NETZEALOUS -MENTORHEALTH 2016 - Seminar on Fundamentals of Statistical Process Control: Implementation and Assurance of SPC at SFO, CA

Website http://www.mentorhealth.com/control/globalseminars/~product_id=200068SEMINAR | Edit Freely

Category Healthcare compliance training provider

Deadline: June 02, 2016 | Date: June 02, 2016-June 03, 2016

Venue/Country: SFO, CA, U.S.A

Updated: 2016-05-26 18:13:53 (GMT+9)

Call For Papers - CFP

Overview:

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

Agenda:

Day One

Lecture 1:

The Regulatory Structure

FDA QSR

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

Speaker:

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

Email: supportmentorhealth.com

Website: http://www.mentorhealth.com/

Registration Link - http://www.mentorhealth.com/control/globalseminars/~product_id=200068SEMINAR

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