Product Complaint Investigations - The application of Lean Six Sigma methodology for U.S. FDA-Regulated Industries

The Lean Six Sigma methodology is emerging as not only the best practice in successfully addressing CAPA opportunities but also quality in general. Organizations, the likes of Abbott, GlaxoSmithKline, GE Healthcare, Sandoz, and Bayer, just to name a few, have been leveraging Lean Six Sigma to improve quality and performance across their value chain. What is more is that these large players expect their suppliers too to have proven, repeatable and effective quality systems in place. This presentation will provide an overview of the Lean Six Sigma methodology, followed by the detailed review of a corrective action initiative. It will take the attendees through the five phases of LSS, helping demonstrate the problem solving approach. The presenter will discuss industry case studies to demonstrate the use of the LSS process to successfully close CAPA activities. Areas Covered include: • Overview of Lean Six Sigma (LSS) Methodology • How LSS fits into the CAPA & Risk Management framework • Specific deliverables in the following problem solving/investigation phases: 1.Define – what is the problem, from the customers’ perspective? Has the process boundaries of the problem been defined? 2. Measure – What is the most effective way for us to measure the problem? How does the process(s) with the largest impact to the non-conformance work today? What is best way to collect process/product data needed for root cause investigation? 3. Analyze – How well does our process perform in relation to customer expectations? What are the key sources to the non-conformance? 4. Improve – based on the identified root causes, what are the optimal “implementable” solutions? Solutions need piloting or full implementation? Were the desired results attained? 5. Control – With the process now in control, how do we best measure “in-process” performance? How do we sustain the improvements long term? • Industry case studies detailing the usage of the LSS process to successfully close CAPA activities. Opportunity Problem Statement The Lean Six Sigma methodology is emerging as not only the best practice in successfully addressing CAPA opportunities but also quality in general. Organizations, the likes of Abbott, GlaxoSmithKline, GE Healthcare, Sandoz, and Bayer, just to name a few, have been leveraging Lean Six Sigma to improve quality and performance across their value chain. What is more is that these large players expect their suppliers too to have proven, repeatable and effective quality systems in place. This presentation will provide an overview of the Lean Six Sigma methodology, followed by the detailed review of a corrective action initiative. It will take the attendees through the five phases of LSS, helping demonstrate the problem solving approach. The presenter will discuss industry case studies to demonstrate the use of the LSS process to successfully close CAPA activities.