Acceptance Sampling Plans - Cutting Through the Jungle

Upcoming Virtual Courses

Overview

To the casual observer, Acceptance Sampling Plans can be incredible complex and hard to apply. Worse yet, the subject is a jungle with non-intuitive jargon and crazy acronyms. So why bother? 

  • The key advantage is that Sampling Plans can save time, money and resources. It certainly answers the question: How much is enough?”
  • Sampling Plans help decision makers understand the risk involved in accepting a product or process.
  • Well-designed training can cut through the jungle and provide a clear pathway.

This workshop provides a set of simple-to-follow procedures that will keep-it-simple to apply. A wide variety of industry applications will motivate the subject. While the terminology and acronyms used are “industry standard”, participants will not be burdened with statistical complexity. Participants do not need any background in statistics.

For FDA-regulated companies, sampling is a key statistical method used for Design Control, Process Validation, CAPA, complaint monitoring, and for Receiving, In-Process, & Finished Device Acceptance. We will discuss the recommendations of the guidance documents developed by the FDA and the Global Harmonization Task Force (GHTF) along with industry standards.  

Objectives

The key to answering the question “How much is enough?” is to identify the risks involved in deciding on the quality of a product or process. At the end of this workshop, participants will be able to:

  •     Describe the factors that influence the selection of a sample size 
  •     Apply valid statistical techniques for establishing sample size
  •     Clearly express the risk in a decision on the quality of a product or process

What to expect

There are two interactive deliveries in this workshop. Each part is two hours.

  •     Acceptance Sampling Plans for Variable Inspections
  •     Acceptance Sampling Plans for Inspection by Attribute

Each fast-paced webinar will cover the details of application without the burden of statistical complexity. Analysis results from popular statistical software programs will be illustrated. 

Who Should Attend?

This workshop is targeted to professionals concerned with the application of Sampling Plans to meet the requirements of the FDA's Quality System Regulation. The content should have great value to individuals in industry and the FDA who are involved with: new product development; process development; manufacturing, process, and quality engineering; operations; quality assurance; quality control; and regulatory compliance. Through this overview of acceptance sampling plans, managers and members of the leadership team would see how value is added to a product or process.

Course Preview

Day 1: Acceptance Sampling Plans for Variable Inspections
A. Defining an acceptance sampling plan pathway
B. Sampling for Process Validation Performance Qualification (PQ)
C. Introduction to ANSI and ISO standards
D. A greatly simplified procedure for application of tables
Day 2: Acceptance Sampling Plans for Inspection by Attribute
A. Defining an acceptance sampling plan pathway
B. Introduction to ANSI and ISO standards
C. A greatly simplified procedure for application of tables

Virtual Training Information

Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email education@aami.org.

Speakers

Peter L. Knepel

President of Peak Quality Services

Dr. Peter Knepell is the President of Peak Quality Services. He is a Certified Master Black Belt (MBB), Certified Quality Engineer (CQE), and Certified Software Quality Engineer (CSQE). He has broad industry experience helping firms adopt Lean Six Sigma quality systems and meet FDA-regulatory requirements. In the mid-1990s, Pete assisted the FDA with the introduction of their Quality System Regulation. Pete has presented over 30 webinars and is on AAMI’s faculty for: Valid Statistical Techniques, Design of Experiments, and Process Validation.