Iqa to Iso9000-2000 New 13 June 01

8/14/2019 Iqa to Iso9000-2000 New 13 June 01

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IQA

TOI

SO90

00:2000

Internal Quality Auditingto

ISO 9000:2000

Pakistan Institute of Quality Control


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IQA

TOI

SO90

00:2000

Principles of Auditing

Audit Terms and Definitions

CONTENTSCONTENTS

1

5

4

ISO 9000 New Family of Standards

2

3

Whats New in ISO 9000:2000 (Outline)

ISO 9001:2000 New/Modified RequirementsIS O

9 0 0 0 :20 0 0

AUD

ITING

Competence of Auditors6

Managing an Audit Program7


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IQA

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SO90

00:2000

ISO 9000 NEW FAMILY OFISO 9000 NEW FAMILY OF

STANDARDSSTANDARDS

1


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I : Fam y oStandards

CORE STANDARDSCORE STANDARDS

ISO 9000:2000 Fundamentals and Vocabulary

ISO 9001:2000 QMS Requirements

ISO 9004:2000 Guidelines for Performance Improvement

SUPPORTING STANDARDSSUPPORTING STANDARDS

ISO 10005:1995 Guidelines for Quality Plans

ISO 10006:1997 Guidelines for Project Management

ISO 10007:1995 Guidelines for Configuration Mgt ISO 10011-1, -2, -3 on Auditing

ISO 10012-1 & -2, Quality Assurance for Measuring

Eqpt.

ISO 10013:1995 Guidelines for Quality manuals


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ISO/TR 10014:1998 Guidelines for managing economics

of quality

ISO 10015 Guidelines for Training

ISO/TR 10017:1999 Guidelines on Statistical techniques


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I

QA

TOI

SO90

00:2000

WHATS NEW INWHATS NEW IN

ISO 9000:2000ISO 9000:2000Compared to ISOCompared to ISO

9000:19949000:1994

2


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ISO 9000:2000 vs 9000:1994

Cancels and replaces second edition of 1994

revised title which no more uses the term QA, instead

just QMS (QA + Customer Satisfaction)

Released on 15 Dec 2000

up-graded in contents, effectiveness, and logical

implementation

9000- and 9004- series guidelines eliminated and 9004

to serve as a general purpose guidelines

Many guidelines available in the form of TR (Technical

Reports)

compatibility with ISO 14001


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Scope (modified): to demonstrate its ability to provide

consistently product that meets customer

and applicable regulatory requirements, and to address customer satisfaction through

the effective application of the system,

including processes for continual

improvement and the prevention of

nonconformity


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ISO 9001, 9002, & 9003 merged into a

single 9001:2000 ISO 8402 and ISO 9000-1 merged into a

new ISO 9000:2000 ISO 10011 will be merged with ISO 14010

into a new ISO 19001 Quality &

Environmental Auditing

3 years for co-existence


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Whats New?

1. The Standard

2. The Structure

3. The Definitions

4. The Emphasis

5. The Requirements

6. The Flexibility

7. The Approach


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ISO 9002 and 9003 dropped

ISO 9001 modified

1. New Standard1. New Standard

20 clauses abandoned

Now 5 sections

2. New Structure2. New Structure


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Supplier: Vendors, subcontractors, etc.

Organization: The company implementing QMS

Product Realization:

The interconnected processes

that are used to bring products into being. When you start

out with an idea and end up with a product, youve gone

through the process of product realization

3. New Definitions3. New Definitions

Customer Focused

Continual Improvement

Integration of Processes with the QMS

4. New Emphasis4. New Emphasis


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1. Communication with customers

2. Identify customer needs and expectations

3. Meet customer needs and expectations

4. Measure and monitor customer needs and expectations5. Meet legal and regulatory requirements

6. Internal Communication

7. Provide necessary facilities and work environment

8. Evaluate the effectiveness of training

9. Measure and monitor realization processes

10.Evaluate the effectiveness and suitability of quality system

11.Identify QMS improvements

12.Improve QMS regularly

5. New Requirements5. New Requirements


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1. Permissible Exclusions from Section 7 if

a. it doesnt apply

b. customers requirements make it reasonable to exclude

c. regulatory requirements make it reasonable to exclude

However, no part can be excluded, if doing so will undermine the

organizations abilities or performance

6. New Flexibility6. New Flexibility


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PROCESS APPROACH TO QMS

QMS can now be considered as a single large process with many sub-processes. Each of these sub-processes uses inputs and outputs.

