GODE HEALTH SCIENCE COLLEGE

Department of medical laboratory

MEDICAL LABORATORY SERVICE LVEL III

ETHIOPIAN SOMALI REGIONAL

STATE
BUREAU OF TECHNICAL AND
VOCATIONAL
EDUCATION AND TRAINING
GODE, SOMALI, ETHIOPIA
MEDICAL LABORATORY SERVICE LEVEL
III
LEARNING GUIDE #1
UnitofCompetence: Apply Quality control
Module Title: Applying Quality control
TTLM LG Code: HLT MLS3 M11 V1 LO1-
05TTLM Code: HLT MLS3TTLM 08/02/16 v1

Instruction Sheet Learning Guide #

This learning guide is developed to provide you the necessary information regarding the
following content coverage and topic

 Quality standards, policies and procedures

  quality standard procedures
 Internal Quality Control
 External Quality Control

Learning Instructions:
1. Read the specific objectives of this Learning Guide.
2. Follow the instructions described in number 2 to 45
3. Read the information written in the “Information Sheets 1”. Try to understand what are being
discussed. Ask you teacher for assistance if you have hard time understanding them.
4. Accomplish the “Self-check 1” in page __.
5. Ask from your teacher the key to correction (key answers) or you can request your teacher to
correct your work. (You are to get the key answer only after you finished answering the Self-
check 1).
6. If you earned a satisfactory evaluation proceed to “Information Sheet 2”. However, if your
rating is unsatisfactory, see your teacher for further instructions or go back to Learning
Activity #3
7. Submit your accomplished Self-check. This will form part of your training portfolio.
8. Read the information written in the “Information Sheet 2”. Try to understand what are being
discussed. Ask you teacher for assistance if you have hard time understanding them.
9. Accomplish the “Self-check 2” in page __.
10. Ask from your teacher the key to correction (key answers) or you can request your teacher to
correct your work. (You are to get the key answer only after you finished answering the Self-
check 2).
11. Read the information written in the “Information Sheets 3 and 4”. Try to understand what are
being discussed. Ask you teacher for assistance if you have hard time understanding them.
12. Accomplish the “Self-check 3” in page __.
13. Ask from your teacher the key to correction (key answers) or you can request your teacher to
correct your work. (You are to get the key answer only after you finished answering the Self-
check 3).
14. If you earned a satisfactory evaluation proceed to “Operation Sheet 1” in page _. However, if
your rating is unsatisfactory, see your teacher for further instructions or go back to Learning
Activity #6.
15. Read the “Operation Sheet 1” and try to understand the procedures discussed.
16. You are provided with a CD containing lessons on how to clean and maintain equipment.
Before you open the CD read the information written in the “Information Sheets 1-2” in pages
___. You will be also provided with additional reference reading materials regarding the
cleaning of masonry hand tools.
17. Request a desktop computer or laptop from your teacher. Make sure the unit is plugged to a
power source before turning on the power O. Then insert the CD in the CD drive located in
your computer. Access the information as described in the Operation Sheet 1 in page __.
18. Read all the contents of the CD and try to understand the procedures discussed.
19. Request access to the equipment and software described in the CD. Practice the steps or
procedures as illustrated in your CD. Go to your teacher if you need clarification or you want
answers to your questions or you need assistance in understanding a particular step or
procedure.
20. Do the “LAP test” in page __ (if you are ready). Request your teacher to evaluate your
performance and outputs. Your teacher will give you feedback and the evaluation will be either
satisfactory or unsatisfactory. If unsatisfactory, your teacher shall advice you on additional
work. But if satisfactory you can proceed to Learning Guide #8.

Information sheet 1 Determine quality standards

Lo1 Determine quality standard
1.1 introduction to quality standards
Before proceeding quality standards in a health it would be useful for us to recapitulate
the definition of the two words; “quality” and “standards” let us define:The definition
of quality depends on the role of the people defining it. Today, there is no single
universal definition of quality. Some people view quality as “performance to standards.”
Others view it as “meeting the customer’s needs” or “satisfying the customer. “Let’s look
at some of the more common definitions of quality. Quality can be defined in many
different ways. For instance, it can mean excellence, zero defects, uniform quality,
satisfying customer needs or operational improvement. Instead of creating a pervasive
and unequivocal definition of production quality, it is more relevant to examine it as a
relative and contextual concept. Quality is always bound to satisfying customer needs.
Defining quality is ultimately a common task for product providers and their key
customer and stakeholder groups.
A ‘standard’ is a result of a particular standardization effect, approved by the
recognized authority. It may take the form of a document containing a set of conditions to
be fulfilled, a fundamental unit or physical constituent or an object for physical
comparison.
Standardization is the process of formulating and applying the rules for an orderly
approachto a specific activity - for the benefit of all - with the co-operation of all
concerned and in particular for the promotion of optimum overall economy, taking due
account of functional conditions and safety requirements. Standardization is based on the
consolidated results of science, technology and experience. It determines not only the
basis for the present but also for future development and it should keep pace with
advances.
In the context of all these factors, application of standards and standardization
There are several aspects of standards. These may include:

 Specifications of products and materials

 Codes of practices
 Standard test methods
 Standard terminologies, symbols, color schemes, nomenclature, notations etc.
 Standard sampling procedures
 Inspection methods
Criteria for conformity
There are different levels of standards, which may be listed as:
• An Individual Standard
• A Company Standard
• An Association Standard
• A National Standard
• An International Standard
The level is determined by the specific interests involved in creating and using the standard in
day-to-day operations.
There are various benefits to standardization. To mention a few briefly; the following are listed:
1. To the Producer — Rationalization of manufacturing processes, improved control of
processes, high rate of production, reduction of inventories ultimate increase in sales and
profits.
2. To the Consumer — Assurance of quality of products and services purchased, better

value for money spent.

