Calibration systems

127
Version 1.0 MIII/CH1/1 STQC CERTIFIED CALIBRATION PROFFESSIONAL MODULE - III

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Page 1: Calibration systems

Version 1.0 MIII/CH1/1STQC

CERTIFIED CALIBRATION PROFFESSIONAL

MODULE - III

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Calibration A set of operations, performed in accordance with a definite documented procedure, that compares the measurements performed by an instrument to those made by a more accurate instrument or standard, for the purpose of detecting and reporting or eliminating by adjustment, errors in the instrument tested.

As per ISO/IEC Guide 2

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Calibration definition (a)operation establishing the relation between quantity values provided by measurement standards and the corresponding indications of a measuring system, carried out under specified conditions and including evaluation of measurement uncertainty

definition (b)operation that establishes the relation, obtained by reference to one or more measurement standards, that exists under specified conditions, between the indication of a measuring system and the measurement result that would be obtained using the measuring system

As per VIM

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Why to Calibrate ?• Initial calibration assures T&ME with in Spec

• Periodic calibration is essential to maintain control of measurement process made by TME

• Assures common reference i.e Traceability to National / International standards

• Ensures that equipment has been satisfactorily working since last calibrated & assumed that the equipment continues to work satisfactorily until next calibrated

• Calibration records study enables extending/reducing the calibration interval

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OBJECTIVES OF CALIBRATION

Uncertainty limits

Traceability

Reference

measurements

Maintaining traceability of measurements

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Why Calibration & Traceability are intertwined?

• To measure the “Same Measure” • Interchangeability of products• Legal requirement & consequence of

liability• To demonstrate metrological confirmation of

product• Consistent control of product/measurement

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When is calibration not required?

• When equipment is not in use .• When eqpt is used as null detector• When eqpt is used as transfer device whose

measurement or output value is not explicitly used.

• Fundamental / Absolute standards.• When instrument is fail-safe• When instrument makes measurements or

provides known outputs which are monitored by a calibrated device, meter or gage during use.

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When to Calibrate ?- Calibrate too often it is waste of time and money.- Calibrate too seldom it is waste of product or

wrong decisions.- Balance between cost to calibrate and cost not to

calibrate- Universally Applicable single best practice for

establishing & adjusting cal interval not available. - Refer DAP, RP1

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Where to Calibrate?• Calibration is performed in the I/II/III party

laboratory under controlled environment. (The environment need only to be controlled to the extent required.)

• Accredited Calibration Laboratory

• Manufacturer’s / Supplier’s Laboratory ensuring valid traceability

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Where to Calibrate ?contd…

• Accredited Laboratory ensuring the quality of calibration services.

• In the absence of the above, the services of calibration laboratory for the parameter of interest may be availed ensuring meeting technical requirements of ISO/IEC 17025.

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Basic Requirements - Location/ Environment

• Noise Level• Vibration• EMI/EMC• Cleanliness• Lighting• Power supply• Accessibility

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Basic Requirements – Location/EnvironmentQuiet * Away from heavy traffic, factories, workshop etc * Effective separation from non compatible areas * Noise : less than 60 dbA * Vibration :

Taken care in building design & site selectionnoticeable in galvanometers, mercury column, massbalance, dimensional measuring equipment 0.25μm max displacement amplitude from 0.1Hz to 30Hz and 0.001 g max 30Hz to 200Hz

* EMI : * taken care in site selection & use of shielding/ filtering * field strength to be less than 100μV /m

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Clean Good house keeping

Higher degree of particulate control (Dimensional & Mass Metrology)

Good lighting Recommended level of illumination is 450 – 700lux

Fluorescent lamps preferred to minimize heating effect Services Separate feeder line

Uninterrupted / Regulated power supply (+- 5%)Adequate measures against spikes & transientsMains Earthing (< 1 ohm)Adequate measures against ground currents

Basic Requirements – Location/Environment

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Accessibility

Standards / equipmentFirefighting devicesQuality System Document & InstrumentManuals

Basic Requirements – Location/Environment

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Calibration laboratory - basic requirements

Location – Permanent/On-site

Environment Equipment Staff Management

Temperature Humidity Air flow Filtration Electromagnetic Screening Noise Level Vibration EMI/EMC Cleanliness Lighting Power supply Accessibility Receiving & Calibration area

Reference standards Transfer StandardsWorking standardsConnecting leads adaptors/accessoriesSubsidiary equipmentComputers & automation software

Training Authority Responsibility Technical Competence

DocumentsRecordsCalibration

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Basic Requirements – Equipment

Transfer StandardsReference standards (Optional)Working standardsConnecting leads and adaptorsSubsidiary equipmentComputers & automation software

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Basic Requirements – Personnel

TrainingAuthorityResponsibilityTechnical Competence

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Basic Requirements – Management

Quality management & Technical operations

TraceabilityCalibration intervalAudits/ Management reviewsImplementation of corrective /preventive

actions

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Calibration System

Why Calibration system ?- To meet the commitment of the industry to

provide quality product.- TMI is required to be controlled to provide this

assurance.- Through calibration- Shall include all the elements necessary for

ready detection of equipment deficiencies and provide objective evidence of conformance in the form of records.

