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Continuous Monitoring

Mesa Laboratories, Inc.12100 W. 6th AvenueLakewood, CO 80228 USA

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monitoring.mesalabs.com

Rev. 2.11.2016

If the installation and implementation of a Continuous Monitoring System (CMS) is on your project radar, then there is a lot of work to be completed. Although the project may initially appear to be simple and straight-forward, it can rapidly become quite complex and require more time and resources than originally anticipated. Below are the 12 Keys to Successfully Implementing a CMS to help guide you through this project:

Keys to Successfully Implementing A Temperature Monitoring System

Key Success Factor Notes and Comments

Assemble a Dedicated Project Management Team

This team will follow the project through from project kick-off to the system go-live.

Compile a Complete Equipment List by Department

Location (Building / Room #), Appliance Type (Refrigerator, Freezer, Incubator, Etc.), Min/Max Limits, Time Delay(s)

Understand the Unique Needs of Each Key Stakeholder

Each group and/or department involved with the project may have its own set of compliance, quality, Standard Operating Procedures (SOPs) and/or operating requirements that need to be addressed.

Secure Commitment from Each Department Director

Ideally, you will want each department to assign at least 2 primary system owners. They will be responsible for managing and maintaining their department system. This includes, but is not limited to, providing resources and committing to the success of the project.

Annotated Floor Plans For the design of the system, it is important to know the locations of all the appliances and/or points that the system will be monitoring.

Select the Right Continuous Monitoring Vendor

You want to ensure that the vendor has an established track record and experience, and that they offer a modular and scalable system to meet your needs, assistance managing the project design and implementation, and on-going support services post-installation.

Post-Installation Transition Period This will include the transition from Legacy to the new CM system and system go-live, dry run, staff training, and the adoption of SOPs.

On-Going System Support and Help Desk

You will want to make sure you know how to contact the vendor’s Help Desk for support, and that there is a clear expectation for their response time.

Annual Probe Calibrations and System Maintenance

Each probe should be calibrated at least once per year to an ISO 17025 or NIST-Traceable standard.

Regular Alarm Checks and Preventive Maintenance

Having scheduled system alarm checks and maintenance are vital to ensuring a reliable system in order to safeguard all assets.

Disaster and Emergency Recovery Plan

You will want to establish SOPs for recovery following any system outage.

Maintain On-Site Spare and Emergency Parts

For efficiency with emergency repairs and installation needs, you should maintain spare parts on hand.



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One of the most important factors to successfully implementing a Continuous Monitoring System (CMS) is to assemble a dedicated project management team that can stay together for the entire duration of the project. Ideally, the core team should participate from initial kick-off all the way through to system Go-Live. The availability of the core team to remain intact for the entire project is crucial to achieving an efficient process and to addressing inherent challenges that could include:

• Long Lead Time – Project Data – It may take a significant amount of time to compile, analyze and understand all of the key data and information (e.g., equipment and asset lists, department-specific monitoring requirements, project resources, etc.) needed for the project.

• Project Complexity – With the number of crucial details (e.g., meeting requirements for regulatory compliance, system configuration, standard operating procedures, staff training, etc.) that must be managed, keeping the team together and on the same page will go a long way to mitigating project risk, staying within budget and delivering on schedule.

• Project Phases– A phased approach is often necessary due to the size and scope of the project and the potential need to spread the project across more than one budget cycle. Seamless teamwork is needed to avoid costly errors and mistakes, which can occur if the project implementation is disjointed.

Projects can often last several months, and more than a year in some cases. Team members need to be available and be an integral part of the entire process from project kick-off to system Go-Live.

First Key: Assemble a Dedicated Project Management Team



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Compiling an accurate and complete Equipment List is a supporting key to a successful project. “Garbage In, Garbage Out” is not just an adage. Investing the time, effort, and resources to accurately and completely capture all vital information will lead to enormous tangible net value.

Each of the following fields taken from Figure 1 – Sample Equipment List is a “Must Have”:

• Equipment Name or Description – If the appliance or point to be monitored has an existing name, then that should be listed. Otherwise, assign a unique name with an agreed-upon naming convention.

