Total QUALITY MANAGEMENT

- Nothing can with stand the power of the determined and resolute mind. Barriers fall, everything succumbs --- if positively inspired, the very gates of heaven open. Unknown

CONTENTS
1 2

Background
Eight Quality Management Principles & other Q.M. Concepts ISO 9001:2000/ 2008 Requirements

By three Methods We May Learn Wisdom:-

First, By Reflection, Which is the Noblest; Second, By Imitation, which is the Easiest; Third, By Experience, which is the Bitterest.

Confucius

What is Quality?
A frequently used definition of Quality is:-

Delighting the Customers by fully meeting their needs

and expectations.
These may include:Performance Appearance Availability Delivery Reliability Maintainability Cost Effectiveness and Price

It is therefore imperative that the organization knows what these needs and expectations are! In addition, having identified these, the organization must understand and measure its own ability to meet these requirements.

The word Quality has many meanings:A Degree of Excellence, Freedom from Defects, Imperfections, Conformance with Requirements Fitness for Use and Intended Purpose. Totality of Characteristics of an Entity that bears on its ability to satisfy stated or implied needs. Delighting the customers.

Quality Definition As Per ISO 9000 Std

By Combining the Definition of the Terms Quality & Requirements in ISO 9000 Standard, Quality has been expressed as:The Degree to which a set of inherent
characteristics fulfill a need or expectation that is stated, generally implied or obligatory.

For Satisfaction From Quality Products Or Services, There Are Three Fundamental Parameters:-

Price,

Customers Approach

Quality,
And Delivery.

Price
Quality

Delivery

Why QUALITY?
To reduce Cost To increase Profits

To instill a sense of satisfaction among your customers and employees

Quality Parameters
Quality is a composite of three parameters:Quality of Design Quality of Conformance Quality of Use Quality of Design
Is the extent to which the design reflects a products or service that satisfies the customer need or expectations.

Quality of Conformance
Is the extent to which the product or service conforms to the design standard

Quality of Use
Is the extent to which a product is easy to use, reliable and maintainable.

The Acceptance Inspection Model

Process

Acceptance Sampling

Inspection

Pass the Inspection? YES Acceptance

NO

Reject,Scrap,Rework,Repair

Next Process

Quality Control
It is that part of Quality Management focussed on fulfilling requirements of the Customers for the quality products.

A Simplest Form of Quality Control is:Requirements

Plan

Do Remedial Action

Check

Conforms

Yes

No Corrective Action

Product Or Service

Quality Assurance
Quality Assurance is that part of the Quality Management focussed on providing confidence that the Quality Requirements will be fulfilled.

Total Quality Assurance Total Quality Management

Total Quality Assurance

Total Quality Management

Quality Assurance

Quality Assurance (Process improvement)

Quality Control

Quality Control (Correction of Defects)

Inspection

Inspection (Sorting out good from bad products)

The Phases of Development of Quality Assurance Systems

Several Methods Have Matured

To Achieve, Sustain and Improve Quality. These methods are

Quality Assurance
Quality Control Continual Improvement

Which Collectively are known as Quality Management System

Quality Management System

Definitions
1. A System is an ordered set of ideas, principles and theories or chain of operations that produce Specific Results and to be a chain of operations, the operations needed work together in a regular relationship.

Quality Management System

2. Deming defines a system as a series of
Functions or Activities within an organization that work together for the aim of the organization.

3. ISO 9000 defines a Quality Management

System as a set of inter- related or inter- acting Processes that achieves the Quality Policy and the Quality Objectives.

Observations From The Work Place Have Been Taken Into:-

Consideration By Academia For Analysis For Synthesis And For Refinement

To Emerge as Universal Principles For Quality Management.

Quality Management Principles

A Quality Management Principle is :A Comprehensive and Fundamental Rule or Belief, for Leading and Operating an Organization, aimed at Continually Improving Performance over the Long Term by focusing on Customers while addressing the needs of all other Stakeholders.

The Eight Quality Management Principles are:Customer Focus

Continual Improvement

Leadership

Mutually Beneficial Supplier Relationship

QMS
Factual Approach

Process Approach

Involvement of People

System Approach

Customer Satisfactions

Universal Corporate Culture

Reliability

Friendly Pleasing Responsive

Credibility

WHAT IS A CUSTOMER?
A CUSTOMER is not an outsider to our business;
he is a definite part of it.

A CUSTOMER is not an interruption of our work;

he is the purpose of it. We are not doing him a favour. He is doing us a favour by letting us serve him.

A CUSTOMER is not a cold statistic; he is a fleshand-blood human being with feelings and emotions like our own.

A CUSTOMER is not someone to argue or match

wits with. He deserves courteous and attentive treatment.
Continued

WHAT IS A CUSTOMER?
A CUSTOMER is not dependent on us. We are
dependent on him.

A CUSTOMER brings us his wants. It is our job to

handle them properly and profitably both to him and to ourselves.

A CUSTOMER makes it possible for the company

to pay our salary. Whether we work in the marketing, production, quality, in the field or in the office.

A CUSTOMER is the most important person in our

business.

PROCESS APPROACH TO MANAGEMENT FOR QUALITY & PRODUCTIVITY

Men Materials Output Methods

PROCESS
Machines Scrap

Environment
Feedback Corrective Action

Process Flowcharting
Products Standard Regulators

Capacity Raw Materials

Internal Control

External

Regulators Requireme Legislation

Product Customers

Data

Input

Process
Resources

Outputs

Service

Supplies Human Skills & Experiences Knowledge

Mechanical

Physical
Site Machine Computer

The Key Roles of Process Management

Effective Process Management requires 4 Key Roles: The Process Sponsor The Process Owner The Process Manager The Process Worker The Process Sponsor is the person who provides direction and ensures that there is sufficient resource available to improve process. He or She is normally at a senior level in an organization. The Process Owner usually sits outside the process, and is directly and personally accountable for the end-to-end process. He or She is the final arbiter for the process and should drive any process improvement initiatives and activities. The Process Manager works inside the process and is responsible for discrete parts of it. He or She ensures day-to-day production performance, directly manages process workers and suppliers relationships and provides the process owner with metrics, reports and improvement ideas. The Process Worker works inside the process with responsibility for specific delivery to agreed standards. He or She may manage small teams of less experienced workers and provide the process manager with metrics, reports and improvement ideas.

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DEMINGS PDCA CYCLE

Analyze the Gaps Take Corrective and
Preventive Actions To fill the Gaps

Define Policy. Set Objective & Targets. Assign Responsibilities. Provide Resources.

DEMINGS CYCLE

Monitor & measure the

Actual Implementation Against the Planned. Identify the Gaps.

Implement according to
Planned Arrangements

DRIVE IS AN APPROACH TO PROBLEM SOLVING AND ANALYSIS THAT CAN BE USED AS PART OF PROCESS IMPROVEMENT.
DEFINE: The scope of the problem, the criteria by which success will be measured and agree the deliverables and success factors.

REVIEW: The current situation, understand the background, identify and collect information, including performance, identify problem areas, improvements and quick wins.

