Lab Management and Quality Assurance

This document discusses the concepts of lab management and quality assurance. It covers topics such as ISO 17025:2018 and ISO 9001:2016 standards, calibration of pH meters, and the importance of NATA accreditation. It also provides information on support programs needed in the HACCP program. Find study material and solved assignments on Desklib.

Lab Management and Quality Assurance 1
University Affiliation
Lab Management and Quality Assurance
By
Name of Student
Date
Name of Lecturer

Lab Management and Quality Assurance 2
Question 1
ISO 17025:2018 is basically a general rules and terms that guides and ensures
laboratories implement a sound quality system as well as demonstrate their high level of
competency and can produce reliable and valid results (Kelechava, 2019). The standard is set in
order to guarantee impartiality, competence as well as consistent operations within all
laboratories irrespective of size or number of workers irrespective of industry (Tranchard, 2019).
On the other hand, ISO 9001:2016 specify and lists requirements for quality management
system in the event a company wants to prove its capability and skills to offer services and goods
that satisfies customer needs as well as conforms to the set regulations and thrives to enhance the
satisfaction of consumers by using the system effectively (Shop.standards.govt.nz., 2016;
Asq.org., 2019).
The two standards are often applied differently. ISO 9001:2016 is applicable to all industries and
companies. On the other hand, ISO 17025:2018 is specifically applicable to calibration
laboratories in all companies and industries. It implies that ISO 9001:2016 requirements are
generic to be applicable to a given industry where as ISO 17025:2018 are exact on what should
be implemented. ISO 19001: 2016 provides processes and resources requirement that are
general while ISO 17025:2018 lists the resources need and all the processes must be performed
in a calibration laboratory (Infostore.saiglobal.com., 2019).
There are some clauses of ISO 17025: 2018 that are similar to ISO 19001 requirements.
For instance clause on management system requirement of ISO 17025: 2018. The ISO
17025:2018 standard specifies that QMS is vital for a calibration laboratory to function properly
and then offer to options on what is required (option A and B). Option B, categorically states
that having QMS that conforms to ISO 19001:2016 requirements, then one has everything that is

Lab Management and Quality Assurance 3
needed. For those who have not implemented ISO 19001:2016, it provides a minimum set of
QMS requirements that are required and are specified in option A.
The minimum requirement for ISO 17025:2016 are quite the same as the requirements of ISO
17025:2018 and include Internal audits, records control, corrective actions, opportunities and
risks handling, management reviews, and improvement among many others.
Things not found in ISO 17025:2018 minimum requirement QMS but are found in ISO
19001: 2016 include
 Organization context: ISO 17025:2017 omits clauses on the identification of company
internal issues on creating a QMS scope.
 Leadership: ISO 17025:2017 fails to include leadership commitment lists with the
quality policy.
 Quality objectives: This standard fails to incorporate key QMS goals, which are only
available in ISO 9001:2015.
Question 2
a. Calibration of a pH meter: SOP Requirement based on ISO 17025:2017 and ISO 9001:2015
1.1 prior to the commencement of the calibration process, ensure to select the correct mode of
measurement
1.2 Thoroughly wash the electrode with a rinse solution or de-ionized water. Wiping of the
electrode is prohibited as this often results in the backlog of electrostatic charge on the
surface of the glass.
1.3 The instrument must be calibrated before each use.

