STANDARD OPERATING PROCEDURE FOR CALIBRATION

1.      Purpose:

1.1.The purpose of this document is to describe the procedure for calibration of machines, equipment’s and apparatus of the facility.

2.      Scope:

2.1.It is applicable in all sections of the plant

3.      Responsibility:

3.1.Quality Assurance Manager

3.2.Quality Assurance Officer

3.3.Section In Charge (Concerned)

4.      Procedure:

4.1.External Calibration

4.1.1.      The Quality Assurance Manager contacts the external party/ company which are authorized to give calibration certificate by some internationally accredited ISO certified company.

4.1.2.      On arrival of the concerned personnel from the relevant calibration company; QA Manager/ Officer shall accompany him/ her within the facility.

4.1.3.      The Quality Assurance Personnel’s provide a list of all the machines, equipment’s, instruments and their accessories which are to be calibrated.

4.1.4.      The calibration team comprising of the personnel’s of the external party/ company along with the quality assurance personnel’s and the relevant section in charge’s calibrate the machines, equipment’s and instruments in the section.

4.1.5.      After performing the calibration, the certified calibrating company shall paste the sticker mentioning that the calibration of the machine/ equipment/ apparatus has been performed.

4.1.6.      After calibration, the certified company verifies the calibration of the machines/ equipment’s/ instruments.

4.1.7.      Following is a list of parameters which require calibration:

                                                                      i.            Rounds Per Minute (RPM)

                                                                    ii.            Pressure Gauges

                                                                  iii.            Temperature Panels

                                                                  iv.            Hygrometers

                                                                    v.            Weight

                                                                  vi.            No. of fills/ minute

                                                                vii.            Machine process controller

4.2.In House Calibration:

4.2.1.      Equipment’s/ instruments/ machines for which in house calibration is to be done are as under:

                                                                    i.            Weighing Scales/ Balances

                                                                  ii.            PH Meter

                                                                iii.            Quality Control Software Based Instruments

4.2.2.      The calibration of weighing balances and PH meters are done in house with a reference standard which is calibrated externally annually.

4.2.3.      In house calibrations for weighing balances/ scales must be done on daily basis.

4.2.4.      Record of in house calibration for all weighing balances present in facility is to be maintained by the quality assurance personnel’s.

4.2.5.      For calibration of PH meter, weekly calibration must be done by the quality assurance personnel’s.

4.2.6.      Quality Assurance Manager is responsible for in house and external calibrations of all the machines/ equipment’s/ instruments/ apparatus.

4.2.7.      It is the responsibility of Quality Assurance Manager to verify that all the machines, equipment’s and instruments are calibrated within the premises.

4.2.8.      Quality Assurance Manager should collect the certificates of calibration and file them properly.

4.2.9.      Any new equipment, machinery or instrument purchased should be calibrated by the certified calibrating company.

5.      List of Recipients:

5.1.Quality Control Manager

5.2.Production Manager

5.3.Quality Assurance Manager

6.      Attached Forms/ Annexure:

6.1.List of equipments, machines and instruments calibrated.

6.2.Daily calibration sheet