Quality Risk Assessment: A Comprehensive Guide
A quality risk assessment is a systematic process of identifying, analyzing, and evaluating the potential hazards and consequences that may affect the quality of a product, service, or process. It is a key tool for quality management, as it helps to prioritize and mitigate the risks, and to ensure compliance with the relevant standards and regulations. It is important the risk assessment objective is fully aware of the application and user environment of the item, and the item under assessment is expertly examined. Defining what you scope is, is of course a key fundamental.
Clearly define the scope and objectives of your quality risk assessment before starting. Identify what you're assessing, why, and what you expect to find.
The Significance of Quality Risk Management
Quality risk management (QRM) is a crucial process for ensuring the safety and efficacy of drugs throughout their lifecycle, from development to commercial manufacturing. By proactively identifying and managing potential risks, manufacturers can minimize the chances of quality issues arising and ensure that the final product is of high quality and safe for patients to use. This process should be considered in a holistic, proactive, and systematic manner, meaning that QRM should be an integral part of the pharmaceutical quality system, focused on identifying and evaluating potential risks throughout the product lifecycle. Being proactive involves anticipating and addressing potential risks before they occur, while a systematic approach requires a structured and consistent methodology capable of identifying, assessing, controlling, and communicating risks.
Implementing a QRM process involves a structured approach to risk assessment, management, and control, as well as ongoing monitoring and reassessment of identified risks. As an initial phase of a QRM process, the subject matter experts (SMEs) must ensure a set of premises to guarantee an efficient risk assessment exercise, encompassing the correct description of the problem, its scope, and the goal of the risk assessment.
Tools and Methods for Risk Assessment
Simple brainstorming tools are the most commonly used tools in a QRM process, whether for gathering data and information or characterizing the process, product, or entity being assessed. A sequential interrogation of the issue by asking “Why?” five times. Although their influence is often less direct than risk analysis or risk classification, these simple brainstorming tools can be critical to planning subsequent QRM activities or can act as complementary follow-ups of more in-depth analysis.
Despite being referred to as "simple tools," these offer a much more sophisticated approach than basic brainstorming by enabling cause-and-effect risk analysis. The fishbone diagram, originally developed by Kaoru Ishikawa in the 1960s, has become a valuable tool for quality management in drug manufacturing and development. This diagram is uniquely designed to map out the various steps of a process, pinpoint potential quality control issues, and determine the necessary resources to address any deviations. Similarly, the cause-and-effect matrix is a risk analysis tool that evaluates the relationship between different causal factors and their resulting effect. Unlike the fishbone diagram, the matrix method is better suited for assessing problems with multiple causal factors, but it may not illustrate interrelated patterns as effectively. Nonetheless, both simple risk analysis tools are important for informing more advanced QRM tools and building an effective quality management system (QMS).
The most complex QRM tools are designed to classify the previously identified and characterized risks by assessing their severity, occurrence, and detection (SOD). A Preliminary Hazard Analysis (PHA) is a powerful tool for product development, particularly in the early stages of the design process. At this stage, modifications are more cost-effective and simpler to implement. Similarly, a Failure Mode and Effects Analysis (FMEA) can proactively identify and address potential problems before they arise. Although FMEA is the most resource-intensive and time-consuming of the QRM tools, it can also serve as the foundation for system design elements and process controls across the entire product pipeline.
Steps in a Quality Risk Assessment
The third step is to identify and analyze the risks, which involves applying appropriate methods and tools to collect and evaluate the information about the potential hazards and their causes, likelihood, and impact on the quality attributes or criteria. Some of the common methods and tools include brainstorming, checklists, fishbone diagrams, failure mode and effects analysis (FMEA), fault tree analysis (FTA), hazard analysis and critical control points (HACCP), and risk ranking and filtering.
As a starting point for identifying risks, tap into your organization's past. Examine your external quality costs like warranty claims, customer complaints, onsite sorting, and returns. Then look at your internal quality costs. Defects, scrap, and regraded material all represent risks to your organization. A third place to look for process risks is "near misses". This is the most difficult area to uncover. What events "almost happened" but didn't because of some timely intervention.
Evaluating the likelihood and impact of each identified risk. The likelihood refers to the probability. severity of the effect on users, customers, etc. Assessing the likelihood of a risk is mostly based on technical considerations related to the product, the risk, the project, and so on.
The fifth step is to treat and control the risks, which involves selecting and implementing the appropriate risk reduction or prevention measures, or accepting or transferring the risks if they are within the acceptable level. The risk treatment and control measures should be proportionate to the level of risk, and should aim to eliminate, reduce, or mitigate the potential hazards or their consequences. Some of the common measures include design changes, process improvements, quality controls, contingency plans, training, audits, and inspections.
Error Proofing (Poka Yoke)
Failures rarely occur because of a single missed step. Many occur because of a series of mishaps. And complex failures usually occur because of the interacting effects of multiple failures that are nearly impossible to see outside a systems approach. Error proofing, also called poka yoke, is the practice of implementing usually simple devices or controls to either prevent a defect from being made or to prevent it from escaping the system. Error proofing methods can be applied to product design, process design, and inspection.
Digitalization of Quality Risk Management
Managing risk effectively can be a significant challenge, particularly when the QRM process is not systematically organized throughout the company. Quality risk management digitalization is a process that consolidates these activities into a single platform. When implemented correctly, this approach enables a centralized and holistic QRM process that connects the entire organization, ensures coherence in processes, and facilitates knowledge preservation and utilization.
This is a space to share examples, stories, or insights that don’t fit into any of the previous sections.