121579766 TrainingMaterials PDF

7/28/2019 121579766 TrainingMaterials PDF

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Quality Management System

:

Internal Auditing


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a s

1. QHSE is the Quality, Health, Safety andEnvironment2. It is the inte rated mana ement s stem that

required to be designed, implemented, reviewedand being always able to continual improvement.

3. DSI is already implementing a QMS complying tothe International Standard ISO 9001:2000


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rgan za on ar


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a s ua y

"the totality of characteristics of an entity that bear onits ability to satisfy stated or implied needs"

ua y anagemen ys em

A quality management systemis a set of interrelatedo interactin elements that or anizations use to

direct and control how quality policies areimplemented and quality objectives are achieved.


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OHSAS 18001:2007

a s ea a e y

Occupational Health and Safety (OH&S)conditions and factors that affect, or could affect, thehealth and safety of employees o othe workers(including temporary workers and contractorersonnel visitors or an other erson in the

workplace (including labor camps as well)

OH&S Management System

part of an organizations management system usedto develop and implement its OH&S policy and


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ISO 14001:2004

a s nv ronmen

Environment issurroundings in which an organization operates,including air, water, land, natural resources, flora,fauna, humans, and their interrelation

Environmental Management System (EMS)

art of an or anization's mana ement s stem used

to develop and implement its environmental policyand manage its environmental aspects


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J ose h J uran & Frank Gr na

er e n ons or ua y

"Quality is fitness for use"

American Society for Quality (ASQ)"Quality denotes an excellence in goods andservices es eciall to the de ree the conformtorequirements and satisfy customers

So Quality Definition is:Satisfaction of Needs & Expectation"


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What are standards?

Are documented agreements containing technicalspecifications or other precise criteria to be used

, ,characteristics, to ensure that materials, products,

processes and services are fit for their purpose.Format of credit cards, phone cards,.


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a s

The International Organization for Standardization is anon-governmental organization established in 1947, its

standardization and related activities in the world with a

view to facilitating the international exchange of goodsand services and ideas.


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1906 Creation of IEC

Creation of ISA1926

1951 Publication of the 1st ISO standard

ISO9000:19871987

ISO9000:1994

ISO9000:20002000


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Where was the first Quality ManagementSystem implemented?

Long before ISO 9000 was ever dreamt up, theEgyptians were implementing a QMS to build the

...


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ues ons

Why is Inter.Stand. needed?What are the ISOs achievements?


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a e s are covere

The scope of ISO is not limited to any particular branch;it covers all technical fields except electrical and,

IEC.


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e sys em s ou pu

ISO has a current portfolio of over 17,000 * standards

that provide practical solutions and achieve benefits

for almost every sector of business, industry and

* J une 2008


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an ar ruc ure

-

ISO 9001 - requremen s

ISO 9004QMS - guidelines for performanceimprovement

ISO 19011 Guide for Auditing Quality Systems


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oncep o

Say what you do Do what you say

Check on the results

Take action accordingly


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: rnc pes

The role of Leadership

The involvement of People

The business process approachA systematic approach to management

Continual improvementPrinciples

A factual approach to decision making

Mutually beneficial supplier relationship


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Quality Management Process Model

QUALITY MANAGEMENT SYSTEM

Management

CONTINUAL IMPROVEMENT

responsibility

Measurement ,Resource

C

u

s

R

eq

C

u

s

S

a

t

i

sf

,

improvementmanagementt

o

m

u

i

r

e

m

e

t

o

m

a

c

t

i

o

n

ro uc(and/or service)realization

rn

ts

rInput Output Product/ /Service


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Take actions to continually

Establish objectives

necessary to deliver

Insert text here (Arial:24)Act

mprove process per ormance

effectiveness and efficiency Plan What to do

How to do it

with customer

requirements

and the organisation's

next time?

Check Did things happen

Do Do what was

planned

Monitor and measureprocesses and product

against policies, objectives

and re uirements

Implement the processes


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Typical network of interrelated or

interactin rocessesPDCA

Insert text here (Arial:24)Process APDCA

PDCA

ersers

ders

ders

Process B

PDCA

PDCA

&s

takehol

&s

takehol

&stakehol

&stakehol

PDCA

Customers

Customers

Customers

Customers

Customer Process F

PDCA

Customer


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: an ar

1. Scope2. Normative Reference

3. Terms & Definitions

4. Quality Management System

.

6. Resource Management

7. Product Realisation

8. Measurement, Analysis & Improvement


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. easuremen an mon orng

Measurement and Monitoring is the checkC ste of the PDCA c cle clause 8.2.2

and include part of the action (A) step

as well.


