Quality Assurance and Quality Control
in the Management and Operation of a
BSL-3 Laboratory
Dr. John Copps CFIA
Why Me ?
John Copps DVM DVSc
1. 10 years experience in a
functioning BSL-3 and BSL-4
Laboratories
2. Laboratory ISO/IEC 17025
accredited since 2002
3. Deputy Director of the
National Centre for Foreign
Animal Disease
4. Reviewer for the Regional
Biological Containment
Laboratories of the USA
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Theory of Quality
Quality Assurance (QA)
is defined as part of quality management focused
on providing confidence that quality requirements
will be fulfilled.
http://www.aoac.org/terms.html
(ISO 9000:2000 3.2.11)
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Theory of Quality
Quality Control (QC)
is defined as part of quality management on fulfilling
quality requirements
http://www.aoac.org/terms.html
(ISO 9000:2000 3.2.10)
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Total Quality Management (TQM)
Total Quality Management
is defined as a management approach that tries to
achieve and sustain long-term organizational
success by encouraging employee feedback and
participation, satisfying customer needs
and expectations, respecting societal values and
beliefs, and obeying governmental statutes and
regulations.
The best form of TQM applies QA and QC in the
process of making quality outputs
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Objectives of a BSL-3 Facility with regard
to QA and QC
Objectives of a BSL-3 Facility are:
1. A Quality Output (diagnostic,
report, data)
2. Protection of the Public, Staff, and
Environment
3. Maximize Efficiency
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Why Are These Objectives Important
1. To allay fears that the general public and
regulators have expressed due to recent accidents
within the bio-containment community. QA/QC can
be an assurance communication tool.
2. Training in basic biological safety deemed
essential in BSL-3 and BSL-4 laboratories. Eg.
WHMIS, Biological Safety, Training recorded and
verified can be based on QA/QC.
3. New requirements which advocate for a thorough
understanding of “exposure” and creating medical
management on and off site. QA/QC will aid in
standardizing responses.
4. The facility management, the public and regulators
insist on security measures which protect people
and the assets of a facility. QA/QC processes will
provide reassure the public.
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An Example of Why QA/QC is Relevant to work
with Exotic Agents such as Avian Influenza.
PROJECT:
XYZ Laboratory has contacted your BSL-3 LAB called
NCFAD (ISO/IEC 17025 Accredited):
To develop a PCR Test for
1. Matrix protein
Within 1 year March 2008-2009
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Project Management and QA/QC
Requirements of our QA/QC system
SOPs and Policies:
(Assuming all negotiations and legal signed off)
1.
All projects in the Lab have a “Project Profile”
2.
A signed internal document for a statement of work
3.
The purpose of the project profile is to
1.
Outline the scope of work - outputs
2.
Identify the collaborators, units and personnel which are asked for a
product
3.
Identify the funding requirements for each phase
4.
Identify the project leader
5.
Identify the timelines
6.
Identify the “Go + NO GO” critical points in the project
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Project Management and QA/QC
Import or Export Permits Required for
Avian Influenza
SOPs are written to outline the procedures of
1. Who has to authorize the permit, and who will
use the permit
2. What quantity you will be using, what will be
stored and where
3. When will the project will be run
4. Where to apply and where you will use the AIV,
Where is the project going to be run
5. Why you want to use the AIV.
6. How to fill out the permit
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Project Management and QA/QC
Virus Storage and Inventory
1. Policy on who can access the Avian Influenza
2. SOP covering entry of the virus into an inventory
system
3. SOP covering how the virus is stored including
emergency procedures for freezer breakdown
4. SOP on how a virus is removed
5. SOP on reporting of entire virus stock
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Project Management and QA/QC
Staff Working on the Avian Influenza Project
1. Policies and SOPs for BSL-3 medical and security
2. SOPs policies on safety training to enter BSL-3
3. SOPs on access, entry and exit procedures
4. SOPs on emergency evacuation (fire, air flow,
threats)
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Project Management and QA/QC
Staff Working on the Avian Influenza Project
SOPs and Policies indicate:
1.
How a person is considered competent to
do the work. (combination of credentials and
onsite training)
2.
Laboratory Notebook SOP – (The Data
which is essential to the validation of the
Test Methods)
3.
Quality of reagents and supplies
(purchasing, storing, thawing)
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Project Management and QA/QC
Animal Work to supply known positive samples fro PRC
1. SOPs/Policies for animal acquisition
2.
