1.0 OBJECTIVE:
To
lay down the calibration procedure of hot incubator to provide a system to calibrate, control and
maintain the equipment used for inspection measuring and test equipment in
order to ensure the correctness of measurement and test status.
2.0 SCOPE:
This
shall be applicable to the hot
incubator of Quality Control Instrument Laboratory.
3.0 RESPONSIBILITY:
3.1
Technical
Assistant/ Helper.
3.2
Q.C Analyst.
4.0 ACCOUNTABILITY:
4.1
Manager-Quality
Control.
5.0 MATERIAL AND
EQUIPMENT:
5.1
Hot incubator.
5.2
Calibrated thermometer.
6.0 PROCEDURE:
6.1
Operate the Hot incubator according to the
SOP.
6.2
Fix the
temperature gauge of the hot
incubator at the 22oC. Wait till the set temperature is
reached.
6.3
Take the
calibrated thermometer in 500.0ml of beaker filled to ¾ of the volume with
glycerol AR grade.
6.4
Keep the beaker
inside, at the center of the incubator.
6.5
Close the door.
Allow the temperature to equilibrate for 30 minutes.
6.6
Observe the
temperature shown by the calibrated thermometer and the temperature shown by
the display thermometer.
6.7
The temperature of
calibrated thermometer should not differ by more than 0.5oC.
6.8
Record the
temperature at two time intervals (with a gap of 6hours) in temperature record.
6.9
By following the
point 6.1 to 6.7 carry out calibration by setting the incubator temperature at
37oC, 44oC and 55oC.
6.10 Record
any discrepancy observed during operation or during temperature monitoring to
Quality Control Executive and notifies the defect to technical assistant for
rectification. Affix “BREAKDOWN”
label on the instrument.
6.11 Record
the result on the “Calibration Record”,
“Calibration Log Book” & paste the “Calibration
Status Sticker” on Hot
incubator.
6.12 Frequency:
6.12.1 Once
a month and after each maintenance job.
6.13 Record
the results on the Calibration Record, Calibration Identification Log and paste
the Calibration Status Sticker on the hot incubator.
6.14 The
following quality records shall be generated and managed in accordance with the
procedure for control of company quality records.
6.14.1
Calibration
record.
6.14.2
Calibration status
sticker.
6.14.3
Under calibration.
6.14.4
Calibration
identification form.
6.14.5
Calibration
identification log.
7.0 REVISION LOG:
Revision No.
|
Effective Date
|
Reason
|
00
|
|
New
SOP
|
8.0 REFERENCES:
8.1 Not Applicable.
9.0 ANNEXURES:
Annexure 1:
Calibration record of hot incubator.
Annexure:
1
Calibration
record of Hot Incubator.
CALIBRATION
RECORD OF HOT INCUBATOR
Observation Chart
Equilibration
time= 30minutes.
Note:
2nd interval must be done after 6 hours of 1st
interval.
Remarks: The
calibration procedure of instrument is within tolerance limit and gives satisfactory/ not satisfactory results.
|
10.0
ABBREVIATIONS:
Abbreviation
|
Expanded Form
|
SOP
|
Standard operating
procedure
|
&
|
And
|
No.
|
Number
|
Ltd.
|
Limited
|
Q.C
|
Quality control
|
Q.A
|
Quality assurance
|
QCEB
|
Quality control
equipment calibration
|
F
|
Format
|
oC
|
Degree centigrade
|