Quality management1

PROJECT QUALITY MANAGEMENT

BYAsim Shahzad

E-mail Address : [email protected]

CONTENTS OF PRESENTATION WHAT IS ISO WHAT IS ISO 9000 PROJECT REQUIREMENTS OF ISO 9000 WHAT IS QUALITY STANDARD DEFINITION OF QUALITY WHO IS YOUR CUSTOMER 5Ms THEORY PROJECT STANDARD CLAUSES QUESTIONS AND ANSWERS

WHAT IS ISO

ISO STANDS FOR “INTERNATIONAL

ORGANIZATION FOR STANDARDIZATION”

ISO IS A GREEK WORD WHICH MEANS

EQUAL, SIMILAR

WHAT IS ISO STANDARDISO IS THE SPECIALIZED INTERNATIONAL

AGENCY FOR STANDARDIZATION

COMPRISING “NATIONAL STANDARD

BODIES” FROM 155 COUNTRIES

INCLUDING PAKISTAN AND IS SITUATED

AT GENEVA, SWITZERLAND.

WHAT IS ISO 9000

IT IS AN INTERNATIONALLY RECOGNIZED SERIES OF STANDARDS FOR THE IMPLEMENTION OF QUALITY MANAGEMENT SYSTEM for example :- ISO 8000 SOCIAL ACCOUNTABILITY ISO 9000 QUALITY MANAGEMENT SYSTEM ISO 10000 QUALITY SYSTEM AUDITING ISO 14000 ENVIRONMENT MANAGEMENT SYSTEM, etc. etc.

PROJECT REQUIREMENTS OF ISO 9000

WRITE WHATEVER YOU DO

DO WHATEVER YOU WRITE

BE ABLE TO PROVE IT


PEOPLE

EQUIPMENT

ENVIRONMENT

PROCESSES MATERIAL

FIVE ELEMENTS REQUIRING CONTROL BY A DOCUMENTEDPROJECT QUALITY MANAGEMENT SYSTEM.

PROJECT QUALITY MANAGEMENT SYSTEM

MUST BE LED BY TOP MANAGEMENT OR CHIEF EXECTIVE OFFICER

FORM PROJECT TEAM (DEPARTMENTAL HEADS)

APPOINT A PROJECT COORDINATOR OR MANAGEMENT REPRESENATIVE

DOCUMENT MANUAL, PROCEDURES, WORK INSTRUCTIONS OF DEPT.

INTERPRET ISO9000 REQUIRMENTS INTO EACH DEPARTMENT

CONDUCT INTERNAL AUDITS IN DEPARTMENTS

INITIATE CORRECTIVE AND PREVENTIVE ACTIONS

IMPLEMENT OF THE PROJECT QUALITY MANAGEMENT SYSTEM

CERTIFICATION AUDIT BY THE CERTIFICATION BODY

WHAT IS QUALITY

i CUSTOMER REQUIREMENTS

ii CUSTOMER NEEDS

iii CUSTOMER EXPECTATIONS

iv FITNESS FOR USE OR PURPOSE

STANDARD DEFINITION OF QUALITY

QUALITY IS THE “ TOTALITY OF

FEATURES AND CHARACTERISTICS OF

A PRODUCT OR SERVICE THAT BEARS

ON ITS ABILITY TO SATISFY STATED

OR IMPLIED NEEDS ”.

DIMENSIONS OF QUALITY Is it suitable for the intended job? Performance Are the needs correctly translated? Design Is it made as per design? Conformance How frequently will it fail? Reliability How long will it last? Durability How easy will it be to repair it? Serviceability What does it look like? Aesthetics What else can it do? Features Does the company/product has

reputation? Perceived Quality

QUALITY PROBLEMS DUE TO

“Management is 94 percent responsible for quality related issues in any organization”

Dr. Deming(Father of TQM)

QUALITY GURUS SAY

QUALITY IS NEVER AN ACCIDENT, IT

IS ALWAYS THE RESULT OF HIGH

INTENTION, SINCERE EFFORTS,

INTELLIGENT DIRECTIONS AND

SKILLFUL EXECUTION.

ISO 9001, QUALITY SYSTEMS

MODEL FOR QUALITY ASSURANCE IN USE WHEN CONFORMANCE TO SPECIFIED REQUIREMENTS IS TO BE ASSURED BY THE ORGANIZATION DURING DESIGNING, DEVELOPMENT, PRODUCTION, INSTALLATION AND SERVICING.

