Understanding and implementing quality management system in medical laboratoriesPathKind Labs
QMS is essential to run a good laboratory, but the various requirements pose a big challenge. Once you understand the reason for these requirements compliance may be easier.
This document discusses quality management in health laboratories. It defines quality and outlines approaches to quality management including planning, organizing, staffing, leading and controlling processes. Key elements of a quality management system are described such as organization, personnel, equipment, purchasing, process control, information management, documents/records, occurrence management and assessment. The document emphasizes that a quality management system involves coordinated activities across all aspects of laboratory operations to ensure quality. External quality assessment through proficiency testing is also discussed as an important tool for evaluating laboratory performance.
This document discusses quality indicators, their history, definitions, and examples. It describes how quality indicators can be used to monitor performance, determine quality of services, and identify areas for improvement. The document provides examples of quality indicators collected by various laboratories and organizations. It also outlines best practices for developing, presenting, and using quality indicators effectively.
Define of quality control & describe your experience regarding qc in your...Rishad Choudhury Robin
Quality control (QC) involves evaluating products and services to ensure requirements are met. It focuses on defect detection through testing and inspection. QC is mainly an output-oriented process used to compare quality to standards. For hospitals, internal QC involves evaluating structure, processes, and outcomes of care. The QC process involves commitment from management, developing quality procedures and plans, training staff, and conducting regular audits. Quality management also requires elements like policies, procedures, education, monitoring, and external evaluation.
Total Quality Management (TQM) by Dr Anurag YadavDr Anurag Yadav
Total quality management principles aim to improve patient care through monitoring laboratory work to detect deficiencies and correct them. Errors can occur in preanalytical, analytical, and postanalytical phases, and quality control procedures help control variables and ensure accuracy. Calibration, precision, accuracy, linearity, and detection limits are important analytical concepts, and factors like equipment, reagents, personnel, and documentation must be controlled and monitored to minimize errors and ensure quality.
This document provides information about quality management systems for laboratories. It discusses key aspects of a quality management system including defining quality, the importance of a QMS for ensuring reliable lab operations, and the benefits of implementing a QMS such as improved efficiency and compliance. It also outlines the 12 essential elements of an ISO-compliant lab QMS and provides details on ISO 15189, which provides standards for quality in medical laboratories.
The document discusses various concepts related to quality including definitions of quality, quality management, quality control, quality assurance, ISO standards, total quality management, and documentation requirements. It provides definitions for quality as fitness for use, conformance to specifications, and meeting customer expectations. Quality management involves building quality into products through controls and preventing deficiencies. Quality control tests and inspects materials and products, while quality assurance reviews quality systems and procedures. Documentation is essential for defining and controlling quality systems.
The issue of laboratory quality has evolved over more than 4 decades since the 1st recommendation for quality control were published in 1965
Now, quality control is seen as only one part of a total laboratory control program
Quality also includes:
a) Total Quality Management (TQM)→ an activity to improve pt. care by having the lab monitor, its work to detect deficiencies & subsequently correct them
Understanding and implementing quality management system in medical laboratoriesPathKind Labs
QMS is essential to run a good laboratory, but the various requirements pose a big challenge. Once you understand the reason for these requirements compliance may be easier.
This document discusses quality management in health laboratories. It defines quality and outlines approaches to quality management including planning, organizing, staffing, leading and controlling processes. Key elements of a quality management system are described such as organization, personnel, equipment, purchasing, process control, information management, documents/records, occurrence management and assessment. The document emphasizes that a quality management system involves coordinated activities across all aspects of laboratory operations to ensure quality. External quality assessment through proficiency testing is also discussed as an important tool for evaluating laboratory performance.
This document discusses quality indicators, their history, definitions, and examples. It describes how quality indicators can be used to monitor performance, determine quality of services, and identify areas for improvement. The document provides examples of quality indicators collected by various laboratories and organizations. It also outlines best practices for developing, presenting, and using quality indicators effectively.
Define of quality control & describe your experience regarding qc in your...Rishad Choudhury Robin
Quality control (QC) involves evaluating products and services to ensure requirements are met. It focuses on defect detection through testing and inspection. QC is mainly an output-oriented process used to compare quality to standards. For hospitals, internal QC involves evaluating structure, processes, and outcomes of care. The QC process involves commitment from management, developing quality procedures and plans, training staff, and conducting regular audits. Quality management also requires elements like policies, procedures, education, monitoring, and external evaluation.
