Two days workshop on
Statistical Process Control with Process Capability Analysis
Coming soon.. Please contact customer care for new schedule at +1-510-857-5896
Course Description
This two-day workshop provides the information you need to use in one of the most powerful tools in quality, statistical process control. The workshop helps people in design, quality, and production understand the concepts and effectively implement them. The examples and issues in the workshop come primarily from the medical device industry, but the material is applicable to any production environment.

Manufacturers must control production process to help ensure they are stable. While there are many control methods, the most powerful and often used is statistical process control, SPC. It uses data from the process itself to detect changes - changes that could result from an unstable process. SPC helps determine if a process continues to operate the way it was set up. If not, SPC produces a signal that calls attention to the problem.

One very important application is process capability analysis. With a stable process, SPC data can help determine if the process is capable of meeting the product specifications. The workshop explores the variety of process capability indices.

Continuous improvement programs can use the information generated by SPC to monitor process variation and identify its causes. These methods can reduce cost, improve product, and enhance customer satisfaction.

Learning Objectives
  • Understand the regulatory environment for device manufacturers including FDA QSR, ISO 13485:2003, and ISO 13485:2016
  • Learn the concepts of production process control
  • Learn the underlying statistical concepts including statistical distributions and decision making
  • Understand data types (attributes and variables)
  • Learn the SPC methods available for the data types
  • Understand the methods to calculate and use process capability
Why Should you Attend
Manufacturing companies, especially medical device manufacturers, must control process. Not only is this a regulatory requirement, but also is a good business practice. The SPC methods from the workshop give you an understanding of the most powerful process control technique.

Who will Benefit
  • Quality Managers and Supervisors
  • Quality Engineers
  • QA/QC Technicians
  • Production Managers and Supervisors
  • Process Engineers
  • Manufacturing Engineers
  • Manufacturing Technicians
  • Design Managers and Supervisors
  • Design Engineers
  • Design Technicians
Agenda

Day One (8:00 a.m. - 8:30 a.m.: Registration Process)

Part A - The Regulatory Structure
  • FDA QSR
  • ISO 13485:2003
  • ISO 13485:2016
  • Statistical standards
Part B - Characterizing Processes
  • Process definitions
  • Distinguishing process from product
  • Product specifications
  • Developing a process map
  • Control and disposition of nonconforming product
Part C - Statistical Basis for SPC
  • Statistical Distributions
  • Control Limits
  • Sample Size and Frequency
  • Rational Subgroups
  • Pattern Analysis and Signal Generation
  • Assignable Causes
Part D - Control Charts for Variables
  • X-bar and R Charts
  • X-bar and s Charts
  • I and MR charts
  • Operating Characteristic Curves
  • Implementation Issues
Day Two

Part E - Control Charts for Attributes
  • Fraction Nonconforming Charts
  • Nonconformities Charts
  • Operating Characteristic Curves
  • Implementation Issues
Part F - Other Charts
  • CUSUM Charts
  • EWMA Charts
  • Implementation Issues
Part G - Other Techniques
  • Short Production Runs
  • Pre-control
Part H - Process Capability Analysis
  • Process Capability Indices Cp and Cpk
  • Process Performance Indices, Pp and Ppk
  • Other indices










Daniel O'Leary - President, Ombu Enterprises, LLC


Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.