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CHG 307 - Qc&is L-4 - 2022-2023

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MWENGE CATHOLIC UNIVERSITY

CHG 307: QUALITY CONTROL AND INDUSTRIAL


SAFETY

BY
Datius REVOCATUS
Email: datisonkoreve01@gmail.com
datius.revocatus@mwecau.ac.tz
Office: Arch. I. AMANI, 3rd Floor near LR 22
May 10, 2023
CHG 307:
QUALITY CONTROL AND INDUSTRIAL SAFETY

Quality Control (QC)

LECTURE 4:
5/10/2023 CHG 307 _ 2022/2023 S_2 2
Quality Control (QC)
 The goal of QC is to:
 Provide quality product and/or service that is satisfactory,
adequate, dependable and economic
 Detect errors and correct them before results are
reported/released.

 QC represents the mechanism established to control errors

5/10/2023 CHG 307 _ 2022/2023 S_2 3


Quality Control (QC)

Quality Control is used to monitor the accuracy and the


precision of the assay.

What are
accuracy
and
precision?
4
Accuracy and Precision

Accurate Precise
and Precise but Biased Imprecise

Accurate = Precise but not Biased


5
What is Quality Control
 Quality Control Refers to:
 The operational technique and activities that are used to satisfy
quality requirement. OR
 The overall system of activities whose purpose is to control the
quality of a product or service so that it meets the needs of
users. OR
 A statistical process used to monitor and evaluate the analytical
process that produces reliable results or products.
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What is Quality Control

 Quantitative, Qualitative, and Semi-


Quantitative Examinations /
measurements

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Quantitative Examinations/ Measurement

 Measure the quantity of a particular substance in a sample.

 Measurements should be both accurate and precise

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Qualitative Examination Methods
 These are examinations that do not have numerical results:
 Such as;
 Growth or no growth
 Positive or negative
 Reactive or non-reactive
 Color change

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Semi-quantitative Examination Methods

 Results are expressed as an estimate of the measured substance:

 “Trace amount”, “moderate amount,” or “1+, 2+, or 3+”

 Number of cells per microscopic field

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Importance of Quality Control
 QC is necessary to ensure that all products sold to customers are of
the highest possible quality.
 QC is important because business owners must ensure they
manufacture products that customers want to buy over and over
again.
 Quality control system ensures that each product meets or exceeds a
specific standard.
 A quality control system helps business owners identify weaknesses in
products and come up with solutions for improving them.
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11
Quality Control (QC)
 Quality control is viewed as a process by which entities review the
quality of all factors involved in production. This approach places an
emphasis on three aspects:
1. Elements, such as controls, job management, defined and well
managed processes, performance and integrity criteria, and
identification of records
2. Competence, such as knowledge, skills, experience, and
qualifications
3. Soft elements, such as personnel, integrity, confidence,
motivation, team spirit, and quality relationships.
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Concept of Quality Control

O
 Specifications I PRODU U Inspect to Standards
N CTION
T
 Materials P
PROCE P
 Tools & U Good Product - to
SS U
Equipment
T External Customers
T
 People
Re-process
Bad Products

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Why Do We Need QC?
 QC ensures that data will meet defined standards of quality with a
standard known level of confidence.

 To Understand data reliability


 Quantify areas of analytical uncertainty
 Standardize measurements to allow for repeatable and
comparable data across time and place
 Need for consistency
5/10/2023
CHG 307 _ 2022/2023 S_2 14
Why Do We Need QC?

 QC is needed for example:

 In monitoring a polluted stream

 Is this problem getting worse or

is being mitigated?

 What level of remediation is

needed?

5/10/2023
CHG 307 _ 2022/2023 S_2 15
General Purposes of QA/QC

 Determine precision and accuracy,

 Demonstrate absence of interferences,

 Demonstrate absence of contamination (from

sampling equipment, glassware, and reagents)

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Quality Assurance VS. Quality Control
QUALITY ASSURANCE (QA) QUALITY CONTROL (QC)
• Process – Oriented • Product – Oriented
• Refers to overall • Routine errors assessing
management and control
• QA is all about • QC is all about detection of
preventation of errors errors
• QA involves processes in • QC is used to verify the
managing quality quality of the product
• Establishes the need for QC • The ‘‘HOW’’ part of QA

5/10/2023
CHG 307 _ 2022/2023 S_2 17
Where is QA/QC Applicable/Used
 Nearly all REGULATORY decisions about:
 Issuing permits,
 Monitoring human health and
environmental quality,
 Pollution investigations and
 Progress of site remediation are based
on one thing -- the data gathered from
a sample.
Others
 Laboratories
 Universities and research organizations
 Industries
5/10/2023 CHG 307 _ 2022/2023 S_2 18
Where is Quality Control Applicable
 Quality control is applicable in all aspects of a project including :

 Field data collection and sampling

 Resources procurement and use

 Laboratory analysis and processing

 Data evaluation and assessment

 Reporting and project documentation


5/10/2023
CHG 307 _ 2022/2023 S_2 19
QC in the Field
 QC is particularly critical in field data collection

 Often the most costly aspect of a project

 Data is never reproducible (repeatability) under the exact

same condition or setting .

5/10/2023
CHG 307 _ 2022/2023 S_2 20
QC in the Laboratory
 Laboratory data analysis,
measurement and acquisition
 Needs:
 Chain of custody forms
 Equipment calibration
 Good storage practices
 Valid analytical methods
 Approved holding times
 Minimum Detection Limits
5/10/2023 (MDLs) CHG 307 _ 2022/2023 S_2 21
Question

 Why do laboratory errors occur ????

