Calibration systems

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Calibration systems

  1. 1. MODULE - III STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/1
  2. 2. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/2
  3. 3. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/3
  4. 4. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/4
  5. 5. OBJECTIVES OF CALIBRATION Maintaining traceability of measurements Uncertainty limits Traceability Reference measurements STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/5
  6. 6. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/6
  7. 7. 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. STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/7
  8. 8. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/8
  9. 9. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/9
  10. 10. 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. STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/10
  11. 11. Basic Requirements - Location/ Environment • Noise Level • Vibration • EMI/EMC • Cleanliness • Lighting • Power supply • Accessibility STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/11
  12. 12. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/12
  13. 13. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/13
  14. 14. Basic Requirements – Location/Environment  Accessibility Standards / equipment Firefighting devices Quality System Document & Instrument Manuals STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/14
  15. 15. 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  AccessibilityTraining Connecting leads  Receiving & Calibration areaAuthority adaptors/accessoriesResponsibility Subsidiary equipmentTechnical Computers & automationCompetence software STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/15
  16. 16. Basic Requirements – Equipment  Transfer Standards  Reference standards (Optional)  Working standards  Connecting leads and adaptors  Subsidiary equipment  Computers & automation software STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/16
  17. 17. Basic Requirements – Personnel  Training  Authority  Responsibility  Technical Competence STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/17
  18. 18. Basic Requirements – Management  Quality management & Technical operations  Traceability  Calibration interval  Audits/ Management reviews  Implementation of corrective /preventive actions STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/18
  19. 19. 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. STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/19
  20. 20. 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. STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/20
  21. 21. Elements of Calibration System • Qualification • Measurement traceability • Adequacy of calibration procedure • Calibration procedure • Qualification labeling • Sealing for integrity • Calibration interval • Records Maintenance STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/21
  22. 22. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/22
  23. 23. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/23
  24. 24. STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/24
  25. 25. CHAPTER - 1 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/25
  26. 26. CALIBRATION PROCEDURES 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. STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/26
  27. 27. CALIBRATION PROCEDURES - 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. STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/27
  28. 28. CALIBRATION PROCEDURES Requirements Source: -Prepared internally -Prepared by the manufacturer -External agency STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/28
  29. 29. CALIBRATION PROCEDURES Completeness: - Sufficient instruction Approval: - shall be approved and controlled to meet regulatory and contractual requirements. Software: - Validation and control STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/29
  30. 30. CALIBRATION PROCEDURES BROADLY COVERS - - Performance requirements of DUC - Performance requirements of standard - Preliminary operation - Calibration process - Calibration results - Closing operation - Storage and handling STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/30
  31. 31. CALIBRATION PROCEDURES – TYPICAL CONTENT • 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. STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/31
  32. 32. CALIBRATION PROCEDURES – TYPICAL CONTENT • 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/32
  33. 33. CALIBRATION PROCEDURE CONTROL  Deviations from instructions authorized & recorded  Assign responsibility  Establish document control with a standard format  Draft, comment and edit procedures/instructions  Review and authorize procedures  Print, bind, present and make available to all operational staff  Regular review and amendment as needed  Archive the superseded methods STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/33
  34. 34. CALIBRATION PROCEDURES EXERCISE – 1 DEVELOPMENT & REVIEW OF PROCEDURES STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/34
  35. 35. CALIBRATION PROCEDURES 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/35
  36. 36. CALIBRATION PROCEDURES 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. STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/36
  37. 37. CALIBRATION METHODS • Standard methods – Direct/Indirect/Ratio/Substitution/Transfer/Differential • Non-standard methods • Laboratory developed methods NEEDS VALIDATION • Expansion of Scope • Customer given method STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/37
  38. 38. VALIDATION OF CALIBRATION METHODS • Selectivity • Uncertainty of the results • Range • Repeatability • Reproducibility • Linearity • Limit of detection • Limit of quantization • Robustness • Bias • Precision STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/38
  39. 39. GENERAL CALIBRATION TECHNIQUES • SPANNING • NULLING • ZEROING • LINEARIZATION STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/39
  40. 40. GENERAL CALIBRATION METHODS NULLING • 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. STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/40
  41. 41. 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. • For zero referencing for >0 measurements • adjusting an instrument to read zero manually / auto zeroing STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/41
