pra sent

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Quality Management System

Introduction to Auditing

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Quality System Audit

Effectiveness of an organisations Quality

Management System is assessed

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Why Audit

Required by the standard

Determine quality system effectiveness

Identify existing nonconformities

Highlight areas of strength

Point out areas for improvement Indicate requirements for corrective and /or

preventive action

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Management System

Management System:

to establish objectives and to achieve those

objectives

Quality Management System:

to direct and control an organisation with

regard to quality System:

set of interrelated or interacting elements

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The process of assessment has to be

OBJECTIVE

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Assessment is a comparison of implemented

Quality System with Quality System

Standards like ISO 9000

However results depend on Auditor

hence this training

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What is sought by Auditor

Established Policy and Objectives

Developed appropriate systems

Necessary documentation of the system Effective implementation of those systems

Since we can never expect absolute

perfection the auditor can only assess

The Degree of Compliance

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Quality System Standards

Lay down principles that requireinterpretation

The auditor must have very strong

understanding of principles to be able toassess whether the standard has been

understood

interpretedand can demonstrate adequate control

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Questions in an auditors mind

Is the system right and sufficient?

Does the organisation do the right things to

adequately control quality of products?

Does the organisation do things properly all

the time?

What is the evidence that things are done

correctly?

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Nagging questions

What is adequate?

When is a thing properly done?

How much evidence is required?

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Auditor

Needs to judge whether an organisation hasarrived at a sensible and acceptable

interpretation of the standard; therefore he

must

study the standard to improve understanding

objective of the system is that quality must be

consistently achieved

consider possible consequences of somethinggoing wrong due to inadequacy

take account of others opinion

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Auditor

Looks for:

established policies and objectives

developed appropriate systems

documentation to ensure adequate control

effective implementation of the system

Since we can never expect absolute perfection,

the auditor can only assess

THE DEGEREE OF COMPLIANCE

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Quality Audit

Systematic, independent and documentedprocess for obtaining evidence and

evaluating it objectively to determine the

extent to which the audit criteria is fulfilled

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Types of Audit

Internal Audit

External Audit

Third Party Audit

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Auditor Competence

Auditors demonstrated capability to apply

knowledge and skills

based on education

experience

training

Qualification process:

process to demonstrate the ability to fulfil specified

requirements (in this case the auditors qualification)

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Audit conventions

Audits create stress. Uncertainty amplifies

stress

Act predictably

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Why conventions?

To reduce stress

To have clear methods of audits

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Audit conventions

Start at the top

Audit must be planned

Examination/Evaluation

Reports

Follow up action

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Types of audit

Process

Product

Quality System

Compliance

Health & Safety

Environmental

Financial

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ISO 9000:2000 - AUDITOR

TRAINING

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Quality Management

PrincipleComprehensive and fundamental rule or

belief, for leading and operating an

organisation, aimed at continuallyimproving performance over the long

term by focusing on customers while

addressing the needs of all otherstakeholders

ISO/TC176/WG15

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Quality Management Principles

Customer-Focused Organisation

Leadership

Involvement of People Process Approach

System Approach by Management

Continual Improvement

Factual approach to decision making

Mutually beneficial supplier relationships

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Customer - Focused Organisation

Understanding customer needs and

expectations

Communicating these needs andexpectations throughout the organisation

Measuring customer satisfaction and acting

on results

Managing customer relationships

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Leadership

Being proactive & leading by example Establishing a clear vision of the

organisations future

Providing people with required resourcesand freedom to act with responsibility and

accountability

Promoting open and honest communication Educating, training and coaching people

Setting challenging goals and targets

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Involvement of People

Accept ownership and responsibility to solve problems

Actively seek opportunities to make improvements

Actively seek opportunities to enhance their

competencies,knowledge and experience Freely share knowledge and experience in teams and

groups

Focus on creation of value for customers Better represent the organisation to customers

