Each department will have its own set of quality standards and operating requirements, and it’s important to secure the Department Director’s commitment to assign department-level system owners to oversee both the initial implementation and the on-going support of the system. The primary goal of the system owners is to ensure the system is initially set up to meet the unique quality standards and operating needs of the department. Thereafter, properly managing the system is key to the overall success of the project. Key success factors include:
- System Owners – Ideally, each department should have at least two primary system owners who have administrator account privileges and who are responsible for the initial system setup. It would be ideal if this same team is also responsible for the on-going management and maintenance of the system after initial setup, but it is not a requirement so long as a smooth transition is effected. It is best to have at least two department-level system owners so that there is a backup in the event the other administrator is not available. Larger organizations may need to assign sub-department level administrators.
- Management of Initial System Setup – The full commitment and participation of each system owner for the entire duration of the initial system setup is vital. For very large or multi-phase projects, engaging a third system owner to ensure there is continuity from start-to-finish may be advisable.
- On-Going Department-Level System Management – After system Go-Live, properly maintaining the Continuous Monitoring (CM) system at the deparment level is necessary in order to ensure a properly functioning system. CM systems are not “install-and-forget,” as neglecting the system for even a short period of time can potentially result in issues. Good management practices should include regular:
- Supervisorial / management review of reports, audit logs, and corrective action history to ensure compliance with quality assurance and regulatory requirements.
- Alarm checks to ensure system is in good working order and recipients receive alarm notifications with the expected timing and sequence.
- Preventive Maintenance –
- Inspect hardware to ensure equipment is properly installed.
- Check battery voltage levels and replace as needed.
- Replace damaged components.
- Software updates.
- Annual probe calibrations to a NIST-traceable standard.
- Review and update (as applicable) of the Standard Operating Procedure.
- Staff education and training.
- Continuous Measurable Improvement of key metrics to minimize –
- Number of overall system alarms.
- Number of open (have not been resolved) alarms that require follow up and corrective action documentation.
- Time to respond to an alarm notification.
(written in collaboration with Roy Chien, Senior Director of Product Management, Continuous Monitoring)
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