Main Services:

Training and consultancy Development and implementation of management systems ISO 9000; ISO 14 000; ISO 22 000; OHSAS 18000; HACCP Contact details:
NIVEN SEENEEVASSEN 722, la Marie road, Vacoas Tel: 684 0842 Fax: 684 6957 Email: scl_msltd@intnet.mu Website: www.sclmanagement.net

AIM OF THE COURSE

Course materials Modules Interactive Dispensed in working language Duration: hrs

On completion of this course, you will be able to:

Understand the requirements of Quality Assurance for SMEs Acquire practical knowledge and skills to establish, implement and maintain a QMS

 Course
7

Materials

Modules

Interactive

(Discussions/questioning/exercises/present ation/assignments)
Workshops Dispensed

and Exercises

in working language to ensure 100% employees understanding at all levels

6

 Mod
Mod Mod Mod Mod

1 - Evolution of QMS
2 - QMS model 3 - Quality Management System 4 Management Responsibility 5 - Resource Management

Mod
Mod

6 - Product Realisation
7 - Measurement, Analysis, Improvement

Evolution of Quality Management

3000 BC

First Example of Quality

NEEDS of the customer

EXPECTATION of the Customer

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NATO North American Treaty Organisation

AQAP Allied Quality Assurance Publication Quality Control / Quality Assurance Prevention v/s Detection

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Quality Management System Model

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Act
How to improve next time?

Plan
What to do? How to do it?

Check
Did things happen according to plan?

Do
Do what was planned

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Customer focus
Leadership Involvement of people Process approach System approach to management Continual improvement Factual approach to decision making Mutually beneficial supplier relationships
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Satisfaction

Where are we now?

Customer Indifference

Dissatisfaction

Delight

Most of the time we do not know what they think and this is dangerous

Anger

No feedback
Some feedback Considerable feedback and referral

Customer Satisfaction is not the opposite of dissatisfaction, they are ends of a spectrum. You cannot measure one by the presence or absence of other except in fairly extreme cases.

Global High Performers- Quality Leadership

A passion for Quality- Work from first principles- study state of the art approaches but make up own minds-pace setter in quality thinking Make their own way to the top. Unlikely to be taken by surprise Examples- Toyota, Komatsu, Minolta, Hewlett Packard, Motorola, Short Bros. CMB, VSEL, Wedgwood, Kodak, GE, Hydropolymer, Allied Signal, ABB, Xerox etc

Good but nothing special-not leaders but good

Me too approach to quality- cautious, rather follow than to lead. Can be better than average depending on effort. Do not have a winning mentality. Survival likely but not guaranteed. Vulnerable to aggressive moves by High Performers. Easily discouraged if no case examples of other organisations in field. The rest-how can you tell?
May have ISO 9000:1994 but only because forced to. Probably get all of the cost of ISO 9000 but very little of the benefithanging on in there! No time for quality improvement because too busy fire fighting- Survival at the mercy of others.

P3: Involvement of People Typical Organisation

Management by function Low performance process output

Global High Performer

Management by process High performance process output

How to get from here---------------to here?

Triple Role

Quality Responsibilities
As a Supplier
Know whom are users

As a Processor
Plan Process to meet user needs

As a Customer
Transmit needs to suppliers

Understand needs of users

Avoid creating problems for users Obtain feedback from users

Control Process to meet user needs

Improve process based on user feedback

Provide feedback to suppliers

Obtain feedback from suppliers

Identifying in process Chronic Problems The internal Customer Supplier process chain
Output KPIs Input

Process

Input Output

Process

Input Output

Process

In Process KPIs

P5: System Approach to Management Jurans Message

Form a Quality Council

Steer programme (2) Take project by project process downwards

Tackle-top level projects (6)

Learn about improvement

through the organisation

1. Select Chronic problem.

Seven Steps to Solving Chronic Problems

Output KPI

2. Record existing method (Map the Process)

3. Examine existing method (Process Analysis) identify in process KPIs 4. Cause analysis-critical examination 5. Develop improved methods 6. Install improved methods 7. Maintain improved methods and monitor results- select new problem!

