The majority of my career at TMAC has been focused on working with companies with the design and implementation of their ISO-based system. Over the past 16 years I have worked with approximately 150 companies in a wide variety of industries to get them registered to various standards, including ISO 9001, ISO 14001, AS 9100, and Safe Quality Foods (SQF). Once I was exposed to Lean Six Sigma, I began incorporating various tools and methods from this powerful problem-solving methodology with my ISO customers. It seemed like a natural thing to do, and helped make for more sustainable and effective ISO programs.
Recently I began thinking about the many parallels in a LSS project – which utilizes the DMAIC process -and the methods used for designing, implementing, and maintaining an ISO-related system. The more I thought about it, the more there seemed to be a natural affinity between these two methodologies. In reviewing these two approaches I decided to put together this side-by-side comparison:
|Step||ISO Implementation Activity||DMAIC Process|
|1||Determine reasoning for why an ISO program implementation is needed (e.g., to add structure to management system)||Define the Problem, and why it is important to solve, in terms of one or more strategic objectives. Establish scope, timeline, and project team. Gather Voice of Customer.|
|2||Identify existing structures (e.g., customer surveys, corrective action process, order database) and metrics (e.g., first-pass yield, on-time delivery)||Measure the Current State of the Process. Confirm the measurement system can be trusted. Gather data and map process. Establish Baseline level of performance.|
|3||Develop Strategy for implementing Corrective Actions, supported by Root Cause Analysis||Analyze the Problem to determine Root Cause(s). This typically requires use of process knowledge and data analysis.|
|4||Decide what improvements can be made for improvement of the Management System, based on the reasoning and/or goals uncovered in previous steps||Decide what Improvements need to be implemented to address the Root Cause(s). Perform a pilot (trial) of these improvements and collect data to compare to the Baseline.|
|5||Apply techniques to achieve long-term sustainment of the Management System. Examples include standard operating procedures, work instructions, and checklists.||Establish Control of the new, improved process by implementing Improvements identified in the Improve Phase. Ensure new process is sustained via standard operating procedures, work instructions, and checklists.|
Step 2 is critical for both LSS and ISO. The activities in this step set the stage for your ability to determine two things: First, Did the organization improve? Secondly, Can the improvement be supported with metrics? These are fundamental questions, and it is important to get them right. A poorly designed or implemented program can result in data that aren’t trustworthy, which will cause all sorts of problems.
Another important thing to keep in mind: This step involves the initial transition from opinion-based decision-making to data-driven decision-making. For some companies this is a major change in their culture. Be sure to set aside enough time for the change management side of the project. For example, you may have to meet 1-on-1 with key stakeholders to go over how to review metrics, establish a cadence for data collection, a cadence for data analysis, and guidelines on what actions should be taken by management for different situations.
The activities for Step 5 are strikingly similar, whether for ISO or LSS implementation. Both programs utilize similar features to control or sustain the gains made over the course of the project. A key thing to remember: The most common failure point for both the DMAIC process and ISO implementation is this last step. This is why it is so important to make sure the last phase is done correctly, and preferably in a very robust manner.
One last point in the connection between LSS and ISO: Both processes require approximately the same amount of time. That is, a timeframe of roughly 6 – 9 months is usually needed to fulfill the requirements and achieve the successes reaped by either.