Continuous Improvement & Quality

This course provides a comprehensive understanding of the current Good Manufacturing Practices (cGMP) in accordance with the quality systems approach currently used in FDA inspections.

Learning Objectives

• Learn cGMP goals and principles including - facilities and equipment, maintenance, validation and testing, procedures, hygiene, documentation, quality and audit.
• Become familiar with FDA enforcement trends.
• Understand internal auditing best practices.

Typical Course Length:  2-4 hours

In this training participants will learn that documentation of every aspect of the process, activities, and operations involved with drug manufacture is a very important part of GDP.  They will understand that the documentation showing how the product was made and tested is correct and in order, so the product will meet the required specifications. Team members will learn the goals and principles of GDP, improve their understanding of FDA GDP documentation requirements, and improve their understanding individual responsibilities in ensuring compliance to FDA GDP.

Learning Objectives

• Maintain comprehensive documentation and records, conduct internal audits, and prepare their operations for FDA inspections, ensuring ongoing compliance. 
• Create and modify documents that align with GDP
• Learn the fundamentals of good communication and technical writing skills applicable to SOPs, lab notebooks, revising batch records, and FDA requirements for process documentation.
• Understand the cost of poor quality in documentation will be discussed.
• Optimize documentation processes and create less errors, increasing the overall efficiency and lessening the potential for internal and external audit findings.

Typical Course Length:  2-4 hours

This course offers techniques for writing clear, concise and usable Standard Operating Procedure documentation that meets FDA, audit and internal specifications for technical documents.

Learning Objectives

• Define FDA and other regulatory agency requirements for SOP development and implementation.
• Apply SOP tools including flowcharting, photos and helpful hints.
• Understand how SOP documentation reflects the audience for which it’s written.

Typical Course Length:  4-6 hours

This course teaches how to leverage Kaizen Events to apply Lean problem-solving fundamentals and applications to rapidly improve business processes and reduce or eliminate non-value-add activities.

Learning Objectives

• Build proficiency with Lean tools through Kaizen Event applications.
• Perform current and future state mapping.
• Learn how to increase Lean awareness among employees, manage a new process implementation and address culture change.
• Understand ways to maintain an improved cadence and sustain a Lean culture.
• Comprehend value stream process and improvement-event selection.

Typical Course Length:  24-40 hours

This course introduces Key Performance Indicators (KPI) used to measure business efficiency, quality, timeliness, and performance, including their selection, measurement and monitoring. It can be customized for all leadership levels within an organization.

Learning Objectives

• Identify critical quality characteristics for KPIs.
• Develop KPIs for individual departments.
• Learn how to effectively measure and monitor KPIs.

Typical Course Length:  16-24 hours

The course provides a broad orientation for anyone in an organization implementing Lean. It incorporates instruction, discussion, and simulation on Lean concepts and tools.

Learning Objectives

• Recognize the value and potential impact of Lean within an organization.
• Learn and understand core Lean concepts: Safety-Purpose-Agenda-Conduct-Expectations-Roles and Responsibilities (S.P.A.C.E.R.); Lean Roadmap; Process Waste; Value; Value-Stream Mapping (VSM) and VSM Tools; Flow and Pull.

Typical Course Length:  6-8 hours

Course provides a solid grounding on Lean Leadership by exploring Lean’s three pillars for effective leadership as well as the importance of self-awareness, effective communication, trust and community building, and supporting employee growth, empowerment and leadership. Lean organizational structures and coaching systems may also be covered along with selected Lean Practitioner material. 

Learning Objectives

• Recognize the unique aspects of Lean leadership.
• Explore Lean’s three pillars of sustainability from a leadership perspective: deep understanding of Lean tools, process improvement culture and leadership requirements.

Typical Course Length:  8 hours

This course is for individuals who are on a team using Lean and seeking to deepen their understanding of Lean tools and applications. It covers topics such as proven Lean deployment structures, value streams, current and future state value-stream mapping, customer demand, continuous flow, leveling tools and Kaizen-event implementation. Office and/or manufacturing versions are available with case studies showing how Lean tools improve process velocity and flexibility. 

