文档介绍：FOOD AND DRUG
ADMINISTRATION
GUIDE TO INSPECTIONS OF
QUALITY SYSTEMS
1
August 19991
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Guide to Inspections of
Quality Systems
This document was developed by the Quality System Inspec-
tions Reengineering Team Members
Office of Regulatory Affairs
Rob Ruff
ia Layloff
Denise Dion
Norm Wong
Center for Devices and Radiological Health
Tim Wells – Team Leader
Chris Nelson
Cory Tylka
Advisors
Chet Reynolds
Kim Trautman
Allen Wynn
Designed and Produced by Malaka C. Desroches
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Foreword
This document provides guidance to the FDA
field staff on a new inspectional process that
may be used to assess a medical device
manufacturer’pliance with the Quality
System Regulation and related regulations. The
new inspectional process is known as the
“Quality System Inspection Technique” or
“QSIT”. Field investigators may conduct an ef-
ficient and prehensive inspection
using this guidance material which will help
them focus on key elements of a firm’s quality
system.
Note: This manual is reference material for investi-
gators and other FDA personnel. The document does
not bind FDA and does not confer any rights, privi-
leges, benefits or immunities4 for or on any person(s).
Table of Contents
Performing Subsystem Inspections. . . . . . . . . . . . . . . 7
Pre-announced Inspections. . . . . . . . . . . . . . . . . . . ..13
Getting Started. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
Management Controls. . . . . . . . . . . . . . . . . . . . . . . .17
Inspectional Objectives 18
Decision Flow Chart 19
Narrative 20
Design Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . .31
Inspectional Objectives 32
Decision Flow Chart 33
Narrative 34
Corrective and Preventive Actions (CAPA). . . . . . . .47
Inspectional Objectives 48
Decision Flow Chart 49
Narrative 50
Medical Device Reporting 61
Inspectional Objectives 62
Decision Flow Chart 63
Narrative 64
Correct