By Tiffany Baker, Danica Brown, and Amanda Bishop McFarland; ValSource, Inc.
In our previous article, we discussed some of the common risk management pain points and mechanisms to overcome those challenges, focusing on the foundation of quality risk management (QRM), which includes using consistent terminology, determining risk strategy, implementing QRM, and the advantages of early implementation.1 This article will focus on risk execution and how we can best get information from our subject matter experts (SME) in a virtual world.
Risk facilitation as we knew it changed in 2020 when the world was placed under “shelter in place” orders. The comfortable paradigm of cross functional team meetings in a conference room to discuss a topic in depth with minimal interruption was no longer an option for most organizations. The new “normal” became a Brady Bunch-esque pattern of boxes on a screen, an evolution of etiquette involving a mute button and a constant battle with off-screen distractions for all participants. The tools normally available to a risk facilitator during a working session were gone. It was much more difficult to monitor heuristics that would bias the outcome of an assessment, physical barriers prevented the facilitator from detecting changes in body language and non-verbal cues, and the challenges of ensuring all viewpoints are captured increased significantly. Adjustments had to be made immediately, with no warning, and will be incorporated into a new way we do business in this post COVID-19 work environment. This article presents some of the challenges encountered and learnings from that adjustment and recommends tips for risk facilitators in the hybrid work environment that has emerged from the pandemic.
Challenge 1: How Can We Assess A Facility, Piece Of Equipment, Or Process That Team Members Have Never Seen In Person?
It can be very difficult to lead an assessment for a complex system or process that team members have not been able to see for themselves.
Digitize your resources – Historically, we would have been able to use tools like walkdowns of equipment and spaces prior to assessment. Where that is not possible, the key to bringing all stakeholders onto the same page in the remote facilitation environment is to leverage the team’s digital resources. Stakeholders often have materials that can prove very useful as visual aids during a working session. Facilities SMEs can often provide maps of rooms, validation and engineering SMEs will be able to share equipment schematics, and manufacturing and quality SMEs can provide people and process flows to aid in the ongoing conversations. Ensuring all stakeholders are informed and aligned on the specifics of a piece of equipment or the personnel flows within a facility can help streamline a conversation.
Be prepared AHEAD of working sessions – The single most important piece of advice for a facilitator of a complex working session is to prepare, prepare, prepare. Fully remote sessions can easily be derailed by a lack of preparation; here are some tips to avoid the delays. Ensure your technology works long before the start time of the session. Remote meeting software often have frequent updates; it’s a good idea to ensure that all software to be used during the session is up to date ahead of time. Open and minimize all large files (i.e., PowerPoints, PDFs, or video clips) that may be shared during a session; these files can cause long delays if opened in real time. Utilize note-taking software like OneNote or Evernote to capture parking lot items and action items for easier follow-ups with the team after the meeting and to keep yourself as organized as possible. Getting into these good habits can save a lot of stress in difficult sessions.
Challenge 2: How Can I Make Sure My Team Stays On Task?
In-person facilitation comes with its own set of controls related to minimizing distractions for our participating SMEs. We can often set ground rules like “in-person participation required,” “no phones,” or “laptop screens must be shut during working sessions.” All these techniques are removed during remote facilitation; you might unknowingly have one SME scrolling on Zillow looking at real estate listings, another completing their coming-due training, and yet another attending three different e-meetings at the same time (talk about a nightmare of distractions)! How can we, as remote facilitators, possibly overcome all these distractions? Try these quick tips to help keep the team engaged and on task.
Share Your Screen During Working Sessions
As simple as this tip may seem, visual cues often direct our conversations during the working sessions.
- Is your team having an involved conversation? Allow the screen to show all participants’ video feeds so SMEs can talk directly to each other.
- Does the conversation require detailed review of the process steps? Share the most current version of the process map to allow for focus on specific steps.
- Are you discussing how personnel and equipment flows could impact contamination-related assessments? Share facility maps so that conversation can be focused to certain rooms or areas.
The content displayed on each participant’s screen during sessions can significantly impact the session efficiency and aid in a successful facilitation.
Keep Your SMEs Engaged
Holding the engagement of all parties on the call is the most tiring part of the working session for the facilitator. You are battling overloaded SME workloads, burnout for some SMEs, and the draw of social media scrolling by disengaged participants. Keeping everyone engaged will require more than just talking on the line and prompting those on mute.
- Are you facilitating a conversation about the process map mentioned above? Ask the SME who owns that function to share the map from their computer, bringing their engagement level up.