IDENTIFY: Improvements of solutions to the problem, required changes to enable and sustain the improvements.
VERIFY: Check that the improvements will bring about benefits that meet the defined success criteria, priorities and pilot the improvements.

EXECUTE: Plan the implementation of the solutions and improvements, agree and implement them, plan a review, gather feedback and review.
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CUSTOMERS (INTERNAL & EXTERNAL)

Who are my customers ? What are there true needs and expectations ? How do, or can, I find out what these are? How can I measure my ability to meet their needs and expectations? Do I have the capability to meet their needs expectations? (if not, what must I do to improve this capability?) Do I continually meet their needs and expectations? (if not, what prevents this from happening when the capability exists?) How do I monitor change in their needs and expectation? How do I process and handle the customer feedback and customer complaints?

SUPPLIER (INTERNAL & EXTERNAL)

Who are my internal suppliers? What are my true needs and expectations? How do I communicate my needs and expectations to my suppliers? Do my suppliers have the capability to measure and meet these needs and expectations? How do I inform them of changes in my needs and expectations? As well as being fully aware of customers needs and expectations, each person must respect the needs and expectations of their suppliers. The ideal situation is an open partnership style relationship, where both parties share and benefit.
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Customers and Managers Need: Knowledge of what is to be Supplied. (May be gained from the sales literature, contract or agreement for customers needs, expectations and requirements). Knowledge of how good the product or service is intended to be supplied or delivered. (May be gained from the suppliers proposal or offer). Knowledge that the declared intentions will be actually followed. (May be gained from proposal assessment or reliance on independent certification). Knowledge that products and service meets the specified requirements. (May be gained from proposal assessment or reliance on independent audits for product / or Service Quality). Knowledge that the declared intentions are actually being followed. (May be gained from proposal assessment or reliance on Independent Customer Audit for the QMS).
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Poor practices
To be able to become a total quality organization, some of the bad practices must be recognized and corrected. These may include: Leaders not giving clear direction; no commitment from the top management. Not understanding, at ignoring competitive positioning. Each department working only for itself; lack of understanding and cooperation. Trying to control people through systems; neglecting motivational aspects and human behavior. Confusing quality with grade. Accepting that a level of defects or errors is inevitable; improper Q.C., monitoring & measurement. Firefighting, reactive behavior; not realizing nature of problem and imposing unresolved solutions. The it is not my problem attitude. How many of these behaviors do you recognize in your organization?
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Underlying Concepts and Techniques for Foundation-Building

For the implementation of a program of foundation-building, the following simple and fundamental management concepts and techniques are used:-

5S (Good Housekeeping Practices)

KAIZEN Concepts and Techniques Waste Elimination

5S (Good Housekeeping Practices)

5 S is a disciplined step-by-step approach to keep the work place clean and well organized. The five Ss come from Japanese words starting with letter S as follows: (Word) 1st S SEIRI (Meanings)
Sort out unnecessary items in the work place and discard them. Arrange necessary items in good order.

2nd S

SEITON

3rd S

SEISO

Clean the workplace

thoroughly to eliminate waste and dust on the floor, machinery and equipment.

4th S

SEIKETSU

Maintain high standards of housekeeping of the work place in order all the time.

5th S

SHITSUKE

Train people to follow good housekeeping disciplines automatically.

5 S is a Starting Point for Productivity and Quality Improvement and Produces the Following Results:
The work place will be clean and better organized. Shop floor / office operations will be easier and safer to carry out.

The results will be visible to every one, both insiders and outsiders.
More new ideas for new improvements are likely to be generated because of visible results. The company image will improve generating more business opportunities, etc.

Tangible Benefits Observed in Companies Practicing the 5 S:

Happier employees with high morale. Greater people involvement. Increased number of suggestions. Better utilization of floor space. Better flow of production. Higher yield of materials. Lower defective and rework ratio.

KAIZEN

KAI

ZEN

(Change)

(Better)

Change for Betterment or Improvement

KAIZEN
KAIZEN is a concept, or state of mind, oriented towards continuous improvement.
KAIZEN is also a body of practical techniques utilized to improve the status quo in daily operations.

KAIZEN TECHNIQUES
KAIZEN techniques consists of the following steps: Identifying problem (s) Examining the problem (s) Finding ideas to solve the problem (s) Developing selected proposal (s) Implementing the proposal (s)

KAIZEN FRAMEWORK OR CYCLE OF CONTINUAL IMPROVEMENT

Define Problem (S) and Targets / Deliverables To be Achieved for Q.A. or TQM

(i) Deploy and Educate Team. (ii) Develop Implementation Plan And Execute The Improvement Plan.
Measure The Improvement Plan

Roll Out Continual Improvement Cycle Again

Quick Strike Breakthrough Improvements

Characterize i.e. (i) Control Process Variations (ii) Stabilize Process Collect Results & Analyze Work Out New Improvement Measures

Work Out Optimized New Plan For CPI & CQI

KAIZEN AND WORK

Where does work end and Kaizen Begins

JOB

Less

important Things Useless things

Things that should never be neglected or omitted

Allocate surplus time and energy to more Important tasks

KAIZEN

Kaizen and Innovation

Kaizen is different from innovation. Innovation generally represents the focus of western management , which results in large, short-term, radical changes in product or process. Often innovation is the result of substantial investment in equipment or technology to the major re-building of entire plant. INNOVATION

ONLY INNOVATION
What Should be the (Standard) Maintenance
What Actually is

What Should be the (Standard)

Maintenance
What Actually is

TIME

INNOVATION & CONTINUOUS IMPROVEMENT

INNOVATION
NEW STANDARD OF PERFORMANCE

INNOVATION

NEW STANDARD OF PERFORMANCE

Continuous improvement TIME

10 Basic Rules for Practicing Kaizen

1. 2. 3. Prepare people to accept change for the betterment. Think of how to do it and not why it cannot be done. Do not make excuses? Start by questioning current practices. 4. Do not seek perfection? Do it even if for only 50% of target. 5. Correct mistakes at once. 6. Do not spend money for Kaizen. 7. Wisdom is brought out when faced with hardship. 8. Ask why? Five times and seek root causes. 9. Seek the wisdom of ten people rather than the knowledge of one. 10. Kaizen ideas are infinite.

More Comments on Kaizen

Kaizen is a system of accumulated improvement. The main purpose of Kaizen is to evolve total employee participation and it also helps in building capable work force for an organization. The results of Kaizen are not very drastic but incremental thats why continuous improvement leads to accumulated improvement. Kaizen is a process-oriented thinking and not result oriented thinking:

Process oriented
Self discipline Time management Skill Management Participation & involvement Communication Morale

Result oriented

I dont care, you get it done just give me one result.

CONTINUOUS IMPROVEMENT OR KAIZEN

1. Kaizen in Japan means on-going improvement which involves everyone in the organization. 2. Kaizen affects all layers of management and workers.
3. In fact, the concepts of Kaizen in Japan is deep rooted and applies to everyday life. 4. Improvement in Japan concerns social life, personal life and working life.

CONTINUOUS IMPROVEMENT OR KAIZEN

5. Kaizen is very much a customer-driven strategy and therefore efforts have to be sustained to maintain the customer satisfaction.
6. The concept is made easily applicable because there is wide recognition that problems exist everywhere in the organizations and that those need to be tackled if the companies are to progress.

