standard operating procedures

standard operating procedures
SOP # A-505-01-069Y
STANDARD OPERATING
PROCEDURES
Page:1 of 3.
CALIBRATION REQUIREMENTS for
LABORATORY EQUIPMENT
1.
PURPOSE
The purpose of this Standard Operational Procedure is to provide a standard
calibration procedure and standard calibration sheets for the calibration of all types
of laboratory equipment.
2.
Responsibility
Π- Symbol indicates routine calibration performed by the departmental staff.
• - Symbol indicates twice annual calibration performed by metrology department
Ž - Symbol indicates annual or biannual calibration performed by an external
contracted third party metrology firm.
3.
Equipment
As defined on the calibration sheet and equipment specific SOPs
4.
Frequency
Internal laboratory calibration ; Prior to routine use of equipment (e.g. daily balance
calibration, system suitability test, pH meter etc.) Œ
Metrology department • calibration ; Monthly (Analytical balances only)
Metrology department • calibration ; Twice per year
Metrology department • ; and after equipment maintenance or relocation
Metrology department • ; and after repair of critical part replacement
External calibration Ž ; Annually or biannually calibration by contracted Third Party
according to equipment specific SOP
5.
Procedure
5.1 Operate the equipment in accordance with the relevant Operating Instructions.
5.2 Perform the equipment calibration according to the equipment specific SOP
5.3 Fill out form “Calibration Record” Sheet, see Attachment 2.
5.4 Evaluate if "SUITABILITY Sticker” has been compromised, [Attachment 1].
5.5 In cases where the SUITABILITY of equipment has been compromised (e.g
dissolution equipment) due to the re-calibration the technician will deface and crossout the "SUITABILITY Sticker” and attach a note stating "Performance Verification
Invalidated Due To Re-Calibration"
5.6 Attach “Calibration Sticker”, to equipment [Attachment 1].
5.7 The performance verification of the equipment (only where necessary) shall be
repeated prior to routine laboratory use.
ED. N0: 02
Replaces Ed 01.
Ed. Status:
Operational
Effective Date :
APPROVED:
June 1999
Laboratory
Maintenance
Metrology
QA
SOP # A-505-01-069Y
STANDARD OPERATING
PROCEDURES
Page:2 of 3.
CALIBRATION REQUIREMENTS for
LABORATORY EQUIPMENT
6.
Re-calibration
6.1 If the calibration does not conform, repeat the procedure.
6.2 If the second calibration does not conform, clean and check equipment
according to the manufacturer's instructions. Then, repeat the procedure.
7.
Limits
Calibration Instructions must be applied in accordance with equipment specific SOP
7.1 General limit of accuracy and sensitivity
Acceptance limits :
Minimum: 95%, maximum 105%.
7.2 If the manufacturer specifies stricter requirements, these specification may be
used.
7.3 If, after the second calibration the equipment still does not conform, replace or
repair the non-functional part or unit.
8.
Documentation
Document calibration results as per the attached “Calibration Record” Sheet.
Refer to attached “Calibration Record” Sheets as guidance.
9.
Labeling
9.1. White label (stuck on the apparatus after apparatus SUITABILITY test).
9.2. Green label (stuck on the apparatus after CALIBRATION of apparatus).
WHITE LABEL
GREEN LABEL
SUITABILITY TEST
CALIBRATION
ANALYST:
Metrology Dept.:
Date:
Next Date: _________
Date:
Next Date: _________
3
[End of Document]
•‚ƒ„…†‡ Œ•Ž
ED. N0: 02
Replaces Ed 01.
Ed. Status:
Operational
Effective Date :
APPROVED:
June 1999
Laboratory
Maintenance
Metrology
QA
STANDARD OPERATING
PROCEDURES
SOP # A-505-01-069Y
Page:3 of 3.
CALIBRATION REQUIREMENTS for
LABORATORY EQUIPMENT
STANDARD CALIBRATION RECORD
Equipment:
Location
I. D. No.
PLANT
Installation Date
Out-of-Use Date
Inventory No
Classification
SOP Number
Last Calibrated
Scheduled For
Next Calibrated
Calibration Expiry
CRITICAL q
MAJOR q
System q
MINOR q
Line
q
TYPE OF EQUIPMENT
Manufacturer
TYPE:
MODEL:
RANGE:
ACCURACY
Max. Deviation
TOLERANCE
GRADUATION
Acceptance Limits
NLT 95 - NMT 105 %
CALIBRATED AGAINST STANDARD
TESTER ID
TRACE TO NATIONAL STANDARDS
YES q - NO q / Certificate q - No q
WEIGHT ID
WEIGHT ID
TEST BEFORE CALIBRATION
REFERENCE
VALUE
MEASURED
q CALIBRATED
RESULTS
Comments:
CALIBRATION
DATES
CALIBRATED
BY
Operational
Effective Date :
MEASURED
DEVIATION
q NOT CALIBRATED
METROLOGIST
DATE
Approved by
ED. N0: 02
Replaces Ed 01.
Ed. Status:
DEVIATION
AFTER CALIBRATION
q IN-HOUSE
q EXTERNAL
SIGNATURE
SIGNATURE
APPROVED:
June 1999
Laboratory
Maintenance
Metrology
QA
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