3. To the Trade — Minimization of delays, workable basis for acceptance or rejection of
goods, opening of larger markets, reduction in cost of handling transactions.
4. To the Technologist— increased knowledge of properties, possibilities of application of
materials, accepted methods of tests and procedures, guidance for formulation of
programs.
What are the quality standards?
This is a more complex question than it might at first appear. They are certainly ‘clear and
explicit statements about key elements of a given service’; they say ‘this is how things
should be in this service’ and ‘this is what we (the purchaser and user) have the right to expect’.
They can be expressed as statements of how much, how well, how often or how quickly
something happens and can be percentages, numbers, frequencies or cost.
In practice we have few standards expressed as numbers or other quantities, because we intend
above all that standards should be focused on outcomes for users, usually expressed at the
individual level.
Standards have certain qualities. They must be: as explicit and precise as possible; justifiable
and logically sound; acceptable (to the stakeholders); Validated; practicable; and written in plain
language (including the ‘plain language’ required by people who do not read printed English
easily for whatever reason).
Standards show the agreed requirements for a service and help build in quality by enabling us to:

 Provide a clear direction for services

 know whom to do business with
 Promote a shared vision and common understanding
 form a baseline for local service specifications

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  Provide a basis for monitoring, inspection, evaluation and future planning

1.2.Implementation of Quality Standards

1.2.1. The process of setting quality standards

In 1990 Devon social services developed a standards for quality with the following aim:
‘to stimulate and support the development of high quality social services – in the public, private
and voluntary sectors – in order to ensure a range of choice to consumers’. The quality
standards set out key expectations of services. They should be:
 effective and efficient and based on the needs of users;
 flexible, sensitive and responsive to the changing needs of users;
 reliable and consistent, with continuity of delivery;
 based on clear aims;
 consistent with our own agreed standards;
 continuously improved and developed by monitoring, evaluation and inspection;
 provided by people with a high standard of professional knowledge and
 practical skills;
 encouraging, enabling and maintaining of the link with the family and friends of the
service users;
 supportive of users in making full use of activities and resources within local
communities;
 valuing user rights to confidentiality;
 open to user participation, encouraging users to become involved in decisions affecting
the care and support they receive;
 Respectful of users’ rights to personal independence and responsibility

1.3. Quality standard procedures and organizational /work

place policies
Policies and Procedures are two words frequently heard in the business world and

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there is often confusion between the two concepts.
What is an Organizational Policy?
A Policy defines an outcome; it is a premeditated rule set by a business to guide
organizational direction, employees and business decisions, and to regulate, direct
and
control actions and conduct. Policies can range from a broad philosophy to a
specific
rule. They are the direct connection between a company's Vision and its daily
operations and the underpinnings to a company's culture.
What is an Organizational Procedure?
A procedure is a means to an end. Procedures are step by step instructions,
prescribing an exact sequence of action. A procedure explains how to and who
(which
position) will implement the policy. Procedures are specific, factual and succinct.
They
may include timelines, specific forms to be used and template forms. Procedures
assist
in eliminating common misunderstandings which can result in costly mistakes.
What is the difference?
Together Policies and Procedures empower a process by providing clear and
concise
direction necessary for consistent operation. The essential differences are outlined
below:
Policies
- General in nature
- Identify company rules
- Explain why rules exist
- Explain when the rule applies
- Describe to whom (what position) it applies
- Explain how it is enforced
- Describe consequences
- Provide guidance for managerial thought and action
- Flexible - allows for discretion
Procedures
- Identify specific and alternative actions
- Explain when to take actions
- Describe emergency procedures
- Include warnings and cautions
- Give examples
- Show how to complete a specific form
- Prescribe how to carry out the action through step by step instruction
- Less flexible - concise and exact sequence of activities
Why does a company need Organizational Policies?

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Policies and Procedures (P&Ps) are essential when a company requires consistency
in

its daily operations. They provide clarity and direction re: accountability. P&Ps
assist
companies in meeting legal requirements set out by the Employment Standards
Act,
the Human Rights Code, the Occupational Health and Safety Act and numerous
other
compliance requirements.
A properly written policy and/or procedure allows employees to understand their
roles
and level of responsibility and conduct their job by making decisions within
predefined
boundaries. By implementing P&Ps, management can provide guidance to
employees
without needing to micromanage, freeing managers to focus on strategic thought.
P&Ps allow the workforce to not only understand the accountabilities and
responsibilities of their own position, but also that of their co-workers, which can
foster
a cooperative work environment.

1.4. Internal quality control (IQC)

– These are controls included with the test kit or prepared in the laboratory and
tested with patient samples.
– Is carried –out by an intra lab programme
– Is based on monitoring the test procedures that are performed in the laboratory
and includes:
• Measurement on a specifically prepared materials( controls)
• Repeated measurement on routine specimens
• Daily statistical analysis of data obtained from routine tests
– IQ control is intended to ensure that there is a continuous evaluation of the
reliability of the laboratory’s work and that control is exercised over the release of
test results
– An IQ control programme should be practical, realistic & economical.
• It should evaluate each procedure, reagent and culture medium according
to a practical schedule.

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 External quality control (EQC)
– EQA evaluates a laboratory analytical accuracy by comparing its results with the
results on the sample or similar samples analyzed in a referral laboratory.
– This is evaluation by an outside agency (International, National or Regional)
about the performance on a number of laboratories on a material that is supplied
particularly for this purpose

The purpose of external quality control programme is:

 To provide assurance to both health professionals & the general public
 To assess and compare the reliability of laboratory performance on a
national scale.
 To identify common errors.
 To encourage the use of uniform procedures.
 To encourage the use of standard reagents.
 To take administrative measures against substandard laboratories.
 To stimulate the implementation of internal quality control programme

SELF CHECK 1 Written Test

Name: _______________________________________________________________________________IDNO________

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Directions: Answer all the questions listed below.
Illustrations may be necessary to aid some
explanations/answers.
1. Discuss the difference between quality and standards
2. What are the aspects of standards?
3. List out the levels of standards
4. Discuss on certain qualities of standards
5. What are the common procedures for checking
completed work?
6. List the difference between policy and procedures ?
7. What is internal quality programme?
8. Describe the purpose of external quality control?
Note: Satisfactory rating – 24 points Unsatisfactory
below 12 point