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Calibration System

It is defined as a set of inter-related and interacting elements which influence the calibration process and ultimately quality of calibration result.

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Elements of Calibration System

• Qualification • Measurement traceability • Adequacy of calibration procedure• Calibration procedure• Qualification labeling• Sealing for integrity• Calibration interval• Records Maintenance

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Elements of Calibration System contd…

• Environmental Controls

• Handling , Preservation & Storage

• Non- conforming Measurement Equipment

• Scheduling / Recall system

• Personnel requirement

• Audit requirement

• Calibration Quality

• Use of outside service

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ACCREDITATION REQUIREMENTS

The laboratory must demonstrate control and competence Environmental control Traceability of standards Calibration procedures Competence of staff / Authorization of personnel Participation in PT programmes In-service checks/ control charts Validation of methods Internal audit & Management review records

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CHAPTER - 1

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Procedure

-Ensures consistency in operation

-Objective evidence

Calibration procedure provides

-Specified performance tolerance and functional criteria

-Essential information & instruction to determine the integrity of eqpt.

-Logical & timely sequence of necessary facts to understand and

verify DUC to its intended performance capability.

CALIBRATION PROCEDURES

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- Guides personnel

- eqpt. Setup, interconnection, control operations

- specification interpretation

- tolerance limits

- any adjustment, correction

- Establish uniformity of methods/techniques

- Shall be written such that personnel shall take minimum interpretation,

effort and time.

- Shall be written by keeping performance of DUC in mind.

CALIBRATION PROCEDURES

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Requirements

Source:

-Prepared internally

-Prepared by the manufacturer

-External agency

CALIBRATION PROCEDURES

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Completeness:

- Sufficient instruction

Approval:

- shall be approved and controlled to meet regulatory and contractual

requirements.

Software:

- Validation and control

CALIBRATION PROCEDURES

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BROADLY COVERS -

- Performance requirements of DUC

- Performance requirements of standard

- Preliminary operation

- Calibration process

- Calibration results

- Closing operation

- Storage and handling

CALIBRATION PROCEDURES

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• Appropriate identification / document control.

• Scope

• Purpose - description & performance requirements of unit being calibrated

• Parameters or quantities and ranges

• Calibration equipment/system/setup

• Reference standards and reference materials required

• Reference Documents – standard/specifications/manuals

• Adaptors/Accessories required

• Environmental conditions required including stabilization period needed.

CALIBRATION PROCEDURES – TYPICAL CONTENT

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• Description of the procedure, including – Apprising of identification mark, sampling, handling, transporting,

storing and preparation of items.

Preliminary Checks to be made before the work is started. Checks that the equipment is working properly, and where required , Calibration process & adjustments if any, of the equipment The method of recording the observations and results. Any safety measures/precautions to be observed.

• Criteria and / or requirements for approval / acceptance / rejection.

• Data to be recorded and method of analysis and presentation.

• The uncertainly or the procedure for estimating uncertainty.

• Calibration status/labeling

CALIBRATION PROCEDURES – TYPICAL CONTENT

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CALIBRATION PROCEDURE CONTROL

Deviations from instructions authorized & recordedAssign responsibilityEstablish document control with a standard formatDraft, comment and edit procedures/instructionsReview and authorize proceduresPrint, bind, present and make available to all operational

staffRegular review and amendment as needed Archive the superseded methods

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CALIBRATION PROCEDURES

EXERCISE – 1

DEVELOPMENT & REVIEW OF PROCEDURES

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Section II

-table defining performance specification (minimum use specification)

required of the standard

-Listing of specific manufacturer model (representative eqpt.) which are

applicable and can operate with in the specified requirements. Equipment

which has no known substitute should be clearly identified and described.

-Environmental condition

-Any special jigs and fixtures required

CALIBRATION PROCEDURES

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Section III

-Listing of all preliminary actions including functional checks to be performed

prior to calibration

Section IV

-Listing of instructions and all steps to be performed in measurement process

Section V

-A results data sheet blank form with nominal values and tolerance limits.

