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Certificates: Certificate "Six Sigma Yellow & Green Belt"
GMP - Good Manufacturing Practice" certificate -
Examination: Praxisbezogene Projektarbeiten mit Abschlusspräsentationen
„Six Sigma Yellow & Green Belt” -
Teaching Times: Full-timeMonday to Friday from 8:30 a.m. to 3:35 p.m. (in weeks with public holidays from 8:30 a.m. to 5:10 p.m.)
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Language of Instruction: German
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Duration: 8 Weeks
Quality management - Six Sigma Yellow & Green Belt
Six Sigma Yellow Belt (approx. 1 week)
Introduction to the Six Sigma strategy - Yellow Belt (approx. 1.5 days)
What is Six Sigma? History and philosophy
DMAIC project phases at a glance and their individual objectives
Roles and responsibilities
Six Sigma in the context of lean and QM (OpEx)
AI as an assistant for structuring the project objective, scope and stakeholders
AI in the improvement project (approx. 0.5 days)
Types of AI (ML,DL,LLM,GenAI)
Data and prompt basics
Governance and security
Define phase (approx. 0.5 days)
Problem and project definition (Project Charter)
Understanding customer requirements (VOC-CTQ)
Process mapping (SIPOC)
Operational definition and data quality
AI-supported clustering of simple VOC examples
Measure phase (approx. 0.5 days)
Process mapping (flow chart and swimlane)
Insight into measurement system analysis (MSA)
Basic key figures (DPMO, Sigma Level)
Data types and collection (graphical analyses)
AI for measurement plan checklists, plausibility checks
Analysis phase (approx. 1 day)
Cause-effect analysis (5-Why, Ishikawa)
Basics of statistical methods
Insight into machines and process capability
Improve phase (approx. 0.5 days)
Generate solution ideas (Poka Yoke)
Risk assessment and introduction of FMEA
Control phase (approx. 0.5 days)
Definition of process monitoring (control plan)
Insight into statistical process control (SPC)
Process documentation and standardization (SOP)
Six Sigma Green Belt (approx. 3 weeks)
Project management with Six Sigma - Green Belt (approx. 1 day)
Green Belts as project managers
Work breakdown structure (WBS), project communication and documentation
Teamwork and leadership
Going through DMAIC project phases using advanced statistics application tools and methods
AI-supported project management: risks/dependencies, schedule risk analysis
Define phase (approx. 1.5 days)
Project profile, business case
Project scoping, stakeholder and risk analysis
VOC in CTQ transformation (CTQ tree)
Team composition, project planning (Gantt chart, milestone planning)
Cost calculation and target formulation (benefit)
Measure phase (approx. 2.5 days)
Advanced statistical basics
Visualization and interpretation (histogram, run chart, box plot)
Short-term vs. long-term capability (MFU, PFU)
Calculation and interpretation of the sigma level
Process indicators (Pp, Ppk, Cp, Cpk)
Measurement system analysis (MSA), bias, gage R&R
AI-supported data checks (missing values, outlier indications)
Analysis phase (approx. 4 days)
Hypothesis development, correlation analysis
Correlation (Pearson) and analysis of variance (ANOVA)
Lean time and value flow (yield, OEE, VSM)
Text/error code clustering for Pareto according to failure modes with AI
Improve phase (approx. 1 day)
Design of Experiments (DoE)
Solution generation and creativity methods (mind mapping, brainstorm/writing, 6-3-5 method)
Testing (Poka Yoke, piloting, cost-benefit analysis)
Risk minimization (FMEA, RPN evaluation)
Implementation
Control phase (approx. 1 day)
Sustainable implementation (control plan)
SPC, quality control charts (X̄-R chart, X̄-s chart)
Process monitoring (KPI, dashboard, BSC)
Project completion and handover
AI-supported KPI story/management summary
Project work, certification preparation and certification examination (approx. 4 days)
GMP - Good Manufacturing Practice
Introduction to GMP (approx. 2 days)
EU GMP guidelines, AMG, AMWHV
Authorities, drug approvals, marketing authorization
Key persons
FDA, CFR 21
International regulations
AI in the pharmaceutical environment
SOP system (approx. 2.5 days)
Requirements for SOPs
Structure of SOPs
Document control and version management
Training system (approx. 1.5 days)
Employee qualification
Training planning and documentation
Effectiveness control
Deviation and CAPA management (approx. 2 days)
Deviations and CAPA
Requirements for deviation and CAPA management
Documentation of deviations
Error cause analysis
Corrective and preventive measures
CAPA process
AI-supported data analysis for root cause identification
Change management (change control) (approx. 1 day)
Requirements for change management
Notifiable changes, classification of changes
Risk management in the change process
Change management process
Validation and qualification (approx. 1.5 days)
