Quality Assurance and Quality ControlQuality Assurance and Quality Controlin the Management and Operation of a in the Management and Operation of a

BSL-3 LaboratoryBSL-3 Laboratory

Dr. John Copps CFIADr. John Copps CFIA

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Why Me ?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 QualityTheory 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 QualityTheory 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 Important1. 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/QCRequirements 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 InfluenzaSOPs are written to outline the procedures of1. Who has to authorize the permit, and who

will use the permit2. What quantity you will be using, what will

be stored and where3. When will the project will be run4. Where to apply and where you will use the

AIV, Where is the project going to be run5. 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 Inventory1. Policy on who can access the Avian

Influenza2. SOP covering entry of the virus into an

inventory system3. SOP covering how the virus is stored

including emergency procedures for freezer breakdown

4. SOP on how a virus is removed5. 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 procedures4. 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 through an Animal Care Committee

2. SOPs for animal procedures (eg. inoculation, blood, swabs and tissue sampling)

3. SOPs for removal of samples to the laboratory for analysis

4. SOPs for animal records and clinical signs5. 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 Profile2. 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/QCDuring the StudyAUDITS !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 AuditsInternal Audits by trained employees will

ensure the QA/QC Day to Day operations are performed to

laboratory SOPs and Policies. “Continuous Improvement”

External AuditsExternal Audits ensure the entire facility is

operating to a standard. Accreditation.

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Project Management and QA/QC Behind the ScenesFacilities

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 ScenesFacilities (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 ScenesFacilitiesSecurity1. 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 has been appraised of all issues and problems

2. Collaborators agree to and understand the quality of the output

3. Funding agencies are aware of the quality of the product

4. Governing Agencies are aware and understand the quality and safety of the output

5. General Public reassured monies spent were for a quality output in a safe manner

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Project Management and QA/QC

PROJECT

Suppliers

Collaborators

Other agencies

Facility SOP

Protocols

Staff SOP

Equipment SOP

Safety SOPs and Policies

Lab Data Repeatability &

Reliability

Quality Output For

Management/Public

Collaborators

Agencies/Regulators

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BSL-3 Funding of Containment OperationsCanadian Federal Government Experience1. Not in the business of generating revenue2. Maintains and operates our laboratory for

Diagnostic and Research within our Scope and Mandate (test improvement)

3. Stimulates Collaboration with other National BSL-3 and BSL-4 laboratories world wide

4. Stimulates Collaboration with Universities and research centers world wide

5. Stimulates Collaboration with other agencies within the Canadian Government

6. Uses the facility to train veterinarians and laboratory staff

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Present Sources of Funding

1. Facility CostsOperations of Facility, Diagnostic Testing,

Equipment and Salary Overhead

Canadian Government

2. Research and CollaborationsSupplies, Project Staff, Consumables, Equipment

Stand Alone Grants, Collaborative Grants, In Kind, Fee for Service