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Quality?
• Philip B Crosby- Quality is free 1979- “The customer is the one you need to make successful. You have to learn what they need and give it to them”.
• Joseph M Juran (Father of Quality Management)-Juran's Quality Handbook -“Some products give little or no dissatisfaction; they do what the producer said they would do. Yet they are not salable because some competing product has features that provide greater customersatisfaction”.
Quality?
• David Gravin- 8 dimensions to quality-– Performance based
– Feature based
– Reliability
– Conformance
– Durability
– Serviceability
– Aesthetics
– Perceived quality
How to get it done?
• Plan- Define course of action toward a measurable goal.
• Organize- How and How much
• Staff- Who does what
• Lead/ Direct- Do it
• Control- system functions in line with the plan
Quality Management System- Core
• Customer focus
• Top management initiation
• Involve all staff
• Process oriented approach
• System orientation
• Factual decision making
• Mutually beneficial supplier relationship
Key elements of Quality Management
• Documenting and Recording strategies
• Organizational structure (Organogram)
• Staff job descriptions and specific roles
• Equipment/ instruments
• Inventory management systems
• Statistical Process control
Quality Assurance and Quality Control
Quality Assurance Quality Control
Management strategy Error detection methodology
Everybody's businessArea specific activity performed by authorized staff only
The 7 common tools of Quality Management
• Cause and effect diagram
• Flow charts
• Checklist
• Control chart
• Scatter diagrams
• Pareto analysis
• Histograms
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- Control charts
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1. Shewhart chart, 1920.2. Mean value in centre.3. Upper cut off limits &
lower cut off limits on either side of mean.
4. 68% of values b/w ±1SD; 95% of values b/w ±2SD; 99.7% values b/w ±3 SD.
7 tools of QC- Scatter diagrams
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1. Determine the correlation b/w events.
2. Shows if a relationship exists b/w 2 sets of data.
7 tools of QC- Pareto analysis
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1. Joseph M Juran, 1940.
2. VilfredoPareto- Italian Economist-80/20 principle.
3. 20% of work generate 80% benefit.
Other Advanced Quality Management strategies
LEAN 6 SIGMA
Toyota production system Motorola corp
Philosophy Metric
5s principle (Seiri, Seiton, SeisoSikethu, Shitsuke)
DMAIC
Eliminate waste (Waiting, Over production, Rejection, Motion, Processing, Inventory, Transport)
Variation minimization
LEAN 6 Sigma= Philosophy + Metric
International Standards Organization
• Merger b/w ISA (International Federation of National Standardizing Association, New York 1926) and UNSCC (United Nations Standards Coordinating Committee, 1944 London)
• ISO set up in 1947 by 67 technical committees
• Firstly called International Standards Coordinating Association by Americans and Britons.
• Later on called as ISO derived from the Greek meaning equal.
The Evolution of ISO standards1 ISO 1: Standard reference temperature for industrial length
measurement1951
2 ISO 31 (Now ISO 80000) document based on SI, ISO has set units and how to measure them
1955
3 ISO/ TC 104 Standard on freight containers 1968
4 ISO 9001 family of standards published 1995
5 ISO 14001 environmental management standards published 1996
6 ISO 17025 Standard for testing and calibrating laboratories 1999
7 ISO 15189 Medical laboratories requirement for quality and competence (From ISO 9001+ISO 17025)
2003
8 ISO/IEC 27001 Management system standard on information security
2005
9 ISO 26000 Guidance on social responsibility 2010
10 ISO 50001 energy management standard 2011
11 ISO 37001 Anti bribery management systems 2016
Medical Laboratory Accreditation
• A process by which an authoritative body gives formal recognition that an organization is competent to carry out specific tasks.
• E.g. Joint commission on accreditation of healthcare organizations (JAHO), National committee on quality assurance (NCQA), NABL, CAP.
• India NABL authoritative body for testing and calibrating laboratories.
Accreditation vs Certification
Certification Accreditation
A procedure by which a third
party* gives a written
assurance that a product,
process or service confirms to
specific requirements.
*Third party- A person or a body that is
recognized to be independent of the
laboratory or parent organization.
