A. Quality ActivitiesSanofi applies its own global policies to improve efficiency of operational processes and identify development areas. This approach allows Sanofi units in all countries to use the same terminology and continue to develop at the same level. Such harmony brings success as well. Improving process efficiency is among the key tasks of the Country Quality unit. Regular audits are conducted both internally and externally at customers to measure process efficiency and measurements are made with the generated reports. Furthermore, surveys or round table meetings are conducted at regular intervals to obtain feedback from process owners. In defining quality processes, the Company considers primarily the Ministry of Health regulations, then Sanofi’s global and regional requirements and lastly feedback received from customers or employees about current processes or the results obtained from monitored processes. Global resources or regional regulations are used as reference documents when defining processes.
A quality policy was established within the company and shared with all employees. Furthermore, quality processes are defined in the quality manual and other relevant regulations and published within the Company. The Quality Assurance Department sets out the Quality Roadmap and the quality priorities of the year annually and the activities stated here can be followed periodically. Quality goals are followed together with department targets and through personal performance forms. Meeting customer expectations in the best possible manner and increasing satisfaction are also part of the Company’s quality policy. Additionally, a Quality Agreement, containing quality expectations, is signed with each customer and Key Performance Indicators are monitored and reviewed with them at regular intervals, taking actions when necessary to ensure improvement.
Key performance indicators determined for each quality standard are monitored and reported at regular intervals (monthly/quarterly). National and international regulations and Sanofi standards (documentation) are closely monitored to raise the quality standards and innovations and updates are implemented within the targeted timeframes. All related SOP and documentation revisions are made accordingly. The effectiveness of quality systems is monitored through internal audits conducted by the Quality Assurance Department through unannounced monitoring/ audit activities and necessary actions are taken. Furthermore, proactive risk studies are conducted regarding the processes and applications to raise quality standards. Aiming to improve quality processes, related activities are determined (Human Error management system, improvement of analysis times, etc.) and results are periodically monitored. Routine informative meetings are organized on a monthly basis to communicate the problems and new developments across the Company, ensuring that corrective and preventive actions determined for the problems are widely disseminated.
In addition to Good Manufacturing Practices (GMP), ISO 9001, 2 7001, 14001 and 18001 standards are also applied at Sanofi Turkey's Lüleburgaz Plant and effectiveness of these processes is monitored in periodic internal audits as well as during certification renewals and interim checks. In cases where improvements are needed, the management ensures that the necessary work is done in a timely manner. Furthermore, Quality Management Review meetings are held annually with the Company management and Global Quality team to evaluate all the results for the relevant year and define the actions for the issues that require improvement.
Sanofi’s philosophy centered around human health is one of the building blocks of process management. Moreover, environmental impacts are also taken into consideration in all quality processes. The impact of environmental factors on targets and business processes is evaluated and monitored in periodic management meetings. New internal processes and current process changes are managed as part of the Change Control Process. In the change control process, assessments are made by considering all internal and external environmental impacts.