About EBSA21 - Course H - The User Requirement Specification (URS): How to start it right, keep it ship-shape not pear-shaped, and arrive at a happy ending

Course description
The course is aimed at biosafety people and others desiring to create User Requirement Specifications (URSs) which optimize the ability to create successful outcomes.
It is proposed that the course will include significant participant interaction. The instructors will prepare and use an appropriate mixture of case studies and realistic scenarios to improve the understanding of participants by direct involvement and feedback.
The instructors intend to prepare a short questionnaire prior to the course date. Registered participants will be invited to provide responses approximately 2 weeks prior to the course date. The answers to this questionnaire will be used to focus the course on areas that participants see as important.
Target audience

1. Biosafety professionals
2. Regulatory and compliance officers
3. Institutional facilities and services people involved with construction and remodeling of biological laboratories and facilities
4. Design and construction professionals seeking to improve knowledge related to biosafety/biocontainment/biosecurity aspects of laboratories and containment facilities.
5. Users with requirements which need specifying

Learning objectives

1. Understand what a URS is and what it is not
2. Understand the appropriate roles of biosafety professionals, facilities officers, designers and builders in the preparation, interpretation and realization of the URS- understand the evolution of the process
3. Understand different building design and construction “models” and how these affect the nature and timing of the URS
4. Look at how to prepare a good URS and how to avoid preparing a bad one
5. Understand how to manage change such that “value management” is not used solely to reduce cost

Main topics

1. The URS
   What it is, what it is for, when it should be prepared Who should participate and their roles How it should be managed; evolution & change control
2. Different building procurement strategies– how this can affect the URS
   Why different procurement strategies can affect the URS Effect on function, suitability, safety, security and compliance When equipment should be selected and how it should be procured How to ensure changes only occur with due consideration of consequences
3. URS Finalization and Delivery
   Confirmation that the URS has been delivered appropriately Who should support and confirm this process

Citation of the respective sections of CWA 16335:2011 Biosafety professional competence
C.2.1.2.7 Facility design, construction, commissioning, decommissioning, validation, operation and maintenance
Objectives: The participant should be able to, understand the construction commissioning and validation processes and have knowledge of basic design features of the most important types of facilities. The participant should be able to consider the biosafety and biosecurity issues in preventive and corrective maintenance, operations and decommissioning.