Slide 87 of 262
7.6 Control of Monitoring and Measuring Devices
NOTE: There are no new requirements for Control of Monitoring and Measuring Devices from the 1994 version.
The company shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 7.2.1).....
NOTE See ISO 10012-1 and ISO 10012-2 for guidance.
This element requires that documented and implemented procedures be established to control, calibrate and maintain inspection, measuring and test equipment used by the company to demonstrate compliance / conformance to specified requirements. This generally requires that equipment that is used to measure and control specified process variables, or to check product or service characteristics, be tested on a regular basis to ensure that the readings are correct.
Element 7.6 deals with the selection, control and calibration of measuring devices that are used to do the inspection and testing. Don’t forget to assess the need for calibration and control of process measurement devices, however, such as pressure gages and such.
Essentially, this clause says: to select the measuring devices carefully, according to the actual measurements needed and the accuracy required and to ensure that they maintain their ability to measure according to a predetermined degree of accuracy.
It is an element that must be approached carefully from a practical and common sense point of view. The procedures need to be developed so that they meet all the many requirements of the standard, while at the same time ensuring that they reflect what REALLY needs to happen in YOUR company to assure quality.
You must remember that the specific scope of this Element includes "…measuring and monitoring devices required to assure conformity of product to specified requirements…”. Therefore, all the measuring devices in your company probably do not have to be calibrated to the same degree of accuracy as set out in the standard. Often devices are used for rough approximations, to help identify product, as tools in Process Control to check machines, or to check the process, rather than to verify that the product meets the specified requirements.
Typical equipment requiring calibration includes: devices for measuring length, distance, weight, temperature, humidity, loudness, hardness, color, gloss, voltage, resistance. Test software must be calibrated as well.
This element is best prepared in the latter part of implementation. The test equipment involved will be defined as the operations control and inspection and test elements are developed.
* Selection of the equipment to be included, and creation of a master log
* Determine calibration required, traceable to International standards
* Define processes for calibration; timing, methods, acceptance criteria, etc
* Physically identify the test equipment included to show status
* Maintain calibration records of all equipment
* Define process to be followed when results reveal out of calibration condition
* Ensure environmental conditions are adequate for calibration
* Ensure handling assures continued fitness for use
* Safeguard equipment from adjustments that would invalidate settings
This element is usually the responsibility of the Quality Manager, although it may be a Laboratory Manager, or an Engineering Manager - or another.
There are several "generic" calibration control systems that can be purchased to run on personal computers that provide the required structure to meet this ISO element. However documented procedures of how this is to be managed are still required.
Key steps in implementing this standard generally follow these main activities:
1. Create master list of test equipment containing details of the equipment, including items such as calibration intervals, procedures etc.
2. Ensure all equipment is covered by calibration procedures (internal or specified where external calibration is used).
3. Identify each selected piece of test equipment with a small "calibration" sticker, that identifies the equipment, and the last and next calibration dates.
4. Ensure that all test equipment has been calibrated and is current.
5. Ensure all methods used for calibration allow validation against a certified national standard.
When these steps have been considered and developed, write procedures as to how this process will actually work and address the remaining points such as dealing with out of calibration equipment, storage, handling, and protection against misuse.
This is often a difficult process to maintain, and care should be taken to ensure that both the documented process as well as the on going implementation are monitored carefully.
Potential Audit Questions:
1. Explain your process for ensuring the control, calibration and maintenance of inspection, measuring and test equipment (including test software) that is used by your company to demonstrate the conformance of your product to the specified requirements? Please explain any procedures involved.
2. Where test software or comparative references such as test hardware are used as suitable forms of inspection, how are they checked?
3. How do you safeguard equipment from adjustments that would invalidate settings?
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