CALIBRATION PROCEDURES

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CALIBRATION METHODS

• Standard methods – Direct/Indirect/Ratio/Substitution/Transfer/Differential

• Non-standard methods

• Laboratory developed methods

• Expansion of Scope

• Customer given methodNEEDS VALIDATION

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VALIDATION OF CALIBRATION METHODS

• Selectivity • Uncertainty of the results• Range• Repeatability• Reproducibility• Linearity• Limit of detection• Limit of quantization• Robustness• Bias• Precision

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GENERAL CALIBRATION TECHNIQUES

• SPANNING

• NULLING

• ZEROING

• LINEARIZATION

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GENERAL CALIBRATION METHODS

• If the nominal value of UUC is same as that of reference comparison may be made using Nulling process.

• Instruments like Galvanometers, Null Detectors & Comparators work on this principle. The scale indicates the sensitivity of detection in these meters.

• Nulling is used for more accurate measurements since Null process can be quite sensitive to minute difference between known & unknown values.

• Note that the Null detectors need not be calibrated at all for the measured values & the sensitivity of detection is by design, by scale of indication.

NULLING

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GENERAL CALIBRATION METHODS

• a compensation technique for offset errors due to device to device offset, variation (trim errors), mechanical stresses (mounting stresses), shifts due to temperature and aging.

• For zero referencing for >0 measurements

• adjusting an instrument to read zero manually / auto zeroing

ZEROING

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GENERAL CALIBRATION METHODS

- is adjusting the instrument to read the known concentration of a gas / material / chemical

- Range of parameter which the unit/equipment can measure

- Scale of measurement

SPANNING

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GENERAL CALIBRATION METHODS

- are commonly performed during instrument start-up or before calibration.

Ex.: The monitor’s combustible and toxic sensors are zeroed (adjusted to zero) in a known fresh air environment and the oxygen sensor is spanned to fresh air (21%). It is critical that this only be con- ducted in a known fresh air environment. 

SPANNING & ZEROING

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GENERAL CALIBRATION METHODSLINEARIZATION

To approximate a nonlinear system by a linear one is called Linearization.

Ex.: Interfacing an NTC thermister to a computerized data acquisition system linearization is used to convert the resistance output of the

thermister to voltage.

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Ensure laboratory has competence to choose the appropriate methods

ensure laboratory selects and uses test and/or calibration methods that:

• meet the needs of the customer • are appropriate for the calibration task• the customer has been informed of the method chosen (if not

specified)• where appropriate, are based on latest international, regional or

national standards and where necessary the standard be supplemented with additional details to ensure consistent approach

• have been verified for use in the laboratory, if a standard method

CALIBRATION METHODS SELECTION

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CHAPTER - 3

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Basic Requirements – Environment

TemperatureHumidity Air flowFiltrationElectromagnetic Screening

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Basic Requirements – Environment

Temperature* Lab design to take into account heat generation through personnel, equipment, light etc

* Recommended continuous & permanent recording* Temperature monitoring to be installed at eqpt. or operator level* Avoid temp gradient through uniform air flow* Precise metrology requires tight temp control & measurement of actual temp. to apply meaningful corrections* Allow artifact / eqpt. to attain thermal equilibrium (warm up)

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Basic Requirements – Environment Humidity

* Both low & high humidity to be avoided : static electricity & leakage path* 45 + 10% RH recommended for all general lab

Air flow* A well designed system to provide uniform air circulation with out stratification to minimize temp gradient in & around the lab* Floor to ceiling vertical laminar flow of air is recommended to minimize temp gradient to + 0.1 0C* Air velocity of 0.71 + 0.28 cubic mts /minute recommended (3 to 5 ft above the floor)

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Basic Requirements – Environment

Filtration* Provide filtration to limit particulates* High degree of particulate control : optical, mass,

dimensional metrology etc. Electro-magnetic Screening

* Field strength to be less than 100μV/m* For conducted electromagnetic energy on power lines,

open circuit voltage to be less than 100mV* Provide adequate shielding/ filtering.

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Accommodation of Cal Lab.Accommodation is the premises where the laboratory functions are carried out.Considerations :

Design and construction materials Space including storage Services and facilities Access, housekeeping, security and safety Separation of incompatible activities Area for administrative duties

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Control of Environmental Parameters

• Define critical environmental parameters that affect quality of calibration result

• Define nominal values & tolerable limits• Monitor environmental parameters• Take remedial measures, if required• Halt Calibration process, if environment is not

conducive.

Refer RP 6 on Laboratory Design

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Recommended Env. Conditions- as per RPCL by CLAS in PALCAN Handbook published by Council of Canada

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1.1. Clean & vibration free location for Monitoring & Clean & vibration free location for Monitoring & Measuring devices.Measuring devices.

