Activity examples based upon experience
Consultancy Training
1. Compliance 1. General quality
GLP or ISO guidelines Introduction to Quality
Guideline analysisProcess, procedure, SOPs
Laboratory situation analysisDefinitions of quality
Installation of quality systems Examples of quality & quality costs
Multi site studies Quality Philosophies &Tools
Situation analysisThe early Americans
Responsibility documentationThe Japanese waves
Service level agreementsThe new Western wave
Inspection preparation Personal quality
Gap identificationCompetences (knowledge, skills, attitude)
Milestone planning& team dedicationProject management & planning skills
Coaching & follow-up Communication & Leadership
2. Improvement  
Analysis & priority planning Organisational quality
Self assessment according to EFQM fields Mission, vision & strategic planning
Scoring techniques & Priority setting Quality systems (QAU, TQM, …)
Translation in SMART actions Success factors & performance indicators
Milestone planning & project teams Formal quality systems
Project definition & determination of needs Quality control, management, assurance
Team composition & responsibilities Introduction to ISO systems
Team life cycle & deliverable planning Introduction to GXPs, Pharmacopeia,
  2. Laboratory quality
Evaluation & Implementation Certification & Accreditation
Plan, Do, Check, Act cycle (Deeming wheel) Product certification (safety, quality, bio, )
Growth by small improvements System certification (ISO 9000, 9001, 9004)
Growth by innovation Laboratory accreditation (ISO 17025, )
3. Efficiency & Excellence  
Vision & Strategy setting Hazard Analysis of Critical Control Points
SWOT analysis Basic principles (kinds of hazards, 7 steps)
Mission & Vision Practical approach: examples
Strategic planning  
Critical success factors Statistical quality methods
Strategic success factors Statistical process control & Six Sigma
Functional success factors Control charts & warning/action limits
Operational success factors Random samples & characteristics
Indicators & results  
Objective indicators & results Measurement uncertainties & implications
Perception measurement & results Daily control methods
Trends Periodical calibration methods
  Initial validation methods
  Instrument life cycle & documentation
  Selection & installation (incl. validation)
  Follow-up (control, calibration, adjustment…)
  Defect & Out-of-use management