Which Method was First – or can I use Both?

Sustaining Edge Solutions, Inc. Newsletter

Performance Improvement Solutions for Your Business                                   June 2011

This Month
* Which Method was First-or can I use Both?
* Quality Objectives
* Root Cause Analysis – Found It?
* In the News
* Training Courses


Lunch and Learn
June 16, 2011


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Our newsletters provide information on business management systems ISO 9001, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental, and others.  This includes process auditing techniques and process improvement methods Six Sigma, Lean Enterprise, and other topics of interest to our readers.


If you have any questions regarding the content or have a topic of interest for a future newsletter, please let us know.




Which Method was First – or can I use Both?


We recently conducted a second Kaizen Event for a medical and dental service provider. During the project a team member asked “Is Kaizen the same as Lean, and is Six Sigma on its way out?” I remember leading my first Kaizen/Lean project 18 years ago and hearing “Is Kaizen replacing Total Quality Management?” Not much has changed over the quality improvement timeline. Many enterprises whether service or manufacturing are looking for simplified answers and methods to cost reduction, improved quality and enhanced customer satisfaction.

It is not about what’s been around the longest, or some new improvement method you heard about that “everyone is doing.” It is about what your organization is facing today, and what it could be facing tomorrow if you do nothing. Do you have customer dissatisfaction, product returns or service issues, high operating costs? Maybe trying to improve cycle time, service delivery or reduce process waste? These are the type of questions you need to ask to determine what to do, and how to focus your resources to improve profit. 

Lean and Six Sigma have become the most widely known methods for creating breakthrough and sustained improvement. Keep in mind that these methods have evolved from previous proven methods such as the plan-do-check-act (PDCA) cycle and Toyota’s process waste elimination system.


Lean Improvement Through Waste Elimination

A lean core principal is based on creating a “pull system” to produce faster, rather than the traditional “push systems” used by most organizations. The goal is to always pull from the customer demand, not push to the customer and suboptimize your capabilities. A method that started in manufacturing to reduce waste is now used to improve cycle time, and workflow in workplace and department performance, and reduce waste in hospitals, insurance companies, financial services, and nonprofit environments.

Value stream mapping is an important tool used in lean. It documents all the tasks (material and information flow) and process metrics (process time, cycle time, inherent costs, barriers) within a system including waste and non-value added activities. An example of a task level metric used in our lean events is called Complete and Accurate (%C&A). This equates to the time the downstream customer can perform the task without having to “CAC” the incoming work:

  • Correct information or material that was supplied
  • Add information that should have been supplied
  • Clarify information that should or could have been clear.

The output metric is measured by the immediate downstream customer and all subsequent downstream customers. This process makes visible the problems or waste so that they can be eliminated, thereby making the processes faster and cheaper to deliver. Creating “value” as seen by the eyes of the customer is the key component to lean. Providing value to the customer is why a supplier exists. Whatever does not provide value to the internal and external customer can be considered as process waste.


Six Sigma Improvement Through Voice Collection and Data Analysis

The fundamental objective of the Six Sigma methodology is the implementation of a measurement-based strategy that focuses on process improvement and variation reduction.

A Six Sigma system is based upon gaining customer, business, and organizational process knowledge “data” for utilizing information to drive performance improvement and measurement of core processes. Two primary methods known as “Voice Collection” and Define-Measure-Analyze-Improve-Control (DMAIC) are used to improve processes and products, and to help ensure that products and processes function well starting with the voice of the customer to the delivery of product and services.

Understanding what your customers consider “critical success factors” are absolutely necessary for determining the depth of your performance improvement system. This information further identifies a cause and effect relationship in regards to how your processes are performing, their capabilities, effective measurement, and the identification of necessary resources for your business to achieve performance excellence.

One of the most distinct differences in Six Sigma is the link to business finances. The DMAIC process is an improvement system for existing processes falling below specification and looking for incremental improvement.

Lean Six Sigma is quite simply the integration of lean and Six Sigma methodologies. Lean focuses on efficiency, and Six Sigma focuses on how effectiveness can lead to faster results than either method applied independently of the other. Any successful improvement deployment depends on a clear understanding of personnel roles, responsibilities, structures, and necessary training requirements for  employees.

Successful companies recognize that comprehensive process improvement is not achieved by a simple “fix it” to one-time problems, or band-aid approaches. Improved profits require a new way of doing business, and the smart companies use continuous improvement as a daily business function.


Quality Objectives


Are you having a difficult time identifying quality objectives for your organization? Think about your business.

According to ISO 9000:2005, 3.2.5, a quality objective is something sought or aimed for, related to quality. ISO 9001:2008, 5.4.1, states your quality objectives must be measurable and consistent with the quality policy.

Clause 5.3 of ISO 9001:2008 says your quality policy is a framework for establishing quality objectives. It also says that the policy must include a commitment to 1) comply with requirements and 2) continually improve the effectiveness of the quality management system. Using the quality policy as a framework, you would have a quality objective to measure the degree to which requirements are being met, as well as, a quality objective that measures the results of the quality management system.

If your quality policy identifies other important areas, for example, product reliability, you would be expected to have another measurable target for product reliability. ISO 9001:2008, clause 8.2.1, says a required performance measure is for customer satisfaction.

Remember, goals are conditions to be achieved in the future. They should be defined consistent with your vision and mission. Goals are established to guide your decisions and actions. They don’t change as much as objectives. Your objectives must involve measurable results to achieve your goals.

Objectives are focused on critical issues and milestones. They describe the activities and targets to achieve your goals. They even identify the dates for completing the activities. They are measurable in terms of being achieved, or not. For example, a general goal might be to reduce waste. The related, specific objective might be to reduce rework from 10% to 5% by the end of 2011.