These are:

1. Resource Management Process 10. Internal Communication Process

2. Regulatory Research Process 11. Document ControlProcess

3. Market Research Process 12. Record Keeping Process

4. Product Design Process 13. Planning Process

5. Purchasing Process 14. Training Process6. Service Process 15. Internal Audit Process

7. Product Protection Process 16. Management Review Process

8. Customer Needs Assessment Process 17. Measurement Processes

9. Customer Communication Process 18. Nonconformance Mgt

19. Continual Improvement P.

7. New Approach7. New Approach


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QA

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ISO 9001:2000ISO 9001:2000

NEW/MODIFIEDNEW/MODIFIEDREQUIREMENTSREQUIREMENTS

3


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Process Approach Model

ManagementManagement

responsibilityresponsibility

Measurement,Measurement,

analysis andanalysis and

improvementimprovement

ResourceResource

managementmanagement

ProductProduct

realizationrealizationOutputInput

ProductProduct

CONTINUAL IMPROVEMENT OF THEQUALITY MANAGEMENT SYSTEM

C

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Contents

Scope 1.1 General

1.2 Application

1

Terms and Definitions3

Normative Reference2


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Contents (cont.)

Quality Management

System 4.1 General Requirements4.2 Documentation Requirements

4

Management

Responsibility5.1 Management Commitment

5.2 Customer focus

5.3 Quality Policy

5.4 Planning

5.5 Responsibility, authority and communication5.6 Management Review

5

Resource Management 6.1 Provision of resources6.2 Human resources

6.3 Infrastructure

6.4 Work environment

6

Product Realization7.1 Planning of product realization

7.2 Customer-related processes

7.3 Design and development

7.4 Purchasing

7.5 Production and service provision

7.6 Control of monitoring and measuring devices

7


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Contents (cont.)

Measurement, Analysisand Improvement 8.1 General8.2 Monitoring and measurement

8.3 Control of nonconforming product

8.4 Analysis of data

8.5 Improvement

8


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1. Scope (applicability)

Product meets customer and applicable regulatory

requirements

to enhance customer satisfaction, including continual

improvement of the system and assurance of conformity to

customer and applicable regulatory requirements

1.1 General1.1 General


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Generic requirements; applicable

to all organizations, regardless of

type, size and product provided

exclusion can be considered if

certain requirements not applicable

Exclusion only allowed from

Clause 7

1.2 Application1.2 Application


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2. Normative Reference

ISO 9000:2000 Fundamentals and vocabulary

(ISO 8402 is now obsolete)


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Terms and definitions

As given in ISO 9000

Product also means services

supply chain

supplierorganization

customer

4 1 ua ty Management


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4.1 ua ty ManagementSystem

INTEGRATION?


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4.1 Quality Management System

Fully

Integrated!

4 Documentat on


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4. Documentat onRequirements

Documented statements of a

quality policy and quality

objectives

a quality manual documented procedures required

by ISO 9000:2000

documents needed by the

organization to ensure theeffective planning, operation and

control of its processes, and

quality records required by this

standard

4.2.1 General4.2.1 General

Documentat on tructure


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Documentat on tructure(Example)

QUALITYQUALITY

MANUALMANUAL(SUMMARY)

RelevantRecords

Relevant

Records

RelevantRecords

Relevant

RecordsRelevantRecords

Applicable

Clauses

Dept B

Procedures

ApplicableClauses

Dept CProcedures

ApplicableClauses

Dept DProcedures

ApplicableClauses

Dept EProcedures

Supporting Documents

e.g. standards, Manuals, GMPs

ApplicableClauses

Dept AProcedures

What How


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Exercise

What are the applicable Quality Processes

(sections/sub-sections) in Production Dept.?