• Min/Max Values – Although it may not appear to be, providing accurate min/max values is very important. This information is used to configure system alarm criteria and to select the appropriate application probe. If a second set of min/max parameters apply, they should be included in the Equipment List.

• Building / Dept. / Room # – Compiling all of this information may require significant time and resources, but if the request is made to each department lead, it is often readily available and can be efficiently provided in the requested format. This information is essential in the project management planning process and for setting up the system, grouping sensors and configuring alarm notification protocols.

• Asset ID Tag # - As a best practice, all appliances and points to be monitored should have a unique and permanent Asset ID tag affixed. This label uniquely identifies the asset and optimizes processes across all stages of the project (estimating scope, project planning, installation, system validation, preventive maintenance, alarm checks, and response to alarm notifications). It is amazing how a simple label can be such a critical and vital element of the overall system.

Second Key: Compile a Complete Equipment List by Department

Figure 1 -- Sample Equipment List



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There is no such thing as “One Size Fits All” when it comes to implementing a Continuous Monitoring System (CMS). 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 parameters 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 Policies & 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.

Third Key: Understand the Unique Needs of Each Stakeholder



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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 System (CMS) at the department level is necessary in order to ensure a properly functioning system. CMS 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 (SOP).• 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.

Fourth Key: Secure Commitment from Each Department Director



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Vital to the overall success of the project, a complete set of annotated floor plans for monitored appliances and points is important to have for the design, implementation and validation stages of system implementation. Here are examples of how and when floor plans are utilized:

• System Design – During the design phase of the project, identifying the optimal number and ideal placement of infrastructure devices (Access Points, Repeaters, Connect Panels, Alert Lamps, etc.) is critical to a well-designed system that is functions well and is reliable. The system will often be designed to meet expected operating requirements and also include some redundancy in the event a device fails. The location of each monitored appliance or point is annotated on the sample annotated floor plan in Figure 2. The number inside each circle corresponds to the Sensor # listed in the Equipment List (Figure 3).

Fifth Key: Annotated Floor Plans

Figure 3 -- Sample Completed Equipment List

Figure 2 -- Sample Annotated Floor Plan

• Implementation – Annotated floor plans are invaluable during the implementation phase of the project. Field engineers and technicians use the annotated floor plans as a roadmap to navigate their way through the installation process and ensure the correct sensors are installed on the appliances and points to be monitored. The floor plan is also scanned in and used for the Floor Map view in the application software, allowing users to quickly identify the location of monitored assets and points.

• Validation – Following equipment installation and setup, the system is validated using an IQ/OQ/(PQ) validation protocol. Annotated floor plans are used during protocol execution to verify sensors are correctly installed on the intended appliance or at the desired point. A record of the location of each monitored appliance or point is an important part of a complete validation protocol documentation package, and annotated floor plans are typically incorporated into the final validation protocol package delivered to the customer.



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After assembling a Project Team, compiling the Equipment List and Annotated Floor Plans, the next key step in implementing a Continuous Monitoring System (CMS) is to evaluate candidate vendors and select the one that will best meet your needs. Not all vendors are alike, and each has their own unique set of strengths and weaknesses. Value propositions also differ from vendor to vendor. Here are some key factors and criteria to use during the evaluation process:

• Product Offering – One of the most important criteria is verifying that the vendor’s product offering meets the entire set of requirements. If the vendor’s product offering is limited, or needed products are in the development phase, then this vendor may not be the best fit. Newly introduced products may potentially have “bugs” and product issues, so selecting a vendor with a comprehensive, stable, proven product offering is a good decision to make.

• Direct Experience – The amount of direct experience the vendor has is critical. It could mean the difference between a smoothly implemented system versus facing a seemingly endless stream of issues. Check references, and ensure that the vendors under consideration have a proven and established track record (and are not new entrants with limited real-world “know-how”). Experienced and knowledgeable vendors will have already solved your problems and have templates and procedures in place for optimal solutions. If you hear “let’s give this a try,” this could be a yellow flag. The preferred answer is: “we have a proven solution for this application, and here’s how it works and what you can expect.”

• Services – If the size and complexity of your project is such that a significant amount of implementation services are needed, make sure that your vendor offers these. The value proposition of some vendors is to focus on low-cost product sales only, and services like assisting with Standard Operating Procedure development, Transition Period Support (from legacy system to a new system Go-Live), and on-going Managed Services may not be available, or what you require.