Total Quality Management (TQM) by Dr Anurag YadavDr Anurag Yadav
Total quality management principles aim to improve patient care through monitoring laboratory work to detect deficiencies and correct them. Errors can occur in preanalytical, analytical, and postanalytical phases, and quality control procedures help control variables and ensure accuracy. Calibration, precision, accuracy, linearity, and detection limits are important analytical concepts, and factors like equipment, reagents, personnel, and documentation must be controlled and monitored to minimize errors and ensure quality.
This document provides information about quality management systems for laboratories. It discusses key aspects of a quality management system including defining quality, the importance of a QMS for ensuring reliable lab operations, and the benefits of implementing a QMS such as improved efficiency and compliance. It also outlines the 12 essential elements of an ISO-compliant lab QMS and provides details on ISO 15189, which provides standards for quality in medical laboratories.
The document discusses various concepts related to quality including definitions of quality, quality management, quality control, quality assurance, ISO standards, total quality management, and documentation requirements. It provides definitions for quality as fitness for use, conformance to specifications, and meeting customer expectations. Quality management involves building quality into products through controls and preventing deficiencies. Quality control tests and inspects materials and products, while quality assurance reviews quality systems and procedures. Documentation is essential for defining and controlling quality systems.
The issue of laboratory quality has evolved over more than 4 decades since the 1st recommendation for quality control were published in 1965
Now, quality control is seen as only one part of a total laboratory control program
Quality also includes:
a) Total Quality Management (TQM)→ an activity to improve pt. care by having the lab monitor, its work to detect deficiencies & subsequently correct them
This document provides information about quality management in embryology laboratories. It discusses how quality standards have evolved from an apprentice-based system with little monitoring to today's highly regulated environment. Key aspects of quality management systems are described, including quality control, document control, audits, risk assessment, and meeting regulatory requirements from bodies like the HFEA. The role of the quality manager is to ensure the quality management system is functional and that quality standards are continuously improved.
Good laboratory practices in a pharmaceutical lab 1Sabahat Ali
This document discusses good laboratory practices in a pharmaceutical lab. It outlines the members of a group project on this topic and provides an introduction to pharmaceutical lab testing. It then covers topics like GMP, GLP, quality control, quality assurance, reducing human errors, and the scope of QA and QC in a pharmaceutical lab. Key points include that pharmaceutical labs test raw materials, finished products, and conduct validation, stability, and analytical method development testing. GMP and GLP aim to minimize risks and ensure consistent quality production. QA and QC work to guarantee drug quality and safety at all stages from development to sales.
The document is a curriculum vitae for S. Kalithas seeking a quality control or quality assurance role in the pharmaceutical or FMCG sector. It summarizes his over 10 years of experience in pharmaceutical quality control, including his current role as Deputy Manager of Quality Control at Biocon Ltd since 2008 where he manages a team of 8 members and oversees analytical work, documentation, and ensuring compliance. It also lists his educational qualifications including an MSc in Chemistry from Madurai Kamaraj University in 2003.
ISO 15189 is an international standard that specifies the general requirements for the competence of medical laboratories. It is based on ISO 17025 for testing and calibration laboratories and ISO 9001 for quality management systems. ISO 15189 has both management and technical requirements that medical laboratories must meet in order to be accredited. The standard is designed to ensure that laboratories consistently deliver accurate, reliable and timely medical testing services.
Dr. Hima Gupta gave a presentation on total quality management. She defined TQM as managing the whole organization to achieve excellence. She discussed definitions of quality, dimensions of quality, and perspectives on quality including customer-focused, value-based, and manufacturing-based views. She outlined principles of TQM including customer focus, continuous improvement, and an organizational infrastructure to support quality practices and tools. TQM aims to close the gap between an organization's potential and current performance levels to increase revenue per staff.
This document discusses quality control and quality assurance. It defines quality control as focused on fulfilling requirements, while quality assurance provides confidence that requirements will be fulfilled. Quality control is reactive and finds defects, while quality assurance is proactive and prevents defects. The document then discusses ISO 9000 standards for quality management systems, including definitions, principles, documentation structure, and clauses. It provides details on quality control and quality assurance procedures and responsibilities.
The ISO 17025 standard: principles and management requirements
Workshop on laboratory basics and fundamentals of ISO Quality Management Standards
March 21-22, 2018, Kyiv, Ukraine
Total Quality Management (TQM) is a company-wide approach to quality that focuses on continuous improvement, customer satisfaction, and employee empowerment. Key aspects of TQM include establishing a commitment to quality at all levels of management, building quality into processes rather than inspecting outputs, and empowering employees. TQM aims to move organizations beyond traditional quality inspection and control methods toward more strategic, system-wide approaches to quality.
