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Statistical Sampling Plans - Methods and Applications 2018


  • Until March 20 Early Bird Price

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    USD 1295
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  • March 21 to April 23 Regular Price

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    USD 1495
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  • Register for 5 attendees

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    USD 3885
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  • Register for 10 attendees

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    USD 7122
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About The Event



Course "Statistical Sampling Plans - Methods and Applications" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.








Acceptance sampling plans are important tools for manufacturers. Effectively used they can help reduce costs while assuring quality and controlling risks. Unfortunately, this rich field of techniques is not as prominent as it once had been. As a result, quality practitioners don't always appreciate the wide range of available options or understand how to choose among alternate statistical sampling plans.


Because there are no published standards or guides to help select the right technique for each application, this workshop invaluable. For example, a sampling plan to make an acceptance decision on an incoming lot is not the right plan to sample records in a quality audit. Even incoming inspection has many viable options - variables sampling plans can significantly reduce inspection cost compared to common attributes sampling plans.


This workshop balances understanding the statistical concepts of sampling and creating practical applications. The workshop uses a large number of exercises to help participants understand the theories, master the techniques, and participate in practical exercises.


Any company that uses sampling plans can benefit from this workshop. The workshop uses examples from medical device manufacturing. However, the methods, tools, and techniques are not industry specific.




Why should you attend:




Nearly all companies use sampling plans as part of quality control and quality assurance. However, some methods are better suited to certain applications. Understanding the available methods can help make better choices to optimize cost and conformance.




Workshop Objectives:




Participants will learn the statistical basis for acceptance sampling plans and the tools and methods to describe them, particularly the Operating Characteristic curve. This forms the basis for selecting sampling plans and understanding the associated risk. In particular, regulators, such as FDA Investigators, expect companies to use this information to help implement valid statistical techniques. However, cost is a consideration as well. Participants will learn how to calculate sampling costs and use the information to help choose efficient plans that control the risk.


Participants receive a set of Excel spreadsheets that help explain and implement the sampling plans.




Who will benefit:




  • Quality Managers
  • Risk Managers
  • Quality Engineers
  • Production and Process Engineers
  • Manufacturing Engineers
  • Design Engineers
  • Purchasing Managers
  • Supplier Quality Engineers
  • Quality Supervisors
  • Quality Inspectors








Day 1 Schedule




Lecture 1:


Fundamentals - Regulatory Requirements


  • Statistical techniques in FDA QSR
  • Statistical techniques in ISO 13485:2016
  • FDA Warning Letters


Lecture 2:


Fundamentals - Statistics


  • Descriptive statistics
  • Graphical techniques
  • The binomial distribution
  • The hypergeometric distribution
  • The normal distribution
  • Tests for normality


Lecture 3:


Sampling Concepts


  • Acceptable Quality Level (AQL)
  • The Operating Characteristic (OC) curve
  • Risk (producer and consumer) and the sampling plan


Lecture 4:


Attribute Sampling (Z1.4 & c=0)


  • Sampling parameters (Level, Lot size, & AQL)
  • Single, double, and multiple sampling plans
  • Normal, reduced, and tightened sampling plans
  • Describing the sampling plan
    • OC Curve
    • Discrimination and the Operating Ratio
    • Average sample number curve (ASN)
    • Average total inspected (ATI)
    • Average outgoing quality (AOQ)


Lecture 5:


Attribute Sampling (Dodge-Romig)


  • Understanding the system
  • Average outgoing quality limit (AOQL)
  • Limiting quality level (LQL)




Day 2 Schedule




Lecture 1:


Variables Sampling Using Z1.9


  • Variability known and unknown methods
  • Using the variability unknown method
  • Comparative sample sizes
  • Combining attributes and variables plans


Lecture 2:


Sequential Sampling Plans


  • The sequential probability ratio
  • Calculating the accept/reject region
  • Using the fan chart as a special case


Lecture 3:


Continuous Sampling Plans


  • Process that don't produce lots
  • Plan Parameters - Clearing Interval & Sampling Fraction
  • OC Curve and Average Outgoing Quality
  • CSP-1, CSP-2, and CSP-3 sampling plans
  • MIL-STD-1235


Lecture 4:


Skip-lot Sampling Plans


  • Defining the Parameters
  • The OC Curve
  • Alternate to Z1.4 Reduced Inspection - S1


Lecture 5:


Chain Sampling Plans


  • Defining the parameters
  • The OC Curve


Lecture 6:


Sampling Plans for Quality Audits


  • Records as Audit Evidence
  • Statistical Samples v. Convenience Samples
  • Bounding the Error Rate
  • Using FDA's Plans in QSIT






Dan O'Leary


President, Ombu Enterprises 


Dan O'Leary is 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 certified by APICS in Resource Management.




Location: Seattle, WA DateApril 26th & 27th, 2018 and Time: 9:00 AM to 6:00 PM


Venue:  Courtyard Seattle Sea-Tac Area   16038 West Valley Highway Tukwila Washington 98188 USA












Register now and save $200. (Early Bird)


Price: $1,295.00 (Seminar Fee for One Delegate)


Until March 10, Early Bird Price: $1,295.00 From March 11 to April 24, Regular Price: $1,495.00


Register for 5 attendees   Price: $3,885.00      $6,475.00 You Save: $2,590.00 (40%)*


Register for 10 attendees   Price: $7,122.00   $12,950.00 You Save: $5,828.00 (45%)*




Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar


At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.


As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.


For More Information- 




Contact us today!




NetZealous LLC DBA GlobalCompliancePanel 


Toll free: +1-800-447-9407


Phone: +1-510-584-9661






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