Quality Digest

Quality by Design and RMM: Helping Manufacturers Balance Quality and Speed to Market Today’s drug development companies face a difficult challenge: balancing the need for product quality and safety while speeding time to market. Championed by the FDA, EMEA, and other global regulatory agencies, quality by design (QbD) represents a systematic approach to building ... [Read More]

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 ... [Read More]

IECQ QC 080000: The Standard for Lean-Green Compliance Although not all manufacturers around the world understand the value proposition of a lean-green, process-based manufacturing program, there are more than 1,250 that do--those that are registered to the IECQ QC 080000 standard. IECQ hazardous substance process management (HSPM) has proven to be ... [Read More]

Editor’s note: This is the first in a two-part series looking at how companies can share best practices such as Six Sigma across the supply chain. The second part of this series, focusing on PACCAR supplier Cummins Engine Co., will appear in an upcoming issue of Quality Digest . Few U.S. manufacturers embrace the challenges and opportunities of quality improvement in quite the ... [Read More]

  Enterprise resource planning (ERP), and the multimillion-dollar technology platforms that have become synonymous with it, are the stuff of which out-of-this-world management ambitions are born. The excitement generated from testing the technical boundaries of ERP is admirable, if only for what it implies about a company’s passion for innovation. Often, however, the excitement ... [Read More]

  Download directory   Welcome to Quality Digest’s 2008 Consultants Directory, listing companies that provide quality consulting services. Check the abbreviation key on page 48 for a preview of the services offered by each company. If additional information was provided to us, you’ll find it online at http://www.qualitydigest.com/content/buyers-guides. As ... [Read More]

Most in the electronic manufacturing services industry are acutely aware of the growing problem of counterfeit and substandard electronic components within the supply chain, as well as the headaches that they cause. Although industry and governments are working diligently in addressing counterfeit abatement, you may already have one of the most useful tools in combating phony parts ... [Read More]

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 ... [Read More]

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 ... [Read More]

A few years ago, we had a mysterious scratching sound in our attic. My 5-year-old daughter was terrified, and everybody’s sleep was being interrupted on a nightly basis. “We need to do something about the noise in our attic,” I told my daughter. “No!” she cried. “Don’t go into the attic. It’s too scary.” I talked to my daughter, and it was obvious that ... [Read More]