QA/QC Induction Pocket Guide - khayyat-qa. · PDF fileQA/QC Induction Pocket Guide 1 . ... –ISO 9001: Quality Management ... •Documented in a suitable form e.g. plan, chart 39

QA/QC Induction Pocket Guide

1

OVERVIEW OF QUALITY MANAGEMENT SYSTEM

2

PART- 1

WHAT IS QUALITY

“The degree to which a set of inherent characteristics fulfils requirements”

– Characteristics are distinguishing features inherent or assigned, qualitative or quantitative

– Requirement is a need or expectation stated, generally implied or obligatory

3

EIGHT QM PRINCIPLES

4

Leadership

Customer

Focused

Involvement

of People

Process

Approach

System

Approach

to Management

Continual

Improvement

Factual

Decision-

Making

Supplier

Relationships

Quality

Management

Principles

PROCESS APPROACH

5

PROCESS

CONTROLSRESOURCES

INPUTS OUTPUT

MEASUREMENT, MONITORING AND ANALYSIS

INTERACTION OF PROCESSES

6

Process

A

Process

B

Process

C

Process

D

Input, Output, Control and Resources

QUALITY MANAGEMENT SYSTEM STANDARD

7

PART- 2

ISO 9000 FAMILY

– ISO 9000: Quality Management

Systems - Fundamentals

and Vocabulary

– ISO 9001: Quality Management Systems - Requirements

– ISO 9004: Quality Management Systems - Guidelines for Performance Improvement

Supported by:

ISO 10005: Quality Management-Guidelines for quality plans

ISO 10012-1: Quality assurance requirements for measuring

equipment

ISO 10013: Guidelines for developing Quality Manuals

– ISO 19011: Guidelines for Auditing Quality and/or Environmental Management Systems

8

ISO 9001:2008 INTRODUCTION

• To assess organisation’s ability to meet customer, regulatory and own requirements

• QMS requirements are complimentary to technical requirements for product

• Adoption of a QMS is a strategic decision

• Design of the QMS is organisation specific

• Standard is based on the eight quality management principles

• ISO 9001 and ISO 9004 are a consistent pair - intended to be used together, but can be used independently

• Different scope but similar structure

• ISO 9001 is the only auditable standard in the series (requirements)

• ISO 9004 provides guidelines for improving performance

9

PROCESS MODEL

10

Customer

Requirements

Management

responsibility

Measurement ,

analysis ,

improvement

Resource

management

Product

realization

Input Output Product

QUALITY MANAGEMENT SYSTEM

CONTINUAL IMPROVEMENT OF

Customer

Satisfaction

P-D-C-A CYCLE

11

Plan

Do Check

Act

STRUCTURE OF ISO 9001 & COMPLIANCE OF KCT MANAGEMENT SYSTEM

12

PART- 3

STRUCTURE OF ISO 9001

13

Section 4 - Quality management system

Section 5 - Management Responsibility

Section 6 - Resource Management

Section 7 - Product realization

Section 8 - Measurement, analysis and improvement

KCT IMS MODEL

14

Quality Management Clauses

4 -Quality Management System

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4.1- General Requirements

o Determining the needs and expectations of customers and other interested parties

o Setting Quality Policy and delivering objectives o Defining processes and related responsibilities and authorities for

attainment of objectives o Providing resources for attainment of objectives o Implementing methods to measure the degree of effectiveness

and efficiency of processes o Preventing occurrence and reoccurrence of nonconformities and

eliminating root causes o Implementing a processes for continual improvement

16

4.2- QUALITY SYSTEM DOCUMENTATION

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QUALITY MANUAL

( KCT Policy document for Integrated

Management System Manual; KCT-IMS-PS-0002)

PROCEDURES

Complete IMS for KCT:KCT-

IMS-M-1009C

QUALITY PLANS

(KCT Procedure for

Project Quality Control

Plan; KCT-IMS-CM-3303)

COMPANY POLICY

IMS Policy: KCT-IMS-PS-0001

H&S Policy: KCT-IMS-PS-0003

Environment: KCT-IMS-PS-0004

Quality Policy:KCT-IMS-PS-0005

DEPLOYMENT OF

POLICY

CONTRACTUAL OR

PRODUCT

SPECIFIC

REQUIREMENTS WORK

METHOD STATEMENTS

4.3- QUALITY MANUAL

18

MAIN PURPOSE

TO COMMUNICATE THE ORGANISATION’S

QUALITY POLICIES & INTENTIONS

INTERNAL

GUIDANCE

REFERENCE

DIRECTION

EXTERNAL

MARKETING AID

CUSTOMER CONFIDENCE

BASIS FOR ASSESSMENT

COMPLIANCE

19

ISO 9001:2008 KCT Integrated Management System

Clause 4.2.1: Quality Policy and Objectives

Quality Policy: KCT-IMS-PS-0005 Quality Objectives:KCT-IMS-CM-3302B

Clause 4.2.2: Quality Manual IMS Manual: KCT-IMS-PS-0002

Clause 4.2.3: Control of Documents KCT-IMS-M-1009 KCT-IMS-M-1006 KCT-IMS-CM-3201

Clause 4.2.4: Control of Records KCT-IMS-CM-3307

The Leadership Clauses

5 Management Responsibility

20

Management Responsibility

• Customer Focus

• Quality Policy

• Planning

• Responsibility, Authority & Communication

• Management Review

21

PLAN - DO - CHECK - ACT

Management Commitment • Top management shall demonstrate its

commitment

• Challenge: – how to prove this to an auditor?

