Quality Metrics

Metrics
Metrics

Hello, good people of the world! If you know me, then you know I’m into “metrics” – ways to evaluate the health of a system or process quantitatively. We know finding and correctly interpreting the “right” metrics is not trivial, and looking at the “wrong” metrics can do more harm then good.

ISPE has recently released a whitepaper suggesting quality metrics for the FDA to use in their inspection process. I’ve uploaded a copy here.

The metrics they propose are:

  1. Batch Rejection Rate = number of batches rejected divided by number of batches dispositioned during a given time period
  2. Rework and Reprocessing Rate = number of batches reworked or reprocessed divided by number of batches dispositioned
  3. Confirmed Out-of- Specification (OOS) Rate = number of confirmed OOS results divided by number of batches tested
  4. Unconfirmed OOS Rate = number of unconfirmed OOS results divided by number of batches tested
  5. “Critical” Complaints Rate = number of “critical” compliants divided by number of complaints
  6. % Annual Product Quality Reviews (APQRs) Completed on Time = number of APQRs completed on time divided by number of APQRs

What do you think about these metrics? Do they accurately correlate to a healthy process and quality system? Are there any that are missing?

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