Ok, men. Leave the room.

How a country copes with a brutal economy depends in no small part on how well its people maintain their confidence in their own personal financial future. Will consumers be confident enough to spend? Will investors be confident enough to buy? Will employers be confident enough to hire?

After years of focusing on the pharmaceutical industry and establishing better controls for reviewing the safety and efficacy of pharmaceutical products prior to approval, the Food and Drug Administration (FDA) is now directing its attention to the medical device industry.

A management system is the framework of processes and procedures used to ensure that an organization can fulfill all tasks required to achieve its objectives. A lean management system consists of the discipline, daily practices, and tools that you need to establish and maintain a persistent, intensive focus on process. It is this process focus that sustains and extends lean implementations.

The following words of an anonymous poet as he (or she) immortalized the lessons from Deming’s funnel experiment.

“Tamper, tamper is the game, try to make all the same. Squeak and tweak it every day, off we go to the Milky Way.” 

—Anonymous 

I offer a corollary that may help understand the underlying problem:

A mechanical engineering firm was contracted to install new cooling equipment in a municipal ice rink’s mechanical room. The challenge was to design the equipment installation without tearing out the old equipment first, and to install some elements and piping that housed the refrigerant around the current equipment configuration to limit downtime of the facility when the cooling unit was actually disconnected.

“Our corporate mission is to deliver the ‘Best Value in Energy and Related Services,’” according to a large Midwestern electric and gas utility company. This is a mission statement, which after a minor modification (just change the industry), could be posted on any boardroom wall and inserted into any number of CEO speeches. But this company actually put its mission statement into practice and reaped the rewards by becoming a superior value provider. Six Sigma marketing was the tool the company used.

The AS9100C standard (also referred to as AS9100:2009 and AS9100 Rev C) has been published since January 2009. You are not alone if you are confused about the delay in being audited to this standard. Like you, most companies seeking registration to AS9100 are in the process of trying to figure out how and when to roll out this standard within their organization and the following information should bring clarity to this subject.