Glossary

Some terms I use over and over again

Term	Definition
21 CFR 211	FDA regulation establishing CGMP requirements for finished pharmaceuticals
5W2H Method	Structured questioning approach (What, When, Where, Who, Why, How, How Much) for problem definition
Adaptive Toolbox	Gerd Gigerenzer’s collection of fast-and-frugal heuristics for decision-making under uncertainty
ALCOA	Attributable, Legible, Contemporaneous, Original, and Accurate – original data integrity framework developed by FDA inspector Stan Woollen in the 1990s
ALCOA++	Enhanced framework adding Complete, Consistent, Enduring, Available, and Traceable to the original ALCOA principles
Apprenticeship Dividend	The accumulated learning value gained through progressive, hands-on experience in quality roles, which cannot be replicated by AI or compressed into senior-level training
Aseptic Processing	Manufacturing technique designed to prevent contamination of sterile products
Batch Records	Documentation of all activities and data related to the production of a pharmaceutical batch
CAPA	Corrective and Preventive Actions – systematic approach to addressing quality issues
Causal Investigation	Root cause analysis methodology focusing on identifying causal mechanisms rather than contributing factors
Causal Reasoning	Investigation approach focusing on understanding causal mechanisms rather than just contributing factors
cGMP	Current Good Manufacturing Practice – FDA regulations for pharmaceutical manufacturing quality
Change Control	Formal process for managing and documenting changes to validated systems and processes
Competency Frameworks	Structured approaches integrating technical knowledge, methodological skills, social capabilities, and self-management
Contamination Control Strategy	Comprehensive approach to preventing, detecting, and responding to contamination events
Control Barrier	System, process, or procedure designed to prevent or detect quality failures
CQV	Commissioning, Qualification, and Validation – integrated approach to equipment and system lifecycle management
Critical Quality Attributes	Physical, chemical, biological, or microbiological properties that should be within appropriate limits
Data Integrity	Accuracy, completeness, consistency, and reliability of data throughout its lifecycle
Data-Centric Architecture	System design treating documents as dynamic views of underlying quality data rather than static containers
Deliberate practice	A purposeful, structured, and feedback-driven approach to skill development that focuses on improving specific aspects of professional competence through repeated, challenging, and thoughtfully designed activities.
Deviation Investigation	Systematic process for identifying root causes and implementing corrective actions for process/product deviations.
Digital Trust	Confidence established through transparent, data-driven digital infrastructure in business relationships
Document Control	Systematic management of document creation, review, approval, and revision processes
EIR	Establishment Inspection Report – comprehensive FDA document detailing inspection findings
Electronic Batch Records	Digital systems for documenting batch production activities
Engineering Quality Process (EQP)	Interface between Good Engineering Practice and Pharmaceutical Quality System
Environmental Monitoring	Systematic sampling and testing of manufacturing environments for contamination
EU Annex 1	European regulation for manufacture of sterile medicinal products
EudraGMDP	European database containing information on GMP compliance status of manufacturing sites
Expertise Hollowing	Organizational phenomenon where surface capability exists but deep competency required for complex challenges is lacking
Falsifiable Quality Systems	Quality systems designed with testable predictions that can be proven wrong, enabling continuous improvement
FOIA	Freedom of Information Act – law requiring government agencies to provide public information
Form 483	FDA inspectional observations document listing deficiencies found during facility inspections
FUSE	Facility Utility System Equipment – framework for describing critical manufacturing components
FUSE(P)	FUSE with Process – expanded framework including process elements
GEMBA Walk	Going to the actual place where work occurs to observe, understand, and gather information about deviations
Golden Day	Critical 24-hour window after deviation discovery for capturing accurate information and containing risks
Grade A/B/C/D	Cleanroom classification levels based on particle counts and environmental conditions
GxP	Good Practice guidelines (GMP, GLP, GCP, GDP, GPvP) covering pharmaceutical development and manufacturing
HEPA Filter	High-Efficiency Particulate Air filter used in cleanroom environments for contamination control
ICH	International Council for Harmonisation – develops technical guidelines for pharmaceutical development globally
ICH Q9(R1)	International guideline on Quality Risk Management for pharmaceuticals
ICMRA	International Coalition of Medicines Regulatory Authorities – strategic coordination among global regulators
Impact Assessment	Evaluation of effects of changes or deviations on product quality, processes, and systems
Known	Information, facts, or knowledge that we are aware of and understand with reasonable certainty. These represent the foundation of our decision-making in quality systems, encompassing established scientific principles, validated processes, documented procedures, and empirically-verified relationships. In quality risk management, knowns provide the baseline from which we assess deviations and uncertainties. However, even “knowns” require periodic reassessment as new information emerges or as contexts change.
