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Quality Systems and Quality Culture Assessment

Clarkston recently partnered with a client on a quality culture assessment project. This client is a leading global pharmaceutical company specializing in the discovery, development, and commercialization of prescription medicines. The organization’s leading products target cardiovascular, metabolic, oncological, and respiratory diseases.  

The company was looking to improve their quality process and culture at a key manufacturing site. Clarkston was engaged to assess the organization’s current processes, documentation, and procedures at this site within the organization’s quality control unit. To do this, Clarkston conducting site surveys and interviews with key stakeholders. These in-depth evaluations of relevant aspects of the quality system and quality culture enabled Clarkston to provide the organization with an external viewpoint that would help drive continuous improvement and enhancement of quality operations. 

Download the Full Case Study Here

The first area surveyed was quality process training with the end goal to uncover the best method for enabling cross department process training specific to the organization. Clarkston additionally guided operational best practices to set quality goals at the site level. These goals were then cascaded through the other relevant departments to ensure organizational alignment. A Change Control (CC) Process Review was also conducted to enable process simplification and streamline this procedure with other concurrent quality processes.  

To culminate, the Clarkston team analyzed site survey and interview results to present client leadership with recommendations built from stakeholder feedback. In this recommendation, Clarkston introduced a methodology to enhance training effectiveness and highlighted avenues through which the client could execute process improvements with focused follow-ups. 

Download the full Quality Systems and Quality Culture Assessment case study here

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Tags: Quality and Compliance Technology, Quality Operations
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