Quality Control and Assurance

QUALITY CONTROL AND ASSURANCE The reputation enjoyed by any organization is it built by:

   

Quality, Services , Price , Facilities, etc

Performance Features

Conformance

Reliability Durability

QUALITY Aesthetics

Serviceability Response

The Production & Operations Process Inputs

Conversion Process

Manufacturing

UB’s Dry Cleaners

Service

Output

What is Quality? Quality of a product or services is its ability to satisfy the needs and expectations of the customer.

“The quality of a product or service is a customer’s perception of the degree to which the product or service meets customer’s expectations.” “degree of excellence of a thing” “totality of features and characteristics that satisfy needs” “ Quality

is never by an accident , it is always the result of an intelligent effort”

“fitness for use”

“conformance to requirements”

Quality

Product Features

Freedom from Deficiencies

That Customers Want

At Six Sigma Levels

Design for Six Sigma

Improve to Six Sigma

Meaning of Quality: Meaning of Quality

Producer’s Perspective

Quality of Conformance Production

• Conformance to specifications • Cost and profit

Consumer’s Perspective

Quality of Design • Quality characteristics • Price

Marketing

Fitness for Consumer Use

Consumer’s and producer’s / Provider’s perspectives depend on each other Consumer’s perspective: A rightful level of expectations to buy high quality products at the lower possible cost Provider’s perspective:

A rightful level of expectations to produce high quality products at the highest possible profits

Consumer’s view must dominate

Who defines Quality - the Q Lens

people

products processes

results

outcomes Lens of the customer

Lens of the organisation

benefits

Right Features

Lower Deficiencies Loyal Customers

Good Price

Mkt. Share

Higher Revenue

Fast Cycle Time

Low Warranty Costs Lower Total Cost

How do we achieve these desired results?

Low Scrap/ Rework

Introduction • Quality control (QC) includes the activities from the suppliers, through production, and to the customers. • Incoming materials are examined to make sure they meet the appropriate specifications. • The quality of partially completed products are analyzed to determine if production processes are functioning properly. • Finished goods and services are studied to determine if they meet customer expectations.

QC Throughout Production Systems Inputs

Conversion

Outputs

Raw Materials, Parts, and Supplies

Production Processes

Products and Services

Control Charts

Control Charts and Acceptance Tests

Control Charts and Acceptance Tests

Quality of Inputs

Quality of Partially Completed Products

Quality of Outputs

QA and QC systems Quality Control: planned activities designed to provide a quality product.

Quality Assurance: planned activities designed to ensure that the quality control activities are being properly implemented.

Dimensions of Quality - Product 1.

2. 3.

4. 5.

Performance  Basic operating characteristics Features  “Extra” items added to basic features Reliability  Probability product will operate over time Conformance  Meeting pre-established standards Durability  Life span before replacement

Dimensions of Quality - Product 6. 7.

8. 9.

Serviceability  Ease of getting repairs, speed & competence of repairs Aesthetics  Look, feel, sound, smell or taste Safety  Freedom from injury or harm Other perceptions  Subjective perceptions based on brand name, advertising, etc

Dimensions of Quality Service 1. Time & Timeliness 

Customer waiting time, completed on time



Customer gets all they asked for



Treatment by employees



Same level of service for all customers

2. Completeness 3. Courtesy

4. Consistency

5. Accessibility & Convenience 

Ease of obtaining service



Performed right every time



Reactions to unusual situations

6. Accuracy

7. Responsiveness

Quality and Value • Value is not a price tag but measure of perceived benefits (meet requirements but…) • Training outcome(50cents

less)

• Quality of the complete transaction counts…service quality as well…human relationship – Banks (attempt to reduce costs)

Importance of Quality Market Gains Reputation Volume Price Increased Profits

Improved Quality Lower Costs Productivity Rework/Scrap Warranty

Cost of Quality Cost of good Quality

Cost of poor Quality

• Prevention • Planning

• Design • Process • Training • Information

• Appraisal (=control)

•Inspection •Testing •Equipment •Operator

• Internal failure • Scrap

?

