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Preface
Contents
Introduction
Quality management concepts
The ISO-9000 family of standards
ISO-9001: 1994, Quality System Model Guidelines
Developing and implementing a quality management system
Quality system documentation
Internal Quality Audit
Assessment and certification
ISO-9000 as a basis for continuous quality improvement
ISO-9000/2000 implications
ISO-9000/2000 Management concerns Conclusion
Model of a process-based quality management system
Note on Author
Disclaimer
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Chapter 6:
Internal Quality Audit

Introduction

Internal audit is an important component of the quality assurance system. It provides information to management about the effectiveness of the implementation of the planned quality system. This section deals with how to plan, carry out and report on an internal audit programme.

Purpose of the internal audit

The internal audit serves several purposes:
· It checks whether the system is working properly and verifies the presence of   defects (nonconformities) in the system.
· It investigates whether previously identified problems have been corrected.
· It brings to light potential problems.
· It uncovers possibilities for improvement.

Guidelines for planning, implementing and following up an audit

The overall objective of internal auditing is to establish whether the quality system is effective and is being followed. However, it is worth making the point that emphasis is on the positive, i.e., establishing that the system works rather than finding faults.
Auditing has four basic phases:
    1. Planning
    2. Implementation
    3. Reporting
    4. Follow-up

Planning:

A planned approach to auditing is required so that all parts of the system and all processes are covered within one-year periods. However, in the beginning, i.e. between the implementation stage and assessment by a certification body when only three to four months` time is usually available, it is advisable to audit all parts of the system within that period. The management representative whose responsibility often includes managing the audit process and ensuring that scheduled audits take place generally carries out planning.
The scope of each audit should be defined, i.e. the process, department, procedure, etc. to be audited. Trained auditors are then assigned to the audit and dates are agreed with the section to be audited.
Preparation should also include confirming arrangements like the audit date, time, place, etc. with the auditors. .

Checklists drawn from relevant procedures and previous audit findings, if any. Implementation:
There are four general methods, which auditors use to check whether procedures are being followed:
· Observation of the work with respect to the relevant procedure
· Asking questions to verify whether the staff know what they ought to be doing.
· Verifying record-keeping to find conformance
· Selecting records freely to examine.
All four methods could be used. The objective is to find evidence supported by records for both conformance and non-conformance.

Reporting
Auditors should record their findings in intended formats in adequate detail and comment as to non-conformance, if any, in clear terms citing the relevant clause of standard as well as procedure. It is advisable to get the auditee to agree to the observation by explaining the discrepancy.
It is not the role of an auditor to establish why the problem (non-conformance) has arisen and to blame anyone for not following the system. It is also not the auditor's job to suggest a solution to the problem.
The auditor usually holds a closing meeting with the Department head as well as all auditees in the presence of the management representative and conveys the findings of the audit starting from positives and going on to nonconformities. A formal report in prescribed format is also produced. The benefit of audits cannot be fully derived unless both corrective and preventive actions are implemented in right earnest by the management and auditees.

Follow-up
Where a corrective action and timeframe has been agreed a follow-up is required.
The auditor verifies in detail and satisfies himself as to the adequacy of the action and then may close the non-conformity report formally. If not satisfied he may insist on further action in a systemic context. Both the original and follow-up audits are recorded.

Selection criteria for internal auditors
Internal auditors are required to have the following traits:
· Independence. The auditor shall not be responsible for or involved in activities   pertaining to the place being audited.
· Attention to detail.
· Good human relations
· Strength to stand by their conclusions
· Objectivity

They need to be formally qualified. An experienced, qualified auditor may impart the training and award certificates.
A trained auditor belonging to the customer department or section auditing the supplier department or section is the best practice in this area.

Documents giving guidelines for auditing quality systems
1. ISO-10011-1: 1990,Guidelines for auditing quality systems-Part 1: Auditing
2. ISO-10011-2: 1991, Guidelines for auditing quality systems-Part 2: Qualification    criteria for quality system auditors
3. ISO-10011-3: 1991,Guidelines for auditing quality systems-Part 3: Management of    audit programmes

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