Derive satisfaction from their work

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Process Approach

Define Processes needed to achieve desired results

Identify & Measure Inputs & Outputs

Identify interfaces

Evaluate risk, consequence and impact on

customers

Establish responsibility authority and

accountability for managing processes Consider methods, training, resources etc to

achieve desired result

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System Approach

Define & Develop processes

Structure the System in most efficient way

Understand interdependencies of processes

in the system

Continually improve through measurement

and evaluation

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Products,Processes & Systems

Incremental & Breakthrough Concepts

Periodic Assessment against established Criteria

Efficiency & Effectiveness of processes

Promote prevention-based activities

Provide training on continual improvement tools

Establish measure & goals to guide & track

improvements

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Continual improvement

Quality

Management

Systemsupport to

achieve the

objectives

Act

Plan

Check

Do

Achieve

objectives

Moving

target

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Continual improvement

Analysing and evaluating the existing situation toidentify areas for improvement;

Establish the objectives for improvement;

Searching for possible solutions to achieve the

objectives;

Evaluating these solutions and making a selection

Implementing the selected solution;

Measuring, verifying, analysing and evaluatingresults of the implementation to determine that the

objectives have been met;

Formalising changes.

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Factual Approach to Decision-

Making Measuring & Collecting Data &

Information

Ensure accurate, reliable & accessible

Analyse data and information

Understand value of Statistical Techniques

Make Decisions and Take Actions on

results of analysis

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Mutually Beneficial Supplier

Relationships

Identify and Select key suppliers

Establish relationships that balance short term

gains with long-term considerations Create clear and open communications

Initiate joint development and improvement of

products and processes

Establish joint understanding of customer needs

Share information and future plans

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Introductory Sections

Scope

Normative Reference

Terms Definitions

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Who Survives?

ISO 9001 9002 9003

ISO 9004 9004-1 9004-2

Adopted from ISO14001:

Statutory & regulatory requirements

Commitment, awareness

Communication


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2000 Family

ISO 9000: Fundamentals Vocabulary(normative)

ISO 9001: Requirements

ISO 9004 Guidelines for Performance

Improvement

ISO 19011: Guidelines for Auditing

management Systems

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Terminology (ISO 9000)

Quality

Ability of a set of inherent characteristics of a

product, system or process to fulfilrequirements of customers and other

interested parties

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Requirement

need or expectation that is stated,

customarily implied or obligatory

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Quality Requirement

Requirement for

inherent characteristics of a product,

process or system

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Inherent Characteristic is part of the product

e.g. diameter of bolt

Assigned Characteristic (e.g. price of

product) is not and inherent characteristic

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Quality Improvement

part of quality management,

focused on increasingeffectiveness and efficiency

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Quality Objective

something sought, or aimed for,

related to quality

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1994 2000

Customer Customer

Supplier Organisation

Subcontractor Supplier

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Procedure

Specified way to carry out an

activity or a process

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Document

Information and its support

medium

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The Charges - General

ISO9001:1994

20 elements

ISO9001:2000


Management Responsibility Resource

Management Product Realization

Measurement, Analysis & Improvement

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4.1 QMS General Requirements

Establish, document, implement, maintain

and continually improve the effectiveness of

a quality management system

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Establishing the System

Determine processes needed sequence and interaction

criteria and methods for operation and

control

information available for operation and

monitoring

measure, monitor, and analyse

implement action to achieve planned results

and continual improvement

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4.2 General Documentation

Requirements

QMS shall include:

documented quality policy and objective

documented quality manual

documented procedures required by 9001

documented required by the organisation to

ensure effective planning operation and controlof processes

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Types of Documents

Quality Policy and Objective

Quality Manual

Scope of System(incl. exclusions)

Procedures or Reference to them

Description of sequence/interaction of

processes

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Types of Documents

Quality Manuals

information, both internally and externally, about the

organizations quality management system

Quality Plans

how the quality management system is applied to a specific

product, project or contract

Procedures

how to perform activities Records

objective evidence of activities performed or results

achieved

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Extent of Documentation

Size of the organisation and type of activity complexity and interaction of processes

competence of personnel

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Control of Documents

Approve, Review, Update

Identify Current Revision Status and

changes

Ensure availability,

Legible Identifiable, Reirlevable

Control External Documents

Control Obsolete Documents

Records are a special type of document

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Control of Quality Records

To provide evidence of conformity to

requirements and system

Legible, identifiable retrievable

Retention time specified

Disposition specified

Requires a documented procedure

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5.1 Management Commitment

Demonstrate Commitment to DevelopmentImplementation & Continually Improving

the effectiveness of System (Including

statutory and regulatory requirements) Communicating Importance of Meeting

Customer Requirements

Establishing Quality Policy & Objectives Conducting Management Reviews

Providing Necessary Resources

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5.2 Customer Focus

Requirements(replaces needs and

expectations)

