Structural Improvement of Quality Management System

Progress recently managed a project to improve the structure of the Quality Management System (QMS) of a pharmaceutical manufacturing company. This company was founded by the integration of two manufacturers . Both companies have been manufacturers of medicinal products and/or intermediates for decades and as such have their own QMS in place.

During a recent inspection, one of the observations was that the Document Management System (DMS) was too complex. This observation and the aim to implement one QMS led to the start of this project. The goal of the project was to restructure the QMS to make it fit for all processes and manufacturing sites and to define which processes and related documents could be combined. The ultimate goal was to have all documents in the electronic DMS linked to a specific element within the QMS.

At the start of the project, an initial version of the QMS framework was present. This version was discussed with relevant stakeholders, expanded where needed, made more detailed and the new version was ultimately approved. During the project revisions and improvements to the framework were made and approved. Also a basic document structure for each element in the QMS was agreed upon and responsibilities were defined.

Sub elements of the QMS were discussed in workshops with owners and subject matter experts of the specific element. In these workshops, the scope of each element was further defined, and more detailed overviews of the related topics were made. Also, it was decided which processes could be combined as global instead of site-specific processes. The next step was to identify all documents related to that element in eDMS and to determine which documents could be merged in case a process would be combined, which documents where redundant or needed to be updated and which documents needed to be created. Per element a proposed document structure was defined and an action list was created with all the steps needed to achieve the proposed document structure. Finally, the documents were linked to the element in eDMS.

In total 57 elements were defined and within the time frame of the project, for almost half of these elements the document structure and action list were created and approved. Also training on the new structure of the QMS was given.

The main difficulty of this project lay in aligning the processes and associated documents at both companies, as, among other challenges, the departmental structures differ significantly. This required active cooperation from subject matter experts on both sides, further complicated by their already very busy schedules. Therefore, the input from Progress consultants was crucial in driving and coordinating this project and remarkable progress was made. The first phase of this project was successfully completed thanks to their broad expertise in the pharmaceutical industry, and ability to consult with their Progress colleagues at company level.

In the next phase of the project the remaining elements will be further detailed and all documents within eDMS will be linked to their relevant QMS element.