• Local Technical Support – If your organization does not have the staffing levels to manage and maintain the CM system, and local technician services are required to address open issues, perform regular alarm checks, and to complete preventive maintenance and annual calibration protocols, then selecting a vendor with a local presence may be important. Some vendors only offer on-site services by sending service technicians from remote locations, which can become costly in the long run.

• Partner Relationship – Installing and maintaining a CM system is a significant undertaking and it requires a significant investment in resources. It’s important to realize that your vendor needs to be more than a just vendor and be more like a “partner” in providing the solution. A key question to ask is: How would I best characterize the experience with the candidate vendor up to this point? Would they just be a parts/product supplier, or would they truly be invested in and provide us with a valuable service and long-term solution?

Sixth Key: Select the Right Continuous Monitoring Vendor



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Following the installation of your Continuous Monitoring System (CMS) is when the fun really begins! Throughout the project definition and pre-implementation planning stages, system requirements were defined based upon user needs. Now that the system has been installed, end users will need to begin the full process of transitioning from the legacy system to the new system and actually using the new CMS in its production environment. The successful completion of Transition Period is a key and critical component of the overall project’s success. Key points and processes to be aware of include:

• Transition Period – The Post-Installation Transition Period (TP) is defined as the point in time immediately following the installation and validation of the CM system until the system becomes the new system of record, which oftentimes is referred to as the “Go-Live” day or event. Note that both the legacy system and new CM system are run in parallel prior to Go-Live. Refer to Figure 4 for an illustration of where and how the TP fits into the overall project.

Seventh Key: Post-Installation Transition Period

Figure 4 -- Transition Period & Overall Project Implementation Timeline

• Running Systems in Parallel – It is recommended that the legacy and new CMS be run in parallel for a period of time between the completion of initial installation and the actual Go-Live date. This parallel effort does require a significant amount of time and resources to manage, but oftentimes it is necessary because of the need to complete any Supplemental Validation protocols prior to Go-live.

Running two systems in parallel also allows the end users to compare results of the new system against the legacy system. Users may even find significant discrepancies between the two systems, which otherwise may have gone undetected.As an example, some organizations find that the new CMS “lights up like a Christmas tree.” Why? Some organizations may be transitioning from a manual paper log system, with temperatures recorded by hand one or more times a day. With a new CM system, temperatures are measured and recorded much more frequently, and end users may find that appliances may be out of allowable temperature limits many times during the day (e.g., when appliance doors are opened during restocking or inadvertently left open). In this scenario, appliances may need thermostats adjusted, and select appliances may need to be replaced altogether.Some organizations elect not to run two systems in parallel and simply “Go Live” immediately following system installation and hand-off from the vendor. If this option is elected, comprehensive training, planning and coordination must be in place prior to system validation and handoff to the end users.



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• User Training – Perhaps the most important TP activity, ensuring that all staff members who have responsibility for using and managing the new CM system are properly trained and have a good working knowledge of the new system is vital. Modern CM system software is designed with many advanced features and functionality, so learning all the “ins-and-outs” of how the system works will likely require a significant investment in time and resources. Make arrangements with your vendor to provide adequate and comprehensive training, including supplementary on-site training as needed.

• Standard Operating Procedures (SOPs) – After users have been trained on how to use the new CM system, draft SOPs may need to be revised. It is commonplace for users to require additional steps and/or clarifying information in the SOPs. Before a system can Go-Live, all SOPs must be approved and adopted. Once SOPs have been adopted, formal Dry Runs are recommended prior to the Go Live day.

• Supplemental Validation – Some organizations have Quality Assurance (QA) requirements that mandate supplemental validations to be completed following the vendor’s initial system Installation Qualification/Operational Qualification/(Performance Qualification) (IQ/OQ/(PQ)) validation. The purpose and scope of these supplemental tests is to complete additional tests to verify/validate functionality or repeatability (performance) that may not have otherwise been tested as part of the vendor’s standard IQ/OQ/(PQ) protocol.

