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The last few years have provided ample evidence that control of food safety is critical. Recent media reports have clearly documented supply chain shortcomings that have threatened consumers’ health and safety. These ongoing problems and the need for consumer safety cry out for additional tools to dramatically reduce or eliminate risks.
Milestones in U.S. Food and Drug Law History
1883 Dr. Harvey W. Wiley becomes chief chemist for the U.S. Department of Agriculture. Campaigning for a federal law, Dr. Wiley is called the “Crusading Chemist” and “Father of the Pure Food and Drug Act.”
1906 The original Pure Food and Drug Act is passed by Congress on June 30 and signed by President Theodore Roosevelt. The Meat Inspection Act is passed the same day.
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.
Qing Rong Zhang (behind computer, center), a Shanghi-based quality engineer with more than 30 years of experience with automotive original equipment manufacturers and tier-one suppliers, handles an overall supplier assessment.
It’s hard not to pick up a newspaper or industry magazine or surf the internet without reading that manufacturing industries are relocating their operations to other countries. During the past couple of years, it’s been equally difficult to avoid articles concerning serious quality issues present in consumer and industrial products produced in emerging economies. Even as product lines move to China, India, and Russia, domestic companies are losing significant numbers of experienced employees throughout their organizations due to early retirement or reassignment. Diminished and often lost in this regard is the tribal knowledge of operators who know the pulse of the manufacturing process. This triple whammy of outsourcing, loss of tribal knowledge, and decrease in product quality has emphasized the need for third-party suppliers of supply chain solutions.
Excellence is a part of life, and we must strive for it, especially if our mistakes create problems for others. Mistakes are costly; they hit the bottom line. Some are costly enough to put us out of business.
The code word for a mistake-free state is quality. The process for achieving that begins long before gauges and calipers arrive on the scene. It’s a route with many stops, any of which can determine whether the final destination will be quality or the scrap heap.
The many stops look so routine and ordinary: choosing the right raw material, correct chemical formula, precise temperature, exact amount, specific tools, proper assembly procedures. The timely output of quality outcomes depends on each of these transactions. How can we ensure that they will all happen accurately and completely? The answer for me is visual thinking, which leads to visual devices and systems.
Visual devices ensure that each stop on the road to quality is executed perfectly, on time, and safely. A visual workplace doesn’t just minimize problems and mistakes; it can eliminate them completely for both final product quality and every transaction along the way.
One of the most important objectives of an internal quality audit is
measuring the effectiveness of an organization's quality management system. For
this to happen, executive management must first meet its overriding
responsibility of establishing and maintaining a system regarding quality
policy, goals, resources, processes and effective performance--including
monitoring and measuring the system's effectiveness and efficiency.
ISO 9001:2000 delineates this responsibility into three distinct areas: 4.1
General requirements, 4.2 Documentation requirements and 4.3 Quality management
principles. If an organization's executive management isn't active in these
three areas, then they won't be addressed and the quality system will be
ineffective. Let's look at them one at a time, first in terms of their meaning
and then as auditable characteristics.
During the 1920s, a British statistician named Ronald Fisher put the finishing touches on a method for making breakthrough discoveries. Some 70 years later, Fisher's method, now known as design of experiments, has become a powerful software tool for engineers and researchers.
But why did it take engineers so long to begin using DOE for innovative problem solving? After all, they were ignoring a technique that would have produced successes similar to the following modern-day examples:
• John Deere Engine Works in Waterloo, Iowa, uses DOE software to improve the adhesion of its highly identifiable green paint onto aluminum. In the process, the company has discovered how to eliminate an expensive chromate-conversion procedure. Savings: $500,000 annually.
• Eastman Kodak in Rochester, New York, learns via DOE software that it needs only to retool an existing machine instead of making a huge capital purchase for a new one. The solution means improved, light-sealing film-pack clips used by professional photographers. Savings: Setup time drops from eight hours to 20 minutes; scrap reduces by a factor of 10, repeatability increases to 100 percent and $200,000 is not spent on a new machine.
For almost 100 years of our quality journey, we increasingly pampered our customers by giving them what they wanted. Customers now assume that quality is a given. Further, in our present information age, customers are more aware of competitive suppliers, as well as suppliers with poor performance. Quality performance has peaked globally, and the faces of quality have moved from the line worker to the corporate executive. Activities that improve quality hardly yield significant benefits anymore. So what else can be done to improve business performance and delight customers?
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 quality into product and process design and development right from the start. QbD and rapid-detection RMM go hand-in-hand, because both share the same goals--to ensure a high-quality manufacturing process that is lean, efficient, and reliable.
Cummins Inc. designs, manufactures, distributes, and services engines and related technologies, including fuel systems, controls, air handling, filtration, emission solutions, and electrical power generation systems. Cummins serves customers in more than 160 countries through its network of 550 company-owned and independent distributor facilities and more than 5,000 dealer locations. Cummins reported a net income of $739 million on sales of $13.05 billion in 2007.
Editor’s note: This is the second in a two-part series looking at how companies can share best practices such as Six Sigma across the supply chain. The first part of this series, which focused on heavy-duty truck manufacturer PACCAR, appeared in Quality Digest’s October 2008 issue. You can view that article online at www.qualitydigest.com/magazine/2008/oct/article/partnering-change-part-1.html.
Welcome to Quality Digest’s 2009 Registrar Buyers Guide. This handy resource includes more than 50 listings of companies that provide registration and auditing services on several standards, from the ubiquitous ISO 9001 for the overall management of quality management systems to any number of sector-specifics.
Included in each description, you’ll find the company name, location, phone and fax number, web site, and abbreviations representing the standards for which each company provides registration services. A key defining these abbreviations is included below.
