|
CAPA manager, 212
Case studies
Growth Corporation Quality Management System (GCQMS) manual, 287–347
invitation to, 283–84
Mike's advice on ISO 9001:2000, 349–54
Certification assessment, 290
Certification audits, 220–31
assessor role, 222–23
audit, 221–22
findings, 222
initial assessment, 229–31
management, 225
need for, 221
nonconformance and, 220
sector-specific requirements, 225–29
structure, 223–25
tip-of-the-iceberg effect, 229, 230
Certification plan (ground floor up), 350–54
illustrated, 351–53
results, 354
writing, 351
See also Case studies
Characteristics
critical, 181
paraphrasing, 252–55
product, 180–81
QMS, 14
specific, 181
Communications
customer, 324
internal, 315–16
of quality policies, 308, 310
Concomitance, 73–80
table, 77–80
training example of, 74–76
types of, 77–80
Continuous/continual improvement
continuous vs., 17–18
cycle, 219
cycle by paragraph, 20
cycle demonstration, 23
cycle within elements, 23–24
defined, 17
design and development, 23
element examples, 25
equivalency, 18
framework, 17–30
GCQMS manual, 344
imperative, 24
intrinsic nature of, 19
production and service provision, 24
as quality management principle, 296
Core competencies, 4–7
characterization, 4
exact choice of, 6
GCQMS, 297
identification of, 51
illustrated, 5
interaction between, 51
strategy, 6–7
typical set of, 5
Corrective action, 345–47
Corrective action reports (CARs), 218
Cover page, 292–93
Cross-functional team organization, 212–15
Current Good Manufacturing Practices (CGMP), 134–36
Customer complaints
corrective and preventative action, 217
filtering, 218
management, 187, 218
as mandatory requirement, 187
Customer-driven program, 19–20
Customer Focus (Section 5.2 GCQMS manual), 308
Customer-Related Processes (Section 7.2 GCQMS manual), 322–24
Customers
communication, 324
defined, 116–17
focus, 296
new, quality manual and, 142
property, 334
requirements, conversion of, 4
satisfaction, 338–39
satisfaction, as gain measure, 207
validation, 343
Cut-and-paste technique, 93–105
at-a-glance chart, 104–5
defined, 93
steps, 93, 103
See also Quality manual
|