Overview

There is one over-riding, eternal question we always ask ourselves when implementing continuous improvement programs: How do we solve the problem? Unfortunately, this question is asked after we have already experienced the problem, and we are left hanging, wondering what to do about it.

Why not solve future problems before they show up at our customer’s doorstep or before we have put costly resources into the process? Potential Failure Mode and Effects Analysis (FMEA) is an important tool for evaluation and process analysis to find and identify any potential irregularities and weaknesses in production and manufacturing processes. The advantage of using FMEA is that it addresses these potential failures before they ever make it into the actual process. FMEA uses past experiences with similar products or processes to design failures out of the system.

This chapter will help you to:

• Recognize the importance of implementing the FMEA process in your process and product design phase
• Learn the basic methodology for creating a FMEA project
• Identify potential problems before they occur or reach the customer

Prevention or Cure?

In the early 1980’s, when Japanese automobile manufacturing hit the United States in the side of the head with its superior quality and efficiency, there was a recession. Japan had perfected their manufacturing processes while American companies dwelled in past
successes that no longer applied to the current economic conditions.

Now the tables are turned and Toyota, the leading auto manufacturer in the world, has fallen. As of last February, over 10 million Toyota cars were affected by formal recalls.1 The cost of curing the problem to date is unknown. Toyota’s conservative estimates predict a loss of US$2 billion: about 56% for repairs and 44% in lost sales.2 Independent analysts with JP Morgan and Deutsche Securities estimate the true range to be US$3.2-5.5 billion, including repairs, litigation and lost sales.3 The damage to Toyota’s reputation is not entirely quantifiable or even known at this point. Only time will tell the total impact of this enormous quality failure.

Prevention is the key success. You may think it is redundant, takes too many hours, too many personnel, it is not in the contract, and it costs a lot of money. As we have seen with the Toyota fiasco, it costs a lot more to cure a problem than it does to prevent one. What if Toyota would have prevented their failures? Where would they be today? Most likely no recalls, no high warranty costs, no tarnished image, greater operating capital and higher stock prices. As Ben Franklin once said, “An ounce of prevention is worth a pound of cure.” Toyota has demonstrated this old adage poignantly.

So What is FMEA?

Continuous improvement systems have plenty of tools for you to put in your toolbox: DMAIC, value stream mapping, VOC, waste walks, cause and effects analysis, red-yellow-green charts and many others. While there are plenty of problem solving tools for you to work with, the challenge is figuring out which one are you going to use. Why not consider a prevention tool instead of a problem-solving tool? FMEA is
just that sort of tool. Used upfront during the design process, FMEA works to prevent all possible failures from ever occurring. Put simply,
FMEA is a tool used to eliminate failure modes (waste, errors, etc.) in product design (DFMEA) and process design (PFMEA) in the future.

FMEA is often misunderstood, and there are many interpretations about FMEAs and how they are applied. There are times when D/PFMEAs contain many errors or conflicting information or the failure mode was never thought of or incorporated into the original documents. Potential failure modes are added after the fact or after the failure occurred. Then the FMEA team scrambles to update the latest documents. On many occasions, the Quality/Engineering Manager or Quality Engineer is the entire FMEA Team and completes the required documentation just prior
to the PPAP (Production Part Approval Process) submission deadlines. People need to understand that all FMEA teams should be crossfunctional,
multi-disciplinary teams.

An important characteristic of FMEA is that it is a process of determining failure modes based on past experience. If we know a certain component in last year’s computer model had a 1 in 1,000 failure rate, we know that it will continue to experience the same failure rateunless we change something. While FMEA is something of an advanced brainstorming process, it is an educated one. The more we know about the components in our process or product, the better we are able to determine our failure rates.

As with most tools, FMEA is a process. It begins first and foremost by selecting a team. The team then a) detects the possible failure modes, b) assesses the severity, c) assesses the occurrence/probability of the failures, d) determines the detectability of the failure, e) assigns an overall risk priority number (RPN), and then f) takes action to eliminate or minimize the failure potential.

Figure 21-1: FMEA Cycle

FMEA Process Basics

Assembling the Team

FMEA is used mainly in process and product design; its focus is on manufacturing.4 The process also relies heavily on engineers to help determine potential process and product failures. Consequently, your FMEA team necessarily will have a heavy concentration of technical people. You should gather your team from a representative cross-section of the company:

• Manufacturing
• Engineering
• Quality

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