What are the applicable Quality Processes(sections/sub-sections) in Purchasing Dept.?


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Top management shall ensure

that customer requirements are

determined and fulfilled with the

aim of enhancing customersatisfaction (7.2.1 and 8.2.1)

Examples

Customer needs

identification

procedure?

(e.g. surveys, focus

groups, contracts)

Top management

verification (through

1st, 2nd, 3rd party

tests etc., that such

requirements are

fulfilled

5.2 Customer Focus5.2 Customer Focus


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Top management shall ensure that the

quality policy:

is appropriate to the purpose of the

organization

includes a commitment to comply with

the requirements and continually

improve the effectiveness of the QMS

provides a framework for establishing

and reviewing quality objectives communicated and understood in the

organization

is reviewed for continuing suitability

What broad Quality aspects

should be Covered in the

Quality Policy?

1. Fulfillment of Customer

needs2. Fulfillment of applicable

national laws and

regulations

3. Minimization of

waste,errors andnonconforming

4. Continual improvement

5. Employees quality and

organizational culture

5.3 Quality Policy5.3 Quality Policy


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Quality Objectives:

are established at relevant functions

and levels, and are measurable and

consistent with the quality policy QMS Planning:

Each applicable process/dept. is

addressed under the PDCA model;

planning at changes is carried out

What does Quality

objectives for each

function means?

What does Quality

objectives for each

level means?

5.4 Planning5.4 Planning


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Responsibility and Authority:

defined and communicated within

the organization

Management Representative:appoint a QMS Coordination role to a

management member

ensure QMS is established,

implemented and maintained

report the performance and the

need for improvement

promote awareness

liaison with external parties

Examples

Job Descriptions

QMRs clear role

5.5 Responsibility, Authority and Communication5.5 Responsibility, Authority and Communication


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Internal Communication:

ensure effective communication

regarding the effectiveness of the

QMS

Examples

Team briefing and

meetings

notice boards newsletter

intranet

employees surveys


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5.6 Management Review5.6 Management Review

ManagementManagement

ReviewsReviews

QUALITY REPORToveringAudit resultsCustomer feedbackprocess performanceproduct conformity

C/P Actionfollow-upschanges / follow-upsrecommendationsor improvements

Improvements in Q

Improvements inProducts/Processe

Resource Needs

OUTPUTSOUTPUTS

INPUTSINPUTSQUALITYQUALITY

PROCESSPROCESS


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6.2 Human Resources

6.2.1 General6.2.1 General

Right person for the right jobRight person for the right job

qualified managers?

qualified supervisors?

appropriate workers?

Qualified /Qualified /

Appropriate meansAppropriate means

1. Education1. Education

2. Training2. Training3. Skills3. Skills

4. Experience4. Experience


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Provide necessary infrastructure

for the QA program, e.g.

building, workspace, utilities process equipment (hardware/

software)

supporting services, e.g. transport,

communication,

6.3 Infrastructure6.3 InfrastructureExamples

suitable machines,

workspaces,

software, hardware,

information


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The organization shall determine

and manage the work

environment needed to achieve

conformity to productrequirements

Examples

work space

heat, humidity, lightairflow,

hygiene, cleanliness,

noise, vibration and

pollution, etc.

6.4 Work Environment6.4 Work Environment


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7. Product Realization

7.1Planning 7.2

Customer

RelatedProcesses

7.3

Design &Development

7.5Production &

ServiceProvision 7.4

Purchasing

7.6Monitoring &

MeasuringDevices PRODUCT

REALIZATION

7 1 Planning of Product


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7.1 Planning of ProductRealization

Quality objectives and

requirements for the product

establish processes, documents,

and provide resources specific tothe product

required verification, validation,

monitoring, inspection and test

activities specific to the productand the criteria for product

acceptance

identification of relevant records

Product Quality

Plans?

