Dijital VSM ile İlaç QC Laboratuvarı İşlem Süresini Azaltma

Özet (abstract)

The quality control laboratory of any industry must ensure the quality of products to meet the regulatory compliances. However, the quality control in healthcare industry and pharmaceutical firms are highly relevant as its products’ quality directly impacts the human health. Hence, quality control laboratories in pharmaceutical firms needs to conduct several tests to ensure drug substances’ efficacy, safety and regulatory compliance to maintain the highest quality standards of effectiveness and precision. Though value stream mapping (VSM), a lean tool, has been widely used to enhance operational efficiency in manufacturing and healthcare operations but their application with pharmaceutical quality control laboratories remains relatively unexplored. Thus, the primary objective of this paper is to propose an optimized methodology for reducing turnaround time in quality control processes of pharmaceutical firms. Existing research primarily highlights production environments or conventional healthcare processes, often examining the factors responsible for efficient performance and waste management in pharmaceutical firms, daily operations and the associated supply chains which do not properly address the unique operational constraints, validation requirements and procedural difficulties essential in quality control laboratories. This research addresses this gap by applying work study based digital VSM framework to identify inefficiencies, reduce turnaround time and enhance operational performance while maintaining regulatory compliance by finding the causes of problems faced by analysts during testing. The proposed integrated framework was validated in a pharmaceutical case company that reduced turnaround time by 38.31%, significantly minimizing errors and decreasing potential delays in the supply chain to the market.

Yazarların özeti; kaynağından alınmıştır. Quality Management Journal, 2026 · DOI ↗