19
Oct 2022

Calibration Management

By Admin

Calibration Management

Created By Ariyono W Ardi , Drs. Apt. MM .on 24 Oct 2022

What is Calibration?

  • Calibration is the process of checking and adjusting the accuracy of measuring instruments by comparing them with standards/benchmarks.
  • Calibration is necessary to ensure that the measurement results are accurate and consistent with other instruments.

Standard Measuring

Instruments Instruments or devices used to calibrate other instruments and these devices are traceable to acceptable national/international standards. 

The test equipment must have greater precision, accuracy and repeatability than the calibrated measuring instrument. 

Traceability 

Measurement traceability is the ability of individual measurement results to be linked to national or international standards through an unbroken comparison. 

For example, the National Institute of Standards and Technology (NIST) is based in the United States 

What is a Qualification? 

Documented evidentiary actions that can guarantee that the machine/equipment can produce the expected output.

What is validation?

Documented evidentiary actions that can guarantee that the system/process (Combination of: tools/machines, procedures, processes and materials) can provide the expected results. 

Accuracy vs. Precision

  • Accuracy/Accuracy
    • The degree to which a quantity measurement is close to an acceptable value.
  •  Precision
    • The ability to measure repeatedly with minimal error.
    • The ability to measure the same subject repeatedly with minimal error.

Responsibilities

  • of Calibration Technician (Calibration Techniciant)
    • Carry out calibration of measuring instruments/test equipment according to SOP.
    • Record all calibration data in the Calibration Report
    • Attach Calibration Status Label as soon as the calibration report is approved by the QA
    • Sending measuring instruments/testing equipment to third parties for recalibration according to the calibration plan.
  • Calibration Technician
    • Carry out calibration of measuring instruments/testing equipment according to SOP
    • Record all calibration data in Calibration Report Affix Calibration
    • Status Label immediately after calibration report is approved by QA
    • Send measuring instrument/test equipment to third party for re-calibration according to plan calibration.
  • User (QC, Production, Engineering)
    • Propose the use of appropriate measuring tools/testing tools and assess whether the measuring tools used are in accordance with their objectives.
    • Identify critical parameters and determine acceptable limits for all measuring instruments used in the area of ​​responsibility.
    • Perform critical level evaluation for each measuring instrument
    • Create calibration procedures for each measuring instrument
    • Make calibration program
    • Evaluate calibration report if found OOC
  • Quality Assurance
    • Evaluation that the calibration limit is acceptable and ensure that the test parameters are in accordance with the established standard.
    • Ensuring that calibration is carried out according to schedule
    • Performing criticality assessments for each test instrument
    • Conducting qualifications and audits of third party calibrator vendors
    • Approving calibration reports
    • Approving deviation reports in the event of OOC

Regulation

  • REGULATION OF THE MINISTER OF TRADE OF THE REPUBLIC OF INDONESIA NUMBER 67 OF 2018
    • MEASURING, MEASURING, WEIGHING, AND EQUIPMENTGOVERNMENT
  • REGULATION OF THE MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA NUMBER 54 OF 2015
    • TESTING AND CALIBRATION OF HEALTH EQUIPMENTS
  • REGULATION OF THE REPUBLIC OF INDONESIA NUMBER 2 OF 1989
    • NATIONAL STANDARD FOR UNITS OF SIZE
  • ISO/IEC 1 regulations that are very appropriate in ISO/IEC 1 ISO7025
    • program calibrations should be assigned to important measuring instruments/instruments that have a significant effect on the results.
    • Prior to operational use, measuring instruments (including those used for sampling) must be checked and calibrated before use.
  • ISO/IEC 17025 regulations that are very much in accordance with the ISO Standard for Laboratory Chemistry:
    • Every measuring instrument including its software (software) used for tests and calibrations that have an impact on the final results, must be recorded and specifically identified.
    • Test/measuring equipment that is damaged or shows results outside the limit must be withdrawn from operation.
  • 21 CFR Part 11 – FDA's Rules regarding electronic records and signatures:
    • Records of calibration and maintenance of measuring/test instruments must be kept and maintained as a controlled document, including the signature of the party evaluating and approving the document.
    • Security using multilevel passwords needs to be implemented to limit access to databases and other important records only for interested parties.
  • 21 CFR Part 11 – FDA's Rules regarding electronic records and signatures:
    • Every test/measurement instrument that uses software in its operations must be downloadable (audit trail) to track changes made to system data.

Why is Calibration Necessary?