Total Quality Management (TQM) is a company-wide approach to quality that focuses on continuous improvement, customer satisfaction, and employee empowerment. Key concepts of TQM include continuous improvement, Six Sigma, employee empowerment, benchmarking, just-in-time production, and quality tools. TQM aims to prevent defects by building quality into processes from the beginning rather than relying on inspection and quality control.
Total Quality Management (TQM) is a company-wide approach to quality that focuses on continuous improvement, customer satisfaction, and employee empowerment. Key concepts of TQM include continuous improvement, Six Sigma, employee empowerment, benchmarking, just-in-time production, and quality tools. TQM aims to prevent defects by building quality into processes from the beginning rather than relying on inspection and quality control.
This document discusses quality standards and quality management processes for surveying projects. It defines key terms like quality, standards, quality assurance and quality control. It describes the benefits of standards and outlines the Plan-Do-Check-Act model for quality processes. Quality standards help ensure accurate, reliable survey results and monitoring is needed to check that standards and requirements are met. The three main quality management processes are quality planning, quality assurance and quality control.
This document provides an overview of CAP accreditation for laboratories. It defines key terms, outlines the history of CAP, and describes the United Labs Consulting Team. It reviews common laboratory requirements and CAP standards. The steps for accreditation include pre-assessment, assessment, and post-assessment phases. Benefits of CAP accreditation include comprehensive evaluations, expert inspection teams, useful inspection tools, and compliance with regulations. CAP focuses on continuous education to improve laboratory quality and patient safety.
This document provides an overview of quality assurance. It defines quality assurance as the process of checking that a product or service meets customer requirements. Key points covered include the difference between quality assurance and quality control, the development of quality assurance concepts, factors affecting product quality, and components of a quality assurance system such as standard operating procedures, training, and quality manuals. The document also discusses quality assurance cycles, quality by design, quality risk management, and the functions of quality assurance professionals.
GMP aims to ensure quality, safety and efficacy of medicines by requiring manufacturers to follow quality standards and comply with marketing authorizations. Inspections verify compliance and identify any deviations between dossiers and actual practices. Quality assurance, GMP, quality control, and quality risk management are interrelated aspects of quality management that are important for producing pharmaceuticals to the required standards.
TQM UNIT-V.ppt TOTAL QUALITY MANAGEMENT1SelvaBabu2
The document discusses quality management standards from ISO. It provides an overview of the ISO 9000 family of standards including ISO 9000, 9001, and 9004. ISO 9000 defines quality management system fundamentals. ISO 9001 specifies quality management system requirements. ISO 9004 provides guidance on quality management systems. The document also outlines the key principles of ISO 9001:2008 and the requirements for quality management systems.
We Build and Breed Success provides quality management training and consulting services to help testing laboratories achieve quality-driven empowerment and optimization through solutions like documentation assistance, gap analyses, process mapping, auditing training, and accreditation support. With over 17 years of experience in various fields like pathology, environmental, agriculture, clinical trials, food, and veterinary testing in South Africa and Africa, they can help laboratories transform through extensive experience in quality system implementation and improvements.
Pre analytic and postanalytic test managementVarsha Shahane
The document discusses principles of pre-analytic, analytic, and post-analytic test management. It covers test selection and evaluation, requisition and test menu formats, and report formatting. The three phases of quality assurance - pre-analytic, analytic, and post-analytic - are described in detail, including factors influencing each phase like specimen handling, equipment calibration, and report review. Quality control procedures are also outlined to ensure test accuracy and reproducibility.
This document discusses quality assurance in the pharmaceutical industry. It defines key terms like quality assurance (QA) and quality control (QC), and explains their objectives. QA aims to achieve product realization and continual improvement through monitoring processes and products, corrective actions, and management reviews. QC ensures products are consistently manufactured and tested according to quality standards. The document also identifies major risks to pharmaceutical production and key factors for achieving an effective quality management system, such as customer focus, leadership, and continuous improvement.
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
This document provides information about quality management in embryology laboratories. It discusses how quality standards have evolved from an apprentice-based system with little monitoring to today's highly regulated environment. Key aspects of quality management systems are described, including quality control, document control, audits, risk assessment, and meeting regulatory requirements from bodies like the HFEA. The role of the quality manager is to ensure the quality management system is functional and that quality standards are continuously improved.
Good laboratory practices in a pharmaceutical lab 1Sabahat Ali
This document discusses good laboratory practices in a pharmaceutical lab. It outlines the members of a group project on this topic and provides an introduction to pharmaceutical lab testing. It then covers topics like GMP, GLP, quality control, quality assurance, reducing human errors, and the scope of QA and QC in a pharmaceutical lab. Key points include that pharmaceutical labs test raw materials, finished products, and conduct validation, stability, and analytical method development testing. GMP and GLP aim to minimize risks and ensure consistent quality production. QA and QC work to guarantee drug quality and safety at all stages from development to sales.
