Protect Your Product From the Risks of Supply Chain Complexity

Sparta Systems

Proactive quality management requires complete visibility into quality—which includes your entire supply chain

If reducing the risk of recalls is one of your top priorities in 2020, then proactive quality management is a natural fit.

Visibility and collaboration are an integral part of a proactive approach, which is challenging when it comes to the supply chain.

Outsourcing, multiple sites and other issues add a level of complexity that can hinder your quality management efforts and increase recall risks.

What can you do?

The High Cost of Quality Events

Recalls are a potentially disastrous—and increasingly common—outcome of quality events.

From 2004 to 2013, FDA drug recalls increased 600 percent. Stericycle Expert Solutions reported that more than one million Class 1 medical device units were recalled in Q1 of 2019 alone. The report cited quality issues as cause of the recall in more than half those units.

A single recall can easily cost your company tens of millions of dollars, not to mention long-term detrimental effects on sales, brand image, and company value.

Major quality events can cost hundreds of thousands of dollars per day and can take weeks-to-months to resolve.

Even a spike in temperature or humidity in a controlled manufacturing environment can shut down manufacturing at the site of the event until the problem is resolved.

Increasing the number of hand-offs from raw material to finished product increases your risk of a quality event.

But regulations are clear that the product owner is ultimately responsible for any quality issues, even those that originate with suppliers.

In ICH Q10 (Pharmaceutical Quality System), the FDA states that pharmaceutical companies are “ultimately responsible to ensure processes are in place to assure the control of outsourced activities and quality of purchased materials.”

Manufacturers must find ways to manage supplier risk if they hope to control their own.

Increased Complexity = Increased Risk

Current Good Manufacturing Practice (CGMP) requires robust quality management systems that can keep up with today’s exacting quality standards.

Yet the quality systems in place at suppliers and smaller contract manufacturing organizations often fail to meet these standards.

A 2018 report in BMJ Global Health noted that inadequate quality systems play a primary role in quality issues across pharmaceutical supply systems in low-income and middle-income countries.

The report stated that “the variability of the quality systems across distributors in a country implies a variable level of QA, and a real risk of exposure to poor-quality or degraded medicines.”

Even under the best circumstances, the use of separate quality systems at suppliers or contract manufacturers increases complexity and can limit your visibility into end-to-end quality.

Issues that stem from supply chain complexity typically involve five factors:

• The number of variables that must be monitored and controlled
• The volume of required transactions, especially if they are manual and involve multiple individuals
• The variability of each interaction, including the levels of interaction that are required for problem resolution
• The extent of visibility into interactions
• Mechanisms for managing and communicating change

Key steps for mitigating these risks, then, are gaining visibility into supply chain and partner quality data and integrating quality management as much as possible.

Expand Visibility to Integrate Supply Chain Quality

Cloud technology, as part of a mature digital quality management ecosystem, can lead to innovation and an integrated quality network across your suppliers. Internal quality management processes connect with ecosystem partners, delivering comprehensive visibility into issues from raw material through manufacturing to customer experience.

The Benefits Can Be Transformative

• Increased visibility and instant awareness of quality issues, from both upstream and downstream partners
• Enhanced accountability for each partner in the supply chain
• Operational efficiencies that make it easy to track and trend quality issues in real time
• Product safety and compliance— ultimately, a healthy, quality supply chain enables production of safe products