Duruman College Gambella Campus

Course tittle: - Applying Quality Control

For Department of Pharmacy{level III}

1st year

:-

Occupational Standard: Level III

Unit Title Apply Quality Control
Unit Descriptor This unit covers the knowledge, skills and attitudes required in applying
quality control in the workplace.

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Elements
LO1. Implement quality standards
LO2. Assess quality of service
delivered
LO3. Record information
LO4. Study causes of quality
deviations
LO5. Complete documentation
Definition of Terms:
Performance Criteria
1.1. Agreed quality standard and procedures are acquired and confirmed.
1.2. Standard procedures are introduced to organizational staff/personnel.
1.3. Quality standard and procedures documents are provided to
employees in accordance with the organization policy.
1.4. Standard procedures are revised / updated when necessary.
2.1. Services delivered are quality checked against organization quality
standards and specifications.
2.2. Service delivered are evaluated using the appropriate evaluation
quality parameters and in accordance with organization standards.
2.3. Causes of any identified faults are identified and corrective actions
taken in accordance with organization policies and procedures.
3.1. Basic information on the quality performance is recorded in
accordance with organization procedures.
3.2. Records of work quality are maintained according to the
requirements of the organization.
4.1. Causes of deviations from final outputs or services are investigated
and reported in accordance with organization procedures.
4.2. Suitable preventive action is recommended based on organization
quality standards and identified causes of deviation from specified
quality standards of final service or output.
5.1. Information on quality and other indicators of service performance is
recorded.
5.2. All service processes and outcomes are recorded.
LO 1: Implement quality standards
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 What is quality?
Quality:- is the general characteristics or attributes of products or services that satisfies the
customer needs or wants .
The term quality might mean different things for different people and for different things
(service, product, education etc…).
For example
 Customer-Based = Fitness for use, meeting customer expectations
 Manufacturing-Based = Conforming to design, specifications, or requirements.
Having no defects.
 Product-Based = The product has something that other similar products do not that
adds value.
 Value-Based = The product is the best combination of price and features.
Quality –is the degree to which a set of inherent characteristics of a product or service fulfill
the needs or expectations of our customer
Quality is one that fulfills minimum predefined and agreed upon set of standards
‘Quality’ is thus attributed to all that fulfills the minimum standards

Quality is defined by the Customer

DESIRED RESULTS
EFFECTIVELY
CUSTOMER MANAGED Quality Products
REQUIREMENTS PROCESSES
Quality Services

Quality is a result

Quality is the result of a comparison between what was required and what was provided. It is
judged not by the producer but by the receiver. The judgment can be made of an intention, as is
the case when selecting suppliers, or an output, as is the case when purchasing a product or
service.

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Customer satisfaction

IS the product or service performance is much as its expection or the product or servie is
accepted by customer or user .
Quality and value

Value is not a price tag but a measure of the benefits derived from a product or service for what
is given in return. A product may well meet physical and functional requirements but are
overpriced when compared to others of the same class and grade. Alternatively, the same product
may be on offer at another store for 50 per cent less, indicating exceedingly good value for
money

customer and supplier will not leads to satisfaction of customers.

What quality is not?

Quality is not perfection, a standard, a procedure, a measure or an adjective. No amount of

inspection changes the quality of a product or service Quality is not a specific characteristic of an
entity but the extent to which that characteristic meets certain needs

Why is Quality Important?

As quality improves:
• Waste is reduced
• Accidents and problems eliminated
• Productivity increases
• Operating costs reduced
• Profitability increases
• Competitiveness improves
Why should an organization be interested in quality?

Providing products and services which meet customer needs and expectations creates satisfied
customers. Anticipating future needs and expectations retains satisfied customers.
Therefore, quality is vital to the survival of every enterprise.
Who is responsible for quality?

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One can only be responsible for doing something relative to quality. Hence a person can be
responsible for:
• specifying quality requirements
• achieving quality requirements
• determining the quality of something
Assigning responsibility means giving a person the right to cause things to happen and with this
right should be delegated the authority to control the processes which deliver the output the
quality of which the person is responsible for.

