The Quality System Inspection Technique (QSIT) provides guidance to the FDA field staff on a new inspectional process that may be used to assess a medical device manufacturer's compliance with the Quality System Regulation and related regulations. Field investigators may conduct an efficient and effective comprehensive inspection using this guidance material which will help them focus on key elements of a firm's quality system.

The QSIT involves four [[Top-Down Inspection]]'s of the four major subsystems of the quality system:
* [[Manufacturing Controls]]
* [[Design Controls]]
* [[Corrective and Preventive actions]]
* [[Production and Process Controls]]

The QSIT (Quality System Inspection Technique) Handbook (copy available [[here|/static/files/FDA/QSIT_Inspection_handbook.pdf]]) is used to train FDA inspectiors in this technique.

Find the FDA description [[here|http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074883.htm]]
bag
fda_public
created
Sun, 01 Jul 2012 19:11:01 GMT
creator
dirkjan
modified
Sun, 01 Jul 2012 19:11:01 GMT
modifier
dirkjan
tags
CFR 21-820.30
Design Controls
FDA
QSIT
Quality System Requirements
Term
creator
dirkjan