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Building a Corporate Culture of Quality

Steve Myers
04/17/2008
Continued from page 2

With the first wave of the federal GMPs (good manufacturing practices) for dietary supplements about to hit the deadline for compliance, many are wondering how this regulation will affect the level of quality in the industry as a whole. One thing is certain—the GMPs place almost all of the burden of proof and responsibility on the manufacturer of the finished product. It is up to this manufacturer to ensure the ingredients or raw materials coming in for formulation are unadulterated and properly identified; packaging and production are also part of this GMP protocol. Should FDA enforce the regs adequately, inferior raw materials and prevalence of low-quality goods should begin to recede into oblivion. Thus, GMPs could help level the playing field.

“Really, manufacturers will need to lean heavily on the ingredient supplier for information on the supply chain, traceability, potential contaminants—a whole host of parameters,” Shao said. “This is where quality-focused ingredient suppliers will have a leg up on competition, the companies which, to this point, have not maintained quality-focused activities in the marketplace, including those who don’t do due diligence, because they won’t know where the raw material came from, what potential contaminants are and at what level. Quality-focused companies know these things, even for the international markets.”

Besides GMPs, there have been many quality systems available that are either specific or non-specific to natural products. Programs such as Six Sigma, Quality Circles and ISO 9000 have helped businesses of all industries systemize their quality activities and create a culture of quality. Pontiakos explained most of these systems came out of the military, which needed a protocol to ensure life safety-dependent products wouldn’t fail in a life safety-challenged environment. These were then adapted to commercial use.

Pharmanex developed a supplement-specific, in-house quality system called 6S®, based on some of these programs. This is a common practice among high-quality, trusted supplement companies. Chang confirmed there is much overlap between all these systems, but Pharmanex needed to adapt and simplify these programs to natural products. Pharmanex decided it was easier for its people to remember six words that begin with the letter ‘S’—selection, sourcing, structure, standardization, safety and substantiation. “Eventually, we feel GMPs will become the dominant quality program in our industry,” he conceded.

An overlooked area of quality is that of claims, claims substantiation, advertising, marketing and related activities. While FTC oversees these parts of business, self-regulation also exists within natural products. CRN has partnered with the National Advertising Division (NAD) of the Better Business Bureau (BBB), offering a grant to NAD’s voluntary program, which looks at supplement advertising for truth and accuracy. Any company with national advertising can participate.

Advertising and claims are important to quality, because the ultimate end game is consumer confidence. “If you have a high-quality product that meets label claim 999 out of 1,000 times, but the health claims are way out there, in terms of reflecting research done on your specific product, then you’re undermining consumer confidence,” Shao said. “When you’re over-promising and under-delivering in terms of efficacy of your product, you’re undermining consumer confidence.”

Pontiakos took this idea one step further: “If you are an entrepreneur or officer in a public or marquee company, and you spent your entire life putting in untold hours to build your business and brand, why would you jeopardize that for few cents per kilo?” However, he said, such destructive behaviors and the underlying attitudes focused on price variance have changed markedly. “Unfortunately, it took a couple of really high-profile companies to go down, but now I’m starting to see significant change in customer base within the market, in terms of high-quality products vs. previously low-quality products. The approaching GMPs are also helping.”

Chang’s wisdom on the importance of building a culture and commitment to quality is, “Quality is the DNA behind your identity and brand. At the end of the day, it is how we define ourselves, as a company, as an industry.”

For Pontiakos, the little steps towards a quality culture could result in giant leaps: “If nothing else, if industry could change one metric and rate their suppliers on total ownership cost of quality, instead of purchase price variance, the quality and confidence problems in this industry would go away immediately.”

Editor's Note: INSIDER's Quality Control section is sponsored by Ethical Naturals; however, the company does not review or approve editorial content.

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