Depending on your industry, you might consider quality objectives such as:

  • Scrap Rate = Product Rejects / Products Produced
  • Return Rate = Products Returned / Products Shipped
  • Complaint Rate = Received Complaints /Total Customers
  • Design Stability = Change Requests / Product Releases
  • Service Quality = Defective Transactions / Total Transactions

Be careful how you set these objectives and how you communicate them. You might find people actually manipulating processes to achieve the desired results, especially if the numbers are used to evaluate employee performance. When handled poorly, performance targets can result in internal competition and a lack of cooperation. In fact, a specific process objective can be optimized at the expense of overall system performance.

If a target is perceived as arbitrary, and set beyond the capability of the process, it may lead to employee frustration, reduced morale, and even lower performance. Individuals must feel they have some control over the outcome for an objective to actually promote improvement. The objectives should help monitor and control the processes, not the people.


Root Cause Analysis – Found It?

Have you found the root cause yet?”

We frequently ask or hear others ask that question. Root cause analysis (RCA) is an old subject and is familiar to many people. If your company is registered to a major global quality standard, you hear it very often and you most likely have contributed to a corrective action using it.

According to Gary Jing, the phrase “root cause” can be somewhat misleading. Many who use it are unaware of the concept’s larger context. Asked what root cause means, some typically respond with:

  • “It is what is really happening.”
  • “It is the one thing that causes everything else.”
  • “It’s the light switch. When you flip it, the lights go on.”

These explanations imply there is one specific thing that is the originator of the considered effects, and the origination is absolute, meaning unconditional and inevitable. This absolute origination is usually referred to as the root cause. The challenge to people is to know when and where to stop drilling down through the infinite layers of cause and effect and conclude they have reached a root cause. The clue resides in the typical business mind-set. It’s similar to selecting something that can yield a high return on investment (ROI), for example. That is how most businesses make decisions.

One key to unlock the root cause chest is called the span-of-control or sphere-of-influence principle.


Span of Control

Many people have not thought much about the deeper meaning of root cause and, therefore, are not clear on when and where to stop searching for root causes. The so-called root causes are what people subjectively choose to serve in the role of origination. The task to pursue the root cause is really the task to decide when and where to terminate the chain of causation to generate high ROI.

Sphere of Influence

Similarly, if a cause is outside the sphere of influence (persuasion only), it’s a good indication you can stop drilling because working beyond that generates no returns. That’s not to say you’ll always give up in this case. The focus then must be shifted to expanding the influence boundaries to enclose the cause currently outside of your influence. In my experience, the sphere of influence is frequently the dominating factor in root cause selection.

Many people have not thought much about the deeper meaning of root cause and, therefore, are not clear on when and where to stop searching for root causes. The so-called root causes are what people subjectively choose to serve in the role of origination. The task to pursue the root cause is really the task to decide when and where to terminate the chain of causation to generate high ROI.


In the News


AS9100 Event

AS9100C:  Are You Ready?

Last month we conducted a workshop in Scottsdale, AZ for companies interested in the AS9100C Aviation, Space and Defense Standard requirements. Interpretation of key requirements were learned by all and attendees were able to share ideas about their company approach and new customer requirements.  If interested in a copy of the material presented or assistance with this new standard  Contact Us.

Eight Annual Medical Device Quality Congress

This year the conference will feature more than 15 in-depth sessions headed up by leading quality experts, including sessions led by 10 officials from the Center for Devices and Radiological Health and five former Food and Drug Administration officials. FDA news has pinpointed the top five most important quality issues-risk management, design control, supplier quality, quality systems regulation (QSR) compliance, and postmarket surveillance-and built this year’s program around them.

For more information visit the Conference Website.

World Accreditation Day

More than 60 countries are participating in World Accreditation Day on June 9, 2011, a worldwide initiative jointly established by the International Accreditation Forum (IAF) and others. Accreditation has been used for more than 50 years as the definitive means of evaluating organizations and is now utilized by all the world’s major economies and many developing economies. Accreditation of conformity-assessment bodies provides businesses and regulators with confidence that products entering the market conform to specifications, meet national legal and regulatory requirements, and fulfill the need to protect public interests.

For more information visit World Accreditation Day.



Training Courses

To see the course description, schedule, and on-line registration click on the course title below. We deliver onsite training for these courses and customized training to fit your specific needs.  We offer group discounts.

View all our Courses


View Our Web Based E-Training Courses


ISO 9001 Quality Management


Understanding and Implementing ISO9001:2008

ISO 9001:2008 Process Based Internal Auditor

Documenting Your Management System


AS9100 Aviation, Space and Defense


Understanding and Implementing AS9100C (9110 &9120) Aviation, Space and Defense

AS9100C:2009 Process Based Internal Auditor

Documenting Your Management System


ISO/TS 16949 Automotive


Understanding and Implementing ISO/TS16949:2009 Automotive

ISO/TS16949:2009 Process Based Internal Auditor
Documenting Your Management System


ISO 14001 Environmental

Understanding and Implementing ISO14001:2004 Environmental
ISO14001:2004 Process Based Internal Auditor

Lean Enterprise and CI

5S Five Pillars of a Lean Workplace Organization
Continuous Process Improvement
Lean Six Sigma
8 Disciplines (8D) of Problem Solving


ISO 13485 Medical Devices


Understanding and Implementing ISO 13485:2003 Medical Devices
ISO 13485 Process Based Internal Auditor


ISO 27001 Information Security


Understanding and Implementing ISO 27001:2005 Information Security
ISO 27001 Process Based Internal Auditor


All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?

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