Known unknowns	A recognized information gap; a question that one is aware of but for which one is uncertain of the answer. It represents a disparity between what the decision maker knows and what could be known. Known unknowns are characterized by two key factors: salience (the degree to which contextual factors highlight the question) and importance (how much one’s utility would depend on the actual answer). These information gaps often exist in the realm of Knightian uncertainty and require deliberate knowledge management strategies to address. In quality risk management, known unknowns represent opportunities for targeted investigation and learning to strengthen decision-making capabilities.
KPI/KBI/KRI	Key Performance/Behavioral/Risk Indicators used to measure quality system effectiveness
Leading vs Lagging Metrics	Predictive indicators vs. historical performance measures in quality systems
Learning Culture	An environment, ecosystem, or organizational norm that prioritizes, encourages, and rewards continuous individual and collective learning in pursuit of organizational improvement, resilience, and adaptability. In a learning culture, every member is engaged in ongoing learning for personal development, team advancement, and the organization’s benefit.
Media Fill	Aseptic processing simulation using sterile microbiological growth medium
Multi-dimensional Document Governance	Systems that simultaneously satisfy engineering, quality, and operational needs without creating redundant documentation streams
PAI	Pre-Approval Inspection – FDA evaluation of manufacturing facilities before product approval
Pattern Recognition	Ability to identify significant deviations from routine variations through experience and expertise
Performance Excellence	Integrated approach to organizational performance management delivering value to stakeholders
PIC/S	Pharmaceutical Inspection Co-operation Scheme – harmonizes GMP standards and inspection practices
Process	A structured sequence of interconnected activities that transforms inputs into outputs to deliver value to stakeholders. In your framework, processes exist within clear boundaries that define start and end points, include specific actors and activities, and can be evaluated on two critical dimensions: complexity/dynamics (how complicated the tasks are and how frequently the process changes) and strategic importance (the value the process contributes to meeting core organizational requirements). Processes are hierarchical, ranging from high-level architectural processes (research, manufacture, distribute) to mid-level discrete activities (perform clinical study) to detailed operational processes (laboratory testing
Process Myopia	Process myopia is the organizational tendency to focus intensely on the mechanics, procedures, and activities of work processes while losing sight of the underlying purpose, desired outcomes, or value creation that those processes are meant to achieve. It represents a form of institutional nearsightedness where compliance with procedures becomes more important than accomplishing the fundamental job the process was designed to do.
Process Owner	The individual accountable for the end-to-end performance of a specific business process, serving as the champion who takes overall responsibility for process design, day-to-day management, and continuous improvement. The Process Owner defines the process including people, process steps, and technology, manages interfaces between cross-functional processes to prevent horizontal silos, ensures adequate training and resource allocation, and drives improvement initiatives using metrics to track and monitor process performance. This role is distinguished from functional management and subject matter experts – it requires being a subject matter expert on the end-to-end process while leading (not necessarily executing) activities like documentation, training development, and technology implementation. The Process Owner sits in a central role for building organizational culture and driving process maturity, and should be supported by appropriate infrastructure and governance structures
Molecule Steward	A designated individual or function responsible for overseeing a product’s safety, regulatory compliance, risk management, and sustainability throughout its entire lifecycle. The Product Steward ensures that global regulatory requirements (e.g., REACH, GHS, FDA, EMA) are anticipated and met, communicates regulatory obligations to stakeholders across the value chain, and integrates product-related risk assessments into business decisions.
Progressive Responsibility Models	Career development pathways with gradual increases in responsibility and complexity
Quality Culture	Organizational culture characterized by shared commitment to quality enhancement
Quality Gardeners	Professionals who nurture quality systems as living ecosystems rather than enforcing compliance through rigid oversight
Quality Intelligence	Strategic use of quality data and insights to drive organizational decision-making
Quality Risk Management	Systematic application of quality management principles to risk assessment and control
Risk	The combination of the probability of occurrence of harm and the severity of that harm, representing the effect of uncertainty on objectives. In your framework, risk can be characterized by reference to potential events and consequences, often expressed as a combination of the consequences of an event and the associated likelihood of occurrence. Risk assessments fundamentally ask “What could go wrong?” and then answer two critical questions: “If it did go wrong, how bad is it?” (the harm) and “How likely is it to go wrong?” (the probability). Risk is then the combination of these elements as a magnitude or priority. You distinguish between risk assessment tools that start with hazards (asking how something can fail) versus those that start with harms (asking what bad things we want to avoid). Under the ISO 31000 perspective you advocate, risk represents “the effect of uncertainty on objectives” where that effect can be positive, negative, or both, opening transformative possibilities beyond traditional defensive approaches.