Instruction
Learning Guide 2
Sheet
This learning guide is developed to provide you the necessary
information regarding the following content coverage and topic
 Assessing quality of work and product delivered
 Checking results and performance
 Quality evaluation parameters
 Evaluation of results
Lo2 Information sheet 1 LO2: ASSESS QUALITY OF WORK AND PRODUCT
DELIVERED
LO2: ASSESS QUALITY OF WORK AND PRODUCT DELIVERED

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 2. 1 checking results and performance
2.1.1 Checking the delivered services against quality standards
I. Understanding of quality
We all have needs, wants, requirements and expectations. Needs are essential for life, to
maintain certain standards of essential for products and services, to fulfill the purpose
for which they have been acquired. These needs determine quality of products or
services we acquire and are fulfilled by the individual purchasing, renting, or leasing.
Most of our lives are dependent in many ways on industrial products such as our shelter,
nutrition, work, communication, health care, recreation and etc.One basic aspect of
products of this type is that they must be fit for use/purpose. Failure in this respect can
lead to death, injury, discomfort or economic loss.
As users of these industrial products we all value their price, quality and delivery. We
require products of a given quality of be delivered by or be available by a given time and
to be of a price that reflects value for money.

II. Feature of Quality

In a manufacturing or service environment, there are major categories of quality, quality
of design, quality of conformance and quality of use. A poorly designed product will not
function properly regardless of how well it meets its specifications. Conversely a product
that does not conform to excellent design specifications will not properly perform its
intended function.
a) Design quality

Design quality refers to the level of characteristics that the designers specify for a
product high grade materials, tight tolerance, special features and high performance are
characteristics associated with the term, high quality product. An example of design
quality may be shown by the comparison between an expensive automobile and an
economy Both will perform the same basic function
In general, design quality refers to the ability of a design to exactly address the design
inputs, such as, intended purpose, regulatory requirements and designer own idea. This
includes:
 Identification of the customers
 Identification of the real needs of the customers and other
requirements
 Converting the customer needs in to technical language

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  Verifying that the technical language reflects the customer needs
b) Conformance quality

After the level of design quality has been determined, the product characteristics are
formed into drawings and specifications. The manufacturing engineers will use the
drawings and specifications to develop manufacturing specifications and design the
operations necessary to produce the product. This includes the machinery, test sets,
tools and other equipment. A plan for the number of employees required may also be
included. The quality engineer works with the manufacturing engineer to make the
quality system and maintenance of conformance quality an integral part of the
manufacturing (production) process.

Any product checks, process checks or quality improvement activities should be an

inherent part of the process. Conformance quality may be defined as the degree of
adherence of the product characteristics to the design drawings and specifications. The
objective of a quality program is to have a system that will measure and control the
degree of product and process conformance in the most economical way.
The quality engineer will determine what product or process characteristics are to be
checked. The quality engineer will also determine the type of data to be collected. The
corrective actions required and the statistical tools or other techniques to be used.
The producer uses the design to develop a product or provide a service with the
available:
 Personnel
 Equipment and material
 Working procedure
 Working environment
If the design quality does not reflect the intended purpose and other requirements or the
organization has no adequate arrangements to convert the design in to the product the
final output will not be fit for the intended use/purpose.

III. Quality Determination and Control

The Determinants of Service Quality
Through interviews with executives and customer focus have identified the ten
determinants of service quality. They are:

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 1) Reliability: consistency of performance and dependability; performing the right
service right first time; honoring promises; accuracy.

2) Responsiveness: Willingness or readiness of employees to provide service;

timeliness.

3) Competence: possession of the skill and knowledge required to perform the

service.

4) Access: approachability and ease of access; waiting time; hours of operation.

5) Courtesy: politeness, respect, consideration and friendliness of contact

personnel.

6) Communication: keeping customers informed in language they can

understand; listening customers; adjusting language to different needs of
different customers; explaining the service itself, how much it will cost, and how
problems will be handled.

7) Credibility:trustworthiness, believability, honesty; company reputation;

personal characteristics of personnel.

8) Security: freedom from danger, risk, or doubt; physical safety; financial

security; confidentiality.

9) Understanding the customer :making the effort to understand the customer’s

needs; learning the customer’s specific requirements; providing individualized
attention; recognizing the regular customer

10)Tangible:physical evidence of the service; physical facilities ;appearance of

personnel ;tools or equipment used to provide service; physical representation of
the service, such as a plastic credit card or a bank statement ;other customers in
the service facility

Lo2 Information sheet 2 2.2 Quality evaluation and parameters

2.2.1Clinical relevance of lab. Procedures

Error

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 • Mistakes that result in a loss of precision and /or accuracy.
• Occur at any time any where
• Refers to deviation of measured value from actual or true value.
Error= observed value-true value
%error=ov-tv x 100
tv
• But there is no true value rather accepted value .thus
%E = ov-av x100
av

TYPES OF ERROR
1. Random
• The degree of scatter of values around the mean value when repeat analyses are
made on the same sample
• Occur without regularity/prediction/
• Affects single test
• Could be minimized but unavoidable
• Occurs due to
- mislabeling of specimen
- Wrong test result on wrong specimen
- Incorrect filing of reports
- Improper specimen collection, handling and processing
- Error in pipe ting and dispensing
- Bubble in reagent
- Slight difference in the wave length of measurements
-contamination of the sample or reagent
Random (imprecision) have 5 independent components
1. Within run error
2. Within day errors
3. Day to day error
4. b/n analyst error
5. b/n lab errors
• Generally happens due to
- carelessness
- In attention
- short cut

2. Systematic
 A predictable regular deviation from the true value
 Affects the whole batch tests at analytical phase
 By taking adequate care ,it could be removable
 Occur due to failure of a system /methodology
 Results affected in either +ve or –ve direction
Example
• Use of faulty reagents ,media or stain
• Consistent faulty technique/instruments
• Wrong calibration of instruments
• Wrong calculation affecting the whole batch