The document is a curriculum vitae for S. Kalithas seeking a quality control or quality assurance role in the pharmaceutical or FMCG sector. It summarizes his over 10 years of experience in pharmaceutical quality control, including his current role as Deputy Manager of Quality Control at Biocon Ltd since 2008 where he manages a team of 8 members and oversees analytical work, documentation, and ensuring compliance. It also lists his educational qualifications including an MSc in Chemistry from Madurai Kamaraj University in 2003.
ISO 15189 is an international standard that specifies the general requirements for the competence of medical laboratories. It is based on ISO 17025 for testing and calibration laboratories and ISO 9001 for quality management systems. ISO 15189 has both management and technical requirements that medical laboratories must meet in order to be accredited. The standard is designed to ensure that laboratories consistently deliver accurate, reliable and timely medical testing services.
Dr. Hima Gupta gave a presentation on total quality management. She defined TQM as managing the whole organization to achieve excellence. She discussed definitions of quality, dimensions of quality, and perspectives on quality including customer-focused, value-based, and manufacturing-based views. She outlined principles of TQM including customer focus, continuous improvement, and an organizational infrastructure to support quality practices and tools. TQM aims to close the gap between an organization's potential and current performance levels to increase revenue per staff.
This document discusses quality control and quality assurance. It defines quality control as focused on fulfilling requirements, while quality assurance provides confidence that requirements will be fulfilled. Quality control is reactive and finds defects, while quality assurance is proactive and prevents defects. The document then discusses ISO 9000 standards for quality management systems, including definitions, principles, documentation structure, and clauses. It provides details on quality control and quality assurance procedures and responsibilities.
The ISO 17025 standard: principles and management requirements
Workshop on laboratory basics and fundamentals of ISO Quality Management Standards
March 21-22, 2018, Kyiv, Ukraine
Total Quality Management (TQM) is a company-wide approach to quality that focuses on continuous improvement, customer satisfaction, and employee empowerment. Key aspects of TQM include establishing a commitment to quality at all levels of management, building quality into processes rather than inspecting outputs, and empowering employees. TQM aims to move organizations beyond traditional quality inspection and control methods toward more strategic, system-wide approaches to quality.
Total Quality Management (TQM) is a company-wide approach to quality that focuses on continuous improvement, customer satisfaction, and employee empowerment. Key concepts of TQM include continuous improvement, Six Sigma, employee empowerment, benchmarking, just-in-time production, and quality tools. TQM aims to prevent defects by building quality into processes from the beginning rather than relying on inspection and quality control.
Total Quality Management (TQM) is a company-wide approach to quality that focuses on continuous improvement, customer satisfaction, and employee empowerment. Key concepts of TQM include continuous improvement, Six Sigma, employee empowerment, benchmarking, just-in-time production, and quality tools. TQM aims to prevent defects by building quality into processes from the beginning rather than relying on inspection and quality control.
This document discusses quality standards and quality management processes for surveying projects. It defines key terms like quality, standards, quality assurance and quality control. It describes the benefits of standards and outlines the Plan-Do-Check-Act model for quality processes. Quality standards help ensure accurate, reliable survey results and monitoring is needed to check that standards and requirements are met. The three main quality management processes are quality planning, quality assurance and quality control.
This document provides an overview of CAP accreditation for laboratories. It defines key terms, outlines the history of CAP, and describes the United Labs Consulting Team. It reviews common laboratory requirements and CAP standards. The steps for accreditation include pre-assessment, assessment, and post-assessment phases. Benefits of CAP accreditation include comprehensive evaluations, expert inspection teams, useful inspection tools, and compliance with regulations. CAP focuses on continuous education to improve laboratory quality and patient safety.
This document provides an overview of quality assurance. It defines quality assurance as the process of checking that a product or service meets customer requirements. Key points covered include the difference between quality assurance and quality control, the development of quality assurance concepts, factors affecting product quality, and components of a quality assurance system such as standard operating procedures, training, and quality manuals. The document also discusses quality assurance cycles, quality by design, quality risk management, and the functions of quality assurance professionals.
GMP aims to ensure quality, safety and efficacy of medicines by requiring manufacturers to follow quality standards and comply with marketing authorizations. Inspections verify compliance and identify any deviations between dossiers and actual practices. Quality assurance, GMP, quality control, and quality risk management are interrelated aspects of quality management that are important for producing pharmaceuticals to the required standards.
