Dody Firmanda 2000 - 019. Df-iso9000

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ISO 9000:2000 Rumah Sakit

Dr. Dody Firmanda, SpA, MA

KOMITE MEDIK

Executive Summary :

Patient Safety, Six Sigma & ISO 9000 Quality Management Today's world health care performing to ensure the delivery of quality patient care at significantly lower level:

1. 2.

3.

‰

An estimated 120 000 deaths occur every year due to medical mistakes?1

‰

The IOM reported that medical mistakes in the United States cause as many as 98,000 hospital deaths per year.2

‰

These stunningly high rates of medical errors--resulting in deaths, permanent disability and unnecessary suffering--are simply unacceptable in a medical system that “promises to do no harm." 3

Gerlin, A. How Your Hospital Could Kill You. Reader's Digest, June 2000, p. 174. Tickner, N, O'Neill M. Preventing Death and Injury From Medical Errors Requires Dramatic, Systemwide Changes. press release, Institute of Medicine, Division of Health Care Services, November 29, 1999. Ibid.

Inspection Inspection

Quality Quality Control Control

Quality Quality Assurance Assurance

Total Total Quality Quality

Understanding Understanding the business the business

a.a.Setting SettingStandards Standards b.b.Conform Conformwith withstandards standards (Audit/Akreditasi) (Audit/Akreditasi) c cMaintained Maintained&&Improve Improve

Evolusi

Understanding Understanding the customers the customers

Health Needs Assessment

NICE Clinical Clinical Governance Governance

Quality Quality System System

CQI CQI

BSI 5751 EN/ISO 9000 MBNQA EQA Benchmarking Award Deming Prize Award SQL

Balanced Scorecard (SFO)

CHImp

Evidence-based Clinical Specialities

Clinical Epidemiology

Readers’ Guides to Medical Literatures

Users’ Guides to Medical Literatures

80an

Evidencebased Medicine (EBM) 90an

Evidence-based Health Care (EBHC): • Policy • Health Technology Assessment • Others

Information Mastery

Abad 21

Quality Quality Tools Tools

Understanding the business

Benchmarking Need Assessment

Understanding the customers

PIP (Investors in People)

Total Quality Quality System

P A S/C

CQI QA Setting standard

Quality Tools

QA Model: ISO 9000 D

TQM Model: MBNQA EQA EFQM

Statistical Process Control

Wants

Goals

Demands

Aims

Needs

Objectives

Input

Process

Ouput

Outcome

Value/ Benefit

Relevance Adequacy Accessability

Efficiency Effectiveness

Maxwell

Impact Targets

Efficacy

Input

Process

Outcome

Donabedian

1. Vision : futuristic mind-setting of the organisation 2. Missions: ways of the organisation towards the vision 3. Goals : are broad statements. There is generally one goal for a service/task. 4. Aims : There are a number of aims relating to the goal. They are specific to particular problems. 5. Objectives : For each programme aim, there may be a number of objectives which are specified in measurable terms. 6. Targets/Minimal Thresholds : For each objective, there may be various points on the way to the attainment of the objective. They are defined in relation to a point in a time. Systems/Standards Criteria

Indicators

ISO 9000: 2000 The ISO 9000 Core Standards There are four Core Documents, as follows: 1. ISO 9000:2000 provides quality management principles and fundamentals. It describes what the series is about and lists basic definitions of terms for use by any organization. 2. ISO 9001:2000 states requirements for quality management systems when it is necessary to demonstrate that an organization is capable of effectively meeting customer and regulatory requirements, such as JCAHO, NCQA, URAC or state and federal requirements. 3. ISO 9004:2000 provides guidance for establishing a quality management system that goes beyond ISO 9001 requirements to meet and exceed customer expectations efficiently. 4. ISO 19011 provides guidance on planning and conducting quality audits.