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• Change in reagent batch
• Temperature change in incubator
• Bias of analyst
• Bias is the consistent deviation of analytical results from the true value caused by
systemic error in a procedure
bias= mean observed v-accepted v
Accepted value
• Bias may occur
- method bias
-lab bias
- sample bias
• Measured value = true value + sys error +random error
Systemic error can be classified
a. Constant –an error that has always the same direction and magnitude even as
the conc. of analyte changes
• Occur when results are consistently higher/lower by the same amount than the
true value
• Constant amount the entire of the analysis process
b. Proportional –an error which is always in one direction whose magnitude is a
percentage of the conc. of the analyte being measured
• Occur when the test results are higher /lower than the true value by the same
percentage
III. DIAGNOSTED VALUE OF TEST RESULT REPORTED
• Refers to the extent at which the test contributes to dx and prevention of disease
• The diagnostic usefulness of a test and its procedure is assessed by:
-reliability of a particular procedure Accuracy and Precision.
-using statistical methods such as sensitivity, specificity and predictive value.

Accuracy and Precision

Accuracy
• The closeness of a result obtained to the measured value
Precision
• Repeatability or reproducibility i.e. the ability to get the same value in subsequent
tests on the sample
• Measure of the agreement b/n results of replicate analysis on similar sample.
• An indication of random error.

Inaccuracy and Imprecision

Inaccuracy
• Numerical difference b/n the means of assets of replicate measurement and true
value
• common causes of inaccuracy
* Incorrect calibration of test method
* Quantitative test being read at in correct wave length
* using automatic pipette set on wrong volume
*consistent calculation error e.g. wrong factor
*Incubating samples at wrong temperature
Imprecision

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• Occasion of independence results of measurement obtained by a measurement
procedure under specific conditions.
Common causes of imprecision
• Incorrect or variable pipetting/dispensing
• Inappropriate mixing of sample with reagent
• Inconsistent incubation of sample
• If not clean ,dry glass or plastic ware
• Incomplete removal of interfering substance etc.

Sensitivity and specificity

Sensitivity
• The ability of a test to detect small amount of analyte.
• The ability of a test to detect truly infected individuals.
• In other words it is the proportion of cases with specific disease or conditions that
give a positive test result.
Sensitivity (%) =TP x100
TP+FN
NB. The more sensitive the result, the smaller the amount of assayed substance that
is measured.
Specificity
• The ability of test to identify all non infected individuals correctly
• The proportion of cases with absence of the specific disease or condition that give
a negative test result
Specificity (%) = TN x 100
FN +TN
• Highly specific test measures only the assay substance in question; it does not
measure interfering or similar substances.
Efficiency
• The overall ability of test to correctly identify all positive and negative
• Combination of sensitivity and specificity
• Number of patients correctly diagnosed
• Efficiency = TP + TN X100
TN +TP +FN +FP

Predictive value
• Describes the value of a test taking in to account the actual prevalence of
information in the proportion
• To assess the Pv for a test the sensitivity, specificity and prevalence of the disease
in the population being studied must be known.
• The prevalence of a disease is the proportion of a population that has the disease.
Positive predictive value
• The frequency of infective individuals among all persons with a positive result
PPV = TP x 100
TP + FP
Negative predictive value
• The frequency of none infected individuals among all persons with a negative
result

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 • NPV = TN x 100
• TN + FN
2.2.2 Checking the delivered services against organizational
specifications
What is a specification?
In a purchasing context, a specification can be defined as a statement of needs. It defines
what the purchaser wants to buy and, consequently, what the supplier is required to
provide. Specifications can be simple or complex Depending on the need.
The success of the purchasing activity relies on the specification being a true and
accurate statement of the buyer’s requirements.
What is a spec

ification?
A GOOD SPECIFICATION SHOULD:
 State the requirement clearly, concisely and logically in functional and
performance terms unless specific technical requirements are needed;

 For goods, state what the item will be used for;

 Contain enough information for offertory to decide and cost the goods or services
they will offer and at what level of quality;

 Permit offered goods or services to be evaluated against defined criteria by

examination, trial, test or documentation;

 State the criteria for acceptance of goods or services by examination, trial, test or
documentation;

 Provide equal opportunity for all potential suppliers to offer goods or services
which satisfies the needs of the user, including goods or services incorporating
alternative solutions;

 Form the fundamental basis of the contract between buyer and seller;

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  Not over-specify requirements;

Types of specifications
There are three types of specifications:
a) Functional specifications

These are specifications that define the function, duty or role of the goods or services. It
nominates what the goods or services are broadly required to do. Functional
specifications define the task or desired result by focusing on what is to be achieved
rather than how it is to be done. They do not describe the method of achieving the
intended result. This enables suppliers to provide solutions to defined problems.
b) Performance specifications

These are specifications that define the purpose of the goods or services in terms of how
effectively it will perform, that is, in capability or performance terms. Performance is a
logical extension of function. Performance specifications define the task or desired result
by focusing on what is to be achieved. They do not describe the method of achieving the
desired result. This enables suppliers to provide solutions to defined problems.
c) Technical specifications

These are specifications that define the technical and physical characteristics and/or
measurements of a product, such as physical aspects (for example, dimensions, color,
and surface finish), design details, material properties, energy requirements, processes,

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maintenance requirements and operational requirements. They are used when
functional and performance characteristics are insufficient to define the requirement.