TQM UNIT-V.ppt TOTAL QUALITY MANAGEMENT1SelvaBabu2
The document discusses quality management standards from ISO. It provides an overview of the ISO 9000 family of standards including ISO 9000, 9001, and 9004. ISO 9000 defines quality management system fundamentals. ISO 9001 specifies quality management system requirements. ISO 9004 provides guidance on quality management systems. The document also outlines the key principles of ISO 9001:2008 and the requirements for quality management systems.
We Build and Breed Success provides quality management training and consulting services to help testing laboratories achieve quality-driven empowerment and optimization through solutions like documentation assistance, gap analyses, process mapping, auditing training, and accreditation support. With over 17 years of experience in various fields like pathology, environmental, agriculture, clinical trials, food, and veterinary testing in South Africa and Africa, they can help laboratories transform through extensive experience in quality system implementation and improvements.
Pre analytic and postanalytic test managementVarsha Shahane
The document discusses principles of pre-analytic, analytic, and post-analytic test management. It covers test selection and evaluation, requisition and test menu formats, and report formatting. The three phases of quality assurance - pre-analytic, analytic, and post-analytic - are described in detail, including factors influencing each phase like specimen handling, equipment calibration, and report review. Quality control procedures are also outlined to ensure test accuracy and reproducibility.
This document discusses quality assurance in the pharmaceutical industry. It defines key terms like quality assurance (QA) and quality control (QC), and explains their objectives. QA aims to achieve product realization and continual improvement through monitoring processes and products, corrective actions, and management reviews. QC ensures products are consistently manufactured and tested according to quality standards. The document also identifies major risks to pharmaceutical production and key factors for achieving an effective quality management system, such as customer focus, leadership, and continuous improvement.
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
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Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
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1. Quality Assurance and Control
Syllabus Outline:
1. Introduction
2. Practical consideration in devel. QA/QC system
3. Elements of QA/QC system
4. Elements of QA
5. Statistical Tools for QA
6. Validation Process
7. Principles of Q. Management (QM)
8. Six Sigma Q tools
9. QA/QC plan
10. QC procedures
11. Documentation and Reporting
2. Quality is a Lousy Idea-
If it’s Only an Idea
What is quality and why quality?
• Quality refers to the sum of the attributes or properties that describe a
product or service
• WHY? In this highly competitive world the success of any business
lies in the quality of its products and/or service
• Definition: Quality means the totality of features and characteristics
of a product or service that bear on its ability to satisfy given needs
• From customer’s perspective, quality of a good or service is fitness for
use of it
3. QA and QC
Applications:
• Education:
• Teaching
• Research
• Project development, execution, monitoring, reporting and dissemination
• Healthcare:
• Medicine
• Health care staff
• Patient’s treatment and management
• Software development,
• Service industry, and
• Other technical areas.
4. WHO:
• QA: Quality assurance has been defined by WHO as the total process whereby
the quality of laboratory reports can be guaranteed. It has been summarized as
the:right result, at the right time, on the right specimen, from the right patient,
with the result interpretation based on correct reference data, and at the right
price.)
• (QC: The term QC covers that part of QA, which primarily concerns the control of
errors in the performance of tests and verification of test results. QC must cover
all aspects of every procedure within the department. It must be practical,
achievable, and affordable. All materials, equipment and procedures must be
adequately controlled. Culture media must be tested for sterility and
performance.
5. What is Quality
• The ability to make the same thing the same way, over and
over again
• Customer buys today is same as what they bought last week
or will buy next week
• Product meets customer’s expectations 100% of the time
6. Why Quality?
Quality was the tool which pushed Japan into the world market
About 38 years ago Japan responded to the call of Dr. Deming,
known as “Quality Guru”.
What was that call ? It was:
• If you listen to me you will be selling your products in the
European markets within 5 years
• If you continue to listen to me you will be the world leader
• My message is: produce quality products at affordable prices
7. What is Quality?
• General Concepts ─ Customer based
• Good design (aesthetics & functionality)
• Good finish (aesthetics & functionality)
• Durability
• Reliability
Expert Concepts
• Of highest possible standard
• Rugged
• Very long life
8. What is Quality?
Manufacturer’s Viewpoint
• Of highest possible standard
• Perfection
• Rugged
• Very long life
The Winning Definition
Customer satisfaction
Fitness for the purpose
Conformance to specification
All at affordable price
“ quality as the degree to which a set of inherent characteristics fulfill requirement”
9. The New Objective
Thus all good manufacturers are
working towards the same objective of:
Improving on the quality attributes
and lowering the cost
(A struggle towards zero defect production)
10. How to go about it?
• Build the quality into the product in the first place
• Reduce the defects
• Avoid reworks
Improving on the quality attributes
and lowering the cost
11. Quality Assurance (QA)
• QA constitutes a system by which analytical laboratory assures proven
and known quality
• QA encompasses a range (set) of activities:
• that enable laboratories to achieve and maintain high level of Accuracy and
Proficiency
• that defines the procedures and standards to develop the product of service
• QA is the tool that helps the laboratory to provide relevant Reliable,
Timely, and Correctly interpreted laboratory results. Leading to overall
performance…
• QA is a part of QM(quality management) ongoing process to monitor and
evaluate …:
• QA is defined as an activity to ensure that an organization is
providing the best product or service to the customers.