A procedure by which an
authoritative body gives
formal recognition that a body
or a person is competent to
carry out specific tasks
(ISO/IEC guide 2).
eg. ISO 9000eg. ISO 15189; 2012, ISO
17043; 2010.
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Accreditation- Why?
Acceptance of test results within & beyond borders.
Greater control of laboratory process.
Customer satisfaction. & Brand value.
Customer can easily find an
accredited laboratory
Accreditation- How?
• NABL embraces the ISO 15189 Medical laboratories- requirements for quality and competence.
• Accreditation given based on laboratories capability to perform tests and provide reliable results.
• Assessment based on the ISO 15189; 2012 standard.
Requirements for accreditation
• Create a policy document (Quality Manual).
• Appoint a Quality Manager.
• Establish the Quality Management system
• Appoint a technical manager.
• Process breakdown & QI identification.
• Monitor quality indicators and undertake appropriate CA/PA.
• Documentation.
• Audits
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Requirements for accreditation
• Quality manual:– Satisfy every clause mentioned in the standard
(ISO 15189).
– Greatest document of the QMS (Level 1).
– Describes laboratory policies, organization structure, job descriptions and personnel interrelations.
Note:
“Every lab policies traceable to its QM”.
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Requirements for accreditation
• Quality Manager:
– Head of the QMS.
– Reports directly to the lab director.
– Keeps the laboratory audit fit.
– Monitors process and continuously improves them various lab processes.
– Involved in educating and training staff.
• Education- change the way people think.
• Training- change the way personnel work.
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Requirements for accreditation
• Quality Management system
– Quality: The degree to which a set of inherent characteristics fulfils requirements.
– Management: Plan, organize, staff, lead and control.
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Requirements for accreditation
• Technical Manager:
– Usually a senior technical person.
– Appointed by HOD.
– Technical workload management and work distribution among existing staff.
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Requirements for accreditation
• Quality indicators:
– “It measures how well an organization meets the needs and requirements of users and the quality of all operational processes”.
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Requirements for accreditation
• Establishing QI & continual improvement:
– Lab process broken down to its components and micro components.
– Identify the common failures or errors that occur frequently.
– Log the most common errors and the reason behind the errors.
– Appoint a person to ensure the log is maintained and updated regularly.
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Requirements for accreditation
• Establishing QI & continual improvement:
– Tabulate and identify the major causes for the errors.
– Present the data with recommended corrective measures.
– Implement the CA and measure the rate of success of the corrective action.
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Requirements for accreditation
• Properties of QI’s:
– Measurable in terms of numbers.
– Benchmarks should be predefined.
– Results should be subjected to statistical analysis.
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Requirements for accreditation
Pre analytical
• Sample collection
• Routing to appropriate location
• Registration into LIS
Analytical
• QC
• Sample processing
• Result genera ration
Post analytical
• Result validation
• Result transfer.
Lab work breakdown structure and QI identification
Sample rejection.Sample missingDouble poke
QC failure.Unscheduled Downtime.
Human error.Software crash
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Documentation
Indicators for good documentation:
• Approved, reviewed and updated regularly.
• Concise, legible, accurate and traceable.
• Amendments & revision are identifiable.
• Current version is available at points of use.
• Follows change control procedure.
• Obsolete documents separated, identified and retained for defined amount of time.
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Document classification in QMS
• Internal documents:
– Documents/ reference material created by the laboratory for use within the laboratory.
– It is subject to the change control procedures created by the laboratory.
– It is approved by appropriate personal before release for use by the laboratory personnel.
– E.g. SOP, QM, QSP.
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Document classification in QMS
• External documents:
– Maintained by the laboratory for reference purposes.
– Created by a third party and is formally published for use.
– Not subject to the change control procedure of the laboratory.
– E.g. ISO 15189; 2012 standard, published book.
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Document classification in QMS
Records
• Proof/ evidence of activity.
• They have a defined retention period.
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Other activities
• Quality Control– Goal to identify errors before they impact the real
test.
– Also called as repeatability testing or precision.
• Proficiency testing– Ensure the laboratory tests are accurate.
• Calibration– All equipment's and instruments are produce
accurate results.
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