ISO9001:2015 New Structure

1. Scope

2. Normative Reference

3. Terms & Definitions

4. Context of the Organization

5. Leadership

6. Planning

7. Support

8. Operation

9. Performance Evaluation

10. Improvement


ISO9001:2015 Risk Analysis

Prevention in ISO9001:2015 has moved from Act to Plan under PDCA. Thus in 2015 a “Risk Program” will be required moving forward. Although not overly complex the idea is to gain traction in preventing problems thus instead of fire fighting will move toward fire prevention.



Problem Solving – The 10 Step Method, Key Factors & Analytical Practice

Who should attend: Shop floor employees, Supervisors, Managers, and Engineers

Class Time: 2 days (6 hours per day) utilizing a current and real problem of yours

This is a great class for shop floor employees with an intermix of Supervisors and Engineers to give everyone a better understanding of problem solving.

Root Cause Analysis

Who should attend: Supervisors, Managers, and Engineers

Class Time: 3 days (6 hours per day) utilizing a current and real problem of yours

This class is an expanded version of Problem Solving but also teaches depth into some Lean Six Sigma Tools

FMEA – Failure Mode Effects Analysis

Who should attend: Supervisors, Managers and Engineers

Class Time: 2 days (6 hours per day) utilizing FMEA on a current issue

This is a great class to tackle new complex projects or existing projects that are constantly giving trouble.

Product Development – Senior Management Buy-In

Product Development – Senior Management Buy In


Ask anyone to identify the factors necessary for the success of continuous improvement initiatives — at least beyond small pockets of improvement — and almost without fail the list includes senior management buy-in.

Not so the case when it comes to generating ideas and new innovations, says new research by the Nielsen Co. In fact, its research suggests that just the opposite is true: Keep senior managers away from the creative process.

Nielsen, which examined the innovation practices at 30 large firms operating in the United States, discovered that companies with less senior-management involvement in the creative end of new development generated 80% better results than those with heavy senior management involvement.

While they don’t dispute senior management’s strengths and good intentions, they are often too quick to get involved in the creative process, especially when things are not going well, and their mere presence can stifle free-thinking and boundary-less ideas.

That’s not to suggest that senior managers should be entirely uninvolved. Their job is to manage the new process, not the ideas, the research indicates. New product development success comes down to two important principles — managing ideas lightly while managing the process.

Another finding sure to raise eyebrows is that innovation takes place best starting with teams at corporate headquarters. In fact, it turns out that having no corporate team at all is better than having a team on-site at corporate headquarters.

Nielsen backs its claims with this data: Firms with teams at corporate headquarters show just 2.7% improvement, compared with 4.8% from companies with no teams and 5.7% from companies whose teams are located away from the corporate headquarters.

A Shoe or a Hammer! Which drives a screw better?

Lean and Six Sigma have taken a beating over the past several years – “It does not work for us and our environment. We are different! Our processes are different than companies that can use it! We have two many special products that does not lend itself to Lean and Six Sigma like the large companies!” However, Lean and Six Sigma a proven manufacturing methodology has been around since the 1930’s with the likes of Deming, Shewhart, Juran and others and although the terms have changed through time and I am sure they will change again with a slight twist on the meaning to get people to bite again – the underlying meanings will never change.


Lean is simply the elimination of waste. Now what company would say that eliminating wasteful steps or wastes in general in their operations or services to reduce cost does not work? Six Sigma is an organized method to apply statistics to best predict your outcome. Gosh wouldn’t that be wonderful to better understand and better predict how and why problems happen! And not just “because it does!”


Let’s look at it like this. Lean and Six Sigma tools are like the tools in your home tool box. There are many different types of tools in your home tool box. Some tools can be used for many different applications, and some tools must be used for very specific application; however, 90% of the time we use a hammer, a crescent wrench, and a screw driver. That’s what works! And in the unusual case you have a special tool that makes your job so much easier then the more power too you! It is the same way with Lean and Six Sigma tools – only a few tools will be needed to solve most of our problems. In addition, there are many specialized tools for specialized situations which help you solve the problem much easier – but these only occur about 10% of the time.


Furthermore, how many times have we misapplied tools at home? We may try to use a hammer or a shoe to drive a screw, but a screw driver works better.  Or we use a standard wrench for a metric bolt. It may work, but eventually, we have rounded the bolt head so bad, that we have to replace the bolt. In addition, you are constantly retightening the bolt (re-fixing the problem) because you cannot get the torque needed to fix the problem to start with.


Lean and Six Sigma tools are the same way. There are many types of Lean and Six Sigma tools; however, you will probably only use a few tools 90% of the time. In addition, misapplying the tools may work, but not to your expectations, and misapplications can create problems down the road, thus leading us to the result that the “this tool does not work!” or “Lean Six Sigma does not work for us!”


It is not the tool, it is not Lean and Six Sigma – the tools and the methodology work fine. It is misunderstanding the concept, misapplying the tool, and using the wrong method to solve the problem at hand. Lean and Six Sigma work, but application is critical to get the results we expect.