Quality Management System ISO 9001 2000 9001:2000 Introduction & Internal Auditing

Training Course December 2008

What i Wh t is QHSE?
1. 2. 3. QHSE is the Quality, Health, Safety and Environment It is the integrated management system that g g y required to be designed, implemented, reviewed and being always able to continual improvement. DSI is already implementing a QMS complying to y p g py g the International Standard ISO 9001:2000

Organization Chart O i ti Ch t

What i Q lit Wh t is Quality

ISO 9000:2005 Quality is "the totality of characteristics of an entity that bear on its ability to satisfy stated or implied needs" Quality Management System (QMS) A quality management system is a set of interrelated or interacting elements that organizations use to g g direct and control how quality policies are implemented and quality objectives are achieved.

What i H lth S f t Wh t is Health & Safety

OHSAS 18001:2007 Occupational Health and Safety (OH&S) conditions and factors that affect, or could affect, the health and safety of employees or other workers (including temporary workers and contractor personnel), visitors, or any other person in the workplace (including labor camps as well) OH&S Management System part of an organizations management system used to develop and implement its OH&S policy and manage its OH&S risks risks

What i E i Wh t is Environment t
ISO 14001:2004 Environment is surroundings in which an organization operates, including air, water, land, natural resources, flora, fauna, humans, and their interrelation Environmental Management System (EMS) part of an organization's management system used p g g y to develop and implement its environmental policy and manage its environmental aspects

Other Definitions f Q lit Oth D fi iti for Quality

Joseph Juran & Frank Gryna p y "Quality is fitness for use" American Society for Quality (ASQ) "Quality denotes an excellence in goods and services, especially to the degree they conform to requirements and satisfy customers So Quality Definition is: Satisfaction of Needs & Expectation"

What are standards?

Are documented agreements containing technical specifications or other precise criteria to be used consistently as rules, guidelines, or definitions of rules guidelines characteristics, to ensure that materials, products, processes and services are fit for their purpose. Format of credit cards, phone cards,.

What i Wh t is ISO?
The International Organization for Standardization is a non-governmental organization established in 1947, its mission is to promote the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services and ideas.

History
1906 1926 1947 1951 1987 1994 2000

Creation of IEC Creation of ISA Creation of ISO Publication of the 1st ISO standard ISO9000:1987 ISO9000:1994 ISO9000:2000

Where was the first Quality Management System implemented?

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

Questions? Q ti ?
Why is [Link]. needed? What are the ISOs achievements?

What fi ld Wh t fields are covered? d?

The scope of ISO is not limited to any particular branch; it covers all technical fields except electrical and electronic engineering, which is the responsibility of engineering IEC.

The Th ISO systems output t t t

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 technology

* June 2008

Standard Structure St d d St t
ISO 9000 QMS - concepts & vocabulary

ISO 9001

QMS - requirements i t

ISO 9004

QMS - guidelines for performance improvement Guide for Auditing Quality Systems

ISO 19011

Concept of ISO 9001 C t f

Say what you do Do what you say Check on the results Take action accordingly

ISO9001:2000 Principles ISO9001 2000 P i i l

Customer satisfaction The role of Leadership The involvement of People The business process approach A systematic approach to management Continual improvement A factual approach to decision making Mutually beneficial supplier relationship

Principles

Quality Management Process Model

QUALITY MANAGEMENT SYSTEM CONTINUAL IMPROVEMENT

C u s t o m e r

Management responsibility
R e q u i r e m e n t s

Resource management

Measurement , analysis, analysis improvement

S a t i s f a c t i o n

Input

Product P d
(and/or service)

Output

realization

Product/ / Service

C u s t o m e r

Plan-Do-Check-Act cycle & continual improvement

Take actions to continually improve process performance i f Insert text here effectiveness and efficiency (Arial:24) Establish objectives necessary to deliver results in accordance with customer requirements and the organisation's policies

Plan
What to do How to do it

Act
How to improve next time?

Check
Did things happen according to plan?

Do
Do what was planned

Monitor and measure processes and product against policies, objectives q and requirements

Implement the processes

Typical network of interrelated or interacting processes

PDCA Process E

Insert text here (Arial:24) Process A

Customers & stakehold C ders
PDCA Process C PDCA Process B PDCA

PDCA

Process D PDCA

Internal Customer

Process F PDCA

Internal Customer

Customers & stakeholders

ISO 9001 2000 St d d 9001:2000 Standard

8 Clauses:
1. Scope 2. Normative Reference 3. Terms & Definitions

4. Quality Management System 5. 5 Management Responsibility 6. Resource Management 7. Product Realisation 8. Measurement, Analysis & Improvement

8.2 Measurement and monitoring 82 M t d it i

Measurement and Monitoring is the check ( ) (C) step of the PDCA cycle clause 8.2.2 p y and include part of the action (A) step as well.

QUALITY AUDIT
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 Objectives

AUDIT CONCEPT
u

u u u u

Opportunity to constructively drive quality improvements Check l Ch k planned versus actual methods of working d t l th d f ki Identify where procedures are not being followed Investigate reasons/causes Develop effective corrective actions

SUCCESSFUL AUDIT STRATEGY

u u u u

u u u u u

Supported by Top Management pp y p g No Blame, No Penalties Sufficient Resources Available, Time & People Auditors Independent of the Person Controlling each Function Careful Selection of Auditors Structured Training & Exposure Planned & Balanced Programme Feedback to Management Review Improvement Not Just Compliance p p

TYPES OF AUDITS

Who is auditing Who - For What P Wh t Purpose

TYPES OF AUDITS
u u u

Internal audit (First Party) Customer audits Supplier (Second Party) Audit by an Independent Body (Third Party - ISO Certification)

ISO 9001 REQUIREMENTS

SAY WHAT YOU DO (Policies and Procedures) DO WHAT YOU SAY (Implementation) CHECK YOU ARE DOING WHAT YOU SAY (Internal Audit) ACT ON FINDINGS (Corrective Action/ Continuous Improvement)

* KEYPOINT *
Failure to implement an effective audit program is one of the most common reasons for deferment of registration. registration An organisation not taking its internal audit program seriously is clearly not taking quality seriously and registration would be inappropriate.