Model of a process-based quality management system

Clauses in the ISO 9001 Quality Systems Standard ISO 9001:2000 consists of: • 5 primary clauses that contain 23 sub-clauses. • These requirements spell out what organization and possibly must do to conform to the standard. • All the requirements must be documented and controlled. The Clauses are as follows: 4. Quality Management System 5. Management Responsibility 6. Resource Management 7. Product Realization 8. Measurement, Analysis and Improvement

Quality Standards (Clauses/Subclauses) Quality Procedures

Quality Records

1. General 1.1. Index and revision status 1.2. Purpose and scope 1.3. Exclusions 2. Company background 2.1. Company background and history 2.2. Activities 3. Definitions and convention 3.1. Definitions and conventions 3.2. Abbreviations

D 0001 Definitions and terminology D 0002 Abbreviations D 0003 Index of the quality manual

Clause 4. Quality Management System (QMS) Quality Standards (subclauses) 4.1. General requirements 4.2. Documentation and records

Quality Procedures

Quality Records

P 421 Quality system documentation D 4301 Procedures D 4302 Process plans P 422 Control of documents D 4303 Work instructions P 423 Control of quality records D 4304 System documents D 4305 Specific documents D 4306 External documents D 4307 Paraphs D 4308 Distribution of the quality manuals D 4309 Distribution of the process files D 4310 Distribution of the personal files D 4311 Table of contents of process files D 4312 Table of contents of personal files D 4313 Document change request

Clause 5. Management Responsibility Quality Standards (sub-clauses)

Quality Procedures

P 521 Customer needs and 5.1. Management commitment 5.2. Customer focus communications 5.3. Quality policy 5.4. Quality system planning 5.5. Organization and communication P 561 Management review 5.6. Management review

Quality Records D 5301 Quality policy D 5401 Quality objectives D 5501 Organization scheme D 5502 Overview of the functions

Clause 6. Resource Management Quality Standards (sub-clauses)

Quality Procedures

Quality Records

6.1. Provision of resources 6.2. Human resources and trainings 6.3. Infrastructure 6.4. Work environment

P 621 Training and awareness

D 6201 Personnel card D 6202 Function descriptions D 6203 Training D 6301 Maintenance card D 6303 Maintenance schedule D 6304 Maintenance contracts D 6305 Different tasks

Clause 7. Product Realisation Quality Standards (sub-clauses)

Quality Procedures

Quality Records

7.1. Planning of product realisation 7.2. Customer related processes 7.3. Design control 7.4. Purchasing 7.5. Operations 7.6. Measuring and monitoring equipment

P 721 Order processing P 731 Design control P 741 Supplier evaluation P 742 Purchasing P 743 Verification of purchased product P 751 Handling, storage, packaging, preservation and delivery P 761 Measuring and monitoring equipment

D 7201 Overview of our own products D 7202 Specifications of our own products D 7203 Customer complaints D 7204 Customer feedback D 7301 Overview of product development D 7302 Design specification D 7303 Design output D 7304 Design review D 7305 Design verification D 7306 Design validation D 7307 Design changes D 7308 Design actions D 7401 Overview of the purchased products D 7402 Specifications of the purchased products D 7403 Supplier assessment D 7405 Approved suppliers D 7406 Suppliers on probation D 7601 Calibration cards D 7602 List of measuring devices D 7603 Calibration schedule D 7604 Calibration survey D 7605 Calibration results

Clause 8. Measurement, analysis and improvement Quality Standards (sub-clauses) 8.1. Planning of monitoring and measurement 8.2. Monitoring and measurement 8.3. Control of non-conforming product 8.4. Analysis of data 8.5. Continual improveme

Quality Procedures

Quality Records

P 821 Customer satisfaction P 822 Internal quality audits P 823 Inspection and test procedure P 831 Control of non-conforming product P 851 Corrective and preventive actions

D 8201 Internal auditors D 8202 Audit schedule D 8203 Audit report D 8401 Customer card D 8402 Supplier card D 8403 Internal problems since one year D 8501 Meeting schedule D 8502 System meetings D 8503 Specific meetings D 8504 Project data D 8505 Projects D 8506 Corrective action request D 8507 Executed actions D 8508 Present actions

Basic Quality Performance Wheel

Program Cost

Performance Measurement

Customer Satisfaction

Partial Wheel with Goals % F ir e /S m o k e C o n ta in m e n t D e f ic ie n c ie s R e d u c t io n

% B a c k I n ju r y R e d u c t io n R a te

EC C u sto m e r S a tis fa c ti o n

% S to r a g e D e f ic ie n c ie s R e d u c tio n

100

O v e r a ll S e r v ic e P a r tic ip a t io n

100

5

95

95 T e le p h o n e C ascade N o tif ic a ti o n C o m p le tio n

80

80

80

100

80 S taff K n o w le d g e

0

N o. of F a ls e F ire A la rm s p e r m o n th

3

S a f e ty M anagem ent

S ta ff K n o w le d g e

95 L i fe S a f e ty M g m t.

E m ergency P r e p . M g m t.

