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Explore This IssueFebruary/March 2015
Wherever you travel around this country—and even internationally—you will likely hear the same rhetoric from dietary supplement manufacturers. Firms claim they have quality, something that their competitors do not, and they are doing it the right way despite not allowing an external audit for quality and compliance by a third party. When one of us hears this from a company, we typically respond by asking how they know this to be true, and we are left feeling surprised that more dietary supplement firms do not use a quality audit from a third-party certification organization to demonstrate the adequacy of their quality systems, considering its benefits to benchmark continuous process improvement and relatively low cost.
When you look up the word quality, you will find that it is an attribute or defining characteristic that has become the standard as measured against other things of a similar kind. In a world where we group according to the buckets of good, better, and best, quality is the degree or extent along the scale to that asymptote we call perfection, an impossible point we can never reach. Many may not be familiar with the teaching of W. Edwards Deming and his 14 points for continuous process improvement, but they are quality concepts that have passed the test of time. Deming was a U.S. statistician of mathematical physics, and a pioneer of modern quality management. He developed the founding principles of Total Quality Management and the System of Profound Knowledge. Deming introduced the DMAIC and PDC(S)A acronyms, which have been quoted in every quality seminar since the 1980s. DMAIC stands for Define Measure Analyze Implement and Control and PDC(S)A stands for Plan Do Check (Study) and Act. These acronyms and Deming’s 14 points of quality management gave birth to Six Sigma by Bill Smith of Motorola, many of the concepts of ISO9000 series and the ANSI Q90 series standards issued today for quality improvement, and Lean training of the ‘90s.
Keeping Up to Standard
Intrinsic to demonstrating quality for any firm is implementation of an external quality audit and certification to an industry standard. Given the choice available to the industry, there is no shortage of auditors for part 111 current Good Manufacturing Practices (cGMPs), but there is quality and, therefore, value in the services of an audit. The results of a third-party quality audit provide a benchmark assessment of the adequacy of the existing program as it sits statically in the present, and an assessment of weaknesses to drive continuous process improvement into the future.
The Natural Products Association (NPA), formerly the National Nutritional Foods Association, created the first GMP standard for performing quality audits as well as certification in the dietary supplement industry. NPA is committed not only to advocating for the rights of manufacturers, suppliers, and retailers to have a marketplace in which to sell products but also to consumers having access to quality products in order to maintain their health and well-being. NPA has developed a long and diverse array of self-regulatory initiatives and programs, all of which were firsts for the natural products and dietary supplement industry.
To advocate both consumer and industry concerns, associations will typically develop self-regulatory programs or initiatives which demonstrate industry transparency and maturity, and provide the consumer valuable information that can be used to evaluate products. The public and private benefits of industry self-regulation are numerous, and they typically outweigh the costs incurred to industry. First, self-regulatory programs and initiatives may lead to the establishment of product or ingredient standards to ensure quality and safety. In turn, these standards may facilitate the emergence of markets by establishing baseline levels of product quality and safety; result in improved consumers’ understanding; impart brand recognition through seals/marks representing third-party certification; induce brand loyalty; and garner trust of new products.