TOTAL QUALITY MANAGEMENTTOTAL QUALITY MANAGEMENTTOTAL QUALITY MANAGEMENT TOTAL QUALITY MANAGEMENT (TQM)(TQM)

R. MohammadiR. MohammadiBiochemist (Ph.D.)Biochemist (Ph.D.)

Faculty member of Medical FacultyFaculty member of Medical FacultyFaculty member of Medical FacultyFaculty member of Medical Faculty

IN A FACTORYIN A FACTORYIN A FACTORYIN A FACTORY

EquipmentEquipmentStaffStaffPrimary

Materials ProductsVariablesVariables

IN A LABORATORYIN A LABORATORYIN A LABORATORYIN A LABORATORY

EquipmentEquipmentStaffStaff

R tR tReagentsReagentsPatientSample Results

VariablesVariables

کيفيت جامع

(آماریسرکارگری

(

رسی صر کنترلکع

کنترل کيفيت آم

ت سرپرستی

س(

رلکيفيت

بازر

ارگری

1980

صر کنع

صر کنترل کيفيت

صر کنترلع

نترل کيفيت کار

19601937

1918

صرع

صر کنتع

19181900

فشارھای عمومی و خصوصی

کاھش ھزينه ھابھبود کيفيت

نياز به مديريت جامع کيفيت

مديريت جامع کيفيت در آزمايشگاه ھای بالينیمديريت جامع کيفيت در آزمايشگاه ھای بالينی

..١١TQMTQM وارد آزمايشگاه ھای بالينی شده استوارد آزمايشگاه ھای بالينی شده است ١٩٩٠١٩٩٠از سال از سال..اف٢٢ افا نTQMTQMا ال ا شگا ا نآز ال ا شگا ا آز در آزمايشگاه ھای بالينیدر آزمايشگاه ھای بالينیTQMTQMاھدافاھداف٢٢..

RepeatabiltyRepeatabiltyReproducabilityReproducabilityReproducabilityReproducabilityTransferability or CommutabilityTransferability or Commutability

TQMTQMفوايد استفاده از فوايد استفاده از

نظارت بر تمامی فعاليت ھای آزمايشگاه به صورت يک سيستمنظارت بر تمامی فعاليت ھای آزمايشگاه به صورت يک سيستم١١..نتا٢٢ ت ف ک ش نتاافزا ت ف ک ش افزا افزايش کيفيت نتايجافزايش کيفيت نتايج٢٢..کاھش اشتباھاتکاھش اشتباھات٣٣..و۴۴ ھا معرف مصرف وکاھش ھا معرف مصرف استانداردھااستانداردھاکاھش استانداردھااستانداردھاکاھش مصرف معرف ھا و کاھش مصرف معرف ھا و ۴۴..کاھش بار و زمان کاری پرسنلکاھش بار و زمان کاری پرسنل۵۵..یکاھش زمان تأخير در جوابدھیکاھش زمان تأخير در جوابدھی۶۶.. و ر ير ن ز یش و ر ير ن ز ش

QUALITY MANAGEMENTTraditional Versus TQM Thinking

TQM ThinkingTraditional ThinkingQuality lowers costsQuality is expensive yy pError-free qualityAcceptable qualityDefects caused by systemDefects caused by workersOrganization focusedDepartment focused Organization focusedDepartment focusedWorker empoweredManagement controls workerIs focused on PreventionIs focused on InspectionProblem solving by groupsProblem solving by managers

TQM Provides BothTQM Provides BothTQM Provides BothTQM Provides Both1)1) A management A management philosophyphilosophy for for

organizational developmentorganizational developmentorganizational developmentorganizational development2)2) A management A management processprocess for improvement for improvement

th lit f ll t f kth lit f ll t f kthe quality of all aspects of workthe quality of all aspects of work

چيست؟ چيست؟کيفيت ؟کيفيت ي چي ؟ي ي چي ي

، جامع کيفيت مديريت ،در جامع کيفيت مديريت باکيفيتکيفيتدر انطباق صورت بابه انطباق صورت به به صورت انطباق با به صورت انطباق با کيفيتکيفيتدر مديريت کيفيت جامع ،در مديريت کيفيت جامع ،نيازھای مصرف کنندگان و مشتريان و رفع نيازھا و نيازھای مصرف کنندگان و مشتريان و رفع نيازھا و

