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A Conceptual Framework for Risk-Based Decision-Making in Good Manufacturing Practice Environments
Subject area: Biological & Medical Sciences · Area of research: Good Manufacturing Practice
DOI: https://doi.org/10.64388/IREV4I6-1719693
Abstract
Decision-making in Good Manufacturing Practice (GMP) environments is increasingly expected to be risk-based, yet the regulatory expectation is articulated far more clearly than the means of meeting it. Practitioners are instructed to manage risk and to allocate effort in proportion to the threat posed to product quality and patient safety, but the published guidance describes principles and tools rather than an integrated account of how risk evidence becomes a defensible decision. This paper develops a conceptual framework that links established quality risk management practice to the wider theory of decision-making under uncertainty. The framework is organized as five interacting layers. A contextual foundation grounds every decision in regulatory mandate, product and process knowledge, and organizational culture. A risk intelligence layer converts hazards into characterized, evaluated risk. A decision logic layer applies explicit criteria, tolerance thresholds, and a principle of proportionality to appraise options. A governance layer assigns decision rights, escalation routes, and documented rationale. A learning layer feeds outcomes back into knowledge and recalibrates the framework over time. The framework treats the risk matrix not as the decision itself but as one input to a structured judgement, and it incorporates well-documented limits on human reasoning so that decisions remain auditable and resistant to bias. The result is a coherent, lifecycle-oriented structure that practitioners can use to design decision processes, that quality leaders can use to evaluate the maturity of those processes, and that researchers can use as a basis for empirical study. The framework is conceptual and is offered as a foundation for subsequent validation in operating manufacturing settings.
Keywords
Quality Risk Management, Risk-Based Decision-Making, Good Manufacturing Practice, Pharmaceutical Quality System, Proportionality, Decision Under Uncertainty, Conceptual Framework
How to cite this paper
@article{1719693,
author = {Oluchi Beatrice Aneke, Abimbola Caleb Adesemoye},
title = {A Conceptual Framework for Risk-Based Decision-Making in Good Manufacturing Practice Environments},
journal = {Iconic Research And Engineering Journals},
year = {2020},
volume = {4},
number = {6},
pages = {325-342},
issn = {2456-8880},
url = {https://www.irejournals.com/formatedpaper/1719693.pdf},
abstract = {Decision-making in Good Manufacturing Practice (GMP) environments is increasingly expected to be risk-based, yet the regulatory expectation is articulated far more clearly than the means of meeting it. Practitioners are instructed to manage risk and to allocate effort in proportion to the threat posed to product quality and patient safety, but the published guidance describes principles and tools rather than an integrated account of how risk evidence becomes a defensible decision. This paper develops a conceptual framework that links established quality risk management practice to the wider theory of decision-making under uncertainty. The framework is organized as five interacting layers. A contextual foundation grounds every decision in regulatory mandate, product and process knowledge, and organizational culture. A risk intelligence layer converts hazards into characterized, evaluated risk. A decision logic layer applies explicit criteria, tolerance thresholds, and a principle of proportionality to appraise options. A governance layer assigns decision rights, escalation routes, and documented rationale. A learning layer feeds outcomes back into knowledge and recalibrates the framework over time. The framework treats the risk matrix not as the decision itself but as one input to a structured judgement, and it incorporates well-documented limits on human reasoning so that decisions remain auditable and resistant to bias. The result is a coherent, lifecycle-oriented structure that practitioners can use to design decision processes, that quality leaders can use to evaluate the maturity of those processes, and that researchers can use as a basis for empirical study. The framework is conceptual and is offered as a foundation for subsequent validation in operating manufacturing settings.},
keywords = {Quality Risk Management, Risk-Based Decision-Making, Good Manufacturing Practice, Pharmaceutical Quality System, Proportionality, Decision Under Uncertainty, Conceptual Framework},
month = {December},
doi = {https://doi.org/10.64388/IREV4I6-1719693}
}