Lab Management and Quality Assurance 4
1.4 The buffers temperature must be maintained at 24 ℃ ± 1℃.
1.5 Carry out five-point calibration using standard buffers of 1.65, 5.00, 7.00, 10.00, and 13
1.6 Dip the bottom (1.5) of the electrode into the calibration buffer. Gently stir the electrode to
form a mixture that is homogeneous
1.7 Press calibration key. The calibration indicated will be displayed. The measured reading will
be indicated in the primary display while the reading of pH standard buffer solution would
be indicated by the secondary display
1.8 Wait until the pH value measured stabilizes
1.9 Press enter button to confirm calibration.
1.10 Rinse the electrode first with de-ionized water, then rinsed it with the next buffer
solution, before dipping the electrode into that next buffer solution.
1.11 Follow steps 1.6-1.10 for additional calibration points
1.12 After all the calibration sets of points, unit configuration structure are completed the
meter will automatically return to measurement mode
1.13 The calibration buffer should be changed on a weekly basis as necessary.
pH testing for water
1.1 Rinse the electron with distilled water
1.2 Dip the end of the electrode (1.5) into the water sample and use a magnetic stirrer to stir.
1.3 Take the reading once the digits do not change and are stable, at least 10 seconds before recorded
the value.
1.4 Rinse the electrode with distilled water until you remove all the residue
1.5 Repeat the procedure for various samples of water.

Lab Management and Quality Assurance 5
Question 2 part b
Calibration sheet
Date Temp °C Electrode serial no. Calibration solution
pH 1.5 pH 5 pH 7 pH10 pH 13
Solution test
Solution/ buffer pH reading Signature

Lab Management and Quality Assurance 6
Question 3
LABORATORY MANAGEMENT AND QUALITY ASSURANCE
New Standard Operating Procedure for Calibration of pH meter & pH testing of a prepared sample
SOP Number: EQ-02-05
Date Revised 2-06-2019

Lab Management and Quality Assurance 7

Lab Management and Quality Assurance 8
SOP No. EQ-02-05
Date Revised 02-06-2019
Title Calibration of pH meters and Testing of Materials
Scope This protocol explains the technique for five-point calibration of pH
meters and testing samples using pH meters in the laboratory.
Application pH meters are employed to establish the pH of various sample including
reagents and substances/ media used in the laboratory. The pH of
reagents and media is a key attribute of such a solution for the standard
performance of reagents and media.
.
Approval Date
SOP Developer:
Print Name
SOP Reviewer: Print Name
Quality Assurance Unit:
Print Name
Branch Chief:
Print Name
Issue date
Controlled Copy Number
Withdrawal Date

Lab Management and Quality Assurance 9
Calibration
of pH meter
1.1 prior to the commencement of the calibration process, ensure to select
the correct mode of measurement
1.2 Thoroughly wash the electrode with a rinse solution or de-ionized
water. Wiping of the electrode is prohibited as this often results in the
backlog of electrostatic charge on the surface of the glass.
1.3 The instrument must be calibrated before each use.
1.4 The buffers temperature must be maintained at 24 ℃ ± 1℃.
1.5 Carry out five-point calibration using standard buffers of 1.65, 5.00,
7.00, 10.00, and 13
1.6 . Dip the bottom (1.5) of the electrode into the calibration buffer.
Gently stir the electrode to form a mixture that is homogeneous
1.7 Press calibration key. The calibration indicated will be displayed. The
measured reading will be indicated in the primary display while the
reading of pH standard buffer solution would be indicated by the
secondary display
1.8 Wait until the pH value measured stabilizes
1.9 Press enter button to confirm calibration.
1.10 Rinse the electrode first with de-ionized water, then rinsed it with
the next buffer solution, before dipping the electrode into that next
buffer solution.
1.11 Follow steps 1.6-1.10 for additional calibration points
1.12 After all the calibration sets of points, unit configuration structure
are completed the meter will automatically return to measurement
mode
1.13 The calibration buffer should be changed on a weekly basis as
necessary.
Question 2
Testing
method
(water)
1.1 Rinse the electron with distilled water
1.2 Dip the end of the electrode (1.5) into the water sample and use a magnetic
stirrer to stir.
1.3 Take the reading once the digits do not change and are stable, at least 10
seconds before recorded the value.
1.4 Rinse the electrode with distilled water until you remove all the residue
1.5 Repeat the procedure for various samples of water.

