QualityGuidances

• OBJECTIVE:

To describe a procedure for the calibration of equipments/instruments.

• SCOPE:

This SOP is applicable for calibration of equipments/instruments which are calibrated externally

 RESPONSIBILITY:

Assistant Engineer/Above – Engineering shall be responsible for implementation and compliance of the Standard Operating                          Procedure.

• ACCOUNTABILITY:

Manager– Engineering / Manager – Production / Head – QA shall be accountable for implementation and compliance the                             procedure mentioned in this Standard Operating Procedure.

5.0       ATTACHMENT:

Annual Equipment/Instrument Calibration Schedule                         -Attachment-I

6.0     PROCEDURE:

• All the equipments/ instruments associated with the processing and testing of materials and products     shall be calibrated as per respective SOPs.
• Each Equipment/ Instrument shall be calibrated periodically In-house (as per respective SOP) or from   certified outside agency traceable to In-House Standards or NIST/ ETDC/NPL any other applicable agency standards.
•  Calibration SOP of respective Instrument/ Equipment shall contain the procedure of calibration and calibration frequency and acceptance criteria.
•  “Annual Equipment/ Instrument Calibration Schedule” shall be prepared by Engineering, Concerned    Department & QA personnel for all equipments/ instruments in Format No. SOP/EN/002
•   The traceable of regular calibration shall be followed as per their frequency and the due date in calibration schedule.
•   The calibration schedule consists of the Instrument ID and its location/ equipment connected, next  due of calibration. After performing the calibration within the grace period from its due date, the date of calibration shall be entered in the schedule with sign.
• The calibration data shall be entered in the calibration report.
• Calibration shall be carried out within +5 days for half yearly & +10 days for annual calibration from the due date. The instruments having daily and monthly calibration schedules should calibrate on the due date itself.
• If there is continuous production even in the total grace period from the calibration due date of  equipment/ instrument. Then the calibration activity shall be performed immediately after completion of production or of any deviation is observed in the instrument related to that equipment/area which is in continuous production.
• Before starting the calibration activity, the same shall be intimated to the concerned user department personnel for clearance.
• During calibration tag the instrument/ equipment with “UNDER CALIBRATION” label filled as per Attachment-I.
• If the equipment’s/Instruments pass the calibration test, put “CALIBRATED” label duly filled as per Attachment-II.
•  If the equipment’s/Instruments fails in calibration test, put “CALIBRATION FAILED” label duly filled as per Attachment-III, and the equipment/Instrument shall not be used till the instrument repaired            or replaced and calibrated.
• If any Equipment/ Instrument fail the calibration, failure shall be investigated by the Head – concerned department, Head – Engineering & Head – QA. The reason for failure and the effects of failure on quality of product since last calibrated shall be covered during investigation and appropriate action is taken.
• In case of the calibration is performed due to a break down repair, change of parts or for any other reason before the next schedule date of calibration the same shall be recorded in the respective calibration record.
• In case of new equipment/instrument installation, the calibration schedule of new equipment/instrument shall be updated for every three months with separate annual schedule sheet adding to the existing schedule.
• In case an external agency has calibrated the equipment, the calibration certificate shall be signed with authorized persons from QA and Engineering personnel as a mark of acceptance.

7.0     REFERENCES:

In-house

• ABBREVIATIONS

SOP       : Standard Operating Procedure

Engg      : Engineering

NIST     : National Institute of Standard Tests

NPL      : National Physical Laboratories

ETDC    : Electronic Test and Development Centre

•    DISTRIBUTION LIST:

10.0    HISTORY OF REVISION:

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