Transforming Data into Information: DATA INFORMATION Effective decision are based on analysis of data and information Information Life blood of an organisation

Supplier

Supplier

Processor

Customer

Customer

Triple role supply chain management

Key

Value adding activities Information flow

Continual improvement of the quality management system

Management responsibility

Customer
(and other interested parties)

Customer
(and other interested parties)
Resource management
Measurement, analysis and improvement

Satisfaction

Requirements

Input

Product realisation

Product

Output

Scope Normative Reference Terms and Definitions Quality Management System Management Responsibility Resource Management Product Realisation Measurement, Analysis and Improvement

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Quality Management Representative (QMR) Quality Coordinators (QCs) Workgroups

Commitment and involvement Stated objectives Project planning Set Steering Committee Nominate:

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 QMS

training development course

Internal
Lead

Auditing course Service

assessor course solving course

Customer
Problem

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 Policies

& Principles Quality Objectives Quality Manual Procedures & Work Instructions Manual Forms and Records Internal Quality Audit Management Review/Ready for certification

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Quality Management System

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Identify processes Sequence and interactions Criteria and methods (effectiveness)

Availability of resources and information

Monitor, measure and analyse processes Implement actions to achieve planned results

Control outsourced processes

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 Quality

Policy Quality Objectives Quality Manuals Procedures Work instructions/Checklist Records

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 Documented statements of a quality policy and objectives

Scope of QMS

Justify permissible exclusions (if any)

Establish documented procedures or their references Interactions between processes

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Documented procedures required by standards Approval prior to issue Review / update and re-approval Identify current revision/ issue status Current versions available at point of use Legible and readily identifiable Identification and control of external document Identification of obsolete documents to prevent unintended use
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Documented procedure required Remain legible Readily identifiable and retrievable Documented procedure to define:
Identification Storage Protection Retrieval Retention time Disposition

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Management Responsibility

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Communicate importance of meeting customer / regulatory / legal requirements

Establish quality policy and quality objectives Conduct management reviews Ensure availability of resources

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Top Management shall ensure that customer needs and expectations are:
Determined Converted into requirements And fulfilled

With the aim of enhancing customer satisfaction

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Appropriate to the purpose of organisation Meet requirements of QMS

Continually improve effectiveness of QMS

Framework to establish and review Quality Objectives

Communicated and understood at all levels

Reviewed for continuing suitability

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Quality Objectives

Established at relevant functions and levels Measurable and consistent with quality policy

QMS planning

Resource requirements Documented Reviewed and identify changes

40

Responsibility and authority

Management representative
Organisation chart Develop and implement system Report to top management Promote awareness of customer requirements Various levels

Internal communication

41

Review input
Quality policy and objectives Results of audits / customer feedbacks Process performance / product conformance Corrective and preventive actions status / changes / follow ups

Review output
Improvement of product/services, processes Resource needs

Records

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Objective 1: Reduce customer complaints by 50% Prepare an action plan for the above for your department..

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Resource Management

44

Determine and provide needed resources in a timely manner Aim is to:

Implement, maintain and improve the effectiveness of the QMS Address and enhance customer satisfaction

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 Assignment of personnel

Competent on the basis of :

applicable education training skills and

experience

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Determine competency
Provide and evaluate training effectiveness Ensure employees are aware of relevance and importance of their contribution to achieve quality objectives Records as evidence

47

Determine, provide and maintain the facilities

to include:
Workspace and associated facilities

Equipment, hardware and software

Supporting services

E.g. transport, communication facilities

48

Identify and manage the human and physical factors

How good is the work environment to achieve conformity to product and /or services ?
(Health and Safety)

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According to you what factors in your work environment can affect conformity to product requirement ?

