Unplanned downtime is an expensive issue, costing companies $50 billion every year, according to research by IndustryWeek and Emerson. Nearly half of this downtime is the result of equipment failure, indicating that more proactive strategies are necessary to keep machinery running smoothly. Effective calibration management is a key part of maintaining uptime and avoiding product failures, market withdrawals and related recalls.
This article looks at common calibration challenges, how automated software can reduce risk, and what to look for when evaluating solutions.
Common Calibration Management Challenges
Manufacturers face a number of challenges when it comes to calibration, all of which can impact product quality. Furthermore, due to the risk involved, calibration should be an element of a quality risk management program.
Documentation is one of the biggest issues. Many companies use labels, cards, and spreadsheets to track calibration records and due dates. However, spreadsheets are an inefficient method for tracking this information because you can’t attach documentation such as the certificate of calibration or analysis. Furthermore, programs like Excel don’t have the kind of built-in data integrity needed to maintain audit readiness.
Stickers on devices are also an unreliable method for keeping up with calibration needs, since labels can get overlooked, damaged, or accidentally removed. They can also become illegible and unreadable if they’re hidden by a machine guard, for example.
With these methods, it’s not uncommon for a recalibration date to get missed until the device fails—allowing bad product to be produced and slip by undetected. It’s especially a risk for critical-to-quality (CTQ) components or devices that have a direct impact on product quality. For these devices, manufacturers also need a way to make sure that there are enough replacements on hand for when devices are out of service for calibration. When there aren’t enough, the result is unplanned downtime, which can be extremely costly.
There are also instances when considerations where calibration priority and/or frequency might be based on the risk of downtime. Scheduled dates may be missed if the only reminder is in one person’s Outlook calendar. Not calibrating frequently enough can have a direct impact on quality, where the device begins to drift unnoticed. Product quality issues that result may be hard to spot, with defects slowly increasing over time until a customer complaint forces the manufacturer to investigate the cause.
Benefits of Automated Calibration Software
Recognizing the risks of inefficient calibration tracking methods, many manufacturers are moving away from spreadsheets and implementing automated calibration management within their enterprise quality management system (EQMS).
Calibration software provides a central location from which to track all calibration needs, which can change over time and may require different actions. Benefits include the ability to:
- Track the calibration frequencies of devices to reduce the risk of quality escapes and analyze whether the frequency requires adjustments
- Identify and catalog CTQ devices so plants can ensure they have enough calibrated spares on hand to avoid costly equipment downtime
- Maintain audit readiness and minimize findings by organizing electronic records of calibration and making them more accessible when auditors visit a facility
- Easily track your entire calibration inventory with a consistent process, forms, and historical reporting
- Identify missing or lost devices as well as replacements, with complete data on service life, number of times calibrated, and other key information
What to Look for in a Calibration Solution
There are several things manufacturers should look for when evaluating calibration management software. To start, it’s important to look for software flexible enough to accommodate both on-premise and external calibration, so you can track device calibration both onsite and with third parties.
In addition, your calibration management software should be able to accommodate any level of detail as needed, such as if your workflow requires moving devices among different departments, sites or offices. The solution should be easily configurable to accommodate changes in processes and make it simple to scale across multiple locations as the business grows.
Manufacturers will also want to look for other key capabilities such as:
- Flexible digital forms that allow you to capture whatever information you need within the calibration records, including model and serial numbers, date of manufacture and all parameters in your requirements
- The ability to attach the certificate of calibration to device records so you can easily identify calibration gaps
- Automated alerts to keep you informed of calibration needs, including which devices are due for calibration plus warnings for pending overdue and overdue devices.
- Controlled access for your calibration services suppliers to login and expedite records, provide status updates, and upload documents, creating a single hub for supplier communication that improves visibility.
Integrating Your Calibration Within the EQMS
Calibration management is most effective when it can easily integrate with other solutions in your quality system. This way, a nonconformance can seamlessly trigger a corrective and preventive action (CAPA).
For example, your calibration system identifies a problem with a CTQ device impacting a specific set of product lots. From there, you should be able to trigger a nonconformance. Doing so will isolate lots and reduce risk while the product is still under your control. The EQMS should automatically connect the nonconformance and any related CAPA with all relevant information from calibration records. Being able to assess and handle the issue according to risk is also key, helping prioritize calibration-related issues and corrective actions through better integration of your EQMS processes.
Calibration management is a critical part of minimizing equipment downtime, production defects and recalls. Automating calibration management within the EQMS is helping manufacturers avoid these problems while increasing efficiency and production capacity. Connecting calibration to processes including nonconformance and CAPA ensures a streamlined workflow that ensures CTQ devices are running when needed.
About the Author
Sal Lucido is Co-Founder and Executive Vice President AssurX. Sal is an unequivocal product evangelist and an expert in the area of quality process automation. He holds a broad array of responsibilities, ranging from overseeing strategic plans and operational improvements to managing tactical alliances.