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 [email protected] http://www.globalcompliancepanel.com https://goo.gl/dqymAj