2.2. Temperature : Ambient / 23 ± 1 °C OR 23 ± 2 °c Temperature : Ambient / 23 ± 1 °C OR 23 ± 2 °c 3.3. Humidity : 50 ± 10 %Humidity : 50 ± 10 %4.4. Illumination level : 250 – 450 (700 lux)Illumination level : 250 – 450 (700 lux)5.5. Noise level – Below 60 dBA where meas. are affectedNoise level – Below 60 dBA where meas. are affected6.6. Rigid table for installation of equipmentRigid table for installation of equipment7.7. Noisy vacuum source and Pneumatic cylinder to be Noisy vacuum source and Pneumatic cylinder to be

outside the calibration/inspection room/areaoutside the calibration/inspection room/area

ACCOMMODATION & ENVIRONMENT - TYPICALACCOMMODATION & ENVIRONMENT - TYPICAL

REFER NABL SPECIFIC CRITERIA 121 - 126

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Laboratory Storage Space Storage must also be such as to not interfere

with test or calibration results. Proper storage is needed for : Calibration jobs (current and retained) Working materials/consumables/adaptors/accessories/cables

etc. Laboratory documents Hazardous substances Staff belongings Clerical materials and equipment Laboratory records

REFER NABL SPECIFIC CRITERIA

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CHAPTER - 4

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a) Handling, storage, preservation, transportation, safety & security of Calibration unit/equipment/job

b) Customer requirements

c) Laboratory capabilities – availability of personnel, cal facilities, technical competence, cal method, accommodation & environment, traceability, sampling etc.

d) Calibration – measurement data, computations, uncertainty budget, compliance of results

e) Reporting results – preparation, approval, issue

f) Labeling

g) Post cal service activities

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• is available and functioning properly• is capable of achieving required accuracy• complies with relevant specifications• has calibration programs established for key quantities or

values• is calibrated or checked before being placed into service• is checked and/or calibrated before use (see 5.6 also)• is operated by authorised personnel• has current instructions on use and maintenance• is uniquely identified, where practicable

Record of specification checking and maintained evidence.

Calibration Equipment

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• identity of the equipment and its software• manufacturer’s name, model, and serial number or other

unique identification• evidence that the equipment complies with the accuracy

requirements and specifications relevant to the tests or calibrations

• current location, where appropriate• the manufacturer’s instructions, if available, or reference

to their location• calibration history and due date of next calibration• the maintenance plan, where appropriate, and maintenance

carried out to date• any damage/malfunction/modification/repair to the equip.

Equipment Records

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ensure procedures for measuring equipment are documented and include:

• safe handling• transport• storage• use• planned maintenance –

Preventive/Breakdown/In-service Checks, Intermediate Checks

• where applicable, that copies of correction factors are correctly updated

Equipment handling

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ensure equipment subjected to overloading or mishandling, giving suspect results, or shown to be defective or outside specified limits is taken out of service, and is:

• isolated or clearly labelled or marked as being out of service

• examined for the effect of the defect or departure from specified limits on previous tests and/or calibrations

• addressed under the “Control of nonconforming work” procedure

Have a procedure for handling such situations

Equipment out-of-service

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• Ensure equipment calibration status is identified• Calibration labelling based on Cal agency

• where practicable and where intermediate checks are needed to maintain confidence in the calibration status that a procedure is documented to carry out these checks

Label that indicates date of calibration due date for next calibration, person responsible for calibration.For items where marking cannot be done it e.g. Weights, gauges, the status can be put in the Register/colour coding etc.

Calibration Status

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CALIBRATION AS A PROCESS

Process A – Preparation of list all test & measuring equipment that need to be under calibration control.

Process B – Calibration of various test and measuring equipment (in-house calibration), if facility exist.

Process C - Calibration of test & measuring equipment (from external Calibration lab)

Process D -Verification of calibration results for compliance to measurement requirements

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Measuring Equipment – Process Model

Instrumentation DisplaySensor

Measurand Result

Sensor may not be required in every case

MEASURING PROCESS

I/PO/P

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Measuring Equipment

• Measuring instrument/system• Software• Reference standard/material• Auxiliary apparatus/Adaptors/Accessories/Cables etc.• Any combination of the above

Measuring equipment requires metrological confirmation

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Leading Instrumental Characteristics• Range• Error• Resolution• Drift• Input Impedance (Loading effect)• Compatibility between sensor & Instrumentation• Input – Output relationship (characteristic)• Hysterisis• Ruggedness• Mounting

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Checks on Measuring Equipment

• Mechanical Zero / Zeroing /Auto zero• Check-up of readings during ascent & descent • Check-up of resolution• Check-up of linearity error, if any• Repeatability of measurements• Reproducibility of measurements

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Metrological Confirmation of Eqpt.