  42. 42. GENERAL CALIBRATION METHODS SPANNING - 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/42
  43. 43. GENERAL CALIBRATION METHODS SPANNING & ZEROING - 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. STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/43
  44. 44. GENERAL CALIBRATION METHODS LINEARIZATION 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. STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/44
  45. 45. CALIBRATION METHODS SELECTION 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 methodEnsure laboratory has competence to choose the appropriate methods STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/45
  46. 46. CHAPTER - 3 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/46
  47. 47. Basic Requirements – Environment  Temperature  Humidity  Air flow  Filtration  Electromagnetic Screening STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/47
  48. 48. 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) STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/48
  49. 49. 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) STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/49
  50. 50. 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. STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/50
  51. 51. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/51
  52. 52. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/52
  53. 53. Recommended Env. Conditions - as per RPCL by CLAS in PALCAN Handbook published by Council of Canada STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/53
  54. 54. ACCOMMODATION & ENVIRONMENT - TYPICAL 1. Clean & vibration free location for Monitoring & Measuring devices. 2. Temperature : Ambient / 23 ± 1 °C OR 23 ± 2 °c 3. Humidity : 50 ± 10 % 4. Illumination level : 250 – 450 (700 lux) 5. Noise level – Below 60 dBA where meas. are affected 6. Rigid table for installation of equipment 7. Noisy vacuum source and Pneumatic cylinder to be outside the calibration/inspection room/area REFER NABL SPECIFIC CRITERIA 121 - 126 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/54
  55. 55. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/55
  56. 56. CHAPTER - 4 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/56
  57. 57. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/57
  58. 58. Calibration Equipment • 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 practicableRecord of specification checking and maintained evidence. STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/58
  59. 59. Equipment Records • 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. STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/59
  60. 60. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/60
  61. 61. 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: • 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/61
  62. 62. Calibration Status • Ensure equipment calibration status is identified • Calibration labelling based on Cal agency 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. • 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/62
  63. 63. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/63
  64. 64. Measuring Equipment – Process Model MEASURING PROCESSI/P Sensor Instrumentation Display O/PMeasurand Result Sensor may not be required in every case STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/64
  65. 65. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/65
  66. 66. Leading Instrumental Characteristics • Range • Error • Resolution • Drift • Input Impedance (Loading effect) • Compatibility between sensor & Instrumentation • Input – Output relationship (characteristic) • Hysterisis • Ruggedness • Mounting STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/66
  67. 67. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/67
  68. 68. 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” STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/68
  69. 69. 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” STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/69
  70. 70. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/70
  71. 71. CALIBRATION JOB FLOW STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/71
  72. 72. 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 DUC with cal report DUC after R&R EXT INT TP & C CAL QA STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/72
  73. 73. Calibration v/s Business Processes Control of outside supplies and services Evaluati In-house Report and record Delivery / Receiving Calibrations processing Shipping on In-house repair Customers STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/73
  74. 74. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/74
  75. 75. Laboratory Manager/Chief Executive • 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. STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/75
  76. 76. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/76
  77. 77. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/77
  78. 78. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/78
  79. 79. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/79
  80. 80. 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. STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/80
  81. 81. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/81
  82. 82. “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
  83. 83. SCHEDULING - CALIBRATION INTERVAL - CONFIRMATION INTERVAL - RECALL NOTIFICATIONS STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/83
  84. 84. Calibration Interval / Reports Initial Calibration: Calibration adj. Final calibration: Procedure adopted Comparison To ensure the To confirm the w.r.t tracking of the successfulness common reference Measurand to that Of the operation Either to know of reference The deviation/value (cal adj.procedure (measurand & Implementation) Measurement (Report2) Uncertainty (Report 1) Report1-Report2 ? STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/84
  85. 85. Within Calibration Interval…. Effect of drift on uncertainty of measurement Uncertainty of measurement Time STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/85
  86. 86. Calibration Interval Management Effect of right time cal. Adj. on uncertainty of measurement adjustment carried out Uncertainty of measurement STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/86