• Rework • Process failure •Downtime •Price reduction

• External failure

• Complaints • Returns •Warranty Claims •Liability •Lost sales

Quality: the performance objective Quality Speed

Dependability Flexibility

Cost

Being RIGHT

Being FAST

Being ON TIME

Being ABLE TO CHANGE Being PRODUCTIVE

Quality Process (Manufacturing)

Customer

Marketing

Engineering

Operations

Specifies Need

Interprets Need

Designs Product

Produces Product

Defines Quality

Plans Quality Monitors Quality

Quality Defects A Defect • Non conformance of a unit of a product with specified requirements Minor- Unnoticeable Major- Cause stoppage of operations, may affect performance Critical- Must be attended to Promptly

Causes of Defects • • • • •

lack of Know How carelessness Improper Designs Lack of or insufficient instructions Inherent errors in Raw Materials , MACHINES

INSPECTION Definition : “The process of - measuring, - examining, - testing, - Gauging, or - otherwise comparing one or more characteristics of a product, or - service with the specified requirements”

INSPECTION Definition : Critical appraisal involving examination, measurement, testing, gauging, and comparison of materials or items. An inspection determines, if the material or item is in proper quantity and condition, and if it conforms to the applicable or specified requirements. Inspection is generally divided into three categories: (1) Receiving inspection, (2) In-process inspection, and (3) Final inspection. In quality control (which is guided by the principle that "Quality cannot be inspected into a product") the role of inspection is to verify and validate the variance data; it does not involve separating the good from the bad.

Inspection

Receive Inputs

• How Much / How Often • Where / When • Centralized vs. On-site

O.K.? Y Process

Measurements

O.K.?

Inputs

Transformation

Outputs

Y Finished Product or Service

Acceptance sampling

Process control

Acceptance sampling

O.K.?

Y Send to Customer

Statistical Methods for Quality Control and Improvement Three major areas: • Statistical process control (SPC) • Design of experiments (DOX) • Acceptance sampling

SQC-SPC

• SQC- Techniques designed to evaluate quality from a conformance view. That is how well we are doing at meeting the specifications that have been set during the design of the parts or services that we are providing. • SPC- Techniques for testing a random sample of output from a process to determine whether a process is producing items within a prescribed range.

Statistical Methods for Quality Control and Improvement Statistical Process Control (SPC) • Control charts are used for process monitoring and variability reduction. • SPC is an on-line quality control tool. Statistical Process Control: Statistical evaluation of the output of a process during production

Statistical process control (SPC) • Statistical process control (SPC)

Cost of detection (Rupees)

– The costs are low, if the problems are detected early – If a large number of defective products are produced, the scrap or rework costs can be high. – Prevention of defects by applying statistical methods to control the process is known as SPC – Prevention refers to those activities designed to prevent defects, defectives, and nonconformance in products and services

Process

Final testing When defect is detected

Customer

Control Chart • Control Chart – Purpose: to monitor process output to see if it is random

– A time ordered plot representative sample statistics obtained from an on going process (e.g. sample means) – Upper and lower control limits define the range of acceptable variation

Control Chart Abnormal variation due to assignable sources

Out of control Limit

UCL Mean Normal variation due to chance

LCL

Abnormal variation due to assignable sources

0

1

2

3

4

5

6

7

8

9

Sample number

10 11 12 13 14 15

Statistical Process Control • The essence of statistical process control is to assure that the output of a process is random so that future output will be random.

Statistical Process Control • The Control Process – – – – – –

Define Measure Compare Evaluate Correct Monitor results

Statistical Methods for Quality Control and Improvement Design of Experiments (off-line quality tools) • Experimental design is an approach to systematically varying the controllable input Parameters / factors in the process and determine the effect these factors have on the output responses. • Experimental designs are off-line quality tools. • Crucial for variability reduction.

Statistical Methods for Quality Control and Improvement Acceptance Sampling • Acceptance sampling is the inspection and classification of a sample of the product selected at random from a larger batch or lot and the ultimate decision about disposition of the lot. • Two types: 1. Outgoing inspection - follows production 2. Incoming inspection - before use in production • Acceptance sampling eliminates the need for 100% inspection

Steps in Quality Control

i) ii) iii) iv) v) vi) vii)

viii) ix)

Formulate quality control Set the standards or specifications on the basis of customer’s preference , cost and profit . Select inspection plan and set up procedure for checking Detect deviations from set standards of specifications. Take corrective actions or necessary changes to achieve standards. Decide on salvage method i.e., to decide how the defective parts are disposed of, entire scrap or network. Co-ordination of quality problems. Developing quality consciousness both within and outside the organization. Developing procedure for good vendor-vendee relations.

