MWENGE CATHOLIC UNIVERSITY

CHG 307: QUALITY CONTROL AND INDUSTRIAL

SAFETY

BY
Datius REVOCATUS
Email: [email protected]
[email protected]
Office: Arch. I. AMANI, 3rd Floor near LR 22
April 21, 2023
 CHG 307: QUALITY CONTROL AND INDUSTRIAL SAFETY

 What is the About ?  Principles of quality assurance, quality control and quality assessment
together with industrial safety
 Course Outline
 Reading Books
1. Principles of quality systems, elements of quality
manuals, quality control and quality assurance activities 1. Skoog, Douglas A, West D. M and Holler, F.
that provide confidence for a product or a service J (2004). Fundamental of Analytical
2. Good laboratory practices (GLP) and Good
Manufacturing Practices (GMP) Chemistry (8th Ed.) New York; Sounders
3. Control tools in monitoring quality College Publishing.
4. Quality management of sampling, records, personnel,
equipment, supplies, methods of analyses, instrument 2. Garfield F.M, Klesta E. and Hirsch J, Quality
performance, method validation, proficiency testing, and Assurance Principles for Analytical
audits.
5. Accreditation and International Organisation for Laboratories, 3rd ed., AOAC International,
Standardization (ISO) documents (ISO 17025 and 9001) Gaithersburg, MD USA, 2000.
as quality assurance requirement.

 Assessment: CW 40% & UE 60%  Course Status: CORE  Course Credits: 9

 LECTURE 1: INTRODUCTION
Definition of Terminologies associated with QA/ QC
 Quality
The totality of characteristics of an entity that bear on its ability to satisfy stated
and implied needs OR
The totality of characteristics and features of a product or service that bear on its
ability to satisfy stated or implied needs [ISO 8402], All industries: ISO 9001
Quality includes; Quality Assurance, Quality Control, Quality Improvement,
Quality Indicators, Quality System and Quality Management
 Quality System
Organizational structure, procedures, processes, and resources needed to
implement Quality management.

 Quality Management
All activities of the overall management function that determine the quality policy,
objectives and responsibilities, and implement them by means such as quality
planning, quality control, quality assurances and quality improvement within
the quality system.
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 Introduction …
Quality Assurance (QA)
All the planned and systematic activities implemented within the quality system
and demonstrated as needed, to provide adequate confidence that an entity will
fulfill requirements for quality.
ISO 8402:1994 Quality management and quality assurance -- Vocabulary)
Includes Internal Quality Control, pre-analytic phase, test standardization, post
analytic phase, management, and organization (WHO, 1992)

Quality Control (QC)

The operational technique and activities that are used to satisfy quality
requirement [ISO8402]
The overall system of activities whose purpose is to control the quality of the
product or a service so that it meets the needs of the users.
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 Introduction …
 Internal quality control (IQC)
Set of procedures undertaken by laboratory staff for continuously monitoring
and assessing of laboratory operations and the results of measurements in
order to decide whether results are reliable enough to be released [ISO 8402]

 Quality Audits
Systematic and independent examination to determine whether quality
activities and related results comply with planned arrangements and whether
these arrangements are implemented effectively and are suitable to achieve
objectives.

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 Quality System
 A Quality System sets out the standards that you are working to, and how
you are going to meet them.
The system should define what people, actions and documents are going to
be employed in order to carry out the work in a consistent manner, leaving
evidence of what has happened.
 It includes manuals, handbooks, procedures, policies, records and templates.

It aims to ensure reproducibility (consistence results) and reconstructability

(validate data), and compliance with whatever standards you have set.

The fundamentals of a quality system are the same regardless of what your
work is.
 The same principles can be applied whether you are an academic research
laboratory, a medical device manufacturer or a hospital clinical unit.
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 Principles of Quality Systems
Quality Systems are founded on four principles:
1. Managing:
 Organisations must manage their physical and human resources to ensure
that plans can be converted to delivery.
2. Planning:
 All research and development should be a planned process, not a series of
random occurrences.
• Planning is a continuous process, not an event.
• It controls the predictable and reacts to the unpredictable to ensure that the
process is under control at all times and that there is clear understanding of
cause and effect .