CONTINUOUS IMPROVEMENT OR KAIZEN

7. The driving force in wanting to improve is not a Management Push but a General Concern on the welfare by the employer organization and the belief that continuous improvement will benefit in turn the work force.

CONTINUOUS IMPROVEMENT OR KAIZEN

8. This is facilitated by the assistance of a positive climate and a culture which supports improvement.
9. The distinction to Kaizen is not one of a cultural bias but is one of Mentality.

Characteristics Of KAIZEN, Concept and Techniques

The Characteristics of KAIZEN are:
Continuous improvement. Accumulation of small steps. Total employee involvement.

INNOVATION
Technology oriented Result oriented Land marking steps for breakthrough

KAIZEN
People oriented Process oriented Accumulation of small steps

TO CONCLUDE KAIZEN WHY?

1. 2. 3. 4. 5. 6.

Because it promotes change. Because it promotes creativity and participation. Because it improves personal development. Because it promotes team work. Because it improves the work environment . For the organization and industrys survival.

Force Field Analysis

A useful technique for helping managers to understand the change process is Force-Field Analysis. This is a process of analyzing the forces for and against a change in behavior by an individual or a group. The forces are illustrated in the following examples:-

Example 1 A Model of Force Field Analysis

Forces for
Divisional Managers View Forces against

Productivity improvement necessary for survival. Improved management control Early diagnosis of potential problems Able to communicate achievements to the management Improved ability to plan Ability to validate staffing levels Ability to recognize good units

Cost Employees lack of understanding Difficulty of establishing valid measures

Example 2 Departmental Managers / Employees Views

Forces for
Top Management Wants it

Forces against
More reports to complete Closer management control Might be embarrassing Boss does not understand our work Nothing in it for me Excuse to cut our resources Cant measure what I do

QUALITY CONTROL CRICLE

HISTORY OF QUALITY CRICLE Quality Circle or Quality Control concept originated from Japan. In April 1962, Dr. K.Ishikawa, Presented this idea in the inaugural issue of journal on QC. In the last 36 years, Quality Circle concept was introduced in as many as 130 countries. Quality Circle concept is well established only in ASEAN countries like Japan, South Korea, Peoples Republic of China, Taiwan etc.

Introduction of Quality Circle Concept

Quality circles are small groups of volunteer workers who come from the same work unit or who do similar work. Meet regularly to identify problems and improvements within their area of responsibility.

Definition of Quality Circle

Original Quality Circle is a small group that performs voluntarily for improvement activities within the same workshop. This small group carries on continuously as a part of company wide improvement activities with the focus on self and mutual developments and improvements within the workshop, utilizing quality control techniques with the participation of all members.

Definition of Quality Circle

Revised
Based on the experience and knowledge gained over 30 years and more, Japanese Body for the movement in Japan has modified the definition of the concept in 1995. Revised Version is Given Below:-

Q.C. Circle is a small group in which people who work in the first line work place, continually improve and maintain the quality of products, services, job and so on.
Comments on Revised Definition of Quality Circles: As we can see, Revised Version clarifies many important points. This version can be broadly divided into two aspects i.e. : a. Connected to workman. b. About managerial responsibilities and activities needed to be carried out by them.

Story Of Toyota (Pakistan) Manager

In 1974, when I was Manufacturing Manager for passenger car assembly plant, in my department there were 50 QC Circles out of 850 production workers which completed 198 projects being reported to me in three months. I showed these projects to my 6 Superintendents, 36 Foremen; asking how many projects (problems) they were aware of in advance

< Sample Size> N=198 QCC Projects

Manager 4% 7% 79% 100% First Line Workers General Foremen (Superintendents) Foremen

Workman Aspects
a. It is a small group activity for the first line work place i.e., for grass root level employees. b. Purposes are : I. To continually improve and maintain the quality of products, services jobs and so on. II. It is volunteer activity. III. To utilize the Quality Control concept and technique i.e. utilizing elementary statistical system, planning tool, etc. IV. To bring self-development and mutual development of the grass root level employees by developing their capability to reach self actualization. V. To make workplace better. VI. Customer satisfaction comes by high quality product at lower cost, free from defects, timely delivery and prompt services. VII. Social contribution.

The Function of Circle Leader/ Assistant Circle Leader

A leader is a person chosen by the member of the circle through consensus. For leader to play an effective role, he should be given the requisite education and training to lead and to develop leadership qualities and skills. Since Quality Circle conceptually is also applied management at grass root level, they are to be given training on management aspects. Aside from the facilitator, the success of the Quality Circles will depend upon how well the leader leads the group.

The other important functions of a leader are:1. 2. 3. 4. 5. 6. 7. Conduct meetings regularly Moderate in meetings Involve all the members Keep the cohesiveness of the group Coordinate Take the team towards achieving the goals Takes care of: i. Task behaviour of the group ii. Team maintenance iii. Disruptive or negative behaviour in the group

The Functions Of Members

Members join the group with full under-standing of the concept and philosophy of Quality Circle. It is recommended for their growth and natural aspiration. They should get involved whole-heartedly for their development and growth.

What Should be the Size of the Quality Circle?

An ideal size is five to eight members but they can be upto a maximum of ten. The size must never be so large that a member cannot have sufficient time to participate and contribute at each meeting. Too few members would also tend to make circle dormant.

Why This Structure?

A structure is a pr-requisite for performance. For any structure to be meaningful, it should first start with the top managements policies which should be laid down and linked to the organizations objectives and goals. The next step is to work out strategies to achieve these through structure and systems by spelling out roles for a concerted effort to accomplish results. Steering Committee M.D./C.E.O Quality Circle

Advisors
Members (Departmental Heads)

Advisor (Dept. Manager)

Coordinator

Facilitator (AM/ Engineer ) Circle Leader (Team Leader)

Members

The Function of Advisor/ Facilitator

Advisor/ Facilitator is a nominated senior person of an area and he/she ought to catalyze and stimulate the Quality Circles. Advisor / Facilitator role is that of a parent, caring for children. Even without Quality Circles, a senior persons role is to develop the people working with him/ her and enable them to achieve and give them the pride of achievement. Advisor/ Facilitator should be a role model and a value shaper. The Advisor/ Facilitator could be rotated once in two years, or as may be deemed fit by the organization.

Managerial Responsibility
i.
ii. iii. iv. In order make QC Circle successfully contribute to the enterprises:Managers should implement TQM or such similar philosophy by themselves so that they can fulfill the primary responsibility to the enterprises. Such knowledge gained helps to give the required environment for Quality Circle activities. Continually give the appropriate guidance and support. Quality Circle activities help to create a respect for support. Also enables to bring participation from every person. Quality Circle activities are important for human resource development and work place utilization.

v. vi.

