By Michelle Gattshall
For those of you who have attended a research sponsor conference, you probably remember certain sessions that made you go “Wow! I wish I had known that before!” I still remember the Southwest Oncology Group (SWOG) conference where I was first introduced to the Lean Six Sigma world. Lean Six Sigma concepts have been used in manufacturing and business for many years but they are still being adapted to the healthcare and medical research fields. In a nutshell, Lean Six Sigma strives to eliminate organizational waste (Lean) while reducing defects (Six Sigma).
Those who attended that SWOG talk were immediately enthusiastic because of the obvious application towards reducing the deviations/violations that we all hate! At that time, I was a supervisor and regional lead for Phase 3 oncology clinical trials at a large healthcare organization. Since the National Cancer Institute (NCI) routine audits were always on the horizon I was thrilled to find ways to reduce reportable events. Little did I know that my professional journey would take me into healthcare quality where I would be diving deep into Six Sigma and process/performance improvement for the next several years. As a certified Lean Six Sigma Black Belt, I have often wished that I had known about the Six Sigma concepts and tools when I was managing Clinical Trials!
For all of you amazing clinical trial site managers and leaders who want their sites to excel, here are my top five favorite tools from the Six Sigma world! If you use these consistently, you will increase your site efficiency and decrease deviations and violations.
1. FMEA – Failure Modes and Effects Analysis
Stop problems BEFORE they happen! How do you evaluate potential research studies for your site? Are you identifying potential issues and creating a mitigation plan before you start enrolling patients?
2. Process Mapping
Did you know that organizations typically increase efficiency by up to 50% for any process that is mapped? Clinical Trial Sites are BUSY, so couldn’t you use 50% more time?!
3. Root Cause Analysis
Yep, if you are a clinical trials site you probably know this term! But are you using an effective Root Cause Analysis method? If you have repeat deviations or violations, it is likely that you have not identified the true root cause.
4. Visual Checklists
An oldie but goodie! There is a reason why even the most experienced pilots still have a pre-flight checklist! How do your checklists measure up?
5. 5 S’s
Sort, Straighten, Shine, Standardize and Sustain. Think of it as Spring Cleaning for your site!
Subscribe as I take you more in-depth into each of these tools from Six Sigma to optimize your clinical research site!
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