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 Principles of Quality Systems
3. Delivering:
 Management and Plans come together to provide the environment in which
effective research and development is delivered.
 Delivery must ensure that inputs and processes are controlled to minimise or
remove variability and that outputs (results, reports, papers, etc) are robust-
(ability of a method to remain unaffected when slight variations) and reliable.
4. Measuring:
 Quality system requires to measure the actual output against the planned
aims (set standards).
 Equally important is the setting of acceptable standards for the performance
of the work and ensuring that there are mechanisms to demonstrate that
4/21/2023 these are met or exceeded. 8
 Elements of Quality System
 Appropriate management support.
 Development, implementation and management of QA/QC system.
 Clear documentation of quality methods, procedures and test results.
 Quality awareness and training of personnel.
 Acceptance and testing of new materials.
 Appropriate maintenance and testing of equipment, materials and
processes.
 Calibration, and verification of the calibration facilities.
 Reliable testing of the system performance.
 Periodic performance testing of the system
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 Quality Assurance
 Quality Assurance - planned and systematic actions necessary to provide
adequate confidence that a product or service will satisfy given requirements
for quality.
 It refers to the full range of practices employed to ensure that laboratory
results are reliable.
 Examples of QA:
 Type testing, performance testing, and quality audits required by a
regulatory body.
 Blind testing and quality audits of the product service provider performed by
the user of the service.
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 Quality Assurance
 Quality assurance may further be defined as the system of
documenting and cross referencing the management procedures of
the organization or laboratory.

 Why Quality Assurance?

 To have clear and concise records of all procedures which may
have a bearing on the quality of data, so that those procedures
may be monitored with a view to ensuring that quality is
maintained.
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 Details on the Concept of Quality

 What is Quality?
 A high standard or level.
 Degree of excellence.
 Distinguishing feature.
 Skill, accomplishment.
 Satisfaction of a customer’s needs or requirements

 Quality is “totality of characteristics of an entity that bear on its ability to

satisfy stated and implied needs”

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 The History of Quality (Q)
 Customer - Craft Q relation
• Design and build each product for a particular customer.
• Producer knows the customer directly.
 Mass production and inspection Q relation
• focus on designing and building products for mass consumption.
• larger volumes will reduce costs and increases profits.
• push products on the customer (limit choices).
• quality is maintained by inspecting and detecting bad products.
 Total Quality Management or “Customer Driven Quality”
• potential customers determine what to design and build.
• higher quality will be obtained by preventing problems. 13
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 Need for a New Strategy; Why?

 Foreign markets have grown

o Import barriers and produce protection are not the answer.

 Consumers are offered more choices

o They have become more discriminating.

 Consumers are more sophisticated

o They demand newer and better products

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 Why Improvement in Quality?
1. Global Competition
 Economic and political boundaries are slowly vanishing.
 Global trade has been accepted.
 The 1990’s slogan “Built by Africans for Africans” is very far from
reality in the 2000’s.
 “We need to export – satisfy wider markets”.
2. It pays
 Less rework, fewer mistakes, fewer delays, and better use of
personnel, time and materials.
 In United States today, 15 to 20% of the production costs are
4/21/2023 incurred in finding and correcting mistakes. 15
 How do organizations compete?

 Most common competitive measures:

 Quality (both real and perceived)
 Cost
 Delivery (amounts, lead time and accuracy)
 Awards given with sale
Other measures:
 Safety,
 Employee morale,
 Product development (time-to-market, innovative products)
Any others ?????
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 The Quality Hierarchy

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 Stages of Quality - Hierarchy

QUALITY MANAGEMENT

QUALITY SYSTEM

QUALITY ASURANCE (QA)

QUALITY CONTROL (QC)

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 Stages of Quality

Quality System

Quality Assurance

Quality Control

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 Before you can think of Quality

 You need to know the standard for the product or service.

 What is the standard for the service or product or package whose

quality you want to improve?

E.g. Shirt, car, bicycle, mobile phone, trouser, book, BSc degree, etc.

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 What is a standard?
NOUN
 a level of quality or attainment.
 Equivalent to: excellence, worth, merit, grade, level
e.g. "the standard of work is very good“
"this restaurant offers a high standard of service“
 something used as a measure, norm, or model in comparative
evaluations. e.g. “the wages are low by today's standards“
ADJECTIVE
 used or accepted as normal or average.
 Equivalent to: normal, typical, customary
e.g. "the standard rate of income tax is ......." 21
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 What is a standard?