KAIZEN/QUALITY CIRCLE-A STEP BY STEP APPROACH

1) Circle Formation

2) Reason For Theme Selection 3) CURRENT ANALYSIS 4) MAKE A PLAN 5) ESTABLISH GOALS 6) PROBLEM ANALYSIS 7) TRY COUNTERMEASURES 8) RESULT CONFIRMATION 9) STANDARDIZATION 10) ACHIEVEMENTS
11) REVIEW AND WORK OUT FUTURE PLAN

12) SUMMARIZING AND REPORTING

Definition Cost of Quality

Quality is measured by the cost of quality which is the expense of non conformance the cost of doing things wrong. Philip Crosby Quality is Free Quality costs usually are defined as costs incurred because poor quality may or does exist.

Quality and cost are sum, not a difference complementary, not conflicting objectives. Armand Feigenbaum

QUALITY COSTS
The cost of quality are generally classified into four categories:1) 2) 3) 4) Prevention Appraisal Internal Failure External Failure

Prevention Costs: Prevention costs include those activities which remove and prevent defects from occurring in the production process. Included are such activities as quality planning, production reviews, training, and engineering analysis, which are incurred to ensure that poor quality is not produced.

Appraisal Costs:
Appraisal costs are those costs incurred to identify poor quality products after they occur but before shipment to the customers. Inspection activity is an example.

Failure Costs:
Failure costs are those incurred either during the production process (internal) or after the product is shipped (external).

Internal Failure Costs:

Internal failure costs include such items as machine downtime, poor quality materials, scrap, and rework.

External Failure Costs:

External failure costs include returns and allowances, warranty costs, and the hidden costs of customer dissatisfaction and lost market share.

Recognition of the relative importance of external failure costs has caused many companies to broaden their perspective from product quality to total costumer satisfaction as the key quality measure.

The figure-1 is an attempt to convey the idea of an iceberg, where only 10 percent is visible and 90 percent is hidden from the view. The analogy is a good one because visible 10 percent comprises of such items as scrap, rework, inspection, returns under warranty, and quality assurance costs; for many companies these comprise what they believe to be the total costs.
When the hidden costs of quality are computed, controlled, and reduced, a firm can achieve the benefits shown at the bottom of figure-1.

Of these types of costs, prevention costs should probably take priority because it is much less costly to prevent a defect than to correct one. The principle is like the traditional medical axiom: An ounce of prevention is worth a pound of cure. The relationship between these costs is reflected in the 1-10-100 rule depicted in figure-2.
One dollar spent on prevention will save $10 on appraisal and $100 on failure costs.

As one moves along the stream of events from design to delivery or dock-to-stock, the cost of errors escalates as failure costs become higher and the payoff from an investment in prevention becomes greater.
Computer systems analysts are aware of this and understand that an hour spent on better programming or design can save up to ten hours of systems retrofit and redesign. One general manager of Hewlett-Packards computer systems division observed:

The earlier you detect and prevent a defect the more you can save. If you catch a two cent resistor before you use it and throw it away, you lose two Cents. If you dont find it until it has been soldered into a computer component, it may cost $10 to repair the part. If you dont catch the component until it is in the computer users hands, the repair will cost hundreds of dollars. Indeed, if a $5000 computer has to be repaired in the field, the expense may exceed the manufacturing cost.

Defects, Scrap, Rework, Inspection, Returns, Warranty, Quality Assurance

Prevention
Design Review, Zero Defects Program, Supplier Training, Supplier Evaluation, Specification Review, Quality Audits, Preventive Maintenance, Engineering Changes, Product Liability, Increased Overhead

Appraisal
Vendor Surveillance, Receiving Inspection, Product Acceptance, Process Control, Inspection Labor, Quality Control Labor, Testing Equipment Costs

Internal Failure
Downtime, Engineering Changes, Excess Inventory, Disposal Costs, Reinsertion

External Failure
Consumer Affairs, Purchase Changes, Service after Sales, Product Liability, Lost Market Share Delivery Delay

Figure-1

1-10-100 Rule
1 $ $ $ $ 10 100 $ $ $

Prevention Correction

Failure

$ $ $

Benefits of Costs of Quality Control Reduced Items Inventory Levels Finished Goods Improved Items Return on Assets Scale Economies

Lead-Time
Time-toMarket Turnaround Work in Process

Warehouse Space
Order Process Time Dock-to- Stock

Return on Investment
Vendor Relations

Scheduling
Productivity

Transportation Learning Curve

Strategic Rational For Benchmarking In Todays Organization

Benchmarking has been described as one of the major management revolutions of the 1990s with its popularity increasing as other management tools and techniques are dismissed as flavour of the day within a short time frame. This growing interest in benchmarking is perhaps to be expected given its usefulness in setting competitive standards and in helping organizations strive for superiority, which are fundamental parts of its nature.

BENCHMARKING
1.General:
How do we know whether our Group is Good, Average or at the Top of the Industrial & Business Sector of our concern. The question is well answered through the Benchmarking Practices. Benchmarking is a technique used by the ambitious companies around the world in the most important aspects of their Business Operations.

All companies have one thing in common: a recognition that profitability and growth come from a clear understanding of how the business is doing, not just last year, but against the best they can measure.

2. Leading Note:
Nobody is good at every thing. One doesnt need to be the best at every thing.

One may be actually the second best in many

performance factors and still be the best overall.

So, an Organization is supposed to set about

learning how people do things and get to the top in key elements.

3. Points To Watch:
Too much information is as bad as too little. Gather only the information you need to make a
direct comparison of performance.

If you have properly defined your benchmark in

the first place, you will be dealing with manageable and useful data.

 Once you have identified that other companies have

a higher level of performance in a particular activity, one should: Quantify it, as closely as possible. Make sure you are comparing like with like.

Get other managers opinion on the lessons you can

learn from the other companies experiences.

4. Key Questions:
These Are: Remember that the most important issues may change with time.
Dont try to benchmark too many things to begin with.

Dont try to benchmark things that are Just Nice to know.

The more precisely you define what you want to measure. Before you start comparing with other companies, test the benchmark within your own organization, to make sure they really work.

5. Benchmarking Features
Change Measurement
Review

Benchmarking Features

6.

Focusing Benchmarking

Mission
Benchmarking

Critical Processes
Critical Success Factors

Benchmarking processes or activities, which do not support any of these statements, should be disregarded, as the benefits will be limited compared to those that could be achieved by deploying resources to other areas.

7.
Benchmarking Type

Selecting Benchmarking Partners

Potential Benchmarking Partners

Internal

Comparable sites, branches, sections, departments within the business

Competitor

Within the same industry sector

Functional

Same function across all industry fields

Generic

All industry fields

8. Definitions of Benchmarking
Definitions of benchmarking are many but an analysis of each reveals similar characteristics:1. An enabler for achieving and maintaining high levels of competitiveness. 2. The measurement of business performance against the best of the best through a continuous effort of constantly reviewing processes, practices and methods. 3. Benchmarking is a process which can be characterized by a standard (an excellence point obtained) and variables (expectations, performance and measurements).

8. Definitions of Benchmarking
4. The continuous process of measuring our products, services and business practices against the toughest competitors and those companies recognized as industry leaders. 5. Emulating the best by continuously implementing change and measuring performance. (Comments:Differences are due largely to a change in focus rather than any fundamental disagreement.)
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9. Outline Plan For Benchmark.