  87. 87. Scheduling Calibration Interval • Client agreed reported as ‘Client Agreed Calibration Interval - . • Client specified reported as Client Specified Calibration Interval - . • Manufacturers recommended reported as Manufacturers Recommended Calibration Interval - . STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/87
  88. 88. 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 T&ME or M&ME ARE TO BE CALIBRATED WHENEVER THEY ARE REPARIED. STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/88
  89. 89. OPTIMUM INTERVAL A 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. STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/89
  90. 90. RECALL NOTIFICATION • INTERNAL EQUIPMENT • EXTERNAL EQUIPMENT STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/90
  91. 91. CHAPTER - 5 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/91
  92. 92. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/92
  93. 93. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/93
  94. 94. 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.. STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/94
  95. 95. Software Programme • Design Application Software • Develop/Construct Application Software • Test Application Software • Procure Application Software • Operate Application Software • Maintain Application Software STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/95
  96. 96. Major Elements of Software Programme • Software development • Software procurement • Software Configuration Management • Software operations • Documents • Record keeping STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/96
  97. 97. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/97
  98. 98. Software Validation • Comparison of manual and automated methods • Inspection of procedure. • Inter-laboratory comparison STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/98
  99. 99. Software Procurement • Requirements & Activities • Applicable Guidelines • Dedicated/designed/custom made STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/99
  100. 100. Software Configuration Management • Identification • Change Control • Status Accounting STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/100
  101. 101. Software Operations • Access Control • Backup & Recovery • Problem Reporting & Corrective Action STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/101
  102. 102. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/102
  103. 103. 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 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. STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/103
  104. 104. Internet Enabled Calibration Recommendations as per NPL, UK Report CMSC 28/03 TECHNIQUES SECURITY ISSUES • userid/password protection • Authentication • Access Control • Algorithms for encryption of sensitive measurement data • Confidentiality • Integrity • Message authentication • Non-repudiation code for certificate, • Availability Measurement data • Audit • MySQL vulnerabilities • Privacy • Certification • Backups and fire safes • General Protection STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/104
  105. 105. STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/105
  106. 106. CHAPTER - 6 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/106
  107. 107. Calibration Results - Based on following technical records • Original Observations • Calculations/Computations and data transfers • Calibration Report Format STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/107
  108. 108. Reporting Calibration Results Report and Certificate format • Appropriate to each type of test/calibration • For easy understanding / to avoid misuse STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/108
  109. 109. 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 manufacturers specification. Measurements made by the instrument being calibrated are compared to the manufacturers specification. If the instrument is within specification, a statement that the instrument meets the manufacturers 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 manufacturers specification takes into account the measurement uncertainty. A statement of conformance to the manufacturers specification may also be given in calibration reports. STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/109
  110. 110. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/110
  111. 111. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/111
  112. 112. Contents of Calibration Report contd..I) Test/Calibration results and units of measurementj) Name, function, Signature of person authorizing the report/certificatek) Statement-result related to the item Tested/Calibratedl) Calibration Results with Unitsm) 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. STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/112
  113. 113. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/113
  114. 114. STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/114
  115. 115. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/115
  116. 116. 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? STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/116
  117. 117. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/117
  118. 118. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/118
  119. 119. CALIBRATION LABELLING Valid Calibration: when all instrument parameters have been calibrated & meets the manufacturer’s specifications. If not affix following type of labels. LABELING LIMITAION OF USE (Refer NCSL RP- 6) Labeling location, content, color & size depends on Calibration agency STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/119
  120. 120. 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 & reviewLaboratory’s responsibility for subcontractors work.Maintain a register of all subcontracting work STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/120
  121. 121. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/121
  122. 122. CHAPTER - 7 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/122
  123. 123. REQUIREMENTS FOR DOCUMENTING RECORDS1. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/123
  124. 124. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/124
  125. 125. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/125
  126. 126. 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 STQCVersion 1.0 CERTIFIED CALIBRATION PROFFESSIONAL MIII/CH1/126
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