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Overview:Many companies use acceptance sampling as a standard business practice. The most common applications use attribute sampling based on ANSI/ASQ Z1.4 and Zero Acceptance Number Sampling Plans by Nicholas L. Squeglia. These common methods are not always the best approaches. This seminar will expose to you to a variety of methods and help you understand when to use them.While many of the examples come from medical device manufacturing because of the rigid regulatory structure, the methods apply in aviation, defense, and other manufacturing settings.This unique hands-on course provides attendees with a solid understanding of acceptance sampling methods and their application to manufacturing. The course delivers tools, templates, and insight that will allow participants to choose and implement the best sampling methods for their application.Many companies have procedures and programs that fall short of the regulatory requirements and good statistical practice. In some cases, FDA may give the firm a 483 or even a Warning Letter. QMS audits may result in nonconformances that need to be addressed. In other cases, the firm may not use the best methods, resulting in waste of resources.This two-day hands-on course provides a clear understanding, with many exercises, of the methods and underlying statistics for acceptance sampling. As part of the practical implementation, the course explains common standards such as Z1.4 for attribute sampling and Z1.9 for variables sampling. In addition, the course covers other, less well know, methods such as sequential sampling, continuous sampling, and chain sampling.The course also covers specific applications of sampling including incoming inspection, design validation, design verification, process validation, and quality audits.
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GlobalCompliancePanel Knowledge, a Way Forward…
Overview
Many companies use acceptance sampling as a standard business practice. The most common applications use attribute
sampling based on ANSI/ASQ Z1.4 and Zero Acceptance Number Sampling Plans by Nicholas L. Squeglia. These common
methods are not always the best approaches. This seminar will expose to you to a variety of methods and help you
understand when to use them.
While many of the examples come from medical device manufacturing because of the rigid regulatory structure, the methods
apply in aviation, defense, and other manufacturing settings.
2-day In-person Seminar:
Statistical Sampling Plans - Methods and Applications
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.
9:00 AM to 6:00 PM October 29 & 30, 2015 San Francisco, CA
Course " " has been pre-approved by RAPS Statistical Sampling Plans - Methods and Applications
as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
GlobalCompliancePanel Knowledge, a Way Forward…
DAY ONE
Agenda:
DAY TWO
Who will benefit:
Quality Managers
Quality Engineers
Supplier Quality Engineers
Quality Analysts
Production and Process Engineers
Design and Development Engineers
Verification and Validation Specialists
Introduction/Fundamentals - Regulatory Requirements
Statistical techniques in FDA QSR
Statistical techniques in ISO 13485
Validated processes
Process and product monitoring
Design verification and validation
FDA Warning Letters
Introduction/Fundamentals - Statistics
Descriptive Statistics
Graphical Techniques
The binomial distribution
The hypergeometric distribution
The normal distribution
Tests for normality
Sampling Concepts
Understanding Acceptable Quality Level (AQL)
Defining the Operating Characteristic (OC) curve
Risk (producer and consumer) and the Sampling
Plan
Attribute Sampling using Z1.4
Setting the sampling parameters (AQL and lot size)
Single, double, or multiple sampling
Acceptance history (normal, reduced, or tightened
sampling)
Describing the sampling plan
OC curve
Average sample number (ASN)
Average total inspected (ATI)
Average outgoing quality (AOQ)
Using Accept on Zero (AOZ) plans instead
Attribute Sampling Using the Dodge-Romig System
Average Outgoing Quality Limit (AOQL)
Limiting Quality Level (LQL)
Using the system
Variables Sampling Using Z1.9
The methods (variability known and variability
unknown)
Variability unknown methods (range and standard
deviation)
Calculating the process parameters - the modern
approach
Comparative sample sizes
Combining attributes and variables plans
Sequential sampling plans
The sequential probability ratio
Calculating the accept and reject regions
The fan chart as a special case
Continuous sampling plans (CSP)
Processes that don't produce lots
Clearing interval
Sampling fraction
OC curve and Average Outgoing Quality Limit
(AOQL)
CSP-1, CSP-2, and CSP-3
Mil-Std-1235
Skip-lot sampling plans (SkSP)
Defining the parameters
The OC curve
An alternate to Z1.4 reduced inspection
(ANSI/ASQC S1)
Chain sampling plans (ChSP)
Defining the parameters
The OC curve
Applications
Design verification and validation
Process validation
Incoming inspection
GlobalCompliancePanel Knowledge, a Way Forward…
Group participations
Price for One Delegate pass Price: $ 1,295.00
Register now and save(Early Bird) (Early Bird) Price $200.
Pricing List
**Please note the registration will be closed 2 days (48 Hours) prior to
the date of the seminar.
Register Now
Kindly get in touch with us for any help or information.
Look forward to meeting you at the seminar
GlobalCompliancePanel
Learning Objectives
Participation certificates
Interactive sessions with the US expert
Post event email assistance to your queries.
Special price on future purchase of web
based trainings.
Special price on future consulting or expertise
services.
Special price on future seminars by
GlobalCompliancePanel.
Seminar Kit – includes presentation handout,
ID card, brochure, trainings catalog, notepad
and pen.
Networking with industry's top notch professionals
What you will get
Credit Card: Use the Link to make Payment by
Visa/Master/American Express card click on the
register now link
Check: Kindly make the check payable to
NetZealous DBA GlobalCompliancePanel and
mailed to 161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA
PO: Please drop an email to
[email protected] or call the
our toll free +1-800-447-9407 for the invoice and
you may fax the PO to 302 288 6884
Wire Transfer: Please drop an email to
[email protected] or call our
toll free +1-800-447-9407 for the wire transfer
information
Payment Option
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10+ Attendees to get offer
Contact Information: Event Coordinator
NetZealous LLC, DBA GlobalCompliancePanel
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
Toll free: +1-800-447-9407
Fax: 302 288 6884
Email: [email protected]
