- SUMMARY
- The aim of this procedure is to define the necessity for calibration or verification of equipment which can be used to determine the acceptability of product.
- The QA/QC Head will be responsible for implementation and management of this procedure.
- PROCEDURE: CALIBRATION
- Devices subject to calibration shall be calibrated by an approved outside service provider, or by trained employees.
- Third party calibration laboratories should be accredited to NABL whenever possible, as this provides the best control of calibration activities, and traceability to national standards.
- When staff perform in-house calibration, this shall be performed in accordance with documented procedures for each & every type of calibration performed.
- Traceability to the national standards should be maintained for all devices where such traceability is possible .
- Approved calibration service providers should maintain suitable environmental conditions for calibration such as temperature and relative humidity on any calibration test certificates. For in-house calibration, the QA/QC head will ensure suitable conditions for calibration.
- The Calibration log will be maintained by the QA/QC Engineer. This document will contain the list & make of all devices with serial number, date of last calibration, and next calibration due date. All calibrated certificates must have the identification of any standards used by the calibration house, and their serial numbers, allowing for traceability to Client/ Independent Engineer.
- For tools calibrated in-house by EPC contractor staff, the results and standards used shall be recorded on the Calibration Record and shall include any standards and/or procedures uses.
- Calibrated devices should contain a calibration sticker that includes the current calibration status, calibration due date, and device identification number. Where the device cannot accommodate a calibration sticker due to size or frequency of use, the device shall be numbered and the QC Manager shall keep a log of those devices and their status.
- QC Manager shall submit expired tools to QC Head for recalibration, and he shall positively recall such expired tools for recalibration.
- An “amnesty window” of 1 week is allowed beyond the due date marked on the device, to accommodate arrangement of calibration or verification, or for production capacity purposes.
- Devices in use for noncritical measurements are to be marked REFERENCE ONLY.
- Any device failing to satisfy calibration standards will immediately be taken out of service. The device may then be sent out for repair. Repaired devices must be calibrated before being returned to service.
- When a measuring device is found to be out of tolerance, and/or reported on the calibration certificate of having been found as “defective” or “out of tolerance” by the third party provider, QC Manager shall be notified immediately. The QC Head shall oversee a study to find out the impact of the out-of-tolerance device on product shipped.
- VERIFICATION
- Where a device cannot be calibrated against traceable standards, it must be verified against some known-good object or method and proven as acceptable.
- Known-good objects must be protected so their status is not altered, either by physical damage or deterioration.
- Known-good methods must be documented in procedures, with a rationale for their acceptability being documented.
