Course Description:

How well do you understand sampling plans and their application in your company? Many companies have procedures and program 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. In other cases, the firm may not use the best methods, resulting in waste of resources.

This unique hands-on course will provide attendees with a solid understanding of acceptance sampling methods and their application to medical device manufacturing. The course delivers tools, templates, and insight that will allow participants to implement sampling methods within their firm.

This two-day hands-on course provides a clear understanding of the underlying statistics used in acceptance sampling. The course uses exercises to solidify understanding. 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 known, 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.

Learning Objective:

Upon course completion, participants will:

  • Understand FDA QSR and ISO 13485 requirements for acceptance sampling
  • Perform calculations using the binomial distribution
  • Perform calculations using the hypergeometric distribution
  • Perform calculation using the normal distribution
  • Apply tests of normality to a data set
  • Understand Acceptable Quality Limit (AQL) and apply it
  • Understand Operating Characteristic (OC) curves
  • Select sampling plans from Z1.4
  • Select sampling plans from Z1.9
  • Implement sequential sampling plans (using the Wald method)
  • Implement continuous sampling plans (CSP)
  • Implement skip-lot sampling plans (SkSP)
  • Implement chain sampling plans (ChSP)

Who will Benefit:

  • Quality Managers
  • Quality Engineers
  • Supplier Quality Engineers
  • Quality Analysts
  • Production and Process Engineers
  • Design and Development Engineers
  • Verification and Validation Specialists

Course Outline:

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  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
  2. Introduction/Fundamentals – Statistics
    • Descriptive Statistics
    • Graphical Techniques
    • The binomial distribution
    • The hypergeometric distribution
    • The normal distribution
    • Tests for normality
  3. Sampling Concepts
    • Understanding Acceptable Quality Level (AQL)
    • Defining the Operating Characteristic (OC) curve
    • Risk (producer and consumer) and the Sampling Plan
  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
      • OC curve
      • Average sample number (ASN)
      • Average total inspected (ATI)
      • Average outgoing quality (AOQ)
    • Using Accept on Zero (AOZ) plans instead
  5. Attribute Sampling Using the Dodge-Romig System
    • Average Outgoing Quality Limit (AOQL)
    • Limiting Quality Level (LQL)
    • Using the system

  1. 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
  2. Sequential Sampling Plans
    • The sequential probability ratio
    • Calculating the accept and reject regions
    • The fan chart as a special case
  3. 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
  4. Skip-Lot Sampling Plans (SkSP)
    • Defining the parameters
    • The OC curve
    • An alternate to Z1.4 reduced inspection (ANSI/ASQC S1)
  5. Chain Sampling Plans (ChSP)
    • Defining the parameters
    • The OC curve
  6. Applications
    • Design verification and validation
    • Process validation
    • Incoming inspection

Meet Your Instructor

Dan O'Leary
President at Ombu Enterprises, LLC

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 master’s 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.

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