A well cultivated critical thinker may employ the following processes:
Gathers and assesses relevant information while also assigning proper risk, abstract ideas for effective interpretation of the data, comes to well-reasoned conclusions and solutions, and tests them against relevant criteria and standards;
Thinks open-mindedly with alternative pathways, recognizing and assessing the importance of the data being generated, as well as the proper assigned risks of the processes involved and practical consequences;
Communicates effectively with others in determining the solutions to complex problems.
Critical thinking is, in short, self-directed, self-disciplined, self-monitored, and self-corrective thinking. It presupposes assent to rigorous standards of excellence and mindful command of their use. It entails effective communication and problem solving abilities and a commitment to overcome our native egocentrism and sociocentrism.
Critical thinking can support informed decision-making and good judgment on where and how to scale testing activities. The extent and depth of activities (and level of documentation formality) can, and should, vary to a considerable degree between different business processes, types of systems, functions within a system/applications and associated risks. Efficiency improvements can be made by focusing on what is really needed and avoiding unnecessary work, mainly focusing on the risks at hand.
Using critical thinking, SME’S experiences with the systems and processes are leveraged by applying them to determine test cases and direction based on documented risk assessment, generating applicable supporting evidence (only where it brings value to the quality of the testing), spending more time actively testing the higher risk functions and less time generating documentation in advance, which may not be needed. This is a shift in thinking in order to focus from documentation to robust testing strategies with better quality assurance. It enables the management of data integrity and software assurance risks, potentially in support of direct/indirect product quality and patient safety.
Similarly in the medical device space, trends are being observed with more emphasis being placed on critical thinking and identifying the most critical impact throughout the process, rather than focusing on documentation and formal testing when validating computerized systems used as part of the medical device manufacturing or quality system.
Quality by Design (QbD), on the other hand, is a systematic approach to development that begins with predefined objectives for a product, process understanding, and process control based on knowledge and quality risk management. All conventional methods may fail to meet the intended purpose during processes such as method development, validation, qualification, process optimization, manufacturing, and quality system design.
According to the FDA, this systematic approach can enhance achieving the desired quality of the product and help the Agency to better understand the sponsor’s manufacturing strategy. The sponsor can update product and process understanding with the knowledge gained over the product lifecycle. The QbD approach helps to facilitate design of product and processes that maximizes the product’s efficacy and safety profile, while enhancing product manufacturability.2
QbD is a concept first developed by the quality pioneer Dr. Joseph M. Juran3. Dr. Juran believed that quality should be designed into a product, and that most quality crises and problems relate to the way in which a product was designed in the first place. The basic principle of QbD is that quality cannot be tested into products, but that quality should be built in by design. It utilizes a more efficient use of development time and costs and enhances the ability to meet FDA submission guidelines and expectations, reduced approval times - and potentially fewer queries - from the FDA.
QbD and a sound quality assurance department are the backbones of the life science industry. They allow companies to confirm that their products conform to applicable quality, drug stability and safety standards while improving the overall processes.
QbD may utilize various tools, including:
These tools enhance the ability to identify the probability that an issue might occur and the level of risk that may come. They assist in distinguishing how easy an issue will be to detect and provide evidence, noting that if the process is understood, the issues can be understood, and the focus of efforts can be recognized.
Bridging these two novel concepts – QbD utilizing Critical Thinking – ultimately ensures that processes are effectively utilized to potentially design a better quality product. Documenting what went right and what went wrong and putting the emphasis where it is necessary in drug development, software validation, computer system assurance, etc., is all about learning from and using the history of experiences, improving or fixing problems as required, and ensuring the process becomes more efficient and risk-focused. Identifying what went right and what went wrong is critical - it’s all about using the history of experiences, improving or fixing problems, and becoming more efficient. And at the end of the day, QbD, together with Critical Thinking, contributes to a high quality process that may be directly or indirectly involved with providing better designed processes which may influence improved technological systems, augmented data integrity, product quality and ultimately, safety to the end user – the patient.
