sop for Calibration and Maintenance of Laboratory Instruments and Equipment

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3 years ago

sop for Calibration and Maintenance of Laboratory Instruments and Equipment

1.0 OBJECTIVE:
To lay down a procedure for the Usage, Calibration and Maintenance of Laboratory Instruments and Equipments in Quality Control Laboratory

2.0 SCOPE:
This procedure is applicable for the Usage, Calibration and Maintenance of Laboratory Instruments and

Equipments which are installed and being used in the Quality Control Department.

3.0 RESPONSIBILITY:
Officer / Executive- QC

4.0 ACCOUNTABILITY:
Head of the QC Department.
To ensure the Compliance of this SOP, in all aspects

5.0 PROCEDURE:
5.1 Before using any instrument, the analyst shall ensure that the respective instrument is placed on a leveled, Sturdy and vibration free platform or table.

5.2 Analyst shall ensure that the respective instrument is neat and clean. In case the cleaning is not proper,

the said instrument shall be cleaned properly by using a soft lint free cloth and or a soft brush.
5.3 Analyst shall check and ensure that all the respective electrical and software connections are fixed properly.
5.4 Prior to usage, the analyst shall ensure the respective instrument is calibrated, and is suitable for the intended usage.
5.5 No instrument should be used immediately after switching “ON” the power supply, adequate time shall be given

(As per the requirement of the respective instrument) to get it stabilized.
5.6 The analyst shall ensure to make the relevant entries in the Usage log book of the respective instrument.
5.7 All the respective entries shall be done as per Annexure-I & Annexure-II (As Applicable).
5.8 After the usage, the analyst shall ensure the proper cleanliness of the respective instrument and record the same as per Annexure-I & Annexure-II (As Applicable).
5.9 For accurate and reliable results all the laboratory instruments should be calibrated as per their pre- defined frequency/schedule, procedure and parameters.
5.10 The instruments, for which calibration facility is not available at Site, shall get calibrated by authorized

approved external agencies, and a record of the same shall be maintained accordingly. The responsibility for the same lies with QA Department.
5.11 Master calibration schedule should be prepared for all the laboratory instruments, and the calibration record shall be maintained accordingly.

5.12 Master Calibration Schedules shall be prepared for the instruments which calibration facility is available within the laboratory/site,

and all instruments which need to be calibrated by an approved / authorized external agency.
5.13 The respective Master schedule(s) shall be prepared as per Annexure-III, on yearly basis.
5.14 The first (Initial) Master Calibration schedule shall have the Version No. as 01, and if due to any updation

(Addition / Deletion) of laboratory instruments list specified in the existing schedule, Change in Calibration frequency

of any Laboratory instrument, or due to any other unavoidable / unforeseen reason, the master calibration schedule needs to

be updated and revised, then the new schedule shall have the Version No. as 02, and next as 03 and so on. Reason for making

any change(s) in the existing master calibration schedule shall be mentioned in the revised schedule, against the Remarks option.
5.15 All the versions (Initial and the revised ones) of the Master Calibration schedule(s) should be maintained, recorded and documented properly.
5.16 After the calibration of the respective instrument is completed successfully, the GLP section in- charge shall update

the master calibration schedule by making the entry in the box mentioned against “Executed On”, and put his / her sign

with date against the option “Checked By/On”. This is applicable for the instruments for which facility for calibration is available at site QC Laboratory.
5.17 For all the instruments which are being calibrated by an approved / authorized external agency, the responsibility for

updating the Master Calibration schedule lies with Manager / Executive / Designee QA Department.
5.18 All the instruments should be calibrated as per their respective calibration frequency and within the

