2018 - Statistics for Process and Quality Control

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.
Description:
This 2-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 presented.
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Why you should attend:
All processes exhibit intrinsic variation. However, sometimes the variation is excessive and this hinders the ability to achieve reliable measurements and desired results. Statistical process control (SPC) and statistical quality control (SQC) allow us to control the functions of our processes (input) and the quality of our product (output) by providing tangible tools for monitoring and testing.
Process and quality control is important for a company’s reputation. A good system of processing and quality checks reduce costs associated with production waste and re-work due to defects, and allows a company to deliver products that are high in quality. Many industries are also required to have a good quality management system in place to achieve compliance with regulatory authorities.
This seminar will provide attendees with the statistical tools necessary to monitor processes and test the quality of manufactured product. Ms. Eisenbeisz will make use of Minitab software in her presentation.
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Areas Covered in the Session:
• FDA QSR, ISO 13485:2016, IS 9001:2015 regulations and harmonization
• Overview of statistical theory and nomenclature for processes and quality control
• Variability and risk assessment in practice
• Control before testing!
• Which chart for which process?
• Setting statistical specifications, control limits, and signals
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Who will benefit:
• Quality Assurance (QA) Engineers
• Quality Control (QC) Engineers
• R&D Engineers
• Process Control Personnel
• Manufacturing/Industrial Personnel
• Production Supervisors
• Management Personnel of Processing Facilities
Agenda:
Day 1 Schedule
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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)
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Lecture 2 (90 Mins): Regulatory Requirements in Quality Management
• FDA Quality System Regulation (QSR)
• ISO 13485:2016
• IS 9001:2015
• Harmonization of regulations with FDA guidance/regulations
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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)
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Lecture 4 (90 Mins): Statistical Basics (cont'd)
• Graphical Techniques:
o Histograms
o Scatterplots
o Pareto charts
o Cause and effect (fishbone) diagrams
o Defect concentration diagrams
Day 2 Schedule
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Lecture 1 (90 Mins): Statistical Process Control: The ABC's of Control Charts
• Elements of a control chart
• Control Charts for Discrete Data
o c chart
o u chart
o p chart
o np chart
• Control Charts for Continuous Data
o X-bar chart
o R chart
o I chart
o MR chart
o Combined charts (Xbar-R, I-MR)
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Lecture 2 (90 Mins): Statistical Process Control (cont'd)
• More Control Charts
o Classical Shewhart control charts
o Cumulative Sum (CUSUM) charts
o Exponentially Weighted Moving Average (EWMA) charts
o Hotelling (multivariate) control charts
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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
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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
Speaker:
Elaine Eisenbeisz
Owner and Principal Statistician, Omega Statistics
Elaine Eisenbeisz, is a private practice statistician and owner of Omega Statistics, a statistical consulting firm based in Southern California. Elaine has over 30 years of experience in creating data and information solutions for industries ranging from governmental agencies and corporations, to start-up companies and individual researchers.
Location: San Diego, CA Date: September 18th & 19th, 2018 and Time: 9:00 AM to 6:00 PM
Venue: DoubleTree by Hilton San Diego Downtown 1646 Front St, San Diego, CA 92101, USA
Price:
Register now and save $200. (Early Bird)
Until August 10, Early Bird Price: $1,295.00
From August 11 to September 16, Regular Price: $1,495.00
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*
Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*
Sponsorship Program benefits for seminar
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