SOP for Calibration Policy

Purpose

This document details the Calibration Policy of equipment/instruments of the Company.

Objective

It is the policy of the Company that the written procedure shall be followed for calibration of all Equipment / Instrument at suitable intervals based on manufacturer’s recommendation, historical experience and criticality of use, used in the process of Manufacturing, Packing, Analytical division, QC, Maintenance and Warehouse other than those Equipment / Instrument that are calibrated with each use.

Purpose

This procedure is to be applied at the time of preparation of the calibration schedule once in a year for both In house calibration and out side party Calibration. The instrument/equipment are to be calibrated as per their individual frequencies stated in the calibration schedule.

Responsibility

Persons along with their responsibilities are given below:

• Executive – Corporate Quality Assurance: To prepare procedures and coordination for calibration with Outside party and concerned department.
• Executive – Quality Assurance: To prepare In house and outside calibration schedule
• Executive – Quality Assurance: Execution and overall responsibility for calibration with Outside party and concerned department
• Manager – Quality Assurance: To ensure that calibration is being done accordingly.
• Manager – Corporate Quality Assurance: To ensure implementation of SOP.

Procedure

• Separate calibration programs for in-house calibration and outside-party calibration shall be prepared in the beginning of each year for all instruments/equipment to be calibrated on dates as per their individual frequencies.
• Calibration of Equipment / Instrument shall be carried out at suitable intervals based on manufacturer’s recommendation, historical experience and criticality of use.
• Calibration standards for in-house or contract service must be traceable to a recognized National Standard and within the calibration validity period.

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• All traceability certificates shall be checked by the Department Head and reviewed by the person responsible for calibration activities.
• Both In-house and outside calibration schedules shall be prepared by the concerned departments as per Annexure I (Format for Outside Party Calibration Schedule) and Annexure II (Format for In house Calibration Schedule) and shall be handed over to the Quality Assurance Department.
• Quality assurance Department on receiving schedules from different departments will prepare a composite Schedule for calibration and will send a copy of the same to all concerned departments.
• On installation of new equipment, during qualification, all instruments that need to be calibrated shall be identified based on manufacturer recommendation and criticality of use. The user department will inform to Quality Assurance Department about the same for inclusion in the calibration schedule on Appendix - I.
• On procurement of new measuring instruments like, thermometers, Thermo hygrometers etc. the user department will inform to Quality Assurance Department for inclusion in the calibration schedule on Appendix-I.

• Once the instrument is included in the calibration schedule, the Quality assurance Department will allot new ID no. of that series based on the type of instrument and will inform to the concerned department.
• The user department will inform to Quality assurance Department about 30 days prior to due date of calibration for outside party calibration so that necessary arrangements can be made on Appendix-III.
• All concerned departments are required to inform the Quality Assurance Department whenever any instrument is replaced, out of use, damaged, out of calibration or when there is no calibration status label.
• The calibration schedule (both In-house and outside) will be a live document and any inclusion can be made manually.

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• Although all efforts will be made to calibrate the instrument/equipment on or before/after due dates the following grace periods will be accepted based on the criticality and frequency of calibrations:

1. Monthly: 1 Week
2. Quarterly: 1 Week
3. Half-yearly : 2 Week
4. Yearly: 4 Week

• The schedule shall have the following information:

1. Names of instrument/equipment
2. Identification Nos. (ID Nos.)
3. Location
4. Name of an outside party
5. Frequency of calibration

Abbreviation

SOP: Standard Operating Procedure

QA: Quality Assurance
QC: Quality Control

Revision History

Nil

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