Judging Quality: Looking Past the Paperwork

Originally Published MDDI November 2003

Outsourcing

Maureen Kingsley

When an OEM is shopping around for an outsourcing partner, one of the most important steps it needs to take is assessing a manufacturer's quality systems. Reviewing the documents and taking a brief tour of the manufacturing floor are helpful, but they're not necessarily enough. And just because a facility is certified to ISO 9000 or is FDA registered doesn't always mean an OEM should be satisfied that the plant's quality systems are effective.

“Because of inconsistencies in how ISO-9000 registration audits are performed, there is a lack of credibility of the entire third-party for-profit registration scheme,” says Andrew Jelen of Encompass International, a firm specializing in quality engineering, regulatory affairs, and process improvement in the United States and worldwide. “Having a certificate no longer means all that much in the United States, and it means even less in Asia.” Jelen is hired by OEMs that are considering outsourcing and that want an assessment or audit of their suppliers' quality systems. “Often,” he says, “the procedures and systems exist, but there's a disconnect between what's documented and how the product is actually designed, developed, and manufactured.” He believes that often, companies miss the real intent of the requirements.

Jelen strongly encourages medical device companies to send their best quality engineers when assessing a potential partner's quality system—especially if the partner is overseas. “Almost half of all medical devices are made outside the country now,” he adds. Quality engineers should verify that the “process and controls [the contract manufacturer] has in place are adequate to ensure that all applicable technical and quality requirements can be met. They should be commensurate with the risk of the product or service being provided.”

Jelen praises the successful application of quality engineering tools and methods in the other industries with which he has experience, including aerospace (NASA and Department of Defense), automotive, and telecommunications. “I strongly believe you can't effectively implement or audit a quality system unless you understand quality engineering. Quality management alone doesn't address many of the technical requirements. Quality engineering covers both the business and technical aspects.” 

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