Quality management • Quality management is concerned with controlling activities with the aim of ensuring that products and services are fit for their purpose and meet the specifications.

Evolution of Quality Management System Inspection

Salvage, sorting, grading, blending, corrective actions, identify sources of non-conformance

Quality Control

Develop quality manual, process performance data, self-inspection, product testing, basic quality planning, use of basic statistics, paperwork control.

Quality Assurance

Quality systems development, advanced quality planning, comprehensive quality manuals, use of quality costs, involvement of non-production operations, failure mode and effects analysis, SPC.

Quality Management System

Policy deployment, involve supplier & customers, involve all operations, process management, performance measurement, teamwork, employee involvement.QA and QC are parts of QMS

Quality assurance • Quality assurance is about how a business can design the way a product of service is produced or delivered to minimize the chances that output will be sub-standard. The focus of quality assurance is, therefore on the product design/development stage.

ISO 9000 ISO 9000 is a series of standards , development and published by the ISO that define,establish and maintain an effective quality assurance system for manufacturing and service industries.

WHAT IS ISO ISO is a name used for the International Organization for Standardization It was formed in 1947 in Geneva, Switzerland. It is a federation of national standard bodies of 162 countries.

NEED 1)By implementing an organization can benefit many industries such as banking, health care, manufacturing etc 2)The goal of this implementation is to achieve customer satisfaction at its highest value 3)To compete in domestic/ international markets 4)To improve quality system

OBJECTIVE 1. To promote development of standardization to facilitate international exchange of goods and services. 2. To promote cooperation in intellectual, scientific, technological, and economic activity

ADVANTAGES For the customer:-Increase satisfaction and growth in confidence. -for the company: 1)Well defined organization and responsibilities, i.e., minimize grey areas and possible resources wastage 2)Establishment of proper communication channel

ADVANTAGES



A greater degree of internal control.

Greater productivity and cost reduction Evidence of compliance

Recognition of standard achieved

STANDARD

CONTENT

APPLICATION

ISO 9000

Provides definition and concepts. Explains how to select other standards for a given business

All industries including software development

ISO 9001

Quality assurance in design, development, production, installation and servicing

Engineering and construction firms, manufacturers that design, develop, install and service products

ISO 9002

Quality assurance in production and installation

Companies in the chemical process industries that are not involved in product design or after sales service

ISO 9003

Quality assurance in test and inspection

Small shops, divisions within a firm, equipment distributors that inspect and test supplied products

ISO 9004

Quality management and quality system elements

All industries

The ISO 9000 Concept… • Represents an international consensus on good management practices for a systematic and generic application of principles and practices based on quality • ISO 9000 is a written standard that defines the basic elements of a QMS that organizations should use to ensure that their products and/or services meet or exceed customer expectations • Is a set of standardized requirements for QMS and is applicable to any organization regardless of it’s size or whether public or private sectors

The ISO 9000 Concept… • ISO 9000 is seen as a vehicle towards TQM • The principal goal of the ISO 9000 Standards is to demonstrate quality assurance • “Quality culture” refers to the degree of awareness, commitment, collective attitude and behaviour of the organization with regard to quality.

QUALITY MANAGEMENT PRINCIPLES The eight quality management principles are:1. Customer focus 2. The role of Leadership 3. Involvement of People 4. Process Approach 5. System Approach to Management

6. Continual Improvement 7. Factual Approach to Decision Making 8. Mutual Beneficial Supplier relationship

The Principles 1.

Customer focus

Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations Implication Customer focused means putting your energy into satisfying customers and understanding that profitability comes from satisfying customers.

2. Leadership Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives. Implication Leadership is providing role model behaviours consistent with the values of the organization. Behaviour that will deliver the organizations objectives. Internal environment includes the culture and climate, management style, shared, trust, motivation and support.

3. Involvement of People People at all levels are the essence of an organization and their involvement enables their abilities to be used for the organization’s benefit implication involving people means sharing knowledge, encouraging and recognizing their contribution, utilizing their experience and operating with integrity.

4. Process Approach A desired result is achieved more efficiently when activities and their related resources are managed as a process Implication Processes are dynamic-they cause things to happen. processes within an organization should be structured in order to achieve a certain objective in the most efficient and effective manner.

