Table of Contents (this product has been updated on 6 Sept, 2009)

EXAM FORMAT
ABOUT THIS BOOK
EXAM TOPICS
EXAM REGISTRATION CONTACTS
STUDY PSYCHOLOGY & EXAM TACTICS

THE QUALITY AUDITING PROCESS
AN OVERVIEW OF THE TERM “QUALITY”
WHAT IS AUDITING, BY THE WAY?
WHAT ABOUT QUALITY AUDIT?
QUALITY AUDIT SYSTEM
STANDARDS & GUIDELINES
STAFFING
PROFESSIONAL CONDUCT
MANAGEMENT AND B.O.D
THE CLIENT
THE AUDITEE
OBTAINING BUY-IN AND SUPPORT
THE CHARTER
THE LEAD AUDITOR'S JOB
THE QUALITY AUDITOR'S JOB
DON’TS FOR THE AUDITORS
THE AUDIT PROCESS FLOW
AUDIT PLANNING
Identifying what to audit
Audit coverage
A Risk Based approach
RESOURCES FOR PERFORMING THE AUDIT
TRAVELING
DELIVERABLES
ORGANIZATIONAL STATUS AND LINE OF REPORTING
AUDIT FIELDWORKS
FIELDWORK ACTIVITIES
FIELD TESTING

118 PRACTICE QUESTIONS

SAMPLE TEXT on control chart

A control chart can be used to detect and indicate an out-of-control condition either when one or more points fall beyond the predefined control limits or when the plotted points exhibit some nonrandom pattern of behavior. Random pattern is fine. Non-random pattern is not.

Generally speaking, a process is considered more or less out of control if any one or more of the criteria is met:

 One or more points outside of the control limits.
 A run of a series of points on one side of the center line.
 An unusual pattern in the data.
 An obvious trend of a series of points in a row either upward or downward.
 Several points grouped almost together near a particular control limit.


Control chart is preferable for describing precisely what is meant by statistical control. It is quite effective in defect prevention and can prevent unnecessary process adjustments. It also provides valuable diagnostic information as well as accurate information on process capability. On the other hand, you use a Cause and Effect Diagram (for example a Fishbone diagram) to give a graphical display of a list in which you identify and organize possible causes of quality problems. You may also use run charts to analyze processes according to time or order. In other words, run charts are useful in discovering patterns that occur over time. Pareto charts (which are a form of bar charts) are useful for identifying those factors that have the greatest cumulative effect. Scatter diagrams are helpful for graphically depicting the influence that one variable has on another.

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SAMPLE TEXT on Audit coverage

In order to properly determine the appropriate level of audit coverage for an organization, you should define an effective assessment methodology that provides the auditor, the audit committee and the board with objective-enough information to prioritize the use of audit resources. This is based on the belief that some areas of your production environment may deserve more efforts and resources than the others.

Important: Do note that the sophistication and formality of risk-based audits often vary a lot depending on the organization’s size and complexity.


Generally speaking, activities all the way from design to production to delivery & servicing should be audited.

- All design activities should be strictly controlled to ensure that the design output information complies fully with customer requirements as well as all design input data.
- All documentation utilized for the execution of individual customer contracts are controlled to ensure that they are issued to the appropriate personnel, under the correct level of authority, and are revised and reissued as necessary to stay updated.
- Suppliers of production materials and services are selected basing on their ability to meet customer requirements and under due consideration to the factors of quality, statutory obligations, timescale and cost.
- All production works should be planned and undertaken in accordance with the quality control procedures and any specific documents agreed for individual contracts.
- Inspection and testing must be properly carried out, with results being documented. As a side note, all the production and measuring equipments in need must be maintained in good condition.
- Along the production process, once non-conforming items have been noticed they have to be identified to prevent their inadvertent use. All non-conforming items and/or customer complaints must be subject to review and rectification. The type and extent of non-conformity should be documented in order to establish trends and identify possible areas for improvement.
- The corrective action required to prevent recurrence should be evaluated, documented, and its effective implementation have to be monitored. The Quality Auditor may not need to come up with a proper corrective action plan. He/she does need to monitor the implementation of corrective actions.
- A Quality Auditor may not be responsible for training quality concepts. He/she does want to audit the training and awareness component of the quality system. Insufficient training and awareness often lead to quality issues. As a side note, all employees should be encouraged by management to suggest improvements in quality methods, materials, suppliers, and other procedures.