S39: Process Excellence Starting in Development

Many people are drawn to careers in science for the challenge of discovery and innovation.  However, once in the workplace, one is met with unexpected and unknown barriers to success.  Some of these barriers are unrelated to the core science, but rather have their roots in the fundamentals of planning, knowledge transfer, and execution.  If not discovered and corrected during development, they can manifest as failures in scale-up and manufacturing.

Typically there is less opportunity to make process changes after transfer from R&D to manufacturing. High quality in manufacturing starts with quality in development.  So, it is absolutely critical to adopt a process excellence mindset in R&D. This can be accomplished by adopting these five routine methods:  gap-risk assessments, T-7 readiness reviews, standard workflow, workplace organization, and lessons learned.  These methods help break down organizational silos by aligning R&D with manufacturing earlier in the lifecycle.  Since most people don’t move along with a product, the body of knowledge must be captured and communicated as it transfers across organizational functions.

During times of crisis, people somehow find the time to fix problems.  Instead, spending a fraction of that time earlier in the lifecycle can save time later.  One can mitigate unknown risks by proactively applying these useful lean methods with key process owners, thereby increasing probability of success