SOP Title: Operation and Calibration of Digital Vernier Calliper
- Objective:
To define procedure for Operation, Cleaning and Calibration of Digital Vernier Calliper.
- Scope:
This SOP is applicable to digital Vernier Calliper used for measuring dimension of tablets and capsules in Production Department.
- Responsibility:
- Production Department: To prepare and review the SOP. To follow the procedures laid down for the operation, cleaning and preventive maintenance of digital Vernier Calliper.
- Quality Assurance Department: To review and approve the SOP and Annexure.
- Engineering Department: To perform the preventive maintenance and calibration of digital Vernier Calliper.
- Accountability:
Head, Production.
Head, Engineering.
Head, QA.
- Procedure:
- Definition:
- Production Associate: Executive or Operator of Production Department trained to perform duties as per this SOP.
- QA Associate: Personnel of QA Department trained to perform duties as per this SOP.
- QC Associate: Personnel of QC Department trained to perform duties as per this SOP.
- Engineering Associate: Personnel or Operator of Engineering Department trained to perform duties as per this SOP.
- Type A Cleaning: Dry cleaning with clean lint free cloth in the following cases:-
- Remove the previous batch residue.
- During end of the shift.
- Before starting the next batch of the same product.
- Prior to execution of higher strength batches, after the execution of lower strength batches of the same product.
- Type B Cleaning: Wet cleaning by using moist clean duster in the following cases:-
- Change in product.
- Prior to execution of lower strength batches, after the execution of higher strength batches of the same product.
- After continuous five batches of the same product .
- After seven days of cleaning before use, if equipment is not in use.
- After replacement or repair of any product contact part.
- Monthly if it is not in use.
- Breakdown: Any activity leading to operation of machine other than the set parameters and / or unusual sound or vibration observed in the machine.
- Preventive Maintenance: Maintenance activity performed to ensure that the equipment will function smoothly and to avoid breakdowns. These activities are performed monthly, quarterly and half yearly.
- Procedure
- Definition:
| Precautions | ||
| 5.2.1 | Switch ‘OFF’ the Vernier Calliper when not in use. | |
| 5.2.2 | After every use dry clean the Vernier Calliper with soft cloth. | |
| 5.2.3 | Do not use solvent or water to clean the display. | |
| 5.2.4 | Do not try to move the thumb wheel of instrument forcefully when the top screw is tightly fitted. | |
| 5.2.5 | If the reading shows on the display is not clear, check the battery and replace. | |
| 5.2.6 | External and internal jaws have sharp edge ,handle with care to avoid injury. | |
| 5.2.7 | Before start of every measurement ensure that zero 0.00mm / 0.0000in displayed on Vernier Calliper. | |
| 5.3 Operation | ||
| 5.3.1 | Ensure that the Vernier Calliper is cleaned and calibrated. | |
| 5.3.2 | Before putting “ON” instrument ensure that, both upper and lower jaws of the Vernier Calliper should touch each other. | |
| 5.3.3 | Following are the buttons and their functions. | |
| 5.3.4 | ▀▀▀ “ON/OFF” : Press button to ON / OFF the Vernier Calliper. | |
| 5.3.5 | ▀ ” in/mm” : Press button to measure the reading in inch / mm alternatively | |
| 5.3.6 | “ZERO”, Press button of this key to set zero.
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| 5.3.7 | Vernier Calliper can be used to take measurement in mm OR inch depending upon the requirement by pressing the (in/mm) required button . | |
| 5.3.8 | Switch “ON” the Vernier Calliper by pressing the “ON / OFF” press button .
