SQA Services

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By: Gerard Pearce As supply chains of medical device manufacturers evolve and the supplier quality function within them adapts accordingly, the issue of supplier data becomes more prominent. This is not just from a regulatory standpoint, but also stems from a need for the supplier quality function to leverage available information to reduce costs and improve quality. Managing and maintaining supplier data is already a requirement of 21 CFR 820 of the U.S. Food and Drug Administration's good manufacturing practices requirements and quality system regulations.

Since its founding in 1995 by father and son Jim McKay and J. Michael McKay, SQA has pursued a vision of helping companies improve. Chaired by Jim McKay, who pioneered Supplier Quality Management services in the 70s, SQA is widely recognized as a key body of knowledge, a flexible global resource, and a proven solution provider for today's complex supply environments. SQA leads in providing managed supplier quality services for audits, corrective actions, inspections and engineering to manufacturers within the healthcare, aerospace and high tech industries.

The challenges of today Supplier audits are a critical component of ensuring the integrity of the supply chain. However, evolving supply chains are outpacing traditional audit program methods. Today, effective supplier audit programs require a fresh look at the people, processes and technology involved. Looking at all of the FDA warning letters for 2008, Medical Device manufacturers still struggle with supplier controls, with nearly one in five highlighting deficiencies in this area.

With many borders bridged and new horizons conquered, companies need to turn their attention to ensuring their supplier quality functions are well-equipped to maintain control over their complex supply chains. Control, in the regulatory sense, begins with an effective and efficient supplier evaluation program. And to achieve this, Supplier Quality Managers need to adopt some creative ways to cover their expanded territory, and take a regular dose of their own quality improvement medicine.

Just several weeks into the year, 2012 is presenting us all with incredible opportunity for growth and improvement. Having learned much from developing and growing complex programs that uniquely assess supplier risk, we are poised to bring our expertise to new industries that are beginning to experience tighter regulations and are looking to leverage our expertise to mitigate risks.

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