Learning Objectives

• Explain Lean’s key concepts and metrics.
• Understand Value Stream Management (VSM) processes and Eight Deadly Wastes.
• Build proficiency in the Three Phases of Lean Application.
• Demonstrate current and future state as well as customer demand phase mapping.
• Create Kaizen plans and their implementation phases.
• Learn strategies for addressing change.

Certificate Qualifications

1. successful completion of a Lean Practitioner course;
2. lead and successfully complete a Kaizen event;
3. pass a 60-question closed-book certification exam with a minimum passing score of 77% (230 points out of 300).

If qualifications are met, participants receive a certificate showing the number of contact hours.

Typical Course Length:  16 hours

This course provides an overview of tools and processes to identify the root causes (what, how and why) of complex problems.  Participants learn to apply tools to sample organizational challenges.

Learning Objectives

• Demonstrate skills in RCA tools to critically analyze data and solve problems.
• Create successful problem-solving processes and strategies.

Typical Course Length:  24-40 hours

This course develops participants’ skills in using 8D problem-solving methodologies for process, product and service improvement. It also explores synergistic ways for teams to efficiently identify root causes and prevent problems from reoccurring. Courses can be customized from basic to advanced.

Learning Objectives

• Demonstrate skills in 8D problem-solving.
• Build competency in the Plan-Do-Check-Act (PDCA) methodology.
• Learn to use the A3 approach to framing and addressing problems.

Typical Course Length:  8-16 hours

FMEA shows participants how to apply Failure Modes and Effects Analysis (FMEA), a proactive, systematic approach used by Product and Process Engineers to ensure that products and processes function properly over their life spans. It demonstrates methods for identifying design and process deficiencies early in the product development process by analyzing potential failure modes and their effects; developing an action plan to preempt failure modes. The course engages participants in hands-on, company-specific exercises and projects.

Learning Objectives

• Learn how to: plan and execute a successful FMEA project and implement each FMEA task steps and timelines.
• Understand System, Design, and Process FMEAs.
• Build competency in strategies for determining Failure Mode root causes.
• Demonstrate ability to quantitatively assess risk in design and manufacturing.
• Understand how other productivity tools complement FMEA.

Typical Course Length:  8 hours

This course provides high-level awareness of key Six Sigma concepts with an emphasis on the concept of process variation, the Define-Measure-Analyze-Improve-Control (DMAIC) process improvement roadmap, and the differences between Six Sigma with Lean methods. 

Learning Objectives

• Define Six Sigma’s essential methodologies and why they are important.
• Understand key Six Sigma roles and responsibilities.

Typical Course Length:  8 hours

This course sets the stage for becoming a Six Sigma Greenbelt team-member by introducing what “Six Sigma” means, the Define-Measure-Analyze-Improve-Control (DMAIC) process improvement methodology, and the typical roles and support systems set-up in a Six Sigma deployment. Emphasizing participant engagement, this course uses business application examples and exercises extensively. 

Learning Objectives

• Define Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC), Design-For-Six-Six-Sigma (DFSS), and key roles and responsibilities.
• Understand Common- vs. Special-Cause Variation, basic statistical concepts.
• Use phase tools and descriptions.

Certificate Qualifications

Successful completion of a Six Sigma Yellow Belt course and serve as team member on a Lean Kaizen event or a Six Sigma Green Belt project (no exam required).

Typical Course Length:  24 hours

The Six Sigma Greenbelt (intermediate) level course provides more advanced exploration and application of core Six Sigma tools and processes.  The course focuses on improving processes that already exist – not creating brand new processes – using the DMAIC methodology: Define, Measure, Analyze, Improve and Control.  Prerequisites: Basic process mapping, risk analysis, basic math and analytical skills, excel and a project scoped by a manager.

Learning Objectives

• Deepen understanding of the DMAIC Six Sigma process-improvement methodology.
• Apply knowledge through participation on company project-selection team, serving as project leader of Green Belt-level Six Sigma project and mentoring Yellow Belt team members.
• Gain a basic-level understanding of statistics (data science) including sample-size calculation and hypothesis testing.