5. System Approach to Management

Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving it’s objectives Implication Systems are constructed by connecting interrelated processes together to deliver the system objectives which in the case of the QMS is the satisfaction of the interested parties.

6. Continual Improvement Continual improvement of the organization’s overall performance should be a permanent objective of the organization Implication Continual improvement is the progressive improvement in organizational efficiency and effectiveness.

7.Factual Approach to Decision Making Effective decisions are based on the analysis of data and information Implication: Facts are obtained from observations performed by qualified people using qualified means of measurements i.e. the integrity of the the information is known.

8. Mutual Beneficial Supplier relationships An organization and it’s suppliers are interdependent and a mutually beneficial relationship enhances the ability for both to create value implication beneficial relationships are those in which both parties are knowledge,vision,values,and understanding.suppliers are not treated as adversaries.

Quality Management System( QMS) Quality Policy: Quality policy means the overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility. Quality System: Quality system means the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.

ISO 9001 : Quality Management System( QMS)

A quality management system (QMS) is a set of policies, processes and procedures required for planning and execution (production/development/service) in the core business area of an organization. (i.e. areas that can impact the organization's ability to meet customer requirements.) ISO 9001:2008 is an example of a Quality Management System. QMS integrates the various internal processes within the organization and intends to provide a process approach for project execution.

A Process based QMS enables the organizations to identify, measure, control and improve the various core business processes that will ultimately lead to improved business performance. A complete ISO 9001 Quality Management System must address all the requirements of ISO 9001, and more specifically must meet the ISO 9001 Documentation Requirements.

ISO 9001:2008 Requirements 1. Scope 2. Normative reference 3. Terms and definitions 4. Quality management system 5. Management responsibility 6. Resource management 7. Product realisation 8. Measurement, analysis and improvement

PDCA Cycle 4. ACT 1. PLAN Permanently Identify imimplement provements and improvements develop plan 3. CHECK Evaluate plan to see if it works

2. DO Try plan on a test basis

ISO Clause Number 0 0.1 0.2 0.3 0.4 1 1.1 1.2 2 3 4 4.1 4.2 4.2.1 4.2.2 4.2.3 4.2.4 5 5.1 5.2 5.3 5.4 5.4.1 5.4.2 5.5 5.5.1 5.5.2 5.5.3 5.6 5.6.1 5.6.2 5.6.3 6 6.1 6.2 6.2.1 6.2.2 6.3 6.4

ISO Clause Name INTRODUCTION General Process Approach Relationship with ISO 9004 Compatibility with Other Management Systems SCOPE General Application NORMATIVE REFERENCES TERMS AND DEFINITIONS QUALITY MANAGEMENT SYSTEM General Requirements Documentation Requirements General Quality Manual Control of Documents Control of Records MANAGEMENT RESPONSIBILITY Management Commitment Customer Focus Quality Policy Planning Quality Objectives Quality Management System Planning Responsibility, Authority, and Communication Responsibility and Authority Management Representative Internal Communications Management Review General Review Input Review Output RESOURCE MANAGEMENT Provision of Resources Human Resources General Competence, Training, and Awareness Infrastructure Work Environment

ISO Clause Number 7 7.1 7.2 7.2.1 7.2.2 7.2.3 7.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.4 7.4.1 7.4.2 7.4.3 7.5 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6 8 8.1 8.2 8.2.1 8.2.2 8.2.3 8.2.4 8.3 8.4 8.5 8.5.1 8.5.2 8.5.3

ISO Clause Name PRODUCT REALIZATION Planning of Product Realization Customer-related Processes Determination of Requirements Related to the Product Review of Requirements Related to the Product Customer Communication Design and Development Design and Development Planning Design and Development Inputs Design and Development Outputs Design and Development Review Design and Development Verification Design and Development Validation Design and Development Changes Purchasing Purchasing Process Purchasing Information Verification of Purchased Product Production and Service Provision Control of Production and Service Provision Validation of Processes for Production and Service Provision Product Identification and Traceability Customer Property Preservation of Product Control of Monitoring and Measuring Equipment MEASUREMENT, ANALYSIS AND IMPROVEMENT General Monitoring and Measurement Customer Satisfaction Internal Audits Monitor and Measurement of Processes Monitoring and Measurement of Product Control of Nonconforming Product Analysis of Data Improvement Continual Improvement Corrective Actions Preventive Actions