• System Go-Live! – Go-Live is the day or event when the legacy system is decommissioned and the new CM system is the system or record. If the Transition Period is well-managed, the Go-Live should be rather un-eventful, which means the TP process was a great success!

During the vendor selection process, evaluate your vendor on how well they can / will provide TP support. The following is a list of suggested questions for prospective vendors:

• In preparation for the transition, are there SOP templates that we can start with?• Based on other customers in the same line of business and of similar size, what were the

biggest challenges they faced and what were the solutions?• Are you able to provide us with your recommendations and/or a Transition Plan that details the

scope of work, deliverables, schedule and project costs?



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After your Continuous Monitoring System (CMS) becomes the production system of record and has gone “live,” there’s certainly reason to celebrate and recognize what has been accomplished. There can also now be a misconception that the system will “run by itself,” that it is “automatic,” and you can “set it and forget it!” However, like any complex system, it requires ongoing support and care in order for it to be in good working order. On-going system support means users must interact with the CMS on a regular basis and verify that it is operating as expected.

Daily reviews of your system are recommended. Daily review of your CMS is an important aspect of qualifying proper operation of the monitoring, data recording and alarm system (CMS) you are using for your facility. Facility/Administrative personnel often believe the CMS is operating at maximum efficiency because it is not alerting them of any problems. While it may be true that it is functioning properly, you are at risk if the CMS is not being reviewed and verified as part of your daily validated system documents and SOPs.

Most CM Systems will operate without issues 98% of the time. They will continue monitoring, recording data and alerting you to issues without any personnel needing to perform manual work that may have otherwise been required. However, the other 2% of the time can cause unnecessary headache, money spent and long hours of extra paperwork if your facility personnel do not take the time each day to check on your CMS.

This 2% can account for issues that range from the system being offline due to network issues, personnel turning off alerts and not resetting them after corrective action was taken or an unnoticed system component failure. While the CMS will notify you of interruptions when it is working properly, there are always outside factors to consider that may prevent these notifications: phone line failure, network down or facility-wide failures.

Taking the time each day to review your CMS operation and maintaining documentation of the review will assure you and your team that you can go through your work day, time off, holiday or weekend with confidence knowing that your system is operating at maximum efficiency.

Key points to consider include:

• Following SOPs – The Standard Operating Procedures (SOPs) established during the Transition Period (TP) should be followed. It most likely took a good amount of time and resources to draft and adopt the SOPs, and they should be set aside or forgotten. A fundamental element of an SOP is to regularly verify that all sensors are in good working order. All readings should be an expected value (e.g., a -20 °C freezer should not have a flatline reading -200 C nor should temperatures spike to +150 °C), and any error conditions need to be addressed and fully resolved. All corrective actions must be documented, time stamped, and signed off as part of the permanent electronic record.

SOPs are a required part of any facility so that employees have clear direction on how documentation, processes, HR, and situations are to be handled. In the Continuous Monitoring (CM) world the SOPs are the most important part of any validation process. They work in conjunction with Installation Qualification/Operational Qualification (IQ/OQ) that should be performed with any CM system as, together, they help to complete your validation process. For example, the following are typically part of an SOP for a CMS:

• Outlining and informing those involved on how alarm situations are to be handled, from turning them off and on to properly documenting the event.

• How often it is required to assess the system and verify that everything is operating properly.

Eighth Key: On-Going System Support & Help Desk



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• How often the sensors need to be calibrated – this may be yearly, twice yearly or quarterly.• Outlining the steps that need to be taken in the case of product loss to ensure the product is

handled and disposed of properly, and the event is documented appropriately.• Outlining the steps involved if the product needs to be moved from one location to another. • The staff should be fully trained on clearly outlined SOPs to ensure the proper procedures are

consistently followed.

• Reference Documentation – During the Transition Period, a standard library of reference documents (Quick Reference Guide, User Manual, FAQs, Installation and Service Manual, Specification Sheets, and SOPs) should have been established. End users should know where to locate and access current releases of this documentation.

• User Training & Continuing Education – Regular user training, continuing education, and user certification is important, especially as new features are introduced and/or new employees use the system. Work with your vendor to schedule annual and as-needed training, and inquire about online training courses and “How To” videos.

