Tag: subjectivity

Q9 (r1) Risk Management Draft

Q9 (r1) starts with all the same sections on scope and purpose. There are slight differences in ordering in scope, mainly because of the new sections below, but there isn’t much substantially different.

4.1 Responsibilities

This is the first major change with added paragraphs on subjectivity, which basically admits that it exists and everyone should be aware of that. This is the first major change that should be addressed in the quality system “All participants involved with quality risk management activities should acknowledge, anticipate, and address the potential for subjectivity.”

Aligned with that requirement is a third bullet for decision-makers: “assure that subjectivity in quality risk management activities is controlled and minimised, to facilitate scientifically robust risk-based decision making.”

Solid additions, if a bit high level. A topic of some interest on this blog, recognizing the impact of subjectivity is critical to truly developing good risk management.

Expect to start getting questions on how you acknowledge, anticipate and address subjectivity. It will take a few years for this to work its way through the various inspectorates after approval, but it will. There are various ways to crack this, but it will require both training and tools to make it happen. It also reinforces the need for well-trained facilitators.

5.1 Formality in Quality Risk Management

“The degree of rigor and formality of quality risk management should reflect available knowledge and be commensurate with the complexity and/ or criticality of the issue to be addressed.”

That statement in Q9 has long been a nugget of long debate, so it is good to see section 5.1 added to give guidance on how to implement it, utilizing 3 axis:

  • Uncertainty: This draft of Q9 utilizes a fairly simple definition of uncertainty and needs to be better aligned to ISO 31000. This is where I am going to definitely submit comments. Taking a straight knowledge management approach and defining uncertainty solely on lack of knowledge misses the other element of uncertainty that are important.
  • Importance: This was probably the critical determination folks applied to formality in the past.
  • Complexity: Not much said on complexity, which is worrisome because this is a tough one to truly analyze. It requires system thinking, and a ot of folks really get complicated and complex confused.

This section is important, the industry needs it as too many companies have primitive risk management approaches because they shoe-horn everything into a one size fits all level of formality and thus either go overboard or do not go far enough. But as written this draft of Q9 is a boon to consultants.

We then go on to get just how much effort should go into higher formality versus lower level of formality which boils down to higher formality is more stand alone and lower formality happens within another aspect of the quality system.

5.2 Risk-based Decision Making

Another new section, definitely designed to align to ISO 9001-2015 thinking. Based on the level of formality we are given three types with the first two covering separate risk management activities and the third being rule-based in procedures.

6. INTEGRATION OF QUALITY RISK MANAGEMENT INTO INDUSTRY AND REGULATORY OPERATIONS

Section 6 gets new subsection “The role of Quality Risk Management in addressing Product Availability Risks,” “Manufacturing Process Variation and State of Control (internal and external),” “Manufacturing Facilities,” “Oversight of Outsourced Activities and Suppliers.” These new subsections expand on what used to be solely a list of bullet points and provide some points to consider in their topic area. They are also good things to make sure risk management is built into if not already there.

Overall Thoughts

The ICH members did exactly what they told us they were going to do, and pretty much nothing else. I do not think they dealt with the issues deeply and definitively enough, and have added a whole lot of ambiguity into the guidance. which is better than being silent on the topic, but I’m hoping for a lot more.

Subjectivity, uncertainty, and formality are critical topics. Hopefully your risk management program is already taking these into account.

I’m hoping we will also see a quick revision of the PIC/S “Assessment of Quality Risk Management Implementation” to align to these concepts.

Teams reason better

Teams collaborate better than individuals on a wide range of problem-solving for two reason:

  • People are exposed to points of view different from their own. If the arguments are good enough, people can change their mind to adopt better beliefs. This requires structure, such as “Yes…but…and“
  • The back-and-forth of a conversation allows people to address counterarguments, and thus to refine their arguments, making it more likely that the best argument carries the day.

Both of these work to reduce bias and subjectivity.

Principles of Team Collaboration

There are a few principles to make this team collaboration work.

  • Clear purpose: What is the reason for the collaboration? What’s the business case or business need? Without alignment on the purpose and its underlying importance to the organization, the collaboration will fail. The scope will start to change, or other priorities will take precedence. 
  • Clear process: How will the collaboration take place? What are the steps? What is the timing? Who is responsible for what?
  • Clear expectations: What is the specific goal or outcome we are striving for through this collaboration? 
  • Clear support: Problems will arise that the team cannot handle on their own. In those cases, what is the escalation process, including who and when? 

Ensure these are in your team ground rules, measure success and perform continuous improvement.

Bias

There are many forms of bias that we must be cognizant during problem solving and decision making.

That chart can be a little daunting. I’m just going to mention three of the more common biases.

  • Attribution bias: When we do something well, we tend to think it’s because of our own merit. When we do something poorly, we tend to believe it was due to external factors (e.g. other people’s actions). When it comes to other people, we tend to think the opposite – if they did something well, we consider them lucky, and if they did something poorly, we tend to think it’s due to their personality or lack of skills.
  • Confirmation bias: The tendency to seek out evidence that supports decisions and positions we’ve already embraced – regardless of whether the information is true – and putting less weight on facts that contradict them.
  • Hindsight bias: The tendency to believe an event was predictable or preventable when looking at the sequence of events in hindsight. This can result in oversimplification of cause and effect and an exaggerated view that a person involved with an event could’ve prevented it. They didn’t know the outcome like you do now and likely couldn’t have predicted it with the information available at the time.