Device, system and room qualification
Process, cleaning and method validation
Qualification and validation process
Qualification and validation documentation
Quality control (approx. 1 day)
Sampling and testing
stability
Dealing with OOS
Storage status
AI-supported evaluation of test data
Complaints management (approx. 0.5 days)
Complaints
Product recall
Audit management (approx. 0.5 days)
Audit types and audit process
Internal audit and FDA inspection
AI-supported data analysis for audit preparation
Supplier qualification (approx. 0.5 days)
Supplier qualification and evaluation
Review and trending (approx. 0.5 days)
Batch Record Review
Product Quality Review
Management Review
Industrial hygiene in the pharmaceutical industry (approx. 2 days)
Personnel hygiene
Hygiene requirements
Clothing and behavior
Production hygiene
Contamination prevention
Hygiene plans
Documentation (approx. 0.5 days)
GMP documentation and data integrity
AI-supported support for document review
Production rooms - clean rooms (approx. 1 day)
General requirements for production rooms
Requirements for premises including storage areas
Avoidance of cross-contamination
Project work (approx. 3 days)
To consolidate the content learned
Presentation of the project results
Changes are possible. The course content is updated regularly.
The course enables you to implement Six Sigma projects independently and successfully in accordance with ISO 13053-1 (DMAIC). You will be able to use the specific tools and methods with confidence and thus implement complex improvement projects responsibly.
Furthermore, you are familiar with the requirements of a GMP system, the applicable regulations and the central processes of pharmaceutical quality management. You will understand the basics of SOP systems, CAPA, change management, audit processes, documentation, quality control, industrial hygiene and cleanroom requirements and be able to classify relevant technical terms with confidence.
People with a degree in engineering, technicians, foremen and specialists from the production and service sectors and people from the areas of quality management, administration and sales who want to carry out and manage improvement projects using the Six Sigma method.
Six Sigma is an internationally standardized and recognized method of quality management and a management tool for process improvement. By obtaining the Green Belt, you demonstrate your mastery of the methodology in your profession. As a Six Sigma project manager, you will be in demand across all industries in medium-sized and large companies, thus enhancing your career profile in the long term.
Additional GMP knowledge is essential in almost all areas of the production of pharmaceuticals and active ingredients, as well as cosmetics, food and animal feed. Your newly acquired knowledge will open up numerous new opportunities for you in these sectors.
Your meaningful certificate provides a detailed insight into the qualifications you have acquired and improves your career prospects.
Didactic concept
Your lecturers are highly qualified both professionally and didactically and will teach you from the first to the last day (no self-study system).
You will learn in effective small groups. The courses usually consist of 6 to 25 participants. The general lessons are supplemented by numerous practical exercises in all course modules. The practice phase is an important part of the course, as it is during this time that you process what you have just learned and gain confidence and routine in its application. The final section of the course involves a project, a case study or a final exam.
Virtual classroom alfaview®
Lessons take place using modern alfaview® video technology - either from the comfort of your own home or at our premises at Bildungszentrum. The entire course can see each other face-to-face via alfaview®, communicate with each other in lip-sync voice quality and work on joint projects. Of course, you can also see and talk to your connected trainers live at any time and you will be taught by your lecturers in real time for the entire duration of the course. The lessons are not e-learning, but real live face-to-face lessons via video technology.
The courses at alfatraining are funded by Agentur für Arbeit and are certified in accordance with the AZAV approval regulation. When submitting a Bildungsgutscheinor Aktivierungs- und Vermittlungsgutschein, the entire course costs are usually covered by your funding body.
Funding is also possible via Europäischen Sozialfonds (ESF), Deutsche Rentenversicherung (DRV) or regional funding programs. As a regular soldier, you have the option of attending further training courses via Berufsförderungsdienst (BFD). Companies can also have their employees qualified via funding from Agentur für Arbeit (Qualifizierungschancengesetz).