Tuesday, December 7, 2010

Records FDA inspectors look for - related to Quality system

The FDA’s QSR expects the manufacturer to maintain a series of documents that describe the design and production of the device. QSR allocated the information into four documents.

  1. The Design History File (DHF) gives a history of device design. One of the design outputs is the Device Master Record (DMR).
  2. The Device Master Record (DMR) contains all the information necessary manufacture, install, service, and maintain the device.
  3. The Device History Record (DHR) has the objective evidence to support the device production history.
  4. The Quality System Record (QSR) contains information that is not device specific.

A compliant Quality Management System (QMS) should be able to address these questions quickly and easily.

  • The list of the records that belong in the Design History File (DHF)?
  • Can your team relate the component specifications in the DMR to the Purchasing Data you use to obtain the components?
  • What are the records you must keep when you verify the component at receiving?
  • Which of these records must go into the DHR?
  • What is the list the activities that require a designated individual?
  • Do you have quality records that designate the individual and demonstrate training to perform the assigned responsibility?
  • How to assure that the designated individual, not somebody else, performed the activity before you released the product for distribution?
  • Some information could be in the DMR or the QSR. Does you team know how to make the decision?


  1. The above items seem to pertain more to devices opposed to pharmaceuticals.