Quality concepts

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Prof.

MOHAMED I. EL KALIOBY

Prof. & Head Of Pediatrics Department

Director of Center for Research and Development in Medical Education and Health Services (CRD),

Member of QAU Executive Council

Faculty Of Medicine,

Suez Canal University, Egypt

INTRODUCTION TO

QUALITY CONCEPTS

Time Schedule of The Day

10.00 – 11.00: Introduction

11.00 – 11.30: Task A (Small groups)

11.30 – 12.00: Large group Discussion

12.00 – 12.15: Comments

12.15 – 12.45: Break

12.45 – 1.30: Task B (Small groups)

1.30 – 2.15: Large group Discussion

2.15 – 3.00: Task C (Small groups)

3.00 – 3.30: Large group Discussion

3.30 – 4.00: Exercises & wrap out

ITEMS

• QUALITY: Definition, Dimensions, Importance.

• HISTORICAL BACKGROUND.

• QUALITY CONTROL

• QUALITY ASSURANCE: Definition, Steps, Goals

• QUALITY IMPROVEMENT

• QUALITY MANAGEMENT

• TOTAL QUALITY MANAGEMENT

• HIERARCHIAL STRUCTURE

• Cost of Quality

• ISO SYSTEM

What do we mean by quality?

• Quality = Good

• The totality of features and characteristics of a product or service that bears on it’s ability to satisfy the stated or implied needs (ASQC)

“Are we doing things right?”

“Are we doing the right things?”

The key twin questions in the

application of quality procedures

in any domain of activity.

What is Quality?

• User-based: “In the eyes of the beholder”

“quality means meeting or exceeding customer expectations”

(Juran, 1951, Feigenbaum, 1962, Deming,1986)

• Manufacturing-based:

“Right the first time or Zero defects ” (Crosby, 1979)

• Product-based: Precise measurement

Dimensions of Quality

• Performance

• Reliability

• Durability

• Service after sale

• Aesthetics

• Special features: convenience, high tech

• Safety

• Perceived Quality

األداء

الصالحية

(العمر االفتراضى) صمود المنتج

خدمة مابعد البيع

شكل وجمال المنتج

مزايا أو خصائص المنتج

األمان والسالمة

سمعة المنتج

Importance of Quality

• Lower costs (less labor, rework, scrap)

• Motivated employees

• Market Share

• Reputation

• International competitiveness

• Revenues generation increased (ultimate goal)

HISTORICAL BACKGROUND Origin of Concepts and methods

which are the basis of quality

procedures were developed, Mainly in

USA and Japan

In industrial environments during and after the 2nd World War.

The aim: *to make production processes more efficient by reducing faults and errors - one of the watchwords was “zero tolerance of error” - and *to produce goods of consistently high, and standardised quality. In order to achieve this, a number of procedures and principles were developed.

HISTORICAL BACKGROUND 2

THE OLDEST TERM QUALITY • QUALITY CONTROL

• QUALITY ASSURANCE • QUALITY IMPROVEMENT • QUALITY MANAGEMENT

• TOTAL QUALITY MANAGEMENT CURRENTLY ENTERPRISES ARE RUSHING

TO • SIX SIGMA (1980s)

• DEMING AWARD (1951) • MALCOLM BALDRIDGE NATIONAL

QUALITY AWARD (MBNQA) (1987)

الجودة•

ضبط الجودة•

ضمان الجودة•

تحسين الجودة•

إدارة الجودة•

إدارة الجودة الشاملة•

QUALITY CONTROL

The procedures used to

check and assess the quality of

the products or services.

It was stressed that correcting mistakes

was expensive and time-consuming.

Therefore the aim was to “get it right the

first time, every time”.

QUALITY ASSURANCE

The systematic procedures and planned steps taken by an institution to make sure that it provides products or services of a high quality.

Goals

Provide management with the data necessary

to be informed about product quality

Make confidence and be sure that product

quality is meeting its goals

QUALITY ASSURANCE 2 Plan: Establish objectives

and processes required to

deliver the desired results.

