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7.6 Control of Monitoring and Measuring Devices (MMD) - Cont'd
Key Explanation Points and Tips:
ÞThere are MMD’s that are capable of being both calibrated and verified (e.g. a CMM- coordinate measuring machine) and may require both to be done in specific situations based on frequency of use and criticality of measurement. This requirement also applies to the use of computer software whose capability and calibration status must be established prior to initial use and reconfirmed (verified) at defined intervals.
ÞYou must define the frequency and method of calibration for each type and level (shop floor; laboratory or standard) of MMD. Your calibration records must identify what standard you used for calibration and show traceability of the standards you use at your facility to national or international standards.
ÞIn rare circumstances, national or international standards may not exist for calibrating a specific MMD. In such situations consider using industry, manufacturer or even your own organizational standard to validate the accuracy and reliability of your MMD. Consult with your customer if the contractual circumstances require it.
ÞYour quality plan must define the measurement and monitoring required and the type of MMD needed for it, including the frequency of measurement and acceptance criteria. Depending on the risk and precision and reliability of measurements needed, you might consider doing statistical studies on MMD’s referenced in your quality plans. Ensure that personnel performing such statistical studies are trained and competent to do so.
ÞA multitude of software tools are available to manage and control MMD’s. There are many acceptable methods to identify MMD’s and their calibration status. The methods you select must consider the manufacturers recommendations; frequency of use; environment the MMD is used in; risk in misuse or incorrect tool being used; etc.
ÞWhere an MMD is found to be out of calibration, you must take appropriate correction action to contain and re-verify the product affected, to the extent practical. This is in addition to containing, repair and recalibration of the defective MMD.
ÞCustomer or internal engineering changes may result in a change in product measurement, requirements and/or the MMD to be used. These changes would normally be reflected in your quality plan.
ÞIf you use external calibration services, you are still expected to impose the specific control requirements of this clause to the external organization. One way to achieve this is by requiring them to be ISO 9001 certified or sector specific standard such as ISO/IEC 17025.
ÞIf the nature of your business does not require the use of MMD’s (e.g. a financial service such as a credit counseling service), then you must clearly state this exclusion to your QMS scope, in your Quality manual.
ÞClause 4.1f requires you to continually improve your processes. Consider using appropriate performance indicators such as the monthly trends in - the number of out of calibration MMD’s; or the number of MMD’s past their calibration due date; number of MMD’s being used and not controlled; etc. Use these indicators to tighten and improve the effectiveness of your MMD process.
ÞClause 7.6 does not require a ‘documented’ procedure. However, you must identify and document all processes addressing this clause as part of your QMS (see clause 4.1). For these processes, you must also identify what specific documents, controls and resources are needed (see clause 4.2.1d. and 7.1b.).
ÞYou could use a product quality plan; documented procedure or other combination of specific practices, procedures, documents and methods. Look at the risks related to your product, processes and resources in determining the extent of documented controls you need to have (also see clause 4.2.1 notes).
ÞPerformance indicators (to measure the effectiveness of processes that control MMD’s) may include reduction - in MMD’s found past due for calibration and being used; reduction in damaged, uncontrolled and uncalibrated MMD’s being used; reduction in untrained personnel found using MMD’s; reduction in lost MMD’s; reduction in MMD’s found out of calibration; etc.
