principles of quality management

Principles of Laboratory QualityManagement

Gift Ajay SamSr. Demonstrator

Transfusion Medicine and ImmunohaematologyCMC, Vellore

[email protected]

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Overview• Laboratory Quality Management– Introduction.• TQM philosophy.• History• Quality Management System.• Essential elements of the QMS (ISO 15189).

– Quality Assurance & Quality Control• QA vs QC.• True value vs Measured value.• Precision & accuracy.

– Calibration.• Instrument vs equipment?• Qualification & calibration?

– Conclusion

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TQM Principles1. Customer focus2. Leadership3. Involvement of people.4. Process approach (maximize profit by

minimizing waste).5. System approach to management (managing

interrelated processes).6. Continual improvement.7. Factual approach to decision making.8. Mutually beneficial supplier relationship.

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History of TQM

1942- 1952US Military develop requirements forcontractors for shell, aircraft, missilesuppliers.

Till 1968 Quality management by weaponindustries.

1979 BSI (British Standard Institute) BS 5750 forcivilian (industry) use.

1987 ISO modified BS 5750 to ISO 9000 forIndustrial standards.

1987- 2012

ISO 9000 (Industry) ISO 14000(Environmental management) ISO17025 (Testing or calibrating laboratories)

ISO 15189 (Clinical laboratories).

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Quality Management System

• What is Quality?– The right thing the first time.– Producing products of consistent characteristics.– Compliance to a standard.

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• ISO 9000- “The degree to which inherentcharacteristics fulfill requirements”.• Management- Plan, organize, staff, lead

(direct) & control.• Quality Management- Quality + Management

+ system.

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• Quality management– “An aggregate of organizational activities, plans,

policies and processes in formulating andimplementing a TQM approach”.

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Essential elements of the QMS

QMS

Processcontrol

Informationmanagement.

Documents &records.

Occurrencemanagement.

Assessment.

ProcessImprovement.

CustomerService.

Safetyfacilities.

Organization

Personnel

Equipments

InventoryControl.

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• Organization

QualityPolicy

Responsibility &authority.

Communication.Provision ofresources

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• Personnel– HR– Qualification & job description.– Orientation & training.– Competency assessment.– Professional development.– Continuing education.

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• Equipment– Acquiring– Installing–Maintaining– Calibrating– Service & repair.– Records.

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• Inventory management– Protocols to select vendors.– Vendor evaluation.– List of vendors & supplies.

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• Process control– QC– Sample management–Method validation & verification.

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• Info management– Confidentiality.– Requests– Logs & records– Reports– LIS

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• Documents & records

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Documents RecordsReference medium approvedfor use by laboratory.

Evidence of activity.

Issued: Revised: Amendment. Collected: Reviewed: Retainedfor a period.


• Occurrence management– Complaints & problems.– Documentation– RCA– CAPA.

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• Assessment

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Internal ExternalQI PTStructured audit programme InspectionManagement review. Accreditation


• Process improvement– Stakeholder feedback.– Opportunities for improvement.– CAPA.

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• Customer service– Customer group identification.– Customer need identification.– Customer feedback.

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• Safety– Safe working environment.– Safe transport.–Waste management– Ergonomics.

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Quality assurance & Quality Control

• Quality Assurance– “Overall management

plan to guarantee theintegrity of data”.– SYSTEM

• Quality Control– “A series of analytical

measurements used toassess the quality ofanalytical data”.– Tools used in the system.

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True value vs Measured value

• True value– “Known accepted value

of a quantifiableproperty”.

• Measured Value– “Result of an individuals

measurement on aquantifiable property”.

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Accuracy vs Precision

Accuracy Precision

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Accuracy vs Precision

Accuracy• How well measurement

agrees with an acceptedvalue.

• Closeness to estimatedvalue that is considered tobe true.

Precision• How well measurement

agree with each other.• Repeatability of results.

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Basic Statistics

Descriptive statistics• Describes the data• E.g. Histograms, pie charts,

scatter plot, etc

Summary statistics• Summarize data.• E.g. Mean, Median, Mode,

range, SD, Correlation.

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Summary statistics• Mean/ Average (x bar) & Median– Measure of centre.– Mean= sum of values / number of values.– Median= the mid value. i.e. half the values on each side.

• Standard deviation (σ)– Measures the distance from average.– Steps

• Square the numbers.• Find the mean of the squared numbers.• Find the square root .

• Correlation (r)– Measures the strength of linear relationship b/w 2 variables.– R always b/w +1 & -1; No correlation r= 0.– Steps

• Convert x & y into standard units (value- mean/ SD).• Take the product of standard units (SU (X)* SU (Y))• Take the mean of the products that is r.

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Quality assurance & Quality Control

• 7 tools of QCa. Cause & effect diagramb. Flowchartsc. Checklistd. Control chartse. Scatter diagramsf. Pareto analysisg. Histograms.

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7 tools of QC- Cause & effect diagram

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1. Ishikawa diagram or fish bone diagram.2. Kaoru Ishikawa 1968.

7 tools of QC- Flow charts

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1. Describe a process.2. Arrows- flow of

direction.

Flow chart example

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7 tools of QC- Checklist

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7 tools of QC- Control charts

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1. Shewhart chart, 1920.2. Mean value in centre.3. Upper cut off limits &

lower cut off limits oneither side of mean.

4. 68% of values b/w ±1SD; 95% of values b/w±2SD; 99.7% valuesb/w ±3 SD.

7 tools of QC- Scatter diagrams

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1. Determine the correlation b/wevents.

2. Shows if a relationship existsb/w 2 sets of data.

7 tools of QC- Pareto analysis

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1. Joseph MJuran, 1940.

2. VilfredoPareto- ItalianEconomist-80/20principle.

3. 20% of workgenerate 80%benefit.

Calibration

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Analytical*Device

Instrument A device used to collect the scientificdata and measurement of results

EquipmentRefers to the various supporting tools

used for performing analysis in thelaboratory

Analytical devices classified into 2

http://www.ispe.org/glossary?term=Equipment#sthash.X6v7BNF6.dpuf

Qualification & Calibration

• Qualification (4 Qs)–basically proves that the equipment works

correctly and actually leads to accurate andreliable results

• Calibration– Ensures that on an on-going basis that the

equipment is performing properly

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Qualification• Design Qualification (DQ)– functional and operational specifications/ requirements (physical environment

in which instrument needs to operate).• Installation Qualification (IQ)– Establishes that the instrument is delivered as designed and specified, that it is

properly installed in the selected environment, and that this environment issuitable for the operation and use of the instrument.

• Operational Qualification (OQ)– Verify that the main operating parameters—injection volume, flow rate,

mobile-phase mixing, column thermostating temperature, and detectionwavelength are within their specified limits for accuracy and precision.

• Performance Qualification (PQ)– Demonstrate that instrument performs consistently as per specifications

defined by the user and is appropriate for the intended use.– Done after AMC.

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Calibration Program

• System must be in place to ensure that allinstruments are calibrated and also to preventuse of an instrument that is not calibrated,unusable due to damage or malfunction, or hasexceeded its established calibration interval• Frequency– manufacturer’s recommendations– relevant procedures – sensitive?– instrument performance history

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Conclusion

• Quality Policy“To provide the best possible, cost effective,

appropriate and maximally beneficial service toour customers while making an impact on nationalpractice of laboratory haematology, transfusionmedicine and immunogenetics through innovationin practice, education, training and research inalignment with the goals of Christian MedicalCollege, Vellore”.

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principles of quality management

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