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.
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.
Why Should you Attend
- 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
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
Part B - Characterizing Processes
- FDA QSR
- ISO 13485:2003
- ISO 13485:2016
- Statistical standards
Part C - Statistical Basis for SPC
- Process definitions
- Distinguishing process from product
- Product specifications
- Developing a process map
- Control and disposition of nonconforming product
Part D - Control Charts for Variables
- Statistical Distributions
- Control Limits
- Sample Size and Frequency
- Rational Subgroups
- Pattern Analysis and Signal Generation
- Assignable Causes
- X-bar and R Charts
- X-bar and s Charts
- I and MR charts
- Operating Characteristic Curves
- Implementation Issues
Part E - Control Charts for Attributes
Part F - Other Charts
- Fraction Nonconforming Charts
- Nonconformities Charts
- Operating Characteristic Curves
- Implementation Issues
Part G - Other Techniques
- CUSUM Charts
- EWMA Charts
- Implementation Issues
Part H - Process Capability Analysis
- Short Production Runs
- 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 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
If you wish to pay by wire transfer. Call us toll free on 510-857-5896
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 firstname.lastname@example.org
. 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 email@example.com
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 firstname.lastname@example.org.
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
Local Attractions :
Passaic River Great Falls
The Passaic River, Great Falls is located in the Paterson city, which is the largest city and located in Passaic County, New Jersey. The Passaic River Falls is a stupendous waterfall measuring 23 meters high in the city of Paterson. Paterson Great Falls National Historical Park was certified to be the National Park System of the US. The largest waterfall played an important role in the industrial development of New Jersey and they were formed approximately 13,000 years ago.
Ocean City is a family resort in Cape May County, New Jersey. The Ocean City boardwalk is 2.5 miles (4.0 km) long. The Boardwalk has wide banquet options and the family amusement parks with Games, Music Pier and Water Park. The beautiful "Wild Waves" ride is a family-oriented place, with a stature of 50 feet (15 m), which will wrap far and wide.
Six Flags Great Adventure
Six Flag Great Adventure is located in Jackson, New Jersey. Great Adventure and Safari Park makes it the most sizable capacious theme park in the world. This park is a great adventure for the family, featuring 100 rides, special events and certain theme related areas such as Boardwalk, Frontier Adventures, Fantasy Forest and Movie town. Fantasy Forest is designed to make its visitors feel like children, and the section's bright colors and fanciful design give it a magical feel. Visitors can ride a Ferris wheel that reaches 150 feet into the sky. During the Halloween season, Six Flags Great Adventure is refurbished with spider webs, smoke machines and other Halloween cognate adornments.
Spring Lake is located in Monmouth County. Spring Lake gives kindness and relaxed atmosphere for the people who visit the shopping geographical area. Two miles of breezy beach and the longest non-commercial boardwalk in New Jersey add to the one-of-a-kind atmosphere of Spring Lake. Spring Lake is designated for the fountains of crystal clear water which arise from a multitude of underground springs. Spring Lake shopping area provides boutiques, different galleries, and fine dining experiences.
Delaware Water Gap
The Area of Delaware Water Gap National Recreation is 70,000 acres and it is protected and maintained by the Department of National Park Service. A Water Gap is an open space where the water flows through the mountain range. Outside of the US, this is called a deep crack in the Earth. The Delaware Water Gap is about 300 meters across at river level and 1,400 meters wide at the top. The river through the gap is 283 feet above sea level.
Morey's Piers & Beachfront Waterparks is located on the boardwalk in the Wildwoods, New Jersey. The Morey's Piers regalement park has over 100 rides and magnetizations for the visitors. Visit them at Surfside Pier, featuring the Ocean Oasis Waterpark and Beach Club at 25th Avenue, Mariner's Landing Pier, featuring Raging Waters Waterpark at Schellenger Avenue, and Adventure Pier at Spencer Avenue.
The Adventure Aquarium is located in Camden, New Jersey. The Adventure Aquarium features one of its kind exhibits with more than 8,500 aquatic species throughout two million gallons of water. Adventure Aquarium also has a wide variety of marine animals. The aquarium was basically known as the New Jersey State Aquarium at Camden.
The Newark Museum is located in Newark, New Jersey. The museum has extensive art collections and is dedicated to natural science. Major support for the Museum's education services is provided by the State of New Jersey, New Jersey State Council on the Arts/Department of the State. The Museum offers a variety of spaces for corporate entertaining, celebration, etc. The vast collections in the museum include American art, decorative arts, contemporary art, arts of Asia, Africa and the ancient world.