There is no such thing as “One Size Fits All” when it comes to implementing a Continuous Monitoring (CM) system. Each department within an organization will have its own unique set of needs and requirements. Having each department follow exactly the same set of specifications and/or standard operating procedures will likely not be an optimal process. It is important to clearly define and understand the unique set of needs for each department, beginning with the following:
- Min/Max & Delay Thresholds – The normal operating range for each appliance or monitored location will depend on the specific stored products and assets. The product manufacturer is the best source of information for the range of temperatures the storage appliance should be maintained at. As an example, many vaccines should be stored between 2°C and 8°C and cannot be outside of these limits for more than a one hour period. Each product will have its own set of requirements, and the min/max set points and time delay parameters used to configure the alarm paratmers in the system software should come from the product manufacturer.
- Alarm Notification Protocol – Should an appliance go out of range, corrective action must be taken so that the product is not damaged, or lost altogether. The Notification Protocol is the list of staff members, and the sequence and manner in which they will be notified (local alarm, e-mail, text message, phone call, etc.) of an alarm condition.
- Responding to Alerts – The specific action(s) that must be taken in response to receiving a notification is the Alert Response protocol. The steps should be defined in a Standard Operating Procedure (SOP), and each staff member should follow the approved steps to address the issue (dismiss the alarm, investigate the root cause of the issue, document the corrective action, electronically sign off the documentation, etc.).
- Standard Policies & Practices – Each department should publish an approved Standard Poicies & Practices document, which defines the department policies, standards, practices, and norms applicable to the department. The need to meet regulatory, quality assurance, safety, and operating metrics is the basis for establishing these policies.
- Managerial Review & Approval Process – A regular review and approval process must be established. This is the set of reviews and approvals by management that is designed to ensure the staff is following the established SOP.
- System Maintenance & Alarm Checks – To ensure the system is in good working order, follow the manufacturer’s recommended protocol for preventive maintenance and alarm checks. Select users often supplement these manufacturer’s guidelines with customized alarm and system checks in accordance with the department’s quality assurance policies.
(written in collaboration with Roy Chien, Senior Director of Product Management, Continuous Monitoring)
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