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By Brenda Boughton

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.

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By Tom Pyzdek

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."

Dave K. Banerjea’s picture

By Dave K. Banerjea

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.

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By S. Bala

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.

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By Quality Digest

 

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Welcome to Quality Digest’s 2008 SPC Software Directory featuring 93 companies that responded to our requests for information. These companies produce or distribute software applications assisting with ANOVA, capability analysis, control charting, data mining, DOE, FMEA, gauge R&R, regression analysis, reliability analysis, and similar functions. If provided, descriptions of their products can be found at www.qualitydigest.com/content/buyers-guides .
As with all Quality Digest guides, the 2008 SPC Software Directory is in no way meant to endorse or exclude any specific organization. Rather, it should be used as the starting point in the data-gathering process. Readers are encouraged to contact these companies directly for more information.

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By Quality Digest


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."

Dirk Dusharme @ Quality Digest’s picture

By Dirk Dusharme @ Quality Digest

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.

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By Quality Digest

 

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When it comes to quality software solutions, it often seems as though there’s something for everyone. Standards compliance, process simulation, and flowcharting
are just some of the solutions that exist for the intrepid explorer of higher quality. Software isn’t just being used in the boardroom, either. Increasingly, computerized systems are finding their way down to the shop floor, where real-time software programs can help ensure that processes remain controlled.

This section contains the ISO Standards Software buyers guide and the Flowcharting/Process Simulation buyers guide. These guides offer a plethora of solutions for your organization. Because there is such a wide variety of statistical process control software, we’ve given that subject its own section. Check behind the SPC Software tab for more information on providers of these solutions.

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By Quality Digest

 

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Welcome to Quality Digest’s 2008 Flowchart/Process Simulation Software Directory. The companies in this buyers guide create or distribute software whose primary function is to aid in analyzing a company’s existing designs or operations to create important process-improvements and cost-savings opportunities. Functions include the flowchart, as in a schematic representation of a process used to help the user visualize the content or to find the flaws in the process; and process simulation, such as viewing a computer simulation that mimics a company’s operations to determine optimal conditions, bottlenecks, or sensitivity to process changes.

Included in this buyers guide are company names, addresses, telephone and fax numbers, and web addresses. Further information that has been provided to us, such as descriptions of the software modules/suites, is available online at www.qualitydigest.com/content/buyers-guides.

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By Chris Watts

During the last 30 years, giant steps have been taken to repair the damage done to the environment by industry. In the United States and elsewhere, rivers that were once dead and filled with toxic pollutants now support fish and are being used for recreation. Humankind’s attitude toward and relationship with nature has drastically changed.

Similarly, government bodies across the globe are planning for future needs and, through legislation, helping to prevent pollution from troublesome chemicals such as lead and cadmium. Companies have figured out ways to reduce the amount of toxic chemicals from their products or manufacturing processes but face new challenges in trying to replicate performance in environmentally friendly ways.