SOP on Calibration Policy
Contents
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1.0
What
This document details the
Calibration Policy of equipment/ instrument of the Company.
Calibration Policy of equipment/ instrument of the Company.
2.0
Why
It is the policy of the Company that the written procedure shall be followed for calibration of all Equipment / Instrument at suitable interval based on
manufacturer’s recommendation, historical experience and criticality of use,
used in the process of Manufacturing, Packing, Analytical division,Q.C.,
Maintenance and Warehouse other than those Equipment / Instrument that are
calibrated with each use.
manufacturer’s recommendation, historical experience and criticality of use,
used in the process of Manufacturing, Packing, Analytical division,Q.C.,
Maintenance and Warehouse other than those Equipment / Instrument that are
calibrated with each use.
3.0
When
This procedure is to be
applied at the time of preparation of 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.
applied at the time of preparation of 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.
4.0
RESPONSIBILITY
Persons along with their
responsibilities are given below:
responsibilities are given below:
|
S. No
|
Designation
|
Responsibility
|
|
01
|
Executive – Corporate Quality Assurance
|
To prepare procedure and coordination for calibration with Outside
party and concerned department. |
|
02
|
Executive – Quality
Assurance |
To prepare In house and outside calibration schedule
|
|
03
|
Executive – Quality Assurance
|
Execution and overall responsibility for calibration with Outside
party and concerned department |
|
04
|
Manager – Quality
Assurance |
To ensure that calibration is being done accordingly.
|
|
05
|
Manager – Corporate Quality
Assurance |
To ensure implementation of SOP
|
5.0
PROCEDURE
5.0.1 Separate calibration programs for in house calibration and outside
party calibration shall be prepared in
the beginning of each year for all instrument / equipment to be calibrated on
dates as per their individual frequencies.
party calibration shall be prepared in
the beginning of each year for all instrument / equipment to be calibrated on
dates as per their individual frequencies.
5.0.2 Calibration of Equipment / Instrument shall be carried out at
suitable intervals based on manufacturer’s
recommendation, historical experience and criticality of use.
suitable intervals based on manufacturer’s
recommendation, historical experience and criticality of use.
5.0.3 Calibration standards for in-house
or contract service must be traceable to a recognized National Standard and within
calibration validity period.
or contract service must be traceable to a recognized National Standard and within
calibration validity period.
5.0.4 All traceability certificates
shall be checked by department Head and reviewed by person responsible for
calibration activities.
shall be checked by department Head and reviewed by person responsible for
calibration activities.
5.0.5 Both In house and outside calibration schedule 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 Quality assurance Department.
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 Quality assurance Department.
5.0.6 Quality assurance Department on receiving schedules from different
department will prepare a composite Schedule for calibration and will send a
copy of the same to all concerned department.
department will prepare a composite Schedule for calibration and will send a
copy of the same to all concerned department.
5.0.7 On installation of new equipment,
during qualification all instruments need to be calibrated shall be identified
based on manufacturer recommendation and criticality of use. User department
will inform to Quality assurance Department about the same for inclusion in
the calibration schedule on Appendix – I.
during qualification all instruments need to be calibrated shall be identified
based on manufacturer recommendation and criticality of use. User department
will inform to Quality assurance Department about the same for inclusion in
the calibration schedule on Appendix – I.
5.0.8 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.
instruments like, thermometers, Thermo hygrometers etc. the user department
will inform to Quality assurance Department for inclusion in the calibration
schedule on Appendix-I.
5.0.9 Once the instrument is included
in the calibration schedule, Quality assurance
Department will
allot new ID no. of that series based on the type of instrument and will inform
to concerned department.
in the calibration schedule, Quality assurance
Department will
allot new ID no. of that series based on the type of instrument and will inform
to concerned department.
5.0.10 User department will inform to Quality assurance Department about 30 days prior to due date of
calibration for out side party calibration so that necessary arrangements can
be made on Appendix-III.
calibration for out side party calibration so that necessary arrangements can
be made on Appendix-III.
5.0.11 All concerned departments are
required to intimate Quality assurance Department whenever any instrument is
replaced, out of use, damaged, out of calibration or when there is no
calibration status label.
required to intimate Quality assurance Department whenever any instrument is
replaced, out of use, damaged, out of calibration or when there is no
calibration status label.
