The need for calibration from the viewpoint of the reliability, repeatability, and accuracy of a measurement has been around for thousands of years, with various requirements and “controlling” systems. In today’s calibration environment, there are basically two types of “official” requirements for calibration: International Organization for Standardization (ISO) standards and regulatory requirements. The greatest difference between the two is simple-ISO standards are optional, and regulatory requirements are mandatory.
A small human error or the failure of an instrument in a pharmaceuticals plant could adversely affect the health of thousands of people. This is why pharmaceutical manufacturing is one of the most stringent, highly regulated industries in the world. The third, newest, and ever-increasing requirement for calibration – or more precisely, requirement for the implementation of a calibration solution-stems from the demand for higher efficiency, reliability, and quality of all industrial processes. Fewer people must do more with fewer errors and less paperwork. Efficient automated calibration procedures together with the most advanced integrated solution are the best way to tackle the challenge.
We have conducted wide global surveys of process manufacturing companies to identify the main challenges in calibration in various industrial sectors. A high proportion of the respondents have agreed that documentation related to instrument calibration takes much time and effort. More than a third of respondents have said that “documentation errors,” which closely relate to the overall quality and accuracy of calibration records, were an issue for their organization.
Regardless of the type of company, a higher level of integration and automation is in the top three of all responses. All this is understandable, taking into consideration the following: A large production plant can have thousands of instruments that require calibration. If they need to be calibrated once a year, thousands of calibration reports are needed. In addition, all of those calibrations must be planned around normal workflow, and information about all instruments must be documented.
The traditional method of calibration management – using pen and paper – is still the most common. Once the report is written, it is put into an archive. This method is time consuming, fraught with errors, and unhelpful for later analysis of the information. Another common method is self-made, computer-based systems, such as an Excel file. Information is stored in an electronic format, but the process of documenting calibration information is still slow and prone to human error.
At this very moment, many companies are dealing with challenges, such as the need to simplify and streamline work processes, cut production downtime, and eliminate double work. These challenges exist in every function, and they all can be tackled by improving the level of system integration and automation. Calibration systems are no different. They can no longer be considered isolated, stand-alone systems or work processes within a company or a production plant.
Just like any other business function, calibration procedures need to be more streamlined, automated, and integrated to achieve improvements in quality and efficiency. An integrated calibration solution is integrated in several directions. Calibration software, which is used for planning, documenting, and managing calibration assets and procedures, is at the heart of the calibration system. The most significant form of integration is between calibration software and documenting calibrators. This combination alone automates many calibration and documentation procedures. The second type of integration is between the calibration system and maintenance management systems. This integration ensures that the calibration system is an integral part of the company’s management system.
I have no doubt that the future of calibration includes a higher level of integration and automation.