Confirm that where measurement traceability is a requirement, instruments which are used for measurement are subjected to the following controls:
- Devices are calibrated at intervals or prior to use, based on recognised standards;
- Devices are adjusted as necessary in accordance with manufacturer’s instructions;
- Devices are identified to enable calibration status to be determined;
- Devices are safeguarded from adjustment, which may invalidate results;
- Devices are protected from damage during handling, maintenance or storage;
- The validity of results from a non-confirming device are re-checked with a conforming device;
- Devices are calibrated by competent external providers e.g. certified to ISO 17025;
- Records of calibration and verification are maintained;
- Computer software which is used for monitoring/measuring is validated prior to initial use;
- Computer software used for monitoring and measuring is re-validated where necessary.
If measurement traceability is not required, verify that those monitoring and measuring resources used by your organisation are suitable. You should ensure that documented information is maintained in order to demonstrate suitability of monitoring and measuring equipment. All equipment requiring calibration must be identified and must be:
Calibrated or verified at specific intervals, or prior to being used. Equipment must be calibrated using measurement standards traceable to international or national measurement standards. Where there is no standard available for the device the basis for calibration or verification must be recorded.
Adjusted or readjusted as necessary. Adjusted/re-adjusted calibration should be done by qualified personnel and the validity of the previous measuring results should be accessed when equipment is found to be out of calibration and appropriate action should be taken (this may include recall of a product). Ideally you need a process to provide traceability of each piece of equipment to the process/product that the equipment was used on.
Identified to show calibration status. Each piece of equipment should be identified in such a way that the user can determine that the device has current calibration. This may be accomplished by the equipment’s unique serial number traceable to the calibration record, however a calibration status label is good practice. Where the environment is not conducive to the use of stickers, status may be identified by colour-coding, identification numbers with associated calibration record, and/or calibrated prior to every use.
Safeguarded from adjustment. You really need a process in place to ensure that users outside the calibration process do not adjust equipment. Methods to safeguard may include locking materials for setscrews, tamper-proof seals, limited entrance to calibration areas, and other methods.
Protected from damage during handling, maintenance and storage. You should ensure that measuring equipment is handled and stored in a manner to protect the equipment from damage.
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