Do: Implement the process

developed.

Check: Monitor and

evaluate the implemented

process by testing the

results against the

predetermined objectives

Act: Apply actions

necessary for improvement if

the results require changes. PDCA, Deming Cycle, Shewhart cycle,

Deming Wheel, or Plan-Do-Study-Act.

QUALITY ASSURANCE 3

How to check?

• Analysis

• Auditing

• Reporting

Who will check?

There are two parts to a QA system:

• internal quality assurance process

• external quality assurance process

كيف تتتم االختبارات ؟

التحليل•

المراجعة أو المراقبة•

التقارير•

من سيقوم باالختبارات ؟

QUALITY IMPROVEMENT

• Quality Improvement is a formal approach for:

* analysis of performance and

* systematic efforts to improve it.

There are numerous models used. The commonly discussed include:

• FADE (Focus – Analyze – Develop – Execute - Evaluate)

• PDSA (PLAN – DO – STUDY – ACT)

• Six Sigma

• CQI: Continuous Quality Improvement

• TQM: Total Quality Management -

QUALITY MANAGEMENT It is a method for

ensuring that all the

activities necessary to

design,

develop and

implement a product

or service

are effective and

efficient with respect to

the system and its performance.

It can be considered to

have 3 main components:

1) Quality control,

2) Quality assurance

3) Quality improvement.

It is focused not only on

product quality, but also

the means to achieve it.

QUALITY MANAGEMENT 2

A systematic set of operating procedures which is:

Company / Organisation wide, documented, implemented and maintained While ensuring the growth of business in a consistent manner

QUALITY MANAGEMENT 3

Flow Chart

It is a tool that

graphically represents

* the steps of a process

or

* the steps that users

have to take to use the

service

(user Flowchart).

QUALITY MANAGEMENT 4 Flow Chart 2

Why use Flow Chart?

Flowchart helps you analyze

*number of steps and

*time required for each step,

*to detect bottlenecks,

*unnecessary steps,

*repetitions, and

*other obstacles.

Who uses Flowchart? The team, the manager.

When to use Flow Chart? When you want to *describe activities, *identify problems, *identify the causes of problems, *detect "bottlenecks," and *define indicators.

QUALITY MANAGEMENT 5 Flow Chart 3

Different symbols are used in a Flowchart to indicate the different types of actions in the process: Circle: the beginning or

end of the process Rectangle: a step in the

process (activities) Diamond: the decision

points

QUALITY MANAGEMENT 6 Flow Chart 4

• How to create a Flowchart: 1) Observe for a few repetitions the process you will be charting.

2) Write down all the steps taken and decisions made in the process.

3) Mark the path of the Flowchart from the beginning to the end by connecting all the rectangles (activities)and diamonds (decision points).

4) Return to the beginning of the path and repeat Step 2 for any paths that branch off from the main path (at the decision points).

5) Record the last step at the bottom of the page, draw a circle around it, and connect the primary path and any branching paths to the last step.

6) Review for accuracy.

TOTAL QUALITY MANAGEMENT

• THE LATEST APPROACH

• IT IS THE PROCESS OF INDIVIDUAL & ORGANISATION DEVELOPMENT

• THE PURPOSE OF WHICH IS TO INCREASE THE LEVEL OF SATISFACTION OF ALL THE STAKEHOLDERS

QM Vs QA

Item Quality Management Quality Assurance

Prime

Focus

Achieving results that satisfy the

requirements for quality.

Demonstrating that the

requirements for quality

have been (and can be)

achieved.

Motivation Stakeholders internal to the

organization, especially the

organization’s management

Stakeholders, especially

customers, external to the

organization

Goal To satisfy all stakeholders To satisfy all customers.

intended

result

Effective, efficient, and

continually improving, overall

quality-related performance.

Confidence in the

organization’s products.

