Quality Assurance

List of figures

1.1	Structure of investigations and remediations	13
2.1	Template of Ishikawa diagram	41
2.2	All candidates for root cause	42
2.3	Disaggregation of a major element	42
2.4	Remaining candidates for root cause	45
2.5	Constituent elements of packaging and labeling	45
2.6	Program logic model of cleaning and sanitizing program	49
4.1	Introductory material of an SOP	87
4.2	Actions and responsibilities	88
4.3	Notice of event (NoE) and deviation investigation	89
4.4	Approvals and version history of an SOP	91
4.5	Room XXX: cleaning and sanitizing schedules	94
4.6	Room XXX: cleaning and sanitizing logs	95
4.7	Cleaning and sanitizing SOP	97
II.1	The two remediation processes	105
5.1	The ADDIE model	111