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