ISA Interchange

From Lab to Line: Navigating Calibration Requirements for Automated Technology in Manufacturing

Written by Ellie Gabel | Jan 9, 2024 4:42:55 PM

Calibration in manufacturing is one of the most vital processes for quality assurance and output consistency. A once manual process has extended into automated realms, making industry professionals wonder how to optimize Industry 4.0 technologies to provide even more efficient and accurate calibrations. What are the requirements for novel automation tools, and how can workforces benefit from revolutionary applying guidelines?

The Fundamentals of Calibration in Manufacturing 

Calibration is responsible for all measurements on production lines. It manages quality control, reduces waste and enhances compliance adherence for manufacturers. Fewer rejected parts fly off the line, reducing material and labor costs from making extra products. For food manufacturers, calibration indicates safety and environmental health attentiveness. 

The only way high-quality products become repeatable is through oversight and maintenance in automated calibration tools. The devices vary widely, with some examples including:

  • Thermometers
  • Pressure gauges
  • Calibration baths
  • Infrared devices
  • Deadweight testers
  • Thermal cameras
  • Dry blocks

Operators also use calibration to signal that the rest of the line is functioning properly. Changes in product appearance and structure hint toward a more significant problem. Machine and product damage, inconsistent results and customer complaints indicate that equipment calibration needs attention and care. Labs constantly attempt to improve the fundamentals of this technology for enterprises inching ever closer to fully transitioning to Industry 5.0. 

 

The Requirements Automation Technologies Require

There are numerous types of calibration tools. They involve instrument, process and system calibration, with varying requirements for automated technologies. 

The primary calibration frameworks are ISO 9001 and ISO/IEC 17025, which are required for industry credibility. Additional industry-specific calibration requirements, such as ISO 15189 for medical calibration, may be necessary. 

ISO 9001 is a blanket standard requiring companies to calibrate these tools regularly. ISO/IEC 18025 is more process- and application-based because it guides labs on producing replicable and accurate results. What are the requirements for each?

ISO 9001

ISO 9001 is the key to solidifying automated processes and quality management systems because it encourages perpetual optimization. Avoiding stagnation is necessary for improved decision-making and heightened customer loyalty. Additionally, automation tools make it easier for manufacturers to stay compliant, so organizations want them to run at top marks as often as possible.

Within ISO 9001 is the Calibrated Equipment Procedure, detailing the requirements for related systems. It has a mandatory schedule for checking calibration tools in automated systems and who is responsible for performing and reporting checks. It has even more specific information regarding the environmental conditions, such as proper lighting and minimal dust. However, the most important are the guidelines for measuring, which inform testers of suitable instruments for calibration testing.

ISO/IEC 17025

ISO/IEC 17025 is more honed, focusing on impartiality and confidentiality in labs. It details how to make an efficient structural setup and what resources are required to function appropriately, such as personnel or ways to capture traceability. Compliance requires following 11 processes, delivering labs a how-to guide to handle everything, including sampling, complaints and nonconforming work. Uncertainty analyses and revision details are necessary to prove viability in automated processes.

None of the setup and operations matter without management systems and auditing. The final requirements include regular reviews and promises for improvement. It explains the necessity for accurate and thorough documentation, including guidance on risk control factors in handling sensitive records.

ISA-RP105.00.01

In 2017, ISA released new guidelines entitled Management of a Calibration Program for Industrial Automation and Control Systems to capture the nuance of calibrating loop-based systems. The topics outlined in this are not required, though highly recommended, including

  • How to monitor and make corrections
  • Performance goal setting
  • Loop-focused instead of field instrument management only
  • Recommendations for smart tech
  • How to verify loop longevity and quality

Calibration Challenges in Automated Technology

Knowing the requests from regulatory bodies is crucial for successful automated technologies, but becoming aware of potential obstacles is equally important. Calibration tech is so diverse that it is essential to maintain appropriate performance expectations. It could include robot calibrators and calibration documentation software. Integrability may be the first hurdle to overcome, but the payoffs are astronomical when the ecosystem is symbiotic.

These requirements summarize the lengths manufacturers must go to fully embrace automated calibration, which may become even more complex as technology advances. These resources are in high demand, expediting research and development. Components, like sensors, will inevitably change to become self-calibrating. Interconnected systems will become more complex, primarily with the advent of commercialized artificial intelligence.

Manufacturers must stay attentive to compliance changes as they respond to developing tech. This means investing more time and resources into testing, auditing, documentation and related work. '

Implementing Effective Calibration Processes

Worldwide, manufacturers are navigating calibration compliance and reaping the rewards for their adherence. The certifications provide corporate resilience and competitive advantage, as more agencies only seek to work with accredited entities to satisfy an ever-demanding customer landscape.

A U.S. brewery decided to automate its RTD thermometers to save 80 hours of labor annually. Downtime to test and verify calibration of automating temperature checks caused short-term financial losses the company was willing to risk. However, it saved operators time and increased safety because the process required interacting with hot oil baths. The plant runs on self-calibrating instruments, constantly monitoring deviations for process discovery.

Another study explored a camera's efficacy in calibrating robotic arms automatically compared to conventional models. Testing reduced absolute error by seven times while increasing the accuracy of small rotations. The trials proved this calibration process was possible for industrial-sized operations.

Enhancing Calibration by Adhering to Requirements

Frameworks recommend modern calibration tools to amplify their usefulness and guide production lines to a productive future. Experts are already discussing what Industry 6.0 could contain when 4.0 and 5.0 have not even been fully fleshed out — noticing the potential for calibration technologies gives an insight into this. 

The outlook is positive, especially as regulators discover optimizations across all sectors. Navigating requirements is worth the time and financial investments for the benefits it brings in the long term.