ISO 9002, QUALITY SYSTEMSMODEL FOR QUALITY ASSURANCE IN

USE WHEN CONFORMANCE TO

SPECIFIED REQUIREMENTS IS TO BE

ASSURED BY THE ORGANIZATION

DURING PRODUCTION, INSTALLATION

AND SERVICING.

ISO 9003, QUALITY SYSTEMS

MODEL FOR QUALITY ASSURANCE IN

USE WHEN CONFORMANCE TO

SPECIFIED REQUIREMENTS IS TO BE

ASSURED BY THE SUPPLIER AT FINAL

INSPECTION AND TEST.

QUALITY ASSURANCE MODELS

ISO 90011. DESIGN & DEVELOPMENT2. PRODUCTION3. INSTALLATION4. SERVICINGISO 90021. PRODUCTION2. INSTALLATION3. SERVICINGISO 9003 1. FINAL INSPECTION AND TEST

QMS AT HOSPITAL

TO GENERALIZE THE IMPLEMENTATION OF

PROJECT QUALITY MANAGEMENT EXAMPLE OF A HOSPITAL IS

CONSIDERED

IN THE TODAY’S PRESENTATION.

THE PATIENT

TYPES OF PATIENTS

* INDOOR

* OUT DOOR

* OUTSIDE THE HOSPITAL

* PARENTS OF SICK CHILDREN

EXPECTATIONS OF CUSTOMERS

IMMEDIATE ATTENTION & CARE

LOVE AND AFFECTION

HIGH QUALITY TREATMENT

EXPECTATIONS OF CUSOMERS CONTINUE…

EARLY APPOINTMENT FOR CONSULTATION / ADMISSION

MINIMUM WAITING TIME FOR TESTS & REPORTING e.g. X-

RAY, LABS, ETC.

QUALITY CONSULTATION SERVICES

PROMPT INFORMATION SERVICES

QUALITY SERVICES FOR PATIENTSIT SHOULD BE BASED ON :- INTERNATIONAL STANDARDS e.g. WHO QUALIFIED AND EXPERIENCED STAFF QUALITY CONTROLLED LABS TESTS AVAILABILITY OF QUALITY MEDICINES PROMPT HOSPITALIZATION SERVICES PROMPT EMERGENCY SERVICES

HOSPITAL TO PROVIDE


SERVICES TO ALL THE

PATIENTS

SATISFACTION OF PATIENTS BASED ON 5Ms THEORY

MENPOWER MATERIALS MACHINES METHODS MEASUREMENTS

MENPOWER

RECRUITMENT ON MERIT BASIS

QUALIFIED AND EXPERIENCED

JOB DESCRIPTION FOR EMPLOYEES

MATERIALS

ALL MATERIALS USED IN THE HOSPITAL

SHOULD HAVE STANDARD

SPECIFICATIONS AND APPROVAL FROM

THE COMPETENT AUTHORITY

MACHINES

ALL ELECTRO-MEDICAL EQUIPMENTS SHOULD BE QUALIFIED AND APPROVED BY THE COMPETENT AUTHORITY, FOR EXAMPLE :-

RESPIRATOR ANESTHESIA EQUIPMENT ECG MACHINES DIALYSIS MACHINE DISPOSABLE EQUIPMENT OFFICE EQUIPMENT etc. etc

METHODSALL PROCEDURES / INSTRUCTIONS SHOULD BE QUALIFIED AND APPROVEDBY THE COMPETENT AUTHORITY LIKE

OPERATION THEATRE MEDICAL STORE ADMISSION/DISCHARGE OF PATIENT PURCHASING HIRING OF HOSPITAL STAFF CALIBERATION OF EQUIPMENT LABORATORY TESTS

MEASUREMENTS

ALL INSTRUMENTS AND EQUIPMENTS MUST BE INSPECTED AND CALIBRATED BY THE NATIONAL STANDARD LABORATORY e.g. FLOW METERS PRESSURE GAUGES TEMPERATURE GAUGES LABORATORY EQUIPMENTS ETC.

PROJECT QUALITY MANAGEMENT SYSTEM FOR

ISO 9000 BASED UPON 5Ms THEORY, ISO9000 QUALITY MANAGEMENT

SYSTEM PROVIDES A STRUCTURE THAT CAN BE USED BY

HOSPITAL AT ALL LEVELS AND IN ALL FUNCTIONS TO

ACCOMPLISH ITS TASKS IN A COMPARATIVELY BETTER AND

COST EFFECTIVE MANNER.