80

U ti lit y M g m t.

13 U n s c h e d u le d S h u td o w n s p e r m o n th

80

0

0

E q u ip t. M g m t.

95 80

S e c u r ity M g m t. H az/ M a t. M g m t.

13 0

0

80

80

0

80

H o t/C o ld E n v ir o n . C a lls p e r m o n th

80

25

80

90 95 P e r s o n a l ly O w n ed D e v ic e D e f ic ie n c ie s

E n v ir o n . In s p e c t. C ite d S m o k in g V io la tio n s / 6 m o n th s

90 M e d ic a l E q u ip . I n v e n to r y D a t a A c c u ra c y

95 S ta ff K n o w le d g e

M SDS P ro g ram

% C r im e R a te p e r Y ear R e d u c t io n

Hospital Based Performance Wheel Im p le m en t N ew C lin ic a l P ra c tic e G u id e lin es

In cr ea se d R evenu e

12

$ 1 5 M il % C o st R e d u c tio n

$ 1 2 M il

10

% In c r e a se d P r o d u c tiv ity

8 20

5

% D ec re a se in In v e n to ry

15

10

P ro g ra m C ost

10

C u s to m e r S a tis fa c tio n

40

20

35

P e rfo rm a n c e M e a s u re m e n t and Im p ro v e m e n t

15 20

60 T im e lin e ss o f A c c e ss

85

20

95

5

30

30

% S a tisfa c tio n per Survey

% D ec re a se A b se n te eism

0 C u sto m er C o m p la in ts

% D e c r e a se in W a itin g T im e

50 D ec re a se O p er a tin g B e d s

% D ec re a se B ed D ays of C are

Statistical Tools

C A U S E S

Data/Check Sheets Statistical Tools

Histograms

Run Charts

Control Charts Process Capability

Pareto Diagrams (Root Cause)

Analytical Tools Data/Check Sheets

C A U S E S

Statistical Tools

Histograms

Pareto Diagrams (Root Cause)

Run Charts

Control Charts Process Capability

S O L U T I O N S

Affinity Diagram

Brainstorming

Matrix Diagrams

Fishbone Diagrams

Analytical Tools Tree Diagrams

Force Field Analysis D.A Simmons 5/97

Scatter Diagram PDCA Model

Nominal Group Techniques

Flow Charts

Tools with Problem Solving Techniques Data/Check Sheets

C A U S E S

1,2,4,5,7,11

Statistical Tools

Histograms

Pareto Diagrams (Root Cause)

4,5,7,10

1,2,4,5,10 Run Charts

4,5,7,11 Control Charts

4,5,7,11 Process Capability 4,5,7,11

S O L U T I O N S

Analytical Tools

D.A Simmons 5/97

Affinity Diagram

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11.

Steps of Problem Solving Prioritize Problems Analyze Symptoms Formulate Theories Test Theories Identify Causes Evaluate Solutions Design Solutions Address Resistance Implement Solutions Check Performance Monitor Controls

Brainstorming

3

Tree Diagrams

Matrix Diagrams

12

7

Fishbone Diagrams

3 Force Field Analysis

Scatter Diagram 4,5,7

PDCA Model

Nominal Group Techniques

Flow Charts

2,4,5,6,7,9

Model: Integrated Health Care Quality Management

Integrated Health Care Quality Management PQM Process Quality Management

OQM Outcome Quality Management

Process Management (Optimization)

Hospital Manual (Documentation)

OQM System (Documentation)

Benchmarking (Evaluation)

Project Work Quality Circles

ISO System Processes/Standard Operating Procedures

Medical Outcomes Financial Results

Quality (Output) Costs (Input)

Pathway Management

Outcome Management

Controlling of Processes and Standards

Controlling of (Financial and Medical) Results

Terima Kasih http://www.members.leeds.ac.uk/d.firmanda97

[email protected]

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