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7.6 Control of Monitoring and Measuring Devices (MMD)
Determine what monitoring and measurement is required and what MMD devices are needed to provide evidence of product conformity (see 7.2.1).
Establish processes to ensure that monitoring and measurement can be carried out and is in fact being carried out in a manner that is consistent with requirements.
When necessary to ensure valid results:
a)Calibrate or verify MMD at specified intervals, or prior to use, against measurement standards that are traceable to national or international standards. Record the basis for calibration if no such standard exists.
b)Adjust or re-adjust MMD as necessary
c)Identify MMD so that its calibration status can be determined
d)Safeguard MMD from improper adjustments that would invalidate the measurement result.
e)Protect MMD from damage and deterioration during handling, maintenance and storage
Assess and record the validity of previous measuring results if when the MMD does not meet requirements.
Take appropriate action on such MMD and any product affected.
Keep records of the calibration and verification of MMD’s.
Confirm the ability of computer software to satisfy the intended application, when it is used to measure and monitor to specified requirements. Confirm this ability prior to initial use and reconfirm as necessary.
Note: See ISO 10012-1 and 10012-2 for guidance
Key Explanation Points and Tips:
ÞRequirements for what needs to be measured (see clause 4.1c & e; 7.1c) and the acceptance criteria (see clause 7.2.1; 7.1c; 7.3.3c) may come from the customer, regulatory, industry and your own organization.
Product realization planning (see clause 7.1) must determine the following - what specific product and process characteristics needs to be monitored and measured; the criteria for product acceptance; the type of monitoring and measurement device needed; frequency - at what stages of realization to do it; sample size; etc.
ÞYou must then determine what MMD is appropriate for each measuring or monitoring requirement. Consideration must be given to the measurement capability (precision) of the MMD which may have to be several times greater than the tolerance criteria for product measurement.
This would depend on the industry you are in and the criticality of end use for the product (e.g. the precision requirements for ball bearings may be much greater than say for cutting cloth to make a shirt).
ÞPersonnel using MMD’s must have competence and training in the use of MMD’s in terms of their function, range and precision of measurement, reliability, use and maintenance.
ÞMMD’s may include measurement and testing tools; equipment; hardware and software. They may be owned by your organization; your employees or the customer. MMD’s may be used to verify product as well as to measure process conformity (e.g. a temperature controller on an oven).
Besides MMD’s used for product conformity, you may need to calibrate and control certain MMD’s used in related and peripheral processes such as production equipment; tooling; maintenance; etc.
ÞTo ensure valid measurement and monitoring results, MMD’s must be controlled. A process is required, to control - the identification of monitoring measurement; selection; purchase; identification; status; calibration; verification; adjustment or re- adjustment; use; handling; maintenance and storage; training; handling of nonconforming MMD’s; etc.
ÞYou must keep appropriate records to demonstrate effective operation and control of your MMD processes (see clause 4.2.4). These records must include calibration and verification records traceable to national, international or other benchmark used for calibration.
ÞAll MMD’s used for product verification must be capable of being calibrated, verified or both. Calibration is setting or correcting an MMD, usually by adjusting it to match or conform to a dependably known and traceable standard (e.g. adjusting a micrometer or caliper to conform to master blocks traceable to national standards).
ÞVerification is confirming that the MMD is meeting or performing to acceptable national measurement standards and does not involve any correction or adjustment (e.g. verifying a ruler or tape measure against a calibrated ruler that has been calibrated to a national standard). A ruler or tape measure is generally not capable of being calibrated and when it gets out of calibration its use must be discontinued.