Quality Management System CUSTOMERS

Feedback

8.2 Monitoring Customer Satisfaction Covering the entire QMS is: 4.2.3 DOCUMENT CONTROL AND 4.2.4 RECORDS CONTROL

8.2 Internal Audits Shipping & Delivery

8.3 Control of Nonconforming Product

8.4 Analysis of Data (Suppliers, Process, Product, Customer)

7.4 Purchasing & Receiving 7.3 Design

7.1 Planning

8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT

6.0 RESOURCE MANAGEMENT

8.5 CONTINUAL IMPROVEMENT

5.0 MANAGEMENT RESPONSIBILITY

7.5 Production Control

8.5 Corrective & Preventive Action

7.0 PRODUCT REALIZATION

7.6 Monitoring & Measuring Devices

5.6 Management Review

5.4 Quality Objectives 5.3 Quality Policy 5.1 Management Commitment

6.2 Human Resources (Training) 6.3 Infrastructure 6.4 Work Environment Bids, Quotations, Orders, and Contracts

CUSTOMER REQUIREMENTS

CUSTOMERS

The Concept of Quality Management Quality Management System in its basic concept is quite simple. It seeks to:  Recognize the external quality related requirements specified in Licenses to Trade, guidelines, specified customer requirements, and the chosen management system standard(s).  Ensure that all requirements have been documented within the management system in the appropriate location in terms of defined specific system requirements

The Concept of Quality Management  Confirm that employees receive applicable training in the quality system requirements.  Outline performance processes, where applicable, to the quality system requirements.  Produce records or evidence that system requirements have been met Measure, monitor and report the extent of compliance with these performance procedures

The Concept of Quality Management

Continually monitor and analyze changes to the requirements and confirm that all changes are reflected in changes to the specific requirements when necessary. Execute the audit and analyze the system processes and correct them when necessary. Includes processes that will help continually improve the quality system.

Salient Features- ISO 9001:2008  Establishes and streamlines processes through complete documentation  Improves and establishes training processes  Defines roles and responsibilities  Greatly increases operational efficiency  Increases ability to troubleshoot  Develops and builds relationships that help to retain existing customers  Provides advantages over competitors that aren't certified ISO 9001:2008

 Builds opportunities for global commerce with international recognition  Improves customer relations

Salient Features- ISO 9001:2008

 Improves relationships with suppliers due to clear, concise production standards·  Provides basis for consistent and fact-based decision making  Carefully planned improvements, based on documentation and analysis  Provides for regular audits/reviews of performance

Key Benefits of ISO 9001:2008

 Increases productivity· Maximizes quality  Increases revenue· Improves employee morale and satisfaction  Saves time and money  Enhances ability to attract new customers that have adopted requirements for certification  Improves accountability of management  Increases employees' understanding of their roles in success of their work and the company  Creates greater motivation and dedication

The Quality Improvement Model Define Process

A Roadmap to Improvement

Select Measures

Collect & Interpret Data

Purpose: To provide a sequence of steps to improve any process so that the customers will realize the highest quality and value.

Is Process Stable ? Yes Improve Process Capability

No

Is Process Capable ? Yes Use SPC to Maintain Current Process

No

Investigate & Fix Special Causes

QUALITY CONTROL “THOSE QUALITY ASSURANCE ACTIONS WHICH PROVIDE A MEAN TO CONTROL

AND MEASURE THE CHARACTERISTICS OF AN ITEM, PROCESS OR FACILITY TO ESTABLISHED REQUIREMENTS.”

QUALITY ASSURANCE “ALL THOSE PLANNED & SYSTEMATIC ACTIONS NECESSARY TO PROVIDE ADEQUATE CONFIDENCE THAT AN ITEM OR A FACILITY WILL PERFORM SATISFACTORILY IN SERVICE.”

Phases of Quality Assurance Inspection before/after production Acceptance sampling

The least progressive

Inspection and corrective action during production Process control

Quality built into the process Continuous improvement

The most progressive

ISO 9001 and ISO 14001 in brief • ISO 9001 and ISO 14001 are among ISO's most well known standards ever. • They are implemented by more than a million organizations in some 175 countries. • ISO 9001 helps organizations to implement quality management. • ISO 14001 helps organizations to implement environmental management.

