FDA Guide to Inspection of Quality Systems.

Performing Subsystem Inspections. . . . . . . . . . . . . . . 7
Table of Contents
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
Corrections & Removals 67
Inspectional Objectives 68
Decision Flow Chart 69
Narrative 70
Medical Device Tracking 73
Inspectional Objectives 74
Decision Flow Chart 75
Narrative 76
Production and Process Controls (P&PC). . . . . . . . 79
Inspectional Objectives 80
Decision Flow Chart 81
Narrative 82
Sterilization Process Controls 91
Inspectional Objectives 92
Decision Flow Chart 93
Narrative 94
Sampling Plans. . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Instructions 104
Tables (Backpage) 107

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