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A Systematic and Independent Examination To:

Determine Whether Quality Activities And RelatedResults Comply With Planned Arrangements And

Effectively And Are Suitable To Achieve Objectives


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u Opportunity to constructively drive qualityimprovements

u ec panne versus ac ua me o s o wor ng

u Identify where procedures are not being followed

u Develop effective corrective actions


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u Su orted b To Mana ement

u No Blame, No Penaltiesu Sufficient Resources Available, Time & People

u Auditors Independent of the Person Controlling

each Function

u

u Structured Training & Exposure

u Feedback to Management Review

u Improvement Not Just Compliance


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Who is auditing Who - Fora urpose


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u Internal audit (First Party)u Customer audits Supplier (Second Party)

u Audit by an Independent Body (Third Party - ISOCertification)


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DO WHAT YOU SAY (Implementation)

CHECK YOU ARE DOING WHAT YOU SAY (Internal

Audit)

ACT ON FINDINGS (Corrective Action/ Continuous


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Failure to implement an effective audit program is oneof the most common reasons for deferment of.

seriously is clearly not taking quality seriously and

registration would be inappropriate.


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Careful planning of audit activities Independent auditors

Audit teams

Frequency of audits

rogram prepara on an ssue


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1) PLANNING 2) PREPARATION

3) PERFORMANCE

5) POST AUDIT 4) PAPER WORK

-


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PLANNING

Schedule Triggers Date Select Auditor

Prepare DocumentationProceduresChecklist

Advise Auditee


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Auditor StudiesDocumentation Finalise

Confirm Readiness Confirm Details

to QMR with Auditee


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Useful tool Avoid overuse

Dont stick to checklist - you will miss other,

IMPORTANT factors


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An audit plan Act as a time planner

Guides the flow of questions

Identifies a complete or part complete audit

rov es a no e pa an a memory ogger

Gives a permanent record


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The organisation structure - is it still current?

Procedures - do they accurately describe theprocesses use

Resources - are they adequate for the processes?

Previous corrective actions - have they beeneffectively cleared?


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PERFORMANCE

Opening MeetingCheck

AvailabilityUnderstanding

Make Notes Observe Work

Use Checklists

Identify RecordsNames


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Study and compare notes and findings

Lists deficiencies found

Complete checklist and corrective action requests

Note areas not covered .

gree pror y ssues

Agree significance - Major / Minor/ Observation


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Question

Who? What? Why? Where? When? How?

Observe

Show me!

er y

Check and confirm!


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FAVOURABLE AUDITORATTRIBUTES

Open minded, unbiased

Observant, encouraging

Communicative, Good Listener

Polite, Professional

poma c, ons ruc ve


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UNFAVOURABLE AUDITOR

ATTRIBUTES

Argumentative, opinionated

Secretive, uncommunicative

Impolite

Shy

PAPERWORK


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PAPERWORK

COMPLETE AUDIT REPORT

Logical

Signatures

Facts

DatesRETURN ALL DOCUMENTS TOQMR


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Include date and sheet number

nc u e spec c es an num ers o ocumen s

Include Interviewee/Responsible Management details

e a non-con ormances an correc ve ac onsagreed

Record observations

Include name of auditor(s)


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u n ng

nonconformity

opportunity for improvement (Observation)


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oncon orm y

The non-fulfilment of a requirement


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oncon orm y

comply with the Standard

mpemen a process or o er ocumen erequirement

implement a legal or contractual requirement

No re uirement =no nonconformit

The non-fulfilment of a requirement


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noncon orm y s a emen

overview of finding

description of nonconformity

example of audit evidence

summary of requirement


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xampe o a s a emen

that not all Materials Receiving Vouchers are being fully.

show quantity units or delivery dates.

All documentation must be completed in accordance

w a era con ro an s ores proce ure no. xxx .


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Corrective Actions Classifications

MAJOR::

total breakdown of a process, procedure or

operation of the quality system total absence of a re uiremen

number of minor lapses indicating a total breakdownof system

mme a e azar o e qua y o e pro uc

a less severe lapse in a process, procedure oroperation of the quality system


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O ortunities for im rovement

organisation

deficiencies given the benefit of the doubt

recommendations for improvement


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Examine objective evidence

Ask open-ended questions

Refer to checklists

Make notes

ons er mpac on o er ac v es

Examine physical conditions

ssess awareness an n eres


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FORMAL :-

Opening meeting

Private review by auditors

Priorities findin s ma or minor or observation Prepare audit report / C.A.Rs

Agree team roles for closing meeting


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Agree actions

Define responsibilities

Set timescales

Follow-up

ec or e ec veness


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Plan/Schedule

Responsible ManagersCarr Out Audit

Implement Actions

Corrective ActionsHighlight Deficiencies


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Meet the Person in Charge First

Talk to the People Doing the Job

Be Calm & Re-assuring

Never Talk Down

sun ers oo s your au

Compliment Good Points


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Special Cases

Interruptions

Missing Documents

Missing People

oo uc e a

Side - Tracking


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E-mail:[email protected]

Integration in Efforts(TEAM WORK)

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