Knowing how to properly use, view and maintain your CMS is an essential part of compliance. Making sure that your personnel have the proper training is an important part of your SOPs and requires diligence in making sure that they are up to date on report setup, programming inputs and most commonly used features that are available on your system.

We always recommend setting up a demo system on a different PC/server than your validated system for the training of new personnel or refreshers for existing personnel. When your system is due for service, Preventative Maintenance (PM) calibration or during expansion it is always a great idea to let your CMS service representative know that you would like some training on your system to go over any changes accompanying your new software update and just a general refresher training from the manufacture.The FDA, AABB, Joint Commission and other organizations all require that your personnel have the proper training to use the system. This training should include:

• How to handle alarm events• How to properly document events for regulatory compliance• Which reports require daily, weekly or monthly review• How to select reports in the system for historical review of collected data

After training is complete, a certificate or signed completion of training document is recommended as part of your validation documentation. With support from you CMS provider, all users on your system will be properly trained and certified to meet your SOPs and regulatory environment requirements.

• Address Non-CM Issues – In addition to ensuring your CMS is in good working order, there will be the need to address issues with storage rooms, appliances, and other systems that comprise the facility’s infrastructure. Room temperature thermostats will need to be adjusted, appliance temperature control adjustments will need to be made, and HVAC systems may need fine tuning as well. It is also common to find that a storage appliance is not properly maintaining temperature and needs to be replaced.

• Help Desk – Finally, perhaps the most important resource is your vendor’s Help Desk. You should ensure all users know where and how to get technical support and customer service. Post the e-mail address, web portal URL, and/or customer service phone number near each work station or in a location where it’s easily located. During the TP, your vendor should have provided training and explained the procedures on how to contact the Help Desk. It’s important to understand what the average turnaround times are, if on-site service is available as part of your support agreement, and what steps should be taken in the event of an emergency.



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It is recommended that your Continuous Monitoring System (CMs) undergoes a “major tune up” at least once annually. Although there are monthly or quarterly alarm checks and preventive maintenance schedules to complete, an annual probe calibration to an NIST or ISO 17025-traceable standard and a comprehensive system check/validation will ensure the system is in good working order.

Annual Probe CalibrationsYour Continuous Monitoring (CM) manufacturer will issue a Certificate of Calibration for probes that are calibrated to an NIST or ISO 17025-traceable standard. Because the accuracy of probes may degrade or drift over time, it is good practice to ensure they are measuring and reading within specifications. The typical interval for recalibration of probes is 12 months, which coincides with the annual system maintenance schedule. Table A is a checklist for the calibration of each probe.

Table A - Probe Calibration Checklist

# Description Notes & Comments

1 Probe Calibration Either replace expired probe or field calibrate the existing probe to the manufacturer’s specifica-tions.

2 Certificate of Cali-bration

A Certificate of Calibration is either issued for each individual probe, or the probe serial number is alternatively listed in a consolidated Certificate of Calibration. In either case, verify the serial number is accurately listed and the expiry date is as expected (e.g., expires in 12 months).

The Certificate should either be maintained electronically in the CM application database or as an original copy with your designated records manager.

3 Serial Number Up-dated in Database

If applicable, verify the probe serial number is updated in your CM application software.

4 Expiry Date Up-dated

If applicable, verify the expiry date is updated in your CM application software.

5 Probe Type If applicable, verify the correct probe type is selected in your sensor profile or properties page.

Ninth Key: Annual Probe Calibrations & System Maintenance

Annual System MaintenanceAs compared to regular system Preventative Maintenance (PM), where limited-scope checks and inspections are completed, an Annual System Maintenance is a “major tune up.” Table B outlines key end-to-end tests and verification checks to complete during annual system maintenance.

Table B – Annual System Maintenance Summary Checklist


1 Equipment Mount-ing and Placement

Based on applicable building codes and requirements, and the CM manufacturer’s specifications, verify all equipment is mounted to the manufacturer’s specifications and recommendations. Transmitters, panels, and other equipment should be mounted at the optimal height, away from potentially damaging environments like water/moisture, excessive heat, cold, humidity, etc.

2 Wiring Checks For wireless systems, verify wiring and cabling is within applicable guidelines and specifications.For wired systems, inspect and verify the integrity of wiring to and from equipment panels.

