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Questions and Answers
A master list is created to catalog all instruments requiring periodic calibration.
A master list is created to catalog all instruments requiring periodic calibration.
True
Calibration documents do not need to be archived according to documentation procedures.
Calibration documents do not need to be archived according to documentation procedures.
False
Critical instruments are calibrated in the same manner as major instruments.
Critical instruments are calibrated in the same manner as major instruments.
False
The calibration period should prioritize frequent calibrations to avoid failures.
The calibration period should prioritize frequent calibrations to avoid failures.
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The calibration standard operating procedure (SOP) includes all necessary instructions for calibration.
The calibration standard operating procedure (SOP) includes all necessary instructions for calibration.
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Specifications for the calibration of an instrument are unimportant and do not require authorization.
Specifications for the calibration of an instrument are unimportant and do not require authorization.
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Training plans and records for calibration technicians are considered part of the calibration documentation.
Training plans and records for calibration technicians are considered part of the calibration documentation.
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Calibration certificates can only be issued by the laboratory itself, not by external bodies.
Calibration certificates can only be issued by the laboratory itself, not by external bodies.
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Calibration frequencies for instruments should always be set on a quarterly basis.
Calibration frequencies for instruments should always be set on a quarterly basis.
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Instruments that are critical to the process should be calibrated at least every six months.
Instruments that are critical to the process should be calibrated at least every six months.
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A thermometer in a warehouse should be calibrated annually.
A thermometer in a warehouse should be calibrated annually.
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All critical instruments must include a current calibration certificate at the time of purchase.
All critical instruments must include a current calibration certificate at the time of purchase.
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Humidity control is not necessary for the calibration laboratory.
Humidity control is not necessary for the calibration laboratory.
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Instruments whose performance affects either the process or product should be calibrated at least every two years.
Instruments whose performance affects either the process or product should be calibrated at least every two years.
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Categorization of instruments must be recorded and authorized after purchase.
Categorization of instruments must be recorded and authorized after purchase.
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Vibrations are among the environmental conditions that should be considered during calibration.
Vibrations are among the environmental conditions that should be considered during calibration.
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If an instrument's 'as-left' condition does not meet the accuracy requirements, a deviation must be raised.
If an instrument's 'as-left' condition does not meet the accuracy requirements, a deviation must be raised.
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Calibration certificates are only relevant for instruments that are regularly used.
Calibration certificates are only relevant for instruments that are regularly used.
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The ultimate standards against which all reference equipment is calibrated are generally less accurate than secondary standards.
The ultimate standards against which all reference equipment is calibrated are generally less accurate than secondary standards.
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External parties involved in calibration should be monitored by internal personnel.
External parties involved in calibration should be monitored by internal personnel.
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An instrument is calibrated and labeled with a calibration sticker only if it meets the 'as-left' condition accuracy.
An instrument is calibrated and labeled with a calibration sticker only if it meets the 'as-left' condition accuracy.
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Calibration should be conducted after the expiration date stated on the calibration certificate.
Calibration should be conducted after the expiration date stated on the calibration certificate.
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The calibration standard maintained within the company is generally less accurate than the measuring standard.
The calibration standard maintained within the company is generally less accurate than the measuring standard.
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It is crucial to store and handle calibration equipment properly.
It is crucial to store and handle calibration equipment properly.
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Certificates must be traceable to local standards.
Certificates must be traceable to local standards.
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Initial calibration is required if certificates cannot be supplied with the instrument.
Initial calibration is required if certificates cannot be supplied with the instrument.
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The frequency of calibration should be determined solely based on the current operational range of the instrument.
The frequency of calibration should be determined solely based on the current operational range of the instrument.
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A training program should only cover the individuals conducting the calibration.
A training program should only cover the individuals conducting the calibration.
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Refresher training for calibration should be conducted every two years.
Refresher training for calibration should be conducted every two years.
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Maintenance includes any activities intended to restore a unit to a specified state.
Maintenance includes any activities intended to restore a unit to a specified state.
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Standard operating procedures do not need to be reviewed when instruments are recalibrated.
Standard operating procedures do not need to be reviewed when instruments are recalibrated.
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Training for new instrumentation should be conducted only if the individual is inexperienced.
Training for new instrumentation should be conducted only if the individual is inexperienced.
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A permanent fault in a system can vanish without any repairs being made.
A permanent fault in a system can vanish without any repairs being made.
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Preventive maintenance is performed after equipment has failed.
Preventive maintenance is performed after equipment has failed.
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Reliability refers to a system's ability to run continuously without failure.
