This training offers a comprehensive understanding of the current Good Manufacturing Practices (cGMP) in accordance with the quality systems approach currently used during FDA inspections.
- Goals of cGMP
- Principles of cGMP
- Facilities and equipment
- Validate and test
- FDA enforcement trends
- Internal auditing trends
Discover the fundamentals of good communication and technical writing skills applicable to Standard Operating Procedures (SOPs), lab notebooks, and revising batch records. This course will explore FDA requirements for process documentation and there will be discussions involving the cost of poor quality in documentation.
- Goals of GDP
- Principles of GDP
- Improved understanding of FDA GDP documentation requirements
- Improved understanding of individual responsibilities in ensuring compliance to FDA GDP
This training provides an overview of ISO 9001:2015 or AS9100D standards and fundamentals of working in a regulated environment.
- Understand and identify tools most relevant and utilized for problem solving
- Know how to develop a quality management system in conformance with ISO 9001:2015 or AS9100D standard
Training takes a deep dive into the requirements of information security and how to create or modify existing quality management document processes, set-up support systems to assure processes and changes are incorporated. Course content can include support and development for achievement of ITAR compliance, Counterfeit Materials, Conflict Materials and FOD activities.
- How to create or modify documentation (first and second level documents)
- Gain understanding and awareness of requirements for ISO 9001:2015 or AS9100D
- How to implement ISO 9001:2015 or AS9100D new processes and support for successful adoption
- How to conduct an internal ISO 9001:2015 or AS9100D audit (required by ISO 9001:2015 or AS9100D)
- If applicable: Understand content, how to apply them, and verify them in a management system context for ISO 9001:2015 or AS9100D requirements for ITAR compliance, Counterfeit Materials, Conflict Materials and FOD activities.
Training is focused on ISO 9001:2015 or AS9100D internal audit that is guided and mentored. An assessment will be completed to determine level of efficient implementation.
- Explain principles of a Quality Management System
- Produce ISO 9001:2015 or AS9100D for their processes and procedures utilizing ISO 9001:2015 or AS9100D standards
- Create instructions and a records retention system to include team leader content
- Prepare for audits and anticipate questions
Learn steps to manage an audit program
Course teaches Kaizen fundamentals and applications. A Kaizen Event is a focused effort to rapidly improve a process. Kaizen is a Lean problem-solving method that applies process improvement within a structured setting. Kaizen’s goal is to reduce or eliminate activities in processes that add cost but not value.
- Learn how to roll-out a Lean Initiative:
- Managing a roll-out, including culture change
- Move to Lean awareness within organization
- Process value stream and improvement-event selection
- Learn Lean tools most appropriate for your initiative
- Mapping process current- and future-states
- Maintaining an improvement cadence
- Sustain changed (Lean) culture
Key Performance Indicators (KPI) are a continuous improvement tool used to measure factors such as efficiency, quality, timeliness, and performance. This course can be customized for all leadership levels within an organization.
- Identify Critical to Quality Characteristics as Key Performance Indicators (KPI)
- Develop KPI’s for individual departments
- Determine how to measure KPI’s
- Monitor KPI’s to analyze quality results
This course is an “all hands” orientation for anyone in an organization implementing Lean. It incorporates instruction, discussion, and simulation on Lean concepts and tools.
- Learn and understand following concepts:
- Safety-Purpose-Agenda-Conduct-Expectations-Roles & Responsibilities (S.P.A.C.E.R.)
- Lean Roadmap
- Process Waste
- Value-Stream Mapping (VSM) and VSM Tools
- Flow and Pull
This course provides a solid grounding on what it takes to be a Lean Leader. For example, we know that great leaders must understand who they are (not their ego or persona identification, but who they really are—their self—in order to have personal power). Next, they must be able to communicate effectively: establishing trust and safety, building community. Finally, they must be able to make these things happen for the people they work with—commitment to growth, employee empowerment, and stewardship. The material covered relies heavily on exploring these and other servant leader characteristics. In addition, as required, Lean organizational structures and coaching systems may be covered, as well as deeper dives on selected Lean Practitioner material.
