces costs associated with manufacturing defects, warranty issues and non-value add operations.
- It improves product quality.
- It makes processes more reliable.
- It can reduce unplanned downtime and production delays.
- By improving product quality, it increases customer satisfaction rates.
What are the different types of FMEA?
FMEA can be categorized into various types depending on the industry. The 2 most common categories are:
Design FMEA (DFMEA)
This explores potential failures related to the product design. It covers issues that could be triggered by the type of material used, tolerances, interfaces with other systems and so on.
Process FMEA (PFMEA)
This looks into potential failures that could arise from existing or new processes. Some of the factors considered include the machines in use, human factors, measurement systems and workflows.
What are the principles of FMEA?
There are 4 key principles that drive FMEA processes.
Failure Modes
This refers to identifying how something may fail. It answers the question, ‘What can go wrong?’ The simplest way to understand the principles of FMEA is with an example.
Let’s take the case of a pharmaceutical manufacturer assessing tablet packaging.
Potential failure modes here could be:
- Very high sealing temperatures
- Product exposed to high temperatures for longer than required
- Product exposed to sealing temperature for not enough time
Failure Causes
The next principle looks at what triggers the failure mode. Rather than look at the symptoms, it dives into a root cause analysis to understand why the issue might arise.
In the above example, incorrect setting could cause high temperatures. This could also affect the time spent in a sealing machine.
Failure Effects
Next, FMEA assesses what might happen as a result of the failure mode. High sealing temperatures and spending too much time in the sealing machine could burn the blister pack. On the other hand, if the pack moves out of the sealing machine too quickly, it may not seal properly.
Failure Criticality
When faced with multiple potential points of failure, manufacturers must be able to prioritize solutions. For this, every issue is given a Risk Priority Number (RPN). This depends on the severity of the issue, the occurrence rate and the likelihood of detection.
Let’s compare the criticality of a burned blister back versus an improperly sealed pack. Both are serious problems but the severity of a burned blister pack is higher than an improperly sealed one. The latter may also be less likely to occur. Hence, the failure criticality or RPN of a burned blister pack may be higher and must be given priority.
How to perform an FMEA analysis?
The steps for FMEA analysis depend on its scope. The first 5 steps aim at identifying potential failures. A further 2 steps extend the scope to finding and implementing solutions. These 7 steps are:
1: Determine the product/ process to be addressed
In addition to new products and processes, manufacturers can perform FMEA to review existing processes with unsatisfactory performance or products facing bad customer reviews.
2: Build a team
An FMEA team must have input from all departments affected by the product/ process. This could include representatives from the design, purchasing, engineering, maintenance, quality testing and customer service teams as well as subject matter experts.
3: Document the process
Documenting the different steps of a process allows all FMEA team members to understand it and makes it easier to identify potential failure modes. A graphical representation such as a flow chart, table or diagram is often the most effective way to document a process.
4: Check each step to identify problem areas
Dive into each step of the process to brainstorm potential problems that may occur. There may be more than one potential issue noted against each step. In some cases, failures at one step may waterfall into further issues in the consecutive steps too.
5: Prioritize failure modes
Determine the criticality of each failure mode in terms of the frequency with which it may occur, detection rate and the effect it could have on overall production. Giving each issue a score from 1 to 10 makes it easier to compare and arrive at an RPN. The typical formula used is:
RPN = Severity x Occurrence x Likelihood of Detection
6: Designing solutions
Having identified and prioritized failure modes, move on to finding solutions to prevent it from occurring. The solutions should ideally address the root cause of the issue.
7: Measure effectiveness
Rather than change an entire system, begin with small changes and monitor how they impact the overall system. This allows you to take an alternative approach if required or standardize the change if it achieves the desired outcome.
Summing It Up
At its core, FMEA is a risk assessment tool. To be effective, it must use consistent rating scales and must engage the team’s collective experience. While FMEA should be started when a product or process design is in its initial stages, the risks must be re-assessed with every improvement or change in the environment.
Visual data management tools can also be a big help. The right tool can help collate data, define the various steps of a process and visualize potential issues. It also improves communication between FMEA team members and supports collaborative brainstorming.
Fabriq could be the ideal visual management tool to support FMEA initiatives. From collecting data from various sources to transforming it into visual formats and making information easy to share, it can play several roles. Its user-friendly interface empowers FMEA teams to quickly identify potential pain points, use root cause analysis tools to determine the underlying trigger and make data-driven decisions on how to optimize the process. Intrigued? Learn more about Fabriq today.