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Product Realisation

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The organisation shall : Determine Quality objectives & requirements for : product, project, contract Establish processes, documents & resources specific to product under study Identify verification, validation, monitoring, inspection and test activities (set criteria for product acceptability) Records evidencing conformity of processes and resulting product Maintain a Quality Plan : documentation
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Determine requirements related to Product

Requirements specified by the customer Unspecified but necessary for specified or intended use Statutory or regulatory requirements Customer communication Product information Contracts/ order handling (+ amendments) Customer feedback mechanism, inclusive of complaints

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Review of requirements related to product

Defined product requirements

Non-documented statements confirmed before

acceptance Ability to meet defined requirements

Records of review, follow-up & changes

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 Planning

- Review, verify and validate activities - Manage interfaces b/w different groups - Update planning outputs

Inputs
- Information from similar designs - Records

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 Outputs

- Meet input requirements - Provide information for purchasing, production/ service - provision - Contain or reference product acceptance criteria

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Review
Review with planned arrangements & evaluate ability of results to meet requirements Identify problems & propose necessary corrective actions Maintain records of results

Verification
Ensure outputs meet input requirements Maintain records of results of verification & actions taken

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Validation Resulting product meet requirements for specified application or intended use Completed prior to delivery or implementation of product Maintain records of results and actions taken Control of changes Identify changes Review, verify and validate changes Approve before implementation Maintain records & actions taken
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Purchasing Process Purchased product conforms to specific requirements Establish criteria to select, evaluate & re-evaluate suppliers Maintain records of evaluation & actions taken
Purchasing Information Describes product to be purchased Ensure adequate specified purchase requirements

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 Verification

of purchased product Purchased product meets specified purchased requirements Establish & Implement inspection or other activities

60

Control of production & service provision Planning Define processes for release, delivery & applicable post-delivery activities Information describing products Availability of work instructions Validation of processes Demonstrate ability to achieve planned results Define criteria for review and approval of processes/ equipment Maintain records
61

Identification & Traceability Identify product status Control & record unique identification of product Customer Property Identify, verify, protect Maintain records Preservation Preserve conformity during internal processing & delivery Includes identification, handling, packaging, storage, production
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Control of Monitoring & Measuring Devices

Identify equipment to determine calibration

status Calibrate/verify at measured intervals Maintain records

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Measurement, Analysis and Improvement

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7.1 General Planning 7.2 Monitoring and Measurement 7.3 Customer Satisfaction 7.4 Internal Audit 7.5 Monitoring and Measurement of Processes 7.6 Monitoring and Measurement of Product 7.7 Control of Non-conforming Product 7.8 Analysis of Data 7.9 Improvement 7.10 Preventive & Corrective Actions
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Plan and implement measurement, analysis and improvement processes to:

Demonstrate conformity of product / service Ensure conformity of QMS Continually improve effectiveness of QMS

Determine appropriate methods, e.g. statistical techniques

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Customer Satisfaction Internal Audit Monitoring and Measurement of Processes Monitoring and Measurement of Product

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Monitor information on customer perception (satisfaction/dissatisfaction) Determine methodologies for obtaining and using information

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Training of auditors Conduct periodic internal audits to determine:

Plan audit programme to be conducted by independent personnel Record results and report to Top Management Take timely corrective actions & monitor follow-up

Conformance to requirements of International Standards and the organisation Effective implementation and maintenance of system

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Apply suitable methods for measuring and monitoring processes Take corrections and corrective actions to ensure conformity of product

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Carry out measurement and monitoring at appropriate stages to: Evidence of conformity against acceptance criteria Indicate authority responsible for release of product Authorise the release of product and delivery of service when planned arrangements have been completed

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Procedure documented to include: Identification and control of nonconformities Responsibilities and authorities Correction of non-conformities Re-verification to demonstrate conformity to requirements

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Collect and analyse appropriate data to determine suitability, effectiveness and improvement of QMS, to include: Customer satisfaction Conformity to product requirements Characteristics and trends of processes & products Suppliers
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Continually improve QMS through: Quality policy Quality objectives Audit results Analysis of data Corrective and preventive actions Management reviews

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Establish documented procedures to include: Review non-conformities and determine causes Evaluating need for actions Determine and implement actions Record results of actions Review corrective actions

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