Aim of enhancing Customer

Satisfaction

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5.3 Quality Policy

Appropriate to purpose for organisation

Commitment to Continually Improve theeffectiveness of the system

Framework for setting and reviewing

Quality Objectives

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5.4 Planning

5.4.1 Quality Objectives

Measurable

Consistent with Policy

The objectives include those needed to meet

requirements for product

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5.4 Planning

5.4.2 Quality Planning

Processes of the System

Resources needed


Change management

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5.5 Responsibility, Authority and

Communication

5.5.1 Responsibility & Authorities

Top Management define and communicate

Responsibilities, Authorities &

Interrelations

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5.5 Responsibility, Authority and

Communication 5.5.2 Management Representative

Only one member of management

Processes Established implemented &

Maintained

Report to Top Management

Promote Awareness of Customer

Requirements

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5.5 Responsibility,Authority and

Communication

5.5.3 Internal Communications

Top management shall ensure

communication between various levels and

functions regarding effectiveness of system

5 6 M t R i (I t )

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5.6 Management Review (Inputs)

Current Performance and ImprovementOpportunities

Audit Results

Customer Feedback Process/Product Conformance

Preventive/Corrective Actions

Actions from previous reviews Planned changes

Recommendations for improvement

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5.6 Management Review

(Outputs)

Actions related to:

improvement of the QMS and its processes, Improvement of product related to customer

requirements,

resource needs

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6.1 Resource Management

Determine & Provide in Timely Manner toImplement, Maintain & Continually Improve

Processes

Enhance Customer Satisfaction

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6.3 Infrastructure

Determine, provide & Maintain

Buildings, Workspace and Utilities

Equipment, hardware & software

Supporting Services (transport orcommunication)

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6.3 Work Environment

Identify & Maintain conditions to achieve

conformity of product

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7. Product Realization

7.1 Planning of Realization Processes Quality Objectives

Processes, Documentation, Resources

Facilities Verification/Validation and Criteria for

Acceptance

Records Planning should be suitable for

organisation,s operations

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7.2 Customer Related Processes

Identify Requirements

Review Requirements not stated but

necessary

Any other requirement of organisation

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7.2.2 Review of Requirement

Tenders and Contracts

Requirements defined

Anomalies resolved

Ability confirmed

Amendments controlled Internet sales addressed

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7.2.3 Customer Communication

Product information

enquiries, contracts or order handing,

including amendments;

customer feedback, including customercomplaints

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7.3 Design and/or Development

7.3.1 Planning 7.3.5 Verification

7.3.2 Inputs 7.3.6 Validation 7.3.3 Outputs 7.3.7 Changes

7.3.4 Review

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7.4 Purchasing

7.4.1 Purchasing Control 7.4.2 Purchasing Information

7.4.3 Verification of Purchased Product

7 5 P d i d S i

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7.5 Production and Service

Provision 7.5.1 Control of production and service provision

Availability of information

Work Instructions, where necessary Use & Maintenance of suitable equipment

Availability & Use of Monitoring & Measuring

equipment

Implement Monitoring Activities

Processes for Release, Delivery & Post Delivery

Activities

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7.5 Production & Service

Provision

7.5.2 Validation of Processes

7.5.3 Identification & Traceability

7.5.4 Customer Property

7.5.5 Preservation of Product

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7.6 Control of Monitoring &

Measuring Devices Determine Measurements

Identify Devices Required

Use & Control

Where applicable

Calibrate or verified, Safeguard, Project, etc includes software

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8. Measurement, Analysis &

Improvement 8.1 Planning

Define, Plan, Implement

Measurement & Monitoring Activities

conformity of product and system Improve

effectiveness of system

Applicable Methodologies (inc. Statistical

Techniques)

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8.2.1 Customer Satisfaction

Monitor Information Customer Perception

Defined Methods

Proactive not Reactive

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8.2.2 Internal Audit

Quality System

Effectively Implemented

Effectively maintained.

