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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 andZero 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 About Speaker - Dan O'Leary 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, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management. Dan is a regular speaker at international conferences including ASQ, ISM, and RAMS. Dan teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. Dan is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; he holds an APICS certification in Resource Management. Course Outline: Day 1 - Agenda 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 • 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 2 - Agenda 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 Date, Venue & Price: Location: SFO, CA May 15th & 16th, 2014 9 AM to 6 PM Venue: DoubleTree by Hilton Hotel San Francisco Airport Venue Address: 835 Airport Blvd., Burlingame, California, 94010-9949, USA Price: $1,295.00 Register now and save $200. (Early Bird) Until March31, Early Bird Price: $1,295.00 from April01 to May 13, Regular Price: $1,495.00 Address: 835 Airport Blvd., Burlingame, California, 94010-9949, USA25, Early Bird Contact Information Event Coordinator Toll free: 1800 447 9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com Website: https://www.globalcompliancepanel.com Event Link - http://bit.ly/1eIz2Uz LIVE CHAT SUPPORT - http://www.globalcompliancepanel.com/chat/client.php GlobalCompliancePanel NetZealous LLC 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.
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Software Validation, FDA Inspections, Acceptance Sampling - Methods and Applications, process validation, Regulatory Compliance, Boston Seminars, USA,
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