Operation & time verification of digital clock
Digital Clock: A digital clock is a type of clock that displays the time digitally (i.e. in numerals or other symbols) as opposed to an analogue clock. Digital clocks are often associated with electronic drives but the “digital” description refers only to the display, not to the drive mechanism. Both analogue & digital clocks can be driven either mechanically or electronically.
ABBREVIATIONS
SVP: Small Volume Parenteral
GPS: Global Positioning System
PLC: Programmable Logic Control
SAP: System Application & product in the data processing
RESPONSIBILITY
Originating department shall be responsible:
- Preparation of the SOPs of a digital clock.
- To verify the timing of the digital clock.
- To maintain the digital clock.
- To follow the described herein.
- To maintain the record.
Dynamic pass box
The head of Originating department/designee shall be responsible for:
- To impart the training of the SOP to concerned personnel before the effective date of SOPs.
- To verify that employees are trained before performing or operating any task relevant to the SOP.
- Checking of the SOP for procedural, technical content, accuracy, and cGMP compliance.
- To get the SOP approval from the Head of Quality Assurance or designee.
- After training the user department Head or designee to ensure the implementation of the SOP on the effective date.
The Quality Assurance department shall be responsible for:
- To checking of the draft SOP from technical, function, regulatory, and cGMP compliance perspectives.
- To maintain the approved master copy of the SOP of all departments for document control.
- To issue the required number of controlled copies to the departments and document the same.
- To verify that all the instructions are followed properly as per the given SOP.
- To ensure implementation of SOP.
Head – Quality Assurance/ Designee shall be responsible for:
- To verify the calibration & verification record of SOP.
- To ensure the implementation of the defined system.
The engineering person shall be responsible for:
- Coordinate with the production person to schedule preventive maintenance of equipment.
- Perform maintenance of the system or coordinate with the vendor for maintenance.
The plant Head shall be responsible for:
- To approve new or revised SOP.
- To ensure the implementation of the defined system.
PROCEDURE:
SAFETY/PRECAUTION/EHS
- Don’t spray IPA directly on the electrical part of the machine.
- Always use a trained person to verify any maintenance.
- Don’t install the clock at the place where is moisture on the wall.
- Always install the clock at a height so that no one could adjust any date or time.
- Don’t mix old & new batteries during battery change.
- During installation of the new battery ensure that the battery has the correct polarity.
Operating process
- After receiving the digital clock engineering person will install a 1.5 V battery (2No.) as per
- The polar mark is displayed & check the clock for proper operation & after satisfactory working will send it to quality assurance for ID & calibration.
- The quality assurance person will send the clock for outside calibration & after calibration he
- will send it to adjust the time adjustment with the server & keep it under observation for 48
- hours for proper working & verification of time difference during operation.
- After a satisfactory result, the QA person will send it to production to install it in the packing hall at a suitable place.
- The production person will install it on the packing hall wall with the mounted hole located on the back
- Side of the clock, afterward connect the 2-pin power cord of the clock with single-phase electrical
- Supply & after automatic switch on the clock production, QA & engineering person will
- Follow it for their documentation & to perform production-related activities as per required Time.
- The production person will maintain the record of the same.
- Digital clock display the time in 12 hours (AM or PM) or 24-hour format it displays the time
- Digitally in HH:MM: SS & clock time shall be adjusted in 24-hour format with setting menu
- Located back side of the clock.
- It displays the date in the format of DD: MM: YYYY format with red color LED light.
- It displays the weekday (i.e. Sunday, Monday, Tuesday, Wednesday, Thursday, Friday Saturday).
- A digital clock will display the temperature of the room but it will not be considered because of
- A calibrated digital hygrometer will be followed for room temperature/humidity.
- Concern department will follow this clock to make entries in documents & to perform any task.
- The noted acceptable gap between the server and to digital clock should be NMT 30 seconds.
- If the time gap is between 30-120 seconds QA/Production will adjust the time of the digital clock.
- If the time gap is above 120 seconds will raise the incident & CAPA to rectify the same.
Verification, battery replacement & maintenance
- A digital clock will be verified with the server every 15 days±3 days & verification record Will be maintained.
- Calibration of the digital clock will be performed on a yearly basis ± 30 days.
- For the maintenance of the digital clock production person will contact to engineering/IT
- Person.
- After maintenance activity clock verification shall be done again.
- Every 3 months battery of the clock will be replaced.
- After battery replacement clock should be kept under observation for 48 hours.
REFERENCE(S)
- Operating Instructions manual of digital clock
- Attachment – Digital Clock verification Record
