FDA/Quality Metrics

Management of FDA-Guidelines: How to implement Quality Metrics?

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Related Companies

Seen from the chair of a top manager in the quality organisation of a pharmaceutical company it makes a lot of business sense to use quality metrics to oversee the organisation — and also to get a status of the current compliance situation in the company. A lot of pharmaceutical companies has a number of different production sites — often in many different countries. Here a standard set of quality metrics can be used internally in the company to better judge the compliance situation among the different production sites. You can even use it to get a high-level indication about how to better distribute cost with in the budget of the quality organisation. Without standardized data, it is more difficult for top management to know which site need more quality funding and which site can hold a little back. As a quality top manager, you will hear a lot of wished for more money when it is budget time of the year.

Quality Metrics as a Chance

Quality metrics can also serve as an indicator of where there are problems in the organisation and which site you can learn better practices from. Last but not least quality metrics will also feed in valuable data for the yearly quality management review which has been mandatory in Europe for a number of years. For a big or mid-sized pharmaceutical company a table like table 1 can be used to get an overview and compare across production sites:


Each company will need to evaluate which specific quality metrics that makes sense in the company, considering aspects such as:

  • Size of the company,
  • The type of products manufactured,
  • The quality issues that have come up in the recent years,
  • Things that consumes a lot of time in production and quality departments,
  • Observations from latest regulatory inspections.

Here are some examples for metrics that makes sense to measure in many companies:

  • “CAPA timeliness” — calculated as % CAPAs on time or still on schedule.
  • “Change timeliness” — calculated as % tasks and actions completed on time or still on schedule.
  • “Temporary changes” — calculated as % temporary changes of all changes.
  • “Deviation timeliness” — calculated as % of all deviations quality approved within 30 days.
  • “Recurring deviations” — calculated as % recurring deviation of all deviations.

How to Change Culture – With Quality Management

It is especially important to ensure that the number of recurring deviations is low. A high number of recurring deviations is a bad signal. It tells you that the organization do not learn enough from failures to prevent it happen again. Thus, it is an indicator of low compliance and a not so good quality culture at the size — and it is very bad business: Recurring deviations cost a lot of money in time wasted and inefficient flow of the products.