Statistics for Process and Quality Control
Course
In Washington, D. C. (USA)
*Indicative price
Original amount in USD:
$ 100 $ 1,495
Description
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Type
Course
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Level
Beginner
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Location
Washington, d. c. (USA)
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Duration
2 Days
Course "Statistics for Process and Quality Control" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
This two-day seminar includes the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products.
The concepts and information presented will be mainly concerned with statistical quality control: obtaining information (data) that is objective, unbiased, and useful for decision making. An emphasis will be placed on the set-up and use of control charts and acceptance sampling systems and procedures.
The objective of the seminar is to provide information that can be used immediately by personnel involved in production operations, and by supervisors and management in decision making. Although the presentation involves use of statistical techniques, presentation of statistical theory will be limited to only what is needed by the attendees to understand and implement processes and testing within the statistical framework.
Presented examples will include an emphasis on the manufacturing processes and quality assurance needs of personnel in the medical device and pharmaceutical industries.
Process and quality control are constantly evolving. Therefore, historical concepts, current trends and regulatory requirements will be discussed. The presentation of statistical charts and analyses, graphical techniques for planning, trouble-shooting and problem solving will also be made.
Facilities
Location
Start date
Start date
Reviews
Subjects
- Decision Making
- Personnel
- Presentation
- Statistics
- Quality
- Quality Training
- Acceptance
- Multivariate
- Control
- Shewhart control
Course programme
Day 1 Schedule
Lecture 1 (90 Mins): It's a System! Elements of Quality Management
- Deming 14 points for total quality management
- Dr. Ishikawa, seven Quality Control tools (7-QC) and supplementals (7-SUPP)
- Pareto Principle (80/20 rule)
- Shewhart (Plan, Do, Study, Act)
- FDA Quality System Regulation (QSR)
- ISO 13485:2016
- IS 9001:2015
- Harmonization of regulations with FDA guidance/regulations
Lecture 3 (90 Mins): Statistical basics
- Check sheets/tally sheets
- Descriptive statistics
- Binomial Distribution (discrete data)
- Hypergeometric Distribution (sampling without replacement)
- Normal Distribution (continuous data)
- Graphical Techniques:
- Histograms
- Scatterplots
- Pareto charts
- Cause and effect (fishbone) diagrams
- Defect concentration diagrams
Lecture 1 (90 Mins): Statistical Process Control: The ABC's of Control Charts
- Elements of a control chart
- Control Charts for Discrete Data
- c chart
- u chart
- p chart
- np chart
- Control Charts for Continuous Data
- X-bar chart
- R chart
- I chart
- MR chart
- Combined charts (Xbar-R, I-MR)
- More Control Charts
- Classical Shewhart control charts
- Cumulative Sum (CUSUM) charts
- Exponentially Weighted Moving Average (EWMA) charts
- Hotelling (multivariate) control charts
Lecture 3 (90 Mins): Statistical Quality Control - Attribute Sampling Plans
- C= 0 /Zero Acceptance
- Single sample plan
- Double-sampling plan
- Multiple sampling plan
- Sequential sampling plan
- Skip-lot sampling plan
Lecture 4 (90 Mins): Statistical Quality Control - Variables Sampling Plans
- Sampling size and critical distance
- Known vs. unknown standard deviation
- One or two specification limits
- Using ANSI Z1.9
Statistics for Process and Quality Control
*Indicative price
Original amount in USD:
$ 100 $ 1,495