The Internal Quality Audit (single user digital version)

Dec 2001
PDA Item Number
PDF Single user
Member Price
Nonmember Price
Government Price

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 MB)

Paper version is not available.

Table of Contents

Table of Contents:

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

    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.