Lab Management and Quality Assurance 10
Question 4
Date Duration Action venue Objective
Morning 1hr Introducing
employees to
new pH
calibration
SOP
Facility
workshop
hall
Make
employees
fully
understand
the new
SOP on pH
calibration
Afternoon 1 hr Question and
interaction
session.
Further
clarification
on the SOP
and ensuring
all employee
master and
understand
the new
procedure
Facility
workshop
hall
Make
employees
fully
understand
the new
SOP on pH
calibration
Morning 1 hr Introduction
to the new pH
test method
for samples
Facility
workshop
hall
Make
employees
fully
understand
the new
testing
methods
using pH
meter
Afternoon 1 hr Further
question
Facility
workshop
hall
Morning 3hr Experimental
session
Lab Gain hand
on
experience
Afternoon 3hr Experimental
session on
testing
Lab Gain hand
on
experience

Lab Management and Quality Assurance 11
Question 5
What NATA provides
The National Association of Testing Authorities (NATA) is a body in Australia task with
accreditation work (Nata.com.au., 2019a). Its roles is to serve both public and national interest
by making sure that companies conform to relevant Australian and global standards thus are
competent to consistently provide reliable calibration, testing, inspection data, and measurement
to industry, government and the community (Nata.com.au., 2019a).
Processes of achieving accreditation ((Nata.com.au., 2019b).
1. Preliminary stage: familiarizing yourself with accreditation criteria of NATA
2. Application for Accreditation
3. Nominating an individual as an authorized representative in the process
4. Advisory visit: a NATA lead assessor to examine the system key non-technical elements
as well as establish notable gaps associated with the accreditation requirements
5. Assessment
6. Granting accreditation
7. Accreditation scope
8. Variations to accreditation scope
9. Continuing accreditation
10. Proficiency testing
11. Confidentiality
Benefits of NATA accreditation
NATA offers an independent review of your lab and provides comprehensive feedback
based on the latest balances and checks on the reliability and competence of your system

Lab Management and Quality Assurance 12
calibration, testing and inspection services. This would help to improve on and fill the gaps
identified. The accreditation also makes your business more authentic and boosts the level of
trusts from customers and stakeholders (Nata.com.au., 2018).
Information to be included in the endorsed report
It should include information stated in relevant global standards against in which the
facility is accredited such as ISO/IEC 17020 for inspection, ISO 17034 for reference material
producers, ISO/IEC 17043 for proficiency testing scheme providers, ISO 15189 for human
pathology facilities, and ISO/IEC 17025 for testing and calibration activities (Nata.com.au.,
2018).
Information not to be included in the endorsed report
Activities outside the scope of NATA cannot be included in the endorsed report
Question 6
Support programs needed in the HACCP program (Foodsafety.com.au., 2019).
 cleaning and sanitation program
 .Pest control: Food pests are insects and rodents (both crawling and flying) that
contaminate food contact surfaces, or food. It is required that every food-processing firm
must have an effective and up to the standard pest control program.
 Recall program: all food processing industries must have a recall program in Australia
 Training: all employees working in food processing firms are required to have in-depth
training on food safety and hygiene. Food handlers should be knowledge and skillful on
safe methods of handling food.
 Facilities construction and maintenance:

Lab Management and Quality Assurance 13
 Personal hygiene
 Equipment— documentation of calibration and maintenance programs (HACCP
Australia, 2019;
 Chemicals control—a documented procedure available to guarantee proper storage and
use of all chemicals in the factory, particularly any non-food chemicals linked to
sanitation, cleaning (Foodsafety.com.au, 2019a).
 Supplier control
 Specifications for packaging and ingredients materials (22000-tools.com., 2019)
b. Cleaning and sanitation program policy
Why this policy is important
A key step in preventing and making food safe from physical, chemical and biological
hazards during production processes that can result in finished products being unfit for human
productions is cleaning and sanitizing equipment, surfaces, and environment where food is being
processed (Quality Assurance & Food Safety, 2019; Troller, 2014).
1. Disinfecting/Sanitizing: removing any dirt as well as applying a sanitizer solution to
reduce pollutants and germs that can contaminate the processed food. Use a standard and
proven sanitizer for disinfecting surfaces and equipment.
2. The places to be cleaned and sanitized in the processing plant including but not limited to
the following:
 Food contact surfaces
 Conveyors
 Packaging materials
 Utensils