12. QA condt.
• QA constitute a SYSTEM:
1. establishes SOPs for each step of testing process.. specimen handling to
instrument performance validation.
2. administrative requirement; record keeping, data evaluation, adherence
to SOPs
3. specifies corrective action, documentation, persons responsible for
carrying out corrective action
4. sustain high quality employees performance
13. Standard operating procedures (SOPs)
Each laboratory must have SOPs, sometimes referred to as the
Internal laboratory bench manual. It is required for the following reasons:
to improve and maintain the quality of laboratory service to
patients and identify problems associated with poor work
performance.
to provide laboratory staff with written instructions on how to
perform tests consistently to an acceptable standard in the
laboratory.
to help avoid short-cuts being taken when performing tests.
to provide written standardized techniques for use in the training
of laboratory personnel.
to facilitate the preparation of a list and inventory of essential
reagents, chemicals and equipment.
to promote safe laboratory practice.
14. Quality Assurance (QA)
1. QA constitutes a system by which analytical laboratory assures proven
and known quality
2. QA encompasses a range of activities that enable laboratories to achieve
and maintain high level of Accuracy and Proficiency despite changes in
the test methods and the volume of specimens tested.
3. QA is the tool that helps the laboratory to provide relevant Reliable,
Timely, and Correctly interpreted laboratory results. Leading to aid
companies in improving the reliability, quality and overall performance of
the organization/department
4. QA is a part of QM(quality management) ongoing process to monitor and
evaluate every step; pre-analytical, analytical and post-analytical
5. QA provides confidence that quality requirements will be fulfilled.
16. The components of QA
Depends of number of inter-related factors:
1. Consistent documented procedures:
1. Pre-analytical, Analytical, Post-analytical
2. Instrument performance:
1. Function checks, Preventive measures
3. Assay performance:
1. Methods, Validation, Control testing
4. Record keeping: documenting all procedure/processes/record
5. Accreditation: ISO, CLIA, NABL, COLA
6. Continuous quality improvement
17. ▪ Pre-analytical process (40%)
▪ Patients preparation
▪ Sample collection
▪ Labeling
▪ Transport
▪ Preparation of sample
▪ Analytical process (20%)
▪ Check requisition
▪ Different results!! ( two different labs)
▪ Post- analytical process (40%)
▪ Calculation
▪ Transcription… into final report
▪ Typing and proper distribution
18. Components of QA
1. Consistent documented procedures:
▪ Pre-analytical: 40% Errors , can affect interpretation of the test result).
(patient’s preparation, sample collections, labeling, transport, preparation of
sample). If you know these the life of the pathologist/microbiologist will be
easy.
▪ Analytical: 20% Errors:
▪ Post-analytical: 40% Errors
2. Instrument performance:
▪ Function checks
▪ Preventive measures
19. • Pre-Analytical Phase: Patient’s preparation:
• Duration of overnite fasting (12-15 hr lipid profile, B. glucose; long
fasting increase S.bilirubin level;
• Time of collection(exercised increase 6% choles.)
• Type of sample (capillary:32% decrease platelets of Healthy adult,
10% increase Hb, 23% increase in leukcocyte; Positioning of
patient: between sitting and lying cause 15% variation in choles.
HDL , Tourniquet: prolonged use increase choles. 1.5% (2 minutes),
10-15% (15’), protein increase 5-8% (1 minute)
• Biological variations: physiological factors (age, sex, pregnancy,
history of smoking) and intra-individual variations ( time of day)
Hb, RBC, hiest in morning, WBC count hiest in afternoon, TriG,
Creatinine: low in morng and hi in evening.
20. • Test should be scrutinized with care: name, age, sex, physician name,
contact number, address,; call in one patient at a time, get all vials labeled,
use good syringe, etc
• Condition during testing: Remove the needle to prevent hemolysis (K, Mg,LDH,
impossible to estimate), use of proper anticoagulant e.g EDTA Transport sample
ASAP.
• Analytical Phase: Requisition for the test must be checked again, if there is any
omission missed. Important is the Q.C during this phase.
• Post Analytical Phase : calculation, transcription of patients data onto final
report…Typing? Missing single value, entering wrong number/decimal.
