Published in Volume 40.2 of Quality Matters, Quality Spotlight Article

 

Quality as a Culture: How Can Early-Career Professionals Make an Impact?

Attrayee Chakraborty
Northeastern University

The talk regarding quality culture has been as old as the tale of time—with various approaches talking about examining how to examine this topic. While there is vast academic research on measuring the efficiency of quality management systems, it seems that more boilerplates are needed to be generated for using such information as actionable advice in the industry. While team leads play a crucial role in convincing management and aligning teams on a high level,  one should not discount the importance of early-career professionals and new employees who can positively affect  quality culture in many ways. 

As an early-career professional myself, working in quality and regulatory domains, I have identified a number of ways in which interns and fresh graduates can bring value: 

  1. Fresh perspectives: Viewing quality systems is almost like viewing art—everyone has a different perspective! Though any quality professional living and breathing ISO 13485:2016 and 21 CFR 820 knows what the FDA or other international regulators would like to see during an inspection, it is often seen that one can get too overwhelmed trying to see the trees instead of the forest. As someone new on the team, having a sound understanding of requirements and identifying potential gaps can be a crucial proactive task, especially when teammates may be busy putting out fires. 
  2. Staying current: Many times, different companies face problems requiring similar solutions. For students attending conferences, information acquired can be brought back to the organization and used to support process improvement initiatives. For example, introducing FDA pilot programs for quality management to teams, or showing a different way to execute CAPA checks can illuminate areas of process control gaps while introducing new ways to collaborate with regulatory bodies. 
  3. Talking quality to non-quality personnel: Often, quality teams are swamped with addressing technical changes and have limited bandwidth to invest resources on supplemental quality culture organizational trainings and educational opportunities. Young professionals can use this opportunity to understand how to explain quality to those not involved in quality. Talking about relatable news, such as the Boeing and Toyota incidents, may help people to have a tangible feel on how quality can impact products and processes. 
  4. Shadowing to observe: An entry-level employee or intern is expected to shadow teams to gain a more holistic understanding of processes. This can be a great opportunity for quality newcomers to see implementation gaps in real-time and make observations. However, instead of creating a huge list as evidence of ineffectiveness, it is advisable to be empathetic and seek to understand why these gaps are occurring the way they are and offer proactive solutions.
  5. Unofficial Gemba walks: As outlined in the previous point, it is easier to convince people when they journey through a rationale and conclude rather than stating the conclusion to them. New personnel have the advantage of subtly pointing out inconsistencies through Gemba walks, informal conversations or just over lunch—a non-adversarial yet effective way of discussing over gaps, instead of accusing teams of not having followed best practice. 
  6. Final presentations: As an intern in a quality or regulatory team, you are expected to show how you’ve contributed to optimizing processes and proposing solutions. In your final talk, you can draw listeners to how quality culture gaps may be a root cause for some problems, while also proposing solutions and being empathetic to teams.
And of course, these actions can only be delivered by completing two preliminary steps: self-awareness and building trust. A lot of quality culture is understanding different psychology and mindsets, and understanding how receptive people may be to certain comments. Being emotionally intelligent while dealing with people can yield great dividends in building trust, an essential component of instilling a quality culture. 

Fresh graduates and interns working in quality—know that you have great superpowers which are waiting to be tapped! 

Attrayee Chakraborty (Atty) is a Master’s student in Regulatory Affairs at Northeastern University, Boston. With a background in working with medical device startups and Fortune 500 companies, Atty is committed to quality improvement in the healthcare space. Atty has previously spoken on AI integration in healthcare systems, drug misinformation, quality culture and international regulations at numerous conferences, including SQA 2024. She has been featured in The Huntington News, International Society of Pharmaceutical Engineering (ISPE) and The Doc Suit. She is also the 2024 Recipient of the SQA Learning Foundation William J. Lander Sr. Memorial Scholarship.