Guidance ISO 10005


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7.2 Customer-related Processes

Determine:

customers requirements

unstated but necessary requirements

statutory and regulatory product reqt any additional requirement

determined by the organization

7.2.1 Determination of requirements related to the Product7.2.1 Determination of requirements related to the ProductExamples

contracts

customer surveys,

focus groups applicable national

regulations


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review contract before acceptance

ensure product reqts are defined

resolve issues before acceptance

confirm organization capability

maintain records

ensure amendments properly

Examples

Contract review

review of results of

surveys and focusgroups, etc.

7.2.2 Review of requirements related to the Product7.2.2 Review of requirements related to the Product


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Make effective arrangements for

communicating with customers in

relation to:

product information inquiries, contracts or order handling,

including amendments, and

customer feedback, including

customer complaints

Examples

printing of product

information on

packaging

internet

catalogs and service

manuals, etc.

7.2.3 Customer Communication7.2.3 Customer Communication


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7.4 Purchasing

PURCHASINGURCHASINGPurch

asin

gP

rocess

PurchasingInform

ation

Verification of

Purchased Product

7 5 Production and Service


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7.5 Production and ServiceProvision

7.5.1Control of

Production &Service

Provision

7.5.2

Validation ofProcesses

7.5.6

Control ofMonitoring and

MeasuringDevices

7.5.4CustomerProperty

7.5.5Preservation

of Product

7.5.3Identificationand

Traceability

8. Measurement, Analysis and


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8. Measurement, Analysis andImprovement

8.38.3Control ofControl of

non-conformingnon-conforming

productproduct

8.58.5ImprovementImprovement

8.28.2Monitoring &Monitoring&MeasurementMeasurement

8.48.4

AnalysisofAnalysisof

DataData

8.18.1

GeneralGeneral

8 Measurement Analysis and


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8 Measurement, Analysis andImprovement

Ensure conformity of the product

ensure conformity of the QMS

ensure effectiveness and

continually improving the QMS

This section is about

Quality Control (QC)

Conformity to customer

needs, contracts, and

national regulation must

be ensured before

product is dispatched

Validation of measuring

procedures

Regularly up-grade

accuracy and

effectiveness of QC

8.1 General8.1 General

8 Measurement, Analysis and


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Customer Satisfaction

device a method to measure and

monitor customer satisfaction from

customer perception point of view

Internal Audit

regularly carry out internal audit to

check conformity and

effectiveness of the QMS

design an effective audit program

and plan, criteria

competent auditors

audit results and records

follow-ups and timely C/A

Examples of CS: Direct interfaces

focus groups

surveys

sector and industry

studies

Examples of IA:

Main objective is to

check the correctness

and performance offunctions and

processes; not

documentation of

processes

8.2 Monitoring and Measurement8.2 Monitoring and Measurement



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Processes

apply suitable monitoring of

processes where required

C/A when deviation occurs

Products

measure product characteristics to

confirm fulfillment of quality

at appropriate stages in accordance

with the quality plans

define acceptance criteria

authorize release and records

8.2 Monitoring and Measurement8.2 Monitoring and Measurement Examples

use of SPC,

especially control

charts

monitoring and

supervision of

process parameters

daily morning reviews

of quality by workers

and their supervisors

Appropriate product

measurement scheme



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Determine, collect and analyze

appropriate data from

measurement sources to check

conformance and analysis forimprovement in:

customer satisfaction

product conformance

process

suppliers

8.4 Analysis of Data8.4 Analysis of Data Analysis is not

compiling of data

Analysis is after

compiling of quality

data

Analysis is part of

Quality Report

Sources of data?



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Continual Improvement

identify opportunities of improvement

from quality policy, objectives, audit

results, analysis of data, C/P actions,

and management reviews

mobilize improvement programs

8.5 Improvement8.5 Improvement Clear evidence of

improvement

processes

Clear evidence of

improvements



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Corrective Action

take timely action to eliminate the

cause of nonconformities.

Review nonconformities determine causes

evaluate

determine and implement action

records of results

review and confirm results

8.5 Improvement8.5 Improvement What is the

difference between

Correction,

Corrective Action

and PreventiveAction?

