Quality Control and Quality Assurance to check the quality and efficacy of different products like pharmaceutical or any other product

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.

15. Components of QA
Instrument
Performance
Consistent
procedures
Assay
Performanc
e
Record
Keeping
Accreditation
Continuous
improvemen
t in quality
QUALTY
ASSUREANCE

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

26. Continuous Quality Improvement CQI

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.”

39. ISO
• International Organisation for Standardisation
• Geneva
• 140 members
• 1979 – Genesis of ISO 9000

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

48. Quality System:
• Organizational structure
• Responsibilities
• Processes
• Procedures
• Resources