Introduction to Charting and Trending
- QbD and trending
- Run Chart vs. Shewhart Control Charts
- Control charts of grouped data versus of individual data
- Examples of microbial charts: grouped vs individual counts
- Variables versus attributes charts
- Poisson and Binomial control chart
- Common cause variation vs. Special Cause (Assignable) variation
- State of control
Regulations on Environmental Monitoring
- Overview of current regulations
- Draft Annex 1
Variability of Data
- Standard deviation of a sample and of population
- Histogram
- Standard deviations of the mean Range
- Relation between standard deviation and Range
- Short-term variation versus global variation
- Separating the signal from noise
Exercise: Calculation of within-group and global Standard Deviations
Control Charts of grouped Data
- Plotting Run chart and control Chart (Process Behaviour Chart)
- Computation of three-sigma Control limits
- Control charts of average, range and standard deviation
Brief Acquaintance with Minitab© 19
- Basic structure of Minitab software
- Drawing a Control Chart
Control Charts of individual microbial Counts
- Moving range (mR)
- Control charts of individual data (XmR)
- Calculation of control limits
- The three-way chart
- Examples of three-way charts
Exercises: Building with Minitab Control Charts of Microbial Counts from passive and active Air Sampling
Data Strategies and Environmental Monitoring – MODA System
- Data requirements for the evaluation and selection of an electronic system
- How to maximise the value of your data
- Trend analysis tools and tips
- Setting alert and action limits
- Data integrity issues
Environmental Monitoring Program to gain strong Data
- Practical aspects of Environmental Monitoring
- How to set up a structured EM program and gain strong data
- Risk based approach
- Handling of big data amounts
- EM program examples from Industrial clean rooms
Contamination Recovery Rates
- Contamination recovery rates (USP approach <1116>)
- Plotting recovery rates and excursion rates
- Limits of rates versus actual values
- Calculations of contamination recovery rates per USP <1116>
Distribution-free Approach
- Disadvantages of the distribution-based approach
- Non-parametric percentile as control limit
- Tolerance intervals limits
- Shewhart approach for setting control limits
Exercises of percentile determination, plotting of Laney’s charts, Calculations of Contamination Recovery Rates per USP <1116>
Trending Tool Applications
- Trending tool examples from industries
- Data collection tools
- Reaction and measures on negative trends
- Responsibilities
General Approach to Microbial Monitoring
- Overall strategy for microbial monitoring
- Plotting Contamination recovery rates
- Laney’s charts
Exercises: Control Charts of Microbial Counts of active Air Samples in Area Grade B and Contact Plates in Area Grade C; Determining Alert Limits with the Methods of Percentile and Confidence Intervals
Exercise on Trending Tool Applications
- Case studies of evaluation of EM Data
- Use of supportive data
Strategy for detecting a trend and for Continuous Improvement
- Phase 1 and Phase 2 in process monitoring
- Statistical Control of a process: Is your EM process predictable?
- Nelson rules
- Trending and continued process verification
- Trending for Annual Product Review document
- Example of detecting a shift in microbial counts