Corrective Action

Form

Control of Corrective

Actions



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Preventive Action

determine potential nonconformities

current mistakes and future planning

determine their causes device actions

implement actions

record results

review action taken

8.5 Improvement8.5 Improvement Outputs of

management

reviews or corrective

actions


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IQA

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ISO90

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Audit Terms andAudit Terms and

DefinitionsDefinitions

Ref: ISO/CD.3 19011Ref: ISO/CD.3 19011

4


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Audit: systematic, independent and documented

process for obtaining audit evidence and evaluating it

objectively to determine the extent to which audit

criteria are fulfilled

Audit Criteria: set of policies, procedures or

requirements used as a reference

Audit Evidence: records, statements of fact orother information, relevant to the audit criteria and

which are verifiable (can be quantitative or qualitative)


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Audit Finding(s): result(s) of the evaluation of

the collected audit evidence against audit criteria

Audit Conclusion(s): outcome of an audit,reached by the audit team after consideration of the

audit objectives and all audit findings

Auditee: organization being audited

Auditor: person with the competence to conduct

an audit


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Audit Team: one or more auditors conducting an

audit (one being appointed as audit team leader)

Technical Expert: person who provides specificknowledge or expertise with respect to the subject

to be audited

Audit Program: set of one or more auditsplanned for a specific time frame and directed

toward a specific purpose


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Audit Plan: description of the on-site activities

and arrangements for an audit

Audit Scope: extent and boundaries of an audit(typically includes a description of physical

locations, organizational units, activities and

processes, as well as the time period covered

Competence: demonstrated capability to apply

knowledge and skills


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IQA

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Principles of AuditingPrinciples of Auditing

Ref: ISO/CD.3 19011Ref: ISO/CD.3 19011

5

Five Principles of Auditing


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Five Principles of Auditing

Ethical Conductthe foundation of professionalism1

Fair Presentationthe obligation to report truthfully and accurately2

Due Professional Careapplication of reasonable care in auditing3

Independence

impartiality and objectivity of the audit conclusion

4Evidencethe rational basis for reaching audit conclusions5

Trust, integrity,confidentiality, discretion

Free from bias and

conflict of interest

Priorities of stakeholders

necessary competence

Accurate and complete

Proper sampling

verifiable


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Elements of Competence


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Elements of Competence

Personal

Attributes

AuditExperience

Work

Experience

Auditor

Training

Education


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There should be an evaluation process that should

first be used for initial evaluation of a person who

wishes to become an auditor

Even in case where he/she doesnt, thedevelopment process of an auditor should be

clearly defined to ensure a sound and professional

function in the organization

Providing competent auditors is only the first steptowards ensuring the reliability of the audit process


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Auditors Personal Attributes


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Auditor s Personal Attributes

Mature

unbiased and fair

ethical

open minded

diplomatic

observant

decisive self-reliant


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Managing An AuditManaging An AuditProgramProgram

7

What is being Audited ?


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What is being Audited ?

Machinery

Facilities Procedures

People

ProcessesProduct

?


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How t e extent o an au tvary?


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vary?

Large TextileSpinning

1000 persons4 processes

Dental Clinic3 person

Many ComplexTreatmentProcesses

AutomobilePlant

400 person3 5 processes

Scope ?Objective?Duration?Expertise?Frequency of Audit?Complexity of Product and Processes?Legal Requirements?

Standards?Audit Criteria?Social Environment?Educational Environment?

What resources are required todit?


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audit?

Large Textile

Spinning1000 persons4 processes

Dental Clinic3 person

Many ComplexTreatmentProcesses

Automobile

Plant400 person

3 5 processes

Number of Auditor(s)?Competence of Auditor(s)?Technical Expertise?Duration?Administration?

Documentation?Stationary?

Can you identify companysP d t / i ?


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Product /services?

Shoe company Pharmacy Hospital Airline

University Primary School Insurance Company


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D scuss on Exerc se - ProcessModel


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Model

You are auditing a purchase dept. that buys

material for the company. How would you apply the

QMS Process Model on the activities of the

department? Identify the sequence of your checkpoints / from the requirements of ISO 9000:2000.

