The Quality Blog

I am in my living room on a Saturday morning and was just thinking about how often things go wrong in our fast paced world. Case in point, I was at my doctor for my full physical and we started discussing Quality Control and Quality Assurance and the topic came up as to medical procedure quality. I have been involed in FMEA developement for hospital process and surgical protocol and have noticed a fairly strong CONTROL emphasis as a result of those activities. Control in the sense of preventing a failure. An example would be the double checking of your bar code on your wrist and the additional questioning by the care giver regarding your name and purpose of your hospital stay. These controls and the FMEA process outputs driving this level scrutiny has made your hospital alittle more safe.

8D or Eight Disciplines for Problem Solving uses many of the most common tools for developing a path to get to the Root Cause. 8D does have one intersting characteristic. The 8D uses the IS/IS NOT exercise to gather facts and do comparative analysis for the purpose of determining where the root cause is not. Let me repaet that. The 8D process attempts to gather facts to prove where the problem is not. After sufficient facts have been gathered the possible causes are eliminated by proving they are not the root cause. This is typically not understood when using 8D as most people are trying to find the root cause directly instead of finding out what it is not.

Can the FMEA process be lean? Based on many experiences with many types of industries, I can say that the vast majority of activity is redundant. Team activity in FMEA should be restricted to only 4 items of discussion only.

• New Content
• Changes to current content
• Past failures
• Increased demand stresses on Carry-over or processes.

The last of these will be my topic of the day. What are increased demand stresses? Demand stresses are based on the noise factors (not audible generally) that are not controlled by the engineer. Noises like Customer usage, Degradation over time, Interfaces with other systems, Environment, and variation sensitivity, are the bases of Robust Engineering. The engineer must attempt to understand these NOISES as they may affect his or her design. The ability of the design (its capacity) to deliver the desired outcomes in the presence of the Demand stress (expected and unexpected) determines how effectively the design satisfies customers. This sounds alittle technical but think of it this way. If an unknown demand on a carryover part is present when the product or process is being used may translate in failure. This means that carryover products and processes which did well in the past may actually fail in the future deployment. Some of my customers indicate that up to 40% of failure comes from what worked in the past but now does not. In order to include these items in future analysis we still need to consider NOISES and their impact on current processes and products.

Currently many companies lean out the FMEA process by creating family FMEA’s. This is not wrong but it can drive the type of behavior that does not consider new or changed NOISES (Increased DEMAND Stress). Currently a cut and paste mentality exists where it does not allow for a efficient review of current designs with respect to new Demands.

In Summary, Lean FMEA is not about cut and paste but instead organization of knowns Causes and Failure Modes, both potential and actual. The additional review of these knowns in relation to new DEMANDS is necessary to assure success.

Just returned to North America from China and India. I was teaching APQP and PPAP to several enthusiastic groups in both China and India. With emerging markets expanding at an exponential rate, the need for supply chain management and development is very strong. Suppliers make up to 70% of the value in most big products produced in these regions. The supply chain is also as diverse as he cultures that I have visited there. Some suppliers are transplants form Europe or North America and are as sophisticated as their inspirations in NA and the EU, while others are just getting started or have been suppliers for a very long time but without the extra expectations of the change management process of APQP. I must say that the groups that I visited were very enthusiastic and quite interested in the possible benefits of Quality Planning. I was very explicit about the danger of the checklist mentality and the temptation to just complete forms and not get the true benefits of FMEA, Special Characteristics and Collaboration. This message is key to ensuring that intelligent supply chain development is the outcome instead of the documentation exercise so often incorrectly depicted as what APQP is.

Just a note to my new friends in China and India, Wow, I had a great time, thanks for the hospitality and the great interchange, questions, and learning experience. I will always remember my trip and your friendliness.

Lee

In Beijing this week teaching 40 or so engineers and suppliers development people in APQP.The tools used in APQP such as FMEA and Design for Assembly were of great interest. I was very pleased at the level of intensity that was demonstrated by the participants. (trying not to fall asleep) But seriously, these tools which have been introduced are not well understood even though many examples exist of their use. I suspect they are filling in the form without getting much value from the tool (FMEA) What is really rewarding to me is when they “get it” and they begin to listen and ask questions and you can see that they will now be using the FMEA as it was intended – to prevent failure and improve controls.