Risk Blindness	Organizational vulnerability to unrecognized risks due to lack of hands-on experience
Risk Perception	The subjective judgment that individuals or groups make regarding the severity and likelihood of a risk, including their intuitive or emotional response to potential hazards. Risk perception influences how people interpret, prioritize, and respond to risks in both organizational and personal contexts.
Risk Priority Number	Numerical assessment combining probability, severity, and detectability of potential failures.
Semantic Drift	Natural evolution of word meanings over time, requiring active management in technical documentation.
Stakeholder	Any individual, group, or organization that can affect, be affected by, or perceive itself to be affected by quality risks and decisions. These are the people and entities whose interests, expertise, or regulatory authority intersect with the quality outcomes of pharmaceutical products and processes. Internal stakeholders encompass quality units, manufacturing operations, regulatory affairs, senior management, engineering teams, and business development functions. These groups directly participate in activities through interdisciplinary teams that combine technical expertise with decision-making authority. External stakeholders include suppliers, contract manufacturers, distributors, auditors, and the broader healthcare ecosystem. Their influence on quality outcomes may be indirect but remains critical for comprehensive management.
Subjectivity	The introduction of personal biases, emotions, opinions, heuristics, or inconsistent interpretations into decision-making processes that should ideally be driven by objective data and facts. Subjectivity is a widespread problem throughout the quality sphere, arising from poorly designed scoring systems, differing perceptions of hazards and risks among stakeholders, and cognitive biases. It manifests through inconsistent decision-making, bias and emotional influence, inadequate risk management strategies, difficulty in measuring performance, potential for misalignment with business goals, and negative impact on team dynamics. A critical aspect of your analysis is the “Fallacy of Expert Immunity” – the incorrect belief that experts are impartial and immune to biases, when in fact expertise and experience may actually increase certain biases through selective attention, chunking, schemas, and reliance on heuristics. While subjectivity cannot be entirely eliminated, it can be controlled through structured approaches including data-driven decision making, standardized processes, education and training, leveraging knowledge management, implementing structured risk-based decision-making, and using well-formulated risk questions that provide clarity, focus, and objective criteria.
System Lifecycle	Comprehensive approach to managing systems from conception through retirement
Take-the-Best Heuristic	Decision-making approach from Gigerenzer’s adaptive toolbox that identifies the most reliable indicator for making quality decisions
Traceability	Ability to track data, materials, and processes throughout the product lifecycle
Trend Analysis	Systematic evaluation of patterns in quality data to identify recurring issues
True North	Ideal state of perfection that an organization should continually strive for, recognizing quality as a journey without absolute destination
Unknown	Information or knowledge that we recognize we lack or are uncertain about. This represents the space between what we currently know and what we need to know for effective decision-making. Unknowns can be categorized as either “known unknowns” (information gaps we’re aware of) or “unknown unknowns” (blind spots we haven’t yet recognized). In quality systems, managing unknowns requires systematic approaches to reduce ignorance through knowledge management, investigation, and learning from experience.
Unknown unknowns	Those things that we don’t even know that we don’t know; blind spots in our knowledge that we haven’t yet recognized as gaps. These represent the most challenging category for quality systems because they can’t be directly managed until they become known unknowns or knowns. Unknown unknowns emerge from six key factors: complexity (many interacting elements), complicatedness (multiple failure points and difficult cause-effect relationships), dynamism (volatile, changing elements), equivocality (imprecise information), perceptive barriers (biases and mindlessness), and organizational pathologies (structural weaknesses). The goal is to systematically convert unknown unknowns into known unknowns through structured approaches including stakeholder interviews, system decomposition, scenario analysis, and cultivating alert cultures that emphasize candor and learning from surprising outcomes.
Validation Discrepancy	Errors or failures during qualification/validation where actual results don’t match expected results
Warning Letter	Official FDA communication describing significant violations of regulatory requirements
Word Stewards	Designated roles responsible for maintaining consistent terminology usage across organizational documents
Zemblanity	Patterned, preventable misfortune that accrues from human agency and organizational design choices that hardwire failure into operations