.
1.0 OBJECTIVE
To define suitable schedule for calibration of Q.C. instruments as
per specified frequency.
2.0 SCOPE
This procedure is applicable to all instruments installed in Q.C. Dept for
calibration, performance check and operational check whichever is
applicable for respective instrument.
3.0 RESPONSIBILITY
3.1 Doing : Technical Assistant / Executive.
3.2 Checking : Executive /Manager
4.0 ACCOUNTABILITY
Head of the Department
5.0 PROCEDURE
5.1 CALIBRATION PROGRAMME
5.1.1 Calibration of Q.C. instruments falls in two
categories.
a. Internal calibration : Such
calibration is carried out by using standards available in laboratory.
b. External calibration : Such
calibration is carried out by third party. (Third party may take Instrument outside premises)
5.1.2 Prepare month wise calibration schedule. This is to be prepared in last week of the month for next month and so on.
5.1.3 Calibration to be carried out as per following
frequencies.
1 +/- 1 day for 15 days
2 +/-
2 days for monthly
3 +/-
1 week for quarterly
4 15 days for half yearly
5.1.4 Before starting calibration, check
availability and validity of the required standards.
5.1.5 Ensure that all standard chemicals meet
requirement of respective pharmacopoeia and
use only qualified instruments (if
required) for calibration .
5.1.6 Issue the calibration /performance/operational protocol duly sign with ref. no and
issued date and maintain the record.
5.1.7 Before starting calibration
/performance/operational check, go through respective procedure and protocol.
In case of any discrepancy, contact Executive / Manager.
5.1.8 Perform the
calibration/performance/operational check as per specified procedure.
5.1.9 After completion of respective check, write
down status of instrument on calibration card and sign it.
5.1.10 In case of results are not
satisfactory, immediately inform to Executive / Manager.
5.1.11 Write down all observations/ results in respective
protocol and take approval
of authorised person.
5.1.12 Before approval of record, authorised person will
check all the calculation and ensure that calibration is carried out as per standard procedure
and results are satisfactory within specified limits.
5.1.13 Make entry by ‘(√ )‘ marking in calibration schedule.
5.2 ACTION PLAN TO BE FOLLOWED BY QC EXECUTIVE / MANAGER :
5.2.1 Ensure that standard operating procedure for
calibration is followed.
5.2.1 Check that all the calculations are correct.
(If applicable)
5.2.2 Ensure that right standards are used
for calibration.
5.2.3 If calibration/operational/performance
check of instrument does not found satisfactory and error is not identified,
label the instrument as ‘Out of Calibration’
5.2.4 Inform to instrument engineer
regarding the problem.
5.2.5 To check the validity of the testing carried out of
all the samples which have been tested on particular instrument after last calibration and
before calibration failure, collect following data for further action.
a. Frequency of calibration
b. Whether the previous calibration done
according to the schedule.
c. Results of previous calibration.
d. Confirm the validity of standards used
e. Check for replacement of any major parts /
parameters ,after previous calibration.
5.2.6 Carry out retesting of samples tested recently (starting from last sample) before
this calibration till three consecutive samples shows the
difference within 2 % w.r.t.
previous results, giving priority to finished product sample.
5.2.7
In case of difference is
observed more than 2% , reanalysed the
samples and document it.
5.2.8 Enter all the data in tabular format for evaluation.
5.2.9 Q.C. head will review the data and give the final
conclusion.
6.0 ABBREVIATIONS
6.1 % = Percentage
6.2 Q.C= Quality control
6.3 w.r.t.= With respect to
6.4 SOP - Standard Operating Procedure
6.4 SOP - Standard Operating Procedure
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