Calibration And Its Application

Group Members: Kashif Bashir Qasim Nazeer Muhammad Shoaib Ali Waqas Ahmed Khawaja

Why calibrate?

Why calibrate?
1. What is calibration 2. Calibration in industrial applications 3. What are the costs and risks of not calibrating 4. Why is calibration important 5. When to calibrate 6. Why calibrate? Cusexplaintomers.

What is calibration

Definition
Matching or reconciliation of a measuring device of unverified accuracy with another device that is known (verified) to be of standard or superior accuracy. Any difference found between their accuracies is used to adjust the first (unverified) device. OR Calibration: The operations which assure that an instrument readings are accurate referenced to known standards.

What is calibration
What time is it? What time is it exactly and how do you know it? Calibration can be briefly described as an activity where the instrument being tested is compared to a known reference value. The keywords here are known reference, which means that the known reference used in the comparison should be traceable to recognized standards. In this case, calibration would be comparing the time an alarm clock shows to a wrist watch, which has been synchronized with a known time signal (e.g. with the radio time signal).

Calibration in industrial applications

When process measuring instruments age and experience physical stress or temperature variations, critical performance gradually declines. This is called drift.
As a result of this, the measurement results become unreliable and ultimately the production quality can suffer. Drift cannot be eliminated, but it can be discovered through calibration. Calibration is the comparison of instrument performance to a standard of known accuracy. Calibration assures that the measurements are accurate and within the required specification limits of the process instrument.

The costs and risks of not calibrating

The costs and risks of not calibrating

1. Neglecting calibration can lead to unscheduled production downtime, quality problems and product recalls. 2. Risking employee safety. 3. Risking customer/consumer safety. 4. Loosing licence to operate due to not meeting regulatory requirements. 5. Direct economical losses in businesses where invoicing is based on process measurements (e.g. energy industry).

EXAMPLES OF CALIBRATION
Temperature Pressure Weight/mass pH RPM Electrical Aseptic Fluid flow Humidity Optical Time Volume

CALIBRATION OF SOME INSTRUMENTS

How to calibrate pH meter How to calibrate Weighing Balance How to calibrate Thermometer

Why is calibration important

Why is calibration important

Specific reasons for calibration Instruments drift during time To keep high and consistent product quality Comply with regulations/quality systems Optimise process and increase capacity Safety reasons Check quality of measurements Direct economic benefits (e.g. from proper billing) Controlling emissions

Instruments drift
One of the main reasons for calibration is that even the best instruments drift and loose their ability to give accurate measurements.

This drift makes calibration necessary.

Environment conditions, elapsed time and type of application can all affect the stability of an instrument. Even instruments of the same manufacturer, type and range can show varying performance. One unit can be found to have good stability, while another performs differently.

Compliance with regulations/quality systems

ISO 9001, 9002 standards ISO 14001 standards
Quality systems (e.g. ISO 9001, ISO 9002, ISO 14001) require systematic and welldocumented calibrations, with regard to accuracy, repeatability, uncertainty, confidence levels, etc. Industries: All process industries

Compliance with regulations/quality systems

ISO 9001:2000(7.6 Control of Monitoring & Measuring Devices):
The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements. The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements. Where necessary to ensure valid results, measuring equipment shall
a) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded; b) be adjusted or re-adjusted as necessary; c) be identified to enable the calibration status to be determined; d) be safeguarded from adjustments that would invalidate the measurement result; e) be protected from damage and deterioration during handling, maintenance and storage.

In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected.
Records of the results of calibration and verification shall be maintained (see 4.2.4). When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.

Compliance with regulations/quality systems

FDA regulations (pharmaceutical companies):
Calibration records must be maintainedand calibrations must be done according to written, approved procedures. Each instrument should have a master history record. All instrumentation should have a unique ID; all product, process and safety instruments should be physically tagged.

A calibration period and error limits should be defined for each instrument.
Standards should be traceable to national and internationalstandards.

Standards must be more accurate than the required accuracy of the equipmentbeing calibrated.

Compliance with regulations/quality systems

FDA regulations (pharmaceutical companies):
There must be documentedevidence that personnel involved in the calibration process have been trained and are competent.
Documentedchange managementsystem must be in place. All electronic systems must comply with FDAs regulation 21 CFR Part 11. All of the above should be implementedin conjunction with following regulations:
21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals 21 CFR Part 11: Electronic Records; Electronic Signatures

Optimize process & increase capacity

Enhanced calibration equipment performance results in better uncertainty levels, with which it is possible to improve annual production levels. For instance, by improving the measurement of the parameters from 2 % to 0.4 % (parameters associated with the determination of reactor power), enabled the power in each unit to be increased by 1.6 % at Nuclear Power Plant Almaraz (Spain). This has a significant effect on the annual production. Industries: Power & Energy

Safety reasons
Employee safety: production environments can involve high pressures and temperatures false measurements could have serious consequences in this type of environment, especially in Oil & Gas, Petrochemical & Chemical industry.
Customer safety: especially in pharmaceutical, food and beverage industry, products with bad quality can have fatal consequences. Industries: Oil & Gas Petrochemical & Chemical Power & Energy Pharmaceutical, Food & Beverage

Economic consequences
If invoicing is based on accurate process measurements (e.g. custody transfer, weighing scales, gas conversion devices), calibration can have a direct impact on financial profits. On the other hand, neglecting calibration can have a direct impact in generating financial losses.

Industries:
Power & Energy Pipelines

Gas
Steel

Consumer goods (e.g. food & beverage)

 Beamex 2009

Economic consequences
The consequence of poor calibration has severe financial impacts*:
The average cost of poor quality calibration costs manufacturers $1,734,000 each year. When considering solely large companies with revenues of more than $1 billion, the cost balloons to an average of $4,000,000 annually.

