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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
PROJECT QUALITY MANAGEMENT
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
PROJECT QUALITY MANAGEMENT
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
PROJECT QUALITY MANAGEMENT
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
THE HOSPITAL SHALL ESTABLISH AND MAINTAIN
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
THE HOSPITAL SHALL ESTABLISH AND MAINTAIN
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