supply chain Posts

Leadership’s Role in Improving Supplier Quality Management in Life Sciences

Leadership’s Role in Improving Supplier Quality Management in Life Sciences

Matthew Littlefield, President and Principal Analyst, LNS Research

The demands on quality organizations are rising across the board, but perhaps none as quickly or urgently as in the life sciences industries. While increased competition and the need to innovate certainly aren’t unique circumstances for life sciences, the level of scrutiny from regulatory agencies and the rapidly evolving nature of the supplier network are, placing an incredible burden on elevating supplier quality management capabilities. (more…)

QMS: Pain Management for Supply Chain Management

QMS: Pain Management for Supply Chain Management

Sandy Carson, Marketing Communications Manager, Pilgrim Quality Solutions

Supply chain management is tougher than it used to be. In just about every industry, it seems OEMs (Original Equipment Manufacturers) are increasingly outsourcing once-traditional in-house functions, adding geographical distance and other external variables to the supply chain. This, of course, adds complexity to the process stream and requires manufacturers to have a pretty high “chain” tolerance as the likelihood that something will go wrong and quality will be compromised grows greater. (more…)

Do You Want to Improve Your Supplier Quality Management Process Today? Here are the Places to Start

Do You Want to Improve Your Supplier Quality Management Process Today? Here are the Places to Start

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Cost of quality, defect rates, and customer complaints can often be tied back to a common cause – poor supplier quality. Supplier-related defects are the most costly and difficult to correct, which is why managing supplier quality properly is incredibly important.

Your organization depends on you to ensure that suppliers are providing high quality materials in a timely manner. This means that you need to filter through a complex and potentially global web of suppliers, and understand where potential problems are occurring (or where they may occur in the future). So let’s take a look at some process improvements that will help you hone in on your most important suppliers and manage their quality activities for maximum impact. (more…)

Supply Chain Management Is a Big Target for the FDA

Mark Crawford

According to Alan Schwartz of mdi Consultants Inc., a former supervisor of field operations for the FDA, supply chain oversight is the FDA’s next big area of concern.

About a year ago the FDA indicated plans to expand its enforcement reach over foreign device suppliers through consent decrees. The FDA also asked manufacturers and importers to assume a bigger role in managing their supply chains. An FDA spokesperson, compliance officer Carmelo Rosa, further stated that “currently the agency only has authority to establish import alerts for foreign companies with good manufacturing practice violations, but is looking at other options.” (more…)

Managing Quality, Compliance and Risk in a Global Economy

Time to market is one of the major reasons we look to the global economy. Acquisitions and mergers can take us across international borders to quickly gain the intellectual property we need. International supplier sourcing can get products more quickly to our manufacturing sites and our customers, or broaden our foot print in a country quicker and faster. (more…)

Are They Just Pulling Our (Supply) Chain?

The FDA, Congress, the US Consumer Products Safety Commission, US Immigrations and Customs Enforcement, the Department of Justice. These and countless other regulatory bodies are more proactively evaluating the potential risk and liability to our country’s goods and products; and as we’ve seen, the sharing of information among these regulatory bodies is leading to more cohesive enforcement activities with the continuous goal of protecting the consumer. (more…)