CLAUSES OF ISO 9000

4.1 MANAGEMENT RESPONSIBILITY

4.2 QUALITY SYSTEM

4.3 CONTRACT REVIEW

4.4. DESIGN CONTROL

4.5 DOCUMENT AND DATA

CONTROL

4.6 PURCHASING

4.7 CUSTOMER SUPPLIED PRODUCT

4.8 PRODUCT IDENTIFICATION AND

TRACEABILITY

4.9 PROCESS CONTROL

4.10 INSPECTION AND TESTING

4.11 CONTROL OF INSPECTION AND

MEASURING EQUIPMENT

4.12 INSPECTION AND TEST STATUS

4.13 CONTROL OF NON-

CONFORMING PRODUCT

4.14 CORRECTIVE AND PREVENTIVE

ACTION

4.15 HANDLING, STORAGE,

PACKAGING AND RESERVATION

4.16 CONTROL OF QUALITY RECORD

4.17 INTERNAL QUALITY AUDITS

4.18 TRAINING

4.19 SERVICING

4.20 STATISTICAL TECHNIQUES

4.1 MANAGEMENT RESPONSIBILITY

THE HOSPITAL’S MANAGEMENT WITHEXECUTIVE RESPONSIBILITY SHALL DEFINETHE FOLLOWING IN A DOCUMENTEDPROCEDURE :-

QUALITY POLICY QUALITY COUNCIL APPOINTMENT OF A QUALITY MANAGEMENT REP (QMR) RESOURCES MANAGEMENT REVIEW MEETINGS

QUALITY POLICY

FOR HOSPITALWE CARE OUR PATIENTS ANDEMPLOYEES

FOR INDUSTRYWE PROVIDE QUALITY PRODUCTSFOR THE ENTIRE SATISFACTIONOF OUR CUSTOMERS

4.2 QUALITY MANAGEMENT

THE HOSPITAL SHALL ESTABLISH, DOCUMENT AND

MAINTAIN ITS QUALITY SYSTEM AND ENSURE THAT ALL

SERVICES CONFORM TO SPECIFIED REQUIREMENTS.

Standard ISO 9000

Quality Manual Policy StatementLevel 1 Commitment, Organization,

ResponsibilitiesProcedures Company Practice &Level 2 Interfaces

Work Instructions Written InstructionsLevel 3 to control Tasks

Forms Quality RecordsLevel 4

Sales Design Purchasing Manufacturer Accounts Personnel After Sales


QUALITY MANUAL

QUALITY POLICYOBJECTIVESOVERVIEW ORGANIZATIONRESPONSIBILITIESREQUIREMENTSPOLICY/REFERENCE

QUALITY SYSTEM PROCEDURES A SET OF PROCEDURES WHICH DETAIL HOW THE

REQUIREMENTS OF THE QUALITY MANUAL ARE TO BE IMPLEMENTED.

DETAILED PROCEDURES WHICH DEFINE HOW THE PROCESSES ARE TO BE PERFORMED AND CONTROLLED.

SPECIFYING WHO IS RESPONSIBLE FOR DOING WHAT?

WORK INSTRUCTIONS DETAILED INSTRUCTIONS FOR THE PERFORMANCE OF

SPECIFIC TASKS. ON THE SHOP FLOOR, LAB, etc

MATERIALS

PROCESSES

4.3 CONTRACT REVIEW

THE HOSPITAL SHALL REVIEW THE REQUIRMENTS OF THE REPORTING PATIENT (CUSTOMER) AND ENSURE THAT :- PATIENT REQUIREMENTS AND SPECIFICATIONS ARE DEFINED. ASCERTAIN THAT THE HOSPITAL

CAN MEET THESE SPECIFICATIONS

4.4 DESIGN CONTROL

THE HOSPITAL SHALL ESTABISH AND MAINTAIN DOCUMENTED PROCEDURES TO CONTROLL AND VERIFY THE MOST SUITABLE SERVICES FOR THE PATIENT IN ORDER TO ENSURE THAT THE SPECIFIED REQUIRMENTS ARE FULFIELD.

4.5 DOCUMENT AND DATA CONTROL

THE HOSPITAL SHALL ESTABLISH AND MAINTAIN DOCUMENTED PROCEDURES TO CONTROL ALL DOCUMENTS AND DATA

GENERATED IN THE HOSPITAL. DATA INCLUDES DATA SHEETS, LAB TESTS AND PATIENT RECORDS ETC. ETC.

