Improving Process Stability and Capability – Tips, Traps and Guidance


FDA’s Process Validation Guidance Stage 3 calls for “ongoing assurance is gained through routine production that the process remains in a state of control.” Two critical considerations in assessing process behavior are process stability and capability. Tools commonly used to demonstrate that a process is in a state of control include: control charts, process capability indices, analysis of variance and graphics. Unexpected problems are often encountered when using these tools. In this session “tips and traps” are discussed that enable pharmaceutical scientists and engineers to develop effective process monitoring systems and avoid commonly encountered problems and pitfalls.

The issues discussed include: how to reduce false out of control signals, measures of process stability, how to identify causes of out of control signals, how to select the appropriate sampling procedures. The approaches and tools discussed are illustrated with pharmaceutical and biotech case studies and examples.

Areas Covered in the Session :

  • Reducing False Out of Control Signals
  • How to Use Process Stability Metrics
  • Selecting Appropriate Sampling Procedures
  • Identifying Causes of Out-of-Control Signals – The Usual Suspects
  • Early Warning Devices for Detecting Process Shifts
  • How to Select the Right Control Chart
  • Can We Reduce Sampling
  • Assessing the Pedigree of Your Data
  • Tips, Traps and Guidance – What to Watch Out For

Who Will Benefit:

  • Production Managers
  • Process and Manufacturing Engineers
  • Quality Assurance Managers, Scientists and Engineers
  • Quality Engineers
  • Lab Testing Personnel
  • Research and Development Scientists
  • Product Development Personnel
  • Biologists and Microbiologists
  • Chemists and Chemical Engineers
  • Supply Chain Professionals
  • Process Improvement Professionals

Dr. Ronald D. Snee

Ronald D. Snee, PhD, is Founder and President of Snee Associates, a firm dedicated to the successful implementation of process and organizational improvement initiatives. He provides guidance to senior executives in their pursuit of improved business performance using Quality by Design, Lean Six Sigma and other improvement approaches that produce bottom line results. Prior to his consulting career he spent 24 years at the DuPont Company in a variety of assignments including pharmaceuticals. He has been developing and applying QbD methodologies for more than 30 years. His recent application and research on QbD has produced more than ten articles on use of QbD in Pharma and Biotech. He has also coauthored 2 books on the methods and tools of QbD and speaks regularly at conferences and meetings on the subject. He teaches QbD and related methodologies as an Adjunct Professor at Temple University School of Pharmacy and Rutgers University Pharmaceutical Engineering program.

Ron received his BA from Washington and Jefferson College and MS and PhD degrees from Rutgers University. He is an academician in the International Academy for Quality and Fellow of the American Society of Quality, American Statistical Association, and American Association for the Advancement of Science. He has been awarded ASQ’s Shewhart and Grant Medals, and ASA’s Deming Lecture and W.J.Dixon Consulting Awards as well as numerous other awards and honors. He is a frequent speaker and has published 5 books and more than 255 papers in the fields of performance improvement, quality, management, and statistics. He is a past recipient of the Institute of Validation Technology Speaker of the Year Award.

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