QMS and Calibration Software: The Perfect Alignment
August 19, 2024
If you work in an industry where accuracy is essential, you need the equipment and tools you use to support that work every day. Whether you work in a lab or in front of a CNC machine, when equipment is not up to standard, accuracy, and by extension quality and productivity, goes out the window.
Calibration software lets you proactively manage regular equipment calibration and easily address any corrective actions that might be necessary. And since calibration processes must be documented for compliance purposes, using calibration software as part of an automated quality management system (QMS) can not only help reduce downtime, but also provide built-in trackability and traceability that address compliance. This article reviews calibration processes and the efficiencies achieved through integration with QMS software.
What is calibration software?
Calibration measures instruments and equipment against known standards so any necessary adjustments can be made, helping to ensure the effectiveness of equipment and keep production processes on track.
Calibration software simplifies the management of calibration tasks, data and documentation. Calibration software centralizes processes and documentation and organizes them around regulatory standards for easier compliance. With it you can store and archive calibration data and easily access it when needed, create calibration schedules, get reminders when a calibration is due, and even integrate supplier records and certificates.
Why is calibration management important?
Many regulatory standards, including ISO 9001, ISO 13485, AS9100 and FDA 21 CFR Part 820, require use of a formal, documented, traceable calibration system that maintains the accuracy of instruments or machinery. If you’re in an industry such as pharmaceutical, medical device or aerospace manufacturing, improper equipment calibration could ultimately have life-altering consequences. Proper equipment calibration is incredibly important and regulations are more exacting for industries where end-user safety is a factor.
Beyond regulatory standards, ensuring that your equipment is properly calibrated verifies the accuracy of your work and attests to the overall quality of the products or services you provide. Regular equipment and instrument calibration is designed to prevent quality events that can interrupt processes and cause inaccurate results.
Why use calibration software?
Calibration is a necessary process that can affect the quality of your outputs and is required by many regulatory bodies. Using software that can centralize, standardize and streamline the calibration process brings a host of benefits beyond equipment accuracy.
Maximize Efficiency
Calibration software ensures that calibration processes and equipment adjustments or replacements are done in a timely manner. Equipment that is performing accurately is less likely to fail, thereby reducing the risk of manufacturing downtime. By automating calibration compliance processes, such as data capture, document management and report generation, equipment managers have more time to focus their attention on more profitable activities.
Reduce Costs
Automating calibration tasks allows users to minimize the errors that are often encountered with manual processes, saving time and expense. With equipment on a systematic calibration schedule, errors are more easily avoided or intercepted before they can escalate, keeping workflows on track. What’s more, maintaining equipment properly helps to extend its lifetime.
Minimize Risk
Inaccurate measurements can lead to equipment malfunctions, resulting in operational delays, stoppages or injury. Sticking to a preventive calibration schedule helps eliminate the risk of inaccurate measurements affecting your company. Having a centralized location where employees can access instructions, SOPs and other relevant data, demonstrates attention to potential risk and helps ensure accuracy and proper use of equipment.
Total Traceability
QMS calibration software enables you to easily trace calibration details, including who performed the calibration, when it was performed, test results, data and historical reports. Automated approval routings and regulatory-compliant electronic signatures are captured and documented as a matter of course.
Consistency
Calibration software standardizes operations so calibration processes are performed the same way each time, improving results and reducing errors. It also provides a centralized database of your machine and instrument assets, as well as maintenance information, across locations. This ensures employees are accessing the most up-to-date data and enables better collaboration.
Regulatory Compliance
Proper equipment calibration helps ensure you don’t become noncompliant due to inaccurate measurements, allowing you to avoid regulatory censure.
How does QMS calibration software manage calibration tasks?
Calibration software manages and tracks the calibration process, allowing you to create and implement calibration schedules, record and store standards, manage documentation and data, and ensure compliance and audit preparedness.
Automated features, such as email alerts and dashboards, provide efficiencies and offer a real-time picture of calibration efforts. A well-designed calibration software system tracks and manages every component of the calibration process to ensures that machines and instruments are calibrated at the appropriate intervals, and are showing accurate and reliable results.
When used as part of QMS software, any problems indicated by calibration applications can be seamlessly sent into the corrective and preventive action (CAPA) process, where the issue is tracked and resolved. Integrations with other QMS applications include:
- Document Control
- Risk Management
- Audit Management
- Deviations
- Supplier Management
- Employee Training
- Corrective Actions
Features to look for in calibration software
When choosing calibration software, the first step is to evaluate your organization’s needs and look for the solution that best addresses those needs and improves the efficiency and accuracy of your work. Some key features to look for include:
Scheduling Capabilities
Effective calibration management software should offer full scheduling capabilities. This includes automated reminders for upcoming calibrations, overdue notifications and the ability to handle recurring calibration tasks. These features ensure that equipment is calibrated on time, reducing the risk of using equipment that is out of tolerance.
Document Management
Your calibration software should provide thorough documentation capabilities, including built-in audit trails. Customizable reporting features are also important, allowing users to generate reports tailored to specific regulatory or business needs. This ensures transparency and facilitates compliance with regulatory and industry standards.
Process Integrations
Integration with other processes, such as document control and corrective actions, ensures seamless data flow and reduces manual data entry. It also helps in maintaining the consistency and reliability of calibration records across the organization.
Regulatory Compliance
Compliance with regulatory standards is a critical aspect of calibration management. The software should support compliance with relevant standards and regulations, providing features that facilitate audits and ensure adherence to best practices. This includes maintaining proper documentation, providing audit trails and supporting electronic signatures where necessary.
User-Friendly Interface
A user-friendly interface is essential for efficient use of any software. The interface should be intuitive, allowing users to navigate easily and perform tasks without extensive training. Customizable dashboards, like those found with QT9 QMS, can provide a quick snapshot of calibration tasks, enhancing user experience and productivity.
In addition, being able to use the software on any browser and any device affords mobile accessibility, so your calibration software can be used on the shop floor or out in the field.
Customization and Scalability
As organizations grow and their calibration needs evolve, the software should be able to scale accordingly. Customizable features allow the software to adapt to specific organizational requirements and workflows. Scalability ensures that the software can handle increasing volumes of calibration data and expand to accommodate new equipment and facilities.
Technical Support and Training
Reliable technical support and comprehensive training resources are essential for the successful implementation and use of calibration management software. Look for providers that offer ongoing support, including user training and troubleshooting. This ensures that users can maximize the software’s capabilities and address any issues promptly.
Related Content
• Calibrations Made Easy
• Quality Management Software
• Document Control
Wrap Up
Don’t let calibrating your equipment sit on the backburner. Better manage your calibration tasks with QMS calibration software that keeps you on schedule and ensures your equipment can support operations in the most productive way. Accuracy, quality and productivity align seamlessly with the help of QMS calibration software, supporting regulatory compliance, reducing risk and improving overall operational efficiency.
QT9 QMS integrates calibration processes as part of its 25-plus standard interconnected modules. It’s cloud-based platform allows you to keep track of calibration processes and synchronize records with anyone, anywhere. Reach out today for more information.
