February 3, 2016 Clincase

Introducing our Quality Assurance Manager

We, QDS and Clincase, are happy to introduce our Quality Assurance Manager, Secil. Here is her talk about her motives and vision at Clincase.


-What do you do at Clincase? 

Secil:  As the Quality Assurance Manager, my role is to ensure to implement the Quality Management System, encompassing all aspects in the company, as a part of the daily routines. Nowadays, we are highly focused on the controlled documents aligning with the processes and industry regulations.

In addition, we are working in collaboration with the department Quality Assurance Representatives in order to ensure all functions in the company have sufficient qualification for conducting their tasks. Hence, we’ve improved our training process accordingly and planned several trainings related to quality and technical awareness. We realize that we could only achieve the maximized quality when involvement of the qualified team is fully devoted to our quality policy and continuous process improvement.


-What’s your background in Quality Assurance?

Secil: I have 7 years of background in quality assurance particularly related to ISO9001, Lean manufacturing systems and problem solving techniques. Before joining the QDS team, I was working in a global company and my role was to implement and train employees with the related production systems in the shop floor such as ISO9001, Lean Administration and Total Productive Maintenance (TPM) including 5S, Autonomous Maintenance, Poka Yoke and Project Management. During the implementation phase, we used several problem solving methodologies such as the 6 Sigma, Kobetsu Kaizen and Figure 8 methods.


-Then what does it mean to have the Quality Management System for Quadratek Data Solutions?

Secil: QDS is an important Electronic Data Capture (EDC) system provider in a highly regulated industry and thereby must comply with the related regulations and laws. Accordingly, QDS has a high focus on the quality and maintains the Quality Management System effectively since 2004.


-What does the Quality Assurance personally mean to you?

Secil: As you know, everybody in the organisation has different roles in order to contribute to its services and maintain the entire organisation. For me, the role of the Quality Assurance Department should be gathering all these different roles in a commonly shared quality perspective and drive the team to its defined vision. Of course this could be only possible when everyone in the team participates and accepts the quality as a part of daily life.


– How can you contribute to QDS and Clincase, do you have plans for the future?

Secil: In the short term, our plan is to improve Corrective Action & Preventive Action (CAPA) process flow for internal topics as well as the audit feedbacks in order to have a systematic methodology to be able to see all items in a single common system. Also, we would like to increase the role of quality in the main processes by involving the development steps with the planned risk analysis and the design reviews in coordination with the Validation & Verification Manager.


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