ISO 9001-Clause 7.6 Control of monitoring and measuring equipment
ISO 9001 Requirement
The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements.
The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.
Where necessary to ensure valid results, measuring equipment shall
a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded (see 4.2.4);
b) be adjusted or re-adjusted as necessary;
c) have identification in order to determine its calibration status;
d) be safeguarded from adjustments that would invalidate the measurement result;
e) be protected from damage and deterioration during handling, maintenance and storage.
In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected.
Records of the results of calibration and verification shall be maintained (see 4.2.4).
When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.
NOTE Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.
Requirements for what needs to be measured and the acceptance criteria may come from the customer, regulatory, industry and your own organization. Product realization planning 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 i.e. at what stages of realization to do it, sample size, etc. You must then determine what Monitoring and Measurement Device is appropriate for each measuring or monitoring requirement. Consideration must be given to the measurement capability (precision) of the Monitoring and Measurement Device 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 for e.g. the precision requirements for ball bearings may be much greater than say for cutting cloth to make a shirt. Personnel using Monitoring and Measurement Device’s must have competence and training in the use of Monitoring and Measurement Device’s in terms of their function, range and precision of measurement, reliability, use and maintenance.
Monitoring and Measurement Device’s may include measurement and testing tools, equipment, hardware and software. They may be owned by your organization, your employees or the customer. Monitoring and Measurement Device’s may be used to verify product as well as to measure process conformity for e.g. a temperature controller on an oven. Besides Monitoring and Measurement Device’s used for product conformity, you may need to calibrate and control certain Monitoring and Measurement Device’s used in related and peripheral processes such as production equipment, tooling, maintenance, etc.
To ensure valid measurement and monitoring results, Monitoring and Measurement Device’s must be controlled. A process is required, to control the identification of monitoring measurement, selection, purchase, status, identification, calibration, verification, adjustment or re- adjustment, use, handling, maintenance and storage, training, handling of nonconforming Monitoring and Measurement Device’s, etc. You must keep appropriate records to demonstrate effective operation and control of your Monitoring and Measurement Device processes. These records must include calibration and verification records traceable to national, international or other benchmark used for calibration.
All Monitoring and Measurement Device’s used for product verification must be capable of being calibrated, verified or both. Calibration is setting or correcting an Monitoring and Measurement Device, usually by adjusting it to match or conform to a dependably known and traceable standard for e.g. adjusting a micrometer or caliper to conform to master blocks traceable to national standards.
Verification is confirming that the Monitoring and Measurement Device is meeting or performing to acceptable national measurement standards and does not involve any correction or adjustment for 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.
There are Monitoring and Measurement Device’s that are capable of being both calibrated and verified for 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.
You must define the frequency and method of calibration for each type and level i.e. whether used in shop floor, laboratory or standard of Monitoring and Measurement Device. 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.
In rare circumstances, national or international standards may not exist for calibrating a specific Monitoring and Measurement Device. In such situations consider using industry, manufacturer or even your own organizational standard to validate the accuracy and reliability of your Monitoring and Measurement Device. Consult with your customer if the contractual circumstances require it. Your quality plan must define the measurement and monitoring required and the type of Monitoring and Measurement Device 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 Monitoring and Measurement Device’s referenced in your quality plans. Ensure that personnel performing such statistical studies are trained and competent to do so.
A multitude of software tools are available to manage and control Monitoring and Measurement Device’s. There are many acceptable methods to identify Monitoring and Measurement Device’s and their calibration status. The methods you select must consider the manufacturers recommendations, frequency of use, environment the Monitoring and Measurement Device is used in, risk in misuse or incorrect tool being used, etc. Where an Monitoring and Measurement Device 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 Monitoring and Measurement Device. Customer or internal engineering changes may result in a change in product measurement, requirements and/or the Monitoring and Measurement Device to be used. These changes would normally be reflected in your quality plan.
If you use external calibration services, you are still expected to impose the specific control requirements of this clause to the external organization. If the nature of your business does not require the use of Monitoring and Measurement Device’s for 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.
Performance indicators such as the monthly trends in the number of out of calibration Monitoring and Measurement Device’s, or the number of Monitoring and Measurement Device’s past their calibration due date, number of Monitoring and Measurement Device’s being used and not controlled, reduction in untrained personnel found using Monitoring and Measurement Device’s, etc. Use these indicators to tighten and improve the effectiveness of your Monitoring and Measurement Device process. You 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.
- Are the monitoring and measurement to be undertaken determined?
- Are the monitoring and measurement devices needed to provide evidence of conformity of product to determined requirements determined?
- Is the measuring equipment calibrated or verified at specified intervals
- Is the measuring equipment adjusted or re-adjusted as necessary
- Is the measuring equipment identified to enable the calibration status to be determined
- Is the measuring equipment safeguarded from adjustments that would invalidate the measurement result
- Is the measuring equipment protected from damage & deterioration during handling, maintenance & storage?
- Determining how product/service is measured during in-bound process, inprocess and out-bound process. Is there a list of equipment requiring calibration? Compare this list to the measurement points in the process. Are there any gaps? Does the equipment listed cover at least the Customer specification ? Check a sampling of equipment on the list and verify that is being calibrated.
- Are records of equipment calibration & verification maintained?
- Who decides the frequency of calibration? Does it ever change?
- How is measuring equipment calibrated? For Internal calibration: Is work instructions used? For External Calibration : Was a PO issued to the calibration service provider?
- Any employee owned tools/equipment used? Are they being calibrated?
- When a measuring equipment is found not to conform to requirements is the validity of the previous measuring results assessed and recorded?
- When a measuring equipment is found not to conform to requirements are appropriate actions taken on the equipment and any affected products?
- If equipment wasn’t measuring correctly, how long before it was discovered? How much product/service would have been produced?
- Any computer software used to measure the product/service? If yes,how do you know it’s working properly?
Mandatory Procedure : Not applicable
1) Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist:- eg Customer specification, corporate standards.( This is bit tricky because for all the organization for which I have worked or consulted, I have never come across a scenario where no national or international measurement was available)
2) Records of the results of calibration and verification shall be maintained :-Record of Measuring and monitoring equipments, Calibration certificate
3) Validity of the previous measuring results when the measuring equipment is found not to conform to requirements
|Example of formats for Instrument calibration history card|
Evidence/ Implementation document ( Not mandatory but helps in fulfillment of requirement):
- Inspection equipment list
- Calibration stickers
- Equipment accuracy
- Corrective action report
|Example of formats for Details of Instruments|
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