3.
4.
5.
through an Animal Care Committee
SOPs for animal procedures (eg.
inoculation, blood, swabs and tissue
sampling)
SOPs for removal of samples to the
laboratory for analysis
SOPs for animal records and clinical signs
SOPs and policies acceptable for
Governing Bodies (CCAC, AALAC, NIH,
PHAC, CFIA)
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Project Management and QA/QC
Data
1. SOPs/Policies for reports and report content
stipulated in the Project Profile
2. SOPs of Data storage short term (who has access)
3. SOPs on data Archiving (for how long, in what
form)
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Project Management and QA/QC
Under a QA/QC systems:
Equipment
1. Maintained according to SOPs generated
from manuals
2. SOPs -Records of daily monitoring (eg
temperature of the fridge)
3. PCR – SOP for operation and maintenance
of light cycler (eg cut off points; # of cycles)
4. SOPs - Availability of a equipment (“In
service – Out of service”)
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Project Management and QA/QC
During the Study
AUDITS !
The purpose of audits are to insure ongoing quality for
all aspects of the project from start to completion,
and to ensure the quality and reliability of the output
data after the project.
Internal Audits
Internal Audits by trained employees will ensure the
QA/QC Day to Day operations are performed to
laboratory SOPs and Policies. “Continuous
Improvement”
External Audits
External Audits ensure the entire facility is operating to
a standard. Accreditation.
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Project Management and QA/QC
Behind the Scenes
Facilities
1. Monitoring of Temperature, Humidity, Air Pressure
throughout the entire experiment.
2. Reporting according to SOPs of Temperature,
Humidity, Pressure throughout the entire
experiment and recording of parameters outside
set points.
3. SOPs/ Policies on maintaining the building
infrastructure (eg. Life Cycles, Crack and
Penetration procedures)
4. SOPs and Polices for Emergency Repairs within
containment or on systems affecting contained
areas during the project.
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Project Management and QA/QC
Behind the Scenes
Facilities (Hidden Policies and SOPs)
Facilities may run under different format of ISO
Certification/Accreditation (Eg. ISO 9000)
1.
SOPs for HVAC system of cleaning, checking, replacement
(HEPA filters, Belts, Fan motors)
2.
How will these procedures affect Program operation.
SOP/Policies on work orders
3.
SOPs for Waste Removal
1.
Building wide standardized procedures, solids, liquids, plastics
2.
Meet all of the federal, provincial (state), and municipal laws
3.
Acceptable to the public
4.
Incineration, autoclaving, chemical treatment, gas treatment
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Project Management and QA/QC
Behind the Scenes
Facilities
Security
1. Standardized security clearance policies.
- acceptable to management, public,
regulatory bodies
2. Standardised security “incident” responses
- SOPs understood and practised by all staff
- SOPs/Policies limited access, lock down,
computer access
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QA and QC Role in the Final Output
1. Management is assured of the project’s output and
2.
3.
4.
5.
has been appraised of all issues and problems
Collaborators agree to and understand the quality
of the output
Funding agencies are aware of the quality of the
product
Governing Agencies are aware and understand the
quality and safety of the output
General Public reassured monies spent were for a
quality output in a safe manner
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Project Management and QA/QC
Safety SOPs and Policies
P
R
O
J
E
C
T
Equipment SOP
Facility SOP
Staff SOP
Lab Data
Repeatability &
Reliability
Protocols
Quality Output For
Management/Public
Suppliers
Collaborators
Other agencies
Collaborators
Agencies/Regulators
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BSL-3 Funding of Containment Operations
Canadian Federal Government Experience
1. Not in the business of generating revenue
2. Maintains and operates our laboratory for
3.
4.
5.
6.
Diagnostic and Research within our Scope and
Mandate (test improvement)
Stimulates Collaboration with other National BSL-3
and BSL-4 laboratories world wide
Stimulates Collaboration with Universities and
research centers world wide
Stimulates Collaboration with other agencies within
the Canadian Government
Uses the facility to train veterinarians and
laboratory staff
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Present Sources of Funding
1. Facility Costs
Operations of Facility, Diagnostic Testing, Equipment and
Salary Overhead
Canadian Government
2. Research and Collaborations
Supplies, Project Staff, Consumables, Equipment
Stand Alone Grants, Collaborative Grants, In Kind, Fee for
Service
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