شود می تعريف آنھا شودانتظارات می تعريف آنھا ..انتظارات آنھا تعريف می شودانتظارات آنھا تعريف می شودانتظارات

گا ک گاف ک تف شکا ا تا ل تشا شکا ا تا ل شا شامل پرستاران و پزشکان ھستندشامل پرستاران و پزشکان ھستندمصرف کنندگانمصرف کنندگانشامل بيماران و سازمان ھای پرداخت کننده صورت شامل بيماران و سازمان ھای پرداخت کننده صورت مشتريانمشتريان

حساب ھا ھستندحساب ھا ھستند

Costs of NonconformanceCosts of NonconformanceCosts of NonconformanceCosts of Nonconformance

Internal Failure CostsInternal Failure Costs External Failure CostsExternal Failure CostsInternal Failure CostsInternal Failure Costs11) ) ScrapScrap22)) ReworkRework

External Failure CostsExternal Failure Costs11) ) ComplainsComplains22) Repeat requests) Repeat requests22) ) ReworkRework

33) ) Repeat runs Repeat runs 22) Repeat requests) Repeat requests

Costs of ConformanceCosts of ConformanceCosts of ConformanceCosts of Conformance

Prevention CostsPrevention Costs Appraisal CostsAppraisal CostsPrevention CostsPrevention Costs11) ) TrainingTraining22)) CalibrationCalibration

Appraisal CostsAppraisal Costs11) ) InspectionInspection22) Quality control) Quality control22) ) CalibrationCalibration

33) Maintenance) Maintenance22) Quality control) Quality control

ھاووکيفيتکيفيتشناختشناخت ھاھزينه موردھزينه در جديدی ديدگاه به موردمنجر در جديدی ديدگاه به منجر منجر به ديدگاه جديدی در مورد منجر به ديدگاه جديدی در مورد ھزينه ھاھزينه ھاووکيفيتکيفيتشناختشناخت::رابطه بين اين دو مفھوم شده استرابطه بين اين دو مفھوم شده است

بھبود کيفيت سبب کاھش ھزينه ھا می شودبھبود کيفيت سبب کاھش ھزينه ھا می شود

W Edwards Deming :W Edwards Deming :W. Edwards Deming :W. Edwards Deming :Quality improvement reduces waste and Quality improvement reduces waste and leads to improved productivity which in turnleads to improved productivity which in turnleads to improved productivity, which in turn leads to improved productivity, which in turn reduces costs and provides a competitive reduces costs and provides a competitive advantageadvantageadvantageadvantage

Problems arise primarily fromProblems arise primarily from imperfectimperfectProblems arise primarily from Problems arise primarily from imperfect imperfect processesprocesses, not from , not from imperfect peopleimperfect peopleIndustrial experience has shown thatIndustrial experience has shown that 8585%%Industrial experience has shown that Industrial experience has shown that 8585% % of all problems are of all problems are processprocess problems that problems that are solvable only by managers withare solvable only by managers withare solvable only by managers, with are solvable only by managers, with remaining remaining 1515% being problems requiring % being problems requiring the action and improvement ofthe action and improvement ofthe action and improvement of the action and improvement of performanceperformance of individual workersof individual workers

Quality improvementQuality improvement occur when problemsoccur when problemsQuality improvementQuality improvement occur when problems occur when problems are eliminated permanentlyare eliminated permanently

Problem SolvingProblem SolvingProblem SolvingProblem SolvingCarefully defining the problemCarefully defining the problemy g py g pEstablishing baseline measures of process performanceEstablishing baseline measures of process performanceIdentifying root causes of the problemIdentifying root causes of the problemIdentifying a remedy for the problemIdentifying a remedy for the problemVerifying that the remedy Verifying that the remedy actualyactualy worksworksS fS fStandardizing or generalization the solution for the Standardizing or generalization the solution for the routine implementation of and improved processroutine implementation of and improved processEstablishing ongoing measures for monitoring andEstablishing ongoing measures for monitoring andEstablishing ongoing measures for monitoring and Establishing ongoing measures for monitoring and controlling the processcontrolling the process

