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.