You can benchmark almost any activity that

can be measured. In practice, however, we shall normally want to start with those things, we are really good at to be successful in our Kind of business. A Routine Benchmarking Scheme will be completed in a period of six months to one years time.

Benchmarking Plan Year ------- (Jan.-Dec.)

Sr.# Benchmarking Parameters Causes of Success
1. 2. 3. 4. 5. Consistency of Products Quality. On Time Delivery. Speed of Service. Material Wastes. Rejects.

Solution Term Long Term

Failure Short

Remarks (FollowUps,etc)

6.
7. 8. 9. 10. 11. 12. 13.

Inventory (Stock) Levels.

Work in Progress. Sales Targets. Employees Performance. Employee Turn Over Rate. More Satisfied Customers and Fewer Complaints. Quality Problems and Reworking. Reputation in the Local and International Markets.

Experts Advice
The most critical elements is Top Managements Commitment. It is a well known fact that major change initiatives will not be successful without a culture of Good Teamwork and Cooperation at all levels in the Organization.

Business Process Re-engineering

(Business Process Re-Design and Transformation)
Definitions of the Concept Include:

The fundamental re-thinking and radical re-design of business processes to achieve dramatic improvements: In critical & contemporary measures of performance, such as cost, quality, service and speed.

 Definition Continues: To re-think, restructure and streamline:a) The business structures & processes. b) Methods of working. c) Management systems and external relationships through which we create and deliver value.

BPR is therefore an approach and takes the form of a project, typically having seven phases:1. Discover 2. Analyze and Document the re-designed Process(es) 3. Involve and rebuild 4. Re-organize and re-train 5. Establish the re-designed process(es) & re-design the work teams. 6. Measure Performance 7. Continuous re-design and improvement

1. Discover Phase: A problem or unacceptable outcome is identified and desired outcome determined. This includes:a) Business Needs b) Processes Involved c) And Effectiveness of Monitoring & measurement Plans.

2. Analyze the Existing Process(es) and Document the Re-designed Process(es): Analyze the current business process(es) & determine new & re-designed Process(es).
Establish Process Flow Charting for Redesigned Process(es). Measure, Test, Analyze, and Finalize the Redesigned Process(es). Use Benchmarking Information, where required.

3. Involve and Rebuild Phase: Redesign & Rebuild the Work Teams. The teams must rethink and fully understand the redesigned or new Process(es). Everybody should be involved for the agreed Action Plan.

4. Reorganize and Retrain: For New Technology and New or Redesigned Processes. BPR may involve Substantial Investment in Training and Top Managements Commitment / Support.

5. Establish the Re-designed Process(es) With Re-designed Work Teams: It is critical for the success of BPR and depends on the scope of the Business Process(es). It therefore includes:

Establish & Implement the Re-designed process(es) with Re-designed work teams (where required) Overall Process Sponsor or Champion (Effective Managerial Skills) Process Owner (Resolver of Process Bottlenecks) Team Leader or Process Manager (Motivator & Resource Provider) Facilitator (Coordinator & Support Services) Team Members (Knowledge, Skills, Attitudes)

6. Measure the Performance: Of the new Process(es), Sub Process(es), Activities and Tasks. Must be Meaningful in terms of inputs and outputs of the Process(es) for the Customers Needs & Expectations.

7. Continuous Redesign and Improvement: Process(es) after Process(es) in BPR will build Improvement Culture across the entire & throughout the Organization.

Defining Total Quality Management (TQM)

TQM is an all-encompassing dynamic process in an organization to promote never-ending improvement in the effectiveness and efficiency of all elements of a business. The TQM Process aims at galvanizing the entire work force to pursue the specific corporate goal of achieving customer satisfaction with regards to Quality, Price and Delivery. The strategy used by an organization that adopts TQM Philosophy is through usage of techniques such as Statistical Process Control, Design of Experiments, Employee Empowerment and Team Structures and Processes.

TQM A PROACTIVE BUSINESS APPROACH

Being adopted by the many Industrial and Business

Organizations to promote: 1. Competitiveness in their Organizations. 2. Growth of Companies Business.

Demings Process Oriented Approach To Achieve TQM

He emphasizes on: a) Quality of Management Processes as well as b) Quality of Work Processes Leading to Continual Improvement Loop

TO ACHIEVE TOTAL CUSTOMER SATISFACTION, TOP MANAGEMENT & EMPLOYEES NEED TO BE COMMITTED TO:
Make Quality a Personal Task & Pride. Perform each Process or Activity if we are the EndUsers / Buyers. Understand each Process Worker in the next Operation is Valued Customer. Do right the first time & every time.

TOTAL PARTICIPATION & COMMITMENT

No Matter how High or how much excellent technology may be and how much capital may be accumulated, unless the groups of human beings which comprise the enterprise work together towards one unified goal, the enterprise is sure to go down the path of decline. (President, Nissan Motor Co.)

DEMINGS FOURTEEN POINTS THE TOTAL QUALITY & PRODUCTIVITY APPROACH

1. Create consistency of purpose towards the improvement of products and services in order to become competitive, stay in business, and provide jobs. 2. Adopt the new philosophy. Management must learn that it is a new economic age and must awaken to the challenges, learn their responsibilities, and take on leadership for change. 3. Stop depending on inspection to achieve quality. Build in quality from the start. 4. Stop awarding contract on the basis of low bids. 5. Improve continuously and forever the system of production and services, to improve quality and productivity, and thus constantly reduce costs.

DEMINGS FOURTEEN POINTS THE TOTAL QUALITY & PRODUCTIVITY APPROACH

6. 7. 8. 9. 10. Institute training on the job. Institute leadership. The purpose of leadership should be to help people and processes must work better. Drive out fear so that everyone may work effectively. Break down barriers between departments so that people can work as a team. Eliminate slogans, exhortations, and targets for the workforce. They create adversarial relationships. Eliminate quotas and management by objectives. Substitute leadership. Remove barriers that rob employees of their pride of workmanship. Institute a vigorous program of education and self-improvement. Make the transformation everyones job and put everyone to work on it.

11. 12. 13. 14.

LIKE DEMING, CROSBY HAS HIS OWN FOURTEEN POINTS:

1. Management Commitment: Top Management must be convinced of the need for quality and must clearly communicate this to the entire company by written policy, stating that the person is expected to person is expected to perform according to the requirement or cause the requirement to be officially changed to what the company and the customers really need. 2. Quality Improvement Team: form a team composed of departmental heads to oversee improvements in their departments and in the company as a whole.

3. Quality Measurement: Establish measurement s appropriate to every activity in order to identify areas in need of improvement. 4. Cost of Quality: Estimate the costs of quality in order to identify areas where improvements would be profitable. 5. Quality awareness: raise quality awareness among employees. They must understand the importance of product conformance and the costs of non-conformance. 6. Corrective Action: Take corrective action as a result of steps 3 and 4. 7. Zero Defects Planning: Form a committee to plan a program appropriate to the company and its culture.

8. Supervisors Training: All levels of managements must be trained in how to implement their part of the quality improvement program. 9. Zero Defects Day: Schedule a day as a signal to employees that the company has a new standard. 10. Goal Setting: Individuals must establish improvement goals for themselves and their groups. 11. Errors Cause Removal: Employees should be encouraged to inform management of any problem that prevents them from performing error free network.

