Quality Risk Management in the Pharmaceutical Industry

The Process of Quality Risk Management

Figure 1: Overview of a typical quality risk management process by ICH Q9 guideline

Quality risk management follows a systematic process that involves five key steps: forming a cross-functional QRM team, risk assessment, risk control selection, risk control implementation, and risk review & communication. These steps, as outlined in ICH Q9, provide a structured approach to identifying, evaluating, and mitigating risks throughout the entire product life cycle.

Step 1: Initiating a Quality Risk Management Process

The initiation of a Quality Risk Management Process, as outlined in the ICH Q9 guidelines, is a critical step in ensuring pharmaceutical quality and safety. This process starts with defining the problem or risk question, which involves identifying potential risks and making pertinent assumptions about them. This step is foundational, as it sets the scope and focus of the entire risk management effort.

Gathering background information or data on potential hazards and their impact on human health is the next crucial step. This phase involves thorough research to understand the nature of the risk, its possible causes, and consequences. This data forms the basis for any risk assessment and helps in making informed decisions.

Appointing a leader and allocating necessary resources is another vital step. The leader plays a pivotal role in steering the risk management process, ensuring that the team remains focused on the objectives and that the process is aligned with organizational goals. The resources – be it personnel, time, or financial – must be adequate to support the risk management activities effectively.

Finally, specifying a timeline, deliverables, and the level of decision-making is essential for keeping the risk management process on track. Setting clear deadlines and expected outcomes helps in maintaining momentum and focus while defining the decision-making hierarchy ensures that decisions are made efficiently and by the right people.

Step 2: Risk Assessment

Risk assessment is a crucial step in quality risk management, where potential hazards are identified, and the likelihood and severity of adverse events are evaluated. This step involves asking critical questions about safety risks, identifying populations at risk, and determining if risks are preventable. By understanding the root causes of risks, companies can measure their probability of occurrence and interpret their impact on product quality.

Hazard Identification

Hazard identification in quality risk management systematically uses diverse information sources, like historical data and expert opinions, to identify hazards related to a defined risk. 

This step addresses the question “What might go wrong?” and its possible consequences, forming the basis for further risk management steps. It’s a critical component, ensuring a comprehensive understanding of potential risks before proceeding to risk analysis and evaluation.

Risk Analysis

In the realm of quality risk management, particularly within the pharmaceutical sector, risk analysis is a pivotal phase that follows hazard identification. This process involves estimating the risk linked to identified hazards, using either qualitative or quantitative methods. 

The essence of risk analysis lies in its ability to correlate the likelihood of occurrence with the severity of potential harms. A unique aspect of some risk management tools is the inclusion of detectability in risk assessment, considering how easily a potential harm can be identified. 

This multi-dimensional approach to risk analysis ensures a thorough understanding of potential risks, which is fundamental to crafting effective risk management strategies.

Risk Evaluation

In the comprehensive process of quality risk management, risk evaluation is a critical stage where the identified and analyzed risks are compared against established risk criteria. This evaluation considers the strength of evidence for the fundamental risk questions, emphasizing the importance of a robust data set. 

It acknowledges the role of uncertainties, arising from incomplete knowledge or process variability, in shaping the risk assessment’s output. This output can be either a quantitative estimate or a qualitative description of risk. 

Quantitative assessments provide specific probabilities, while qualitative assessments use terms like “high”, “medium”, or “low”. Some tools also incorporate a relative risk measure, blending various levels of severity and probability into a consolidated risk estimate, often enhanced by intermediate steps of quantitative estimation.

Step 3: Risk Control 

Risk control in quality risk management is an essential component in ensuring product safety and efficacy in various industries, including pharmaceuticals. This process involves critical decision-making aimed at reducing or accepting risks to maintain them at an acceptable level. 

The extent of effort invested in risk control is directly proportional to the significance of the risk involved. Key aspects of risk control include evaluating whether the risk is above an acceptable level, identifying strategies to reduce or eliminate risks, balancing benefits against risks and resources, and assessing the potential for new risks introduced by risk control measures.

Risk Reduction

Risk reduction strategies focus on mitigating or avoiding quality risks that exceed acceptable levels. These strategies often include actions that reduce the severity and probability of harm and can involve enhancing the detectability of hazards and risks. 

An important consideration in risk reduction is the potential for introducing new risks into the system or increasing the significance of existing ones. Therefore, following the implementation of risk reduction measures, it may be necessary to revisit the risk assessment process to identify and evaluate any changes in risk.

Risk Acceptance

Risk acceptance is another facet of risk control, where a decision is made to accept a certain level of risk. It acknowledges that in some scenarios, even the most robust quality risk management practices might not eliminate all risks. 

In such cases, it is determined that an appropriate risk management strategy has been applied and that the risk has been reduced to a specified acceptable level. This acceptable level varies depending on many factors and should be decided on a case-by-case basis.

Overall, risk control is a dynamic and critical process in quality risk management, requiring continuous evaluation and adjustment to ensure that risks are maintained at acceptable levels while achieving the desired balance between risk reduction and resource allocation.

Step 4: Risk Communication

Risk communication in quality risk management is a crucial process of sharing information about risk and risk management among decision-makers and other stakeholders. This communication can occur at any stage of the risk management process and involves conveying information about various aspects of risk, such as its existence, severity, and control measures. 

The goal is to ensure all parties, including regulators, industry, and patients, are informed about the risks and the decisions made to manage them. Effective communication is integral for transparency and informed decision-making, and it often occurs through established regulatory channels and internal company procedures.

Step 5: Risk Review 

Risk management in quality management should be a continuous process, involving regular monitoring and review. The risk management outcomes should be periodically reassessed in light of new information or experience. This ongoing process applies to both planned events (like audits or product reviews) and unplanned events (such as failure investigations). 

The frequency of reviews depends on the risk level, and it’s important to reconsider risk acceptance decisions as part of this process. This approach ensures that risk management remains dynamic and responsive to changing circumstances.