*Nielsen Research /ATS Studies, 2006 & 2008

Controlling emissions
For the efficient combustion in furnaces and the associated emissions, the calibration of instruments is crucial. Government regulations can require that specific instruments must be calibrated, for example instruments related to CO2 and NOx emissions. Emission-related instruments are usually considered to be critical, as they are associated with the license to operate. Industries: All process industries

Common misbelieves
1. We dont need to calibrate. We dont need to calibrate Fieldbus instruments, because they are digital. And a digital output is always accurate and correct. New instruments do not require calibration.
2. 1. If accuracy of measurements is important for your plants processes, then how do you know your instruments display correct measurements? Does your plant operate according to regulatory requirements (e.g. ISO, FDA)? If you are following regulatory requirements, calibration is a necessity The main difference between fieldbus and conventional transmitters is that the output signal is a fully digital fieldbus signal. Changing the output signal does not change the need for periodic calibration!Although modern fieldbus transmitters have been improved compared to older transmitter models, it does not eliminate the need for calibration. First of all, the fact that an instrument is new does not guarantee automatically that it is within required specifications. In addition, by calibrating an instrument before installation you are able to enter all the necessary instrument data to calibration database (e.g. calibration management software) as well as start following the instruments stability.

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When to calibrate

When to calibrate
After a period of time, instruments drift and can no longer give accurate measurement results. To resolve this issue, instruments must be calibrated at regular intervals. But how often?
Calibration interval can be determined by:
1. 2. 3. 4. Following manufacturers recommendation According to criticality of the instrument Quality standard guidelines (e.g. ISO) Based on history trend analysis

The most optimal calibration interval for different instruments can only be determined with software-based history trend analysis as a result, highly stable sensors are not calibrated as often as sensors that tend to drift.

Why calibrate? Customers explain.

Shell Netherlands
Ed de Jong, Instrument Maintenace Engineer: Until recently calibration was mainly driven by economic motives: even the smallest of errors in delivery quantities are unacceptable in Shells operation due to the vast sums of money involved for both customers and governments (fiscal metering). Nowadays calibration has an important role especially for the license to operate. Government regulations demand that specific instruments must be calibrated, for example instruments related to CO2 and NOx emissions.

Heineken Espaa
Armando Rivero Rubalcaba, Head of Instrumentation: For Heineken, the quality of the beer is a number one priority.All the plants in Spain have received ISO 9001 and ISO 14001 certifications, in addition to the BRC certificate of food safety. They must therefore ensure that all processes correspond to the planned characteristics, and the role of calibration is very important to ensure the quality and safety of the processes.

 Beamex 2009

Nokian Tyres Heikki Karhe, Measurement Technician: Calibration is of great importance, especially from the viewpoint of production safety and quality of the final product. Preparation of the right rubber mixture is precision work and a sample is taken from each rubber mixture to ensure quality. Measuring instruments which yield wrong values could easily ruin the final product. The factory is also full of pressure instruments and it is also important for the safety of the workers that those instruments show the right values.

Eli Lilly and Company Limited, Speke Operations

Derek Cross, Reliability Engineer:

Apart from being a heavily regulated industry, manufacturing medicines is a serious business that affects everyones lives directly or indirectly, including our own employees and their families who are also customers. The importance of quality calibration of instrumentation, and how it relates to the manufacture of our products, cannot be overstated. We invest heavily in the finest instrumentation, control systems, and secondary standard test equipment available to ensure we achieve the high standards of compliance we demand.

Mazovian Gas Company

Jacek Midera, Measurement Specialist:

Most importantly, accurate measurements ensure proper billing. The impact of even a small measurement error can be tremendous in terms of lost revenue. Customers want to pay for the exact amount of gas theyve received. Therefore, gas conversion devices must be extremely accurate in measuring delivered gas. This means that requirements for the calibrators are especially high.

IMPORTANCE IN PHARMACEUTICAL INDUSTRY

The pharmaceutical industry produces products that directly affect the life of the majority of the billions of people that inhabit the Earth. As such, a seemingly small mistake or failure could adversely affect the health of thousands of people. Regulators in the pharmaceutical industry recognize these stakes and have implemented various regulations to ensure the integrity of pharmaceutical processes and, hence, the safety and efficacy of the pharmaceutical products on which billions of people rely.

Continued
Today, calibration is basically used for the process of manufacturing so less and less possible mistakes and errors can be made. This process or measuring apparatus is also used to lower the cost of manufacture or possible production by determining or ensuring the quality.

Continued
Calibration is also ideal in minimizing possible errors because it uses scientific method to determine impending miscalculations while doing something to correct the errors if there were any. Calibration becomes more and more popular to companies because the method aims to economize time, labor, and other resources in any production by means of accurate verification.

Continued
If there were one industry that benefits a lot in the discovery and utilization of calibration, that would be the numerous laboratories all over the world that conduct seemingly endless and continuous research. The researcher or the tasked observer usually uses this measuring apparatus to refine his or her work.

Continued
Calibration is also greatly beneficial to a researcher is he or she doesn't the time to develop his/her own apparatus due to lack of time and he/she needs a set of methods for accurate testing.

Continued
Aside from the field of research laboratories, calibration is also extremely beneficial because it makes the construction of instruments that are capable of measuring with sufficient precision and lesser probability to ensure correction.

Continued
Considered as the actual accuracy of a scale or balance, calibration is widely used in testing the products to get their accurate weight. In the United States alone, an agency called National Institute of Standards and Technology that is tasked to maintain standards for values of SI units and industrial standards, calibration has become a helpful tool in providing the traceability of their subjects of study by adhering to the basic standards of calibration