Annexure - 31 Calibration Procedure
Annexure - 31 Calibration Procedure
Annexure - 31 Calibration Procedure
1. SCOPE
This procedure applies to the Shopfloor equipment used by the technician in shopfloor.
2. PURPOSE
This procedure specifies the schedule and requirements for calibration, performance verification,
and maintenance of shopfloor testing instruments and equipment.
3. REFERENCE DOCUMENTS
1
SATHYAVATHI ELECTRICAL SERVIES PVT LTD
4.7 Performance Verification – The confirmation of the reliability of a previously validated
method(s) or equipment.
5.1 Quality Assurance – is responsible for preparing, implementing and maintaining this
procedure. In addition, QA is assigned Calibration Administration responsibilities as defined in
this procedure
5.2 Calibration Administrator/Operations – is responsible for following the procedure defined
in this document.
6. DETAILS OF PROCEDURE
6.1.1 The QA Manager or designee shall maintain an equipment inventory that shall include the
following information:
6.1.2 All equipment in the equipment inventory system shall be identified uniquely (e.g., DOJ
bar code number).
6.1.3 All equipment shall be maintained in good operating order and according to the
manufacturer and/or Section maintenance requirements.
6.1.4 All critical equipment shall be calibrated or verified before use.
2
SATHYAVATHI ELECTRICAL SERVIES PVT LTD
6.3 Equipment Calibration and Verification
6.3.5 When external calibrations are performed, service providers that demonstrate competence,
measurement capability, and traceability shall be used. Calibration certificates from these
providers shall contain the measurement results, including the measurement uncertainty and/or a
statement of compliance with an identified metrological specification. When possible, providers
accredited to ISO 17025 shall be used. Copies of the provider’s accreditation documentation
shall be maintained by the Quality Manager (QM).
6.3.6 If calibrations are performed by an outside vendor, the Section document control custodian
shall maintain the original calibration records provided by the vendor and a copy of the relevant
records shall be readily available.
6.3.7 Laboratory equipment requiring calibration shall be labeled or coded to indicate the
calibration status, including the date when last calibrated and the due date for recalibration (or
expiration criteria for when recalibration is due).
3
SATHYAVATHI ELECTRICAL SERVIES PVT LTD
manuals shall be readily available to the operator. In the absence of the manufacturer’s
instructions, instructions shall be provided in the technical procedure.
4.3.3 Preventative maintenance procedures (other than basic cleaning) for each equipment item
shall be developed by each Section unless already described elsewhere (e.g., the equipment
manual) and shall be performed according to a regular, predetermined schedule. Preventive
maintenance shall be documented in the maintenance records.
Type of equipment.
Equipment serial number or unique identifier.
Date of maintenance.
Adjustments or repairs made.
The identity of the individual performing maintenance.
6.6.1 Equipment that has been subjected to overloading or mishandling, gives suspect results or
has been shown to be defective or outside specified limits, shall be taken out of service. It shall
be isolated and/or clearly labeled (Out of Service – Do Not Use) to prevent use until repaired and
shown by calibration or test to perform correctly.
6.6.2 Prior to returning a piece of equipment to use (out of service for any reason – e.g.,
maintenance, malfunction, leaving the direct control of the Laboratory), the correct operation
shall be demonstrated by calibration or performance verification. Laboratory personnel shall
examine the effect(s), if any, of a malfunction on analysis results and implement the Procedure
for Corrective Action as required.
6.6.3 An exception may be made if the equipment failure is not directly related to its analytical
function, such as a problem with peripheral equipment.
Quality control checks may be carried out at appropriate intervals to verify that equipment is
functioning as expected. The procedures for quality control checks shall be included in the
technical procedure for which the equipment is being used.
4
SATHYAVATHI ELECTRICAL SERVIES PVT LTD
6.8 Correction Factors
Where calibrations give rise to a set of correction factors, the Section shall ensure that software
is updated with these correction factors.
6.9 Safeguards
The QA Manager/Supervisor shall designate the personnel (Equipment Monitor) responsible for
equipment calibration, maintenance (including outside vendors used for these services).