• Set of operations required to ensure that measuring equipment conforms to the requirement for its intended use.

- Brings in the concept of “Calibration”

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Calibration

• Comparison of an unknown measurement device against an equal or better device (TUR/TAR)

• Unknown device is called– Equipment under Calibration (EUC)– Unit under Calibration (UUC)– Device under Calibration (DUC)– Device being Calibrated (DBC)

• Equal or better device is called “Standard”

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Calibration Process• Identification of need/Customer’s requirements• Availability of specifications for DUC• Serviceability status of DUC• Laboratory Capability• Availability of validated method/competence• Availability of Instruments /Standards• Technical comparison of DUC with Instrument / Standards• Repair / adjustment / recalibrate, if required• Verification of Confirmation• Uncertainty computation• Preparation of Calibration Report/Certificate• Status Identification

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CALIBRATION JOB FLOW

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Calibration - Job Flow Chart

Customer Service

Ext Int

Job card to SCL

Calibrate

Compile result error/uncert.

Fix label

DUC with cal report

TP & C

QA

Job accepted

Int. DUCOut of Spec

R & M

DUC after R&R

CAL

N YAny

Non-confor-mance

CERT. Cleared

T P & C

CERT. Issuedwith Item

EXT INT

Check pointsY

N

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Receiving Evaluation

In-house Calibrations

Report and record processing

Delivery / Shipping

In-house repair

Control of outside supplies and services

Customers

Calibration v/s Business Processes

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Role, Responsibilities & Authority Job descriptions

• HOL,Technical & Quality Managers• Scientists and Technicians • Attendants• Those who verify, test and check• Sampling officers• Those who act in Emergency

Performance Criteria Performance appraisal

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• Provide direction and coordinate the departmental activi ties in technical, commercial and service establishment

• Reviews and analyzes reports, records, and other information for planning laboratory’s growth, such as new commitments, status of work in progress and problem encountered.

• Assigns or delegates respon sibility for, specified work or functional activities and disseminates policy to down the line.

• Gives work directions, resolves problem and set deadlines to ensure timely completion of work.

• Coordinates activities of various departments with related activities of other departments to ensure efficiency and economy.

• Monitors and analyzes costs and prepares budget. • Prepares reports and records on department activities for management. • Evaluate current procedures and practices for accomplishing

department objectives to develop and implement improved procedures and practices.

Laboratory Manager/Chief Executive

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• Assurance of Quality of Calibration Results• Ensuring implementation of Management system • Document Control activity• Planning, conducting, compiling & analyzing Internal audit

programme• Organizing, conducting Management Review & maintaining

records • Monitoring corrective & preventive actions on non-

conforming cal services ensuring effectiveness• Handling, investigating, analyzing & resolution of Customer

complaints• Liaison with internal/external customers, accreditation

body w.r.t quality matters affecting calibration.• Reports to Management

The Role of Quality Manager

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• selection, approval and commissioning of test methods• Management and training of staff• Evaluation and sign-off of staff competency• Management of laboratory equipment and facilities• Design and implementation of the QC programme• Stopping work when QC criteria are exceeded• Attention of matters relating to impartiality and

confidentiality• Responsibility for the technical validity of results• Liaison with the QM in relation to Quality matters affecting testing or calibration.• Reports to TM

The Role of Technical Manager

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The Role of METROLOGIST

• Develops and evaluates calibration system that measure characteristics of objects, substances, or phenomena, such as length, mass, time, temperature, electric current, luminous intensity, and derived units of physical or chemical measure

• Identifies magnitude of error sources contributing to uncertainty of results to determine reliability of measurement process in quantitative term

• Redesigns or adjusts measurement capability to minimize errors • Develops cal ibration methods and techniques based on principles of

measurement science, technical analysis of measurement problem, and accuracy and precision requirements

• Directs engineering, quality and laboratory personnel in design, manufacture, evaluation, and calibration of measurement standards, instru ments, and test system to ensure selection of approved instrumentation

• Advises others on methods of resolving measurement problem and exchanges information with other metrology personnel through participation in govern ment and industrial standardization committees and professional societies

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• Review/Acceptance/follow-up of jobs received from customer service to meet committed PDC for the same.

