Part 3: Managing and minimizing subjectivity

Subjectivity is an element that can greatly influence the outcome of Quality Risk Management (QRM) activities and therefore can have a direct impact on the product quality and patient safety. Hence, it was naturally considered as one of the key areas that needed to be addressed within ICH Q9 (R1) and it is thoroughly discussed within the Q9 (R1) training material. According to the ICH Q9 (R1) concept paper, subjectivity can be introduced to and might affect several steps within the QRM process including :

✓ Poorly defined risks questions

✓ Risk assessment

✓ Risk scoring (poorly designed tools)

✓ Identification of hazards

✓ Estimation of probability of occurrence and severity

✓ Perception of hazards, risks and harms by different stakeholders

✓ Estimation of risk reduction

Understanding subjectivity and how it can influence the process, is a key step towards its management and minimization.

Subjectivity- what does it actually mean?

There is no single, globally accepted definition of subjectivity. According to the Cambridge dictionary, subjectivity is the influence of personal beliefs or feelings rather than facts whereas the Oxford Dictionary of Sociology defines it as the self-conscious perspective of the person or subject. One of the two main principles of QRM is the evaluation of the risk to quality based on scientific knowledge. And this is where the problem arises; when non-fact- based elements get intermingled into a process which is supposed to be conducted based on facts.

Factors that contribute to Subjectivity

Understanding subjectivity and the factors that introduce it to the QRM, is a good starting point to build a strategy for its management and minimization. The following factors are considered as key contributors to subjectivity within QRM:

· Uncertainty → is the lack of knowledge about hazards, harms and therefore their associated risks. It is almost impossible to eliminate uncertainty from the QRM process as risk is by definition probabilistic in nature (combination of the probability of occurrence of harm and severity of the harm).

· Heuristics → simple decision rules that allow one to make judgments without integrating all the information available, in other words cognitive “rules of thumb” that allow quick problem solving and decision making. They are often employed -sometimes unconsciously- when decisions need to be made and there is uncertainty. Heuristics contribute to subjectivity indirectly by introducing bias which can lead to inaccurate assumptions, decisions and judgment.

Knowledge is (again) the key

As mentioned within our article on risk-based-decision making (Blog post part 2), knowledge is important within many aspects of QRM processes. In this case, knowledge is detrimental in minimizing subjectivity as directly or indirectly (via heuristics and bias), it decreases uncertainty. Increasing knowledge can be achieved in many ways and here we outline some good starting points:

QRM Tool Experts

When deciding on how to set up a team to conduct a QRM activity, ensure that it includes people who are highly knowledgeable on QRM tools. Apart from ensuring the proper usage of existing tools and therefore effectiveness in the QRM deliverables, experts can also contribute by “setting up” new or customized tools which might be more relevant to the topic (process) in question. Furthermore, such experts can increase the group understanding on QRM tools via knowledge transfer.

QRM Facilitator

Besides their expertise on QRM methodologies, a QRM facilitator can be beneficial within QRM activities also when it comes at decreasing subjectivity. The role of a facilitator can enhance the process by structuring the risk assessment and guiding the team members to avoid bias. Being unbiased themselves, facilitators can increase objectivity by ensuring that all team members are heard, have adequate knowledge, and bring in their own expertise. A good facilitator needs to have good leadership, communication and management skills in order to effectively lead the team throughout the QRM process and direct team members to search for strength of evidence when discussing and deciding on risk ratings. At last, but not least, part of their role entails informing QRM team members about potential biases and how to avoid them.

Teams that are aware of subjectivity

It might seem as something rather obvious but should not be disregarded. Subjectivity will never completely be excluded out of the QRM, as it is driven by humans (=subjects). This should be accounted for, as subjectivity is more likely to be introduced within the QRM process when team members are unaware of how to counteract subjectivity and biases. Teams which are competent in this area usually avoid bringing in bias and uncertainty within assessments and decision making, leading to a more effective process.

Cross-functional teams

As for most aspects of the QRM process, here as well, power lies in unity. Within teams which are built up by members who have expertise in different areas, departments or functions, the risk assessment is focused on a broad range of knowledge and experience. Interestingly, bringing together both more experienced and less experienced individuals can also decrease subjectivity; more experienced members will bring in their knowledge but also biases whereas less experienced members might be helpful in mitigating the latter by questioning the status quo.

It’s all about communication

Teams which are well informed prior to the QRM activity, are more likely to focus on the objectives of the activity and the tasks to be accomplished. Information which can be helpful might include the following:

✓ Scope of the activity

✓ Risk questions to be addressed

✓ Risk methodology to be used

✓ Map of the process and associated data

✓ Comprehensive data on the specific process or area of the QRM activity

Are you and your team members aware of subjectivity within QRM and how to decrease it? If you need guidance on this matter, do not hesitate to contact us.