Case study | Enhancing Quality and EfficiencyReduced deviations and complaints by more than 30% in pharmaceutical company
In today’s highly competitive pharmaceutical industry, maintaining the highest standards of product quality and minimizing deviations and complaints is paramount.
This case study delves into how OSICS NETWORK, a renowned consulting firm, successfully partnered with a prominent pharmaceutical company to tackle their challenges head-on and achieve remarkable results. By applying a strategic approach and leveraging expert knowledge, OSICS NETWORK helped the pharmaceutical company reduce deviations and complaints by over 30%, demonstrating the power of proactive problem-solving and continuous improvement in the corporate world.
SITUATION
The pharmaceutical company in question was grappling with a significant volume of deviations and complaints, posing a substantial risk to their reputation and product integrity. The key challenges included:
- High Number of Deviations: The company was experiencing an alarming number of deviations, which were impacting their overall operational efficiency and compliance.
- Recurring Deviations: More than 30% of these deviations were recurring, indicating underlying systemic issues that required urgent attention.
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Human Error: A root cause analysis revealed that human error was responsible for over 20% of the deviations, underscoring the need for comprehensive training and corrective measures.
APPROACH
OSICS NETWORK’s approach to addressing these challenges was meticulous and structured:
- Training Trainers: Recognizing the importance of root cause investigation, the first step involved training internal trainers to become experts in the field. This ensured that knowledge and expertise were disseminated effectively within the organization.
- Broad-based Training: Over 70 Subject Matter Experts (SMEs) from various departments, including HR representatives, underwent rigorous training on how to conduct investigations. They were equipped with tools such as fishbone diagrams and the “5 Whys” technique to enhance their investigative capabilities.
- Certification Process: OSICS NETWORK implemented a certification process, wherein each investigator was required to submit and review five investigation reports. Feedback was provided to authors, ensuring continuous improvement in investigative skills.
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Emphasis on Preventive Actions: The approach also placed a strong focus on preventive actions, leading to a significant increase in their implementation compared to corrective actions.
IMPACT
OSICS NETWORK’s partnership with the pharmaceutical company yielded impressive results:
- Deviation Reduction: In the first year of collaboration, the number of deviations decreased by a remarkable 30%, reflecting a substantial improvement in operational quality.
- Packaging Area Complaints: Complaints in the packaging area were reduced by an impressive 40%, indicating a higher level of customer satisfaction and product reliability.
- Reduced Recurring Deviations: The company successfully lowered the occurrence of recurring deviations, achieving a reduction of 10% overall and a mere 3% attributed to human errors.
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Efficient Investigations: The investigation time in the packaging area was reduced to less than 10 days, and in bulk production, it was lowered to under 20 days, streamlining processes and enhancing efficiency.
In this case study, we have witnessed the transformation of a pharmaceutical company’s quality management system through its partnership with OSICS NETWORK. By addressing the root causes of deviations, enhancing investigative capabilities, and prioritizing preventive actions, the company not only improved its operational efficiency but also strengthened its reputation in the industry.
OSICS NETWORK’s commitment to delivering innovative solutions and fostering a culture of continuous improvement has undoubtedly set a new standard for corporate excellence in the pharmaceutical sector. This case study serves as a testament to the impact of strategic consulting and proactive problem-solving in the corporate world.