Six Sigma Methodology Consists Six Sigma Methodology Consists DMAIC Fi StDMAIC Fi StDMAIC Five StagesDMAIC Five Stages

Define (D)Define (D)M (M)M (M)Measure (M)Measure (M)Analysis (A)Analysis (A)Improve (I)Improve (I)Control (C)Control (C)Control (C) Control (C)

DefineDefineDefineDefine

The first step in achieving qualityThe first step in achieving qualityThe first step in achieving quality The first step in achieving quality laboratory processes requires a definition laboratory processes requires a definition of goals and objectives and theof goals and objectives and theof goals and objectives, and the of goals and objectives, and the establishment of quality requirements to establishment of quality requirements to satisfy the customers and userssatisfy the customers and userssatisfy the customers and users.satisfy the customers and users.Without these definitions, there is no way Without these definitions, there is no way to measure whether acceptable quality isto measure whether acceptable quality isto measure whether acceptable quality is to measure whether acceptable quality is being achieved.being achieved.

Quality Planning

(QP)

Goals, Objectives,Quality Requirements

QUALITY PLANNING (QP)QUALITY PLANNING (QP)QUALITY PLANNING (QP)QUALITY PLANNING (QP)

QP encompasses the creation selectionQP encompasses the creation selectionQP encompasses the creation, selection, QP encompasses the creation, selection, and validation of the methods used in the and validation of the methods used in the laboratorylaboratorylaboratory.laboratory.What are the best available methods?What are the best available methods?D th t th lit i t ?D th t th lit i t ?Do they meet the quality requirements?Do they meet the quality requirements?The selection of quality control method is The selection of quality control method is an example of quality planning.an example of quality planning.

Quality Planning

(QP)

Quality Laboratory

Process (QLP)

Goals, Objectives,Quality Requirements

QUALITY LABORATORY QUALITY LABORATORY PROCESSES (QLP)PROCESSES (QLP)PROCESSES (QLP)PROCESSES (QLP)

QLP describe the means by which work isQLP describe the means by which work isQLP describe the means by which work is QLP describe the means by which work is conducted in the laboratory.conducted in the laboratory.Personnel policies, standard operating Personnel policies, standard operating p , p gp , p gprocedures (SOPs), specimenprocedures (SOPs), specimen--collection collection guidelines all belong to QLP domain.guidelines all belong to QLP domain.But no process is perfect and the remaining But no process is perfect and the remaining components of the TQM serve to monitor these components of the TQM serve to monitor these

d id i if h d id id i if h d iprocesses and provide correction if they deviate processes and provide correction if they deviate from the established quality management.from the established quality management.

Quality Planning

(QP)

Quality Laboratory

Process (QLP)

Goals, Objectives,Quality Requirements

Quality Control

(QC)( )

QUALITY CONTROL (QC)QUALITY CONTROL (QC)QUALITY CONTROL (QC)QUALITY CONTROL (QC)

QC provides tools to detect analytical problemsQC provides tools to detect analytical problemsQC provides tools to detect analytical problems QC provides tools to detect analytical problems early and making corrections prior to reporting early and making corrections prior to reporting results.results.Statistical QCStatistical QC is the major procedure for is the major procedure for monitoring the analytical performance of monitoring the analytical performance of laboratory.laboratory.QC also includes QC also includes nonstatisticalnonstatistical check check

dd h li i h k dh li i h k dproceduresprocedures, such as linearity check, reagent and , such as linearity check, reagent and standard checks, and temperature standard checks, and temperature monittoringmonittoring..

Quality Planning

(QP)

Quality Laboratory

Process (QLP)

Goals, Objectives,Quality Requirements

Quality Control

(QC)

Quality Assessment

(QA) ( )

QUALITY ASSESSMENT (QA)QUALITY ASSESSMENT (QA)QUALITY ASSESSMENT (QA)QUALITY ASSESSMENT (QA)

QA includes all actions a laboratory takes toQA includes all actions a laboratory takes toQA includes all actions a laboratory takes to QA includes all actions a laboratory takes to measure and monitor performance of the measure and monitor performance of the laboratory laboratory procecessprocecess..