Conform to ISO9001

8 2 3 Monitoring & Measurement

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8.2.3 Monitoring & Measurement

of Processes

Suitable Methods

Realisation Processes

Demonstrate Ability

Achieve planned results

Correction and Corrective action

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8.2.4 Monitoring & Measurement

of Product Measure and monitor characteristic of the

product to verify that requirements are met

Appropriate Stages

Evidence of conformity (records)

No release/delivery until all OK (approved

by relevant authority)

8 2 3 C l f N f i

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8.2.3 Control of Nonconforming

Product Related to Product

Identified and Controlled

Prevent Unintended Use or Delivery

Corrected and re verified

Applies to post delivery problems which

will require

appropriate action

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8.4 Analysis of Data

Customer Satisfaction

Conformance to Product RequirementsCharacteristics and Trends of Processes, &

Products

Suppliers

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8.5 Improvement

8.5.1 Planning for Continual Improvement

Plan and Manage the processes necessaryfor continual improvement

(quality policy, quality objectives, audit

results, data, corrective/preventive action


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Defining, measuring and analysing existingsituation;

Establishing objectives for improvement;

Searching for possible solutions; Evaluating solutions;

Implementing, selected solution;

Measuring verifying, and analysing resultsof implementation;

Formalising changes.

8

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8.5 Improvement

8.5.2 Corrective Action Review Nonconformities (incl. Complaints)

Determine Cause

Evaluate Need for Action

Determine &Implement Action including

prevention of recurrence

Record Results

Review Corrective action

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INTERNAL AUDIT

WHAT IS

AUDIT?

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WHAT IS AN AUDIT

A health check

Key words

- Systematic- Documented

- Periodic

- Objective- Verification

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KEY CONCEPTS

Verification Evaluate compliance to requirements

Systematic Carried out in accordance to set protocols

Periodic Conducted to established schedule Objective Auditors have some independence,

Evidence for audit findings.

Documented Reports are prepared

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WHY AUDIT?

Required by the standards.

To identify and define AREAS OF

IMPROVEMENT

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TERMINOLOGY: AUDITS

AUDITS- Period over which ALL

parts

of organisation checked to

planned arrangements

- determine whether MS has

been properlyimplemented

and maintained

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AUDIT TERMINOLOGY

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AUDIT TERMINOLOGY

Audit Protocol/Procedure:

detail of individual audit including

- audit scope

- audit frequency

- audit methodologies

- personnel and experience

- documentation required

- reporting and distribution

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AUDIT SCHEDULING

Scheduled - routine auditing

- High risk/potential for harm( I.e significant aspects)

e.g. every 6 months

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AUDIT SCHEDULING

Unscheduled - usually prompted by:

Significant change in personnel

Change in regulations

Process change

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AUDIT APPROACH

Product line

By work area / activity

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AUDIT PROGRAMME

HOW TO ACHIEVE

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CONTINUAL IMPROVEMENTActual

Performance

Time

Preparatory

quality review

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AUDIT TEAM

AUDIT TEAM

SELECTION

AUDIT TEAM PERSONNEL

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AUDIT TEAM PERSONNEL

REQUIREMENTS Independent from area / activity under audit

Experience and expertise including:

