Statistics for Process and Quality Control Seminar

Global Compliance Seminars

This two-day seminar includes the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products.

Course Description

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.

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 are important for a company's reputation. A good system of processing and quality checks reduces 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.

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
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

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)

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

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)

Lecture 4 (90 Mins): Statistical Basics (cont'd)

Graphical Techniques:
- Histograms
- Scatterplots
- Pareto charts
- Cause and effect (fishbone) diagrams
- Defect concentration diagrams

Day 2 Schedule

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)

Lecture 2 (90 Mins): Statistical Process Control (cont'd)

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

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.

In addition to her technical expertise, Elaine possesses a talent for conveying statistical concepts and results in a way that people can intuitively understand.

Credits Available

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.

More Seminar Information

Global Compliance Panel
Summary	This two-day seminar includes the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products.
Delivery Method	Seminar
Who Should Attend	Quality Assurance (QA) Engineers, Quality Control (QC) Engineers, R&D Engineers, Process Control Personnel, Manufacturing/Industrial Personnel, Production Supervisors, Management Personnel of Processing Facilities