Product Complaint Investigations - The application of Lean Six Sigma methodology for U.S. FDA-Regulated Industries 2013

Key Topics

• How LSS fits into the CAPA & Risk Management framework
• Overview of Lean Six Sigma (LSS) Methodology
• Industry case studies detailing the usage of the LSS process to successfully close CAPA activities
• Specific deliverables in the following problem solving/investigation phases
  • 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?
  • Define – what is the problem, from the customers’ perspective? Has the process boundaries of the problem been defined?
  • Improve – based on the identified root causes, what are the optimal "implementable" solutions? Solutions need piloting or full implementation? Were the desired results attained?
  • Analyze – How well does our process perform in relation to customer expectations? What are the key sources to the non-conformance?
  • Control – With the process now in control, how do we best measure "in-process" performance? How do we sustain the improvements long term?

Who should Attend

Attendees involved in CAPA, Complaint Investigations, Engineering, QA/QC, Process Development, Manufacturing, Internal audits and Compliance.