3 Labeling Verify all monitoring equipment and appliances are properly labelled with the correct asset ID #, and as applicable, appliance name, calibration information, etc.

4 Probe Media & SDS Check

For probes that are immersed in a liquid media, verify the fluid levels are topped off and the media itself has not expired. Verify the bottle is properly labelled and Safety Data Sheets (SDS) are current and readily avail-able.

5 Battery Replace-ment

Although batteries may have been replaced and “have a few more months of life left,” replacing batteries on the annual anniversary is a good practice to minimize the risk of a power loss due to drained batteries.



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6 Main Panel Battery Check / Replace-ment

The wiring panels of a hard wired system oftentimes include a backup battery that needs to be inspected, tested and replaced on the recommended interval.

7 Alarm Checks Perform alarm checks on all probes to verify standard min, max, and time delay settings. Some organizations elect to perform alarm checks on one quarter of their sensors each quarter. At the end of a 12 month cycle, an alarm check has been completed for every probe. Consult with your CM manufacturer for recommendations.Some CM systems support multiple set points for alarm and time delay thresholds, in which case additional testing to verify at least a representative sample of points is advisable.

8 Alarm Notification & Escalations

In addition to trigger high and low alarms, it is also important to verify the alarm notification protocol is as expected. Test procedures should include, at a minimum, the verification of:

a. All designated recipients receive each notification message and the notification message contents are accurate and correctb. Each type of notification (email, SMS text, page, phone call, etc.) is received, in the proper sequence, and for the designated test sensorc. Notification escalation protocol is correct

Systems with mobile apps should also verify that users receive alerts and can, as applicable, interact with the CM system via the mobile app and its device (mobile phone and/or tablet).

9 Line Power For sensors and equipment that are AC line powered, verify the integrity of the connections and that overloading is not an issue. As applicable, AC adapters may need to be “secured” so that they are not unplugged.

10 UPS Test For systems on emergency uninterruptible power supplies (UPS), verify the expected transition from standard to emergency power is as expected.

11 Emergency Proce-dures

Review emergency procedures and ensure they are up to date and readily available.

12 Disaster Recovery As applicable, test and verify that disaster recovery procedures are current and a recovery is suc-cessfully completed. Verify system limitations, such as maximum database file size constraints, are not exceeded or close to reaching the limit. Consult with your CM manufacturer for additional recommendations.

13 Application Soft-ware Update Verifi-cation

As applicable, verify the application software is up to date and is the desired release version. Verify that the latest release of software is the version that you want. Some users elect to forego the latest build in favor of an older or future build.

14 Firmware As applicable, verify the firmware for all devices is up-to-date and is the desired version.

15 System Validation As applicable, perform an incremental or full system validation in accordance with your CM manu-facturer’s Operational Verification & Input Calibration (“OVIC”), or equivalent, protocol.

16 User Training & Cer-tifications

Annual user training and certifications are recommended to ensure all end users can optimally utilize the system. Verify the latest training resources (manuals, specifications, online links, etc.) are current.

17 Spare Parts Inven-tory Check

Verify the recommended quantity of on-site spare parts on-hand and maintenance procedures are current and up-to-date.

18 Record Keeping Verify all system checks, validation protocols, and maintenance records are up-to-date and avail-able to support applicable reviews and audits.

19 Contact Informa-tion Updates

Verify all CM manufacturer or vendor contact information (Sales Representative, Help Desk, Cus-tomer Service, etc.) is up-to-date and readily accessible.

20 Other Each organization’s CM system is unique. Consult with your CM manufacturer to plan for and implement other procedures and protocols that may apply to some or all of your facilities.

In summary, performing your annual probe calibrations and system maintenance is vital to maintaining a system in good working order and ensuring your end users are utilizing the system in an optimal manner. Your CM manufacturer is a key resource and partner in this annual protocol.



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An extension of on-going support for your Continuous Monitoring System (CMS) is to complete regular alarm checks and perform Preventive Maintenance (PM). These two activities are vital to ensuring the integrity, quality and reliability of the system.