5.0.12 Calibration schedule (both
In-house and outside) will be live document and any inclusion can be made
manually.
In-house and outside) will be live document and any inclusion can be made
manually.
5.0.13 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 :
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 :
Monthly :
1 Week
1 Week
Quarterly :
1 Week
1 Week
Half yearly :
2 Week
2 Week
Yearly :
4 Week
4 Week
5.0.14.1
Names of instrument /
equipment
5.0.14.2
Identification Nos. (ID Nos.)
5.0.14.3
Location
5.0.14.4
Name of outside party
5.0.14.5
Frequency of calibration
5.1
Outside Party Calibration
5.1.1
In case of outside party
calibration, a technical contract shall be signed with the party specifying the
general conditions of calibration using agreed methods.
In case of outside party
calibration, a technical contract shall be signed with the party specifying the
general conditions of calibration using agreed methods.
5.1.2 Calibration shall be carried out at the site in presence of a supervisor
/ officer of the concerned department.
/ officer of the concerned department.
5.1.3
If calibration is not possible at the site, shall be send to the site of
outside agency.
If calibration is not possible at the site, shall be send to the site of
outside agency.
5.1.4 Calibration of Equipment / Instrument shall be carried out as per the
Standard Operating Procedure.
Standard Operating Procedure.
5.1.5
HOD of the concerned department shall ensure that
calibration is being carried out as per SOP.
HOD of the concerned department shall ensure that
calibration is being carried out as per SOP.
5.1.6
If any equipment / instrument found out of calibration, label it as “UNDER MAINTENANCE” , update the Instrument History Card as per Appendix II and inform to
Quality Assurance for appropriate action.
If any equipment / instrument found out of calibration, label it as “UNDER MAINTENANCE” , update the Instrument History Card as per Appendix II and inform to
Quality Assurance for appropriate action.
5.1.7 In case
the instrument is out of calibration it gets promptly reported and steps taken
to remove it from service.
the instrument is out of calibration it gets promptly reported and steps taken
to remove it from service.
5.1.8 Instrument
/ equipment shall not be further used till complies the calibration
requirements.
/ equipment shall not be further used till complies the calibration
requirements.
5.1.9
The acceptance criteria for
calibration of instrument / equipment shall be provided by the company to the
outside party agent based on the cGMP requirements.
The acceptance criteria for
calibration of instrument / equipment shall be provided by the company to the
outside party agent based on the cGMP requirements.
5.1.10
On successful calibration of any equipment / instrument the calibrating
agency personnel shall label the instrument with a green coloured calibration
sticker.
On successful calibration of any equipment / instrument the calibrating
agency personnel shall label the instrument with a green coloured calibration
sticker.
5.1.11
Calibration sticker shall have
information like date of calibration, Instrument ID No., Calibration date,
signature of the person who carried out the calibration and next due date of
calibration.
Calibration sticker shall have
information like date of calibration, Instrument ID No., Calibration date,
signature of the person who carried out the calibration and next due date of
calibration.
5.1.12
The calibrating agency shall
issue a certificate of calibration in respect of each instrument / equipment
calibrated.
The calibrating agency shall
issue a certificate of calibration in respect of each instrument / equipment
calibrated.
5.1.13
Calibration certificate shall have details
like identification of the instrument, the range of calibration, standard
calibrators used and their traceability, the date of calibration, the actual
values obtained, the date on which the next calibration is due and the signatures
of the person who carried out the calibration activity.
Calibration certificate shall have details
like identification of the instrument, the range of calibration, standard
calibrators used and their traceability, the date of calibration, the actual
values obtained, the date on which the next calibration is due and the signatures
of the person who carried out the calibration activity.
5.1.14
Each certificate of calibration
of instrument / equipment shall be reviewed by concern Department.
Each certificate of calibration
of instrument / equipment shall be reviewed by concern Department.
5.1.15
Along with these calibration
certificates the calibrating agency shall also provide copies of the calibration certificates of the standard
calibrators used, traceable to National Standards.
Along with these calibration
certificates the calibrating agency shall also provide copies of the calibration certificates of the standard
calibrators used, traceable to National Standards.
5.1.16
All traceability certificates shall be checked by department Head and
reviewed by person responsible for calibration activities.
