2021 Student Impact Award
Congrats to ISE student Libby Woods for being awarded one of the 2021 Student Impact Awards. Below are excerpts from the nomination that was submitted by her supervisor.
Optotherm, Inc., Summer 2020, Autumn 2020
What were the student's main responsibilities?
- In charge of ISO 9001 Quality Management System planning and implementation.
- In charge of CFR 820 Medical Device Quality Management System planning and implementation.
- In charge of managing another intern as part of the above efforts.
What is one specific accomplishment of your intern/co-op?
Thanks to Libby, this October, we achieved ISO 9001 certification for the first time in Optotherm's history. In addition to serving as the driving force and leader of the ISO 9001 certification effort, she facilitated our transition away from a third-party ISO 9001 documentation compliance platform to a system that is hosted on our internal server, which is proving to be much easier to use than the third party platform and will save us a lot of money. In each of these tasks, Libby generated the ideas for how to structure our frameworks and templates and she established her own timeline and benchmarks. Libby was able to do all of this in a remarkably short period of time.
What impact did the student have on your organization?
When we brought Libby on at the beginning of the summer, our idea was to have Libby help us learn a little bit about what ISO 9001 would entail. Libby was initially to work as a part of a team to prepare us for ISO 9001 QMS certification, but she quickly proved herself capable of leading the entire effort with minimal direction and assistance, freeing up other employees to work on different initiatives. We could not have dreamed that we would actually achieve certification before the end of the year! It is hard to believe that she is not a full-time employee with years of experience.
What makes this student stand out among others and deserving of the SIA?
Libby is the most independent and hardworking person I have managed in my career, so much so that "manage" begins to feel like the wrong word.
Libby had a sharp sense of what needed to get done on a day-to-day, hour-to-hour level to meet our long-term, multi-month timeline. At one point, overwhelmed by the amount that lay ahead of us, I proposed pushing back our certification audit by a couple months. Libby, who kept complete ownership over the project timeline, calmly pushed back and showed me that our original date was achievable. She was convincing and, ultimately, correct: we passed both Stage 1 and 2 audits with no non-conformances or observations (i.e., with flying colors), achieving certification.
There were many other times that Libby pushed back to suggest simpler, quicker, or more accurate ways to accomplish our goals. Every time she did so, she was structured and convincing with her thinking. And pretty much every time she was correct in what she suggested. From simplifying our document and record control structure (the pared-down version ended up being north of 120 documents!, virtually all created by Libby) to finding quicker ways to collect customer satisfaction data, Libby has saved Optotherm countless hours and pages of unnecessary documentation.
Libby is fantastic at keeping the big picture in mind, and she is always there to provide me with helpful direction out of the weeds. I truly look to Libby as an inspiration with long-term project time-management, and I feel like I have grown as a worker and a manager having her as an example. I do not exaggerate when I say that without Libby leading this process, we would not have achieved our certification this year, let alone ahead of the timeline initially laid out by our consultant.
I am grateful for the opportunity to work alongside Libby, who is sort of like an entire company rolled into one person, and I know that every single person at Optotherm feels the same way (I have heard so firsthand, many times).
What three words would you use to describe this student?
Brilliant, Tireless, Efficient.
Full list of winners at the ECS website.