A colleague of mine with more than 40 years of experience in the quality sciences at several large corporations in North America once said to me, "You know quality is like water, right? It flows toward the gaps." Of course, if you have worked in the quality arena for an extended period of time, you can immediately understand exactly what this means. If not, it may sound odd. Quality is an organization that is structured to support almost every part of a business: management, administrative functions, product development, operations, customers, suppliers, and other interested parties. In the simplest terms quality is everything we do and how we do it. Quality as an organization is like a liquid that flows toward the weakness, the problems, the communication gaps, and the needs. If you are interested in understanding the truth, the reality on the ground, the unfettered cold hard facts, your quality organization will have them. Your quality organization has no other motivation than improving your processes and products and no other primary interest beyond customer satisfaction.

People can often become confused about what exactly a quality management system (QMS) is and what it represents. One of the most common misconceptions is that a quality management system is entirely about quality. And if it is only about quality, then it is only about traditional product quality tools, such as customer complaint management, corrective actions, internal audits, control charts, inspection, gage R and R, and so on. The reality is that the term quality management system is a misnomer. To take full advantage of the structure and process that is built into a world class QMS, we need to change the name from a quality management system to a business management system.

If you take a gander through your ISO9001 standard, you can understand that the goal of this entire exercise is to define, develop, and improve all of your business processes. The standard covers top management, resources, product development, operations, suppliers, HR processes, and every other aspect of your business. It is, in effect, everything we do and how we do it, or stated more succinctly, everything we do and how we can do it better tomorrow. Unfortunately, this business management system is administered by your quality organization, so it is called a quality management system for that reason. If you limit yourself to those traditional quality tools when you think about quality management, then you limit your ability to improve unilaterally throughout your enterprise. This article is about how to expand and improve your quality management system to have the broadest impact on your enterprise as a whole.

Let’s begin with the more or less traditional quality management system tools and processes, which we can largely categorize as reactive in nature. They are an important baseline which most businesses consider necessary to meet minimum requirements. Customer complaints and corrective actions - we have to listen to our customers, understand the problems, and make improvements. Gage R and R, inspection and test - we have to ensure that the products we make conform to requirements. Internal audits – we have to check to see that the execution of our process matches our intentions. These processes are critically important to the business and represent a solid foundation for improvement. However, they are largely reactive in nature. In each of them, we wait for an outcome, analyze the problem, and come up with an improvement. It is human nature to operate in this way, because we learn through trial and error. We make mistakes, we look at why the mistake happened, and we make an improvement; we learn from mistakes and we get better. The next step in building a state-of-the-art quality management system is developing processes that are geared toward prevention.

If we could prevent everything, then we would have flawless execution of our product development, zero cost overruns, schedules that were on time, and 100% production yields with zero customer complaints. Of course, this is unrealistic; the cost of preventing everything would quickly put us out of business. The goal of prevention within the context of an enterprise is to add more preventive thinking and processes to our QMS that allow for affordable and achievable outcomes. It is not possible to prevent everything, but preventing more tomorrow than we did yesterday will typically have a 10/1 savings multiplier. Prevention is about imagination. When you analyze product lifecycles, from development through production and to end of life, and you integrate that over many years, it becomes clear that the biggest problems which occur are the things that we could never have imagined. It turns out that our imaginations are not big enough. And while the problem that never happened in the first place is the very best way to solve a problem, the outcome itself is insidious. Because nothing terrible happened, we have no data on the cost impact of that outcome. In effect, there is no reward for averting a disaster and so the feedback loop for spending on prevention becomes difficult to quantify and justify. It is only the most sophisticated, and advanced thinking management team that understands the value and supports these activities. When quality professionals are at their best, they are helping the enterprise save millions of dollars, while no one notices. The tools and processes described below are, in essence, an attempt to stimulate our imaginations. They are mechanisms and methods that induce us to think ahead. Similar to a game of chess, the further ahead we can think, the more likely we are to win the game.

Strategic planning is at its heart about prevention. Enterprises often spend a lot of time counting. Counting failures, counting money, and counting people. These are critically important activities, but they don’t prevent anything. At least once a year, it is important for the business to conduct a strategic planning exercise with the leadership team. Depending on the size of the organization, it may be necessary to conduct multiple strategic planning events at various levels. The basic process is to understand what the organization would like to accomplish at the top level, and then gather inputs from the leadership team in the form of advantages, disadvantages, strengths, weaknesses, external/internal threats/risks, external/internal opportunities. A thorough discussion around all of these will normally produce a series of strategic objectives. These objectives can then be communicated and staffed as required. The objectives could be reviewed and modified throughout the year as business conditions change.

Design/Process Failure Mode Effects Analysis is entirely about prevention. This goal is to conduct a detailed review of a design or process and identify any potential risk to low yield, a process that is in too narrow of a window to control, or a risk to customer failure, quantify those risks and then develop a plan to prevent based on the risk and impact. This is a line-by-line exercise and requires deep thinking and careful planning. If it is done properly, it can be a huge benefit to prevent downstream losses.

Statistical process control is about prevention. The goal here is to develop control charts on the inputs to your process. If your process has inputs that can be measured, then it has process that can be controlled. But the key here is to monitor those inputs and investigate potential actions when things appear to be headed out of control. This will prevent downstream losses and the investment in the development of the charts and their regular review will quickly pay for itself in the problems that never happen.

New product introduction process is, among other things, about prevention. If you have one, you can always make it better. As businesses grow and develop more and more products, a solid new product introduction process becomes increasingly important. There are many ways to improve a product introduction process, but one of the best ways is to just have a regularly scheduled meeting every six months and talk about what could be improved. Could we add more lessons learned, could we make sure we check on some additional items, could we add another deliverable that could be done in parallel so we don’t slow down, but we ensure that we meet new customer requirements or improve quality?

Cost of Quality (COQ) can be about prevention. COQ is a process for measuring losses and taking actions to make improvements. The way to add more prevention to your cost of quality process is to add more losses to consider for improvement. Don’t limit yourself to the standard losses related to yield, scrap, and customer returns. Think about unplanned machine downtime, low margin products, cost of carbon, turn over with replacement, obsolete inventory and others. Think about spending on prevention and categorize those as losses. In this way, you can measure your spending on prevention and track it against losses over time with the goal of increasing preventive spending which will, in turn, lower your COQ losses downstream. The more waste streams you consider, the more you can expand your imagination to come up with prevention and improvement strategies.

An employee suggestion process is about prevention. Some of our best ideas come from our employees on the ground and in the trenches. But we need to listen. It takes time to set up an email server or physical box to gather employee inputs, read through them, and consider them for action. It takes time to respond to them and celebrate the employees whose suggestions are implemented. But this time and effort pays itself back with the problems that are prevented.

These are a few important examples around prevention that you could use to expand and improve your quality management system, but they all have one thing in common. None of them is something that I must absolutely do today. The biggest hurdle to putting prevention and continuous improvement in place is that there are typically a multitude of more critical activities that take greater priority on any given day, week or month. The key for quality and operational leadership is to find the right balance. Preparing for and scheduling regular meetings with key stakeholders to put these processes in place is the only way to make them successful. A self-motivated administration to drive the improvement over time with the patience and flexibility to meet the schedules and needs of the enterprise is key to the success of any continuous improvement project. But the benefits of persistence will pay itself back in spades as the massive lever arm of prevention converts losses into gains and time into money.