NC State of Business

When considering implementing a certified quality management system like ISO 9001, AS9100, or ISO/TS 16949, there is an important set of questions to initially think about. Why is it important for your organization to pursue this? Is your customer requesting it? Have you heard that you can’t bid on certain government contracts unless you are certified to ISO 9001 or AS9100? Why do you care right now?

The drive to implement a program because “our customer wants it” could lead you to a suboptimal outcome. For example, you may create the quality manual and the other required procedures because you “have to” not because you see a genuine need to do so, giving voice to the program, but no real action. If you are considering a quality management system just to be able to check a box, then I would encourage you to do some additional soul searching. If you start out doubting that a quality management system can improve your business, you may never achieve the full power of the system and it will become a burden not a benefit.

Steven Covey says “start with the end in mind”. So what does this mean for a quality management system? It means visualizing the system fully implemented and seeing the expected results of: increased customer satisfaction; improved consistency in your processes; reduced costs due to reductions in scrap and rework; improved employee morale because of improved communications; and increased business opportunities. Once you can visualize and internalize the benefits you can gain from an effectively implemented quality management system, then you can put the necessary plans in place to turn that vision into reality.

Start by building on the processes you already have in place and making adjustments as needed to meet any new requirements from the standard. The practices put in place should become part of your daily activities as opposed to something done only at certain times – like when it is time for an internal or external audit. Once you have defined your processes, then develop and track performance metrics for them so you know if they are effective. Next you need to continually improve your processes to enhance customer satisfaction, increase your competitive edge, and strive for excellence.

“We are what we repeatedly do. Excellence, then, is not an act, but a habit.” Aristotle

Last week I visited a meeting in Williamston hosted by the Northeast Alliance for Agricultural Biotechnology. There was a buzz around this group as they received a check from the NC Tobacco Trust Fund and as we where shown some preliminary design and location analysis models for an area Pilot Extraction Facility. This project will allow the Alliance to attract research and development activities into the eastern NC area leading to important breakthroughs in agricultural biotechnology. From food to medicine to fragrance, we rely on the extraction process to convert the important ingredients from specialty grown plants to chemicals ready for use by production processes.

I was intrigued by the emphasis placed on establishing a formal quality management system in support of the development and operation of this new facility along with the interaction between local biotech growers and agricultural biotech companies to safely grow new genetically modified crops. We have been asked to support their efforts in creating the appropriate quality management system processes to align with the emerging USDA Biotechnology Quality Management System (BQMS) program.

It seems like just yesterday when business owners more often than not spoke of ISO 9000 and its quality management system standard requirements as a relic destined for extinction. As I look at the draft version of the BQMS, I see the familiar structure and basic quality management system requirements of the ISO 9001 standard as it was released in its new process-focused format during 2000. We now see the biotechnology industry join what now appears to be a worldwide consent that the fundamental guidelines of ISO 9000 represent a successful blueprint for consistency, quality, and safety.

So from the brink of perceived extinction, certified quality management systems based on ISO 9001 requirements now appear to have amazingly proliferated so much so that emerging industries are investing in establishing appropriate standards as part of new process commitments. What an evolutionary concept!

Recently I was asked whether formal Quality Management Systems like ISO 9001, and programs like Lean and Six Sigma can work together effectively. Many people think that there are conflicts between the goals of ISO 9001 and the goals of Lean and Six Sigma. In reality, the goals of the three programs are generally the same – to continually improve processes, remove waste and non-value added activities, reduce process variation and enhance customer satisfaction.

We know that a quality management system like ISO 9001 (or AS9100, TS16949, etc.) provides the basic framework for managing a company’s processes as an integrated system with the goal of enhancing customer satisfaction. The standard requires that the processes must be defined and “criteria and methods” must be determined to “ensure that the operation and control of the processes are effective.” The standard also requires that the quality management system be continuously improved and suggests potential sources of improvement will come from the corrective and preventive action (CAPA) programs. This is where Six Sigma and Lean programs can add value and be integrated into the ISO 9001 program.

Six Sigma emphasizes the Define, Measure, Analyze, Improve, and Control (DMAIC) process for continual improvement. The focus of DMAIC is to define potential process problems, measure the processes to determine the critical factors which affect process performance, analyze the data and look for root causes, improve the process by implementing actions to fix the root cause problems and implement controls to “sustain the gains”. It is not much of a stretch to see that a well managed Six Sigma process would provide potential preventive actions for the CAPA program and could be a method to solve some of the recurring Corrective Actions.

