University of Toronto Office of Environmental Health and Safety. Technology, Processes, Communication. Biosafety Programs

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1 University of Toronto Office of Environmental Health and Safety Technology, Processes, Communication and the Human Touch in Biosafety Programs Susan Fern-MacDougall Director, Environmental Health and Safety University of Toronto

2 Biosafety Management Integration of biosafety into existing systems Utilizing recognized best practice management systems through process Ensuring buy-in through communication Utilizing Technology Utilizing the Human Touch

3 Integration of Biosafety Existing Management Structure

4 University of Toronto 26,000 employees 70,000 students 1500 laboratories 33 buildings mostly labs 3 campuses

5 University of Toronto Governance Structure

6 University Oversight Committees

7 University Environmental Health and Safety specific Committees Senior Health and Safety Management Committee Institutional Biosafety Committee University Radiation Protection Authority Laser Safety Committee Chemical Safety Committee 56 Joint Health and Safety Committee

8 Buy-In for Biosafety The right people within the University have to know about it The message has to be delivered by the senior most people Processes have to work so that it feels like it is working Must be supported with tools that work and sufficient back-room support

9 Buy-In for Biosafety

10 Overlapping Best Practice Management Systems onto University Processes Needs the credibility of something established (homemade could be questioned) Utilize known multi-functional full cradle to grave system Utilize known management systems to Integrate the biosafety program into other University processes

11 Processes Utilize ISO 9000/14000/18000 concepts Standards are available Translatable to any process Building sustainability and something that could be auditable ISO 9000 family The ISO 9000 family addresses "Quality management". This means what the organization does to fulfil: the customer's quality requirements, and applicable regulatory requirements, while aiming to enhance customer satisfaction, and achieve continual improvement of its performance in pursuit of these objectives

12 ISO Standards Table IV-2 Element of Biosafety Program Formal lab inspections Biosafety permits Biomedical surveillance Training Import of Biologicals Import of Toxins Animal biosafety Activity based on new regulations x x New program development x x x Required maintenance of established programs x x Key processes Key Performance indicators Documentation of procedures Senior Level buy-in Mechanism for customer satisfaction Continuous Improvement

13 Processes Performance Indicator Biosafety certificate application processed Lab Inspections (CL 1 labs once CL2 labs twice CL2+ three times and CL3 four times a year) Determine key processes (should be fewer than 10) Biosafety Orientation Sessions Participants trained in biosafety Participants trained in blood borne pathogens Participants trained in Transportation of Dangerous Goods for Biologicals Import Permits 3 19 New Regulation Stakeholder Sessions with University of Toronto Stakeholders 3 2 Develop teams to develop workflow of key processes Establish buy-in for processes that must change

14 Documenting Processes

15 Developing Key Processes Step by step documentation with diverse group included in developing Establish benchmarks or markers which will provide year/year changes with the program Procedure for identification of risk and recommendation of controls

16 Capturing Incoming Research into our Risk Assessment & Permit System

17 Communication Content of program Delivery of content

18 Communicating Content Is it intended to train? Is it a procedure that must be followed daily? Is it an overview to describe? Is it intended to stir to action? Is it intended to inform of a specific? Why are you telling the story? What should they do with the information Who are the stakeholders?

19 Communicating the Content Processes and KPIs need buy-in across organization Internal and external Stakeholder groups must be identified/formed Key Senior level people identified

20 Internal and External Audit

21 Delivering the Communication Strategize the delivery: who takes the messages, what will be delivered, when and where Senior Administration: Annual report Biosafety Officer and staff: grass roots advocacy; training; inspections Other Advocates: JHSC s Training: in class vs. online Electronc: website General: Printed signs Stakeholders: integrated business meetings

22 Technology Website Link between biosafety department and labs

23 Website

24 Human Touch Sustain the Program Make the program live Stages of a Program as felt by lab workers Dependent Independent Interdependent Observations systems; Reporting incidents and follow up

25 Human Touch Integration of Processes into the University Institutional Biosafety Committee Biosafety Officer Reporting of program progress to the organization: (senior committees, business board, internal departments)

26 Integrated Approach Systems Technology Communication Human Touch will prevent.

27 Unanticipated Lab Accidents

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