It can be difficult for organizations to identify critical areas of improvement within the Quality Control (QC) department to ensure high quality of processes and (analytical) methods and reliable sample test results. Therefore, it can be helpful to have an expert objectively determine the QC organization’s strengths and challenges. A practical instrument for this is the Quick Scan QC, where improvement points are defined in a brief time and practical recommendations are made to increase quality and compliance with regulations.

How can we help you

Progress has extensive experience with Quality Control and has therefore developed a specific risk survey for QC activities: the ‘Quick Scan QC.’ With the help of this scan, Progress can determine together with you whether the activities that your QC organization conducts comply with the applicable and current regulations. We use a clear, compact, and structured approach to identify and analyze gaps. The outcome can serve to determine your risk areas, whether and how work processes can be optimized for efficiency, or where your quality management system can be optimized to achieve reliable test results according to WHO Annex 1 good practices for pharmaceutical QC laboratories.

In consultation with you and/or your team, we determine an objective baseline measurement for several key improvement areas. We can help you prioritize the areas for improvement and determine the target levels. One or two of our experts will visit your organization to assess the current situation, by asking questions, working closely and in an open and transparent manner with your relevant subject matter experts. We will provide documented recommendations to achieve the target level of your QC organization.

The Quick Scan QC consists of several questionnaires, one for each of the distinct aspects that are important for a QC laboratory:

• The QC organization itself (roles and responsibilities)
• Reporting, data management and documentation systems
• Sample and material management
• Method validation and knowledge transfer
• Equipment management and qualification
• Laboratory setup based on the activities performed (e.g., microbiological, or radiological activities)
• Environmental monitoring
• Outsourcing and Quality Agreements