- Learn the three pillars required to be effective and sustainable
- Proper understanding and use of tools
- Process-improvement culture
- Understand what’s different about a Lean Leader
Certificate Qualifications for Lean Leader: Successful completion of a Lean Leader course, have an existing Lean Practitioner certification, lead and successfully complete a Kaizen event, (no exam required). If qualifications are met participants will receive a certificate showing the number of contact hours.
Designed for individuals on a Lean Leader team or other teams implementing Lean tools. Offers a solid understanding of all things Lean, taking a Value-Stream Management approach. Topics include structure of a proven Lean deployment, discussion of Value Stream, current-state and future Value-Stream Mapping, and a cursory explanation of Customer-Demand, Continuous-Flow, and Leveling tools. Office and/or manufacturing versions are available with case-studies showing how the use of these tools improve process velocity and flexibility. Course concludes with a discussion of Kaizen-event implementation.
- Value Stream Management (VSM) Process
- Key concepts of Lean
- The Eight Deadly Wastes
- Three Phases of Lean Application
- Map the Current State
- Identify Lean Metrics
- Map the Future State
- Draw the Customer-Demand-Phase Map
- Create Kaizen Plans
- Plan Implementation Phases
- Recommendations for Coping with Change
- Running a Kaizen event in your organization
Certificate Qualifications for Lean Practitioner: Successful completion of a Lean Practitioner course, lead and successfully complete a Kaizen event, 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 will receive a certificate showing the number of contact hours.
A method of problem solving used for identifying what, how and why something happened. The purpose is to identify the root cause factor of the fault/problem that if removed, prevents the final undesirable event from recurring.
- Increase skills to effectively analyze data
- Improve problem solving abilities
- Create superior and successful processes
- Utilize Root Cause Analysis tools
Wouldn’t it be nice if our designs worked right the first time and that they are manufacturable, reliable, easily maintained and serviceable, good for the environment and at reasonable cost? These are the goals of the suite of best practices called Design-For-Six Sigma (DFSS) whose focus is to meet the organization’s customers’ requirements in a timely and cost-effective manner. Designs may be in any business or industry: manufacturing, services, financial, healthcare, research, and many others.
This course assumes that the student is already familiar with both Lean and Six Sigma technology as DFSS combines the best of these process-improvements ideas to develop defect-free and error-free results in an efficient and a waste-minimized design process.
Prerequisites: Six Sigma Green Belt course (certification ideal), Lean Practitioner
- Define-Measure-Analyze-Design-Verify (DMADV)
- Identify-Design-Optimize-Verify (IDOV)
- Define-Concept-Design-Optimize-Verify (DCDOV)
- Define and identify Project Selection, Project Charter, Voice-of-Customer (VoC) including diagrams
- Understand the concepts of Quality-Function-Deployment (QFD), House of Quality, Process Capability, Creative Brainstorming, and Concept Selection
- Learn to design
- 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
Course is crafted for a high-level Six Sigma awareness. Emphasis is placed on the concept of process variation, the Define-Measure-Analyze-Improve-Control (DMAIC) process improvement roadmap, and how Six Sigma is different than Lean as a process-improvement methodology. This course sets the stage for rapid implementation and application in the workplace.
- Definitions of Six Sigma
- Why a Six Sigma Process Improvement methodology is needed
- Define-Measure-Analyze-Improve-Control (DMAIC) process improvement roadmap
- Roles and responsibilities
Crafted with the Six Sigma Greenbelt team-member in mind. The student is taken through a Six Sigma journey from introduction to 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. Of particular importance at the Yellow-Belt level is to keep participants engaged. To that end, a minimum amount of lecture, maximum amount of examples and exercises are employed in this course.