QA includes verification of the quality of sample QA includes verification of the quality of sample q y pq y pcollection, sample processing, reporting of collection, sample processing, reporting of results, and interpretation of the final report by results, and interpretation of the final report by h h i ih h i ithe physician.the physician.

QulityQulity Assessment (QA)Assessment (QA) VesusVesusQ lit C t l (QC)Q lit C t l (QC)Quality Control (QC)Quality Control (QC)

QAQA is a complete system of creating andis a complete system of creating andQAQA is a complete system of creating and is a complete system of creating and following procedures and policies to aim for following procedures and policies to aim for providing the most reliable patient laboratory providing the most reliable patient laboratory results and to minimize errors in the results and to minimize errors in the preanalyticalpreanalytical, , analyticalanalytical, and , and postanalyticalpostanalytical

hhphases.phases.QCQC is a component of QA in which known is a component of QA in which known samples (QC samples) is analyzed along withsamples (QC samples) is analyzed along withsamples (QC samples) is analyzed along with samples (QC samples) is analyzed along with unknown (patient) samples to test for unknown (patient) samples to test for analyticalanalyticalproblemsproblemsproblems.problems.

TWO COMPLEMENTARY TWO COMPLEMENTARY COMPONENETS OF TQM ARECOMPONENETS OF TQM ARECOMPONENETS OF TQM ARECOMPONENETS OF TQM ARE

Internal Quality Control (IQC) Internal Quality Control (IQC)

External Quality Assessment (EQA)External Quality Assessment (EQA)

INTERNAL QUALITY CONTROL INTERNAL QUALITY CONTROL ( QC)( QC)(IQC)(IQC)

Is necessary for the daily monitoring of Is necessary for the daily monitoring of precision and accuracy of analytical methodprecision and accuracy of analytical method

Only Detects changes between present Only Detects changes between present performance and previous stable performance and previous stable p pp pperformance (Baseline)performance (Baseline)

Undetected systematic errors duringUndetected systematic errors duringUndetected systematic errors during Undetected systematic errors during baseline period would included in the mean baseline period would included in the mean that was used to calculate the control limits that was used to calculate the control limits

EXTERNAL QUALITY EXTERNAL QUALITY SS SS ( Q )SS SS ( Q )ASSESSMENT (EQA)ASSESSMENT (EQA)

Is a process by which a laboratory uses an outside Is a process by which a laboratory uses an outside unbiased source to verify the quality of patients unbiased source to verify the quality of patients resultsresultsresults results

allows a laboratory to confirm that its results are allows a laboratory to confirm that its results are i t t ith th f th l b t i i thi t t ith th f th l b t i i thconsistent with those of other laboratories using the consistent with those of other laboratories using the

same or similar methods for an same or similar methods for an analyteanalyte and thus to and thus to confirm it is using a method correctly confirm it is using a method correctly

Is important for maintaining the longIs important for maintaining the long--term accuracy term accuracy of the analytical methodsof the analytical methodsof the analytical methodsof the analytical methods

Quality Planning

(QP)

Quality Improve-

ment

Quality Laboratory

Process (QI) (QLP)

Goals, Objectives,Quality Requirements

Quality Control

(QC)

Quality Assessment

(QA) ( )

QUALITY IMPROVEMENT (QI)QUALITY IMPROVEMENT (QI)QUALITY IMPROVEMENT (QI)QUALITY IMPROVEMENT (QI)

If QA activities determine that quality If QA activities determine that quality requirements are not being achieved then QIrequirements are not being achieved then QIrequirements are not being achieved, then QI requirements are not being achieved, then QI processes must determine the cause of the processes must determine the cause of the problem and provide input to further quality problem and provide input to further quality p p p q yp p p q yplanning to eliminate the problem.planning to eliminate the problem.

PDCAPDCA Cycle for ObjectivelyCycle for ObjectivelyPDCAPDCA Cycle for Objectively Cycle for Objectively Monitoring of QualityMonitoring of Quality

PPlan lan DDooCCheckheckCCheckheckAActct