Insights for FDA Regulated and HIPAA Compliant Organizations
The Breaking Point for Supply Chains
Over the last decade, many companies faced extreme supply chain challenges that stretched their capabilities to the breaking point. The emergence of COVID and the pandemic of 2020, and now 2021, has only intensified the pressure.
Supply chains, which once functioned almost on autopilot, face many dangers today in both the global and the domestic markets.
Due to its global nature and systemic impact on the firm's financial performance, the supply chain arguably faces more risk than other areas of the company. Risk is a fact of life for any supply chain, whether it's dealing with quality and safety challenges, supply shortages, legal issues, security problems, regulatory and environmental compliance, weather and natural disasters, or terrorism.
There's always some element of risk. Life Science companies with global supply chains face additional risks, including, but not limited to, longer lead times, supply disruptions caused by global customs and foreign regulations.
The life sciences industry is one of the most highly regulated industries in the world. More than risk management, regulatory compliance requires a 360-degree view of the entire product development and delivery chain.
Perhaps the number one strategy used to mitigate supply chain risk is to choose financially strong, competent, world-class suppliers. This is easier said than done. Many firms report that it takes approximately two years to develop and fully certify a global supplier.
Following that is a focus on compressing global shipping time and cycle time variation. Leading firms apply Lean principles and Six Sigma techniques to this effort. They value stream map the end-to-end global shipping process and look for ways to reduce or eliminate waste and delays at every step.
Another key strategy used to mitigate supply chain risk involves the use of visibility tools to closely track global shipments and take action when necessary.
Leading firms use supply chain event management technology to send alerts to key personnel when action needs to be taken by someone, somewhere in the global supply chain, to correct delays.
A lack of quality and responsiveness can result in missed revenue, recalls, and other significant business problems. Only by creating high quality processes to keep up with the ever-changing industry and market conditions can you ensure peak performance in warehousing, inspection, kitting, distribution and tracking outcomes.