A dit P


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Audit Process

Initiating the Audit1 Definition of scope, objective andcriteria

Establish audit team and contacts

Document Review2 Review the documents of the QMS andestablish their completeness and correcness (relevance to their processes)

Site AuditPreparation3

.

Planning Team assignments Preparing working documents

A dit P ( t )


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Audit Process (cont.)

Site Audit4.

Opening Meeting Verification Process (collecting and

verifying information), audit findings,communicating findings, closing meeting

Audit Reporting5 audit report preparation report review, approval and distribution retention of documents

Audit Completion

6

confirmation of completion as per theaudit plan

Audit Follow-up7 Verification of Corrective, Preventiveand/or Improvement Action

Key Points of the Audit Process


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Key Points of the Audit Process

Audit Objectives, scope, and criteriaAudit Objectives, scope, and criteria

to be defined by the auditee

Objectives: compliance to all applicable ISO 9001 QMS

requirements, legal obligations (illegality) for product

conformity, contractual obligations to clients, and

consumer protection (in general)

scope: boundaries of audit, I.e. location, organizational

units, activities and processes to be audited

criteria: applicable policies, procedures, standards, laws,QMS requirements, contractual requirements, industry

codes,

Audit Teams Requirement


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Audit Team s Requirement

GENERAL

independence, process familiarity, mature personality,

good communicator and analyzer, motivated, physically fit,

socially disciplined, free from conflict of interest, honest,

capable to write objective audit findings/reports, not

submissive, and interactive

APPROPRIATE COMPETENCE

relevant technical expertise or take assistance of technicalexperts with appropriate technical knowledge, skills and

experience.

Auditees Right on acceptabilityf A dit


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of Auditors

Both the audit client and auditee have a right to

request the replacement of particular team

members on reasonable grounds, which should be

communicated to those responsible for managingthe audit program.

Examples of reasonable grounds can be conflict of

interest situation (formal employees, consultant),

unethical behavior, lacking appropriate professional

background of the audit team, non-professional

behavior (e.g. violating confidentiality), etc.

Document Review


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Document Review

A necessary step before site audit

Should be reviewed in light of audit objectives,

scope and criteria

A preliminary on-site visit may be necessary to beable to carry out the document review

Document Review should be done very carefully,

and is most effectively done with the support of

relevant records.

Planning for On-Site Audit


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Planning for On Site Audit

Parameters of plan: auditor(s), departments /

sections, time (usually hours), applicable QMS

processes (clauses), applicable criteria (standards,

legal, contractual, etc.), locations / sites, logistics,language limitations, technical expertise (doctors,

computer specialists, pharmacists, architecture,

etc.)

Working Documents


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Working Documents

Audit procedure

audit checklist(s)

sampling plan

forms / papers for recording information andsupporting evidence

NCR forms

On-Site Activities


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On Site Activities

Opening Meeting

Investigation

Observation

Interviews confirmations

Communication

Audit Findings

Closing Meeting

Opening Meeting


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Opening Meeting

Establish an Audit Environment and

Communication links with the management

Inform about the audit plan and methodology

confirm the audit criteria (contractual, legal,industrial, and companys obligations and

standards)

confirm the sampling plan (number of samples to

be used in the width and depth of audit) confirmation of relevant work safety, emergency

and security procedures for the audit team


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(cont.)


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( )

Interviews:

relevant people must be interviewed directly at all levels

auditor should go to the relevant people to interview; they

should not be called to answer the auditor

tone must be respectful and genuine

objective of interview must be clarified to the interviewee

Types of questions: Open-ended, Closed-ended, Leading-

questions, Personal -questions, Interrogative-questions,

taunting-questions. Certain types must be avoided. The results from the interview should be summarized and

reviewed with the interviewed person

End must be with thanks

Exercise


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Break the group into teams

Suppose you are auditing the (activity to be given

by the course facilitator)

Prepare an audit program keeping in view therequirement of relevant sections of the ISO-9001-

2000 and the objectives of the audit (intent,

efficiency and effectiveness)

Present in the plenary session

(A)

(cont.)


