Meet Fiona Chung, Quality Specialist in Sogeti’s Life Science practice
Fiona sees a move towards intelligent industry, believing in the ability of AI and automation to transform the manufacturing industry
Sogeti Ireland recently launched a new Life Science department and we would like to take a moment to introduce you to some of the team. Meet Fiona Chung, Quality and Compliance Specialist at Sogeti Ireland and one of our key people on the team
Fiona is a quality and compliance specialist at Sogeti and works with a variety of both Medical Device and Pharma companies in this role. While Fiona’s qualifications are in biopharmaceutical science, she has a broad experience including QA compliance for clinical trials, temperature mapping for GDP, industrial machine build, medical device development, prototyping and manufacturing.
So, what does Fiona see as the future of the medical device industry? From a manufacturing perspective, we are seeing a significant move towards automation and the integration of AI. From implementation and day to day operations of these systems, there is a significant role for quality and compliance to play.
This work starts with the creation and documentation of an implementation strategy, which will need to adhere to both the company’s own quality policy and current regulatory standards. A key element here is the functional design verification of the system through CQV (commissioning, qualification, validation). This will help to define the quality standards and quality control methods. A significant task in the system implementation needs to focus on the users and operators, where induction training is created and integrated into the system roll out. Communication and data visualisation also need to be considered to ensure that defects or potential issues are reported in an actionable way.
For day to day operations, procedures are created for handling ongoing quality control to ensure the systems continues to operate within the predefined limits for that operation. These procedures will include the criteria for and the management of non-conformance, preventative maintenance, system upgrades and requalification requirements.
Fiona understands well the critical role that external consultant and resources can play in the success of an implementation program. “At Sogeti, we strive to place teams that have high levels knowledge and experience not only within their own role, but also within the clients manufacturing and product domain, which allows for faster onboarding and understanding of project plans. As no two clients or projects are the same, listening to our clients is key to understanding and solving problems. This enables problem solving in a wide and non-isolated way, allowing for a broad evaluation of your situation and the identification of the best suitable solution.”
To conclude, Fiona advise in the implementation of complex systems and using external resources is to establish trust and build communication channels. “The key to working with a client team on any project is trust. This can be cultivated by doing the simple thing well; doing what you say you’ll do – such as meeting deadlines, producing quality work, and having good communication. Good communication means not only responding to emails promptly, but also keeping the client up to date on the status at key milestones throughout the project. This can be in the form of scheduled weekly status updates with the project team, to ensure you consistently understand client expectations. This ensures effective feedback loops, where the implementation strategy, program goals, and deadlines can be established and reviewed accordingly”.
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