21. Components of QA
3. Assay performance:
▪ Methods
▪ Validation-standards calibration-
▪ Control and proficiency testing
4. Record keeping:
▪ Documenting all procedures, processes, and record of vital
importance
22. Components of QA
5. Accreditation:
▪ ISO: International Organization for Standardization
▪ NABL: National Accreditation for testing and
calibration Laboratories
▪ COLA: Commission of Office Laboratory Accreditation
6. Continuous Q improvement: (to be discussed further in Slide #33)
23. QA
• WHO: as the total process whereby the quality of laboratory reports can
be guaranteed. It has been summarized as the:
• “Right test is carried out on the right specimen and right result and right
interpretation is delivered to the right person/patient, at the right time and at
the right price”
• QA: “aims simply to ensure that the results, generated by the test are
correct”
24. QA in Microbiology
Microbiology investigations have become important for:
diagnosis, prophylaxis and treatment of diseases.
• Objectives:
• To improve quality of health care
• To achieve reliable, consistent error free test result
• To understand and find out commonest causes of
inaccuracy, misinterpretation and sources of error
• To prevent legal complication
• To establish credibility of laboratory.. Public /doctors
• To motivate staff and keep them abreast current
development
• To aid implementation of SOPs
• To review periodically : procedures, processes etc
25. SOPs: Microbiology
• Collection, transport, storage of specimens
• Processing of specimens
• Criteria for rejecting of samples
• Recording and reporting of results
• Maintenance of equipment
• Bio safety precautions
• Waste management of infectious material
• Referrals
27. CQI
• Research and Development: Three main components of R &D.
1 Basic Research is purely exploratory and has no practical
end in mind, no immediate commercial application, theory
formation, adds to existing knowledge (gut feelings)
2 Applied Research is aimed at solving real world problems,
specific practical problems facing the society , and
3 Experimental Development involves developing new
medical devices, prototypes and conducting trials to create new
and improved products or services.
28. CQI
• Validation: “Action of proving, in accordance with the principles of Good
Manufacturing Practices (GMP), that any procedure, process, equipment, material,
activity or system actually leads to the expected results….” consistently produce a
product meeting its pre-determined specifications and quality attributes
• The field of validation is divided into # of subsections including:
• Equipment validation
• Facilities validation
• HVAC system validation (Heating,Ventilation,Air Conditioning)
• Cleaning validation
• Process validation
• Analytical method validation
• Computer system validation
•
29. CQI
• Keen analysis of complaints:
• Customer feedback:
• Product quality reviews:
• Measurement and Control:
30. CQI (example Health Care)
• CQI encourages all team members to continuously ask:
“How are we doing?” and “Can we do it better?”
More specifically,
Can we do it more efficiently?
Can we be more effective?
Can we do it faster?
Can we do it in a more timely way?
• Continuous improvement begins with the culture of improvement
(specifically) for the patient, the practice, and the population in general.
31. Quality Control (QC)
• What is the Aim and Purpose of QC ? To provide a stable
measurement system.
• QC is a management system for initiating and coordinating:
• Quality development, quality maintenance and quality improvement
• Its objective is to provide products which are
dependable, satisfactory and economical
• It aims at finding / detecting the defects: therefore it
must be Practical, Achievable, and Affordable.
32. Quality Control (QC)
Observation of procedures and performance of staff members for
identification of obvious protocol deviations
• Strategies include:
• Over-the-shoulder observation of staff
• Taping all interviews and reviewing a random sample
• Ongoing field supervision:
• field editing : first by interviewer, field supervisor
• Office editing: coding,
• log book maintenance
• Statistical assessment of trends over time in the performance of each
observer/interviewer/technician, etc.
33. QA QC
Definition
• QA is a set of activities for
ensuring quality in the
processes by which products
are developed.
Focus on
• QA aims to prevent defects
with a focus on the process
used to make the product. It is
a proactive quality process.
Definition
• QC is a set of activities for
ensuring quality in products.
The activities focus on
identifying defects in the actual
products produced.
Focus on
• QC aims to identify (and
correct) defects in the finished
product. Quality control,
therefore, is a reactive process.
34. QA QC
Goal
• The goal of QA is to improve
development and test processes
so that defects do not arise when
the product is being developed
How
• Establish a good quality
management system and the
assessment of its adequacy.
Periodic conformance audits of
the operations of the system.
Goal
• The goal of QC is to identify
defects after a product is
developed and before it's released
How
• Finding & eliminating sources of
quality problems through tools &
equipment so that customer's
requirements are continually met.
35. QA QC
What
• Prevention of quality problems
through planned and
systematic activities including
documentation.
