3-Hour Virtual Training: Lean and the Manufacturing Process

Why Should You Attend:

The first virtual training program in the lean series - Achieving Lean Operational and Compliance Excellence – Lean Leadership - looked at the role leadership plays in a successful on-going lean implementation. This webinar will begin by looking at lean in terms of its characteristics, considerations, tools and techniques.

The Gemba reports or the reporting process results in the identification of areas, processes, operations, actions, etc. requiring improvement. The Gemba triggers improvement action. What to look for and how those findings are identified is addressed in this session, in terms of the “8 wastes” and 4Ms – man, machine, material, method.

Once issues are identified, root causes must be determined and that means problem-solving. There are many approaches that can be applied and the most common will be covered. Finally, the principle that defects can only be prevented by carefully simplifying processes so that mistakes/human error are impossible to make is addressed. This principle or process is called mistake-proofing and is fundamental to lean. Numerous examples of each lean principle will be presented to aid in understanding and enhance learning.

Learning Objectives:

• Define the GMP rules of manufacturing
• Explain how the rules are used
• List and describe the contents of the GMP rules of manufacturing and how they vary from industry to industry
• Explain how the rules translate into observable action on the production floor
• Define Gemba and how it fits into the lean manufacturing scheme
• Define the 8 wastes and 4Ms and explain how they relate to Gemba
• Describe the tools used to report Gemba findings
• Explain how the Gemba process is deployed
• List and describe the steps for completing the Gemba Walk
• List and describe the mistake proofing tools
• List each of the common problem solving methods
• Explain when each method is appropriately used
• Explain how each method is used
• Define mistake proofing
• List and describe the types of errors and defects and their relationship
• List and describe the methods for error elimination
• Explain how mistake proofing is implemented

Areas Covered in the Webinar:

• How lean applies directly to the manufacturing process as well as other functions in the organization
• GMP as the cornerstone of lean within the life sciences
• The GMP rules of manufacturing and how they can significantly impact quality, efficiency, effectiveness and human competency
• The rules of manufacturing and how they are applied on the production floor
• The concept of “managing by walking around” and how it evolved into the more formalized Gemba
• The focus of Gemba – the 4 Ms
• The eight wastes and their impact on the production process
• Conducting the Gemba Walk
• Reporting Gemba Observation results
• Human errors and their impact upon the operation
• Mistake-proofing as Poka Yoke
• Levels of mistake-proofing
• Common mistake-proofing techniques and how they are applied
• Implementing Poka Yoke
• The common problem-solving methods and how they are applied
• The types of problems, their impact, and how they are addressed

Who Will Benefit:

This webinar is applicable to the medical device, pharmaceutical, foods, beverages, consumer products, and cosmetics industries:

• Operations personnel – operators, technicians, and supervisors
• Engineers and tech services personnel to include managers and directors
• Quality and compliance personnel
• Middle and senior operations management

Charles H Paul
President, C H Paul Consulting Inc

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems.

The firm works globally completing projects throughout the EU, UK, South America, and Asia.

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