Scope covers all activities that affect

the total quality-related business

results of the organization

covers activities that directly

affect quality-related

process and product results

HIERARCHIAL STRUCTURE

Costs of Quality

Means to

quantify the

total cost of

quality-

related

efforts and

deficiencies.

by Armand V. Feigenbaum, A (1956)

Costs of Quality

Prevention costs • Quality planning

• Formal Technical Reviews

• Test equipment

• Training

Appraisal costs • In-process and inter-process

Inspection

• Equipment calibration and maintenance

• Testing

Failure costs Internal failure • Rework

• Repair

• Failure mode analysis

External failure • Complaint resolution

• Product return and

replacement

• Help line support

• Warranty work

ISO SYSTEM Various organizations have been set up

to establish standards, (general or for a particular activity), and

to validate that

the standards are being kept.

The International Standards Organization (ISO) has a series of norms (eg ISO 9000, ISO 9001-2000, ISO 14000, ISO 17025)

which is applied to service industries, including a range of schools of different kinds.

ISO SYSTEM 2

The ISO certification checks that there are proper procedures for ensuring quality standards and these are consistently applied, but makes no judgment of the quality of the product or service itself.

Eg In an educational context, it would check that there were procedures for observing and assessing the quality of the teaching, but it would not make an assessment of the work in the classroom.

TQM ISO 9000 Item

DEFINITELY NOT NECESSARILY CUSTOMER FOCUS

PHILOSPHY, CONCEPTS, TOOLS & TECHNIQUES

TECHNICAL SYSTEM PROCEDURES

FOCUSING ON

NECESSARY NOT NECESSARY EMPLOYEE INVOLVEMENT

CQI &TQM ARE SYNONYM LESS OR NO FOCUS CQI

ORGANIZATION WIDE CAN BE DEPATMENTALLY FOCUSED

EVERYONE QUALITY DEPARTMENT RESPONSIBILITY FOR QUALITY

IMPROVES PROCESS & CULTURAL CHANGE

PRESERVES THE STATUS FUNCTION

ISO Vs TQM

Six Sigma

• Six Sigma is a business management strategy originally developed by Motorola (mid-1980s), that today enjoys widespread application in many sectors of industry.

• A measure of quality that strives for near perfection.

• Six Sigma seeks to identify and remove the causes of defects and errors in manufacturing and business processes

• It uses a set of quality management methods, including statistical methods.

• It creates a special infrastructure of people within the organization ("Black Belts" etc.) who are experts in these methods.

Six Sigma 2

• Each Six Sigma project carried out within an organization follows a defined sequence of steps and has quantified financial targets (cost reduction or profit increase).

• Originally, Six Sigma was defined as:

a metric for measuring defects and improving quality; and a methodology to reduce defect levels below 3.4 Defects Per (one) Million Opportunities (DPMO).

(driving towards six standard deviations between the mean and the nearest specification limit) in any process -- from manufacturing to transactional and from product to service.

Six Sigma 3

• Models:

DMAIC (define, measure, analyze, improve, control): is an improvement system for existing processes falling below specification and looking for incremental improvement.

DMADV (define, measure, analyze, design, verify) is an improvement system used to develop new processor products at Six Sigma quality levels.

DEMING AWARD

Japan’s national quality award for industry.

It was established in 1951 by the Japanese Union of Scientists and engineers (JUSE).

W. Edwards Deming. He brought statistical quality control methodology to Japan after World War II

MBNQA (MALCOLM BALDRIDGE NATIONAL

QUALITY AWARD)

The Baldrige Award was established in 1987 to promote quality awareness, understand the requirements for quality excellence, and share information about successful quality strategies and benefits.

Three eligibility categories: manufacturing, services, and small firms.

Only five

companies who

received this

prize.

There are no

service

companies

Task A (30 min) • During periodic evaluation in a

health care center , there was a decrease in the flow rate of users.

• The quality improvement team reviews the data to identify the problem.

