Making sure that measuring instruments are properly calibrated is critical to quality manufacturing operations. A gauge that doesn't read accurately and repeatably can compromise the integrity of quality control and quality assurance documentation, and destroy confidence in measuring results. At their worst, inaccurate gauges can result in the production of nonconforming parts.

Gauge calibration represents an important, if not fully appreciated, manufacturing discipline. It should be viewed as an investment. Gauge calibration is the foundation upon which a quality program can be built.

More than simple adjustment

Gauge calibration determines the deviation from the true value of the indication supplied by a measuring instrument. The results of the calibration process can be used for gauge adjustment. Calibration goes beyond simple adjustment, however. A calibrated gauge can be traced back to a master source. Traceability provides the value added to the calibration process.

In the field of medical products, devices, and components, regulatory requirements and customer expectations are demanding. Throughout the world, manufacturers and their suppliers are expected to comply with the highest standards and regulations.

ISO 13485--”Medical devices--Quality management systems--Requirements for regulatory purposes” is the standard for organizations engaged in the manufacture of medical devices. According to the most recent survey by the International Organization for Standardization ( www.iso.org/iso/survey2006.pdf ), there were a total of 8,175 current ISO 13485 registrations across 82 countries in 2006. Approximately 30 percent of all ISO 13485 registrations were issued in the United States, compared to only 6 to 7 percent of all ISO 9001 and ISO 14001 registrations. According to the survey, the 2006 total represents an increase of 3,110 (61%) compared to 2005, when there were 5,065 registrations across 67 countries and economies. Other major markets include Europe, Japan, Canada, Sweden, and Israel.

Tough economic times are upon us. The leaders of the Big Three automakers have to stoop to driving their own cars, our nation’s leaders have to separate themselves into two parties, and the people affected by the layoffs have to go home and lead their families through troubled times. Which do you think is the toughest job and requires more leadership?

We all accept the role as leaders of our families, churches, the neighborhood association, or perhaps the local school board. Those roles are more important to us as individuals than the roles played by Congress or the car manufacturers’ officers. It is a choice that we make personally, and this decision requires us to question not only our time commitment, but also the alignment of our personal belief system with that of the organization.

Here's the nightmare: You arrive at work to find your best customer has just returned $10,000 worth of precision ceramic parts. They are all neatly boxed and sitting on the inspection room floor with a nasty note saying that they are all out of tolerance. You stand to lose one of your best contracts, not to mention your job, unless you get to the bottom of the problem right away.

So you immediately go to your tool crib and remove your precision digital micrometer from its padded box where it lay with its anvils neatly closed.

First, you check the calibration sticker. The micrometer has a six-month calibration schedule and was calibrated five months ago. No problem there. You check the absolute zero setting on the micrometer. It reads 0.00000". Exactly where you set it when you put a fresh battery in last month. So the micrometer should be OK. The micrometer and the parts have been at the same temperature for several hours, so you should be OK there, too. It's time to check the parts. You remeasure every one of them. They're in spec. All of them.

The customer must be wrong.