The challenges of managing supply chain disruption are complicated and can have serious consequences. When news about sea freight and shipping containers became national headlines and the world was riveted by the drama of a ship stuck in the Suez Canal, we knew that supply chains were facing new challenges. From ketchup to appliances, consumers are feeling the effects of a finely tuned global trade network unable to keep up with abrupt changes in market demand.
During the COVID-19 pandemic, supply chain vulnerabilities were exposed. Early in the pandemic it was toilet paper, paper towels and sanitizing wipes. But as time wore on, consumer behavior evolved, constantly challenging the supply chains to keep up.
Brand loyalty vs. regulatory concerns
Consumer brand loyalty took a hit during the pandemic as people explored ways to reduce spend and increase convenience while coping with life during COVID-19. It seems that no industry is untouched by this, and each manufacturer has been challenged to find a solution to the supply interruption of a critical component, material or ingredient.
Brand loyalty in the medical device and pharmaceutical industries is not a matter of taste but is instead driven by the regulatory requirement to ensure the safety of the devices or drug products. Even the equipment used to manufacture drug products is subject to this requirement, establishing the need for a state of control back into the supply chain. Reusable equipment is typically qualified for use at installation, whereas single-use systems are reliant on the supply chain for a continued supply of materials meeting the requirements.
This typically means that a component, material, ingredient or process equipment is selected, specified, validated and immortalized on a regulatory submission in a way that makes changing to a different version complicated. Most single-use medical devices and single-use systems for bioprocessing are made of plastic, an industry that has seen supply tightening and shortages, threatening manufacturers with supply interruptions. Within the past several months, shortages have been reported in materials and components for medical devices and single-use systems. Silicone and TPE tubing, specific connectors, clamps and medical adhesives are just a few examples.
A science- and risk-based approach
How can medical device, pharmaceutical or single-use system manufacturers manage short-term interruptions to the supply chain without shutting down production? The answer lies in qualifying a functionally equivalent replacement using a science- and risk-based approach.
The difference between the validated and documented item and the proposed replacement should be assessed first by a science-based comparison of the current choice and the proposed alternative. A formal risk assessment should then be performed (usually an FMEA) to evaluate the risk posed by the differences between the incumbent and the proposed replacement. If the science supports equivalency of the alternative and the risk is considered to be low, a decision to use the different item can be supported. The FMEA may also highlight areas where targeted qualification studies can mitigate any risks.
Longer term, business continuity should be a consideration when selecting a specific component and supplier. Although second sourcing remains an important tool to mitigate risk, business continuity is a complex topic with many potential solutions. Choosing a supplier who takes business continuity seriously and has the expertise to assist with implementing a second source during development or a crisis will enable a manufacturer to create a more robust supply chain that will serve them well for years.
In today’s uncertain and ever-changing world, it’s more important than ever to ensure your business can keep mission-critical functions up and running during an emergency situation. In 2017, Qosina started a rigorous process to ramp up our business continuity management system (BCMS) and get ISO 22301 certified. And in 2020, when the world was turned upside down by the COVID-19 pandemic, our solid BCMS served us well in that we had a playbook in place, allowing us to immediately assess the crisis and begin to implement the actions needed to keep our business operations and the supply chain running as close to normal as circumstances would allow and without any major hiccups.
We hope to never experience another pandemic or catastrophic event, but Qosina is prepared to help maintain the important continuity of critical components needed to supply the medical and bioprocess industries. Please contact us at +1 (631) 242-3000 or email@example.com to discuss your component needs and learn more about how we can help select an alternative item today or de-risk your supply chain for the future.