Guest Column | December 21, 2020

The 12 Months Of Quality: Tips For Building A Voluntary QA Culture In A 2021 COVID World

By Judy Carmody, Ph.D., Carmody Quality Solutions, LLC

As we close out 2020, which can’t come soon enough, it is fitting to look at how to build a voluntary quality culture in our  “new normal” work environment. 

I don’t need to tell anyone in a quality role how COVID plans and precautions have added an entire new level of complexity to what we do. What has worked best for me has been finding ways to connect with people, being compassionate and patient, while helping companies remain compliant and guiding people to do the right thing.

So let’s get into it. I hope you find something that connects with you that you can use with your staff to help people in these more-than-trying times.

January: Share your objectives for the upcoming year.
A good way to kick off the year is to educate your employees about what quality objectives you want to accomplish in the new year. As we get back to work after the holidays, return with a plan to share. Not a plan that needs review, dollars, or approvals; rather, a plan for change or improvement. It can be a personal plan outlining what you are committed to change and/or what you want help other functions change in the new year. Focus on the four pillars of a Voluntary Quality Assurance (VQA)® culture as you set the framework for your plan:

  • Collaboration, not confrontation
  • Proper education and training
  • Setting proper expectations
  • Accountability

Use this as an opportunity to educate personnel on the elements of a VQA® culture with the goal of building the kind of culture where people feel comfortable asking the hard questions and knowing they are safe doing so, where quality is part of the product, and people know they matter and have value.

February: Are you ready for a remote audit?
If you haven’t reviewed your internal auditing procedures to make adjustments for conducting remote audits, you need to prioritize that in your quality plan for 2021, as the need for remote audits will not go away in 2021. Also of note: The cost of conducting audits has increased; what used to take two days on-site now can take up to three or four days for remote audits. Prepare management and the finance group and adjust budgets where needed.

The main issues include gaining access to required documents, scheduling interviews, and conducting/supporting tours. And when (not if) problems are identified, it could require an on-site follow-up, which can impact the status of the vendor. Organization is the key to successful remote audits, as indicated by this detailed overview from the Regulatory Affairs Professional Society and this piece from Bioprocess Online. Developing a checklist, as indicated in the FDA Group’s blog, also helps to capture and recognize important elements to consider so remote audits run as smoothly as possible.

March: Quality is still everyone’s responsibility, pandemic or not. Work on building teams to help people feel supported and valued.
This July 2020 Harvard Business Review article provides suggestions to evolve a teamwork approach. My favorites are encouraging naïve questions and constructive challenges, something referred to as the “obligation to dissent,” which empowers people to share viewpoints in a safe nonjudgmental environment.  

People are on edge; they are unsure and anxious. Work to bring people together so everyone feels supported and heard. Be more patient with people. Find simple ways to help, such as providing more time to accomplish tasks and review documents. If you want something reviewed by Friday, build in time so that if it comes on Monday, there is no harm. Or ask people if they can review it by Friday or Monday. The more you engage with people and understand where they are coming from and the demands on their time, the more they will feel like you are on their side.

April: Engagement is the new metric.
Institute methods to ensure you are reaching out to people in a more meaningful manner. Are you sending more emails than having phone calls or video calls? Ask more questions, such as “What would help you review and approve this document faster, more easily?” Have clear agendas for meetings. Provide materials beforehand if it helps facilitate a meeting. Ensure you complete a brief wrap-up with action items, so people know what is expected of them. Such steps show people you value their time and their input because you captured it, heard what they said, and know to what they are willing to commit.

May: Listen to understand, not to respond.
Think again of simple tasks that can increase engagement. Stop trying to multitask during video calls. Stop doing email during virtual meetings, and come prepared, so meetings move more quickly. Be an active contributor and ask follow-up questions, which you can only do effectively when you are actively listening. Here are tips for how to be an active listener.

June: Collaboration is just as vital. Find ways to be a partner, rather than a policing presence, to help people move along.
Quality can take a leading role in fostering an environment of openness and information sharing. When quality operates as a collaborator instead of an enforcer, people see quality as playing a role on the team, which can contribute to improving levels of confidence and trust among employees.

