Risk Assessment & Testing

In order to find the right type test for this specific equipment, we had to run a validation assessment form.

Steps

  • We decided the impacted systems are the equipment and the computer system/software.
  • This is a change to an existing system
  • The change is to make the metal particulate test automated. Visual inspection is still required for any errors during automated tests. New test will have its own set of instructions for use, but will use current metal particulate testing criteria.
  • We then do a Risk Assessment: Impact & Control

Impact Assesment

  • Quality Attributes: There are two critical quality attributes (CQAs) associated with the metal particulate testing process: CQA ID 3.8 Cleanliness (Metal Particulate) and CQA ID 3.10 Fluid Path Clogged (HP Test). However, the implementation of this change does not impact relevant CQAs.
  • Process Parameters: There are two process parameters associated with the metal particulate testing process: the “Metal Particulate Test” and “Flow rate”. However, the implementation of this change does not impact relevant process parameters.
  • Impact to User: Easier useability, less labor intensive
  • Impact to Patient: If product passes with false-positive, patient health at risk
  • Impact to Compliance: Potential oversights will make product unsafe for use, direct impact on patient safety
  • Impact to Functionality of Product: Product may be unsafe for use if false-positive occurs
  • Impact to Business: Product recall if product passes with false-positive, disruption in quality assurance process
  • Based on the previous statements, we decided this equipment will have a medium impact

Control Assessment

There is no downstream check needed for this test. However, we need one test or inspection for the handpiece. Therefore, it has low control

A medium impact with low control leads to a functional test

Installation Qualification