Have you ever gone out to buy something new and said, “I want the highest quality product available”? To create these “quality” items, companies rely on different approaches that are referred to as quality engineering, quality assurance, quality processes, quality auditing, and many more approaches to produce a quality product.

ISO9000 (International Organization for Standardization) and its various derivations have served to establish a method to evaluate or ability to comply to recognized quality systems approaches. Many companies choose to be compliant to these standards rather than certified to them because of the cost and necessary delays caused by scheduling the outside inspections and the registration requirements.

ISO is not a panacea but rather a process to establish and control product/process/system quality. It helps to establish a framework to help you replicate the best qualities of your product and to develop metrics that will help you to measure and improve your product. In today’s competitive world this is not only nice to have but nearly a requirement to stay in business and earn a profit.

The use of quality tools like: PPAP (Production Part Approval Process), FMEA (failure modes and effects analysis), 5Whys; Ishakawa fishbone analysis; Zero Defect; 6 sigma (six sigma) and many others has sometimes caused more confusion then it has enabled the user to contribute to improving their product(s) or systems. For example, the concept of 6 sigma has earned negative points because of the implied cost structure of it but the concept of zero Defects, while having many of the same aspects as 6 sigma is different, but at times conceptually thought of as the same as 6 sigma.

Because these quality tools have perceived costs associated with them, many companies do not use or many times give lip service to them. It is important that they reconsider the application of these tools not just to please customers but have a positive impact on their bottom line. Corrective actions based on these tools can and do eliminate waste, reduce the loss of expensive materials (after all most of the product cost today is material based), build and keep customer loyalty because of the excellent quality and performance of their products; help to transfer the process to other facilities with the minimum of issues and finally help the manufacturer to capture and keep their customers while earning market credibility and improved bottom line results.

Duran, Crosby, Deming, Ishakawa and many others have demonstrated that the cost of quality is more than just scrap. It is the cost of losing a customer that you have worked hard to get; the cost of having to repair a product that should have been made correctly the first time; poor reliability that could contribute to suits or other claims; loss of market standing and credibility; a focus to price rather than value.

Under good accounting practice the ability to demonstrate high quality, excellent MTBF (mean time between failure), excellent control of your logistics and supply chain, robust systems and process control, true implementation of FMEA (failure modes and effects analysis) and related quality metrics can help reduce balance sheet accruals for loss and reduce insurance premiums to say nothing of better customers and reduced costs. In the end, as many of the gurus of quality have demonstrated, the cost of quality is really zero. I once heard it said, at a company with $15B in sales, that the cost of the lack of quality was more than $1B. Imagine if that was zero, a $1B dollar contribution to the bottom line and fully satisfied customers.

Reliability Centered Maintenance (RCM) uses a number of the above techniques to address potential system weaknesses that develop after the system is installed. For example, an oil products pipeline from a deep-sea drilling platform has been designed to withstand significant exposure to the environment and hurricanes/typhoons. Unless you understand the application of quality techniques you may over or under maintain the pipeline. These are costly operations to say nothing of the cost of interruptions and down time. By not only planning ahead before it is even designed or purchased, but combining this with a solid understanding of the process to anticipate how to keep it at its optimal operational objectives, oil producing and distribution companies can and do save hundreds of millions of dollars over the course of 20 years plus. I have seen where the proper application of this process can save more than $100 million per year, maintain constant supply and optimize the delivery process to keep customers and income.

We sometimes take exception to the requirements promulgated by the FDA under its GMP (Good Manufacturing Practices) program. I have heard many complain about the process because they think it is to bureaucratic. This type of bureaucracy is needed to protect lives. This is a great case for zero defects. A 99% success ratio sounds great but how would you like to be the 1% failure case when dealing with your heart? This same concept can be addressed to many items like airplanes, cars, elevators and many other applications that we take for granted. This is because they have every high levels of quality, application of quality tools and we continuously work to make them even better than before.

In summary, no matter what you call it: Quality engineering; quality assurance; zero defects; 6 sigma; FMEA, PPAP, ISO9000; FDA GMP; quality metrics; quality processes; MTBF; 5Whys; RCM and many other quality tools and processes they can more than return any investments you make in them and at the same time define you as a value added supplier to your customers.

This article was written by Herb Dwyer, Lead Consultant for Kevin Kennedy Associates. Herb has more than 40 years of experience spanning the engineering, manufacturing and business fields. Herb can be reached at 317-536-7013 or via email at This e-mail address is being protected from spambots. You need JavaScript enabled to view it .