 A ‘standard’ is a document that provides requirements, specifications,

guidelines or characteristics that can be used consistently to ensure
that materials, products, processes and services are fit for their
purpose.

 A ‘standard’ is a published specification that establishes a common

language, and contains a technical specification or other precise
criteria and is designed to be used consistently, as a rule, a guideline,
or a definition.

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 Standard?

 Standards are applied to many materials, products, methods and services.

They help to make life simpler, and increase the reliability and the
effectiveness of many goods and services we use.
 Standards are designed for voluntary use and do not impose any
regulations.
 However, regulations and laws may refer to certain standards making
compliance with them compulsory.
 These are universally or widely accepted, agreed upon, or established
means of determining what something should be.

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 Categories of standards
 In the global environment there are three different official categories of
standards:
 International standard – a standard adopted by an international
organization for standardization e.g. ISO, WHO, USEPA, (and
accepted globally)
 Regional standard - a standard adopted by a regional
standardization body or area such as European, Asian, African,
American standard – e.g. SANAS (South African National
Accreditation System),
 National standard – a standard adopted by a national
standardization body and made available to the public e.g. TZS, KES,
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 What is a quality standard?

 A system for ensuring the maintenance of proper standards in manufactured

goods, especially by periodic random inspection of the product.
 Ensuring quality means, making sure that products are made to a minimum
standard or better.
 The British Standards Institute (BSI), and (International Equivalent) ISO)
publishes standards for many kinds of product and services that can be
seen as a badge of quality.

 BS5750 is a British Standard for quality assurance and ISO 9000 is

the international equivalent.
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 Standard?
 The ISO 9000 series of international Quality Management Standards was
developed to help organizations establish an effective quality management
system capable of inspiring confidence among consumers and business
partners that products/services are quality compliant.
 E.g
 National Ambient Air Quality Standards (NAAQS)
 TZS 789:2004 Drinking (potable) water-Specification
 TZS 760:2002 (Part 2) Methods of testing cement: Chemical
analysis
 TZS 102:2010 White bread – Specification. (Prescribes the
requirements and methods of sampling and test for white bread,
whole meal (brown) bread, enriched bread, fortified bread, fruit
bread and composite bread)
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 Components of Quality Assurance
1. Management:
 One of the most important components of the quality assurance
programme in the organization and/or laboratory are the comprehensive
management documents which should describe, in detail, the management
structure of the organization and/or laboratory. Such documentation should
provide clearly defined communication channels and a clear reporting
structure.
 Within that structure each member of staff should be able to locate his or
her own job description and responsibilities and their relationship with other
staff members who are subordinate or superior.
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 Components of Quality Assurance
2. Training:
 It is important that all staff are adequately trained for the task they have
to perform.
 Training must be documented in order that management and other
personnel can verify that staff are competent to conduct the duties
required.
 The level of training required for each procedure should also be clearly
defined to ensure that staff ability and training are matched to
procedural requirements.

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 Components of Quality Assurance
3. Standard Operating Procedures:
 Standard Operating Procedures (SOPs) provide the core of most of the
day to day running of any quality assurance programme.
 They are the documents describing in detail every procedure conducted
by the laboratory including: Sampling, transportation, analysis, use of
equipment, quality control, calibration, production of reports, etc.
 They are the laboratory’s internal reference manual for the particular
procedure to which they are dedicated and, for that reason, SOPs must
document every relevant step in the procedure.
 An SOP should be clear, concise and contain all the relevant information
to perform the procedure it describes. 29
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 Components of Quality Assurance
4. Laboratory Facilities:
 These are resources required for regular laboratory work.
 It is essential that these resources, i.e. space, staff, equipment and
supplies, are sufficient for the volume of work to be done.
 Equipment should be available to allow the procedures performed in the
laboratory to be conducted efficiently.
 The environment in which the work is conducted must be clean and tidy,
have adequate space to work without risk to personnel or to the
analytical sample, and there should be sufficient storage space for
glassware, chemicals, samples and consumables.
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 Components of Quality Assurance
5. Equipment Maintenance and Calibration:
 All equipment must be maintained on a regular basis, consistent with
the documented criteria of the laboratory and normally accepted codes
of practice.
 The care and cleaning of the equipment is extremely important to
ensure quality.
 Frequent checks on the reliability of equipment including calibration
checks on all relevant equipment, such as balances, pipettes, etc.

