P.138 Effects of cannabis use on neural progenitors and neuronal differentiation in humans

Abstract

An effective and efficient quality management system (QMS) requires a well-equipped toolbox for monitoring processes, determining root cause, and driving continuous improvement. A common approach and lexicon enhance improvement activities as well as communications. Corrective and preventive action, failure investigation, statistical process control, and root cause analysis are critical to success. A well-defined, preplanned inspection management process should also be in the toolbox to present the QMS in the most correct and favorable manner. An ongoing focus on improvement is essential to thrive or even survive in the highly regulated medical device industry. Maintaining acceptable performance levels, meeting quality objectives, and driving continuous improvement require a well-equipped toolbox. There are many approaches, tools, and techniques for improvement. These tools vary in favorability over time. However, they have many similarities. And they are known by an alphabet soup of acronyms such as CAPA, RCA, A3, 5S, 5 whys, Six Sigma, 6Ms, DMAIC, DMADV, DFSS, PDCA, PDSA, TQM, SPC, FMEA, FMECA, FTA, DOE, ANOVA, Cpk, Ppk, C&E Matrix. Medical device manufacturers can benefit by having a rigorous and consistent methodology for problem analysis and improvement. Effective use of these tools can support a culture of data-based decision making. CAPA is the single most important process for improvement and has very specific regulatory requirements.