MCC Cost of Poor Quality Estimator Tool

The MCC Study Quality Trailblazer Group (a Risk and Quality Management Support Group) is a forum for member organizations interested in developing and utilizing approaches and tools to demonstrate that investing time and resources up front can yield higher quality clinical study performance at a lower cost than fixing quality issues during the study. The MCC Cost of Poor Quality Estimator Tool was developed, with input from Study Quality Trailblazer Group members, to provide a way to quantify the impact that quality-related problems have on operational costs and study timelines.


  • Establishes a baseline value of the current impact of quality problems
  • Raises the visibility of prevention efforts instead of rewarding “fire fighting” activities
  • Improves decision-making on quality investments by demonstrating the cost impact of failures and the benefits of implementing prevention and/or appraisal measures into processes
  • Considers cost in addition to the impact considered in ICH E6 (R2) for data integrity and human subject protection
  • Assist with change management efforts by providing the additional cost dimension to the impact of failures

How it Works

The MCC Cost of Poor Quality Estimator Tool is an easy-to-use Excel®-based tool. It has three categories for cost of poor quality:

  • Direct, operational costs (16 items)
  • Operational cost of study extension
  • Delay to market costs

An extensive review of available literature provided estimates for seven of the direct, operational costs, which are included in the model as default values.

The tool allows users to override the default values if company-specific data are available. Users may add additional costs of poor quality, if available.

The tool includes a table and a graphical representation of the different direct, operational costs of poor quality. These can be displayed in reverse order of cost (a Pareto chart) to help users see clearly the items that have the largest impact on cost of poor quality.

The MCC Cost of Poor Quality Estimator Tool is available to all MCC member organizations. MCC representatives are invited to log in to the MCC Member Portal to download the toolkit. Contact MCC Customer Service if you need assistance.

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