Here is the common-sense guidance you need to perform an effective, systematic
internal quality audit. As a quality professional, you are well aware of the
repercussions caused by a nonconforming product entering the marketplace; customers
may experience adverse effects or worse, and your company will certainly lose
credibility and profit. This book helps you identify and prevent systemic weaknesses
by providing the evaluation tools you need to prevent such occurrences.
Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file - 4.09
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Paper version is not available.
Table of
Contents:
Introduction
1. The First Step
Deciding to Audit
Staffing the Audit Function
Setting the Tone
Determining Audit Roles
Focusing on Areas Prime for Internal Audit Attention
Setting Workable Time Frames for Conducting Audits
Setting a Company-Wide Audit Schedule
Making Audits a Way of Life
2. The Homework
Establishing the Scope of the Audit
Determining the Depth of the Audit
Selecting the Audit Team
Determining the Binding Regulations
Reviewing the Documents In Place
Reviewing the Previous Audits Reports and Records
Scheduling the Audit
Making the Preliminary Contacts
Putting It In Writing
3. The Measurements And Tools
Understanding Measurements
Charting the Course: The Audit Plan
Preparing Checklists
Confirming the Audit
Keeping Notebooks
4. The Audit
Auditing a System or Process
Interviewing the Players
Posing Open-Ended Questions
Listening Actively
Reading Non-Verbal Communication Signals
Observing the Activities
Identifying Non-Conformances
Looking at Related Systems for Disconnects
Auditing Batch Records, Device history Files,
or Other Documentation
Hitting Records Page by Page
Exchanging Information During the Audit
Reporting Verbally
5. The Evaluation And Report
Compiling the Audit Observations
Remaining Unbiased
Preparing the Report
Writing Guidelines
Formatting the Report
6. The Next Step
Receiving a Response in Chart Form
Receiving a Response in Letter or Memo Form
Evaluating Responses
Closing the Loop
Archiving Records
Establishing an Audit Schedule
Making Audits an Integral Part of Operations
A Final Note
7. References
About the Authors:
Monica Grimaldi is a senior auditor with pharmaceutical and
medical device experience. A chemist with a background in quality control and
method development, she now conducts internal and external quality audits
internationally for a major healthcare company. She is also an ISO Certified
Lead Auditor.
Janet Gough is the director of technical communications for
Cerus Corporation, a biotech company. Her background includes consulting to the
pharmaceutical industry and teaching technical writing and English as a Second
Language (ESL) at the university level.
She is the author of Write It Down:
Guidance for Preparing Effective and Compliant Documentation, Second Edition.