• Preparation of calibration schedule if required and Allocation of work

• Maintenance of lab. environment conditions ensuring good house keeping

• Periodic monitoring of observations/ measurements/ compiled data during execution of the job & responsible for the technical validity of results

• Preparations of test/cal procedures & implementation after due approvals

• Qualifying label for the T&M equipment calibrated

The Role of Laboratory In-Charge

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• Maintenance of equipment in the qualifying condition along with respective manuals/ technical data & history log books ensuring traceability

• Maintaining registers used in the laboratory of the laboratory area

• Co-ordination with lab. staff, customer service & other support services

• Technical guidance to the laboratory personnel in calibration & Implementation of the QC programme

• Attention of matters relating to impartiality and confidentiality

• Liaison with the Quality Manager in relation to Quality matters affecting calibration.

The Role of Laboratory In-Charge

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Roles of Cal Lab. personnel• Responsible for the calibration activity

• Carrying out Calibration as per standard/validated cal methods

• Preparation of Cal reports, affixing cal label on equipment calibrated.

• Building technical competence in the area of service being provided

• Any cal facility giving intermediate operation/ambiguous results/mal-

functioning should be immediately reported to LIC/TM

• Maintain the laboratory facility with appropriate use

• Maintaining calibration service related records

• Maintaining records reg. environmental controls

• Maintaining Calibration/Maintenance manuals of cal facilities & traceability

records

• Reporting to LIC/TM

• Any other as assigned from time to time

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“Approved Signatory” Personnel Technical Competence including: Relevant qualifications and/or experience. Close involvement in the day-to-day operations. Familiarity with test procedures including scientific basis

and technical limitations. Ability to make critical evaluation of test results. Knowledge of Quality Management system. Knowledge of and commitment to AB and their criteria

and ISO/IEC 17025. Sufficient time in the laboratory to become fully familiar

with the operating systems of the laboratory.

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SCHEDULING

- CALIBRATION INTERVAL

- CONFIRMATION INTERVAL

- RECALL NOTIFICATIONS

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Calibration Interval / Reports

Initial Calibration:

Comparison w.r.t common referenceEither to know The deviation/value(measurand &MeasurementUncertainty (Report 1)

Calibration adj.Procedure adopted To ensure the tracking of theMeasurand to that of reference

Final calibration:

To confirm thesuccessfulnessOf the operation

(cal adj.procedureImplementation)(Report2)

Report1-Report2

?

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Time

Effect of drift on uncertainty of measurement

Uncertainty of measurement

Within Calibration Interval….

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Effect of right time cal. Adj. on uncertainty of measurement

Uncertainty of measurement

adjustment carried out

Calibration Interval Management

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Scheduling Calibration Interval

• Client agreedreported as ‘Client Agreed Calibration Interval - '.

• Client specifiedreported as 'Client Specified Calibration Interval - '.

• Manufacturer's recommendedreported as 'Manufacturer's Recommended Calibration Interval - '.

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• MANUFACTURER’S RECOMMENDATION• EXTENT & SEVERITY OF USE• MAX. ALLOWED DEVIATION• UNCERTAINTY OF MEASUREMENT REQUIRED• INFLUENCE OF ENVIRONMENT• ADJUSTMENT/CHANGE REQUIRED• PUBLISHED DATA ON SIMILAR DEVICES • BY EXPERIENCE• HISTORY OF EQUIPMENT• QUALITY OF CALIBRATION & COST FACTOR

T&ME or M&ME ARE TO BE CALIBRATED WHENEVER THEY ARE REPARIED.

INITIAL CHOICE OF CI INITIAL CHOICE OF CI

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OPTIMUM INTERVALOPTIMUM INTERVALA BALANCE BETWEEN THE COST TO CALIBRATE & THE COST NOT TO CALIBRATE SHOULD BE EVALUATED.

AT PRESENT THERE IS NO UNIVERSALLY APPLICABLE SINGLE BEST PRACTICE FOR ESTABLISHING AND ADJUSTING CAL INTERVAL.

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RECALL NOTIFICATION

• INTERNAL EQUIPMENT

• EXTERNAL EQUIPMENT

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CHAPTER - 5

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Manual Calibration

• Availability of Calibration facilities / System

• Qualified & trained personnel

• Availability of suitable environment

• Traceability of standards

• Device under calibration• Calibration Method (Validated)

• Measurement records

• Uncertainty computations

• Calibration Reporting

The traditional method of obtaining parameters, requiring extensive training, time, and labor

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Automated Calibration

1. Computer Systems or Automated Equipment

2. Calibration software / Automated SW Program are useful to process

• Large quantity of TME• Lower skilled personnel• Large volume of data used for capture, processing ,

recording, reporting, storage or retrieval of calibration data.