One manager cannot be made responsible for quality within an organization. All a specialist
manager such as a Quality Manager can do it is to enable others to achieve quality by providing
encouragement, leadership, training, tools, techniques and performance data.

• Quality Assurance(QA)

– It is the sum of all activities and responsibilities intended to ensure the products
meet all the applicable quality specifications in the final dosage form.

– System of management activates involving

 Planning
 Implementation
 Assessment
 Reporting to make sure that end products

– Quality management plan

Is formal plan that documents an entity management system for the envormantal
work to be performed

To improve your work performs use kaizen in the work place .

– Efficient QA program is important to monitor and evaluate effectiveness of

policies and procedures of quality control

• Good manufacturing practice (GMP)

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 – The part of the QA that ensures products are consistently produced and
controlled to the quality standard appropriate to their intended use.

• Quality control (QC)

Is the process of managing or supervising about whole activates of quality or to full fill
the requirements of the quality.

The part of GMP which is concerned with sampling, specification and testing and
organization, documentation and release of procedure to ensure the quality of the drug.

Service quality (SQ), is a comparison of perceived expectations (E) of a service with

perceived performance (P), giving rise to the equation SQ=P-E.
Service quality is an achievement in customer service.

Components of service quality

O Assessing own work
O Evaluating Service rendered
O Identifying Quality deviations
O Taking corrective actions
O Documentation

How can quality be achieved?

Several methods have evolved to achieve, sustain and improve quality. They are known as
quality control, quality improvement and quality assurance - collectively known as quality
management. Quality management is not the preserve of one manager but of all managers

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Summary question

Give the short answer

1. Define quality
2. Explain why quality is defined by customers
3. Define quality control?
4. What is services quality?

LO 2: Assess quality of service delivered.

Service delivered are cheeked against organizations quality, standard, specification.

Specification :-means statements of particular needs
A specification often refers to a set of documented requirements to be satisfied by a material,
design, product, or service. A specification is often a type of technical standard.

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The word specification is broadly defined as "to state explicitly or in detail" or "to be specific".

Specifications are an imprecise means of conveying subjective aspects

Specifications may also refer to technical standards, which may be developed by any of various
kinds of organizations, both public and private.

Service deliver are cheeked through

 Visual inspection
 Chemical test
 Physical measurement
 Templates

Source of quality information

You can gathering or collecting about quality information by using different methods those are :-

 Quality slandered procedure

 Work instruction
 Manufacturing instruction
 Interview external personnel
 Customer requirements

Inspection is an important tool to achieve quality concept. It is necessary to assure confidence to

manufacturer and aims satisfaction to customer. Inspection is an indispensable tool of modern
manufacturing process. It helps to control quality, reduces manufacturing costs, eliminate scrap
losses and assignable causes of defective work.

Good medicine dispensing practice

 Good medicine dispensing practice refers to the delivery of the correct medicine to the
right patient, in the required dosage and quantities, in the package that maintains

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 acceptable potency and quality for the specified period. This practice is a key step for
effective treatment outcome.
 Quality of drugs should meet the standards related to safety, potency, and efficacy.
 A quality control program for drug industry involves with batch-to-batch uniformity of a
product insuring that the final product possesses desired characteristics of identity, purity,
potency, uniformity, safety, efficacy and stability with in established levels which meet all
the legal, professional and company standards

Dispensing environment

The dispensing environment should possess:

• Appropriate temperature
• Sufficient lighting
• Optimum humidity control
• Cold storage facilities
• Adequate number and type of shelves
• Lockable cabinet for Narcotic medicines,Psychotropic substances and poisons
• Patient/care provider waiting area
• Dispensing aids, etc.
• Smoking should be prohibited in any area where medicines are dispensed, sold or
supplied.

Dispensing equipment
All equipment should be kept clean and should be checked for cleanliness prior to each use.
Equipment should include:

• A dispensing bench having a smooth, impervious working surface.