All traceability certificates shall be checked by department Head and
reviewed by person responsible for calibration activities.
5.1.17
Ensure that resolution (least
count) of calibrator should be less than the resolution of equipment/instrument
to be calibrated.
Ensure that resolution (least
count) of calibrator should be less than the resolution of equipment/instrument
to be calibrated.
5.1.18
The certificates shall be
documented & maintain the record.
The certificates shall be
documented & maintain the record.
5.2
In house Calibration
5.2.1
A calibration schedule shall be
prepared in the beginning of each year for all instruments / equipment which to
be calibrated as per their individual frequencies.
A calibration schedule shall be
prepared in the beginning of each year for all instruments / equipment which to
be calibrated as per their individual frequencies.
5.2.2
Calibration of instruments
shall be done as far as possible in the location of its use.
Calibration of instruments
shall be done as far as possible in the location of its use.
5.2.3
In case the instrument /
equipment is found out of calibration, it shall be immediately labeled “UNDER MAINTENANCE”, update the Instrument History
Card as per Appendix II and inform to Quality Assurance
for appropriate action.
In case the instrument /
equipment is found out of calibration, it shall be immediately labeled “UNDER MAINTENANCE”, update the Instrument History
Card as per Appendix II and inform to Quality Assurance
for appropriate action.
5.2.4 In case
the instrument is out of calibration it gets promptly reported and steps taken
to remove it from service.
the instrument is out of calibration it gets promptly reported and steps taken
to remove it from service.
5.2.5 Instrument
/ equipment shall not be further used till complies the calibration
requirements.
/ equipment shall not be further used till complies the calibration
requirements.
5.2.6
After successful calibration, the instrument shall be labelled with a
Green calibration sticker indicating the Instrument name, date of calibration,
Tag No. / ID No., signature of the person who carried out the calibration and
next due date of calibration.
After successful calibration, the instrument shall be labelled with a
Green calibration sticker indicating the Instrument name, date of calibration,
Tag No. / ID No., signature of the person who carried out the calibration and
next due date of calibration.
5.2.7
Calibration reports shall be prepared by the person carrying out the
activity and shall be reviewed by
designated person and documented.
Calibration reports shall be prepared by the person carrying out the
activity and shall be reviewed by
designated person and documented.
5.2.8
Maintenance or moving of an instrument can alter calibration status and
accuracy of data. Hence after any such activity with
the instrument shall be assed and recalibrated (whenever required) and document
the calibration record.
Maintenance or moving of an instrument can alter calibration status and
accuracy of data. Hence after any such activity with
the instrument shall be assed and recalibrated (whenever required) and document
the calibration record.
5.2.9
Re-calibration shall be done in
case of any maintenance or re-installation of instrument / equipment (wherever
applicable) and record shall be maintained.
Re-calibration shall be done in
case of any maintenance or re-installation of instrument / equipment (wherever
applicable) and record shall be maintained.
5.3
FOLLOW-UP FOR OUT OF
CALIBRATION
5.3.1
The details of ‘Out of Calibration’ shall be
recorded in the logbook of respective instrument / equipment and inform to Quality
assurance Department.
The details of ‘Out of Calibration’ shall be
recorded in the logbook of respective instrument / equipment and inform to Quality
assurance Department.
5.3.2
Fill the form on JOB ORDER attached in Appendix IV and send it to engineering department.
Fill the form on JOB ORDER attached in Appendix IV and send it to engineering department.
5.3.3
HOD – Engineering shall take
the corrective action accordingly.
HOD – Engineering shall take
the corrective action accordingly.
5.3.4
The QA Officer shall assess the
number of Sample affected or the number of analysis affected and the impact of
the same on the quality or system.
The QA Officer shall assess the
number of Sample affected or the number of analysis affected and the impact of
the same on the quality or system.
5.3.5
Record the maintenance details
in the log of instrument / equipment.
Record the maintenance details
in the log of instrument / equipment.
5.3.6
Calibrate the instrument/
equipment after rectification as per the respective calibration SOP.
Calibrate the instrument/
equipment after rectification as per the respective calibration SOP.
5.3.7
Record the calibration in the log of the
instrument / equipment.
Record the calibration in the log of the
instrument / equipment.