- Define Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC), Design-For-Six-Six-Sigma (DFSS), Roles and Responsibilities
- Understand Common- vs. Special-Cause Variation, basic statistical concepts
- Ability to use the Phase Tools and Descriptions
Certificate Qualifications: Successful completion of a Six Sigma Yellow Belt course, team member on either a Lean Kaizen event or a Six Sigma Green Belt project (no exam required). If qualifications are met participants will receive a certificate showing the number of contact hours.
This 80-hour class will introduce the participant to the basics of the Six Sigma at the Greenbelt (intermediate) level. The application will be limited to improving processes that already exist – not creating brand new processes – using the D-M-A-I-C methodology: Define, Measure, Analyze, Improve and Control.
Prerequisites: Basic process mapping, basic risk analysis, basic math and analytical skills, basic excel and a project that has been scoped by their manager.
- Have a much more in-depth understanding of the D-M-A-I-C Six Sigma process-improvement methodology
- Ability to take part on Company project-selection teams
- Be a Six-Sigma project leader of Green Belt-level Six Sigma projects
- Mentor Six Sigma Yellow Belts
- 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. If qualifications are met, participants will receive a certificate showing the number of contact hours.
This course is a natural follow-on to the Green Belt course. Class will take a deep dive into statistical methods designed to address the more difficult task of delayering common-cause variation. Focus will be on improving processes that already exist—not to creating brand new processes—although the tools described work well in process/product design applications. A portion of class-time will be spent on the subject of Designs of Experiments. General Linear Models in the form of Analysis of Variance (ANOVA) and several aspects of Regression will also be explored. A capstone project will be completed in parallel with class lecture and exercises.
Prerequisites: Green Belt certification (this means successfully completing Green Belt training and a project).
- Understand and utilize more demanding statistical tools including
- Multiple regression
- Mixed Analysis of Variance (ANOVA)
- Design of Experiments (DOE)
- At conclusion of training, candidates will be poised to receive their Six Sigma Black Belt certification
Certificate Qualifications: Successful completion of the requisite Green Belt training, passing score on written and oral exam, and completion of capstone project the student will be in position to receive their Six Sigma Black Belt certification.
Given that a process—any process whether operational (manufacturing or otherwise) or transactional—is repeatable and able to be described in process-map form, how might we ensure that this process is under control, i.e., predictable? Poka Yoke (a mistake proofing approach to eliminate or prevent errors) either eliminates the possibility of process drift, or alerts us to that condition, and Standard Operating Procedures (SOPs) do a good job as well (assuming they’re followed), but there is another way. Statistical Process Control (SPC) does a great job at maintaining process control before the process drifts out of specification. In other words, it’s a proactive approach to control making it an excellent tool to maintain processes. In addition, given process drift, SPC will indicate what data signature has emerged, helping in the identification of root-cause.
The core content of the course is basic Control Charting for both continuous and attribute data. As always, this training will be customized to meet your needs whether introductory, intermediate or advanced level participants.
- Complete and discuss case model examples
- Define common cause and special cause variation
- Determine management and employee roles in reducing common cause variation
- Setup, compute and interpret a variable control chart
- Review and interpret various types of attribute control charts
- Compare and contrast process specs to process capability
This course addresses the goals and objectives of your business. Includes project scoping, value stream mapping and implementation planning skills for everyone responsible for improving a selected business process. It is important to identify a future state vision and detailed action plan with leadership commitment in support of these projects and value stream changes. To ensure project execution a 30/60/90-day review is an option to evaluate the implementation plan with countermeasures that create meaningful, sustained business results.
- Shared organizational understanding of current opportunities for elimination of non-value adding activities
- Establishment of a proactive operations vision that dramatically improves performance
- Development of an implementation plan to achieve vision
- Training of internal resources on value stream mapping techniques
- How to read a Value-Stream Map (VSM)
- VSMs of the current-state and future-state
- Some VSM tools
- Sort-Set in Order-Shine-Standardize-Sustain (5S)
- Spaghetti Diagram (a mapping tool used to identify the distance traveled by a product or people)
- Visual Management