Conducting Risk Assessments
It is commonly understood that risk is defined as the combination of the probability of occurrence of harm and the severity of that harm. Achieving a shared understanding of the application of risk management among diverse stakeholders is difficult because each stakeholder might perceive different potential harms, place a different probability on each harm occurring and attribute different severities to each harm. Subjectivity can directly impact the effectiveness of risk management activities and the decisions which are made. Therefore, it is important that subjectivity is managed and minimized. In relation to pharmaceuticals, the protection of the patient is of prime importance when managing the risk to product quality and availability, when availability risks arise from quality/manufacturing issues.
It is important to understand that product quality is assured based on appropriate risk-based decision making throughout the product lifecycle, such that the attributes that are important to the quality of the drug product are maintained and the product remains safe and effective.
ICH Q9(R1) Quality Risk Management Guidance for Industry is one guidance document designed to offer a systematic approach to quality risk management that leads to better, more informed, and timely decisions. There are other risk assessment processes used in the pharmaceutical industry that provide systematic processes to identify, evaluate, and prioritize potential risks associated with pharmaceutical products and processes, and changes made during the products lifecycle, such as X, Y and Z.
Two primary principles of Quality Risk Management are (1) the evaluation of the risk to quality, and (2) the level of effort, formality and documentation of the quality risk management process that should be commensurate with the level of risk . The risk evaluation should be based on scientific knowledge and ultimately link to the protection of the patient. (Note: Risk to quality includes situations where product availability may be impacted, leading to potential patient harm)..
Quality risk management is a systematic process for the assessment, control, communication, and review of risks to the quality of the drug (medicinal) product across the product lifecycle. The systematic process for risk management starts with Risk Assessment includes Hazard Identification, Risk Analysis, and Risk Evaluation, followed by Risk Control, including Risk Reduction and Risk Acceptance, Risk Communication, and Risk Review, with possible Risk Events. A robust process will incorporate consideration of all the elements at a level of detail that is commensurate with the specific risk.
Medvacon Life Sciences provides risk assessment services to help you establish a quality risk management process to identify and mitigate risks effectively. Our experienced consultants utilize tools such as Failure Mode and Effects Analysis (FMEA) to systematically evaluate potential failure modes and develop targeted mitigation strategies. By proactively addressing potential risks, you can minimize the likelihood of quality issues and regulatory non-compliance.
Risk Management process flow chart
