1 AUDIT PROCESS. 2 3 4 5 6 7 8 Quality Degree to which a set of inherent characteristics fulfils a need or expectation that is stated, generally.

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AUDIT PROCESS

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QualityDegree to which a set of inherent

characteristics fulfils a need or expectation that is stated, generally

implied or obligatory.ISO 9000:2000Definition 2.2.11

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Quality audit

Systematic, independent and documented process for obtaining evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.

ISO 9000:2000 Definition 2.9.1

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Audit criteria– – Set of policies, procedures or

requirements against which collected audit evidence is compared.

– Ex: Customer requirements, Documented quality system, Company standards, ISO 9001:2000

– ISO 9000:2000– Definition 2.9.4

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ISO 19011:2001 m Scope

It is applicable to all organizations implementing, maintaining or auditing a quality and/or environmental management system and thus having a need to conduct and manage internal and/or external management system audits.

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Quality system audit types

1st Party - WE auditing our own system (Internal)

2nd Party - WE auditing our supplier (External)

3rd Party - WE being audited by a registration body, (TUV) (External)

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Audit objectives

Objectives for an audit might be any of the following: a) determining the extent of conformity of the auditee's

management system to specified requirements. b) evaluating the capability of the management system

to ensure compliance with legislative requirements c) evaluating the effectiveness of the implemented

management system in meeting specified objectives d) identifying areas of potential improvement of the

management system

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Auditing benefits

* Verifying compliance

*Providing information for management review * Increasing quality awareness

*Reducing risk of product/service failures Identifying improvement opportunities

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Auditors responsibilities

* Complying with company requirements* Assist with preparing audit schedule* Carrying out the audit* Record and report the findings* Carry out follow-up audit* Maintain independence and confidentiality* Maintain audit records

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Auditor attributes

Open mindedness Tenacity Diplomacy Decisiveness Observant Self-reliance Perceptiveness Integrity

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Auditing Process

Six phases of a structured audit: - audit scheduling - Preparation - conducting the audit - reporting the results recording proposed corrective action and timescales -following up actions

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Audit planning

*The organization shall plan the audit programme taking into account the status and importance of the activities and areas to be audited as well as the results of previous audits (ISO 9001:2000 Clause 8.2.2)

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Audit planning Departments Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov

Dec Principals offi p p A p

A Agricultural Coll. P City college p A A Eastlands college p

A Technical college A p

A Purchasing A p A

p Kitchen A A p Chem. Laboratory A

p Documents/records A A

p Auditing A A

p Food store A

p Key: P = Audits scheduled on the basis of IMPORTANCE only A = Additional audits taking into account the STATUS and IMPORTANCE.

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Planning decisions

frequency timing scope objectives auditors

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Preparing for the audit

An audit plan needs to be prepared which includes as appropriate: a) audit objectives and scope b) audit criteria and reference documents c) areas and /or activities to be audited and

the agreed dates of the audit(s) d) identification of any processes to be audited e) audit duration f) the need for guides and their responsibilities g) audit method

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Audit documents

* audit procedures* nonconformity report forms* audit summary report forms* corrective action schedule* checklists

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Checklist benefits

Maintains clear audit objectives Evidence of planning Maintains audit pace and continuity Reduces risk of auditor bias Manages auditor workload Records sample of activities in the

audit

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Audit method

• Vertical (Upstream/ downstream)

* Horizontal

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Conducting the audit Opening meeting Collecting and verifying

information Record audit findings Keep auditee informed Prepare reports Report audit findings

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Questions

The six "friends" of an auditor: The auditors seventh "friend"

What? Show me (please) Why? Where? When? How.? Who?

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Classifying

Major nonconformity might be

defined as: A nonconformity of such severity that its

existence would indicate that a nonconforming product or service could be released to the customer or, where the requirements of an appropriate clause of ISO 9001:2000 has not been adequately addressed.

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Classifying

Minor nonconformity might be defined as:

A situation where there is a likelihood that nonconforming product or service will occur, or where the benefits of ISO 9001-.2000 are not being realised, because of the absence of, or lack of adherence to a procedure.

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Report meeting

Summarise findings Review nonconformities Agree commitment for corrective

actions Agree timescales

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Follow-up options

Verification at location of audit

findings Review of documentation Verification at next audit