Certificate Qualifications

Successful completion of a Six Sigma Green Belt course, lead and successfully complete a Six Sigma Green Belt project, toll-gated by a certified Black Belt or Master Black Belt, pass a certification exam.

Typical Course Length:  80 hours

This course provides an advanced level of Six Sigma knowledge and skills application, including a deep dive into statistical methods designed to address delayering of common-cause variation. Class focus is on improving existing processes although participants will be prepared to use the tools in process/ product design applications. Designs of Experiments, Analysis of Variance (ANOVA) and several aspects of regression will also be explored. A capstone project must be completed in parallel with class lecture and exercises. Prerequisites: Green Belt certification (successful completion of Green Belt training and a project).

Learning Objectives

• Understand and utilize statistical tools including multiple regression, Analysis of Variance (ANOVA), Design of Experiments (DOE).
• Scope and apply statistical tools to improve an existing company process.

Certificate Qualifications

Successful completion of the requisite Black Belt training, passing score on written and oral exam, and completion of capstone project. 

Typical Course Length: 20 hours in class plus self-directed project time of 8-12 hours

This course covers the processes and tools established to produce designs that are manufacturable, reliable, easily maintained and serviceable, good for the environment and at reasonable cost from the onset, based on customer requirements. Designs applications may be in any business or industry: manufacturing, services, finance, healthcare, research, and many others. The course assumes familiarity with both Lean and Six Sigma technology.  Prerequisites: Six Sigma Green Belt course (certification ideal), Lean Practitioner.

Learning Objectives

• Understand Define-Measure-Analyze-Design-Verify (DMADV), Identify-Design-Optimize-Verify (IDOV), and Define-Concept-Design-Optimize-Verify (DCDOV) practices.
• Define and identify Project Selection, Project Charter, Voice-of-Customer (VoC) and diagrams.
• Understand the concepts of Quality-Function-Deployment (QFD), House of Quality, Process Capability, Creative Brainstorming, and Concept Selection.
• Learn to design and incorporate optimization with Design-of-Experiments (DOE), Tolerance Analysis and Reliability.
• Understand and utilize validation/verification including Statistical-Process-Control (SPC) with Control Charts, Piloting and Project Closure.

Typical Course Length:  32-40 hours

This course explores Statistical Process Control (SPC) and offers participants basic control charting tools for continuous and attribute data. Participants will learn to use SPC to capture a data signature, use it in the identification of root-cause, and to avoid process drifts from specification. It can be customized for introductory, intermediate or advanced level participants.

Learning Objectives

• Complete case model examples.
• Define common and special cause variation.
• Determine management and employee roles in reducing common cause variation.
• Set-up, compute and interpret a variable control chart.
• Review and interpret various types of attribute control charts.
• Compare and contrast process specs to process capability.

Typical Course Length:  32 hours

This course builds understanding of Total Productive Maintenance (TPM), a comprehensive approach to equipment and asset management that is used in Lean and Continuous improvement to maximize operational productivity. Participants build a foundational knowledge of its key concepts, methodologies and best practices.

Learning Objectives

• Learn core TPM principles and apply tools related to autonomous, planned and quality maintenance; focused improvement; early equipment management; education and training; safety, health, and environment.
• Demonstrate the step-by-step process of implementing TPM, including overcoming common challenges and developing a TPM roadmap.
• Identify key performance indicators and metrics to assess the effectiveness of TPM initiatives and to drive data-driven decision-making.

Typical course length:  6-8 hours

This course provides strategies for improving business outcomes including visioning, planning and value stream mapping (VSM).  The course covers project scoping, value stream mapping and implementation planning to improve a selected business process.

Learning Objectives

• Develop a proactive operations vision to dramatically improve performance, an implementation plan to achieve it and regular reviews to evaluate its success.
• Demonstrate reading VSMs, creating current and future state VSMs and using other VSM tools.
• Learn ways to identify non-value adding activities.

• Explain Sort-Set in Order-Shine-Standardize-Sustain (5S), Spaghetti Diagrams, and Visual Management.

Typical Course Length:  16 hours