Training voor QC Leiden People Leaders
Driving Results through Individual & Organizational Accountability
Petra de Kruijf on the Leiden Credo Wins 2025
Living the Credo
Credo sessions
Batch Release made easy!
Ik ben heel blij dat de Batch RelEASY-applicatie in oktober vorig jaar met succes is gelanceerd. Deze innovatie verbetert de operationele efficiëntie en zorgt ervoor dat de Quality Standards worden nageleefd. Batch RelEASY is een van de eerste applicaties die GxP-rapporten live genereert op het Self-Service Statistical Reporting Platform.
Wat is Batch RelEASY?
Batch RelEASY is een digitale tool voor het maken van rapporten die het genereren van release packages automatiseert en eenvoudiger maakt voor Remicade, Stelara en Simponi (P)FB materiaal op onze Bio sites in Leiden en Cork. Het haalt data op uit onze bronsystemen, zoals SAP, MES, eLIMS, Trackwise en binnenkort Comet, en organiseert deze in rapporten die nodig zijn voor batch release. Het is echter geen transactiesysteem voor batch release. Het registreert geen beslissingen, activiteiten of data. De gegenereerde rapporten vragen om een 'handmatige review stap' op volledigheid, door een QA Officer, voordat een QP ze beoordeelt voor batch release.
De reis – Succes is niet altijd direct een feit, en onze reis was daarop geen uitzondering. In eerste instantie probeerden we Tableau te gebruiken om releaserapporten te genereren, maar dat bleek niet haalbaar. Dit leidde ertoe dat we andere opties onderzochten en uiteindelijk Posit.co kozen als het platform van onze keuze. Posit biedt een betere manier om op R & python gebaseerde oplossingen te implementeren en stelt developers in staat om de open-source tools te gebruiken die ze kennen en waar ze van houden, met het gecentraliseerde beheer, de beveiliging en de ondersteuning die ze nodig hebben.
“De moeite vermindert van uren tot slechts een minuut”
In december 2022 kregen we groen licht van de wereldwijde Digital & Technology Council om Posit voor Batch RelEASY-ontwikkeling aan boord te nemen en te implementeren. Budgetgoedkeuring volgde in april 2023 en we begonnen met de bouw van Batch RelEASY. Het platform werd binnen J&J omgedoopt tot het Self-Service Statistical Reporting Platform (SSSR) en in januari 2024 werd het opgeleverd als een volledig GxP-compliant applicatie. In de zomerperiode hebben we de gebruikersacceptatietests voor Batch RelEASY uitgevoerd en de kwalificatie afgerond. Als eerste gebruiker van dit nieuwe platform werden we geconfronteerd met tal van uitdagingen.
Door gebruik te maken van agile methodologie en het software development life cycle (SDLC) framework werd Batch RelEASY op 29 oktober succesvol gelanceerd op de Bio sites in Leiden en Cork.
The Leiden Credo Wins 2025 initiative is in full swing, and it’s clear that every employee’s contribution matters. We sat down with Petra de Kruijf to get her perspective on the Leiden Credo Wins.
Petra has been part of J&J IM, Biologics since September 2021 and has been actively involved with Our Credo since January of last year. She is the Manager of Release & Stability for QC Leiden and serves as the designated Credo Champion for the QC team.
The importance of the Leiden Credo Wins 2025 – Our Credo goes back as far as J&J itself, and it’s deeply woven into our daily operations. A large part of it focuses on employees, because they play a central role in bringing Our Credo to life.
Petra views Our Credo like a marriage: “It’s easy to make promises on your wedding day, but the true test lies in living up to the wedding vows every day. Similarly, having a Credo is only the start; as an organization, we need to continually evaluate how we’re living it. This means listening to everyone and gathering feedback. The Our Credo survey is our primary tool for collecting this feedback, keep doing what we are doing well, identifying areas for improvement, and creating an actionable plan to take responsibility. We’ve been doing this for years, and 2025 is no different!”