Lab Management and Quality Assurance 14
 Equipment surfaces
 Outside of equipment
 Tables and preparation areas
 Floors
 Walls
 Light fixtures
 Drains
 Bins and totes
 Light fixtures
3. Employees must wash and disinfect their hands and legs when entering the processing
room and before handling any food
4. The four major steps that should be followed in cleaning washing are:
 Pre-rinse
 Rinse
 Post rinse
 Sanitize

Lab Management and Quality Assurance 15
References
22000-tools.com. (2019). HACCP? The 7 Principles of HACCP Explained. [online] Available at:
https://www.22000-tools.com/what-is-haccp.html [Accessed 2 Jun. 2019].
Asq.org. (2019). ISO 9001:2015 - What is the 9001:2015 Standard? | ASQ. [online] Available at:
https://asq.org/quality-resources/iso-9001 [Accessed 2 Jun. 2019].
Foodsafety.com.au. (2019). Everything You Need To Know About HACCP. [online] Available at:
https://www.foodsafety.com.au/resources/articles/everything-you-need-to-know-about-
haccp [Accessed 2 Jun. 2019].
Foodsafety.com.au. (2019a). The Seven Principles of HACCP. [online] Available at:
https://www.foodsafety.com.au/blog/the-seven-principles-of-haccp [Accessed 2 Jun.
2019].
HACCP Australia (2019). HACCP Australia Services. [online] HACCP Australia. Available at:
https://haccp.com.au/ [Accessed 2 Jun. 2019].
Infostore.saiglobal.com. (2019). General requirements for the competence of testing and
calibration laboratories. [online] Available at:
https://infostore.saiglobal.com/preview/310698125066.pdf?
sku=99068_saig_as_as_208312 [Accessed 2 Jun. 2019].
Kelechava, B. (2019). Changes to ISO/IEC 17025:2017, Testing and Calibration Laboratories
Standard - ANSI Blog. [online] The ANSI Blog. Available at:
https://blog.ansi.org/2017/12/changes-to-isoiec-170252017/ [Accessed 2 Jun. 2019].
Nata.com.au. (2018). NATA - Reports issued by NATA-accredited facilities. [online] Available
at: https://www.nata.com.au/publications/204-reports-issued-by-nata-accredited-facilities
[Accessed 2 Jun. 2019].

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Nata.com.au. (2019a). NATA - Our Role. [online] Available at: https://www.nata.com.au/about-
nata/our-role [Accessed 2 Jun. 2019].
Nata.com.au. (2019b). NATA - How to become Accredited. [online] Available at:
https://www.nata.com.au/accreditation-information/how-to-become-accredited [Accessed
2 Jun. 2019].
Quality Assurance & Food Safety. (2019). The Importance of Sanitation. [online] Available at:
https://www.qualityassurancemag.com/article/aib0614-plant-sanitation-program/
[Accessed 2 Jun. 2019].
Shop.standards.govt.nz. (2016). AS/NZS ISO 9001:2016. [online] Available at:
https://shop.standards.govt.nz/catalog/9001:2016(AS%7CNZS%20ISO)/scope [Accessed
1 Jun. 2019].
Tranchard, S. (2019). New edition of ISO/IEC 17025 just published. [online] ISO. Available at:
https://www.iso.org/news/ref2250.html [Accessed 2 Jun. 2019].
Troller, J. (2014). Sanitation in Food Processing. Saint Louis: Elsevier Science.