Responsibility
• Everyone on the team involved
in developing the product is
responsible for quality
assurance.
What
• The activities or techniques
used to achieve and maintain
the product quality, process
and service.
Responsibility
• Quality control is usually the
responsibility of a specific team
that tests the product for
defects.
36. QA QC
Example
• Verification is an example of QA
Statistical Techniques
• Statistical Tools & Techniques can
be applied in both QA & QC.
When they are applied to
processes (process inputs &
operational parameters), they are
called Statistical Process Control
(SPC); & it becomes the part of QA
As a tool
• QA is a managerial tool
Example
• Validation/Software Testing is an
example of QC
Statistical Techniques
• When statistical tools &
techniques are applied to finished
products (process outputs), they
are called as Statistical Quality
Control (SQC) & comes under QC
As a tool
• QC is a corrective tool
37. Quality Assurance Quality Control
• A set of activities designed to ensure that the
development and/or maintenance process is
adequate to ensure a system will meet its
objectives.
• activities ensure that the process is defined and
appropriate:
• Methodology and standards development
• Product and Services
• Constant effort to enhance the Q practice of
org.
• Team:
• Defines the process in achieving /improving Q
• Use various tools
• Process oriented practices
• Documentations
• Sops
• QC samples
• A set of activities designed to evaluate a
developed work product
• QC activities focus on finding defects in
specific deliverables :
• are the defined requirements the right
requirements
• Defined standards and procedures
• Verification process
• QC Manual:
• Q. Focus & Objectives
• Diff. depts. diff. functions
• Product oriented process
• Procedures used:
valid & reliable
38. • QA“ALL THOSE PLANNED & SYSTEMATIC ACTIONS NECESSARY TO PROVIDE
ADEQUATE CONFIDENCE THAT AN ITEM OR A FACILITY WILL PERFORM
SATISFACTORILY IN SERVICE.”
• QC:” THOSE QUALITY ASSURANCE ACTIONS WHICH PROVIDE A MEAN TO CONTROL
AND MEASURE THE CHARACTERISTICS OF AN ITEM, PROCESS OR FACILITY TO
ESTABLISHED REQUIREMENTS.”
40. ISO 9000
• ISO 9000 standard represents an international consensus on (GMP)
good management practices with the aim of ensuring that the
organization can time and again deliver the product or services that
meet the client’s quality requirements. These good practices have
been distilled into a set of system, regardless of what the
organization does, its size, or whether it is private or public sector.
41. ISO
• Objective:
• To promote the development of standardization
and related activities in the world with a view to
facilitating international exchange of goods and
services, and to developing cooperation in the
spheres of intellectual, scientific, technological
and economic activity.
42. Principal concepts
• Demonstrate ability to consistently provide product to meet customer
and applicable regulatory requirements
• Enhance customer satisfaction
• Improve the quality of its own operations
• Provide confidence to internal management and interested parties that
the requirements of a quality management system are being effectively
implemented.
43. Benefits
• ISO 9000 certification has become the de facto minimum requirement
for entering into global markets
• It provides an opportunity to increase value to the activities of the
organization, by streamlining quality management system.
• Improves the performance of processes/ activities continually thereby
reducing the cost of production
44. Benefits
• It gives importance to customer satisfaction
• It helps to improve customer relations by providing quality product
or service
• It also acts as an incentive to develop employee relations, employee
empowerment and organizational development
45. Quality assurance:
• Importance of systems and standard operating procedures
(SOPs):
• Sponsors: to establish, manage, & monitor their QC and QA systems and
SOPs…
• To provide high quality product and service ( for customers need and expectation)
• QA and QC together constitute Q. Management / Q. Systems:
• QM: commitment and active involvement.. Critical
• Suitability, effectiveness, efficiency
46. • High level of Q: to achieve your objectives or any business
• Q should remain the hallmark of Product and Services
• Not only to product and services but to employees (how they are doing
their jobs, and work processes they to follow to produce product and
service..)
• Work processes should be efficient n continually improving
• Top Management: training, motivating environment
Verification and Validation and QA
Are we developing the system properly?
Are we developing the proper system?
47. Verification and Validation and QA
1. Are we developing (creating) the system properly?
2. Are we developing (creating) the proper system?
Verification: System has the necessary parts according to specified
requirement. Process of evaluating the intermediary work, the lifecycle, of
a product development to check if we are in the correct track of creating
the final product.
Validation: at the end of the development process, we will focus our
efforts on assuring that the system satisfies the needs and expectations of
the end-user. That is the final product meets the needs of its end-user.
Both, verification and validation are vital in QA; both will identify defects
one in the specifications and one in the implementation