University of Twente Student Theses


Compliance management ; Design of a system monitoring local implementation of global best practices and standards

Fransen, Stefan (2013) Compliance management ; Design of a system monitoring local implementation of global best practices and standards.

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Abstract:Since six years, when the company was taken over by a much larger conglomerate, a lot had changed to the company. Slowly it had encorporated working methods and technical standards, a process still underway in the time my research took place. My research actually focussed on the implementation of the so-called Deviation Management Procedure, the prescribed working methods in case of noncompliance; in other words, compliance management. In the early phase of my thesis, I found that the implementation of this Deviation Management Procedure (DMP) was only partial: business processes were not fully adjusted to the working methods and reporting style required and there was no workflow modelled of the process. For managers, there was insufficient management information available to control the process. Using global guidelines and specialists’ and manager’s insights I created workflows for the different actors and different types of deviations, set deadlines for process steps and classified all current cases. Using this information I set up a monthly update, with deadlines and steps to take on all current active cases. I worked mostly with the Production department in this period, as they were facing an external Audit during the internship period, pressuring them in getting all processes compliant. A prototype of the to be implemented system was created based on Excel (with VBA to create necessary functionaly) in parallel with a selection process of the final system. Using the SMART rating technique multi-criteria analysis was performed on seven possible implementation routes. Based on this analysis it was decided that the developed prototype would be built into a fully operational system based mainly on cost and availability criteria. During the second half of the internship period, using a participative design process we tested the new procedures and the IT system, based on an evolving prototype. In three steps improvements were tested and feedback was received and processed. This report contains further recommendations for an integrated system for compliance management organized globally. During the latter part of the project, the Laboratory and Packaging departments were catching up on a backlog of internal audits, leading to both departments to get acquainted with the new working methods as well. After the development period, the system continues to be used. Employees involved expressed that they value the extra overview the system gives on a monthly basis to better keep track of progress made, or lack thereof. This is now also visible for the cases waiting for approval, as progress is checked systematically, there is now an overview of what cases lie waiting at the European headquarters extended amounts of time. On the administrative side, in the Quality Assurance department, the implementation of the system lead to an improved awareness of other departments’ performance on this issue, and relieved employees of much handwork related to keeping track of progress of filed cases. A secondary outcome of this research is a new kpi ‘adjusted compliance’, measuring efforts in closing the compliance gap as well as the actual compliance. For managers a dashboard was createdthat allowed them to see progress made in the different steps of the improvement process, by graphically displaying the progress in the different elements the performance indicator. Finally also a customizable waterfall graph was produced for the companies’ Technical Director, enabling to graphically display compliance improvement over time against required expenses and investments. Parts of programming code produced during this thesis was also used in other parts of the company for easing the transition between filled in document templates via a structured list to performance dashboards. Finally recommendations where made to research the possibilities to roll out a system for handling the deviation management procedure work flow to other plants within the organization.
Item Type:Essay (Bachelor)
Faculty:BMS: Behavioural, Management and Social Sciences
Subject:85 business administration, organizational science
Programme:Industrial Engineering and Management BSc (56994)
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