Understanding Attribute Acceptance Sampling Plans Including the Z1.4 and c=0 Plans

Attribute acceptance sampling is a common tool for medical device manufacturers. Unfortunately, many people don't understand the underlying concepts or the basis for decision making. This presentation explains the underlying ideas of attribute sampling plans and how to use the two most common published plans, Z1.4 and c=0. In addition, the presentation describes the major differences between the approaches. Attribute sampling plans are characterized by the operating characteristic curve (OC curve) which provides the basis for sampling risk. The presentation explains how to read the OC and use it to help select sampling plans.

Why should you Attend: If your production process or incoming inspection uses attribute sampling plans, then you must understand how they work and their associated risk. For example, in FDA QSR, you must determine that they are adequate for the intended use and reviewed when you make process changes.

Learning Objectives:

• Understand why the binomial distribution applies
• Understand the operating characteristic, OC, curve and how it quantifies risk
• Use Excel to calculate the OC curve
• Use the sampling tables to determine the sampling plan
• Understand the difference between single, double, and multiple sampling plans
• Learn why double sampling plans are the most economical choice
• Understand when to switch between normal, reduced, and tightened inspection
• Use the switching rules to help improve your supplier management program
• Learn how the switching rules can help reduce inspection cost

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