Risk Management Best Practices (3) The Culture Perspective

Ten Golden Tips for Assembling Effective Risk Assessment Teams in Pharma

Together we can assess risks far more effectively. SME’s (Subject Matter Experts), Quality Assurance and Heads of Departments (amongst others) should all be involved in the risk assessment process. After all, they are all highly familiar with their part of the system/process that is being assessed. This group of people cannot, however, be assumed to lead themselves in properly executing a risk assessment. They need someone to guide them. What they need is a Team Leader. A leader who teaches them not only how to work together or how to perform the risk assessment but also manages emotions and safeguards deadlines as well as predefined criteria.

You may know a lot about risk assessment already. Perhaps you have even written the company’s risk assessment policy. In this article, I am not going to write about the guidelines, the practical approach or the requirements of risk assessments. These aspects will be thoroughly explained in our one-day training “Risk Management”. In this article I will share my thoughts about the Team Leader.

I believe the Team Leader’s role is often underestimated. I know from experience that little thought is given as to who should lead a Risk Assessment team. That’s a costly mistake. Risk Assessments are huge time consumers, often leading to frustrations. The quality of the Team Leader is directly linked to the success of the Risk Assessment.

As performing FMEA’s (Failure Mode and Effects Analysis) and related methods, cost time and money, you better make sure you are getting the most out of it. To give you some practical support, we are more than happy to share our 10 Golden Tips for Effective Teams performing Risk Assessments;

  1. Choose the right size of the Risk Assessment team

            A Risk Assessment team is usually comprised of four to six persons.

  1. Composing the perfect team

            Every relevant area of expertise should be represented within the team. Think
            about manufacturing, production, technical services, purchasing, warehousing, 
            quality, etc. Consider including the client of the process or product.

  1. Combine experienced and less experienced team members

            The most experienced team may share valuable insights butmay miss the
            obvious, superficial risks, as they are too focused on the details. In many cases,
            there is a large emotional engagement and sensitive responses when potential
            shortcomings are being addressed (which is the objective of a Risk Assessment).
            Less experienced team members may have a fresh mindset and unbiased
            insights.

  1. Appoint an experienced Risk Assessment Team Leader

             The Team Leader is coordinating the Risk Assessment process, including:

  • Planning and facilitatingthe meetings,
  • Ensuring all team members are provided with the required resources,
  • Monitoring the progress of the team and deadlines.
  1. The Team Leader is the facilitator

            And should, ideally, not be taking any decisions.

  1. Provide the team members with a solid foundation on the selected Risk
        Assessment Process

            A basic training and a proper procedure to use as a reference are sufficient.
            Extensive class room training sessions are not required. Make sure however
            that the Team Leader is very knowledgeable on the method which is being used.

  1. On the Job Training – The most powerful way of learning is by experiencing

            You can work on an actual Risk Assessment project with no prior knowledge of
            risk assessments, as long as the team members have experience in how to work
            in teams and have proper knowledge of risk assessments (see bullet 8) 

  1. Teach team members to work in teams

            This avoids personal issues getting in the way of productivity and quality.
            Techniques for creating consensus, maintaining project documentation,
            brain storming, flow charts, and data analysis are imperative to working in teams 

  1. Define the objective of the Risk Assessment Project

            Define the objective in clear wordings, you can use the SMART technique for this.
            Every team member should fully understand the objective as the project will
            be hard to manage otherwise.

  1. Demarcate the project properly

            The team is free to operate within certain parameters. Consider the budget
            available, the responsibilities, the timelines, which process to follow in case of
            escalation, how to communicate within the organization, etc.


Kind regards, Karen Zimmerman



Do you want to learn more about Risk Management? 

Have a look at our “Risk Management” training on the 20th of September