12.Recognition. Give public recognition, nonfinancial appreciation, to those who meet their quality goals or perform outstandingly. 13. Quality Councils. Composed of Quality professional and team chairpersons, quality council should meet regularly to share experiences, problems and ideas. 14. Do It All Over Again: Repeat steps 1 to 13 in order to emphasize the never-ending process of quality improvement.

JURANS TEN STEPS TO QUALITY IMPROVEMENT ARE:

1. Build awareness of opportunities to improve. 2. Set goals for improvement. 3. Organize to reach goals. 4. Provide training. 5. Carry out projects to solve problems. 6. Report on the progress made. 7. Give recognition to achievements. 8. Communicate results. 9. Keep score of performance. 10. Maintain movement by making annual improvement part of the regular system and processes of the company.

COMMENTS:
Juran is the founder of the Juran Institute in Wilton, Connecticut. He promotes a concept known as managing Business Process Quality, which is a technique for executing cross-functional quality improvement. Jurans contribution may, over the longer term, be greater than Demings because Juran has the broader concept. While Demings focus on statistical process control is more technically oriented.

ARMAND FEIGENBAUMS APPROACH

Build it in at an earlier stage of the process. Armand Feigenbaum, like Deming and Juran, Achieved

visibility through his work with the Japanese. Unlike the latter two, he used a total quality control approach that may very well be the forerunner of todays TQM. He promoted a system for integrating efforts to develop, maintain, and improve quality by various groups in an organization. To do otherwise, according to Feigebaum, would be to inspect for and control quality after the fact rather than

KAORU ISHIKAWA
Ishikawa is considered as Japans leading figure in the area of Total Quality Management. His inspiration came from the work of Deming and Juran and, to a lesser extent, Feigenbaum. He is well respected for the following contributions: 1. Quality Control Circles-he was the first to introduce this concept and to have put it into practice successfully; 2. He is the originator of Fishbone Diagrams or Ishikawa Diagrams which are now used worldwide in continuous improvement to represent cause-effect analysis; 3. Ishikawa has commented that Feigenbaum approach to Total Quality Control includes many non-specialists and therefore the input on quality problem solving may be limited.

4. He argues that Company Wide Quality Control (CWQC) Has to rely on the wide use of statistical techniques. 5. He has classified statistical techniques in three categories. 6. Ishikawa argues that nearly 90-95% of the problems can be solved using elemental statistical techniques, which do not require specialist knowledge.

TQM FOR MANUFACTURING COMPANY

Identify Customers
Identify Customers Requirements and Translate To Suppliers Specifications For Each Successive Customer (Internal & External)

Design Requirements

Part Characteristics
Manufacturing Operations
Production and External Vendor Requirements

Delivery Requirements Customer Satisfaction & Feedback

Sink suggested 7 x Stages for the Design, Development & Implementation of TQM: Stage 0: Understanding Organizational System

Stage 1: Developing Strategy For TQM Effort

Stage 2: Planning For TQM Stage 3: Specifying TQM Objectives Stage 4: Implementing TQM Stage 5: Project Management Sate 6: Measurement and Evaluation Sate 7: Accountability, Follow-ups For Effective Implementation (i.e. Improvements)

Oaklands 13 Steps for Achieving TQM Leading TO Continual Improvement Loop

Understanding Quality Commitment To Quality Policy For Quality Planning For Quality Design For Quality

Organization For Quality System For Quality Control For Quality Measurement Cost For
Quality

Implementation Of TQM

Teamwork For Quality Capability For Quality Training For Quality

Thereby, Achieving & Maintaining Continual Improvement Loop

TOTAL QUALITY MANAGEMENT (TQM)

(British Model)
TQM is the way of Managing the future, and is far wider in its application than just assuring product or service quality it is a way of managing people and business processes to ensure complete customer satisfaction at every stage, internally and externally. TQM, combined with effective leadership, results in an organization doing the right things, first time.

PEOPLE

CULTURE

COMMUNICATION

CUSTOMER/ SUPPLIER

SYSTEM

PROCESSES

COMMITMENT

The core of TQM is the customersupplier interface, both externally and internally, and at each interface lie a number of processes. This core must be surrounded by commitment to quality, communication of the quality message, and recognition of the need to change the culture of the organization to create total quality. These are the foundations of TQM, and are supported by the key management functions of people, processes and systems in the organization.

In the Name of Allah the Most Beneficent, the Most Merciful

TRUTHFULNESS AND YOU MUST NEITHER CONFUSE THE TRUTH WITH FALSEHOOD NOR HIDE THE TRUTH WHILE YOU KNOW
VERSE 42, SECTION 5, SURATUL BRAKRA, PARA A AL-QURAN

Origin of ISO 9001 Std on QMS

ISO 9001/02/03:87 ISO 9001/02/03:94 ISO 9001:2000/2008 BS5750 1979 AQAP1 (NATO) 1970s MIL-STD-9858 (1940s)

ISO 9000 - WHAT IS IT?

Do what you document and document what you do. The Standards say that Quality is not what you do as much as how you do it. The Standards are like a Checklist.

ISO 9000 - WHAT IT REQUIRES?

ISO 9000 demands a culture of quality in an organization seeking accreditation. It requires Top to Down Support.

Why ISO 9000 is necessary for Pakistan?

We want to foster continuous quality improvement and gain a competitive advantage in the world market for achieving business excellence at the global level. In other words

We want to survive!!!!

ISO 9001:2000/2008 Characteristics of the ISO 9001:2000/2008 New content wise emphasis results into four distinct features:
Process Orientation, Customer Focus, Implementation of an improvement process (CPI, CQI), and Quantified (examinable) quality objectives.

ISO 9001:2000/2008

0. Introduction

1. Range of Application

8. Measurement, Analysis and Improvement

2. References On Other
ISO 9001 : 2000 Standards 3. Terms & Definitions

7. Product Realization
6. Resource Management
5. Management Responsibility

4. Quality Systems

ISO Process Model for Quality Mgt.

CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM

CR e U q S u i T r e Om Me n E t R s

Management responsibility

Resource management

Measurement, analysis and improvement

ISO 9001:2000/2008
input

output

Product realization

product

CS a Ut S i s T f Oa c Mt i Eo Rn

ISO 9001:2000/2008
Clause 1.0 SCOPE
ISO 9001:2000/2008 Clause 1.1 General Demonstrate ability to consistently provide product to meet customers and applicable regulatory requirements. Aims to: (i) Enhance Customer Satisfaction (ii) To Continually Improve QMS (iii) Assurance of Product Conformity through QMS.

The Scope has been enhanced to address:Management Responsibility

(Clause 1.0, 4.0, 5.0)

Resource Management

Measurement, Analysis & Improvement Realization of Products & Services

(i) Customer Satisfaction (ii) Continual Improvement (iii) Prevention of Non Conformity (i.e. Assurance of Product Conformity) (All New).

Customers Requirements

Customers Satisfaction

ISO 9001:2000/2008 Clause 1.2 PERMISSIBLE EXCLUSIONS.