Instrumental errors can occur due to various factors:

  • Shifting the value of the instrument indication (Drift)
  • Environment (Temperature, Humidity, vibration)
  • Stability of electric currents
  • Addition of installation in the output circuit (amplification)
  • Process changes (heating process with steam is replaced by heating element).
  • Frequently moved sensitive instruments (analytical balances)

Calibration Interval

  • The period of time the measuring instrument is used to ensure the equipment remains reliable.
  • Short calibration interval → high cost.
  • Long calibration interval → risk of measurement result failure.

Calibration Management System

Several important elements are required:

  • Trained personnel
  • Assessment of instruments/tools
  • Management
  • Documentation
  • Corrective Action Procedures

Calibration Management Requirements

  • Each measuring instrument must have a Master History Record
  • Each measuring instrument must be identified with a unique number
  • Method calibration according to approved procedures.
  • Calibration frequency and process limits must be established for each measuring instrument.
  • There must be a system to determine the calibration status of each measuring instrument
  • Have a standard calibrator and test equipment.
    • The standard calibrator must have an accuracy of 4X higher than the measuring instrument to be calibrated.
    • Traceable to NIST

Critical Level Assessment

  • Each measuring instrument directly or indirectly involved in an individual process must be evaluated against a critical level that can affect the process.
  • Evaluation is carried out at least by:
    • Process Owners
    • Engineering
    • Quality Assurance
  • The evaluation. above must be documented

 

Criticality Classification of Measuring

  • Instruments Critical Measuring Instruments Impact on the Product
    • Failure of this measuring instrument can have a direct impact on the quality of the final product
    • This critical measuring instrument is calibrated a minimum of 2X in a year
  • Critical Measuring Instruments Impact on the System
    • Failure of this measuring instrument can have a direct impact on process/system performance and have no impact on final product quality or safety.
  • Critical Measuring Instruments Impact on Safety or Environmental Control
    • Failure of these measuring instruments can have a direct impact on the level of security (safety) or environmental control (environtment).
  • Non-Critical Measuring Instruments (Non Critical Instruments)
    • Measuring instruments if a failure does not have an impact on product quality, system/process performance, safety (safety) and environmental control (environment control).

Calibration Program

  • Recommendations for measuring instrument manufacturers
  • Frequency of use of measuring instruments
  • Compliance with procedures/SOPs
  • History of measuring instrument performance
  • Based on experience from staff implementing calibration

 

Unplanned Calibration

  • There are dubious or questionable test results or are part of an investigation.
  • If the measuring instrument is moved to a different location.
  • Environmental conditions can affect the performance of the measuring instrument.

 

Out of Calibration

  • Inconsistency of calibration results must be investigated, record failure of calibration results and corrective actions taken in Deviation Report.
  • Immediately label the measuring instrument with the label “Out of Calibration” and remove the measuring instrument immediately from the operation process.
  • Adjustments or repairs to measuring instruments may be made after the deviation report has been approved by QA and re-calibration is required.
  • If adjustment or repair cannot improve its performance, replace the "OOC" instrument with a new measuring instrument and calibration must be carried out before the tool is used for operations/processes.
  • OOC metrics are removed from the process/operations room and supervision must be in place to ensure that no OOC metrics are used for critical processes.

 

Activities After Calibration

  • Ensure that all calibration activities have been carried out completely, the results meet the acceptance criteria that have been set.
  • Measuring instruments can be calibrated by third parties, labels and instruments must be removed from the process room.
  • Periodically evaluate the calibration history of each measuring instrument, if necessary changes in the calibration frequency can be changed based on the evaluation of the calibration history.

 

Labeling System

  • The calibration status of critical measuring instruments must be provided as soon as the calibration report is approved by QA.
  • Calibration labels must be made of materials that are resistant to water or sanitary materials so that no information is erased from the status labels.

 

Calibration By Third Parties

  • If calibrations are carried out by “Third Parties”, they must be qualified to calibrate measuring instruments in accordance with SOPs of “Third Parties”. First".
  • “Third Party” qualification must be carried out by QA together with other relevant parties.
  • QA must ensure that calibration procedures are followed correctly.
  • Calibration data, “Third Party” calibration reports and certificates must be evaluated by QA before the measuring instrument is assigned a status label.

 

Change Control

  • Updates and/or changes to the calibration system must be methodical, planned and documented.
  • Changes must be evaluated and approved by all stakeholders including tool users, engineering, quality assurance and process owners.
Next Article:
Good Documentation Practices (GDocP)
ID