Two days workshop on
Statistical Process Control with Process Capability Analysis
Date: Thursday, 01 June 2017 - Friday, 02 June 2017 | Location: Atlantic City, NJ | Download Workshop Brochure
Course "Statistical Process Control with Process Capability Analysis" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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

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

Part A - The Regulatory Structure
  • 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.

Register yourself for this brainstorming session Now . You can do single registration or group or register via P.O/Check or Wire.

Register Online
Single Registration
Special Group Discount
2 Attendees - Get 10% off
3 to 5 Attendees - Get 20% off
5+ Attendees - Get 30% off
Your registration fee includes the workshop, all course materials and lunch.
Register by P.O. / Check / Wire Transfer
Excited to join the workshop on "Statistical Process Control with Process Capability Analysis" then register for the same by P.O. / Check / Wire Transfer. Call us Toll Free at (510)-857-5896 for any registration related assistance.

If you are Paying by Check:
Checks should be payable to Holkoi LLC and mailed to:
38780 Tyson Lane Suite 210 Fremont
California 94536, USA

Wire Transfer:
If you wish to pay by wire transfer. Call us toll free on 510-857-5896
Need Help!
In case you find difficulty in registering, availing the discount or need further information regarding the workshop, please feel free to contact our customer support team at (510)-857-5896 or send an email to We will help you.
Terms & Conditions to Register for the Workshop
Your registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for the workshop call us at (510)-857-5896 or email us at

Payment Process
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to HOLKOI LLC. (our parent company)

If you are paying by check, the check should be payable to Online Compliance Panel and mailed to: 38780 Tyson Lane Suite 210 Fremont California 94536
The registration fee includes: The workshop; all related course materials; tea/coffee and lunch on both the days

Cancellations and Substitutions
For online registration, use your American Express, Visa or MasterCard.

In case you find difficulty in registering, call us at (510)-857-5896 or sent an email to We will help you to register hassle-free.

Any cancellation request received at least 10 calendar days prior to the start date of the event will receive a refund with a $200 administration fee deduction. No cancellations will be accepted - nor refunds issued - within 10 calendar days from the start date of the event.

On request (before the commencement of the workshop) a credit for the amount paid minus administration fees ($200) will be transferred to any future Online Compliance Panel event and a credit note will be issued. Substitutions may be made at any time.

Onsite registrations are also possible. However we accept only credit card payments and check payments. Conference material will be issued on the spot depending on the availability. In case it is not available we will send the material by post after the conference is over. In the event, Online Compliance Panel cancels the workshop; the company is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Conference Photograph / Video
By registering and attending Online Compliance Panel workshop, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to Online Compliance Panel using these photos and videos for marketing, archiving or any other conference related activities. You agree to release Online Compliance Panel from any kind of claims arising out of copyright or privacy violations.

Documents to Carry
Online Compliance Panel will issue an electronic event pass to each registered candidate once the registration is confirmed. Please bring the pass to the venue of the event.

Atlantic City, NJ


Sheraton Atlantic City Convention Center Hotel

Two Convention Boulevard

Atlantic City ,New Jersey -08401

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