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Reporter: Sanglad, Chariezza Lei J. Date Submitted: February 20, 2019 Topic: Introduction To Quality Assurance and Quality Control

Quality assurance includes quality control and quality assessment. Quality control ensures accurate and reliable results through good laboratory practices, good measurement practices, and standard operating procedures. Good laboratory practices are general laboratory operations like properly recording data, maintaining records, and cleaning equipment. Good measurement practices outline proper equipment use. Standard operating procedures describe safe and effective laboratory processes. Quality assessment evaluates if quality control is adequate and effective.

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98 views5 pages

Reporter: Sanglad, Chariezza Lei J. Date Submitted: February 20, 2019 Topic: Introduction To Quality Assurance and Quality Control

Quality assurance includes quality control and quality assessment. Quality control ensures accurate and reliable results through good laboratory practices, good measurement practices, and standard operating procedures. Good laboratory practices are general laboratory operations like properly recording data, maintaining records, and cleaning equipment. Good measurement practices outline proper equipment use. Standard operating procedures describe safe and effective laboratory processes. Quality assessment evaluates if quality control is adequate and effective.

Uploaded by

Yen Bum
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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Reporter: Sanglad, Chariezza Lei J.

Date Submitted: February 20, 2019


Topic: Introduction to Quality Assurance and Quality Control

INTRODUCTION TO QUALITY ASSURANCE

 QUALITY ASSURANCE
-steps taken during an analysis to ensure that the analysis is under control and that it is
properly monitored.

 Under Quality Assurance are:

1. Quality Control
2. Quality Assessment

 QUALITY CONTROL
-includes all operational techniques and activities that are used to fulfill requirements
for the quality of a product. It ensures that all operating procedures and activities used
in the laboratory provide reliable and accurate results suitable for an intended purpose.

 The techniques or operations under Quality Control are:


1. Good Laboratory Practices (GLP’s)
2. Good Measurement Practices (GMP’s)
3. Standard Operating Procedures (SOP’s)

 Good Laboratory Practices (GLP’s)


-the general laboratory operations that need to be followed in any analysis. GLP’s are
the set of activities intended to ensure and promote safety during analysis and
generation of high quality and reliable test results.

These include practices such as:

 Properly recording data


 Maintaining records
 Cleaning, maintenance and calibration of apparatus
 Chemicals, reagent and solutions should be labeled to indicate identity,
expiry and specific storage instructions
 Records of source, date of arrival and arrival conditions of samples
 Cleaning and sanitization of containers
 Wearing safety gears inside the laboratory
 Good Measurement Practices (GMP’s)
- instructions outlining how to properly use equipments and instrumentation to
ensure the quality of measurements.

These include practices such as:

 Calibrating the pH meter using buffer solutions and rinsing the pH electrode
with distilled water, drying it with tissue before placing to a new solution.
 Burette readings should be made consistently along a line perpendicular to
the burette, to avoid parallax error
 Allowing sufficient time for the light source to warm up in
Spectrophotometer in order to stabilize the equipment to produce consistent
result.

 Standard Operating Procedures (SOP’s)


- set of instructions that describes how to perform a laboratory process safely and
effectively.

Examples:
 Determination of Moisture Content (AOAC,2000)
- dry the sample in the oven at 105°C to a constant mass.
 Determination of Ash Content (AOAC,2000)
- place the crucible without lid containing the sample in the furnace at 550°C
overnight and weigh the ash with crucible and lid after heating.
Questionnaire:

1. Who approves the SOP’s of the Quality Assurance Unit?


a. Contractor
b. Agency
c. Laboratory management
d. Sponsor
e. Production team
2. Can the study director authorize changes in SOP’s?
a. Yes
b. No
c. Either a or b
3. What are GLP’s?
a. Good Manufacturing Practices
b. A Quality Assurance System
c. Great Listening Procedures
d. A Quality Control Program
e. All of the Above
4. How records are created?
a. By planning documents (protocols and SOP’s)
b. By checking documents
c. By improvement documents
d. By doing documents
e. All of the Above
5. What are the principles of Quality assurance?
a. All for one
b. Fit for purpose
c. Right first time
d. B and C
e. A, B and C
6. What is the Standard Operating Procedure for the determination of fat content
(AOAC,2000) ?
a. Place the bottle in the incubator at 105°C overnight
b. Place the bottle and lid in the incubator at 105°C overnight
c. Place the bottle and lid in the incubator at 300°C overnight
d. Place the bottle in the incubator at 300°C overnight
7. The following are NOT the methods used in calibrating the thermometer EXCEPT:
I. By Ice Water Method
II. By Air Method
III. By Boiling Water Method
IV. By Warm Water Method
V. By Tap Water Method

a. I an IV b. V only c. III and V d. I and III e. II, III and IV


8. Quality assurance intermediate includes management of the quality of raw materials and?
a. Assembles
b. Product and compartments
c. Services
d. All of the above
e. No response at all
9. Statistical control is based on analyses of objective and ?
a. Subjective data
b. Analytical data
c. Quality data
d. None of the above
10. The quality of the products is dependent upon that of the participating ___________.
a. Members
b. Constituents
c. Safety
d. Handling
e. All of the above
11. ISO 17025 is an international standard that specifies the general requirements for the
competence to carry out tests and or ____________.
a. Calibrations
b. Testing
c. Quality Control
d. Quality Assessment
e. All of the above
12. Quality Assurance is not limited to manufacturing and can be applied to any business or
non-business activity, including?
a. Design and Consulting
b. Banking and Insurance
c. Software Development and Retailing
d. A and B
e. B only
f. A, B and C
13. It is the world’s most popular, latest and most commonly used standard for quality
management systems that provides confidence in the conformance of your product to
established or specified requirements.
a. ISO 14001
b. ISO 13485
c. ISO 14000
d. ISO 9001
e. ISO 17025
14. It ensures that all operating procedures and activities used in the laboratory provide
reliable and accurate results suitable for an intended purpose.
a. Standard operating procedures
b. Quality assurance
c. Quality control
d. Quality assessment
e. Quality Evaluation
15. Set of activities intended to ensure and promote safety during analysis and generation of
high quality and reliable test results.
a. Standard operating procedures
b. Good Measurement Practices
c. Quality Evaluation
d. Quality assessment
e. Good Laboratory Practices

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