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STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/1
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
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/2
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
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/3
Why to Calibrate ?
• Initial calibration assures T&ME with in Spec
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/4
OBJECTIVES OF CALIBRATION
Maintaining traceability of measurements
Uncertainty
limits
Traceability
Reference
measurements
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/5
Why Calibration & Traceability are intertwined?
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/6
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.
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/7
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
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/8
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.)
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/9
Where to Calibrate ?contd…
• Accredited Laboratory ensuring the quality of
calibration services.
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/10
Basic Requirements - Location/ Environment
• Noise Level
• Vibration
• EMI/EMC
• Cleanliness
• Lighting
• Power supply
• Accessibility
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/11
Basic Requirements – Location/Environment
Quiet
* 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 selection
noticeable in galvanometers, mercury column, mass
balance, 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
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/12
Basic Requirements – Location/Environment
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 & transients
Mains Earthing (< 1 ohm)
Adequate measures against ground currents
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/13
Basic Requirements – Location/Environment
Accessibility
Standards / equipment
Firefighting devices
Quality System Document & Instrument
Manuals
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/14
Calibration laboratory
- basic requirements
Location – Permanent/On-site Temperature
Humidity
Environment Air flow
Equipment Filtration
Electromagnetic Screening
Staff Noise Level
Vibration
Management EMI/EMC
Documents Cleanliness
Reference standards Lighting
Records
Transfer Standards Power supply
Calibration
Working standards Accessibility
Training Connecting leads Receiving & Calibration area
Authority adaptors/accessories
Responsibility Subsidiary equipment
Technical Computers & automation
Competence software
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/15
Basic Requirements – Equipment
Transfer Standards
Reference standards (Optional)
Working standards
Connecting leads and adaptors
Subsidiary equipment
Computers & automation software
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/16
Basic Requirements – Personnel
Training
Authority
Responsibility
Technical Competence
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/17
Basic Requirements – Management
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/18
Calibration System
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/19
Calibration System
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/20
Elements of Calibration System
• Qualification
• Measurement traceability
• Adequacy of calibration procedure
• Calibration procedure
• Qualification labeling
• Sealing for integrity
• Calibration interval
• Records Maintenance
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/21
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
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/22
ACCREDITATION REQUIREMENTS
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/23
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/24
CHAPTER - 1
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/25
CALIBRATION PROCEDURES
Procedure
-Objective evidence
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/26
CALIBRATION PROCEDURES
- Guides personnel
- specification interpretation
- tolerance limits
Requirements
Source:
-Prepared internally
-External agency
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/28
CALIBRATION PROCEDURES
Completeness:
- Sufficient instruction
Approval:
requirements.
Software:
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/29
CALIBRATION PROCEDURES
BROADLY COVERS -
- Preliminary operation
- Calibration process
- Calibration results
- Closing operation
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/30
CALIBRATION PROCEDURES – TYPICAL CONTENT
• Appropriate identification / document control.
• Scope
• Calibration equipment/system/setup
• Adaptors/Accessories required
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/31
CALIBRATION PROCEDURES – TYPICAL CONTENT
• Description of the procedure, including –
Apprising of identification mark, sampling, handling, transporting,
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/33
CALIBRATION PROCEDURES
EXERCISE – 1
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/34
CALIBRATION PROCEDURES
Section II
-Environmental condition
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/35
CALIBRATION PROCEDURES
Section III
prior to calibration
Section IV
Section V
-A results data sheet blank form with nominal values and tolerance limits.
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/36
CALIBRATION METHODS
• Standard methods –
Direct/Indirect/Ratio/Substitution/Transfer/Differential
• Non-standard methods
• Expansion of Scope
• Selectivity
• Uncertainty of the results
• Range
• Repeatability
• Reproducibility
• Linearity
• Limit of detection
• Limit of quantization
• Robustness
• Bias
• Precision
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/38
GENERAL CALIBRATION TECHNIQUES
• SPANNING
• NULLING
• ZEROING
• LINEARIZATION
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/39
GENERAL CALIBRATION METHODS
NULLING
• If the nominal value of UUC is same as that of reference
comparison may be made using Nulling process.
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/40
GENERAL CALIBRATION METHODS
ZEROING
• 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.
• adjusting an instrument to
read zero manually / auto
zeroing
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/41
GENERAL CALIBRATION METHODS
SPANNING
- Scale of measurement
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/42
GENERAL CALIBRATION METHODS
SPANNING & ZEROING
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/43
GENERAL CALIBRATION METHODS
LINEARIZATION
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/44
CALIBRATION METHODS SELECTION
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/45
CHAPTER - 3
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/46
Basic Requirements – Environment
Temperature
Humidity
Air flow
Filtration
Electromagnetic Screening
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/47
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)
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/48
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)
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/49
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.
