HUMAN ERROR AND RETRAINING: APPLYING THE SYSTEM OF PROFOUND KNOWLEDGE TO INVESTIGATIONS IN PHARMACEUTICAL QUALITY CONTROL LABORATORIES _________________ A Thesis Presented to the Faculty of California State University, Dominguez Hills ________________ In Partial Fulfillment of the Requirements for the Degree of Master of Science in Quality Assurance ________________ by Marc R. Bell Fall 2017 TABLE OF CONTENTS PAGE TABLE OF CONTENTS .................................................................................................... ii LIST OF TABLES ............................................................................................................. iii LIST OF FIGURES ........................................................................................................... iv ABSTRACT ........................................................................................................................ v CHAPTER 1. INTRODUCTION .......................................................................................................... 1 Background ............................................................................................................. 1 Statement of the Problem ...................................................................................... 12 Purpose of the Study ............................................................................................. 13 Theoretical Bases and Organization ..................................................................... 14 Limitation of the Study ......................................................................................... 15 Definition of Terms............................................................................................... 16 2. REVIEW OF THE LITERATURE .............................................................................. 19 Introduction ........................................................................................................... 19 Brief History of Quality Management .................................................................. 20 System of Profound Knowledge ........................................................................... 23 Appreciation for a System .................................................................................... 37 Psychology ............................................................................................................ 63 3. METHODOLOGY ....................................................................................................... 84 Design of the Study ............................................................................................... 84 Data Analysis Procedure ....................................................................................... 85 4. RESULTS AND DISCUSSION ................................................................................... 87 Discussion of Results ............................................................................................ 91 5. SUMMARY, CONCLUSIONS, AND RECOMMENDATIONS ............................. 111 REFERENCES ............................................................................................................... 116 ii LIST OF TABLES PAGE 1. Comparison of Analysis and Synthesis ........................................................................ 30 2. Summary of Literature Search Results.......................................................................... 88 3. Evaluation of Literature Search Results ........................................................................ 90 iii LIST OF FIGURES PAGE 1. Graphical Summary of the Evaluation of the Literature Search Results ......................................................................................................... 91 iv ABSTRACT Remedial training is a common corrective action when failure investigations identify human error as a causal factor. Over time, however, human error persists, and problems recur. Literature research supports the hypothesis that recurrence stems from the inappropriate use of remedial training, which fails to comprehend two elements of Deming’s System of Profound Knowledge: Appreciation for a System and Psychology. This thesis seeks to identify a tactic to improve how pharmaceutical quality control laboratories conduct failure investigations. To accomplish this, this thesis extracts applicable discussion points from a literature review and uses them to evaluate twelve proposed implements against Deming’s Appreciation for a System and Psychology. Based on this evaluation, this thesis identifies four implements of interests, and then summarizes elements common to each. These elements include adequately justified conclusions, solicit honest feedback, adopt a system perspective, recognize bias and evaluate established support, and promote organizational learning and improvement. 1 CHAPTER 1 INTRODUCTION Best efforts and hard work, not guided by new knowledge …only dig deeper the pit that we are in. W. Edwards Deming Human error and retraining are expansive topics not limited to pharmaceutical quality control (QC) laboratories. To clarify its scope, this thesis first summarizes the regulatory environment familiar to pharmaceutical QC laboratories and then a theoretical basis to confront the issue of using remedial training to resolve human error. Background Pharmaceutical products intended for sale in the United States (US) are subject to the regulations established by the US Food and Drug Administration (FDA). For the manufacture of pharmaceuticals for human use, the FDA requires laboratory testing to determine “satisfactory conformance to final specifications” (21 CFR 211.165 (a)). With respect to pharmaceutical QC laboratories, these tests may include the evaluation of physical appearance and color, chemical identity and purity, or biological indicators such as bacterial endotoxin count or product sterility. Concurrent with testing, the FDA requires that investigations be conducted for “any unexplained discrepancy” or when specifications are not met (21 CFR 211.192). Not meeting specifications include results determined to be out of specification (OOS) or out of tolerance (OOT). Unexplained 2 discrepancies include deviations from standard operating procedures (SOPs) and instrument or software errors. The FDA and Root Cause Analysis As the investigation identifies problems, the laboratory or parent organization applies short-term corrections in order to resume business operations. However, while short-term corrections are vital to the success of a business, the underlying objective of investigations is to determine the root causes of problems and prevent their recurrence (U.S. Food and Drug Administration [FDA], 2009). A problem’s root causes are its fundamental contributing factors “that can be reasonably identified and that management must control” (Vinnem, Hestad, Kvaløy, & Skogdalen, 2010, p. 1142). Specific root cause analysis (RCA) methods are “approaches, tools, and techniques” used to investigate the root cause of problems (American Society for Quality [ASQ], n.d. e). RCA methods vary in complexity, but they typically involve a documented approach to brainstorming and analysis of results. Examples of RCA methods include the Five Whys method of successive questioning, frequency prioritization via Pareto Analysis, and causal factor trees such as Ishikawa’s Fishbone Diagram. Other approaches include the Interrelationship Diagram to tally contributions of related factors, Current Reality Trees linked by arrows of causation, the Kepner-Tregoe Is-Is Not approach, and complex, data- driven approaches supported by proprietary software (Yuniarto, 2012). The complexity of RCA methods varies, and they can work independently or combine to assess multiple factors (Jayswal, Li, Zanwar, Lou, & Huang, 2011). A detailed evaluation of each method is beyond the scope of this thesis. Nevertheless, when used properly, RCA 3 methods produce corrective actions that prevent the recurrence of problems and help demonstrate a “robust quality culture” (FDA, 2015, p. 12). Corrective Actions and Remedial Training When investigating problems influenced by human interaction, a common corrective action is used to provide awareness or remedial training for the operators. The primary argument for remedial training is that humans caused the problem (root cause); therefore, those humans need more training (corrective action). Responses to FDA audit observations include statements that demonstrate this approach as follows: “Isolated human error… the analyst and lab auditor have been counseled on this error” (Perrigo, 2008, p. 3 & 18). “All employees in dispensing have been retrained …relative to the dispensing process as referred in SOP…” (Caraco Pharmaceutical Laboratories LTD, 2009, p 3). The “technician who committed the error received awareness training” (Meridian Medical Technologies, 2012, p. 4). The remedial training approach views human errors as “moral issues …[due to] aberrant mental processes such as forgetfulness, inattention, poor motivation, carelessness, negligence, and recklessness” (Reason, 2000, p. 768). Because of this, organizations focus their corrective actions on “reducing unwanted variability” (Reason, 2000, p. 768) by correcting the errant behavior with additional training, and employees who fail to assimilate the training eventually face termination (Reason, 1990/2003, pp. 211-212). While not explicitly stated, “followers of [this approach] …assume that bad things happen