I completed Yellow Belt training in 2007, followed by Lean Green Belt training shortly thereafter. During my time as a Manufacturing Supervisor at Baxter, I had the opportunity to focus heavily on Kaizen events for 18 months, leading numerous initiatives across multiple departments, including Biologics Manufacturing, Device Manufacturing, Quality Assurance, Quality Control, Supply Chain, Warehouse, and Facilities. A highlight of my work was leading a project that reduced the Japanese reject rate of a device product from approximately 22% to under 5%.
Additionally, I was part of a three-person team tasked with training all employees at the Hayward Baxter facility in Yellow Belt methodologies. I also led Kaizen events aimed at improving business processes with Contract Manufacturing Organizations (CMOs), specifically focusing on Change Control, CAPA, and Product Recall strategies.
During this period, I earned my Six Sigma Lean Black Belt and developed and facilitated training sessions on DMAIC (Define, Measure, Analyze, Improve, Control), Mistake Proofing, and Process Mapping.
I find great value in the Kaizen process as it engages employees at all levels, giving them a voice and making them feel heard. This inclusive approach not only drives improvements but also creates a network of champions who support and promote the changes, making the transformation more sustainable and impactful.
Kaizen, a Japanese term meaning "change for the better" or "continuous improvement," is a business philosophy that emphasizes ongoing efforts to improve processes incrementally. It involves all employees in identifying opportunities for improvement and making small, gradual changes that enhance productivity and efficiency over time. Kaizen views improvement as a methodical and continuous process rather than a one-time event, fostering a culture of continuous learning and innovation within organizations.
DMAIC, an acronym for Define, Measure, Analyze, Improve, and Control, represents a structured approach used in Six Sigma and Lean Six Sigma methodologies for process improvement that guides in improvesing the activity, identifying the opportunities for improvement, setting project goals, and meeting the needs of the customer (internal and external).
Mistake-proofing, known as poka-yoke in Japanese (pronounced PO-ka yo-KAY), as well as fool-proofing, error-proofing, and fail-safing, involves using automatic devices or methods that either prevent errors from happening or make errors immediately obvious once they occur. The goal is to design processes or systems in a way that minimizes the likelihood of mistakes and their impact.
Streamlining, mapping, and mistake-proofing offer significant value across all processing needs. Whether it's tech transfer, yield improvements, or scaling up, Lean Six Sigma can benefit all these processes.
Lean Six Sigma can streamline both your production processes and your business processes. Mapping out these processes can reduce re-work, waiting times, clarify responsibilities, and eliminate non-value-added steps.
Support for designing, creating, or updating SOPs, Batch Records, and Visual Aids to ensure improvements are effectively captured and easily understandable. The aim is to make these documents clear, user-friendly, and aligned with operational enhancements.
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