Winners of last month’s quiz and a copy of Quality Gamebox are Barbara Brunell (John Muir Health); Robert Buckley (Coca-Cola); Ian Hendra (Clearline Services Ltd); and Jim Judge (Energy Laboratories Inc.). Congratulations! For this month’s quiz, and a chance to win a copy of Quality Gamebox, go to Quality Quiz. Submit your response by July 27 to be entered in the drawing.

R. U. Serious has been appointed as quality manager for Precise Processes, a company that manufactures small medical devices used in hip replacement surgeries. The company slogan, “If you fall, we fail,” seems particularly apt in the current situation, since the company is facing legal action for a number of devices that have proved to be defective. R.U. Serious has been hired to address this problem of defects and to reverse the pattern of sinking sales of these devices.
Feeling overwhelmed by the task facing him, Serious turns to a former colleague from his business school days, when they had both been enrolled in a business statistics course. Mark Miwerds had had special success in the course, while R.U. often missed the 8:00 a.m. class, and barely passed the course.
Mark has ready advice for R.U. “Statistical process control is what it’s all about,” he exclaimed, recommending process charts for every process in the organization. “You just need charts—lots of charts—to solve your quality problems.” He added that control charts would probably be most useful.
Encouraged by the possibility of making an immediate splash at Precise Processes, R.U. Serious set out to collect data from processes throughout the company. Charts began to surround every work station and hang above every machining device. R. U. Serious was certain of his success in improving quality.
Is he on the right track with this approach?
a) Yes. SPC is definitely the way to go when it comes to improving processes.
B.
SPC will be helpful to understand the process and its failures.
A Quality Plan must be created. That is procedures and audits to show compliance to the procedures.
Are the failures due to:
1) materials
2) understanding the requirements
3) equipment
4) competency
Understand the process failure and develop corrective actions to eliminate future concerns.
B.
SPC is definitely the way to go when it comes to improving processes BUT SPC FOR ALL PROCESSES WOULD ONLY ADD TO PREVAILING CONFUSIONS.
R.U. Serious should have conducted a preliminary analysis with the existing information available to identify certain critical processes and even sub-processes which are potentially adding to failures. Collecting data for these processes and analyzing it to reach the root cause of the problem(s) would have been the right way.
B.
SPC is definitely good in improving processes but can create a regimented system of work culture. It may stiffle creativity if not properly deployed. So SPC is not the whole answer.
A complete investigation of the Root Cause of failures would be required so that time is well used and the task is accomplished within good cost (very important to consider cost of quality so as to provide competitve product/services). For example, its not clear if the company, has quality tools to prevent failures. for example FMEA or FMECA or Six Sigma or other operational excellence tools. If they do, why are there problems? At what points are the tools and processes failing? are the sales engineers not giving the customised advice and are the users not understanding what type of device and how to use the devices? For example not all devices will be appropriate for all client. Is there a need for customization? This draws the investigation to the customers/users angle. Of course, the customer define the quality of the product to produce and what they will pay for.
In any case, SPC is good but not the overall answer.
best regards.