Actually, in analyzing the language of the ISO 9001 standard, you will find that it has some terms in commom with the DMAIC process. There is a section in the standard titled “Measurement, analysis and improvement” which is the middle three steps of the DMAIC process. Control is required throughout the standard, specifically addressing monitoring and measurement activities and the use of monitoring and measurement equipment to provide the “controlled conditions” necessary for the effective operation of the processes. A Define focus is implied throughout the standard in determining the processes and their interactions, defining the root causes of problems and potential problems, and in reviewing the data collected for potential process problems.

So how does lean fit in? We know that Lean is focused on eliminating waste and non-value added steps in processes. Exploring the language of the standard again, we can find where the company is required to determine the processes needed for the quality management system and their application, sequence and interaction throughout the organization. Lean tools like Value Stream Mapping could be a robust way to address this requirement. We can look at the control of non-conforming materials requirements to see the importance of eliminating the waste of rejected parts. The Corrective/Preventive action program requirements seek to further eliminate waste by identifying and correcting product or process problems. Overall ISO 9001 requirements for Customer Focus and Continual Improvement align with the Lean enterprise focus on satisfying the customer and continuous improvement.

Integrating your ISO 9001, Lean and Six Sigma programs will align all your process improvement initiatives and increase the success of your business management system. This should lead to common goals instead of conflicting goals and, in the long run, increase the effectiveness and efficiency of your organization.

An ISO 9001 implementation client called me the other day to share the good news. They had just passed their first ISO 9001 registration audit with only one minor nonconformance. I expected to hear that the nonconformance was in one of the traditional problem areas for new quality management systems, like document control, record control, or calibration. Instead, they received their nonconformance because in conducting the internal audits, they did not highlight where their processes were performing effectively! This made me realize that I too, may have fallen into the trap that catches many of us – we are so focused on what is wrong, that we forget to provide needed recognition when things are going well. Now, in truth, it may be a bit of a stretch to interpret the requirements to mean that you must document something specific about the system effectiveness; however, the standard does give that as a reason to perform internal audits.

When coaching the clients on how to conduct audits, I often emphasize that we want to find and fix as many problems in their processes as we can. We are attempting to clear the way so that when their registration auditor comes, there should be only minor findings, if any, left to discover. However, in paying so much attention to pointing out problems, it would be very easy for internal audits to become a dreaded activity both for the auditors and the people being audited. We can advocate that the focus of audits is on the process, not the people, but it is difficult to control the feeling that audits are bad when many nonconformances are discovered.

Let us all plan to put a greater emphasis on looking for process improvements and identifying areas of good practices in addition to identifying problems that need to be resolved. A strong internal audit program needs the continued cooperation of all employees. If appropriate recognition is communicated when things are being done well, the audits can be seen more as a positive process rather than a negative one. Another important point to remember is that, since internal audits are reviewed by management, this is a good way to keep them informed about the positive things that are taking place throughout the business system.

I recently visited an ISO 9001 implementation client in Western North Carolina and learned that their corporate office had asked them to slow their progress toward ISO 9001 certification because of the slump in the economy and layoffs at their plant. With this in mind, we discussed the best way for them to move forward and not lose all the gains they have made so far. Without the final certificate, we determined that their focus should be on maintaining compliance to their recently developed program. I think they were a little surprised that I recommended they maintain everything as if they had been certified!

I challenged them to keep up with their Internal Audit program to know where their strengths and weaknesses are. They should use their Corrective/Preventive Action program to help discover opportunities for continuous improvement. They need to stay current with their Calibration process because inaccurate measuring devices put the quality of their product at risk. It will be important for them to maintain Control of Documents and Records to avoid a major clean up once their business starts to improve. Most importantly, they should continue to hold Management Review meetings so management will see the return on their investment in the program and continue to provide the necessary support. Keeping up with these activities will allow them to be ready for the certification audit once their business conditions improve.

If you find yourself in a similar situation, it is important to keep focused on doing the right things right and don’t let compliance become complacency. When you don’t have the extra motivation that an outside auditor brings to the situation, it is very easy to let your system slide and become complacent. When this happens, your system will become nonfunctional and your good efforts are lost along with your investment.