5/10/2023 CHG 307 _ 2022/2023 S_2 22


5/10/2023 CHG 307 _ 2022/2023 S_2 23
QC in the Labs
 In the Labs experimental result may be quantitative, qualitative or
semi-quantitative.
 Thus laboratory QC results are used to validate whether the used
instrument is operating within predefined specifications, inferring
that the experimental results are reliable.
 Therefore, the question of reliability for most of the experimental
results in the laboratory can be resolved by regular use of quality
control techniques.
5/10/2023 CHG 307 _ 2022/2023 S_2 24
QC in the Labs
 Quality control is used to:

 Prevent errors from happening.

 Identify and correct errors that have taken place.

 Protect the health and provide safety to participants

and the environment.

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QC in the Labs
 Variables that affect the quality of results:
 The educational background and training of the laboratory
personnel
 The condition of the specimens
 The controls used in the test runs
 Reagents
 Equipment
 The interpretation of the results

5/10/2023
 The reporting of results 26
CHG 307 _ 2022/2023 S_2
QC: Errors in measurement

 Error - the disagreement between a result of a measurement

and the true or accepted value.

5/10/2023 CHG 307 _ 2022/2023 S_2 27


QC: Sources of Error in Measurements
 Input data required - such as standards used, calibration values, and
values of physical constants.
 Inherent characteristics of the quantity being measured.
 Instruments used - accuracy, repeatability.
 Observer fallibility - reading errors, blunders, equipment selection,
analysis and computation errors.
 Environment - any external influences affecting the measurement.
 Theory assumed - validity of mathematical methods and
approximations.
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QC: Two Types of Errors in Measurements
 Random Error
 An error which varies in an unpredictable manner, in magnitude and
sign, when a large number of measurements of the same quantity are
made under effectively identical conditions.
 Random errors create a characteristic spread of results for any test
method and cannot be accounted for by applying corrections.
 Random errors are difficult to eliminate but repetition reduces the
influences of random errors.
 Random errors can be minimized by training, supervision and
adherence to standard operating procedures
5/10/2023 CHG 307 _ 2022/2023 S_2 29
QC: Two Types of Errors in Measurements
 Systematic Error:
 An error which, in the course of a number of measurements of the
same value of a given quantity, remains constant when measurements
are made under the same conditions, or varies according to a definite
law when conditions change.
 Systematic errors may be induced by factors such as variations in
incubation temperature, blockage of plate washer, change in the
reagent batch or modifications in testing method
 Occurs if the instrument is wrongly used by the experimenter/analyst.
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Categories of Quality Control:
 Internal Quality Control (IQC)
 Internal quality control (IQC) consists of the operational techniques
used by the laboratory staff for continuous assessment of the quality
of the results of individual analytical procedures.
 It is “Controllable” by those responsible for undertaking the project or
directly “involved in the program”
 It focuses on the individual method and tests its performance against
mathematically derived quality criteria.
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Internal quality control (IQC)
 Internal Quality Control items:
 Equipment calibration
 Proper training and certification of
participants
 Proper sampling and containment
techniques
 Proper data documentation
 Proper report writing
5/10/2023 CHG 307 _ 2022/2023 S_2 32
External Quality Control (EQC)
 A “set of measures” established for and conducted by those people and
organizations “outside of the program”
 External quality control (EQC) is a way of establishing the accuracy of
analytical methods and procedures by comparing the results of analyses
made in one laboratory with the results obtained by others conducting
the same analysis on the same material.
 This is usually accomplished by one laboratory, the reference laboratory,
sending out sets of specimens with known and unknown concentrations
of variables to all of the participating laboratories.
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External Quality Control (EQC)

 External quality control items:

 Performance audits

 Split sample analysis

 Replicate (duplicate) sample analysis

 Inter-Laboratory Proficiency testing

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Data Objective and Key Concepts
 The concept of QC (in QA) depends on “PARCC”
Parameters
 Successful data collection and analysis depend on
“The PARCC Parameters”:
 Precision
 Accuracy
 Representativeness
 Completeness
 Comparability
5/10/2023 CHG 307 _ 2022/2023 S_2 35
Key Concepts of QA/QC: P & A
 Precision -
 degree of agreement between
repeated measurements of the
same characteristic.
 can be biased – meaning there is a
consistent error in the results.
 Accuracy –
 measures how close data results
are to a true or expected value –
does not allow for bias

5/10/2023 CHG 307 _ 2022/2023 S_2 36


Key Concepts of QA/QC: Representativeness

 Representativeness:

 extent to which measurements actually represent the

true environmental condition or population at the time

a sample was collected.

 Representative data should result in repeatable data

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Key Concepts of QA/QC: Completeness
 Completeness -
 comparison between the amount of data intended to
be collected vs actual amount of valid (usable) data
collected.
 In the design of the QAPP (Quality Assurance Project
Plan) – will the goals of the plan meet assessment
needs?
• Will sufficient data be collected?

5/10/2023 CHG 307 _ 2022/2023 S_2 38


Key Concepts of QA/QC: Comparability
 Comparability -

 the extent to which data can be compared between

sample locations or periods of time within a project,

or between projects .

Will similar data


from these sites be
Comparable ??

5/10/2023 39
CHG 307 _ 2022/2023 S_2
Individual Work

 Explain your thoughts, theories, and ideas


on the importance of quality control in
analytical Laboratories.

5/10/2023 CHG 307 _ 2022/2023 S_2 40


5/10/2023 CHG 307 _ 2022/2023 S_2 41

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