3. Interface / Compatible DUC

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Examples: Automated Calibration- to the extent supported by HW

1. DMM Calibration batch-wise

2. Batch temp. probe calibration

3. Batch Energy Meter Calibration

4. Calibration of ref. pressure transducers

5. Calibration of RF Power sensors

6. AC/DC Transfer standards Calibration

7. Etc..

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Software Programme

• Design Application Software

• Develop/Construct Application Software

• Test Application Software

• Procure Application Software

• Operate Application Software

• Maintain Application Software

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Major Elements of Software Programme

• Software development

• Software procurement

• Software Configuration Management

• Software operations

• Documents

• Record keeping

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Software Development

• Quality planning based on requirements

• Multi-phased Software Life Cycle Process– Requirements, design, construction, testing, installation,

operation, maintenance & retirement

• Software Review, Verification & Validation

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Software Validation

• Comparison of manual and automated methods

Inspection of procedure.

• Inter-laboratory comparison

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Software Procurement

• Requirements & Activities

• Applicable Guidelines

• Dedicated/designed/custom made

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Software Configuration Management

• Identification

• Change Control

• Status Accounting

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Software Operations

• Access Control

• Backup & Recovery

• Problem Reporting & Corrective Action

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Documentation/Records

• Software Design & Development Procedure

• Plan for Software QA

• Software Requirements Documentation

• Software Design & Implementation Documentation

• Software verification & validation Documentation

• User Documentation

• Standards / Specifications applicable

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SAMPLE OF AUTOMATED AND MANUAL SYSTEM EQUIPMENT COSTS

Equipment Automated ManualSPRT $ 3,000 $ 3,000Recording thermometer $ 7,000Nano volt meter / Mohm $ 3,500Ice point reference for T/Cs $ 600Dual Dry-Block –35 ºC to 670 ºC $ 8,900 $ 8,900Computer $ 1,500 $ 1,500Automated software $ 1,300Report generation software $ 500Total $ 21,700 $ 18,000

Automated Calibration

(Fluke analysis)

Automated batch calibration systems for industrial sensors may have batch/volume efficiency advantages, in time savings and increased productivity for calibration laboratories that find themselves with increasing temperature probe workloads.

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Internet Enabled CalibrationRecommendations as per NPL, UK Report CMSC 28/03

SECURITY ISSUES

• Authentication• Access Control• Confidentiality• Integrity• Non-repudiation• Availability• Audit• Privacy• Certification• General Protection

TECHNIQUES

• userid/password protection • Algorithms for encryption of sensitive measurement data

• Message authentication code for certificate, Measurement data

• MySQL vulnerabilities

• Backups and fire safes

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CHAPTER - 6

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Calibration Results

- Based on following technical records

• Original Observations

• Calculations/Computations and data transfers

• Calibration Report Format

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Report and Certificate format • Appropriate to each type of test/calibration• For easy understanding / to avoid misuse

Reporting Calibration Results

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Calibration Reports / Certificates • Calibration Report

A calibration report usually provides a set of results that show the performance of the instrument being calibrated in comparison to a reference instrument or standard. Measurements are recorded for each function, range and points tested, and the uncertainty of each measurement is reported.

• Calibration Certificate

A calibration certificate usually states the compliance of an instrument with the manufacturer's specification. Measurements made by the instrument being calibrated are compared to the manufacturer's specification. If the instrument is within specification, a statement that the instrument meets the manufacturer's specification at the points tested is made in the conformance certificate. Any points that are outside specification, or not able to be determined, are reported as exceptions. Assessment of meeting the manufacturer's specification takes into account the measurement uncertainty. A statement of conformance to the manufacturer's specification may also be given in calibration reports.

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Calibration Reports / Certificates

• Accurate, clear, unambiguous & objective• No recommendation for Calibration interval,

unless asked for• Confidentiality in electronic transmission• Specified & approved format• Specific statement for amendment• Must include information requested by customer

Sample report/certificate formats refer NCSL, RP-11

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Contents of A Calibration Report a) A title -Test report/Calibration certificate

b) Name and Address of laboratory

c) Unique identification of the report/certificate

d) Name and address of customer

e) Identification of method used

f) Unambiguous identification of item

g) Date of receipt / performance of Test / Calibration

h) Reference to sampling plan / procedure

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Contents of Calibration Report contd..I) Test/Calibration results and units of measurement

j) Name, function, Signature of person authorizing the report/certificate

k) Statement-result related to the item Tested/Calibrated

l) Calibration Results with Units

m)Name(s), function(s) and signature(s) or equivalent identification of person(s) authorizing the report or certificate;

n) Statement to the effect that the results relate only to the items tested or calibrated, where relevant;

o) Subcontracted results clearly identified.