– How can they demonstrate this?

– How much is enough?

• Opportunity: – every workplace benefits from leaders who set a

good example

– improve staff morale

22

5.1 Customer Focus

23

Requirements Needs &

Expectations

Statutory &

Regulatory

Communication

& Feedback

5.3 Quality Policy

24

What is our

purpose?

What do we

want to be

known for?

Who are our

customers?

What do we need

to achieve?

CONSTANCY

OF PURPOSE

COMMIT TO

IMPROVE

5.4 Planning

• Quality objectives established at relevant functions and levels

• The quality objectives shall be measurable and consistent with quality policy including commitment to continual improvement

• Resources needed to achieve quality objectives are identified and planned

• Planning shall ensure that change is conducted in a controlled manner

25

5.5 Responsibility, Authority & Communication

• Responsibility and authority • Management representative –a member or members of management –promote awareness

• Internal communication

26

5.6 Management Review

27

ACTIONS

IMPROVE

RESOURCE

AUDITS

FEEDBACK

CHANGES ACTIONS

RESULTS

A Business Control Process!

COMPLIANCE

28


Clause 5.1: Management Commitment IMS Manual: KCT-IMS-PS-0002

Clause 5.2: Customer Focus A- Determination of Requirements related to product B- Customer Satisfaction Survey

A- KCT Project Quality Plans and HSE Plans B- KCT-IMS-CM-3302; KCT-IMS-M-1004

Clause 5.3: Quality Policy KCT-IMS-PS-0005

Clause 5.4: Planning KCT-IMS-M-1008; KCT-IMS-CM-3302; KCT-IMS-CM-3801-3808

Clause 5.5: Responsibility, Authority and Communication A- Responsibility & Authority B- Management Representative C- Internal Communication

A- KCT-IMS-PS-0002 B- SHEQ Director C- KCT-IMS-M-1001; KCT-IMS-M-1002;KCT-IMS-M-1003;KCT-IMS-PS-0018

Clause 5.6: Management Review KCT-IMS-M-1001

The Asset Clauses

6 Resource Management

29

Resource Management

• Provision of Resources

• Human Resources

• Infrastructure

• Work Environment

30


Resource Management

Human Resources

Infrastructure

Work Environment

31

PROCESS

6.1 Provision of Resources

• Determine and provide in a timely manner • Resource for:

– implementing QMS – improving QMS – address customer satisfaction

32

6.2 Human Resources

• Assignment of Personnel

• Competence, awareness and training – identify and address needs

– Evaluate the effectiveness of training

– awareness of how job contributes to objectives

• Challenge: – how can this be measured?

– Evaluate the improvement of a person or activity following training

• Opportunity: – identify where is most cost benefit for training 33

6.3 Infrastructure

• Identify, provide and maintain the infrastructure

• Include

a) buildings, workspace and associated utilities

b) equipment, hardware and software

c) supporting services

34

6.4 Work Environment

• Determine and manage the work environment needed to achieve conformity to product requirements

35

COMPLIANCE

36


Clause 6.1: Provision of Resources 4000- Human Resources Procedure

Clause 6.2: Competence, Training and awareness

KCT-IMS-HR-4009;KCT-IMS-HSE-6011

Clause 6.3: Infrastructure 4000- Human Resources Procedure 5000- Information Technology 9000- Plant, Motor and Vehicle 15000- Labor Resource Department

Clause 6.4: Work Environment 6000- Health, Safety and Environment Procedure

The Delivery Clauses

7 Product Realisation

37

Product Realisation

• Planning of Realisation Processes

• Customer-Related Processes

• Design and Development

• Purchasing

• Production and Service Provision

– Control of production & service provision; validation of processes; identification and traceability; customer property; preservation of product; control of monitoring and measuring equipment

38


7.1 Planning of realisation processes • Product realisation?

– Sequence of processes required to achieve the product

• Planning includes: – quality objectives for product/project/contract – need for processes and documentation – resources and facilities – verification and validation activities and criteria – records to give confidence of conformity

• Documented in a suitable form e.g. plan, chart

39

7.2 Customer-related processes

Identification of Customer Requirements

• specified requirements – incl availability, delivery, support

• non-specified requirements – necessary for intended/specified use

• obligations – statutory, regulatory, …?

40

Now is that with or

without the

chilli sauce?


Review of product requirements

• prior to commitment

• requirements are defined and confirmed

• ability to meet requirements?