Air traffic controllers work together shepherding planes to keep them safe and get them to where they need to go. Quality personnel need to be good air traffic controllers when they get people around a table and facilitate conversations. It allows people to think more broadly and ask the question, “What can we do as a team to make what we do here better?” In a time of COVID-19, collaboration can help people feel less isolated and feel safe asking for help and for other perspectives to help solve challenges. It also allows groups to work a problem, rather than have people feel it is all on their shoulders. In its role working across a company, quality is well-positioned to foster such an environment.

July: Think creatively about reaching your remote younger audiences. Learn how they are learning. Or better yet, ask them. Remote teams have different needs WFH (working from home).
Disruption to the way we work has been massive, so find new and better ways to keep people engaged, so they build resilience. Daily check-ins can help create routines that can help. Don’t just email; use other communications tools as well. Helping people understand expectations can help remote workers. Above all, offer encouragement and empathy; acknowledging stress, anxieties, and concerns can go a long way to helping people get by and feel valued.

Keep meetings to 30 to 45 minutes to allow for bio-breaks or to prepare for the next meeting. Try to end early so you “give back” time to people. Set a timer and commit to a finite period. Place items that require deeper discussion or are off topic in a “parking lot.” There are a number of tools to allow people to be engaged in virtual settings. Here is one list of four ways to improve your meetings.

August: Spend less time in other people’s bedrooms.
A new type of MBWA (managing by walking around) is MBPA (managing by phoning around). Be mindful of how much time people spend on video calls. While they are the go-to method for professionals to connect in this pandemic, in some instances they can be draining. Moderation is best. Workers are busier than ever and strapped for time, so a quick phone call or text can be a better method. Find out what works best for people. Someone may just want a brief text check-in and if there is an issue, ask to get on the phone to talk live.

September: Rethink training to find new methods of investing in your people.
Asynchronous learning can be one way to implement training regimens. In this COVID-19 environment, I have seen courses take on an entirely new look and feel. Many of the platforms have tools, such as polls, breakout rooms, whiteboards, and team exercises, that help employees stay engaged and feel that the training is more interactive and worth their time. Don’t forget to allow your people time to fully immerse themselves in training to realize the benefits. It demonstrates your commitment to their learning and support of the training process.

October: SOPs don’t care about global pandemics.
Don’t forget the importance of the three rules of SOPs: Specificity, specificity, and specificity. Here’s a refresher. Use new tools for collaboration like SharePoint, OneDrive, Teams, or Google docs, where people can share input. Create a recurring working session where people screen share to collaborate and engineer procedural solutions to regulatory gaps.

November: Don’t lose the big picture; remain in compliance but avoid bottlenecks and unnecessary procedures.
When working remotely, it is easy to feel disconnected from our procedures. Make an effort to map your processes to ensure you have needed procedures in place, eliminate redundancies, and remove unnecessary processes that can bog down productivity. If you get bogged down in procedures, pause and ask, what do we want to accomplish here? What is the end goal? Is what we are grinding on right here and right now going to get us to that end goal? You may be surprised at the answer and what happens next to get you there.

December: What can we be thankful for?
Communicate what has been working and celebrate it. Call people and teams out for their success and improvements in quality and finding ways to operate in new ways and in new environments.

Wishing you a happy, safe, healthy, and compliant 2021!

About The Author:
JudyJudy Carmody, Ph.D., is the founder and principal consultant of Carmody Quality Solutions, LLC (CQS), an innovative consulting agency that provides quality services to the pharmaceutical, biologics, and medical device industries. Carmody has 25+ years of specific expertise driving vision in operations, quality assurance, control, systems, validation, and analytical development. She has held quality leadership positions at several pharma/biopharma companies and built quality management systems for both start-up and Fortune 500 companies. Carmody is the author of many articles on quality, including a recent e-book on the subject of building a VQA Culture®. She holds a Ph.D. in analytical chemistry from Clark University in Worcester, MA. Please connect with her on LinkedIn.