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Calibration IS 2020 Lecture 1 - 2

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Calibration IS 2020 Lecture 1 - 2

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Meena
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© © All Rights Reserved
Available Formats
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Selection, Calibration, Installation and Maintenance of Field Devices

Lecture
Date : 23/07/2020

Prof. Alpesh Patel


Assistant Professor
Instrumentation and Control Engineering
Unit Name : Selection, Calibration, Installation and Maintenance of
Field Devices
Selection criteria for flow, temperature, level and pressure 02
instruments
Range selection, Instrument calibration, Traceability with standard 02
laboratories, Installation guidelines for various field instruments,
Redundancy for devices
Importance of maintenance, different approaches of maintenance 02
Introduction to Instrument Asset Management System (IAMS) 01
Equipment/Instrument - Classification
All analytical devices can be classified under 2 categories viz.
Equipment and Instrument.

A device used to collect the scientific


Instrument
data and measurement of results
Analytical
Device
Refers to the various supporting tools
Equipment used for performing analysis in the
laboratory
What is Calibration?

A test during which


known values of
measured are applied
to the transducer and
corresponding output
readings are recorded
under specified
conditions
WHAT ARE THE CHARACTERISTICS OF A
CALIBRATION?

Accuracy: The ratio of the error to the full scale output or the
ratio of the error to the output, expressed in percent span or
percent reading, respectively.

Accuracy :The closeness of the agreement between the result


of a measurement and a true value of the measurand.

Tolerance: Permissible deviation from a specified value; may


be expressed in measurement units, percent of span, or
percent of reading.
Contd..
Traceability: The property of a result of a
measurement whereby it can be related to
appropriate standards, generally national or
international standards, through an unbroken chain
of comparisons.

Note this does not mean a calibration shop needs


to have its standards calibrated with a primary
standard.

For example, the National Institute of Standards


and Technology (NIST), formerly National Bureau of
Standards (NBS), maintains the nationally
recognized standards.
Traceability Pyramid
WHY IS CALIBRATION REQUIRED?

Instrument error can occur due


to a variety of factors: drift,
environment, electrical supply,
addition of components to the
output loop, process changes,
etc. Since a calibration is
performed by comparing or
applying a known signal to the
instrument under test, errors
are detected by performing a
calibration.
Errors

An error is the algebraic


difference between the
indication and the actual
value of the measured
variable.

Different types of error:


• -Span Error
• -Zero Error
• -Combined Zero and Span Error
• -Linearization Error
Contd..
-Zero error
Contd..
-Span error
Contd..
-Combined Zero and Span error
Contd..
-Linearization Error
INTERNATIONAL ORGANIZATIONS

International Bureau of Weights and Measures, France

International Electrotechnical Commission, Switzerland

International Federation of Clinical Chemistry and Laboratory Medicine, France

International Organization for Standardization, Switzerland

International Organization of Legal Metrology, France

International Union of Pure and Applied Chemistry, United Kingdom

International Union of Pure and Applied Physics, Sweden


Lab’s Goal - Reliable Results
Reliable instruments
• Buying the right instrument
• Ensuring its performance (accuracy, precision, etc)

Validity of analytical methods

Proper training of analysts


Choosing the Right Instrument
Start with Accurate Monitoring Instruments:
No matter how sophisticated the calibration
procedure is, it cannot compensate for the
inherent performance limits of the
instruments it calibrates.

No amount of calibration or re-calibration


will improve the accuracy of an instrument
as a measuring device.
Choosing the Right Instrument - Contd

Is the instrument calibration NIST traceable?