4.6 PURCHASING

THE HOSPITAL SHALL ESTABLISH AND MAINTAIN DOCUMENTED PROCEDURES TO ENSURE THAT PURCHASED ITEMS CONFORMS TO SPECIFIED REQUIRMENTS.FOR EXAMPLES :- LIKE MEDICINES, SURGICAL INSTRUMENTS, HOSPITAL FURNITURES, FOOD ITEMS, LABORATORY EQUIPMENTS, ETC.

4.7 CONTROL OF CUSTOMER SUPPLIED PRODUCT

THE HOSPITAL SHALL ESTABLISH AND MAINTAIN DOCUMENTED PROCEDURES FOR THE CONTROLL OF VERIFICATION, STORAGE AND MAINTENANCE OF CUSTOMER SUPPLIED PRODUCTS. FOR EXAMPLE LAB SAMPLES, PATIENT’S OLD RECORDS ETC.

4.8 PRODUCT IDENTIFICATION AND TRACEABILITY

WHERE APPROPRIATE, THE HOSPITAL SHALL ESTABLISH AND

MAINTAIN THE DOCUMENTED PROCEDURES FOR IDENTIFYING

PATIENT, MATERIAL AND SERVICES BY SUITABLE MEANS.

4.9 PROCESS CONTROL

THE HOSPITAL SHALL ESTABLISH AND MAINTAIN

DOCUMENTED PROCEDURES TO IDENTIFY AND PLAN THE

TREATMENT AND OTHER SERVICING PROCESSES TO

ENSURE THAT THE SAME ARE CARRIED OUT UNDER

CONTROLLED CONDITIONS.

4.10 INSPECTION AND TESTING


DOCUMENTED PROCEDURES FOR INSPECTION AND

TESTING ACTIVITIES IN ORDER TO VERIFY THAT THE

SPECIFIED REQUIRMENTS FOR PATIENTS AND ALSO FOR

ALL INCOMING MATERIALS ARE MET.

4.11 CONTROL OF INPSECTION, MEASURING & TEST EQUIPMENT

ALL INSTRUMENTS AND EQUIPMENTS USED IN THE HOSPITAL SHOULD BE INSPECTED AND CALIBERATED ACCORDING TO THE DOCUMENTED PROCEDURES APPROVED BY THE COMPETENT AUTHORITY. NON CALIBERATED INSTRUMENTS SHOULD NOT BE USED

4.12 INSPECTION AND TEST STATUS

THE HOSPITAL SHALL ESTABLISH AND MAINTAIN DOCUMENTED PROCEDURES FOR ALL INCOMING MATERIALS AND PATIENT’S TEST SAMPLES TO ENSURE THAT THEIR TEST STATUS (CONFORMANCE OR NON-CONFERMANCE) IS PROPERLY IDENTIFIED BY SUITABLE MEANS.

4.13 CONTROL OF NON-CONFORMING PRODUCTS

THE HOSPITAL SHALL ESTABLISH AND MAINTAIN DOCUMENTED PROCEDURE TO ENSURE THAT ALL INCOMING MATERIALS LIKE MEDICINES, SURGICAL INSTRUMENTS, LABORATORY EQUIPMENT, HOSPITAL FURNITURE ETC THAT DO NOT CONFORM TO SPECIFIED REQUIREMENTS ARE PREVENTED FROM UN-INTENDED USE OR INSTALLATION.

4.14 CORRECTIVE AND PREVENTIVE ACTION


DOCUMENTED PROCEDURES FOR IMPLEMENTING

CORRECTIVE AND PREVENTIVE ACTION TO ELIMINATE THE

CAUSES OF ACTUAL OR POTENTIAL NON-

CONFORMITIES.

4.15 HANDLING, STORAGE, PACKING, PRESERVATION

AND DELIVERY

THE ORGANIZATION SHALL PROVIDE ADEQUATE HANDLING,

STORAGE, PRESERVATION, PACKAGING, AND DELIVERY OF

YOUR PRODUCT TO ENSURE THAT IT MEETS SPECIFIED

REQUIREMENT.

4.16 CONTROL OF QUALITY RECORDS

THE ORGANIZATION SHALL ESTABLISH AND MAINTAIN DOCUMENTED PROCEDURES FOR IDENTIFICATION, COLLECTION, INDEXING, ACCESS, FILLING, STORAGE, MAINTENANCE AND DISPOSITION OF QUALITY RECORDS.

4.17 INTERNAL QUALITY AUDITS

THE INTERNAL QUALITY AUDIT SHALL IMPROVE THE EFFECTIVE IMPLEMEN- TAION OF ALL THE PROCEDURES AND QUALITY SYSTEMS. THIS ACTIVITY WILL HELP TO IDENTIFY AND IMPROVE THE NON-CONFORMANCES AND ITS EFFECTIVENESS FOR THE QUALITY SYSTEM.