Reliability refers to a system's ability to run continuously without failure.
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Intermittent faults can occur and then disappear, following a predictable pattern.
Intermittent faults can occur and then disappear, following a predictable pattern.
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Scheduled maintenance and preventive maintenance are always considered two distinct categories.
Scheduled maintenance and preventive maintenance are always considered two distinct categories.
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Safety in a system means that catastrophic events do not occur when a failure happens.
Safety in a system means that catastrophic events do not occur when a failure happens.
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The main goal of maintenance is to increase production loss from failures.
The main goal of maintenance is to increase production loss from failures.
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Corrective maintenance is conducted to fix problems that have already caused system failure.
Corrective maintenance is conducted to fix problems that have already caused system failure.
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Scheduled maintenance is performed only after a breakdown has occurred.
Scheduled maintenance is performed only after a breakdown has occurred.
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Preventive maintenance aims to locate weak spots in machinery and take timely actions to prevent failures.
Preventive maintenance aims to locate weak spots in machinery and take timely actions to prevent failures.
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Corrective maintenance can be used for equipment regulated by statutory provisions without any restrictions.
Corrective maintenance can be used for equipment regulated by statutory provisions without any restrictions.
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Predictive maintenance uses real-time data to optimize maintenance resources based on equipment performance indicators.
Predictive maintenance uses real-time data to optimize maintenance resources based on equipment performance indicators.
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An excessively hot electric cable does not predict potential equipment trouble.
An excessively hot electric cable does not predict potential equipment trouble.
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Preventive maintenance reduces downtime and improves product quality.
Preventive maintenance reduces downtime and improves product quality.
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Neglecting scheduled maintenance will likely result in a decrease in equipment life.
Neglecting scheduled maintenance will likely result in a decrease in equipment life.
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Corrective maintenance incurs lower costs compared to preventive maintenance.
Corrective maintenance incurs lower costs compared to preventive maintenance.
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Study Notes
Equipment Technology and Maintenance(1) Lecture 3
- Calibration Documentation is needed for the calibration program
- A master list/inventory of all lab instruments & instrument specifications is needed.
- Standard operating procedures (SOPs) for calibrating instruments are necessary
- A plan listing individual calibrations, preferably as a planned preventive maintenance program.
- Records of internal lab calibrations, external calibration certificates, & calibration technician training are required
- Calibration records and certificates must be completed, stored, & archived
- The purpose of the Instrument Calibration Index/Calibration Master List is to catalogue instruments for calibration, triggering calibrations at set times
- Records for each instrument needing periodic calibration must include last due date, last calibration date, expiry date, next due date, & calibration period
Instrument Specifications
- Specifications for calibrating an instrument are essential and require appropriate authorization and control
- Instrument category (critical, major, or reference) affects calibration specifics
- Accuracy and range must meet the needs of the measured parameter
- Calibration period needs to balance frequent calibration against instrument failures (durability, accuracy, & environment)
Calibration Standard Operating Procedure (SOP)
- SOPs must contain all instructions needed for a craftsperson to correctly calibrate an instrument
- Each SOP should have a unique identity & be included in the instrument calibration index
- SOPs must be signed by appropriate lab functions (instrument specialist, process specialist, quality assurance representative)
- Changes to the SOP format need authorization by the same signatories
- Revisions should be recorded on a revision-tracking sheet
Calibration Record
- This record details every calibration report, including creation date, due date, calibrator, & pass/fail results
- The record should include fields for Measurement Device, Calibration SOP No., Equipment Name, ID No, Location, Report No., Calibration Date, Calibration Due Date, SN, Manufacturer, Calibrated By, Cal. Interval, Passed/Failed, & Remarks
Calibration Certificates (Report)
- Calibration certificates are issued only if the calibration meets accuracy requirements
- Certificates must have a unique number, along with tag number, plant number, or manufacturer's serial number
- Certificates must contain calibration date, next due date, expiry date, the calibrator and their signature
Calibration Report
- Includes fields for Report No., Equipment Name, Equipment ID No., Calibrated By (name), Measurement Device (MD), MD-Description, MD-Precision, Calibration Reason, Standard Calibratorused, Acceptance Criteria, Cal. Due Date, Standard Calibrator SN, Standard Calibrator Certification No., Standard Calibrator ID No., Standard Calibrator Cal. Due Date, MD Full Scale, Calibration Range, Standard Calibrator Test Point, MD Reading, Reading No. Reading, Operating Range, Deviation (MD - Standard Calibrator), % Deviation, Calibration Date, Due Date, Calibration Condition (Temp, RH), Calibration Result (Passed/Failed), Remarks, Calibrated-By, Checked-By, Approved-By, and dates for each
Calibration Label
- Calibration labels are unique identifiers for instruments within a lab
- Labels should include a summary of the instrument's calibration history
- Information should include instrument ID number, previous calibration date, next calibration due date, and calibrator's signature
Carrying Out Calibration
- Calibration should be done following the appropriate SOPs and completed worksheets
- The "as-found" condition (instrument accuracy before adjustments) is assessed
- If "as-found" condition does not meet requirements, a deviation is raised
- Post-calibration: the master list is updated to reflect the completion with the new calibration Master List
Carrying Out Calibration (cont.)