AUDIT PROGRAMME
Careful planning of audit activities Independent auditors Audit teams Frequency of audits Program preparation and i P ti d issue

AUDIT CYCLE
1) PLANNING 2) PREPARATION )

3) PERFORMANCE

5) POST AUDIT
Follow-up Follow up & close out

4) PAPER WORK Reporting

PLANNING
Schedule Triggers Date Select Auditor

Prepare Documentation Procedures Checklist Previous Audits

Advise Auditee

PREPARATION
Auditor Studies Documentation

Finalise Checklists

Confirm Readiness to QMR

Confirm Details with Auditee

CHECKLISTS
Useful tool Avoid overuse Dont stick to checklist - you will miss other, IMPORTANT factors Use it as a reminder or as a guide only

AUDIT CHECKLISTS
An audit plan Act as a time planner Guides the flow of questions Identifies a complete or part complete audit Provides P id a note pad and a memory j t d d jogger Gives a permanent record Detail depends on auditors experience

CONSIDERATIONS
The organisation structure - is it still current? Procedures - do they accurately describe the processes used? d? Resources - are they adequate for the processes? Verifications - are they being carried out? Previous corrective actions - have they been effectively cleared?

PERFORMANCE
Opening Meeting Document Control Check Issue Availability Understanding Make Notes Use Checklists Record Facts Identify Records Names Observe Work

Verify

AUDITORS REVIEW OF FINDING

Study and compare notes and findings Lists deficiencies found Complete checklist and corrective action requests Note areas not covered . Agree priority i A i it issues Agree significance - Major / Minor/ Observation Agree to Agree

AUDIT TECHNIQUES
Question Who? What? Why? Where? When? How? Observe Show me! Verify V if Check and confirm!

FAVOURABLE AUDITOR ATTRIBUTES

Open minded, unbiased Observant, encouraging Communicative, Good Listener Polite, Professional Diplomatic, C Di l ti Constructive t ti

UNFAVOURABLE AUDITOR ATTRIBUTES

Argumentative, opinionated Secretive, uncommunicative Impolite Shy

PAPERWORK
COMPLETE AUDIT REPORT

Legible Logical Signatures

AGREE WITH AUDITEE

RETURN ALL DOCUMENTS TO QMR

Facts Dates

REPORTING AUDIT FINDINGS

Use a standard reporting format Include date and sheet number Include I l d specific titl and numbers of d ifi titles d b f documents t Include Interviewee/Responsible Management details Detail D t il non-conformances and corrective actions f d ti ti agreed Record observations Include name of auditor(s)

Audit Finding A dit Fi di

An audit finding may be: nonconformity opportunity for improvement (Observation)

Nonconformity N f it
ISO 9000:2005

The non-fulfilment of a requirement

AN Nonconformity f it
May be a failure to: comply with the Standard i l implement a process or other d t th documented t d requirement implement a legal or contractual requirement

No requirement = no nonconformity

The non-fulfilment of a requirement

A nonconformity (NC) statement f it t t t

Includes: overview of finding description of nonconformity example of audit evidence summary of requirement

Example of a NC statement E l f t t t
Stores documentation is not being implemented in full in that not all Materials Receiving Vouchers are being fully completed. completed For example: MRVs #123 and 125 do not show quantity units or delivery dates.

All documentation must be completed in accordance with M t i l control and stores procedure no. ( ) ith Material t l d t d (xxx).

Corrective Actions Classifications

MAJOR: total breakdown of a process, procedure or operation of the quality system total absence of a requirement number of minor lapses indicating a total breakdown of system immediate h i di t hazard t th quality of th product d to the lit f the d t MINOR: a less severe lapse in a process, procedure or operation of the quality system

Opportunities for improvement pp p

good points which may benefit other areas of organisation areas of concern deficiencies given the benefit of the doubt recommendations for improvement

CONDUCTING THE AUDIT

Examine objective evidence Ask open-ended questions Refer to checklists Make notes Consider i C id impact on other activities t th ti iti Examine physical conditions Assess awareness and i t A d interest t

AUDIT PERFORMANCE
FORMAL :Opening meeting Conduct audit Private review by auditors Priorities findings ( j , minor or observation) g (major, ) Prepare audit report / [Link] Agree team roles for closing meeting

CORRECTIVE ACTIONS
Agree actions Define responsibilities Set timescales Follow-up Check for ff ti Ch k f effectiveness

Audit Team
Plan/Schedule Carry Out Audit y

SUMMARY
Responsible Managers
Implement Actions

Planned vs Actual
Highlight Deficiencies

Discuss/Agree Corrective Actions

AUDIT CONSIDERATIONS
Meet the Person in Charge First Talk to the People Doing the Job Be Calm & Re-assuring Never Talk Down If Misunderstood its your fault Mi d t d it f lt Compliment Good Points Keep to Your Schedule

TYPICAL AUDIT PROBLEMS

Special Cases Interruptions Missing Documents Missing People Too M h D t il T Much Detail Side - Tracking Choose Your Own Evidence

Thank You

 Wael Salah Corporate QHSE Manager

E-mail: [Link]@[Link]

Integration in Efforts
(TEAM WORK)