All requirements (Specs) are Generic. Applicable to all Orgs regardless of Type, Size and the Product Provided. Any requirement (s) that do not apply to the Org and its product are considered for exclusion from the QMS. Exclusions are limited to requirements in clause 7.0. Claims for conformity of the QMS are not acceptable unless these exclusions are limited to requirements within clause 7.0. Such exclusions do not affect the Orgs ability or responsibility to provide quality product.

Management Responsibility
(Clause 1.0, 4.0, 5.0)

Resource Management

Measurement, Analysis & Improvement Realization of Products & Services

Customers Requirements

Customers Satisfaction

ISO 9001:2000/2008 Clause 2.0 Normative Reference: ISO 9000:2000/2008

ISO 9001:2000/2008 Clause 3.0 Terms & Definitions

Clause 4.0 QMS REQUIREMENTS ISO 9001:2000/2008 CLASUSE 4.1 GEN REQUIREMENTS
The Org shall Estb, Doc, Implement and Maintain QMS & Continually Improve its effectiveness. The Org shall:a Identify Processes needed for the QMS (Processes For Mngt Activities, Provision of Resources, Product Realization and Measurement.) b Determine sequence and interaction of these processes. c Determine Criteria and Methods for the effective operation and control of these processes. d Availability of information necessary for operation and monitoring of these processes. e Measure, Monitor and Analyze these Processes. f Implement action to achieve planned results and Continual Improvement of these

processes.
Management Responsibility
(Clause 1.0, 4.0, 5.0)

For Outsourced Process(es), the Org shall identify & control such Processes for Products Conformity. Measurement, Analysis & Improvement

Resource Management

Customers Requirements

Realization of Products & Services

Customers Satisfaction

Clause 4.2: Documentation Requirements

4.2.1: Quality Policy / Quality Objectives 4.2.2: QMS Docs Quality Manual
(Policy/ Objectives)

Level 1 4.2.3 Control of Documents Level 2

Quality System Procedures WIs, PSs, Ref Stds, Drgs, etc

Level 3 4.2.4 Control of Records

Records/Reports/Logs

Level 4

Introduction to ISO 9001:2000/2008

4.2.3 DOCUMENT CONTROL

Review & Approval

Obsolete Document Control

Distribution Control

DOCUMENT CONTROL

External Document Control

Change Control

4.2.4 CONTROL OF RECORDS

Retrieval Identification Indexing

Disposition

RECORDS CONTROL

Retention

Maintenance Storage

Filing

ISO 9001:2000/2008 CLAUSE 4.2 GEN DOCUMENTATION REQUIREMENTS

4.2.1 GENERAL QM LEVEL I Doc Statement of Q / Policy & Q / Objectives. QSPs LEVEL II QM. Ref Std, WIs, LEVEL III Process Sheets, QSPs (Mandatory) LEVEL IV Records & Results Docs for Effective Planning, OP and Control of QMS Processes. Records. Note: 4.2.2 QUALITY MANUAL Scope of QMS 1) Docs can Vary due to the Orgs Size, Exclusions & Justifications (if any) Type of Activities, Complexity of Description of QMS, Policies, Processes Related Details, etc. Processes & Competence of Personnel. 4.2.3 CONTROL OF DOCS 2) Docs can be in any Form or Media. QSP is required for:(i)Control, (ii) Approval, (iii) Review, (iv) Changes, (v) Revision Status, (vi) Aval at Point of Use, (vii) External Docs (viii) Legible (ix) Identification of Obsolete Docs (x) Maintenance. 4.2.4 CONTROL OF RECORDS QSP is required for:(i) Control (ii) Evidence of Conformity (iii) Legible (iv) Identifiable (v) Storage (vi) Retrieval (vii) Protection (viii) Retention Time (ix) Disposition.
Management Responsibility

Resource Management

Measurement, Analysis & Improvement

Customers Requirements

Realization of

Customers Satisfaction

ISO 9001:2000/2008 Clause: 5.0 MANAGEMENT RESPONSIBLITY

New 5.1: Management Commitment New 5.2: Customer Focus

5.3: Quality Policy 5.4: Quality Objective & Planning

5.5.1: Responsibility & Authority 5.5.2: Management Representative 5.5.3: Internal Communication

New

5.5: Responsibility, Authority and Communication

New

5.6: Management Review

5.1 MANAGEMENT COMMITMENT

Establishing Quality Objectives

Setting Quality Policy

Supporting Quality Initiatives & Programs

Participating in Quality Reviews & Meetings

Providing Resources

Motivating & Involving people

5.2 CUSTOMER FOCUS

IDENTIFY & REVIEW MONITOR & MEASURE
Complaints Feedback

C U S T O M E R

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

C
U S T O M E R

Inputs

Organization s Processes
Product

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

5.3 QUALITY POLICY

QUALITY POLICY MEETING REQUIREMENTS CONTINUAL IMPROVEMENT

COMMITMENT

5.4 PLANNING
Rejection Rate = ?? Rework rate = ?? Failure rate = ?? On-time delivery = ?? Response time = ?? Complaints = ??

QUALITY OBJECTIVES

MEASURABLE

ACHIEVABLE

TIME-BOUND

REALISTIC

SPECIFIC

5.5 Responsibility, Authority & Communication

Defining responsibilities & authorities in the form of: Organizational Charts Job Descriptions Appointing the ISO 9000 Project Coordinator, called Management Representative (MR) Establishing Internal Communication Channels, which may include: intranet, memos, internal meetings, emails, phones, etc.

5.6 MANAGEMENT REVIEW

INPUTS OUTPUTS

Results of Audits
Complaints/Feedback Product Quality Status Pending Actions External Market Status Improvement Actions
Improvement Suggestions

Top Management Review Meeting

Resource needs Revision of policy Revision of objectives Corrective Actions

ISO 9001:2000/2008 Clause: 6.0 RESOURCE MANAGEMENT

6.1: General 6.2: Human Resources New 6.3: Infrastructure
6.2.1: General

New

New
6.2.2: Competence, Awareness & Training

6.4: Work Environment

6.2 HUMAN RESOURCES

COMPETENCE
Education Experience Skills Training

Identify training needs

TRAINING & AWARENESS

Provide training Evaluate the effectiveness of training

Maintain records of training

6.3/6.4 INFRASTRUCTURE & WORK ENVIRONMENT

WORK ENVIRONMENT
Temperature Humidity

Noise

Dust

INFRASTRUCTURE

Ventilation

Work Space

Equipment (hardware, software)

Health & Safety

Cleanliness

ISO 9001:2000/2008 Clause: 7.0 PRODUCT REALIZATION

7.1: Planning of Realization Processes 7.2: Customer-related processes
7.2.1 Determination of requirements New
7.2.2 Review of requirements 7.2.3 Customer Communication
New

7.5: Production
7.5.1 Control of Production 7.5.2 Validation of Processes 7.5.3 Identification and Traceability 7.5.4 Customer Property 7.5.5 Preservation

7.3: Design & Development 7.4: Purchasing

7.6: Control of Monitoring & Measurement Equip.

ISO 9001:2000/2008

7.0 Product Realization

The process:

Other processes

Cust.

