ROLE OF EFFECTIVE QUALITY RISK MANAGEMENT IN DRUG SAFETY PROJECT

Author

Bhawna Sharma, Harrisburg University of Science and Technology

Completion Date

Spring 4-9-2018

Document Type

Thesis

Degree Name

Master of Science (MS)

Program or Discipline Name

Project Management

First Advisor

Stephen Onu

Abstract

Identifying risk is one of the key topics of discussion in project planning and update meetings. Project managers have to identify and manage different risks at various levels of projects. These risks must be managed and eradicated in the effective and structured manner to perform effective quality risk management and thus leading to adequate project management. The research investigates the potential root cause of the quality risk management issues using tools such as the fishbone diagram (Ishikawa), 5-Whys, FTA etc. which could remedy this situation. An effectiveness check measure can also be implemented after applying corrective/preventive actions to ensure that quality is met at each step of the process. Over 90 articles were searched using keywords risk minimization plan, benefit-risk assessment, drug safety, and pharmacovigilance. The search was further narrowed to 16 articles which had information based on human studies and drug safety. Non-human studies and single case assessments were excluded from the research.

The quality data of 20 large pharmaceutical companies were surveyed extensively and it was suggested that only limited number of projects used very rare risk management practices and most of the projects do not use all the current tools of risk management. The most extensively used method of quality risk management included failure mode and effects analysis. This technique was mostly utilized in assessing change control and failed investigations. The data of this analysis suggested that risk management strategies are not used extensively. This research recommends the practice of tools used for quality risk management such as fish-bone diagram (Ishikawa) and FTA at early stages of drug development. Effectiveness check measure is also suggested to ensure that quality is met at each step of the drug safety. There may be other risk-benefit assessment methods which are not identified by this research and further research is warranted to guarantee the success of these measures.

Recommended Citation

Sharma, B. (2018). ROLE OF EFFECTIVE QUALITY RISK MANAGEMENT IN DRUG SAFETY PROJECT. Retrieved from https://digitalcommons.harrisburgu.edu/pmgt_dandt/41