• Tells about the instrument/standard that was used for calibration
• Nothing about the performance of the test instrument itself
Components of Analytical Instruments

The collective analytical


measurement instruments, in A device or collection of
conjunction with firmware, components that perform a
assembled to perform a process to produce a result
mechanical process.
Instrument Procurement and Life Cycle

IQ – Installation qualification , Operating Performance , User Requirement Specification ,


Standard operation procedure
Calibration Program – Quality System
System must be in place to
ensure that all instruments are
calibrated and also to prevent
use of an instrument that is not
calibrated, unusable due to
damage or malfunction, or has
exceeded its established
calibration interval

System must be in place that


identifies instruments that do
not require calibration to be
performed beyond the original
or factory calibration to
distinguish from those
instruments that do require
scheduled calibrations
Calibration Frequency
manufacturer’s recommendations

relevant procedures – sensitive?

instrument performance history

overall impact of non-compliances in the


calibration process and previous experience of the
laboratory technical staff.
Unplanned Calibration

“Unplanned” Calibration can


be called for:

When the instrument is


physically moved to a
different location within a
lab

Questionable or ambiguous
results are obtained –
perhaps as a part of
investigation
Calibration Specification

Instrument calibration tolerance limits should be established


so problems are identified and corrected in a timely manner

When assigning tolerances, considerations given to:

• Capability of the instrument being calibrated (what the manufacturer


claims the instrument can achieve).
• Parameters at which the instrument operates (ex: if testing accuracy of +
0.5% is required, the instrument calibration tolerances should be <0.5%)
• Work environment - environmental conditions can affect the performance
of the instrumentation
Success of Calibration

Recognition and
Consistency of mitigation of
results obtained outlier/potential
outliers

Scientifically
designed
calibration
frequency
Calibration – Quality System
Systems to
prevent
usage of
Limits of instruments
Specific accuracy & failing
Directions precision calibration

Schedules Remedial
Actions
Tracking Instruments for Calibration Status

Each instrument given a unique identifier

Instrumentation details associated with this number must be documented and available
(e.g. serial number, model number, location, etc.)

Each instrument should be labeled with the unique identifier physically and in database
also

Calibration status of each instrument , the date of calibration, the next calibration date and
the identification of person performing calibration should be readily available

Appropriate systems to document calibration status include calibration logs and calibration
stickers
Calibration Process
Written calibration procedures that use traceable calibration standards or
calibration equipment.

Qualified individuals (having the appropriate education, training, background


and experience) responsible for calibrating & maintaining instrumentation

Second person check of all calibration tests

Qualified individuals responsible for monitoring the calibration

Ensure the calibration program and procedures are reviewed and approved by
Quality
Calibration Process - Contd
Each calibration & maintenance procedure should
include the following:
• Identification of department responsible to perform the
calibration or maintenance
• Step-by-step calibration instructions, reference to appropriate
calibration procedures or instrument manuals
• Methods for preventive maintenance or reference to
appropriate instrumentation manuals
• Calibration equipment used in the calibration are valid (e.g.
spectroscopy filters, voltmeters, digital thermometers, etc)
• Calibration parameter and tolerance ( + )
Out-of-Calibration Procedure

• If calibration is not complete within time.


• Results from the calibration do no meet set criteria.

Identification of Causes
• Training of analyst for calibration procedures.
• Glassware/Standards – Cleanliness, Validity etc.
• History of malfunction/breakdown and maintenance.
• Review of previous calibration report.
Out-of-Calibration Procedure - Contd

• Data generated from the successful calibration till the next


calibration is evaluated for the “Impact”. If Impact analysis reveals
suspect results, random batches/products are picked up and
analyzed and results are compared to the ones obtained from
OOC instrument.
• If the results are different, then appropriate evaluation and
justification need to be provided (QC/QA).
• Based on the outcome of the investigation, CAPA is implemented
and the re-calibration is performed.
Records for Calibration

• All calibration records must be retained per document retention


procedures
• Should include “as found” measurements, results of adjustments (“as
left”) and appropriate review & approval of all results
• Tolerance or limit for each calibration point
• Identification of standard or test instrument used
• Identification of persons performing the work and checking the
results with dates
After Calibration

 Review must ensure the approved activities have been completed


and all results have passed the established acceptance criteria
 Actions to be taken if instrumentation cannot be calibrated (e.g.
contact appropriate service people, label and remove from service)
 A step to record all calibration & maintenance activities
 Periodic review of historic calibration & maintenance data to
evaluate appropriateness of established frequencies

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