Principles of Management System Auditing Managing the Internal Audit Program Planning the Internal...

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IN TER N AL Q U ALITY AU D IT 1.0 Principles of Management System Auditing Managing the Internal Audit Program Planning the Internal Audit Conducting the Internal Audit Reporting the Audit Findings Post-Audit Activities

Transcript of Principles of Management System Auditing Managing the Internal Audit Program Planning the Internal...

Page 1: Principles of Management System Auditing Managing the Internal Audit Program Planning the Internal Audit Conducting the Internal Audit Reporting the Audit.

INTERNAL QUALITY AUDIT

1.0

Principles of Management System AuditingManaging the Internal Audit ProgramPlanning the Internal AuditConducting the Internal AuditReporting the Audit FindingsPost-Audit Activities

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INTERNAL AUDIT

The Internal Audit function is the mechanism through which the operation of the Quality Management System is formally monitored and conformance with the documented quality system is assured. 1.1

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WHAT IS INTERNAL AUDIT ?

It is a process and Opportunity to identify Conformance of the implementation of procedure Compliance and adequacy for ISO 9001-2000 requirements Improvement of a system. Chance to get innovative ideas for improvement. Ensure CAPA is initiated and find its effectiveness.

1.2

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REGULAR FREQUENCY. 1.3

Audit Criteria – Set of policies, procedures or requirements used as a reference against which audit evidence is compared.

Audit Evidence – Records, statements of fact or other information, which are relevant to the audit criteria and verifiable

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Find the effectiveness of Implementation of ISO 9001- 2000 System in the work place

QUALITY POLICY

QUALITY OBJECTIVE OVERALL OBJECTIVE FUNCTIONAL IOBJECTIVE PROCESS PARAMETERS. DOCUMENTS WORK INSTRUCTIONS.

1.5

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POSITIVE CONTRIBUTION FOR IMPROVEMENT

Not fault finding X 1.4

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AS PER ISO 9001-2000 STANDARDS 8.2.2. Organisation shall conduct internal audits at planned intervals to determine whether the Quality management system: a). Conforms to the planned arrangements to the requirements of this international standard and to the quality management system requirements established by the organization, and b) Is effectively implemented and maintained. 1.7

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IS THIS INTERNAL AUDIT REALLY NECESSARY!

? 1.8

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INTERNAL AUDIT

Where we are lagging in the implementation of QMS

Ensure the system of Corrective Action & Preventive Action are initiated and their effectiveness.

Handling of Customer complaints. Documents and Records verification as mentioned.

1.9

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TYPES OF AUDIT

FIRST PARTY AUDIT

SECOND PARTY AUDIT

THIRD PARTY AUDIT.

1.6

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EFFECTIVE IMPLEMENTATION

SYSTEM EFFECTIVENESS. 1.10

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TREND OF NON CONFORMANCE No.Of NCRs 1 2 3 4 5 6 7 8 Audit No.

X 1.11

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TREND OF NON CONFORMANCE No. of NCRs 1 2 3 4 5 6 7 8 AUDIT NO.

X 1.12

Trends

TREND OF NON CONFORMANCE 30 No.of Ncrs 20 10 1 2 3 4 5 6 7 8

1.13

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OBJECTIVE Make clear understanding about the concept and the purpose of internal audit related to quality management system Types of audit and its purpose The role of the auditor and the auditee. Way to perform internal quality audit. How to get the benefit of internal audit. ?

2.0

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INTERNAL AUDIT.

ROLE OF THE AUDITOR AND THE AUDITEE 2.1

AUDITOR. Well conversant with the ISO 9001-2000 QMS Well conversant with the Document procedures and Systems of QMS. The auditors must be independent of the function or Department being audited. Should be a good listener Should be able to ask the right questions in order to get the required information. Audit the area towards the improvement of Organisation. 2.2

AUDITEE. Should be highly cooperative with the Auditor.

Ready to accept the Audit findings.

Implement the Corrective and Preventive actions within the specified date.

Show the documents and records within 3 minutes.

2.3.

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CONTENTS.

1. Internal Audit. 2. Role of the auditor and the auditee in internal audit 3. Internal auditing techniques.

4. Corrective and Preventive actions. 5. IQA Process chart.

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INTERNAL AUDIT TECHNIQUES.

1. Check list methodology 2. Focus on Objective.

3. Audit the place, based on the customer requirements.

WHAT?

WHY?

WHO ?

WHEN ?

WHERE ?

HOW ?

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* IDENTIFY THE UNWANTED RECORDS

* SUGGEST FOR THE NEEDED RECORDS.

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1. CORRECTIVE ACTION 2. PREVENTIVE ACTION. 4.0.

CORRECTIVE ACTION *. ACTION REQUIRED TO AVOID REOCCURENCE PREVENTIVE ACTION

ACTION REQUIRED TO AVOID OCCURRENCE ONCE FOR ALL

4.1

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INTERNAL AUDIT – FLOW CHART. 5.0

Internal audit - flow chart Audit Plan

Audit Schedule

Internal Audit Report. M.R. Disposal of corrective and Preventive action With time bound

Verification of the activities By the Auditor.

Management Review Meeting 5.1