5.19 If due to any unforeseen / unavoidable circumstances, any instrument is not calibrated within the specified period,

a Deviation shall be raised for the same by Head –QC, with proper justification, and the respective instrument can only be used for routine analytical activities after the deviation is accepted and approved by the Head – QA.
5.20 Same shall also be informed to the Head Quality
5.21 Head QC shall ensure that the respective instrument be calibrated at the earliest and get the respective deviation closed.
5.22 In case the respective instrument is malfunctioning, is out of order and / or is not complying with the specified acceptance criterion

of calibration, then immediately inform the Head – QC, site engineering department, QA and the respective service provider – As applicable,

and the user should immediately put a tag having the information as shown below.
5.23 Same shall also be recorded in the usage log book of the respective instrument, and in the “Maintenance/Service History Card”

for the maintenance and service activities of the said instrument, as per Annexure-IV.
5.24 No instrument should be used for routine analytical activities if its calibration fails to comply with the pre-defined acceptance criterion.
5.25 For non-functioning instruments give detail of follow up in progress register for their fault rectification and arrangement of spare

part for the same instruments as per Annexure-V of this SOP.
5.26 After the error / fault is rectified, the respective instrument should be calibrated and shall be used for routine analytical

activities only if it complies with the pre-defined acceptance criterion. impact analysis for the various Materials / Products which were analyzed

using the instrument which failed to comply with the acceptance criterion.
5.28 The impact analysis shall be carried out for the products / materials which were analyzed using the respective instrument,

from the date when the respective instrument fails to comply with the acceptance criterion to the Last successful calibration date of the said instrument.
5.29 For impact analysis, all the materials / products which were analyzed using the said instrument in the last 24 hours should

be reanalyzed (Immediately) as per the respective Specifications and MOA.
5.30 The impact analysis shall be extended to rest of the materials / products which were analyzed using the said instrument

by selecting randomly the samples analyzed as per the criteria described below:
5.31 Any material / product analyzed one week before the date when the instrument fails to qualify the calibration acceptance criterion.
5.32 Any material / product analyzed 15 days before the date when the instrument fails to qualify the calibration acceptance criterion.
5.33 Any material / product analyzed one Month before (And thereafter on monthly basis) the date when the instrument fails to qualify

the calibration acceptance criterion, till the date of the last successful calibration.
5.34 If all the reanalyzed materials / products meet the respective acceptance criterion (Specifications), the results of the initial analysis remain valid.
5.35 If any of the reanalyzed materials / products fails to meets the respective acceptance criterion, proceed as per the SOP on “Handling of Out of Specification” .
5.36 If the findings of OOS investigation complies with the respective acceptance criterion, then the
result(s) of the initial analysis stands valid, and if after the OOS investigation the respective
material / product fails to comply with the predefined acceptance criteria, In such cases Head QC shall immediately inform to Head QA

for further action and appropriate decision.
5.37 Following Tolerance Window(s), shall be followed, As mentioned in Table-I, while calibrating the respective instruments:
5.38 The respective instruments shall be calibrated as per the Frequency mentioned in Respective SOP.

S.No.	CALIBRATION	TOLERANCE
1.0	Daily	Same day
2.0	Weekly	± 1 Day
3.0	Fortnightly	± 2 Days
4.0	Monthly	± 3 Days
5.0	Quarterly	± 7 Days
6.0	Half Yearly	± 10 Days
7.0	Yearly	± 15 Days

5.4 Note: The tolerance window shall be applicable for working days only if any holiday falls in between tolerance window date then it shall extend accordingly.

5.39 Initial (First Time) Calibration date should be denoted with a ‘Standard Date’. Instrument having Calibration Frequency as Quarterly,

and 15/04/20 being its “Standard Date”, shall have calibration schedule as 15/04/20 (Initial), followed by 15/07/20; 15/10/20 and 15/01/20. However

the respective (Followed after initial calibration) calibrations can be performed within the Tolerance Window of ±7 days. Hence all the calibrations,

Followed by the initial calibration, can be performed anywhere between 8th and 22nd of the respective month, When the calibration is due.
5.40 In case the respective instrument is required to be calibrated, in between, before the next due date, For Example: After performing any

maintenance activity, which may be required due to the malfunctioning of the instrument, Change of any part of the said instrument,

or Relocating the respective instrument, etc., then the next due date of the calibration of the respective remains “Unaffected”.

6.0 ABBREVIATIONS:
SOP Standard Operating Procedure
No. Number
QA Quality Assurance
QC Quality Control
MOA Method of Analysis
GLP Good Laboratory Practice
S.No Serial Number.
E and M Engineering & maintenance

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