Quality management • ISO 9001 is for quality management. • Quality refers to all those features of a product (or service) which are required by the customer. • Quality management means what the organization does to • ensure that its products or services satisfy the customer's quality requirements and • comply with any regulations applicable to those products or services.

Quality management (cont.) • Quality management also means what the organization does to  enhance customer satisfaction, and  achieve continual improvement of its performance.

Environnemental management • ISO 14001 is for environmental management. This means what the organization does to:  minimize harmful effects on the environment caused by its activities,  to conform to applicable regulatory requirements, and to  achieve continual improvement of its environmental performance.

Management systems • Management system means what the organization does to manage its processes, or activities in order that  its products or services meet the organization’s objectives, such as  satisfying the customer's quality requirements,  complying to regulations, or  meeting environmental objectives

Management systems • To be really efficient and effective, the organization can manage its way of doing things by systemizing it. • Nothing important is left out. • Everyone is clear about who is responsible for doing what, when, how, why and where. • Management system standards provide the organization with an international, state-of-the-art model to follow.

Management systems (cont.) • Large organizations, or ones with complicated processes, could not function well without management systems. • Companies in such fields as aerospace, automobiles, defence, or health care devices have been operating management systems for years. • The ISO 9001 and ISO 14001 management system standards now make these successful practices available for all organizations.

Processes, not Products • Both ISO 9001 and ISO 14001 concern the way an organization goes about its work. • They are not product standards. • They are not service standards. • They are process standards. • They can be used by product manufacturers and service providers.

Accreditation • Accreditation is like certification of the certification body. • It means the formal approval by a specialized body - an accreditation body - that a certification body is competent to carry out ISO 9001:2008 or ISO 14001:2004 certification in specified business sectors. • Certificates issued by accredited certification bodies and known as accredited certificates - may be perceived on the market as having increased credibility. • ISO does not carry out or approve accreditations.

Benefits of ISO 9001 and ISO 14001 • International, expert consensus on stateof-the-art practices for quality and environmental management. • Common language for dealing with customers and suppliers worldwide in B2B. • Increase efficiency and effectiveness. • Model for continual improvement.

Benefits of ISO 9001 and ISO 14001 (cont.)

• Model for satisfying customers and other stakeholders. • Build quality into products and services from design onwards. • Address environmental concerns of customers and public, and comply with government regulations. • Integrate with global economy.

Benefits of ISO 9001 and ISO 14001 (cont.)

• Sustainable business • Unifying base for industry sectors • Qualify suppliers for global supply chains • Technical support for regulations

Benefits of ISO 9001 and ISO 14001 (cont.)

• Transfer of good practice to developing countries • Tools for new economic players • Regional integration • Facilitate rise of services

Certification not a requirement • Certification is not a requirement of ISO 9001 or ISO 14001. • The organization can implement and benefit from an ISO 9001 or ISO 14001 system without having it certified. • The organization can implement them for the internal benefits without spending money on a certification programme.

Certification is a business decision • Certification is a decision to be taken for business reasons: • if it is a contractual, regulatory, or market requirement, • If it meets customer preferences • it is part of a risk management programme, or • if it will motivate staff by setting a clear goal.

ISO does not certify • ISO does not carry out ISO 9001 or ISO 14001 certification. • ISO does not issue certificates. • ISO does not accredit, approve or control the certification bodies. • ISO develops standards and guides to encourage good practice in accreditation and certification.

The ISO 9000 family • ISO 9001 is the standard that gives the requirements for a quality management system. • ISO 9001:2008 is the latest, improved version. • It is the only standard in the ISO 9000 family that can be used for certification. • There are 16 other standards in the family that can help an organization on specific aspects such as performance improvement, auditing, training…

Seven Tools for Quality Control Pareto Charts Check Sheets Cause & Effect Diagrams Scatter Diagram Histograms Graphs or Flowcharts Control Charts

Pareto Charts Purpose: Prioritize problems.

How is it done? • Create a preliminary list of problem classifications. • Tally the occurrences in each problem classification. • Arrange each classification in order from highest to lowest • Construct the bar chart

Pareto Charts Benefits:



Pareto analysis helps graphically display results so the significant few problems emerge from the general background It tells you what to work on first

100

80 Quantity



120

60

40

20

0 Defects

Dent

Scratch

Hole

Others

Crack

Stain

Gap

104

42

20

14

10

6

4

Pareto Charts  Weighted Pareto charts use the quantity of defects multiplied by their cost to determine the order.