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/50
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
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/51
Control of Environmental Parameters
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/52
Recommended Env. Conditions
- as per RPCL by CLAS in PALCAN Handbook published by Council of Canada
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/53
ACCOMMODATION & ENVIRONMENT - TYPICAL
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/54
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
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/55
CHAPTER - 4
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/56
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
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/57
Calibration Equipment
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/59
Equipment handling
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
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/60
Equipment out-of-service
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:
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/63
Measuring Equipment – Process Model
MEASURING PROCESS
Measurand Result
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/64
Measuring Equipment
• Measuring instrument/system
• Software
• Reference standard/material
• Auxiliary apparatus/Adaptors/Accessories/Cables etc.
• Any combination of the above
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/65
Leading Instrumental Characteristics
• Range
• Error
• Resolution
• Drift
• Input Impedance (Loading effect)
• Compatibility between sensor & Instrumentation
• Input – Output relationship (characteristic)
• Hysterisis
• Ruggedness
• Mounting
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/66
Checks on Measuring Equipment
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/67
Metrological Confirmation of Eqpt.
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/68
Calibration
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/69
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
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/70
CALIBRATION JOB FLOW
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/71
Calibration - Job Flow Chart
Ext Int
Check points
Customer Service Y
N Y
Job Job card to SCL
Any
N
accepted
Non-confor- CERT. Cleared
mance
Calibrate
TP&C
Int. DUC
Compile result error/uncert.
Out of Spec
CERT. Issued
Fix label with Item
R&M
TP & C
CAL
QA
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/72
Calibration v/s Business Processes
In-house repair
Customers
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/73
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
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/74
Laboratory Manager/Chief Executive
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/75
The Role of Quality Manager
• 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
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/76
The Role of Technical Manager
• 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
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/77
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
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/78
The Role of Laboratory In-Charge
• 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
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/79
The Role of Laboratory In-Charge
• 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.
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/80
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
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/81
“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.
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/82
SCHEDULING
- CALIBRATION INTERVAL
- CONFIRMATION INTERVAL
- RECALL NOTIFICATIONS
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/83
Calibration Interval / Reports
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/84
Within Calibration Interval….
Uncertainty of measurement
Time
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/85
Calibration Interval Management
Uncertainty of measurement
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/86
Scheduling Calibration Interval
• Client agreed
reported as ‘Client Agreed Calibration Interval - '.
• Client specified
reported as 'Client Specified Calibration Interval - '.
• Manufacturer's recommended
reported as 'Manufacturer's Recommended Calibration Interval - '.
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/87
INITIAL CHOICE OF CI
• 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
• INTERNAL EQUIPMENT
• EXTERNAL EQUIPMENT
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/90
CHAPTER - 5
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/91
Manual Calibration
The traditional method of obtaining parameters, requiring extensive
training, time, and labor
• 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
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/92
Automated Calibration
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/93
Examples: Automated Calibration
- to the extent supported by HW
1. DMM Calibration batch-wise
7. Etc..
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/94
Software Programme
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/95
Major Elements of Software Programme
• Software development
• Software procurement
• Software operations
• Documents
• Record keeping
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/96
Software Development
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/97
Software Validation
• Inspection of procedure.
• Inter-laboratory comparison
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/98
Software Procurement
• Applicable Guidelines
• Dedicated/designed/custom made
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/99
Software Configuration Management
• Identification
• Change Control
• Status Accounting
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/100
Software Operations
• Access Control
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/101
Documentation/Records
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/102
Automated Calibration
SAMPLE OF AUTOMATED AND MANUAL SYSTEM EQUIPMENT COSTS
(Fluke analysis)
Equipment Automated Manual
SPRT $ 3,000 $ 3,000
Recording thermometer $ 7,000
Nano volt meter / Mohm $ 3,500
Ice point reference for T/Cs $ 600
Dual Dry-Block –35 ºC to 670 ºC $ 8,900 $ 8,900
Computer $ 1,500 $ 1,500
Automated software $ 1,300
Report generation software $ 500
Total $ 21,700 $ 18,000
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/104
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/105
CHAPTER - 6
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/106
Calibration Results
• Original Observations
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/107
Reporting Calibration Results
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/108
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.
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/109
Calibration Reports / Certificates
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/110
Contents of A Calibration Report
a) A title -Test report/Calibration certificate
n) Statement to the effect that the results relate only to the items tested
or calibrated, where relevant;
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/112
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
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/113
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/114
Amendment/Supplement to Report
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/115
Acceptance of Calibration Report
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/116
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
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/117
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
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/118
CALIBRATION LABELLING
Valid Calibration: when all instrument parameters have been calibrated &
meets the manufacturer’s specifications. If not affix following type of labels.
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/120
External Calibration
When Cal Services is availed, ensure:
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/121
CHAPTER - 7
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/122
REQUIREMENTS FOR DOCUMENTING RECORDS
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/123
Why Calibration Records are necessary?
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/124
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 STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/125
Management of Calibration Records
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/126
STQC
Version 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/127