Better Risk-Management Alternatives to AQL Sampling Plans in Incoming QC Inspection

Joy L. McElroy
Jun 27, 2019 - 01:00 PM EDT
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$249

Premier price: $224 (save 10%)

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Attend this webinar to learn the serious disadvantages of basing incoming QC inspection on AQL sampling plans (e.g., ANSI Z1.4 or Squeglia's C=0). You will also learn several better risk management alternatives that provide much better quality control and risk management.

Why Should You Attend:

The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. The advantages of "confidence/reliability" calculations are explained. Such calculations are demonstrated for Attribute data (pass/fail, yes/no data) as well as for variables data (i.e., measurements). If variables data is "Normally distributed" the calculations are extremely simple. The webinar explains how to handle "non-Normal" data, and provides the methods, formulas, and tools to handle non-normality.

The training includes a discussion of how one OEM manufacturer has implemented "confidence/reliability" calculations instead of AQL sampling plans for all of its clients. And suggestions are given for how to use "confidence/reliability" QC specifications instead of "AQL" QC specifications. The use of "reliability plotting" for assessing product reliability during R&D is also discussed.

The training also includes an examination of ISO and FDA regulations and guidelines regarding the use of statistics, especially in regards to Sampling Plans.

Areas Covered in the Webinar:

  • AQL and LQL sampling plans
  • OC Curves
  • AOQL
  • ANSI Z1.4
  • Squeglia's C=0
  • Confidence/Reliability calculations for
    • attribute data
    • Normally-distributed variables data
    • non-Normal data
  • Transformations to Normality
  • K-tables
  • Normal Probability Plot
  • Reliability Plotting

Who Will Benefit:

  • QA/QC Supervisor
  • Process Engineer
  • Manufacturing Engineer
  • QC/QC Technician
  • Manufacturing Technician
  • R&D Engineer
Webinar Events
Attend Live Webinar
Jun 27, 2019 - 01:00 PM EDT

Duration: 90 Minutes

Single attendee

Premier price: $224 (save 10%)

Group of 3 to 5

Premier price: $ 359 (save 10%)

Group of 6 to 10 + DVD-USB

Premier price: $ 719 (save 10%)

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Premier price: $ 539 (save 10%)

Recorded video

Recorded video session

Premier price: $ 314 (save 10%)


Speaker: Joy L. McElroy,

Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab. In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt. With 10 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing. In 2013 Joy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.