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Calibration Reporting

Calibration Result Interpretation where necessary ensure calibration certificates include the following:

• Calibration conditions• Uncertainty of measurement• Measurement traceability statement• Statement of compliance with an identified metrological specification or clause• Compliance data records• Repairs/adjustments if any• Calibration Interval• Estimated Uncertainty

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Amendment/Supplement to Report

• Identification or reference to the original report identity.

• when a complete new test report or calibration certificate is required, it must be uniquely identified and include a reference to the original it replaces

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Acceptance of Calibration Report

• Do you accept them or not? • How do you know if they are okay to

accept? • What are the related issues? What are the

steps to determine what is okay and what is not?

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Acceptance of Calibration Report• evaluate the "scope of accreditation." The laboratory scope, which is

published with the accreditation or recognition certificate, defines the parameters and associated uncertainties that have been assessed by the accreditation bodies.

• An accreditation body logo• evaluate standards to ensure suitability & Forward traceability report

5.6.2 Show unbroken chain of traceability from an instrument to national standards.

• Rights to revoke acceptance of certificates for cause (bad measurement results) & seek clarifications

• Calibration certificate contents as per 5.10 of ISO/IEC 17025.• Due for calibration 5.6.1 – determine instrument exceeded cal interval. • Reverse Traceability report 4.9.1- Identify all the instruments that

are affected if corrective action is neccessiated

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HANDLING DEVIATIONS - FROM CALIBRATION QUALITY LEVEL

1. Interval adjustment

2. Procedure Changes

3. Specification Revision

4. Derating or limited Calibration

5. Removal of equipment from services

6. Instrument Repair & Recalibration

7. Upgradation of equipment

8. Replacement

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CALIBRATION LABELLING

Labeling location, content, color & size depends on Calibration agency

LABELING LIMITAION OF USE (Refer NCSL RP- 6)

Valid Calibration: when all instrument parameters have been calibrated & meets the manufacturer’s specifications. If not affix following type of labels.

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External Calibration

When Cal Service is subcontracted, ensure:Approval from customer, preferably in writing,

when the lab intends to subcontract.Ensure and demonstrate subcontractors

competence through evaluation & reviewLaboratory’s responsibility for subcontractors

work.Maintain a register of all subcontracting work

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External Calibration When Cal Services is availed, ensure:

Credibility of Cal agency through accreditation & scope of accreditation covering your requirements

Gain confidence in their services through visits/audits on:– type of calibration service– applicable documents, technical reference, or standard– equipment specification– service performance requirements– physical, environmental, and data-format requirements– safety and biohazard requirements– confidentiality and security requirements – certificate of calibration requirements

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1. ISO/IEC 17025:2005, clause 4.12, paragraph 4.12.2.1, states: "The laboratory shall retain records of original observations, derived data. . . to estab lish an audit trail . . . for a defined period. The records for each calibration shall contain sufficient information to . . . enable the test or calibration to be repeated." Paragraph 4.12.2.2 states: "Observations, data and calculations shall be recorded at the time they are made. . . ."

2. ISO 9001:2000, clause 7.6.on Control of Monitoring & Measuring equipment.3. ISO 14001:2004, Clause 4.5.2 on equipment used for environmental

maesurements.4. ISO 10012:2003, clause 6.2.3 states: "Records containing information

required for the operation of the measurement management system shall be maintained. Documented procedures shall ensure the identification,

storage, protec tion, retrieval, retention time and disposition of records." 5. NCSLI RP-6, clause 5.6, Records, states: "Records should be maintained for all

test and measuring equipment that is included in the calibration system

REQUIREMENTS FOR DOCUMENTING RECORDS

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Why Calibration Records are necessary?

• Understanding the relationship of historical data and stability of a standard

• As Found, and when needed, As Left readings giving reliability of equipment

• Log book of Instruments logging Calibration history on maintainability

• Trend of measurements from periodic Calibration Reports

• Authentication of Calibration Data/Results

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Calibration Records• Service Request Forms• Work Orders/Job Orders• Planning / Job allocation Records• Observations/data computations/Measurement sheets, Uncertainty

Budget records• Preliminary performance/verification records• Calibration records of equipment used for cal. Control Charts on

trends of calibration standards• Calibration Report / Certificates• Replicate/ Retesting records• Training records• Proficiency/ Inter-laboratory Comparison records• Nonconforming calibration, Customer complaints, CA/PA records• Calibration System Audit records• Repair/Adjustment/Maintenance Records

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Management of Calibration Records

• Legibility & Indelibility of records• Identification of records• Storage of records• Maintenance/Preservation of records• Retention & Disposition of records• Amendment of records with authentication

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