- Are you assessing something with your team that members of the team have not seen yet? If you have the technology and on-site personnel available, send someone to the process area with a camera (most laptops have them these days) for a real-time view of what’s being discussed.
- Do you need to capture all SMEs’ opinions on a rating decision? There are now plenty of free polling apps and websites. Use the poll function to connect with all team members and ensure continued engagement.
Challenge 3: How Can I Manage Bias And Be Mindful Of Heuristics Remotely?
For a facilitator, a remote session can feel like some of your most valuable senses are being blocked, and your ability to detect heuristics biasing the session is challenged. You can no longer sense if an uncertain SME is hesitant to offer new information. It’s much more difficult to see subtle body language that would indicate disagreement during a scoring session. Overcoming these blind spots starts with awareness of the issue and the conscious decision to put more effort into managing bias and heuristics than you would in an in-person session.
Be knowledgeable about what you should be looking for — Heuristics are “mental shortcuts that can facilitate problem solving and probability judgements...however, they often result in irrational or inaccurate conclusions.”2 It is important for a facilitator to not only understand what the most common methods to bias an assessment are but also how to spot them. Tversky and Kahneman’s work identified representativeness, anchoring, and availability3 as some of the most prominent biases.
Engage SMEs directly —This tip is especially important for quiet or shy SMEs. They can be quiet for several reasons, ranging from benign distraction or multitasking to intimidation due to the presence of an aggressive participant or high-level manager. Engaging an SME directly is a way for a facilitator to ensure that all viewpoints are represented, and there are some novel ways to engage in the remote setting. As previously mentioned, asking a quiet SME to share information by sharing their screen is a great way to get that engagement. If feasible, private chat functions can be utilized if the problem is an intimidated or shy SME.
Allow for full discussions with minimal facilitator interruption — The term “facilitate” is defined as “to make (an action or process) easy or easier.”4 It is tricky to succeed in that goal during a remote facilitation, where we experience unusual conversational cadences, participants interrupting or starting statements at the same time, and longer than usual polite pauses to allow others to speak. Allowing those uncomfortable pauses can help ensure that everyone has a chance to speak and that all viewpoints are considered. Additionally, as a facilitator, it can be helpful to follow up with participants who may have been interrupted or stopped talking to allow others to contribute. Capturing all sentiments is a great way to combat the biases that may appear if only a segment of the participants gets a chance to contribute.
Remote sessions are a necessity during the COVID-19 pandemic, but they appear to be here to stay. We see COVID variants on the horizon, and a return to a “new normal” with organizations implementing hybrid work as a path forward. As with individual sessions, a facilitator who fails to prepare for this new way of working will struggle to be successful. The facilitator of the future must be adaptive to the new technology that connects teams, aware of interactions between team members regardless of their location, and proactive in encouraging engagement from and between SMEs5.
About The Authors:
Tiffany Baker is a quality risk management (QRM) and microbiology senior consultant with ValSource, Inc. She specializes in development and implementation of innovative approaches to QRM, QRM program design, creation of risk-focused culture, and development risk-based approaches to support contamination control strategies. Baker is an active member of the PDA, a faculty member for PDA’s Training Research Institute, and an instructor for PDA courses on QRM. She is also the co-lead for the PDA Task Force on remote audits and Inspections. Baker was a coauthor on ISPE’s Baseline Guide Volume 5 - Commissioning and Qualification. She has a B.S. in microbiology and chemistry from the University of Rhode Island and an MBA from Providence College. She can be reached at firstname.lastname@example.org.
Danica Brown is a consultant with ValSource, Inc., and is an ASQ Certified Quality Engineer. She has expertise in the development and deployment of customized solutions to quality risk management (QRM), including QRM program design, development of risk-based approaches, and integration of QRM within quality systems. Her expertise also spans various quality functions in the pharmaceutical, biopharmaceutical, and medical device industries, including quality strategy and process improvements, deviations/investigations, and design verification and validation. She has a B.S. in biochemistry from Simmons College, earned her Lean Six Sigma Green Belt from the Johnson & Johnson Supply Chain Academy, and is an active member of the PDA. Brown can be reached at email@example.com.
Amanda McFarland is a quality risk management and microbiology senior consultant with ValSource, Inc. She specializes in the creation and implementation of risk management programs and developing risk-based strategies for use in clinical and commercial settings. McFarland is an active member of the Parenteral Drug Association (PDA), a faculty member for PDA’s Training Research Institute, and an instructor for the PDA course on quality risk management implementation. She has a B.S. in entomology and an M.S. in mycology, both from the University of Florida. Amanda can be contacted at firstname.lastname@example.org.