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Energy generation is a multifaceted industry comprising dozens of major discrete technologies and thousands of companies. For reasons that are at once political, economic, and environmental, the energy industry occupies a central place in modern human society, and it will for the foreseeable future.
Alternative energy resources, such as photovoltaic modules and wind turbines, represent a particularly fast-growing segment of the industry. This article will look at this sector from the perspective of quality assurance and safety testing, two extremely important concerns for producers, as well as consumers, of alternative energy.
Manufacturers’ efforts to do more with less have resulted in purchasing departments sourcing cheaper products and parts, often from overseas. Such cost-cutting certainly makes purchasing look good to management. But the effect on quality professionals may be just the opposite: product or part defects, malfunctions or undesirable side effects, not to mention the challenge of producing high-quality end-products within narrow timelines and budgets. Many sleepless nights are a frequent outcome.
Because cost cutting and global sourcing are here to stay, how can quality professionals combat these monumental challenges? Root cause analysis (RCA), when fully utilized, can eliminate defects in your operations as well as defects that you inherit from suppliers, ultimately helping to maintain a satisfied and engaged customer base.
Electronic records--theircreation, modification, maintenance, retrieval, and archiving--can create ongoing challenges for all organizations. For industries regulated by the U.S. Food and Drug Administration (FDA), such as pharmaceutical companies, medical device manufacturers, food processing plants, and biotech companies, the FDA’s Code of Federal Regulations Title 21 Part 11 applies to the specifications, use, and control of electronic records and electronic signatures.
The requirements of FDA 21 CFR Part 11 for electronic records are based on good practices, organization, and, most of all, common sense to ensure the efficient and secure handling of these records. In general, these requirements state that:
• All information is complete, and all records can be tracked to their originator and corresponding records.
• Appropriate securities are in place to ensure that tampering that would alter the record from its original intent does not take place.
• Only the appropriate parties can access the records, and only those so identified can create, modify, or review those records.
One day, early in my quality career, I was approached by my friend Wayne, the manager of our galvanizing plant.
"Tom," he began, "I've really been pushing quality in my area lately, and everyone's involved. We're currently working on a problem with plating thickness. Your reports always show a 3-percent to 7-percent reject rate, and we want to drive that number down to zero."
I, of course, was pleased. The galvanizing area had been the company's perennial problem child. "How can I help?" I asked.
"We've been trying to discover the cause of the low thicknesses, but we're stumped. I want to show copies of the quality reports to the team so they can see what was happening with the process when the low thicknesses were produced."
"No problem," I said, "I'll have them for you this afternoon."
If your company is involved in manufacturing, chances are that a good portion of your company's assets include measurement and test equipment (M&TE). This includes everything from simple go/no-go plug gauges to air-pressure gauges, voltmeters, micrometers and calipers on up to very sophisticated equipment such as robotic coordinate measurement machines and scanning electron microscopes.
M&TE are those assets your company uses to make critical decisions on whether to pass or fail incoming materials, in-process work and finished goods.
Of course, M&TE itself must be periodically inspected, tested and calibrated as part of the quality process. Poor or unreliable measurements result in faulty decisions and questionable product quality. Calibration management software can be crucial to helping maintain equipment accuracy and properly calibrated testing equipment.
Calibration management software saves time, effort and money. Computerizing your calibration records makes them instantly available in the event of product quality problems or a quality system audit.
In its optimum form, Six Sigma is anything but simple or practical. Given its considerable upfront cost and ongoing complexity, it’s best viewed as a results-driven expedition of Homeric scope, one where the final destination is 3.4 defects per million opportunities. It’s not a journey for the faint-hearted. You must be seriously committed to pursuing it for the long term, or you’ll never recoup your sizable upfront investment, let alone enjoy a net return.
So you have a customer complaint. It’s not just any complaint, but a huge one from your biggest customer. The problem affects millions of dollars in business and threatens the survival of your company. Are you going to take action? Of course! You put together a team of top players and attack it head-on.
Team members investigate the problem and perform a detailed 5-Why analysis. They start with the problem statement and ask, “Why did that happen?” repeatedly, drilling down deeper with each iteration:
Problem: There were seven data errors in reports issued to our largest customer in the last month
• Why? Because lab reports are getting in the wrong project folders.
• Why? Because the project numbers are written illegibly on the folders.
• Why? Because the customer service representatives are rushed when preparing folders.
• Why? Because there are only two representatives taking calls for all divisions.
Essential in quality control, vision-based multisensor metrology allows supplied components and materials to be quality-checked before, during, and after incorporation into a final product. It can also provide an audit trail enabling a point of failure to be accurately pinpointed in time as well as providing a means of early detection and diagnosis of the problem. Early correction can save time, reduce waste, save money, and most important, safeguard a company’s reputation for reliability and quality.
This is how our readers define quality. (Note: these definitions are straight from our database and have not been edited.)
"Quality itself has been defined as fundamentally relational: 'Quality is the ongoing process of building and sustaining relationships by assessing, anticipating, and fulfilling stated and implied needs.'
"Even those quality definitions which are not expressly relational have an implicit relational character. Why do we try to do the right thing right, on time, every time? To build and sustain relationships. Why do we seek zero defects and conformance to requirements (or their modern counterpart, six sigma)? To build and sustain relationships. Why do we seek to structure features or characteristics of a product or service that bear on their ability to satisfy stated and implied needs? (ANSI/ASQC.) To build and sustain relationships. The focus of continuous improvement is, likewise, the building and sustaining of relationships. It would be difficult to find a realistic definition of quality that did not have, implicit within the definition, a fundamental express or implied focus of building and sustaining relationships."
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.