“The Credo is like a marriage”
The QC Credo team – For Petra, being involved in the Leiden Credo Wins 2025 is all about listening to your team and connecting with others. This helps to gain a deeper understanding of what's really happening at the Leiden site. She explains: “Our goal as Credo Champions is clear: help our organization act on the input from the Our Credo survey. I feel fortunate to be in a position where I can make a meaningful contribution to this mission.”
Along with her QC Credo colleagues, Petra has hosted eight Credo sessions within the QC department in Q1, with another eight planned for Q2. These sessions encourage open conversations about the Our Credo Survey results. “The survey itself consists of 40 statements that take only 15 minutes to complete, but the insights we gain from them are far more valuable if they are combined with dialogue. Because only with dialogue can we understand perspectives and clarify misunderstandings.”
The importance of these efforts for our Leiden site’s future is very clear. The senior leaders at J&J consider the Our Credo scores as one of the factors when deciding where to invest. These investments directly impact the work environment, and Petra highlights several examples: “the new R-building labs, the redesign of the B/C-building, and the upgraded canteen in the B-building.”
The fruits of labor – When asked about the impact of the Leiden Credo Wins, Petra responds that it’s too early to gauge the full impact of the Leiden Credo Wins just yet. The true test will come in September when every employee is invited to complete the 2025 Our Credo Survey. However, there are already some noticeable changes happening, also within the QC department.
For example, in response to the feedback from the Our Credo survey regarding accomplishment-based recognition, the QC team pays much more attention to reward base business achievements and efforts, and not only project work. The QC Credo team has also given transparency about compensation during the Credo sessions and shared an information package on this topic. On top of that, the Credo champions will share insights on the strategic direction of Leiden QC in the upcoming sessions.
Petra's own wedding day
Our Credo
Challenges for the Credo Team – From Petra’s perspective, the biggest challenge isn’t enthusiasm, since all employees of the QC department are highly motivated to contribute and engage in conversation. However, there are hurdles.
With employees from various backgrounds, experiences, and perspectives, the way each person interprets the survey statements can vary widely. This may also impact how a person chooses to respond to an item. “For example, during our Credo sessions it became apparent that the way the survey items are stated may not be clear. Take the statement “calculated risk-taking is encouraged here”. What exactly is calculated risk-taking and how does this relate to innovation? Only through open dialogue can we truly understand and act on the feedback.” Petra says.
Another challenge arises from the interpretation of the responses. For example, the “Neither agree nor disagree” option can be seen as neutral by some, but according to Our Credo’s interpretation, it’s considered unfavorable and thus equals disagree and strongly disagree. By helping others understand how the responses are interpreted, we ensure the collected feedback reflects what employees mean.
“The true test will come in September”
Recommendations for all Leiden site colleagues – To make real progress and overcome these hurdles, we need everyone’s involvement. “Our Credo is an important aspect of working at J&J, and the effort our colleagues, managers and directors invest in it is inspiring,” Petra emphasizes. When asked what others can do to help, Petra highlights three actions that can make a difference in the Leiden Credo Wins:
- Listen & participate: Share your thoughts, participate in Credo sessions, and listen actively to understand your colleagues.
- Provide deeper feedback: The Our Credo survey allows for open comments. Use this space to provide additional suggestions or perspectives.
- Avoid “neither agree nor disagree”: If you disagree with a statement, select “Disagree.” If you agree, select “Agree.” Avoid choosing “Neither agree nor disagree” if you are neutral about a statement.
As a final remark, Petra encourages anyone with questions about Our Credo, the Survey, or the 2025 Credo Wins to speak up: “Whether it’s with your people leader, Credo Champion, or Credo Lead, Jose Antoranz, sharing feedback is essential. Only through transparent participation can we truly understand everyone’s perspectives. While we might not be able to address every concern to everyone’s satisfaction, if concerns aren’t voiced at all, we won't know if they can get resolved.”
Naam Achternaam
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