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.
- The Design History File (DHF) gives a history of device design. One of the design outputs is the Device Master Record (DMR).
- The Device Master Record (DMR) contains all the information necessary manufacture, install, service, and maintain the device.
- The Device History Record (DHR) has the objective evidence to support the device production history.
- 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?