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 case...
Read more
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.
Who will benefit:
Quality Managers
Quality Engineers
Supplier Quality Engineers
Quality Analysts
Production and Process Engineers
Design and Development Engineers
Verification and Validation Specialists
Agenda:
Day One:
Lecture 1: 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
Lecture 2: Introduction/Fundamentals - Statistics
Descriptive Statistics
Graphical Techniques
The binomial distribution
The hypergeometric distribution
The normal distribution
Tests for normality
Lecture 3: Sampling Concepts
Understanding Acceptable Quality Level (AQL)
Defining the Operating Characteristic (OC) curve
Risk (producer and consumer) and the Sampling Plan
Lecture 4: 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
Lecture 5: Attribute Sampling Using the Dodge-Romig System
Average Outgoing Quality Limit (AOQL)
Limiting Quality Level (LQL)
Using the system
Day Two:
Lecture 6: 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
Lecture 7: Sequential sampling plans
The sequential probability ratio
Calculating the accept and reject regions
The fan chart as a special case
Lecture 8: 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
Lecture 9: Skip-lot sampling plans (SkSP)
Defining the parameters
The OC curve
An alternate to Z1.4 reduced inspection (ANSI/ASQC S1)
Lecture 10: Chain sampling plans (ChSP)
Defining the parameters
The OC curve
Lecture 11: Applications
Design verification and validation
Process validation
Incoming inspection
Speaker:
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: San Francisco, CA Date: October 29 & 30, 2015 Time: 9:00 AM to 6:00 PM PDT
Venue: DoubleTree by Hilton Hotel San Francisco Airport
DoubleTree by Hilton Hotel San Francisco Airport 835 Airport Blvd., Burlingame CA 94010-9949
Price: $1,295.00 (Seminar for One Delegate)
Register now and save $200. (Early Bird)
Until August 15, Early Bird Price: $1,295.00 from August 16 to October 27, Regular Price: $1,495.00
Contact Information:
NetZealous LLC,
DBA GlobalCompliancePanel
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
USA Phone: 800-447-9407
Fax: 302-288-6884
support@globalcompliancepanel.com
http://www.globalcompliancepanel.com
https://goo.gl/dqymAj
10 September 2015 |
163 views