Calibrate the production & quality control instruments and preparation of calibration plan.
1.0 OBJECTIVE:
To
lay down the procedure for calibration of instruments.
2.0 SCOPE:
This
SOP shall be applicable for calibration of critical and non-critical
instruments.
3.0 RESPONSIBILITY:
3.1
Officer/
Executive/ Assistant Manager.
4.0 ACCOUNTABILITY:
4.1
Head of Quality
Assurance Department.
5.0 PROCEDURE:
5.1 Engineering
department should identify with concerned departments critical/ non-critical
instruments.
5.2 The
frequency shall depend upon the critically of the instruments.
5.3 The
type of instruments is classified in two categories. Instruments that are
calibrated in-house and the instruments that are calibrated by the external
agencies.
5.4 In
case of in-house calibration, head of Engineering/ Q.A/ Q.C/ Production/
Warehouse is responsible to ensure that the calibration is performed using the
certified standards traceable to national or international standards.
5.5 In
case of the instruments that are to be calibrated by outside agencies, an
annual calibration plan for the entire year is prepared by engineering
department.
5.6 A
monthly supplement to the original calibration plan shall be prepared to
incorporate any new equipment/ instrument received and is qualified.
5.7 Based
on the yearly plan, monthly schedule for calibration of the instruments is
prepared by engineering department and is communicated one week in advance to
the outside agency as well as the concerned departments.
5.8 The
calibration by outside party shall be done as per the approved procedures.
5.9 The
calibration of the instruments shall be carried out on or before fifteen days
of the due date.
5.10
The original
calibration plan shall not be changed in case if any of the instrument is
calibrated prior to the planned activities due to major maintenance of the
equipment.
5.11
During
calibration, tag the instrument/ equipment with “UNDER CALIBRATION” label duly
filled by the department.
5.12
The calibration of
the instruments shall cover the entire range of the instrument including the
minimum, maximum and the operational range.
5.13
The calibration
data shall be entered in the calibration record. The record shall contain the
details of the standards used for calibration indicating traceability,
instrument serial number, validity, and the details of the instrument under
calibration indicating name of the instrument, make, ID number, least count,
accuracy and range.
5.14
The calibration
date shall be verified by the concerned department personnel.
5.15
If the instrument/
equipment pass the calibration test, put label duly filled.
5.16
Symbolically
update the annual calibration palm and monthly calibration schedule as
indicated below:
5.16.1 O
= Scheduled.
5.16.2 • = Calibrated.
5.16.3 • =
Rescheduled & Calibrated.
5.17
If the instrument/
equipment ail in calibration test, stop usages of the instrument/ equipment and
put “UNDER MAINTENANCE” label duly filled.
5.18
In case the
critical instrument/ equipment fails in calibration. Such failure shall be reported
to the Head Q.A through incident report and same shall be investigated as per
SOP for incident reporting and investigation.
5.19
The reason for
failure and the effect of failure on the quality of product since last
calibration shall be covered during investigation and a copy of incident report
shall be filed in a respective calibration file.
5.20
After
investigating the reason for failure, the instruments shall be
repaired/replaced as appropriate and calibration shall be performed. If the
instrument is not repairable, make the instrument unusable and send it to scrap
yard for disposal.
5.21
Executive
engineering department shall fix the calibration tag on the instruments and
maintain the related certificates.
5.22
For the
instruments to be calibrated by external agency, the frequency for calibration
of critical instruments shall once in six months and for non-critical
instruments once in a year.
5.23
The frequency for
calibration of the pressure gauges of chilled water and hot water coil in air
handling units shall be once in a three years.
6.0 REVISION LOG:
|
Revision No. |
Effective Date |
Reason |
|
00 |
|
New
SOP |
7.0 REFERENCES:
7.1
Not Applicable.
8.0 ANNEXURES:
8.1
Not Applicable.
9.0 ABBREVIATIONS:
|
Abbreviation |
Expanded Form |
|
SOP |
Standard operating
procedure |
|
& |
And |
|
No. |
Number |
|
Ltd. |
Limited |
|
QA |
Quality assurance |
|
F |
Format |
|
QC |
Quality control |
|
ID |
Identity |