Regular Alarm ChecksRegularly scheduled alarm checks should be completed for: 1. All monitored parameters (temperature, humidity, differential pressure, CO2, O2, etc.).2. System error conditions (detailed in Table C and Table D, respectively).

Table C - Monitored Parameter Alarm Checks

Alarm Check/Test Description

High Alarm Check (1) Verify the high alarm threshold and alarm time delay, and(2) Trigger a HIGH alarm event.

Low Alarm Check (1) Verify the low alarm threshold and alarm time delay and (2) Trigger or simulate a LOW alarm event.

Verify Alarm Notification Protocol Verify alarm notification protocols: All expected alerts should be received (no missing alerts), in the desired escalation sequence, and with the correct alarm notification information / content.

Test boundary conditions, which are usually at the transition between work shifts or notification schedules.

Test holiday and non-standard schedule protocols.

System Error Condition TestingSelect CM systems have comprehensive system error condition detection capabilities. If available, and as applicable, test the system errors listed in Table D. Due to the nature of some error conditions, select tests may need to be simulated.

Table D - System Alarm Testing

Alarm Check/Test* Description

Probe or Measured Value Error Error conditions include:• Probe unplugged/disconnected, damaged• Wire severed• Signal Flatline for a defined period of time• “Railed Value” – measured value exceeded maximum or dropped below the minimum value

Signal Transmission Error Continued loss of a data signal that exceeds a threshold period of time.

Device Offline Devices that can potentially go offline include:• Server• Access Point• Repeater• Sensor• Connection Panel• Other System Device

Power Loss Power events include:• Complete loss of power• Power spike• Power cycling / Oscillations • Voltage drop

*As applicable.

Tenth Key: Regular Alarm Checks & Preventive Maintenance



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Testing Interval & MethodologyThe testing interval and methodology depends on many factors, including the type of product that is monitored, its sensitivity to changes in its environment (temperature, humidity, etc.), quality assurance procedures, and/or regulatory requirements.

One option is to test each sensor, once per month or per quarter. Another approach is to test a portion of the installed sensors each period, resulting in all sensors being tested at least once for each 12 month period (e.g., test 1/12th of the sensors on a monthly basis).

Mesa Labs recommends the testing interval and methodology be in accordance with the facility’s approved Standard Operating Procedure (SOP).

Preventive Maintenance ChecklistPerforming regular PM and keeping logs of the completed procedures optimizes the system’s integrity and reliability. Table E is a sample PM checklist to be completed on a quarterly or regular basis.

Table E – Preventive Maintenance Checklist

Alarm Check/Test Description

Batteries • Verify batteries have a minimum voltage level and are not damaged or leaking• Check any expiry dates• Replace at least once per year or per the manufacturer’s recommendations

Line-Powered Devices • If the sensor is line powered, verify that it is properly plugged in or wired per the manufac-turer’s installation guidelines

Probe Bottle Solution or Media

• Verify media / fluid levels are not below recommended minimum level• If applicable, verify media has not expired

Device & Probe Mounting • Verify device, probe and any applicable wires are properly installed per the manufacturer’s guidelines

Labeling • Verify labels for monitored appliances and points are up-to-date and correct



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While we hope that it never occurs, a disaster or emergency can happen unexpectedly. Establishing a disaster or emergency recovery plan is an important element of a Standard Operating Procedure (SOP).

Emergency Contact ListIn the event of an emergency, it’s important to know where emergency contact information is and to follow the established notification procedures:

• Emergency Contact #1 (phone # and/or email)• Emergency Contact #2 (phone # and/or email)• Emergency Contact #N (phone # and/or email)• Continuous Monitoring System (CMS) Help Desk: Phone #, Email, Website – As applicable, contact your CMS manufacturer for assistance.

Table F - General Recovery Steps


1 Secure Vital Assets The first step in an emergency is to secure vital assets. The procedure may include verifying the status of storage appliances and/or moving assets to emergency storage appliances or locations.

2 Identify Failure Mode(s)

The first step in the recovery procedure is to identify the failure mode. Examples of common failure modes include:(1) Power Loss(2) Network Outage(3) Server or Host Failure(4) Device and/or Probe Failure

3 Replace Failed Device(s)

As applicable, repair and/or replace any damaged or failed devices.

