quality auditing

7/28/2019 Quality Auditing

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QUALITY AUDITING


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Quality is viewed from mltiple perspectives:

atributes of the product (performance,

durability, etc.), customer satisfaction,

conformity with manufacturing specifications,

and value (relation of quality and price)

Total quality management (TQM) is a approach

to quality. It treats to pursuit of quality as A

basis organizational function.

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TOTAL QUALITY MANAGEMENT


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Doing the activities right the first time

Employees training and empowerment

Promotion of teamwork

Improvement of processes

Attention to satisfaction for customer Identifies customers needs

Recognizes that everyone in a process is at some time a

customer or supplier of someone else.

TQM IS PHILOSOPHY


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The internal audit activity should perform procedures to

provide assurance that the basis objectives of TQM are

reached:

Customer satisfaction

Continous improvement

Promotion of teamwork

International Standards Organization (ISO) defines The

Quality As: ISO 9000:2000

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QUALITY is the totality of characteristic of an entity that

bear on its ability to satisfy stated and implied needs.

conformance to requirements. degree of excellence

QUALITY MANAGEMENT INCLUDES:

Quality Control

Quality Assurance

Quality Policy

Quality Planning And Improvement

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QUALITY CONTROL: concerns the operational means tofulfit the quality requirements

QUALITY ASSURANCE: aims at providing confidence in

this fulfitment, TOTAL QUALITY MANAGEMENT:

Brings To There Concepts A Long Term Global

Management Strategy

Participation Of All Members Of The Organization For The

Benefit Of The Organization Itself, Its Members, Its

Customers And Society As A Whole

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Aim To The Organization At Long Term Sucess Throught

Customers Satisfaction

Notes From This Concept Designates :

All Members Personnel In All Departaments And All

Level Of The Organizational Structure

The Strong And Persistent Leadership Of Top Management

And The Education And Training Of All Members Of The

Organization Are Essential For The Success Os This

Approach.

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TOTAL QUALITY MANGEMENT


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In total quality management, the concept of quality relates to

the achievement of all monogerial objectives

Benefits to society imply the fultilment of requirements of

society.

Total quality management or part of it are sometimes called

total quality, CWQC (company wide quality control),TQC,

total quality control

Framework of quality auditing

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QUALITY AUDITING: is a systematic and independent

examination to determine whether quality activities and related

results comply with planned arrangements and whether these

arrangements are implemented effectively and are suitable to

achieve objective

NOTES:

The quality audit applies, but is not limited, to a quality

system or elements thereof, to processes, to products or to

services.

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QUALITY AUDITING


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Quality Audits Are Carried Out By Staff Not Having Direct

Responsibility In The Areas Being Audited But Working In

Cooperation With The Relevant Personnel.

To Evaluate The Needed For Improvement Or Corrective

Action. Should Not Be Confused With Inspection, Activities

Performed For The Purpose Of Process Control Or Product

Acceptance

Quality Audits Can Be Conducted For Internal Or External

Purposes. (ISO 9000; ISO/DIS 8402)

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QUALITY AUDITNG


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Quality System Audit Provides Objective Evidence Concerning The

Need For The Reduction, Elimination And Prevention Of

Noncorformities.

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QUALITY AUDITNG


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QUALITY AUDITNG

THE AUDITOR OF QUALITY

is a person who has the qualification to perform quality audits

To perform a QUALITY AUDIT, the

auditor must be authorized for that

particular audit

An auditor designated to manage

a quality audit is called a LEAD

AUDITOR


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AUDIT OBJECTIVES

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QUALITY AUDITING

To determine the conformity or noncorformity of the

quality system elements with specifies requirements

To determine the effectiveness of the implemented

quality system in meeting specified quality objectives

To provide the aditee with an opportunity to improve the

quality system

To meet regulatory requirements

To permit the listing of the audited organizations quality

system in a register.


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QUALITY AUDITING

To Evaluate A Supplier Where There Is A Desire To

Establish A Contractual Relationship

To Verify That An Organizations Own Quality

System Continues To Meet Specified Requirements

And Is Being Implemented.