Lo2. Information sheet 3 2.3 Evaluation of results

Before the results service delivered to the end user it should be evaluate to do
so there is method of quality evaluation. Those methods are:
 Against the designed standards
 Against the specification
 By visual inspection
 Why inspection?
By “inspection” it is usually meant that, at certain stages in the course of production, a
comparison is made between what has actually been produced and what should have
been produced. The standard of reference may be a specification, drawing or a visual
quality standard. The check made must be appropriate to the job and must be made with
suitable measuring instruments. Inspectors should not waste time checking things that
do not matter or fail to do a check that is important. Things those are unlikely to go
wrong need little checking and those which are difficult to hold within limits will need a
considerable amount of attention. It is a misconception that the inspector alone is
responsible for quality.
Quality results from a combination of quality of the original designs, the methods,
equipment and materials used, and the skill and care of the operator. In spite of these, if
the job is still wrong, no amount of inspection will put it right.
Different forms of inspection
According to production flow, the inspection may be divided into:

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A. Incoming inspection concerns goods upon delivery from vendors and/or suppliers. It
consists of inspection of raw materials, components, sub-assemblies and so on. The
aim of incoming inspection is to prevent goods that do not fulfill the quality
requirements from entering the production process.
Incoming inspection is one of the following steps in the control of the quality of
supplies:
 A buying specification is prepared, setting out exactly what quality of material has
to be obtained;

 Possible suppliers are checked for their ability and willingness to provide this
quality. This is called “vendor appraisal” or “supplier evaluation”;

 If the results of the vendor appraisal are satisfactory, then the supplier is placed
on an approved list and purchase orders are placed when goods are required;

 When goods are received, they are subjected to some form of goods inward
inspection;

 The results of the inspection are used to give each supplier a numerical rating,
showing how satisfactory or otherwise his suppliers are. This is called “vendor
rating”;

 The results at every stage are monitored and steps taken to improve or
discontinue unsatisfactory suppliers.

B. . In-process inspection: In-process inspection aims to prevent products of

unacceptable quality from being manufactured. It provides data for making
decisions on the product (accept or rework or reject), as well as on the process (run
or stop).
C. Final inspection: final inspection and/or testing is done after manufacture has been
completed, with the object of making sure that the goods concerned are satisfactory
for dispatch to the customer or maybe to another department for the next operation.

Based on the product specifications, inspection instructions are prepared that lay down
the details of the tests to be carried out, the measuring instruments or test equipment to
be used and the criteria for deciding acceptance of the product with respect to each
characteristic. Inspection instructions should also include details of the sampling plan
such as size of sample and the criteria of acceptance to be followed. Measuring

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instruments or test equipment used for inspection should be calibrated periodically to
verify their accuracy.
It is necessary to exercise suitable control over the movement of the product through the
inspection area in order to avoid a mix-up of accepted and rejected products. Ways to
exercise such control include:
 Provision of clear labels (preferably of different colors) for products awaiting
inspection, accepted products, rejected products, products on hold awaiting the
results of tests and/or inspection and so on;

 Separation of accepted and rejected products;

 Review of rejected products for rectification or repair or for sale as seconds;

 The accepted product should only be released to the next process or to the
customer by a person who is authorized to do so.

2.3.2 Identifying and isolating faults and taking corrective

actions
In problems will occur. You will need to decide what to do about them. The standard
requires you to have ways to identify a product or service nonconformity and to decide
what to do about it. It might be necessary to keep it separate from acceptable products
and services. You also need to have a documented procedure describing how you comply
with the requirements and to record any such activities. When nonconformities are
found after delivery or use has started, appropriate action could include informing all
those affected. The methods and techniques you use for controlling and recording
nonconformities should be appropriate for your organization. While the use of formal
nonconformity reports, or customer complaint forms, etc. may be necessary for large
companies (where there is a need to communicate widely), a small business can achieve
the same level of control by much simpler and less bureaucratic means. For instance,
where customer complaints on nonconformities are infrequent, the entire history of the
complaint, its investigation and the corrective action taken can be recorded in a
correspondence file. If you are in service business, you might not detect
nonconformities as these can occur while the product or service is being delivered to
your customer.
The following are internal sources to show up problems of product or service;

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  Verification of purchased product

 Production and service provision

 Monitoring and measurement

The following are the most common external indications, which enable you to target
where attention is needed;
 Customer complaints

 Warranty claims

The organization shall ensure that the product which does not conform to product
requirements is identified and controlled to prevent its unintended use or delivery. A
documented procedure shall be established to define the controls and related
responsibilities and authorities for dealing with nonconforming products. Where
applicable the organization shall deal with nonconforming product by one or more of the
following ways:
 By taking actions to eliminate the detected nonconformity;
 By authorizing its use , realize or acceptance under concession by a relevant
authority and where applicable, by the customer;
 By taking action to preclude its original intended use or application;
 By taking action appropriate to its effect, or potential effects, of nonconformity
when nonconforming product is detected after delivery or use has started

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 Self-Check 1 Written Test

NAME:_______________________________________________________
____ID,NO_______ s

Directions: Answer all the questions listed below. Illustrations may be necessary to aid
some explanations/answers.
1.List out Determinants of Service Quality

2.Compare and contrast Sensitivity and Specificity

3. Define inspection.
4. How Systemic error can be classified
5.
Note: Satisfactory rating - 25 points and above Unsatisfactory - below
25points

You can ask your teacher for the copy of the correct answers

Instruction Sheet 3 Learning Guide

This learning guide is developed to provide you the necessary information regarding the following
content coverage and topic
 Assessing quality of work and product delivered
 Checking results and performance
 Quality evaluation parameters
 Evaluation of results
Information sheet 3 LO3: RECORD INFORMATION

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LO3: RECORD INFORMATION
3.1. Recording Quality of work
Records established to provide evidence of conformity to requirements and of the effective
operation of the quality management system shall be controlled. The organization shall
establish a documented procedure to define the controls needed for the identification,
storage, protection, retrieval, retention and disposition of records. Records shall remain
legible, readily identifiable and retrievable.
Records exist in all companies. These records can provide you with information to help
your business effectively. You will need to show that you have actually done something,
recorded certain information, or met a particular requirement. It is important that a small
business does not burden itself with piles of paper that serve no purpose. You should
decide;-
 What records are required in relation to your business?

 What is requiring by the standard.

 You should identify how long each type of records need to be kept where it will be
found and how it is to be disposed of only keep what needs to be kept.

 Records should not be kept just to satisfy an auditor.

