The Risk of Operating Obsolete CMS Equipment
Posted: July 30th, 2024
Authors: Ben J.Continuous Monitoring Systems (CMS) are required by applicable regulations to demonstrate compliance with emissions standards and/or parametric operational limits. Facilities have an obligation to minimize CMS downtime to maintain a continuous compliance demonstration. What if CMS downtime is incurred because a component of a CMS malfunctions and parts, service, or even technical expertise are no longer available by the manufacturer to correct the issue? How can this be avoided? What are your facility’s obligations to replace antiquated or obsolete equipment needed for regulatory purposes?
Your facility is potentially at risk of violations and enforcement due to increased CMS downtime related to obsolete equipment. Agencies typically use enforcement discretion when a catastrophic CMS malfunction occurs. However, the agency may be less forgiving if the CMS downtime could have been avoided by utilizing equipment that has available parts and support, especially if you were made aware of the obsolescence by the manufacturer and neglected to act. In most cases, the manufacturer will issue an obsolescence letter that establishes a schedule for when the analyzer or monitor will no longer be supported. CMS support can include providing replacement parts, malfunction service, and technical expertise.
The recommended steps for managing the obsolescence of your CMS components are presented below.
Development of an Obsolescence Plan
It is important to develop and maintain an obsolescence plan for your CMS that tracks the remaining lifespan of the CMS components to properly plan and budget for replacements. An obsolescence plan includes tracking manufacturers’ websites and compiling obsolescence letters to develop a schedule for capital expenditures over the next five years or so. The obsolescence plan is a living document and should be reviewed at least annually.
Budget Accordingly
The easiest part of the obsolescence plan is its development. The hardest part of the obsolescence plan is staying true to the capital expenditures. It can be a hard decision to spend money to replace CMS equipment that work fine today. However, what happens when it breaks tomorrow and cannot be repaired? An obsolescence plan may outline the replacement schedule and associated effort, but it is the allocation of capital that executes the obsolescence plan. If you still can’t budget the capital, there may be other options depending on how you want to manage risk. Evaluate similar components across all your (and maybe a sister facility’s) CMS components to stock replacement components that can be available across the facility (or facilities). Engage a third-party integrator and discuss replacements. Some integrators maintain an inventory of replacement parts that can be immediately deployed upon request.
Even though the supply-chain restraints are easing, it has taught us that next day overnight delivery options aren’t available for all CMS components. Some analyzers can still take up to a year to procure. Understanding the lead times for replacements of obsolete CMS should also be considered when executing your obsolescence plan (i.e., if CMS components are projected to be readily available and quickly procured, then the risk of quickly obtaining the equipment would be low).
Plan for Initial Certification or Recertification
Facilities should operate CMS in accordance with a Quality Assurance/Quality Control (QA/QC) Plan. The QA/QC Plan outlines the actions to be taken if an analyzer or major CMS component is replaced. Depending on the nature of the replacement, the CMS may need to be initially certified or recertified. A CMS certification can be a long and tedious process, so it is best to be prepared for it before it is suddenly upon you after a malfunction event. ALL4 presented a webinar in November 2023 that covered the steps of recertification and the importance of a plan for analyzer malfunction for both temporary and permanent replacements. To summarize those steps, when recertifying an analyzer you will need to notify the agency, test the analyzer for accuracy and validity, and update associated plans. If you would like more information about CMS recertification, you can watch the webinar or reach out to me or anyone on the ALL4 CMS team.
Additional Risks to Consider
Some additional risks to consider when thinking about your now-obsolete analyzer include the potential to accrue excessive monitor downtime or whether process downtime is needed to avoid accruing said monitor downtime. To prevent excessive monitor or process downtime, you may want to acquire a backup or replacement analyzer to allow for a temporary or permanent installation and recertification of the CMS. Large durations of monitor downtime are best avoided because they can trigger additional scrutiny or even an audit from the regulatory agency.
Takeaways
If you have obsolete CMS, put an obsolescence plan in place! Hoping that obsolete CMS will last another year or budget cycle can be risky. With some analyzer lead times as high as they are right now, it might be wise to order a backup or replacement for your now-obsolete analyzer as soon as possible. Limiting both monitor and process downtime is crucial to keeping a site productive and in compliance. If you have any questions, feel free to reach out to me at bjohnson@all4inc.com or (502) 874-4500.