Facility risk assessments have an enormous potential to improve the safety of a laboratory facility by recognising and eliminating potential problems at the design stage. An acceptable risk profile can only be achieved by identifying hazards, assessing the associated risks and control measures, together with any actions required to reduce the residual risk to tolerable levels. Obtaining an acceptable risk profile will be achieved by defining controls and taking associated actions.

Purpose

The design of any biological containment facility is complex, given the potential risks associated with constructing and operating these facilities. Addressing these risks and ensuring that the laboratory facility has been designed in accordance with internationally recognised good practice is greatly supported by conducting a facility risk assessment.

Facility risk assessments can be carried out at different times in a facility's life, from the early concept and design stage to key change points in its operating life, or even prior to de-commissioning. DNV has developed facility risk assessment tools by considering the biorisks in a high containment environment and are recognised as industry leaders in this field.

The objectives of a risk assessment are to:
• Review the design around a structured methodology
• Identify the failure modes and associated risks
• Check if the proposed control measures are adequate
• Identify recommendations to obtain a more acceptable risk level if required.

Benefits

Facility risk assessment allows and ensures:
• A structured and comprehensive review of high containment facility design
• Identification of the risks associated with the laboratory facility and how best to address them
• Follow up to ensure all identified risks are addressed with appropriate actions
• Minimizing risks of rework and extra costs during construction
• An independent, open and transparent process demonstrating a responsible and structured approach to risk management in high containment facility

Features

Risk assessments are normally planned around a series of workshops where a range of expertise is brought together to identify and assess the risks. A number of recognised approaches can be used and this includes:

1. SWIFT (Structured What If Technique)
A SWIFT method examines the potential failure scenarios based a around a series of What If questions. This method can be more readily applied at an earlier stage in the design or where protocols also need to be considered.

2. HAZOP (Hazard and Operability Study)
The detailed HAZOP technique will consider process deviations (no flow, more flow, contamination, cleaning, etc.) for different nodes (kill tank, filter, etc.).

3. AR&M (Availability, Reliability and Maintainability) ARM studies are used to predict system availability (potential downtime) and to identify ways to improve reliability by considering both equipment failures and maintenance requirements. AR&M study complements a HAZOP.

4. SIL (Safety Integrity Level) method can be applied at any stage of the design lifecycle and provides a practical way of demonstrating risk acceptability, including compliance with legislative requirements.

DNV provides a leader and recorder for the workshops, together with the associated software tools, checklists, risk criteria and other supporting information.

The output is transferred to a risk register for ongoing risk management activities (DNV tool - EasyRisk Manager). This will allow followed up by a DNV risk manager to ensure all actions identified are closed out in line with the project schedule.

The resulting report identifies potential undesired events and the agreed controls and further actions required for a successful outcome.

Facility risk assessment can be included as part of commissioning activities and will ensure all integrated systems, systems, components to test will be identified during the conduct of facility risk assessment.