As director of quality management at Teckro, it’s my role to get the best out of my team when it comes to problem-solving, and this is why I encourage critical thinking. It’s very easy for assumptions, irrationality and bias to creep into our thought process. Critical thinking - or “thinking about thinking” doesn’t happen automatically; it requires continuous improvement and vigilance.
Edward M. Glaser who wrote An Experiment in the Development of Critical Thinking in 1941, said: "The ability to think critically, as conceived in this volume, involves three things:
This concept still stands today.
Quality management is a discipline that demands intense analysis and concentration. This applies 10-fold to quality management supporting the clinical research sector because the stakes are so high.
For Teckro, ensuring consistent quality of processes, data and documentation that support sponsor and contract research organizations (CROs) and their regulatory requirements is key. The combination of critical thinking and asking the right questions guides our teams with decisions on how best to support our customers with Teckro solutions and services to improve their clinical trial operations.
As requirements and regulations change, so too quality management must change. For example, we are currently seeing a significant transformation with clinical trials as the pandemic has led to widespread uptake of new technology by sponsors and CROs.
However, as is the case with any technology, technology for its own sake is not enough. This is where I see the need for critical thinking to avoid getting swept up in “hype” and deeply consider how the technology will improve clinical trial operations for better patient outcomes and research data integrity.
Similarly, there are quality management systems widely available on the market. However, we must bear in mind that whereas technology enables us to follow correct processes, it doesn’t eliminate the need to think. In Teckro, this is why we take a proactive rather than a reactive approach to tackle problems at their core.
An important part of any decision-making process always keeps in mind delivery to the client, client satisfaction, continuous improvement and growth, business and industry requirements.
The main factors that are considered a risk to the above are reviewed regularly. The key is to think ahead and use lessons learned to pre-empt issues before they arise.
In order to demonstrate how to approach problem-solving using a “thinking about thinking” approach, let’s have a look at the five main components of critical thinking.
Effective risk management and planning is about understanding the scenario we are addressing and correctly identifying the factor(s) that can positively or negatively influence it. This may seem straightforward, but critical thinking involves challenging assumptions and personal opinion, so it’s important to get the fundamentals correct. At this stage, being as precise as possible is fundamental to achieving a successful outcome.
The goal at this stage is to learn as much as possible about the scenario. At Teckro, we have several methods of collecting, analyzing and investigating information, including Corrective and Preventive Actions (CAPAs), information security risk management, and risk management and planning procedures. In all approaches here’s what we take into consideration:
One approach I like to use is to involve multiple stakeholders to get a fair and balanced representation of knowledge and facts. By understanding as many perspectives as possible early on and tapping into wider team expertise, better decisions are made when it comes to approaching new problems. However, an open mind is also needed to take new information into consideration as it becomes available.
At this stage, the facts need to be analyzed and evaluated while accounting for any bias or persuasion identified in step 2.
Taking into consideration factors such as judgement of those involved, past experiences and best practices, historical evidence, previous assessment results, and lessons learned are all vital to understand the facts.
However, this approach of cross-departmental experience and opinion in itself nearly guarantees that each team will evaluate and value information differently and may even reach different conclusions when faced with the same data.
On the other hand, teams that are willing to embrace a systematic approach to logical thinking that allows both an understanding of these differences and all voices to be objectively and respectfully heard, will reach a decision on the best approach, understanding that an approach may not always benefit them as individuals, but supports the greater good.
The team achieves this by checking for logic in the data accumulated. In doing so, we may draw conclusions, find alternative approaches that also make sense, or discover unintended consequences. In the end we need to ensure the following is clear:
Once the risk is evaluated, the next step is to consider proposed solutions, taking into account the identified advantages and disadvantages of each of these options. We also think about short- and long-term results the solution could have. Here, it helps to examine previous risks and to use judgement to establish what is likely to work well (or not) while at the same time, considering new approaches to problems.
The next stage is to put an action plan together in order to decide whether to:
And throughout the process, we regularly communicate with our stakeholders to make sure everyone is suitably informed.
When it comes to quality management, it is not enough to rely solely on technology but to support it with enquiring, curious human minds. We constantly strive to rigorously apply critical thinking to the process by digging deep into the issues as they arise and asking pertinent questions to tackle problems at their core. This ensures a fresh angle can be taken on new problems – while also applying lessons learned from the past.