operation management (Updated)

7.6 Control of Monitoring and Measuring Equipment/ Observations/Comments

Results

Has your organization identified both the measurements to be made, and the measuring and monitoring equipment needed in order to assure your product meets requirements?
Has your organization established a mechanism to ensure monitoring and measuring is performed consistent with requirements?
Is the measuring equipment:
* Calibrated at specified intervals against standards traceable to international or national standards? If those standards do not exist, are the basis used for calibration recorded?
* Adjusted or re-adjusted as necessary?
* Identified with calibration status?
* Safeguarded from adjustments that would invalidate the measurement results?
* Protected from damage and deterioration during handling, maintenance and storage?
If equipment is found to be outside of requirements, how does your organization assess and record the validity of previous measuring results?
Does your organization take appropriate action on the equipment and any product affected above?
Where are the results of calibration and verification being recorded?
Is software used for measuring and monitoring verified prior to use and reconfirmed as necessary?
Additional questions
Does the company take any punitive actions of employees indicted with tampering with measurement equipment for self-gain?

My organization has specified necessary measurements. We also have measuring and monitoring equipment to ascertain product requirement.
In my organization, there are defined mechanisms and procedures to ensure monitoring and measuring conform to requirements.
* Our measuring equipment are calibrated at specified intervals traceable to international standards.
* YES
* YES
* Equipment are safeguarded from unnecessary adjustments that would invalidate measurement results
* YES, equipment is protected from adjustment invalidating results with strict control measures
The equipment is within the requirements, however, in a worst case scenario, our organization keeps records of measurements every time. We will only need to retrieve them and adjust the measurement.
YES, actions are taken on equipment
Results are recorded on daily occurrence book. This is the book used every time a measurement is done, any changes, adjustments are recorded in it.
YES, the software is verified
YES, there are very strict measures to control such adjustments, but serious control and punitive measures are also implemented.

PASS

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