Management system and standardsSystem auditing

Product requirements

Technical knowledge of area/activity

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AUDITOR QUALIFICATION

Education

- at least secondary or equivalent

with5 years work experience

or

- degree with 4 years workexperience

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AUDITOR SKILLS

Personnel Attributes

Open mined

Mature/sound judgementanalytical skills/tenacity

perceives situations in a realistic way

Understands complex operations from a broadperspective

Understands role in individual units

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AUDITOR REQUIREMENTS

Personal Attributes

Obtains and assesses objective evidence faidy

Remains true to purpose of audit

Evaluates audit observations and personal

interactions during audit

Treats concerned personnel with humility

Reacts with sensitivity to nationalconventions/customs

Performs audit audit without distractions


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Personal Attributes

Ability to listen - Test

Gives full attention to audit process

Reacts effectively in stressful situationsArrives at generally acceptable conclusions

based on audit observations

Remain true to a conclusion

Able to organize and conduct and audit

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AUDITOR GUIDELINES

Maintains competence

Knowledge of standards and

requirement is current

knowledge of audit procedure and

methods is current

Participates in refresher training where

necessary

AUDIT TEAM SELECTION

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Process should consider:

- qualifications as identified in the standard

- type or organisation, processes, activities or

function

being audited

- number and composition of audit teams

- language skills and expertise of the individual

audit team

members


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Process should consider:- potential conflict of interest between audit team

members

and auditee- requirements of clients, certification and

accreditation

boards- need for skill in management the team

- skills needed to deal with a particular auditee

AUDIT TEAM

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AUDIT TEAM

REQUIREMENTS

Audit team should include experience as:

- Team leader

- Systems auditor- Product Quality specialist

- Technical specialist

- if not resourced internally then externally

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INTERNAL AUDIT

Audit

Methodology

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STAGES OF AN AUDIT

Pre - audit activities

Audit activities Post audit activities

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CONDUTING AN AUDIT

Pre - Audit

- Agree the scope of the audit

- Establish methods of assessment- Select auditors, Team leader

- Briefly review documented MS and other

background information- Plan the audit (checklists etc.) Conduct a pre-

audit meeting

CONDUCTING AN AUDIT

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CONDUCTING AN AUDIT

USE OF CHECKLIST DISADVANTAGES

ADVANTAGES

- useful guide to the audit process - preparation time

needed- records evidence - blinkered view

- record of audit - somewhat cumbersome

- part or report

- good help for beginners

AUDIT ACTIVITIES

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AUDIT ACTIVITIES

Opening meeting

Review documents

Interview Collect evidence/site inspection

Closing meeting

AUDIT ACTIVITIES

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AUDIT ACTIVITIES

INTERVIEWING SKILLS

Explain why asking a particular question

Ask a question in different ways if notunderstood

If auditee becomes stressed - take a break!

Speak to supervisor first

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AUDIT ACTIVITIES

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AUDIT ACTIVITIES

INTERVIEWING SKILLS

Do you know how to carry out thickness

checking of this plate? How thickness measurement of this plate is

done?

AUDIT ACTIVITIES

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AUDIT ACTIVITIES

INTERVIEWING SKILLS

DEVELOPING A QUESTION TECHNIQUE

- Show me!

- I dont understand, please explain.

- What if ..

- Are you saying that?

- Silent approach

- Puzzled look

- Good or You have under control !

G S S

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INTERVIEWING SKILLS

ASK LOOK

Mainly open ended Observe what is

questions which happening

provide information

REORD CHECK

objective evidence- instructions

positive and negative

AUDIT ACTIVITIES

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AUDIT ACTIVITIES

INTERVIEWING SKILLS

Ensure interviewee:

Hears or sees what you tell or show them

Understands what they have heard Agrees with what they have heard or seen

Takes action

Provides feedback

AUDIT ACTIVITIES

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AUDIT ACTIVITIES

If something is wrong:

Do not criticise

Investigate Do not undermine supervisor

Record specific details

Also record compliance!

AUDIT ACTIVITIES

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AUDIT ACTIVITIES

Be objective

Persist if a non-conformity exists

Dont get annoyed Dont take sides

Make your own judgements

Plan time effectively

Be positive

INTERVIEWING SKILLS

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INTERVIEWING SKILLS

On completion

- say Thanks!

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POST - AUDIT ACTIVITIES

Audit reporting

- facts- probabilities

- uncertainties

POST AUDIT ACTIVITIES

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POST AUDIT ACTIVITIES

Audit reporting - distinguish between

- observations

- interpretations

- assessments

- opinions

- advice

- recommendations