NB: In some instance, the retention period is dictated by statutory or regulatory

requirements, financial requirements, and possible product liability claims or customers
specifications. These details should be recorded or referenced in the documented
procedure.Some examples of what quality management system might generate as records
(quality records) are:
 Design files, calculations

 Customers’ orders, contract review,

 Meeting notes(management review)

 Internal audit reports

 Details of nonconformance(service failure reports, warranty claims, customer

complaints)

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  Corrective and preventive action reports

 Purchase orders

 Files on suppliers(evaluation of suppliers and their performance history)

 Process control details

 Calibration and verification reports

 Training details and

 Details of goods received and delivered

 Records indexing and filing may be in any appropriate form (hard copy or
electronic).

 Storage will need to be appropriate for the medium and should be such that the risk
of deterioration, damage or loss is minimized. It is useful to decide who has access to
the records and how readily available these need to be.

If you use computer techniques to store records, be aware that developments and evolution
of software programs can result in reading records made several years ago. It is also
important that up-to-date anti-virus software is used. Back up of records stored
electronically is also part of records management. After complete record and an
organization have to maintain the work quality records from different damages

Self-Check 1 Written Test

Name _________________________ Date: _______________

Directions: Answer all the questions listed below. Illustrations may be

necessary to aid some explanations/answers.
1. Discuss recording information on quality performance.

2. What information you record in relation to your business?

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Note: Satisfactory rating - 15points and above Unsatisfactory - below
15points

You can ask your teacher for the copy of the correct answers.

Answer sheet
1.____________________________________
______________________________________
______________________________________
______________________________________
______________________________________
______________________________________
______________________________________
2.____________________________________
______________________________________
______________________________________
______________________________________
______________________________________
______________________________________

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 GODE HEALTH SCIENCE COLLEGE

ETHIOPIAN SOMALI REGIONAL STATE

BUREAU OF TECHNICAL AND VOCATIONAL

EDUCATION AND TRAINING
GODE, SOMALI, ETHIOPIA

MEDICAL LABORATORY DEPARTMENT

Programme title:- MEDICAL LABORATORY SERVICE

LVEL III

LEARNING GUIDE #4
Unit of Competence: Apply Quality control
Module Title: Applying Quality control

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 TTLM LG Code: HLT MLS3 M12 V1 LO1-05 TTLM
Code: HLT MLS3TTLM 08/02/16 v1

LO 4 STUDY CAUSES OF QUALITY DEVIATION

Instruction Learning guide 4

sheet

This learning guide is developed to provide you

the necessary information
regarding the following content coverage and
topics--

 4.1.Checking and reporting the couse of quality

deviation
 4.2 Causes Of Corrective Action

Learning Instructions
1. Read the information written in the
“Information Sheets”.
2. If you earned a satisfactory evaluation
proceed to next module. However, if
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your rating is unsatisfactory, see your
teacher for further instructions.
3. Read the “Operation Sheet” and try to
understand the procedures discussed.
4. Practice the steps or procedures as
illustrated in the operation sheet
Go to your teacher if you need clarification
or you want answers to your questions or
you need assistance in understanding a
particular step or procedure
5. Do the “LAP test” (if you are ready).
Request your teacher to evaluate your
performance and outputs. Your teacher will
give you feedback and the evaluation will
be either satisfactory or unsatisfactory. If
unsatisfactory, your teacher shall advice
you on additional work. But if satisfactory
proceed to the next Learning guide

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 Information sheet 1 Checking and reporting the couse of quality deviation

LO 4 STUDY CAUSES OF QUALITY DEVIATION

4.1.Checking and reporting the couse of quality deviation

Some of the most challenging quality problems are those which are connected with defect
investigation in spite of careful planning and proper process control, certain defects may
still be revealed during assembly or in final inspection. To prevent these defects from
recurring, they have to be investigated to find the underlying causes, so that efforts can be
made for its elimination. The causes of certain defects are fairly obvious and can directly be
identified. In fact ,the ‘analysis’ element in any process control system is a form of defect
investigation ,in the sense that based on the defects observed ,the causative factor is
identified ,which in turn gives a clue to the corrective action required . However, there are
other defects which cannot be readily explained. There may be so many possible causes
that it may be difficult to spot with any degree of certainty the factor which has caused a
particular defect. In such cases, formal defect studies may be carried out to find the real
cause and the remedial measures required. An organized method of defect investigation is
discussed in this topic.

4.1.1 Which defects should be investigated?

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A quality enthusiast may say that every single defect must be investigated to assure defect –free
production. Unfortunately, this may not be practicable or economically desirable. Defect studies
cost money in the form of the time of engineers and technicians, test facilities and then products
destroyed in testing, and therefore, unless the expected benefits from the prevention of defects are
likely to exceed the cost of the defect study, it will not be economically justifiable. Further, the
resources at the disposal of the quality manager will normally be limited; therefore, he will have to
undertake defect studies on a selective basis.
The defects may be broadly grouped into two classes, namely, sporadic and
chronic. A sporadic defect generally signifies that some new factor has entered into the
process, and unless this factor is identified and eliminated, the process will remain out of
control. Therefore, such defects have to be investigated on priority. On the other hand,
chronic defects are the various types of defects which have been occurring in a certain
percentage of the product, due to unknown causes. Generally, chronic defects comprise a
large number of different types of defects of varying magnitude. Since all of these cannot be
taken up for investigation simultaneously, it is advisable to concentrate on the’ vital few’
rather than the ‘trivial many’. To identify the ‘vital few’ the resultant losses due to different
defects may be evaluated. The defects showing highest losses merit first attention. There
may be certain defects which result in serious failures of equipment in service. Though
direct losses (such as warranty claims) due to these defects may not be appreciable, the
loss in customer good will may be considerable. Therefore, the quality manager should be
on the alert for such defect which will not figure as major defects in a purely financial
analysis.