A few ways to address our biases include:

  • Bouncing ideas off of others, especially those not involved in the discussion or decision.
  • Surround yourself with a diverse group of people and do not be afraid to consider dissenting views. Actively listen.
  • Imagine yourself in other’s shoes.
  • Be mindful of your internal environment. If you’re struggling with a decision, take a moment to breathe. Don’t make decisions tired, hungry or stressed.
  • Consider who is impacted by your decision (or lack of decision). Sometimes, looking at how others will be impacted by a given decision will help to clarify the decision for you.

The advantage of focusing on decision quality is that we have a process that allows us to ensure we are doing the right things consistently. By building mindfulness we can strive for good decisions, reducing subjectivity and effective problem-solving.

Overcoming Subjectivity in Risk Management and Decision Making Requires a Culture of Quality and Excellence

Risk assessments, problem solving and making good decisions need teams, but any team has challenges in group think it must overcome. Ensuring your facilitators, team leaders and sponsors are aware and trained on these biases will help lead to deal with subjectivity, understand uncertainty and drive to better outcomes. But no matter how much work you do there, it won’t make enough of a difference until you’ve built a culture of quality and excellence.

The mindsets we are trying to build into our culture will strive to overcome a few biases in our teams that lead to subjectivity.

Bias Toward Fitting In

We have a natural desire to want to fit in. This tendency leads to two challenges:

Challenge #1: Believing we need to conform. Early in life, we realize that there are tangible benefits to be gained from following social and organizational norms and rules. As a result, we make a significant effort to learn and adhere to written and unwritten codes of behavior at work. But here’s the catch: Doing so limits what we bring to the organization.

Challenge #2: Failure to use one’s strengths. When employees conform to what they think the organization wants, they are less likely to be themselves and to draw on their strengths. When people feel free to stand apart from the crowd, they can exercise their signature strengths (such as curiosity, love for learning, and perseverance), identify opportunities for improvement, and suggest ways to exploit them. But all too often, individuals are afraid of rocking the boat.

We need to use several methods to combat the bias toward fitting in. These need to start at the cultural level. Risk management, problem solving and decision making only overcome biases when embedded in a wider, effective culture.

Encourage people to cultivate their strengths. To motivate and support employees, some companies allow them to spend a certain portion of their time doing work of their own choosing. Although this is a great idea, we need to build our organization to help individuals apply their strengths every day as a normal part of their jobs.

Managers need to help individuals identify and develop their fortes—and not just by discussing them in annual performance reviews. Annual performance reviews are horribly ineffective. Just by using “appreciation jolt”, positive feedback., can start to improve the culture. It’s particularly potent when friends, family, mentors, and coworkers share stories about how the person excels. These stories trigger positive emotions, cause us to realize the impact that we have on others, and make us more likely to continue capitalizing on our signature strengths rather than just trying to fit in.

Managers should ask themselves the following questions: Do I know what my employees’ talents and passions are? Am I talking to them about what they do well and where they can improve? Do our goals and objectives include making maximum use of employees’ strengths?

Increase awareness and engage workers. If people don’t see an issue, you can’t expect them to speak up about it.  

Model good behavior. Employees take their cues from the managers who lead them.

Bias Toward Experts

This is going to sound counter-intuitive, especially since expertise is so critical. Yet our biases about experts can cause a few challenges.

Challenge #1: An overly narrow view of expertise. Organizations tend to define “expert” too narrowly, relying on indicators such as titles, degrees, and years of experience. However, experience is a multidimensional construct. Different types of experience—including time spent on the front line, with a customer or working with particular people—contribute to understanding a problem in detail and creating a solution.

A bias toward experts can also lead people to misunderstand the potential drawbacks that come with increased time and practice in the job. Though experience improves efficiency and effectiveness, it can also make people more resistant to change and more likely to dismiss information that conflicts with their views.

Challenge #2: Inadequate frontline involvement. Frontline employees—the people directly involved in creating, selling, delivering, and servicing offerings and interacting with customers—are frequently in the best position to spot and solve problems. Too often, though, they aren’t empowered to do so.

The following tactics can help organizations overcome weaknesses of the expert bias.

Encourage workers to own problems that affect them. Make sure that your organization is adhering to the principle that the person who experiences a problem should fix it when and where it occurs. This prevents workers from relying too heavily on experts and helps them avoid making the same mistakes again. Tackling the problem immediately, when the relevant information is still fresh, increases the chances that it will be successfully resolved. Build a culture rich with problem-solving and risk management skills and behaviors.

Give workers different kinds of experience. Recognize that both doing the same task repeatedly (“specialized experience”) and switching between different tasks (“varied experience”) have benefits. Yes, Over the course of a single day, a specialized approach is usually fastest. But over time, switching activities across days promotes learning and kept workers more engaged. Both specialization and variety are important to continuous learning.

Empower employees to use their experience. Organizations should aggressively seek to identify and remove barriers that prevent individuals from using their expertise. Solving the customer’s problems in innovative, value-creating ways—not navigating organizational impediments— should be the challenging part of one’s job.

In short we need to build the capability to leverage all level of experts, and not just a few in their ivory tower.

These two biases can be overcome and through that we can start building the mindsets to deal effectively with subjectivity and uncertainty. Going further, build the following as part of our team activities as sort of a quality control checklist:

  1. Check for self-interest bias
  2. Check for the affect heuristic. Has the team fallen in love with its own output?
  3. Check for group think. Were dissenting views explored adequately?
  4. Check for saliency bias. Is this routed in past successes?
  5. Check for confirmation bias.
  6. Check for availability bias
  7. Check for anchoring bias
  8. Check for halo effect
  9. Check for sunk cost fallacy and endowment effect
  10. Check for overconfidence, planning fallacy, optimistic biases, competitor neglect
  11. Check for disaster neglect. Have the team conduct a post-mortem: Imagine that the worst has happened and develop a story about its causes.
  12. Check for loss aversion