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[资源] Laboratory Auditing for Quality and Regulatory Compliance

Laboratory Auditing for Quality and Regulatory Compliance.jpg
Preface . . . . iii
Introduction . . . . vii
I. Quality and Auditing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Quality Control and Quality Assurance
in a Laboratory . . . . 1
The Regulated Industries . . . . 3
Goals of a Laboratory Quality Audit .... 5
Audit Tools: Observation, Working Knowledge,
and Audit Documents . . . . 7
II. Nontechnical Parameters for Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . 9
Quality Programs, Documentation, and Organizational
Structure .... 9
Personnel . . . . 14
Facility and Environment .... 15
III. Technical Parameters for Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Sample Control .... 19
Instrumentation . . . . 20
Automation of Analytical Process .... 22
Acquisition and Processing of Data . . . . 23
Uncertainty of Measurements . . . . 24
Reliability of Measurements . . . . 26
Standards and Standardization . . . . 26
Supplies Organization . . . . 27
Proficiency Testing .... 28
IV. Other Areas to Consider . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Customer Satisfaction . . . . 29
Laboratory Health and Safety .... 29
V. Communications and Follow-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Closing Conference, Final Report, and
Follow-Up .... 31
Frequency of Audit . . . . 33
Epilog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Appendices
A . Sample Laboratory Quality Audit Document .... 37
B. National Voluntary Laboratory Accreditation Program,
NIST Handbook 150 . . . . 51
C. Guide to Quality in Analytical Chemistry
(Eurachem=CITAC) . . . . 117
D. Quality Assurance for Research and Development and
Nonroutine Analysis (EURACHEM=CITAC) . . . . 175
E. Accreditation for Microbiological Laboratories
(Eurachem=EA) . . . . 229
F. EPA Manual for Certification of Laboratories Analyzing
Drinking Water . . . . 253
G. Federal Register (FDA): Good Laboratory
Practice Regulations for Nonclinical
Laboratory Studies . . . . 443
Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 465
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 469

[ Last edited by 1949stone on 2013-8-23 at 15:15 ]

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2013-08-23 15:11:59, 7.03 M