4.1.2 Defining Responsibility and conducting a defect study

A defect study, like any other activity, requires proper planning and organization to be
fruitful. The object of a defect study and its responsibility should be clearly defined. The
task is generally entrusted to a team rather than an individual. The team may be composed
of personnel from quality control, engineering production, or wherever expertise is
available. For proper direction and coordination, a study coordinator is also named who
coordinates the activities of the team and keeps the management informed about the
progress of the study.
Once then study team is formed and the objective of defect study has been explained to
them, the first question which arises is how to go about it and where to start? Although
there is no cut and dried method of defect investigation, which will be valued for all

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situations the general approach to the organized study of defects in different products and
processes is more less the same. The main steps of this approach are discussed below.

1. Study of the products and data collection

2. Identification of defective component/process

Types of quality deviation

Following are some example of deviation raised from different functional areas of business
1) Production deviation usually raised during the manufacture of a batch production

2) Quality improvement deviation may be raised if a potential weakness has been

identified and the implementation will require project approval

3) Customer service deviation: - rose to track implementation measure related to

customer complaints.

4) Technical deviation:- can be raised for validation discrepancies example change in

manufacturing instructions

5) Materials complaint: - rose to document any issues with regarding to

nonconforming, superseded or obsolete (out of date) raw materials components,
packaging or imported finished goods.

Causes of Quality Deviations

1. Design and Specification

a) Vague or insufficient manufacturing particulars or illegible drawing prints

b) Impracticable design or incompatible component and assembly tolerance.

c) Obsolete drawing being used.

2. Machinery and equipment

a) Inadequate process capability

b) Incorrectly designed tooling

c) Worn tools

d) Non-availability of measuring equipment

e) Poor maintenance of machines

f) Equipment affected by environment condition such as temperature, humidity

etc;

3. Materials

a) Use of untested materials.

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 b) Mix-up of materials

c) Substandard material accepted on concession because of the non-availability

of correct material

4. Operating and supervisory staff

a) Operator does not possess adequate skill for operating the process
equipment.

b) Operator does not understand the manufacturing drawing or instructions

relating to the process.

c) Machine setter does not know how to correctly set the machine.

d) Careless operator and inadequate supervision

e) Undue rush by the operator to achieve quantity targets

5. Process control and inspection

a. Inadequate process controls

b. Non availability of proper test equipment

c. Test equipment out of calibration

d. Vague inspection /testing instructions

e. Inspectors do not possess the necessary skil

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 Lo4Information sheet
4.2 Causes Of Corrective Action
2

4.2.1 PHASES OF QUALITYASSURANCE

1. Internal QC
is based on monitoring the test procedures that are performed in the lab.
There is continual evaluation of the reliability of the work of the laboratory with
validation of tests before reports are released.
2. External Qc
Is evaluation by an outside agency.
It is a kind of proficiency testing.

Aspects of QA program

1. Preventive activities
2. Assessment procedure
3. Corrective action
Characteristics of QA
 Comprehensive –covers all components of QA
 Rational-covers critical steps
 Regular –continuous process
 Frequent- action to detect and correct error
Quality assurance cycle
3 Phases of quality assurance:
I. Pre-analytical stage
 Includes steps starting from request form.
 Specimen collection ,handling & transporting
 Specimen identification
 Client communication and education
 Personnel safety
 Laboratory environment
II. Analytical stage
 Includes all the processes that are carried out during the test
 It includes the activities of performing the test, verifying the validity of the test
results & interpreting the findings
 The analytical phase of quality assurance includes
a. instrument operation & maintenance

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 b. Test reagent
 Supplies
 Personnel
 Actual test performance
-internal quality control
-external quality control
 Analytical process
III. Post analytical stage
All processes following lab examination includes:
 Reporting results to appropriate party
 Timely reporting data
 Reference range included
 Immediate reporting of results exceeding ‘critical limits ’
 Recording the data
 Specimen management
Rewards of a quality assurance program
 Generation of reliable service
 Establishing proper diagnosis
 Builds trust on the laboratory
 Creates motivation for better work
 Mandatory requirement for accreditation
IV. Standard operating procedures (sops)

What is SOP?
 JApproved document or manual that describes how to perform various operations
in the lab
 Contains step by step instructions that laboratory staff should carefully follow to
produce the right result at the right time on the right specimen from the right
patient with result interpretation based on correct reference data in consistent
manner & with safe practice.
Features of SOP
 Applicable and achievable
 Clearly stated/written and easy to understand and to follow.
 Kept up to date
Benefits of SOP
 Serves as a guide for new staff training
 Reduce time in documenting routine tasks
 Minimize errors
 Allow management to assure correct scientific practice
SOPs Process
 Preparation
 Revision
Writing a SOP
 Should be written by individuals who have long exposure for the procedure.
 Should be comprehensive
 Written in a simple language
 Signed and dated authorized personnel`s
 Should be reviewed regularly
 Should be access to all who use it
Content of Sop

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 The content of SOPs depends on the quality assurance phase for which the SOP
is written.
A. SOPs for pre analytical
two types are recommended
1. SOPs for specimen collection &transport
each SOP include the following information
-specimen type
-positive patient identification
-procedure for collection
-verification of test request for completeness
-date and time of collection
-Correct labeling
-equipment and materials required
-specimen transportation
-specimen rejection criteria
-correct action to be taken for rejected specimen
-registration of specimen collected
-received and rejected (include type)
-safety and waste disposal
SOPs should be available at a collection site Of a central lab, distributed to wards
and carried by field specimen collectors .
2. SOPs for specimen receipt &processing
Should contain the following content
-checking for proper specimen for requested
-specimen rejection: unlabeled, insufficient, volume, wrong container,etc…
-registration (dated) of both accepted & rejection specimen
-corrected actions to be taken for rejected samples
-turnaround time for specimen preparation
B. SOPs for Analytical & Post analytical
A single sop is prepared for a test in the analytic and post analytic phases by
combining documented procedure required for the execution each key process.
Each sop contains the following information.
1. Test name
2. Clinical significance of the test
the purpose of this procedure is to (detect, examine, analyze, identify, establish,
etc…
3. Test principle: including a brief statement concerning the type of reaction,
specimen, and organism involved
4. Patient preparation: special directions for patient preparation are required they
should outline here.
5. Specimen requirement:
 Type of specimen /priority attention
 Site of specimen collection
 Sample volume required
 Use of any anticoagulant
 Collection material
 Procedure /criteria for rejection of specimen
 Sample handling/processing.
6. Instrumentation, equipment and material