PURPOSE OF AUDITS TO DETERMINE IF THE QUALITY SYSTEM IS OPERATING AND IS

EFFECTIVE TO DETERMINE THE DEGREE OF COMPLIANCE TO THE SPECIFIED

STANDARD. TO DETERMINE THE DEGREE OF COMPLIANCE TO THE REGULATORY

REQUIREMENTS (HEALTH AND SAFETY/ ENVIRONMENTAL ETC). TO ENABLE CERTIFICATION OF THE SYSTEM. WHEN THE QUALITY OF THE PRODUCT OR SERVICE IS SUSPECT TO DETERMINE IF IMPROVEMENTS CAN BE MADE.

AUDITING

AUDITING IS A FACT FINDING TASK NOT A POLICING OPERATION.

QUALITY CONTROL IS A POLICING OPERATION

AUDIT DEFINITIONS

LEAD AUDITORA PERSON APPOINTED TO MANAGE THE AUDIT. THE AUDITOR: A PERSON QUALIFIED TO PERFORM QUALITY AUDITS.

AUDITEEORGANIZATION (OR PERSON) BEING AUDITED

CHECKLISTS

USED BY THE ASSESSOR AS AN AIDE MEMOIRE. ENSURE THAT ALL ELEMENTS OF A SPECIFICATION ARE

ADDRESSED. ARE COMPILED FROM THE RESULTS OF A DETAILED

STUDY OF THE PROCEDURE/SPECIFICATION. ENSURE THAT ALL RELEVANT REQUIREMENTS

CONTAINED IN THE SPECIFICATION ARE COVERED.

4.18 TRAINING THE HOSPITAL SHALL IDENTIFY

TRAINING NEEDS OF OFFICERS AND PARAMEDIC’S STAFF PERFORMING THOSE ACTIVITIES WHICH AFFECT QUALITY.

PERSONNEL PERFORMING ASSIGNED DUTIES SHALL BE QUALIFIED ON THE BASIS OF SPECIFIED EDUCATION, TRAINING, EXPERIENCE AS REQUIRED.

THE HOSPITAL SHALL ESTABLISH AND MAINTAIN DOCUMENTED PROCEDURES FOR PATIENT’S VISIT FOR THE FOLLOW-UP CONSULTATION AND TREATMENT AS PER APPROVED POLICY BY THE COMPETENT AUTHOURITY.

4.19 SERVICING

4.20 STATISTICAL TECHNIQUES

THE ORGANIZATION SHALL IDENTIFY THE NEED FOR

STATISTICAL TECHNIQUES REQUIRED FOR ESTABLISHING,

CONTROLLING AND VERIFYING PROCESS CAPABILITY AND

PRODUCT CHARACTRISTICS.

SIX MYTHS ABOUT ISO 9000

MYTH-1: ONCE YOU HAVE GOT ISO 9000, YOU CAN ONLY BUY FROMOTHER ISO 9000 COMPANIES.

MYTH -2: ISO 9000 IS ONLY FOR BIG COMPANIES.MYTH-3: IT PRODUCES LOTS OF PAPER WORK.MYTH-4: IT REQURES LOTS OF EXTRA STAFF.MYTH-5: IT IS ONLY FOR MANUFACTURERS.MYTH-6: ISO 9000 WOULD FORCE US TO ADOPT A SPECIFIC LEVEL OF QUALITY PERHAPS LOWER THAN WE ALREADY HAVE.

KEY BENEFITS OF ISO 90001. ORGANIZATION WIDE QUALITY MANAEMENT SYSTEM.2. LESS REWORK, REDUCED MATERIAL AND LESS WASTAGE OF RESOURCES.3. GREATER PRODUCTIVITY AND COST REDUCTION4. UP-GRADING BUSINESS TO THE WORLD CLASS LEVEL5. WORLDWIDE RECOGNITION6. IMPROVEMENT IN COMPANY WIDE PERFORMANCE7. ACHIEVEMENT / MAINTENANCE OF PRODUCT/SERVICE QUALITY8. BETTER CONSISTENCY IN PRODUCTION WORK9. OPPORTUNITY TO COMPETE WITH LARGER

ORGANIZATION

ACCREDITATION SCHEMEDepartment of Trade & Industry Example shown for UK

DTI Registration

United Kingdom Accreditation Service

UKAS

Accredit

Certification BodiesCalibration & Test Houses

Certify

Companies/Organizations

Education

Quality management1