• Tablets and capsules counting devices.
• A refrigerator equipped with a maximum/minimum thermometer
Summary question
Instruction give the short answer

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 1. Write the source of quality information ?
2. Explain what mean that good medicine dispensing or delivering practice?
3. The quality of druges should meet related to ________,_________,___________.

LO 3: Record information.

What is record ?
Record is written or electronic document to preserve information or keep a record of a
transaction.
 Are the source of information or document which an organization wants to retain or to set
 Record information can provide with you to ran business effectively .
What is information?
Information is the collection of data that is used to make decision about one purpose.

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 The need of recording information
 to make internal audit report
 corrective and preventative action report
 details of goods received and delivered
 parches order
 customer satisfaction
 process control details
Methods of recording information
 by note taking.
 Summary of information found.
 Reading.
 consulting with other .
 subjective area :-means location source of information found .

Summary question
Give the short answer
1. What is recored ?
2. What is information
3. Write the advantages of recording information ?

LO4:Study causes of quality deviations.

Quality deviation is departure from standard procedure or specification result from non
conformance materials.The action of doing some things that is different from you planned.

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Examples of quality deviations in different areas of business

1. production deviation
usually raised during manufacturing of batch products .
2. quality improvement deviations
may be raised if potential weakness has been identified and the implementation required
project approval.
3. Customer service deviation
Raised the track implementation measures related to customer compliant .
4. Audit deviation
Raise non conformance identified during internal and external audit or use incorrect
information
5. Technical deviation
Can be raised for validation discrepancies
Example: change in manufacturing process
6. Material compliant
Raised to do document any issue with regarding to non conformance .
Example :lack of enough materials .

Cause of quality deviation

a. Design and specification
Insufficient manufacturing particular
b. Machinery and equipment
 Incorrect design tools
 Poor maintains of machineries
c. Materials
 Use untested materials
 Mix up of materials
d. Operating and supervisory staff

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 Operators dose not posse adequate skill operating the process equipment .
Machine setter does not know how to correctly seat the machine .
e. Process control and inspection
 Inadequate process control
 Vague inspection or testing instruction

Impacts of low-quality medicines

Poor-quality medicines may cause a number of serious problems including: -
 Lack of therapeutic effect that may lead to prolonged illness or death
 Toxic or adverse reactions
 Waste of limited financial resources
Summary question
Give the short answer
1. Write the examples of quality deviation?
2. Explain quality deviation?
3. List the cause of quality deviation?

LO 5: Complete documentation.
What is document ?
– Is an original or official paper relied up on proof
– Is an written account of an idea .
Documentation ,is the process of transferring or exchanging ideas in to document
– ,some thing transposed from a through to document
Values of documentation
1. Achievements of conformity to customer requirement and quality improvement

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 2. Provision of appropriate training
3. Provision of objective evidence
4. Evaluation of effectiveness and suitability of the quality management system.
Give the short answer
1. What is the document ?
2. Explain the difference between the document and documentation

Name _____________________________id_________dep___________
Level______________________
Section ____________________

Assignment for( 50%)

Give the short answer
1. What is quality ?
2. What is mean that customer satisfaction and dissatisfaction?
3. Write the advantages of recording information ?
4. What is quality deviation ?
5. Write the some examples of quality deviation ?
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6. How to collect about quality information ?
7. What mean that good medicine delivering practice ?
8. _______is the statements of particular needs or wants .
9. What is difference between the record and information ?
10. Write the benefits of producing different products or services with keeping of their
quality performance?
11. Write the cause of quality deviation?
12. The managing about the whole activates of quality or over all systems of operational
techniques and activates that are used to fulfill requirements of quality is known as
_______________________
13. Write the impacts of low quality performance?
14. List the values of documentation?
15. Service delivery are cheeked through
 ____________________________
 ____________________________
 ____________________________
 ____________________________
16. Dispensing the environment should be possess
17. What is customer satisfaction ?
18. Define about the customer ?
19. What understand about this course ?
20. What is deference between data and information ?

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