CHAPTER 2

Quality Models and Methods

Overview of Common Quality Models

There have been many popular quality models and methodologies over the last several decades.1 I have had to opportunity to work with each of these models, to varying degrees. So, below is a brief synopsis of some that are most familiar based on my experience with them.

ISO 9000

ISO 9000 is a series of international standards to help companies effectively document their quality management system (QMS). They are not specific to any one industry and the ISO 9000 certification verifies your company complies to the standard. There are many other standards, such as for medical devices and food. But the ISO 9000 set of standards are most broadly used. The common phrase given to keep the ISO implementation as reasonably simple as possible is: “Say what you do and do what you say.” There are some companies and countries that will not accept a product if your business is not ISO certified.

Key Point. ISO certification conveys to customers that you have met a tangible standard that provides them confidence in your ability to produce a quality product or service.

Quality Management System

A quality management system (QMS) defines the elements required within your business model for ISO compliance. These elements normally include customer focus, leadership, engagement of people, supplier quality, continuous improvement, document management, process management, and corrective and preventative action.

Key Point. A QMS provides a repeatable structure that helps you consistently meet your quality needs, as long as you maintain it. I have seen where a QMS was put in place to achieve ISO certification. Once certified, the QMS was never updated (at least until the next audit). If you are going to take the time to establish a QMS, make it useful and update it as your business changes.

Statistical Process Control

One of the best practices in quality is to identify defects as early as possible. Control of key processes so that issues can be detected early as possible and can be done through statistics. Statistical process control (SPC) is a set of methods first created by Walter A. Shewhart at Bell Laboratories in the early 1920s. W. Edwards Deming standardized SPC for the American industry during World War II and introduced it to Japan after the war. SPC quantitatively measures the outputs of a process, looking for small but statistically significant changes, so that corrections can be made quickly. SPC was first used within manufacturing, where it could help reduce waste from rework and scrap. However, SPC can be used for any process that has a measurable output. SPC is used to monitor processes through control charts to show whether a process is in control or not. Control limits are used to provide quick identification of points outside the expected variance of the process.

Key Point. SPC is an invaluable tool to measure and monitor your processes. When used properly, SPC gives you an “early alert” system to head off major problems.

Total Quality Management

Some background on total quality management (TQM) was provided earlier. With TQM, everyone in the company or organization is responsible for quality assurance and problem prevention. TQM uses business strategy, data analysis, and communication across different business functions to improve quality across the company and the processes of the organization. Many of the TQM concepts are exceptionally good, starting with the idea that quality is a companywide effort. However, the larger the company, the larger the effort is to get everyone trained, coordinated, and committed. It requires strong leadership to keep the momentum going.

Key Point. TQM is a companywide approach to quality. I still believe there are some powerful concepts within TQM. In particular, there is great value in everyone working together toward a common goal.

Lean

Lean began from a manufacturing process that was developed by Toyota in 1988, known as the Toyota production system (TPS). It is based upon two key principles: the removal of irregularity and the removal of irrelevance. Specifically, this means trying to get uniformity within production and removing wasteful steps or processes. The main idea behind a Lean process is to get the most efficient process within a production environment. Lean strives to create the most consistently good product in the most efficient way. However, Lean is not limited to a production environment. Lean principles are now being used across a variety of industries, such as health care, hospitality, and government agencies.

Key Point. Lean principles focus on removing waste and improving productivity. Lean provides a continuous emphasis on seeking out and eliminating waste. This helps you to reduce costs and improve value.

Six Sigma

Six Sigma is a methodology focused on creating breakthrough improvements by managing variation and reducing defects in processes across the enterprise. If we can measure the process variations that cause defects, that is, unacceptable deviation from the mean or target, we can work toward systematically managing the variation to eliminate defects. Introduced at Motorola in the mid-1980s, Six Sigma was initially targeted to quantify the defects occurring during manufacturing processes, and to reduce those defects to a very small level. Motorola claimed to have saved several million dollars. GE also experienced popular success. Six Sigma contributed over $300 million to GE’s 1997 operating income. The Six Sigma belt system uses a ranking structure similar to the belt structure used in martial arts disciplines to identify levels of expertise in the Six Sigma methods.

Key Point. Six Sigma provides quantitative tools and a structured approach to drive improvement on a specific project. Six Sigma is more tactical compared to TQM, which is more strategic.

While all the above methodologies have been successful, why has there not been one dominate methodology? Why do some efforts fizzle out? What is missing or why have they not been sustainable?

I believe the missing ingredient is culture. Without a strong and healthy culture, none of these methodologies will work for the long term. How can you focus on improvement for the long term when there is fear, doubt, or confusion in the organization? You need a solid foundation to implement change. We will be taking a much deeper dive into culture and how it relates to quality in the following chapter.

1 Alansohn, et al. (2012).

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