• You are trying to fully describe the problem to understand its causes and roots.

A) How to analyze this problem?

الدورى التقييم أثناء فى•

الرعاية مراكز أحد فى

انخفاض تبين الصحية

.األهالى تردد معدل

تحسين فريق عكف•

مراجعة على الجودة

لتحديد المعلومات

.المشكلة

الفريق أفراد أحد بصفتك•

توصيف تحاول فإنك

أسبابها لفهم المشكلة

.وجذورها

المشكلة؟ هذه تحلل كيف

Root Cause Analysis Tools Fishbone Diagram

The 4 P's: place, procedure, people, policies

المكان•

اإلجراءات•

(الناس)البشر •

السياسات•

The Five Whys Method

Users Surveys

Steps for Developing a Questionnaire

1. Determine the purpose & objectives. الغرض واألهداف 2. Develop questionnaire specifications. الخصائص 3. Review existing questionnaires. مراجعة المتوافر 4. Develop new questionnaire items. إضافة بنود جديدة 5. Develop directions for administration and examples of how to complete questions. إرشادات وأمثلة عن كيفية االستيفاء 6. Establish procedures for scoring the questionnaire. كيفية الحساب 7. Conduct a preliminary review of the questionnaire with colleagues or coalition members. مراجعة أولية 8. Revise questionnaire based on review. إعادة النظر 9. Pilot test the questionnaire with twenty to fifty subjects. تجريب 10.Check questionnaire for reliability and validity. االختبار 11.Provide questionnaire specifications and present to a panel of experts for review. مراجعة نهائية بواسطة خبراء 12.Revise the questionnaire based on comments from the panel of experts. إعادة النظر من جديد

Developing questionnaires takes a great deal of time and expertise.

Using questionnaires that have already been developed by experts may be a more efficient option.

Task B (45 min)

You decided to develop a questionnaire to the users attending the health care center to find out the root causes of problems that may face them.

Develop a preliminary questionnaire to be reviewed by your colleagues.

استمارة تصميم قررت

لألهالى استبيان

مركز على المترددين

لتحديد الصحية الرعاية

الجذرية األسباب

تواجههم التى للمشاكل

عن عزوفهم إلى وتؤدى

.الحضور

استبيان استمارة صمم

على لعرضها مبدئية

زمالئك

Task C (45 min)

• There are many issues that affect the users, yet through the user survey, one major problem is revealed.

• Users wait too long when they come to the health center for services.

االنتظار لمدة طويلة عند حضورهم للمركز الصحى

• Since they feel that they waste time by waiting too long, most of them decide to use the health center services less regularly, or not at all.

Task C (cont1)

• You and your team decide to use a flowchart to analyze the process the users go through in using the health center's services, and to visualize when the waiting time occurs.

• You will observe the user from his or her arrival in the center to his or her departure , observing all the steps taken by the users in the health center.

• The team draws the process that users follow from their arrival at the health center to their departure by putting each activity in a rectangle and each decision point in a diamond, and connecting all these rectangles and diamonds in order.

Task C (cont2)

• The flow chart allows the team to replicate the steps each patient goes through.

• Try to do the flowchart.

REFERENCES • http://erc.msh.org/quality/pstools/psflcht.cfm

• Deming, E, W. (1986): Out of the Crisis. Cambridge, Mass.: Massachusetts Institute of Technology, Center for Advanced Engineering Study. ISBN 0-911379-01-0.

• Frank Heyworth: Concepts of Quality, http://www.ecml.at/html/quality/english/framework/FH1_concepts%20of%20quality_e.htm

• www.pu.edu.pk/departments/lectures/BASICCONCEPTSOFQUALITY%5B1%5D.ppt -

• ASQC: American Society for Quality Control

• Patient safety, quality improvement, Department of community & Family Medicine, Duke Univ Med Center, http://patientsafetyed.duhs.duke.edu/module_a/module_overview.html

Prof. M. I. El Kalioby

kalioby@kalioby.com