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( )

Observations and Confirmations

actual products

actual processes (operators, skill levels, equipment,

material)

actual operators

actual environment

actual records

external documents (customers, vendors, legal, and

referenced standards) computerized data bases

effectiveness of procedures

(B)

Audit Findings


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g

Auditors should review all facts and the overallsituation

Conformities should be summarized to at least

indicate locations, functions, processes, or

requirements that were audited, where nononconformities were observed

Nonconformities should be recorded and supported

by audit evidence. It should be reviewed by the

auditee to ensure accuracy and understanding. Difference of opinions should be resolved before

finalizing

Nonconformity Statement -a critical output of an Auditor


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a critical output of an Auditor

Few auditors write accurate, clear, and complete

statements of non-conformity

Example of a good non-conformity statement

One of the voltmeters, number 389000, used for

the testing of generators at the final test bench of

the main assembly shop was not calibrated, as

required by the Quality Procedure No.

QSP4.11/2000. All test equipment which affect

product quality shall be calibrated to ensure

accuracy of results

(cont.)


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Poor way of writing NC statements:

Rewrite the statements as audit findings and

discuss in the plenary session: quality objectives were not defined test equipment was not calibrated

there were no training programs

identifications were missing

the procedure for SPC was wrong

(cont.)


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Statements blaming to wrong people !

An operator was repairing the machine with wrong

methodOR

The operator was not properly trained to repair the

machines

who is to be blamed in the same incident above?

Prepar ng or t e os ngMeeting


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g

Review the overall audit findings

Prepare the list of audit findings

reach consensus on the audit conclusions

agree on the roles and tasks for the closingmeetings (for more than one auditors)

prepare recommendations

discuss subsequent audit follow-up

Closing Meeting


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g g

Present overall conclusion and findings. Address

your summary of Conformity and Non-conformity,

both.

Present non-conformities in order of priority (frommore important findings to less important)

Provide direction to management on Corrective,

Preventive and Improvement actions. It is auditee's

responsibility to identify C/A or P/A; however theynormally do not understand the difference.

Confirm follow-up audit

Auditor-Auditee Roles


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AuditAudit

ReportApprove

C/A

TakeC/A

Identify

Rootcause &Suggest

C/A

Verify

C/A

Improve-

ment

AUDITO

R

AUDI

TEE

Audit Report


96/102

Should provide a complete, accurate, concise and

clear record of the audit and should contain audit

conclusions on the following issues:

extent of conformance of the management system to theaudit criteria

effective implementation and maintenance of the

management system, and

the ability of management review process to ensure the

continuing suitability, adequacy, and effectiveness of themanagement system

Contents of Audit Report


97/102

The second/third party reports are formal, whereas,

first party audit can be less comprehensive and

may include just nonconformance reporting.

Audit Follow-up


98/102

Focus should be on whether the auditee has goneinto the root cause of the nonconformance, and

whether solution provided by the auditee eliminate

the root cause(s)

Auditee tend to neglect timely corrective actions.Therefore, auditor should ensure timely corrective

actions. Appropriate time should be ensured, as

most often daily or weekly solutions are projected

into monthly tasks. Just recorded answers to solutions are not

sufficient. Physical verification of effectiveness of

the solution is necessary

Audit Completion


99/102

An audit is completed when all activities in the audit

plan have been finalized and the approved audit

report has been distributed

Normal Problems in Audits


100/102

Lack of Product Orientation Lack of Process Orientation

Non-technical audits in technical areas

Incomplete audits

depth

width

Final Words ...


101/102

Audits driven by professional programs can be highly

valuable in improving the Quality of organizations. On

the other hand, if conducted unprofessionally, the same

can be damaging Auditors and audit programs should also be subject to

checking and improvements

Progressive development of auditors is generally

neglected, resulting in poor value Technical competence and personal attributes are both

important parts of the auditors

Announced audits can be mixed with unannounced ones


102/102

QA

TO

ISO9

000:200

0

THE ENDTHE END