Seminar on Fundamentals of Statistical Process Control: Implementation and Assurance of SPC at SFO, CA

Seminar on Fundamentals of Statistical Process Control: Implementation and Assurance of SPC at SFO, CA

Thu Jun 2 2016 - Fri Jun 3 2016, 9:00 am - 6:00 pm

Course “Fundamentals of Statistical Process Control: Implementation and Assurance of SPC” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.


This 2-day seminar provides the information you need to use one of the most powerful tools in quality, statistical process control. It will help people in design, quality, and production understand the concepts and effectively implement them. The examples and issues in the seminar come primarily from the medical device industry, but the material is applicable to any production environment.

Production process must be controlled 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. These are often expressed as 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.

Why should you attend:

Manufacturing companies, especially medical device manufacturers, must control process. Not only is this a regulatory requirement, but is a good business practice. Without a solid understanding of SPC, you put yourself and your company at a disadvantage.

On a personal basis, the material in this seminar will help improve your skills; it aligns with the ASQ Body of Knowledge for the Certified Quality Engineer, Green Belt, and Black Belt. These are areas you should master. On a company level, SPC has become an expected methodology to control processes. Without it, your company could be left behind.

This seminar provides a practical approach to understanding and implementing SPC. It provides the tools you need, presents an explanation of how to use them, and offers practice through exercises.

Areas Covered in the Session:

  • The regulatory environment for manufacturers including FDA QSR, ISO 13485:2003, ISO 9001:2008, and ISO 9001:2015.
  • The concepts of production process control
  • Statistical theory including statistical distributions and decision making
  • Implementing statistical process control
  • Determining process capability


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



Day One

Lecture 1:

The Regulatory Structure

  • ISO 13485:2003
  • ISO 9001:2008
  • ISO 9001:2015
  • Statistical standards

Lecture 2:

Characterizing Processes

  • Process definitions
  • Distinguishing process from product
  • Product specifications
  • Developing a process map
  • Control and disposition of nonconforming product

Lecture 3:

Statistical Basis for SPC

  • Statistical Distributions
  • Control Limits
  • Sample Size and Frequency
  • Rational Subgroups
  • Pattern Analysis and Signal Generation
  • Assignable Causes

Lecture 4:

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

Lecture 1:

Control Charts for Attributes

  • Fraction Nonconforming Charts
  • Nonconformities Charts
  • Operating Characteristic Curves
  • Implementation Issues

Lecture 2:

Other Charts

  • CUSUM Charts
  • EWMA Charts
  • Implementation Issues

Lecture 3:

Other Techniques

  • Short Production Runs
  • Pre-control

Lecture 4:

Process Capability Analysis

  • Process Capability Indices Cp and Cpk
  • Process Performance Indices, Pp and Ppk
  • Other indices




Dan O’Leary

President, Ombu Enterprises

Dan O’Leary 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.


Location: SFO, CA Date: June 2nd & 3rd, 2016 and Time: 9:00 AM to 6:00 PM


Venue: DoubleTree by Hilton Hotel San Francisco Airport   835 Airport Blvd., Burlingame CA 94010-9949


Price Details: $1,495.00   (Seminar Fee for One Delegate)



Quick Contact:


NetZealous DBA as MentorHealth

Phone: 1-800-385-1607



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DoubleTree by Hilton Hotel San Francisco Airport
835 Airport Blvd., Burlingame CA 94010-9949
San Francisco, California, San Francisco, CA 94010

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