Project Description

The challenge

The Quality group in a global pharmaceutical company decided to review and redefine existing site level quality metrics.

While some metrics had existed before, the revised set of metrics was more forward-looking and focused on potential risks rather than past performance.

Metrics were grouped into five areas and overall performance was captured at an individual site level and then consolidated across sites:

  • Quality Risk Identification and Mitigation
  • Training Definition and Competency
  • CAPA Effectiveness
  • Right First Time Performance
  • Deviation and Complaint Management

The client needed to be able to easily collect, input and analyse data from a large number of sites.

Our approach

In order to minimise the burden on the sites, we improved the data capture process, making adjustments to way information was recorded in existing systems.

In order to make the analysis and reporting process efficient for the central Quality group, we designed an automated, Ms Excel based tool.

The tool automatically generated impactful visuals and summary tables from raw data copied into an input sheet.

The dashboard displayed a high-level summary of the metrics with a clear ‘traffic-light’ system to indicate areas with current issues or risks.

Table 1 below illustrates the layout used:

In addition, each section could be expanded to display a data plot, detailed data and additional management commentary (Figure 2).

The result

The analysis, which had previously been an onerous process, was now much more efficient. Impactful reports facilitated decision-making and supported continuous improvement.

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