Acceptance Sampling Plans: Inspection by Attributes

WEBINAR

Click here for Part 2: Inspection by Variables »

Note. It is not a requirement to attend both parts.

Course description

Acceptance sampling plans are often misunderstood and misapplied in industry. What a terrible way to introduce a subject! Unfortunately, it is true. The goal of these two webinars is to foster an understanding of the terminology and goals of acceptance sampling plans without delving deep into the statistical theory. The presenter’s “keep-it-simple” approach will avoid statistical complexity – participants do not need to have a background in statistics.

This first webinar will cover inspection by attributes – that is, parts are inspected for defects so each part is classified as either Accept or Reject. The second webinar will cover inspection by variables. In this case, inspections will result in a measurement that must satisfy a lower or upper specification limit or both.

While participants may be familiar with ANSI Standards Z1.4 and Z1.9 or ISO Standards 2859 and 3951, this webinar will motivate and provide a more straightforward methodology for application. The goal is to avoid confusing terminology, provide clear options, aid in correct application, and help participants understand the risk in their decisions.

Acceptance Sampling Plans, when used, must be based on valid statistical rationale. That is required by the FDA’s Quality System Regulation. Sampling plans can be applied for Receiving, In-Process, & Finished Device Acceptance and for Process Validation. The presentations will discuss the recommendations of the guidance documents developed by the FDA and the Global Harmonization Task Force (GHTF).

These fast-paced webinars will cover the details of application together with some examples of best practices in industry. Analysis results from popular statistical software programs will be illustrated.

Program objectives

The key to creating and applying Acceptance Sampling Plans is to quantify the risks involved in making a decision on the quality of a product or process. At the end of each webinar, participants will be able to:

• Define the fundamental concepts for Acceptance Sampling Plans
• Create Acceptance Sampling Plans
• Establish an appropriate sample size
• Explain the risks involved with decisions

Program-at-a-glance

• Quick Introduction to Acceptance Sampling Plans
  • Definition of Acceptance Sampling Plans
  • Regulatory Issues and Guidance Documents
  • Key Considerations
• Acceptance Sampling Plans
  • Introduction to Terminology
  • Motivational Example
  • Deriving Sample Size
  • Acceptance Sampling Plan Pathway
  • Summary Example of Application
• Q&A

Who should attend

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

Prerequisites

There are no prerequisites for these webinars. No background in statistics is necessary. That is the foundation of our “keep-it-simple” approach.

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