- All instruments must be calibrated before the expiry date
- External parties can be involved, but need internal monitoring to ensure adherence to facility procedures.
Different Types of Standards
- Absolute/International standards are the ultimate reference points for calibrations
- Primary standards are used to calibrate other instruments and are maintained at national labs or company-level facilities
- Secondary standards are used for routine calibrations within a company (usually 4x more accurate than measuring standards)
- Measuring standards are instruments used for routine measurements and control within a company
Maintenance of Calibration Equipment
- Calibration equipment should be stored and handled appropriately (consider temperature, humidity, vibrations)
Categorization of Instrumentation
- Calibration frequency depends on factors like instrument usage, process sensitivity, manufacturer recommendations, and previous calibration history
- Instruments with consistent, long calibration history may not need quarterly calibrations
Critical, Major, and Reference Instruments
- Critical instruments affect both the process and product (e.g., autoclave temperature control; calibrated at least six monthly)
- Major instruments affect either the process or product (e.g., dispensary balance; calibrated at least annually)
- Reference instruments only act as reference points and don't affect the process or product (e.g., ambient warehouse thermometer; calibrated on installation)
Purchase of New Instruments
- When purchasing new instruments, the instrument group should be informed, a tag number issued, and the instrument categorized (critical, major, or reference).
- This categorization and the rationale must be recorded and authorized.
- Calibration certificates should accompany new equipment; they should cover appropriate accuracy, range, and specify an expiry date.
- The certificates must be traceable to national standards. If certificates aren't supplied, initial calibration is needed
Review of Calibration Programme
- Review the calibration program annually to ensure its appropriateness and effectiveness
- Assess instrument calibration frequency based on prior calibration histories and decide the most appropriate frequency
Training of Calibration Technicians
- Training programs should cover calibration procedures and data review for those involved
- Written training plans and records of training completion are essential
- Refresher training is recommended annually
- New personnel should be trained on new instrument methodology and protocols
What is Maintenance
- Maintenance encompasses all activities (tests, measurements, replacements, etc.) to keep or restore a unit's function
- All technical and management actions to maintain or restore an item's functionality are included as maintenance
- Fixing machinery that's broken or out-of-order, as well as performing routine actions to prevent issues
Maintenance Burdens and Objectives
- Operator inabilities to repair equipment, machine/product failure, idle workers, and breakdown losses
- Achieve product quality and customer satisfaction, maximize equipment lifespan, maintain equipment safety, minimize interruptions, maximize production efficiency, prevent breakdowns, and increase operating system reliability
Basic Concepts of Maintenance
- Reliability: System operates continually without failure
- Availability: System is ready to be used immediately
- Maintainability: System can be repaired easily and quickly
- Safety: System failure will not cause catastrophic events
What is Failure?
- A system fails if it doesn't meet its promises or can't perform functions as expected
- System failures are caused by errors
- The cause of an error is a "fault"
Types of Faults
- Transient Fault: Appears & disappears
- Intermittent Fault: Appears, disappears, reappears inconsistently
- Permanent Fault: Requires component replacement to function properly
Types of Maintenance
- Corrective/Breakdown Maintenance: Repairs occur after equipment failure
- Preventative Maintenance (PM): Regular maintenance inspections, lubrication, repairs, and overhaul to avoid failures
- Scheduled Maintenance: Follows a pre-determined schedule for inspections, lubrication, repairs, and overhauls
- Predictive Maintenance: Uses data to predict and schedule maintenance based on equipment condition
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Description
This quiz covers essential aspects of calibration documentation and maintenance equipment protocols as discussed in Lecture 3 of the Equipment Technology course. It includes topics such as SOPs for calibrating instruments, the importance of maintaining a master inventory, and detailed records for instrument calibrations. Test your knowledge on these critical procedures and standards in laboratory settings.