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| 5.3.9 | Loose the top screw slightly to move the display block smoothly. | |
| 5.3.10 | Push the movable jaw on the scale with the help of thumb so that, the movable jaw of lower side should touch the fixed jaw at zero on the scale. | |
| 5.3.11 | Hold the jaw with thumb and Press the “zero” Yellow colour press button to set the display zero. | |
| 5.3.12 | Press the in/mm button, the display should show the selected mode in inch / mm only (0.0000 in/ 00.00mm). | |
| 5.3.13 | Select the required mode mm/inch by pressing the in/mm button to measure the thickness / dimension. | |
| 5.3.14 | Ensure the zero setting on Vernier display. | |
| 5.3.15 | For External Measurement: Open the movable jaw and hold the tablet / capsule firmly in-between the lower jaws of the Vernier Calliper with the help of thumb, to measure the dimension /thickness of the tablet / capsules or any change parts. | |
| Note:
The tablet/capsule should be held firmly in such a way, that test sample should not fall down and it should not get damaged in between the jaws. |
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| 5.3.15.1 | Actual measured value of the tablet / capsule in inch/mm should be displayed on the Vernier. | |
| 5.3.15.2 | Note down the reading displayed on the Vernier Calliper on the product BMR. | |
| 5.3.16 | For Internal measurement: Open movable jaws of Vernier Calliper by thumb, carefully insert the top grooves of Vernier Calliper into the sample, and pull to hold firmly so that, jaws should touch both side of the sample . | |
| 5.3.17 | Reading should show the actual internal diameter of the measured test sample. | |
| 5.3.18 | After completion of measurement, remove sample from the instrument, bring the jaws to initial position at zero on the scale and press the ON / OFF button to put “OFF” instrument. | |
| 5.4 TYPE A Cleaning | ||
| 5.4.1 | Switch “OFF” the Vernier Calliper by pressing ON / OFF button. | |
| 5.4.2 | Dry clean, the Vernier Calliper with soft clean duster/soft brush. . | |
| 5.5 TYPE B Cleaning | ||
| 5.5.1 | Switch “OFF” the Vernier Calliper by pressing “ON / OFF “ button. | |
| 5.5.2 | Dry clean, the Vernier Calliper with soft clean duster / soft brush. | |
| 5.5.3 | Clean the Vernier jaws, scale and display with soft moist duster then with soft dry duster. | |
| 5.5.4 | Keep the Vernier in dedicated box with “Cleaned “status label. | |
| 5.6 | Action in case of breakdown or out of calibration: | |
| 5.6.1 | If Vernier Calliper shows error, inform the department head, Quality Assurance and Engineering Department. | |
| 5.6.2 | Fill the “Complaint Note” and submit to Engineering Department. | |
| 5.6.3 | Fill the “Incident Report” and submit to Quality Assurance Department. | |
| 5.6.4 | Rectify the problem and check zero setting. If the breakdown is major, test can be continued on another calibrated Vernier Calliper. | |
| 5.6.5 | Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed | |
| 5.6.6 | After completion of repairs, the operations can be resumed. If break down is major perform Type A or Type B cleaning as per the requirement. | |
| 5.7 | Preventive Maintenance | |
| 5.7.1 | Perform the preventive maintenance as per Annexure. | |
| 5.7.2 | If preventive maintenance activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached. | |
| 5.7.3 | Attach the preventive maintenance label on the equipment. | |
| 5.8 | Calibration: | |
| 5. 8.1 | Calibrate the Vernier Calliper once in a year by approved external party for length 0-200 mm(±0.01mm). | |
| 5. 8.2 | If calibration activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached. | |
| 5. 8.3 | Affix the calibration label on the equipment. | |
- Abbreviation
| Abbreviation | Expansion |
| in | Inch |
| mm | Millimetre |
| ± | Plus or minus |
CALIBRATION OF DIGITAL VERNIER CALIPER OBSERVATIONS
| Sr. No. | For External Measurement (mm)
|
For Internal Measurement (mm) | ||||
| Reading on UUC in mm | Reading on standard slip guage in mm | Deviation
(± 0.2mm) |
Reading on UUC in mm | Reading on standard slip guage in mm | Deviation
(± 0.2mm) |
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| 1 | ||||||
| 2 | ||||||
| 3 | ||||||
| 4 | ||||||
| 5 | ||||||
| 6 | ||||||
| 7 | ||||||
| 8 | ||||||
| 9 | ||||||
| mm : Millimeter | ||||||
| Remarks: The results comply / Not comply with the acceptance criteria | ||||||
*Note – Ready to use SOP available in “DOWNLOAD” Section.