To Verify That The Supplier s Quality Systeme

Continous To Meet Specific Requirements And Is

Being Implemented

To Evaluate An Organizations Own Quality System

Against A Quality System Standard

AUDITS ARE

INITIATEDFOR

FOLLOWING

REASONS


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QUALITY AUDITING

COMPLYING WITH THE APPLICABLE AUDIT

REQUIREMENTS

COMMUNICATING AND CLARIFYING AUDIT

REQUIREMENTS

PLANNING AND CARRTYING OUT ASSIGNED

RESPONSIBILITIES EFFECTIVELY AND EFFICIENTLY

DOCUMENTING THE OBSERVATIONS

REPORTING THE AUDITOR RESULTS

VERIFIYING THE EFFECTIVENESS OF CORRECTIVE

ACTIONS TAKEN AS A RESULT OF THE AUDIT (IF

REQUESTED BY THE CLIENT)

AUDITORS

RESPONSILIBITIES


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QUALITY AUDITING

Retaining and

safeguarding documents

to the audit

Cooperating with and

supporting the lead

auditor

Auditors should be free

from bias and influences

which could affect

objectivity


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QUALITY AUDITING

AUDITORS ACTIVITIES:

THE LEAD AUDITOR SHOULD

Define the

requirements of

each assigment,

including the

required auditor

qualifications.

Comply with

applicable

auditing

requirements

and other

appropiate

directives

Plan the audit,

prepare working

documents and

brief the audit

team

Review

documentation

on existing

quality system

activities to

determine their

adequancy

Report critical

nonconformities

to the auditee

inmediatly


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AUDITORS

SHOULD

Remain within the audit scope

Exercise objectivity

Collect and analyze evidende that is relevant and sufficient to

permit the drawing of conclusions regarding the audited quality

system

Remain alert to any indications of evidence that can influence the

audit results and possibly require more extensive auditing

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QUALITY AUDITING


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QUALITY AUDITING

Are the procedures, documents an other information describing or supporting the

requiere elements of the quality system known, available, understood and used by the

audit s personnel?

Are all the documents and other information used to describe the quality system

adequate to achieve the required quality objectives?


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The Audit Plan Should Be Approved By The Client And Communicated To The Auditors

The Audit Plan Should Be Designed To Be Flexible In Order To Permit Changes In Emphasis Based On

Information Gathered During The Audit, And To Permit Effective Use Of Resources

The Plan Should Include:

1. The Audit Objective And Scope.

2. Identification Of The Individuals Having Significant Direct Responsibilities Regarding The Objectives & Scope

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QUALITY AUDITING PLAN


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IDENTIFICATION OF AUDIT TEAM GROUP AND MEMBERS

THE LANGUAGE OF THE AUDIT

THE DATE AND PLACE WHERE THE AUDIT IS TO BE CONDUCTED

IDENTIFICATION OF THE ORGANIZATIONAL UNITS TO BE UNITED

THE EXPECTED TIME AND DURATION FOR EACH MAYOR AUDIT ACTIVITY

CONFIFENTIALITY REQUIREMENTS

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QUALITY AUDITING PLAN


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IT SHOULD CONTAIN THE

The Scope And Objectives Of The AuditDetails Of The Audit Plan, The Identification Of

Audit Team Members, Dates, Identification Of TheSpecific Organization Audited

AUDIT REPORT

IT SHOULD BE DATED AND SIGNED BY THE LEAD AUDITOR

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QUALITY AUDITING REPORT


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IDENTIFICATION ON THE REFERENCE DOCUMENTS AGAINST WHITH THE AUDIT

WAS CONDUCTED (QUALITY SYSTEM STANDARD, ETC)

OBSERVATION OF NONCONFORMITIES

THE SYSTEMS ABILITY TO ACHIEVE DEFINED QUALITY OBJECTIVES

THE AUDIT REPORT DISTRIBUTION LIST

ANY COMMUNICATION MADE BETWEEN THE TIME OF THE CLOSING MEETING AND

THE ISSUE OF THE REPORT SHOULD BE BY THE LEAD AUDITOR

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QUALITY AUDITING REPORT


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The internal audit system should be well qualified to

perform risk assessments and promote continous

improvement of controls

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QUALITY AUDITNG


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quality auditing

Documents