Main process
Supporting processes

Cust.

is a system of activities, which converts inputs by

the help of resources into results. an action chain, index steps for reaching a working result, with a defined beginning and termination point. (from enterprise practice)

Product Realization Processes

Management Responsibility

Resource Management

Measurement, Analysis & Improvement Realization of products & services

Customers requirements

Customers satisfaction

Business processes and sequence identified Processes documented (e.g. in flow-chart) Criteria and methods determined for process control Measuring and monitoring activities defined and implemented Processes for release, delivery and post- delivery defined and implemented Validation of processes if applicable

7.1 PLANNING OF REALIZATION PROCESSES

QUALITY PLAN
Process stages Inspection and test stages Parameters to be controlled/checked Reference standards

Related records
Responsible persons

7.2 CUSTOMER-RELATED PROCESSES

CUSTOMERS SPECIFIED REQUIREMENTS

CUSTOMERS INTENDED REQUIREMENTS

STATUTORY & REGULATORY REQUIREMENTS

ORGANIZATIONS INTERNAL REQUIREMENTS

7.2.2 REVIEW OF REQUIREMENTS

Product requirements are defined

Records of review are maintained

Review of Requirements

Differences/ conflicts are resolved

Organization has the ability to meet the requirements

7.2.3 Customer Communication

CUSTOMER COMMUNICATION

Product Information (catalogues, brochures, website)

Enquiries, Orders, Contracts, (Meetings, Visits, Phone, Fax)

Customer Feedback, including customer complaints, customer service

7.3 DESIGN & DEVELOPMENT PROCESS

DESIGN REVIEW

Requirements - Customer - Technical - Legal INPUT Design & Development OUTPUT

VERIFICATION

VALIDATION

7.4 PURCHASING
Procedure

Purchasing Process (Evaluation and selection of suppliers)

Purchasing Information

Complete product specs. Personnel qualifications Approval of purchase documents

Verification of Purchased Product

Records

7.5.1 CONTROL OF PRODUCTION

Product Specifications Production planning

Availability of work Instructions

Production records

CONTROL OF PRODUCTION

Use of suitable Equipment

Maintenance of equipment
Availability of monitoring equipment

In-process monitoring & measurement

7.5.2 VALIDATION OF PROCESS

Review & Approval of Processes
Approval of equipment & qualification of personnel

Revalidation

Use of specific methods and procedures

Requirements for Records

7.5.3 IDENTIFICATION & TRACEABILITY

IDENTIFICATION

TRACEABILITY

INSPECTION & TEST STATUS

Article #/Model #/ Item #/Design #

Lot #/Batch #/ Serial #/Mfg. date

Tags/Stickers/Trays for rejected/reworked items

7.5.4 CUSTOMER PROPERTY

CUSTOMER PROPERTY

Segregation & Maintenance

7.5.5 PRESERVATION
Handling

Delivery

Storage

PRESERVATION

Protection

Packing

7.6 CONTROL OF MEASURING & MONITORING DEVICES

Identification of measuring equipment

Calibration Schedule
External & Internal Calibration

Calibration Sticker

Calibration Seals
Handling, Maintenance & Storage

ISO 9001:2000/2008 Clause: 8.0 MEASUREMENT, ANALYSIS & IMPROVEMENT

8.1: General 8.2: Monitoring and Measurement
8.2.1: Customer Satisfaction 8.2.2: Internal Audit
New 8.2.3: Measurement of Processes New

8.4: Analysis of Data

New

Customer feedback Product Performance Product & Process Trends

Suppliers

8.5: Improvement

New

8.2.4: Measurement of Products

8.5.1: Continual Improvement 8.5.2: Corrective Action

8.3: Control of Nonconformity

8.5.3: Preventive Action

8.2.2 QUALITY AUDITS

Procedure

AUDIT PLANNING

AUDIT EXECUTION

AUDIT REPORTING

CORRECTIVE ACTION & FOLLOW UP

Records

8.2.3/8.2.4 Monitoring of Processes & Products

Quality Plan or Inspection/Test Plans

Test records

INSPECTION & TESTING

Receiving In-process Final

Availability of specifications

Inspection and Test Methods

8.3 CONTROL OF NONCONFORMITY

Procedure

Alternative use

Reject/ Rework

Control of nonconformity

Accept-as-is

Re-grade

Records

8.4 ANALYSIS OF DATA

Analysis of Customer Data

Analysis of Suppliers Data

Analysis of Product Data

Analysis of Process Trends

8.5.1 CONTINUAL IMPROVEMENT

Quality Objectives

Management Review CONTINUAL IMRPROVEMENT

Data Analysis

Corrective/ Preventive Action

Quality Audits

ISO 9000:2000/2008
8 Measurement, analysis and improvement 8.5.1 Improvement

Q-policy
Management review
Q-objectives

Processes, products, services, QM system

Audits
Corrective and preventive measures

Data analysis

8.5.2 & 8.5.3 CORRECTIVE & PREVENTIVE ACTION

Identify the problem

CORRECTIVE ACTION
Action taken to eliminate the problems occurred to avoid their recurrence

Investigate the root causes Propose solutions

PREVENTIVE ACTION
Action taken to eliminate the potential problems to avoid their occurrence

Implement solution

Evaluate the effectiveness of solution

 For your employees:

1. Staff gets a better understanding of their role and objectives, by having a documented management system. 2. They benefit from reduced stress levels, because they are using an efficient management system and because they know what is expected of them. 3. They get increased morale and a sense of pride through achieving the goals of registration and customer satisfaction. 4. New staff can immediately learn their job, because the details are in writing.

 For your organization:

1. Your products will be of a more consistent quality, and you will produce fewer rejects.

2. You gain cost savings, because your production will be more efficient. There are economies in production (because your systems are controlled from start to finish), and economies in time that was formerly spend re-doing work.
3. You can improve the quality of your raw materials by requiring your suppliers to have a ISO 9001 system. 4. Export marketing is easier, because some foreign buyers recognize ISO 9001 (BS 5750).

5. You can expect preferential treatment from potential customers who have ISO 9001 certification. This means an increase in new business.
6. You secure greater customer loyalty, because you continuously satisfy their needs and give them no cause to seek another supplier. That means you suffer fewer customer losses.

7. You can use ISO 9001 in your publicity to win more sales.
8. ISO 9001 helps you minimize the risk of producing unsafe products. It may also give you some protection law against product liability claims. 9. Being first in your area or industry may put you ahead of your rivals by 18 months to two years.

 For your customers:

1. Your customers get a known level of quality that is independently audited.

2. They get a means of choosing between competing suppliers.

3. They can have more confidence in your goods.

4. ISO 9001 minimize their risk, by publishing responsibility on to their supplier (i.e. you).
5. They can manage you, their supplier, better by specifying that you must have a ISO 9001 system. 6. They can assess your quality system, and thus check your ability to produce satisfactory goods and services.

ISO Process Model for Quality Mgt.

CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM

CR e U q S u i T r e Om Me n E t R s

Management responsibility

Resource management

Measurement, analysis and improvement

input

output

Product realization

product

CS a Ut S i s T f Oa c Mt i Eo Rn