NC State of Business

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.