4 Data Restoration Depending on system capabilities, any gaps in data may be restorable. Sensors and/or system devices often have on-board memory to temporarily store data in the event data cannot be stored in the central database.Restoration of data can be automatic, or it may require following the manufacturer’s data restora-tion procedures. In certain cases, data may not be fully restorable, and applicable documentation and corrective action follow-up is required.

5 Verify Normal Operations

Once the system is back up and running, it is important to verify that the system is operating normally and can be relied on to monitor and safeguard the assets. Follow the manufacturer’s guidelines on how to verify Normal Operations. In certain cases, it may be necessary to perform an IQ/OQ/(PQ) validation.

6 Perform Select Alarm Checks

After it has been verified that the system is up and running normally, it is advisable to perform select alarm checks to verify that alarms are functioning normally. Alarm checks are typically a standard part of an IQ/OQ/(PQ) protocol.

7 Verify Alarm Notifi-cation Protocol

Verify alarm notification protocols: All expected alerts should be received (no missing alerts.), in the desired escalation sequence, and with the correct alarm notification information / content. Verification of alarm notification protocols are usually a standard part of an IQ/OQ/(PQ) protocol.

“( )” Designates an Optional Protocol

Redundancy & Automatic FailoverDevice redundancy and automatic failover may already be designed into your CMS. If this is the case, there may not be any lost data or discontinuation of the operating of your system. Follow the manufacturer’s guidelines on how to “reset” or “reconfigure” the system to address any failed devices and/or components.

Establishing a disaster or emergency recovery plan should be a standard component of your SOP. Periodic testing of recovery procedures is also a good practice – consult with your CM manufacturer for recommendations and guidelines. Don’t wait until an emergency or disaster occurs!

Eleventh Key: Disaster & Emergency Recovery Plan



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Establishing an inventory of on-site spares and emergency parts is important to minimize potential downtime. Select parts or components may have a long procurement lead time, and there may also be times during the year when your Continuous Monitoring (CM) manufacturer is not able to process orders. Contact your supplier for recommendations and incorporate the procedures into your Standard Operating Procedure (SOP).

Spare Parts - What to StockYour CM manufacturer can make recommendations on the types and quantities of spare parts to maintain in on-site inventory. Table G is a sample list of typical components to stock for immediate availability to replace damaged components or devices.

Table G - Sample Spare Parts Inventory Items

Description Notes & Comments

Probes Probes are typically the component that most frequently fails. Stock the recommended minimum quantity or a percentage of the total number of installed sensors.

Transmitters or Readers

Although these devices do not have a high failure rate, failures can and do occur.

Access Points and/or Repeaters

If applicable, maintain at least one of each device type.

Accessories & Other Items

Accessories and other items can include batteries, extension cables, probe bottles, media, and/or other components required for the system.

Maintaining spare parts on-site also enables quick and easy expansion. In the event there is an urgent need to monitor a new appliance, the components and devices are available for rapid installation and deployment.

Spare Parts - Inventory ManagementIt is recommended that inventory levels be regularly checked to verify the minimum quantities are available. A standard interval is a monthly check, but a quarterly check should be the longest interval.

How-To ProceduresIn addition to maintaining spare parts on site, contact your CM manufacturer to obtain available How-To procedures or resources. As applicable, training or certification may be available or required.

Excluded Components or DevicesNote that certain components or devices can only be replaced or serviced by the manufacturer. Contact your CM manufacturer for recommended procedures and guidelines for these types of components or devices.Establishing and managing an on-site spare parts inventory will minimize any potential system downtime and enable rapid installation/expansion when needed. Contact your CM manufacturer for guidelines and recommendations.

SummaryA Continuous Monitoring System (CMS) is a powerful resource to help manage and safeguard your invaluable assets. The project size and scope of implementing a CMS, however, can quickly become very large and overwhelming. Knowing and understanding where the key signposts are, and what they mean, can really help you navigate your way through a journey that can be fraught with complex roadblocks and pitfalls. This compendium of Key Success Factors will guide you through the most important steps and highlights the most important factors that are critical to understand and embrace. Ready for a challenging but fun and rewarding journey? Let’s go!

Final Key: On-Site Spares & Emergency Parts

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