PARETO CHART A graphical representation ranking discontinuities from the most to least significant. Used to help brainstorm what discontinuities, if worked upon first, would be the most likely to produce the greatest improvement in quality. 900 800

Total

Cost 4 104 20 10 42 14 6

200 2 5 8 1 1 1

700 600

Weighted Cost

Defect Gap Dent Hole Crack Scratch Others Stain

Weighted cost 800 208 100 80 42 14 6

500 400 300 200 100 0

Weighted cost

Gap

Dent

Hole

Crack

Scratch

Others

Stain

800

208

100

80

42

14

6

Checksheets Purpose: – Tool for collecting and organizing measured or counted data – Data collected can be used as input data for other quality tools

Benefits: – Collect data in a systematic and organized manner – To determine source of problem – To facilitate classification of data (stratification)

Fishbone Diagram Purpose: Graphical representation of the trail leading to the root cause of a problem

How is it done? • Decide which quality characteristic, outcome or effect you want to examine (may use Pareto chart) • Backbone –draw straight line

• Ribs – categories • Medium size bones –secondary causes • Small bones – root causes

CAUSE AND EFFECT DIAGRAMS (Fishbone Diagram) Used in brainstorming session to help identify the causes of quality losses. This diagram is particularly useful after the flow chart and the Pareto diagrams have been developed.

Cause

QUALITY (Effect)

Step 1: Decide on the quality characteristic Step 2: Set up the fish bone backbone Step 3: Identify main factors causing effect {e.g. Personnel (Workers), Materials, Procedures, Equipment, Inspection, Tools , and others} Step 4: Add Cause to each branch

Cause & Effect Diagrams Benefits: • Breaks problems down into bite-size pieces to find root cause

• Fosters team work • Common understanding of factors causing the problem • Road map to verify picture of the process • Follows brainstorming relationship

Cause & Effect Diagrams

Sample Manpower

Materials

Typos

Source info incorrect

Wrong source info

Didn’t follow proc. Dyslexic Transposition

Wrong purchase order

Incorrect shipping documents

Glare on display

Temp. Environmen t

Corrupt data

No training No procedure

No communications Software problem Methods

Machine

Keyboard sticks

Scatter Diagrams Purpose: To identify the correlations that might exist between a quality characteristic and a factor that might be driving it • A scatter diagram shows the correlation between two variables in a process. – These variables could be a Critical To Quality (CTQ) characteristic and a factor affecting it two factors affecting a CTQ or two related quality characteristics. • Dots representing data points are scattered on the diagram. - The extent to which the dots cluster together in a line across the diagram shows the strength with which the two factors are related.

Scatter Diagrams How is it done?: • Decide which paired factors you want to examine. Both factors must be measurable on some incremental linear scale. • Collect 30 to 100 paired data points. • Find the highest and lowest value for both variables. • Draw the vertical (y) and horizontal (x) axes of a graph. • Plot the data • Title the diagram The shape that the cluster of dots takes will tell you something about the relationship between the two variables that you tested.

Scatter Diagrams •

If the variables are correlated, when one changes the other probably also changes.

•

Dots that look like they are trying to form a line are strongly correlated.

•

Sometimes the scatter plot may show little correlation when all the data are considered at once.  Stratifying the data, that is, breaking it into two or more groups based on some difference such as the equipment used, the time of day, some variation in materials or differences in the people involved, may show surprising results

Scatter Diagrams

Scatter Diagrams • You may occasionally get scatter diagrams that look boomerang- or banana-shaped. To analyze the strength of the correlation, divide the scatter plot into two sections. Treat each half separately in your analysis Benefits:

• Helps identify and test probable causes. • By knowing which elements of your process are related and how they are related, you will know what to control or what to vary to affect a quality characteristic.

Histograms or Bar Charts Purpose: To determine the spread or variation of a set of data points in a graphical form

How is it done?: • Collect data, 50-100 data point • Determine the range of the data • Calculate the size of the class interval • Divide data points into classes Determine the class boundary • Count # of data points in each class • Draw the histogram

Stable process, exhibiting bell shape

Histograms or Bar Charts Benefits: • Allows you to understand at a glance the variation that exists in a process • The shape of the histogram will show process behavior •

Often, it will tell you to dig deeper for otherwise unseen causes of variation.