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 Components of Quality Assurance
6. Sampling:
 Procedures for sampling operations should be carefully documented.
 Clear details should be given for precautions to be taken while sampling
and the sampling strategies.
 Careful documentation during sampling is required so that all relevant
information on the nature of the sample (when it was taken, where it was
taken and under what conditions it was taken) are clearly recorded on site
by the person conducting the sampling.
 This is necessary because variations in sampling procedures can have a
marked effect on the results of analysis.

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 Components of Quality Assurance
6. Sampling…
 Quality assurance of sampling can be achieved in the following ways:
 Strictly adhere to standard operating procedures for sampling.
 Ensure all equipment is clean and in working order.
 Record all conditions which applied during sampling.
 Take strict precautions to avoid contamination.

 By observing those simple procedures will ensure that the quality of

samples matches the quality of analysis.

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 Components of Quality Assurance
7. Sample Receipt, Storage and Disposal
 Proper storage of samples prior to analysis is as important as proper
sampling.
 It is important to ensure that the passage of a sample through the
laboratory’s analytical systems is fully documented, and corresponds to the
practices laid down in the relevant SOPs.
 Arrangements for disposal of samples when exceed their stable storage time.
 With some forms of analysis which are required for legal or for regulatory
reasons there may be a requirement to store a suitable aliquot of a sample
safely, for a given time, to allow for re-examination when necessary.
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 Components of Quality Assurance
7. Sample Receipt, Storage and Disposal…

 Procedures for sample handling should ensure that the sample is not

compromised. The sample should be logged in and stored in such a way

as to minimize its deterioration. The condition of each sample and its

storage location should be recorded.

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 Components of Quality Assurance
8. Reporting of Results
 The final products of the laboratory are the data that it reports.
 Therefore, the efforts of quality assurance are directed towards seeing
that these data are suitable for use in an assessment.
 This includes the final stage of reporting and interpreting the results
which have been generated.
 The first stage in this process is examination of the data to determine
whether the results are fit to report.
 Data should be examined at many stages in the quality assurance system
and no data should be reported from assays that are out of control.
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 The Quality Assurance Cycle for a Lab

Preparations for  Pre-analytic

Sample Collection phase;
covering all
activities before
 Post-Analytic phase; Reporting
Personnel Competency analysis is
covering the all Test Evaluations conducted.
•Data and Laboratory
activities after Management
analysis including •Safety
•Customer Service
reporting, archiving Sample Receipt
of results, etc and Accessioning

Record Keeping
Sample Transport
Quality Control
Testing  Analytic phase;
covering the part of
Analytic
testing, analysis as well
4/21/2023 Quality Control as quality control. 37
 The Quality Assurance Cycle for a Lab

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 QA Cycle in Industrial Production

 covering all
activities before the
manufacturing
 covering the process, i.e.
activities after resources
making the mobilization,
product, e.g. collection & quality
labeling, checking of inputs
for the process
storage,
transporting
 covering the
for sale, etc.
reaction for
production and
obtaining the
product
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 Implementation of quality assurance
 The ultimate objective of a QA programme is to ensure that the laboratory
functions efficiently and effectively.
 One logical way to tackle the task is first to write the Quality Manual, then to put
in place documentation such as SOPs and laboratory records, then to test run
the system for a limited period (i.e. three to six months) and finally, to conduct a
detailed review which identifies successes and failures within the system.
 This is best done by inspection of key areas such as laboratory records
and by conducting audits.
 An efficient auditing system is to pick data at random and then trace the
documentation pertaining to those data back to sampling and sample

4/21/2023 receipt. 40
 Implementation of quality assurance
 A common method of implementing a QA programme is to apply for

accreditation.

 Accreditation is the implementation of a QA programme in conformity

with a recognised QA system.

 Alternatively, QA can be implemented by reference to international

standards such as ISO 9000 without necessarily going to the expense of

accreditation

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 Checking Compliance
 In order to maintain the quality assurance (QA) system it is necessary to

check periodically each area of the laboratory for compliance with the QA

system.

 This involves auditing of the component parts to assess whether they

continue to meet the original criteria.

 Reports on all audits should be made available to management, and to the

individuals responsible for the work concerned.

 Deviations from required standards must be corrected immediately.

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