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Imagine you’re a pharmaceutical company developing a very crucial drug on an emergency basis for something new like the COVID-19 pandemic. You do not have enough time to research, you do not have enough data about the disease, very less time for trials and you have to scale the production for billions of tablets every month for global consumption. How do you go about making sure that you are able to meet your targets without onsetting a global catastrophe? The answer lies in the strength of your processes. There is no way you can get additional data or time so you have to adapt your processes to match your needs. However, there is possibly one way you can minimize failures or damages. It is with the active use of Failure Modes and Effects Analysis (FMEA).
Failure Modes and Effects Analysis, FMEA, is an analytical technique for identifying at what stage or endpoint are processes or designs possibly going to fail and why. It is not only used in retrospective reviews but also to develop a process and efficient process control. Suddenly, the likelihood of the pharmaceutical company creating a disaster seems lower, right?
Furthermore, FMEA is a structured approach that determines each failure mode with analysis. It then goes on to estimate the effects of the determined failures and helps in planning ways of controlling the process in such a way that failure can be deterred. FMEA can also be further categorized based on its application domain.
The most widely used FMEA in lean six sigma is the Process FMEA. It is the least complex to implement and is extensively used to evaluate manufacturing and assembly-line processes. Furthermore, another category of FMEA is the application in system analysis. System FMEA process analyzes complete organizational systems and subsystems and is implemented during the design concept stage. Additionally, the Design FMEA analyses product designs before their clearance for manufacturing.
FMEA helps leaders understand where, when, how, and why things may go south in a process. These failures can come from a variety of issues such as:
As demonstrably evident, the procedure of FMEA can be an increasingly effective way to evaluate processes, systems, or designs. It can also be greatly advantageous in implementing the lean six sigma continuous improvement process. FMEA, done right, can be a critical and structured way to determine areas of potential problems while enforcing cost reduction.
FMEA can also be valuable in the interoperability of processes where one process for a system is transformed and applied to another system. In lean six sigma, FMEA also highlights operations where performance might be waning like sales or customer satisfaction ratings or high expense to income ratios. However, one of the most crucial benefits is the early identification of single failure points and system interface problems that can hinder success and impact the overall safety of the stakeholders.
Teams with a working functional knowledge of the process benefit greatly from FMEA. (Source) When functional knowledge is strictly demarcated by well-defined project scope, the results of the FMEA exercise are even more significant. In order to apply FMEA well, you must undertake a series of steps as detailed below:
Discovery: Compile a list of possible failures that could occur along each step of the process.
Impact: Measure the impact of every failure by asking “What happens when this failure occurs?”
Severity: Determine the severity of the failure by rating it on a ten-point scale. A score of 1 is a defect that the customer is highly unlikely to notice whereas a score of 10 is a catastrophe.
Occurrence: Use another 10-point scale to measure the likelihood of these failures. Here a score of 1 indicates the least likelihood and a score of 10 signifies a guaranteed failure.
Detection: Approximate the probability of discovering the error before the customer or a public catastrophe. On a 10-point scale, 1 is an easily detectable failure, and undetectable failures are assigned a 10.
Risk Potential: Combined with Severity & Occurrence, Detection makes up for a risk priority number (RPN) through multiplication and is assigned to a specific failure. When the multiplication is complete, every potential cause of failure will have a risk priority number between 1 and 1,000. The largest numbers represent the potential errors that make the process most vulnerable.
Using the FMEA procedure to assess every phase of the process helps teams identify the most likely sources of failure. Most skilled lean six sigma professionals know that of the three elements that make up the risk potential number, addressing occurrence will have the biggest impact on the customer and must be focused upon diligently.
Despite all its benefits, the FMEA can have a few limitations. For example, it’s only as good as the team conducting it. Issues beyond team members’ knowledge aren’t likely to be detected or resolved – constituting unknown unknowns. Therefore, it is best to take a two-fold approach while implementing FMEA in lean six sigma.
Firstly, onboard a consulting company, such as Arrowhead Consulting, to implement a solid FMEA procedure for your organization and its systems. Secondly, ensure you organize FMEA training specific to your region of operations such as FMEA training in India for your Indian teams. By training your teams in FMEA and having experts craft your implementation, you are likely to avoid a lot of failures in advance and save costs greatly. To sum up, with our pharmaceutical example, you will finally be able to deliver your amazing life-saving drug and avoid a cataclysm with FMEA.
ARROWHEAD is a consulting services firm with emphasis on reducing all LEAN wastes and improving consistency through Six-Sigma concepts.
By reducing Lean waste, you can remove all non-value added activities thereby improving speed of reaching your customer at better margin and by improving consistency you are able to meet customer demand in terms of quality expected.
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