Integrating the HACCP and SPC for hazard control and process improvement: a case of pharmaceutical industry

Abstract

Purpose The purpose of this study is to integrate two well-established frameworks with an aim to reduce the unwanted rejection rate recurring in the drug production process in pharmaceutical industries. The effectiveness of an integrated framework has been demonstrated by a real-time case study in a complex industrial environment, providing a platform for quality tools application in the pharmaceutical industry. Design/methodology/approach The hazard analysis and critical control points (HACCP) provided a basic framework for hazard analysis and its blending with statistical process control (SPC) aided in data-driven decision-making. The extensive brainstorming and Pareto analysis helped to identify potential critical-to-quality characteristics followed by SPC, x¯ and R charts, histograms and Cp and Cpk analysis to spot the critical control point. The fishbone diagram led to the extraction of the leading cause behind the identified problem. Then, based on recommended corrective actions, control limits were adjusted and the process was brought into control. Finally, a product-based cost analysis is also performed to illustrate the financial impact resulting from the proposed method’s successful implementation. Findings The integrated framework is applied to a drug production process which has a higher rejection rate (3%) because of the non-conformities. Based on Pareto analysis, potential failure causes were classified and prioritised as inappropriate composition (2.54%), packaging (0.35%), out-of-specification (0.069%), equipment failure (0.022%), input materials (0.018%) and miscellaneous (0.002%). It is found that 84% of the total rejection rate is contributed by inappropriate composition. After taking corrective actions, it is observed that the proposed method has helped to reduce the process rejection rate significantly (2.54-0.82%). In the monetary terms, 2.50% decline per unit costs is noted in this case study work. The proposed integrated framework’s success is further motivating other pharmaceutical industries to implement and expand it to other processes. Originality/value The case study is an attempt to contribute to the existing literature of quality management in pharmaceutical industries. In particular, it is a novel example to introduce the simple and user-friendly SPC tool into well-established HACCP framework to enhance its effectiveness in hazard identification. The case study results motivate managers to adopt quality techniques for achieving a higher quality standard and operational excellence.