• The shape and size of the dispersion will help identify otherwise hidden sources of variation •

Used to determine the capability of a process

• Starting point for the improvement process

Purpose:

Flow Charts

Visual illustration of the sequence of operations required to complete a task  Schematic drawing of the process to measure or improve.  Starting point for process improvement  Potential weakness in the process are made visual.  Picture of process as it should be.

Benefits:  Identify process improvements  Understand the process  Shows duplicated effort and other non-value-added steps  Clarify working relationships between people and organizations  Target specific steps in the process for improvement.

Benefits • Simplest of all flowcharts • Used for planning new processes or examining existing one • Keep people focused on the whole process How is it done? • List major steps • Write them across top of the chart • List sub-steps under each in order they occur

Flow Charts Top Down

Measure

Analyze

Improve

Control

Problem report

Customer input

Hardware procurement

Fleet leader reports

Hardware return

Stress analysis

Customer coordination

Service reports

Failure analysis

Heat transfer analysis

Compliance verification

Operational statistics

Life analysis

Documentation

Substantiation

FAA approval

Benefits • Show what actually happens at each step in the process • Show what happens when non-standard events occur • Graphically display processes to identify redundancies and other wasted effort

How is it done? • Write the process step inside each symbol • Connect the Symbols with arrows showing the direction of flow

Flow charts Linear

Toolbox

FLOW CHARTS Flow charts are graphical representations of the steps involved in a process. Constructing a flow chart helps give a better understanding of the systems involved.

Process

Data

Decision

Y es

Process

Terminator

No

Process Control transfer

Control Charts Purpose: The primary purpose of a control chart is to predict expected product outcome.

Benefits: • Predict process out of control and out of specification limits • Distinguish between specific, identifiable causes of variation • Can be used for statistical process control

Control Charts • Strategy for eliminating assignable-cause variation: – Get timely data so that you see the effect of the assignable cause soon after it occurs. – As soon as you see something that indicates that an assignable cause of variation has happened, search for the cause. – Change tools to compensate for the assignable cause. • Strategy for reducing common-cause variation: – Do not attempt to explain the difference between any of the values or data points produced by a stable system in control. – Reducing common-cause variation usually requires making fundamental changes in your process

Control Charts • Control Chart Decision Tree –

Determine Sample size (n)

–

Variable or Attribute Data

• Variable is measured on a continuous scale • Attribute is occurrences in n observations

–

Determine if sample size is constant or changing

Control Charts What does it look like? o Adding the element of time will help clarify your understanding of the causes of variation in the processes. o A run chart is a line graph of data points organized in time sequence and centered on the median data value.

Quality

Services Processes Human Resources

Price

Technology

Facilities

Reliability

Delivery

QUALITY ASSURANCE & INSPECTION

CQA ROLE IN SPECIFICATION FINALISATION AND PRE-AWARD AGREEMENT QA REQUIREMENTS IN MODULAR SPECIFICATION BID EVALUATION

PRE-AWARD AGREEMENT WITH IDENTIFIED VENDORS/ MAIN CONTRACTORS FEEDBACK OF SUBVENDOR PERFORMANCE BY RIO / SITE

ANALYSIS OF PREVIOUS NON-CONFORMITIES (NCRs)

VALIDATION FOR PACKAGE CONTRACT SPECIFICATION

C Q

BID EVALUATION REPORT

(I) LIST OF ITEMS REQUIRING QP AND SUB-VENDOR APPROVAL (II) QA&I CO-ORDINATION PROCEDURE (III) SUB-VENDOR ASSESSMENT PROCEDURE

A

E N G G

(IV) QUALITY AUDIT REQUIREMENTS

TO CS & FORM PART OF LOA

QUALITY ASSURANCE & INSPECTION

1975-1980 THE INFANCY : DEVELOPMENT OF STRONG BASICS

1990-1995 ENTRY INTO BULK O&M PHASE OF PLANTS. STRONG BASE OF FQA

1980-1990 ESTABLISHING MATURE SYSTEM. IMPLEMENTATION OF SAME IN POWER PLANTS

1995-2004 AMBITIOUS GENERATION AND CAPACITY ADDITION PLAN. STRONG BASE OF FQA, RIOs & CQA