Equipment Technology Lecture 3

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