• Control and awareness of any changes

41


42

Customer communication

Product

Information Orders &

Enquiries

Feedback &

Complaints

7.3 Design and Development

• Design and development planning – in stages e.g. feasibility, specification, simulation – planning output updated with progress

• Design and development inputs – documented – include specified and other requirements

• Design and development outputs – documented to allow verification against inputs – incl information for subsequent production/service – identify safe and proper use issues

43

7.3 Design and Development • Design and development review

– able to fulfil requirements?

– Problems and solutions

• Design and development verification

• Design and development validation

• Design and development changes

– consider effect of changes (side-effects)

– verified and validated before implementation

44

7.4 Purchasing • Purchasing Process

– control depends on criticality – evaluation and selection of suppliers – periodic re-evaluation criteria defined

• Purchasing Information – description of purchase – approval/qualification requirements – QMS requirements

• Verification of Purchased Product

45

7.5 Production and Service Provision • Control of production & service provision

– information and equipment: availability and use

– monitoring activities

– delivery and release activities

• Validation of processes

• Identification and traceability

• Customer property

• Preservation of product

46

7.6 Control of monitoring and measuring equipment

• Measurement uncertainty no longer specific – measurement capability

• Ensure that measurements are valid • calibrate periodically or prior to use • calibrated according to standards • protect between calibrations • test software needs to be validated

47

COMPLIANCE

48


Clause 7.1: Planning of Product Realization KCT Project Quality Plans KCT-IMS-CM-3302; KCT-IMS-CM-3304

Clause 7.2: Customer related Process KCT-IMS-PS-0018; KCT-IMS-M-1004;KCT-IMS-CM-3302; KCT-IMS-CM-3402.

Clause 7.3: Design and Development KCT is not involved directly with the design and development, Consultant are hired as per KCT Procedure No KCT-IMS-CM-3402.

Clause 7.4: Purchasing Procurement Procedures (KCT-IMS-CM-3401-3403.

Clause 7.5: Production and Service provision Procurement Procedures (KCT-IMS-CM-3401-3403; KCT-IMS-CM-3402

Clause 7.6: Control of Monitoring and Measuring Equipment

KCT-IMS-CM-3304

The Closed-Loop Clauses

8 Measurement, Analysis and Improvement

49

Measurement, Analysis & Improvement

• General

• Monitoring and Measurement

• Control of Nonconforming Product

• Analysis of Data

• Improvement

50


8.1- General

• More planning! – Measurement and monitoring activities – to assure conformity – to achieve improvement – determine statistical techniques

51

Measurement and Improvement

52 Customer Satisfaction

Internal Audits

Processes

Product

8.2 -Monitoring and Measurement

• Customer Satisfaction

– monitor information relating to customer perception as to whether the organization has met customer requirements

• Internal audit

– periodic

– conformance to requirements of ISO9001

– effective implementation and maintenance

– based on status and importance

– scope, frequency and methodologies to be defined

– timely corrective action

– reported verification

53

8.2 Monitoring and Measurement

• Processes – monitor realisation processes to meet requirements – confirm ability of processes to satisfy purpose

• Product – verify requirements are met at appropriate stages – evidence of conformity and release authority

documented prior to release/delivery

54

8.3 Control of Nonconforming Product

• Identification and control against unintended use • re-verify after correction • detection of NCP after delivery

– review consequences

• May need to notify other parties

55

8.4 Analysis of Data

• Collect and analyse appropriate data : • the suitability and effectiveness of the QMS • identify improvement that can be made a) customer satisfaction b) conformity to customer requirements c) characteristics and trends of processes and

products d) suppliers

56

No longer an option

8.5 Improvement

• Continual improvement

• Corrective action

• Preventive action

57

COMPLIANCE

58


Clause 8.2: Monitoring and Measurement KCT-IMS-M-1005;KCT-IMS-CM-3302; KCT-IMS-CM-3402.

Clause 8.3: Control of Non Conforming product

KCT-IMS-CM-3305

Clause 8.4: Analysis of Data KCT-IMS-CM-3302

Clause 8.5: Improvement KCT-IMS-M-1003 KCT-IMS-CM-3302 KCT-IMS-CM-3306

KCT INTEGRATED MANAGEMENT SYSTEM DOCUMENTATION INDEX

59

PART- 4

Contnd.

60

Doc Ref Title 0000 POLICY & SYSTEM

1000 MANAGEMENT

2000 COMMERCIAL & CONTRACTS

3000 CONSTRUCTION MANAGEMENT (PROJECTS)

Project Construction

Project Technical

Project Document Control

Project Quality Control

Project Procurement

Project Store Keeping

Project Time Keeping

Project Contracts and Commercial

Project Planning

4000 HUMAN RESOURCES

5000 INFORMATION TECHNOLOGY

6000 HEALTH, SAFETY AND ENVIRONMENT

7000 PROCUREMENT

8000 ACCOUNTS AND FINANCE

9000 PLANT, MOTORS AND VEHICLE

10000 LABOUR CAMP

15000 LABOUR RESOURCE DEPARTMENT

16000 OPERATIONS

17000 FACILTIES MANAGMENT

Thank You!

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