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 7. Reagent preparation: name, chemical formula, grade of each reagent and
standards should list. Direction for preparation of reagents and standards, storage and
usable shelf time should be specified
8. Test procedure: complete instruction for performing the test .preparation of all
standards and step by step calibration procedure first part of this section .next,
procedure for performing the test is described .the procedure should be simple,
direct, & follow a logical order.
 Procedure for reporting the result ,including the measuring unit ,the number of
decimal should be describe
9. Calculation (formulas & example)
10. Quality control /control preparation: name of control material and lot number
including how to prepare, when to use where to record and how to interpret the
control result.
11. Reference interval
12. Reporting results/ interpretation
13. Procedure limitation
14. Maintenance schedule
15. Reference
16. Approval and review
SOPs review
 Should be reviewed annually and whenever necessary or there is change a
method .
 The sop reflects the lab’s attitude and approach towards quality assurance.
Characteristics of good SOP
 Comprehensive – covering all aspects of details
 Are written clearly and concisely
 Follow the national sop template
 Provide an easy efficient means to document complicated technique
 Communicate what is exactly done in lab
 Do not use more words than necessary
 Are easily understood by new lab personnel
 Do not require frequent updates and corrections
 Are annually reviewed and kept up to date
 Are acceptable by QA directors

Self-Check 1 Written Test

NAME: _________________________ Date: _______________

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Directions: Answer all the questions listed below. Illustrations may be
necessary to aid some explanations/answers.
1. What is quality deviation?
2. Write down types of quality deviation which arise from different functional
areas
3. What are causes of quality deviation?
4. Which defects should be investigated?
5. What is the difference between preventive action and corrective action?

Note: Satisfactory rating - 5points and above Unsatisfactory - below

5points
You can ask your teacher for the copy of the correct answers.

LO5:COMPLETING DOCUMENTATION
5.1. Records information on quality and other indicators of service
performance
Documentation includes mandatory documented procedures as required by the standard
and other documents such as specifications, records, etc. the important issue is that your
people have the information they need to do their job. Some common terms used are:
 Work practices

 Operating practices, operating instructions or operating procedures

 Specifications and

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  Drawings

Documentation should indicate, who does what, where, when, why, and how. It should not
be a wish list of what you would like to happen in your business, but should clearly and
accurately reflect what really happens. For example, it is not necessary to have a formal
document on how to open a door- simply putting “push” or “pull” on the door suffices.
You have to decide how much detail is needed. This will depend largely on the method
used, the skills needed, the training undertaken and the extent of supervision required.
Excessive detail does not necessarily give you more control of the activity and should be
avoided. Training can reduce the need for detailed documentation, provided that everybody
has the information they need to do their job correctly.
Existing documentation might be adequate, and may then be simply referenced in the
quality manual.
Remember documentation may be in any reproducible form and can vary enormously
ranging from separate formal documents, to technical notes incorporated into a drawing to
instruction manual equipment.
They could also be in pictorial or video form. Graphic formats or a video or simple set of
pictures can be particularly useful since visual aids can often convey the information more
accurately than a lengthy detailed description.
5.1.1. Documentation requirementsand Value of documentation
The quality management system documentation shall include
a) Documented statements of a quality policy and quality objectives

b) A quality manual

c) Documented procedures required by international standard

d) Documents needed by the organization to ensure the effective planning, operation and
control of its processes

e) Records required by international standards

Documentation enables communication of intent and consistency of action. Its use

contributes to
a) Achievement of conformity to customer requirements and quality improvement

b) Provision of appropriate training

c) Repeatability and traceability

d) Provision of objective evidence

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 e) Evaluation of the effectiveness and continuing suitability of the quality management
system

5.1.2.Types of document used in quality management system

The following types of document are used in quality management system

a) Documents that provide consistent information, both internally and externally, about
the organization’s quality management system: such documents are referred to as
quality manuals;

b) Documents that describe how the quality management system is applied to a specific
product, project or contract; such documents are referred to as quality plans;

c) Documents stating requirements; such documents are referred to as specifications;

d) Documents stating recommendations or suggestion; such documents are referred to as

guidelines;

e) Documents that provide information about how to perform activities and processes
consistently; such documents can include documented procedures, work
instructions and drawing;

f) Documents that provide objective evidence of activities performed or results achieved;

such documents are referred to as records;

Each organization determines the existent of documentation required and the media to be
used. This depends on factors such as the type and size of the organization, the complexity
and interaction of processes, the complexity of products, customer requirements, the
applicable regulatory requirements, the demonstrated ability of personnel, and the extent
to which it is necessary to demonstrate fulfillment of quality management system
requirements.

1.1. Documenting quality standards

The following are common procedures for checking the quality of completed work against
work place standards;
1) Select work product to be evaluated based on documented work place standards
Note; work products can include services produced by a process whether the recipient of
the service is internal or external to the organization.

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2) Establish and maintain clearly stated criteria for the evaluation of selected work products.
The intent of the above procedure is to provide criteria, based on business needs, such as
the following;
 What will be evaluated during the evaluation of a work product
 When or how often a work product will be evaluated
 How the evaluation will be conducted
 Who must be involved in the evaluation
3) Use the stated criteria during the evaluations of selected work products
4) Evaluate selected work products before they are delivered to the customer
5) Evaluate work products at selected time intervals
6) Identify each cases of noncompliance found during the evaluations
After setting (establishing) quality standards for organization/company/. The new
established quality standards should be introducing to organization staff and also if it is
necessary, the new standard procedures should be updating.

Self-Check 1 Written Test

Name: _________________________ Date: _______________

Directions: Answer all the questions listed below. Illustrations may be necessary to aid
some explanations/answers.
1. Define the term documentation?

2. List out the documentation requirements.

3. Discuss on values of documentation?

4. Write the types of document used in quality management system.

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