Posts Tagged ‘calibration’
Calibration, What’s Missing from Your System?
Quality management system standards homogeneously have requirements for controlling the devices used to measure, verify, test, and accept product and monitor the processes used to achieve specified results. As a third party auditor it has come to my attention that everyone seems to miss something. It’s almost unavoidable. Perchance it’s because this process is by and large referred to as “calibration” and the rational image it invokes is associated primarily with things like micrometers, depth gages, and comparators. The process is often much more complex, addressing apt consideration for gages, thermostats, software, jigs, timers, known-good-samples – a multiple of devices for measuring product or process. Controlling monitoring and measuring devices must, therefore, include multiple aspects.
Some areas which you should consider when setting up your system should included:
*Identifying which devices need to be calibrated and which do not (you decide based on your quality criteria and your customer requirements).
* Defining the frequencies needed to insure calibration is well controlled
* Indicating the status of equipment; calibrated or out of calibration
* Determining alternate methods of “control”
* Determining what to include in the procedure
* How will you handle certificates of calibration
* Will you use outsourced calibration services and how will you control this if you do
* Defining storage and preservation criteria in your process
* Defining recall programs and contingency plans
AS9100 Calibration Requirements
Using measuring devices of known accuracy, and this may include computer-assisted measuring and test equipment is essential in the verification process for any quality management system. Maintaining a calibration history of this equipment and documented proof that it’s reviewed and verified periodically underlies the entire metrology system.
Clause 7.6 states: The organization shall ensure that environmental conditions are suitable for the calibrations, inspections, measurements and tests being carried out.
Where necessary to ensure valid results, measuring equipment shall
a) be calibrated or verified 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;
b) be adjusted or re-adjusted as necessary;
c) be identified to enable the calibration status to be determined;
d) be safeguarded from adjustments that would invalidate the measurement result;
e) be protected from damage and deterioration during handling, maintenance and storage;
f) be recalled to a defined method when requiring calibration.
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.
Auditing Calibration: ISO 9001
In the internal auditing of monitoring and measuring processes, it is important for auditors to understand the difference between monitoring and measuring:
1. monitoring implies observing, supervising, keeping under review (using monitoring devices); it can involve measuring or testing at intervals, especially for the purpose of regulation or control
2. measuring considers the determination of a physical quantity, magnitude or dimension (using measuring equipment)
Section 7.6 of the ISO 9001:2008 standard requires that an organization must determine the monitoring and measurement to be done and the monitoring and measurement equipment needed to provide evidence of conformance of products to requirements.
Auditors should confirm that, in addition to providing the necessary calibration records and assuring the related measurement uncertainty and traceability, their organization is aware of and has implemented, as appropriate, a metrological confirmation system as described in ISO 10012 adequate to the extent and types of the measurements performed.
The internal auditor needs to understand how their organization performs process control and the impact that the information, obtained from using these “devices”, has on this process control.
When the impact is relevant, auditors should evaluate issues such as:
- How their organization validates that “the monitoring and measuring device” is consistent with the monitoring and measurement requirements.
- How their organization assures the information validity.
- The competence of the responsible to design “the monitoring and measuring device”
- How their organization validate the consistency of the results
What Has To Be Calibrated: ISO 9001
Measuring and test equipment that has an effect on the product/service you supply to your customer must be objectively verified and calibrated (where possible) so that the degree of measurement uncertainty is known. Devices used to “demonstrate conformance to requirements” must be “controlled and calibrated.
The further away a measurement device is, in the process, from the product/service, the less critical this is. If a measurement is worth doing, it’s worth doing with a device that you can have confidence in because it’s been objectively verified.
It is not necessarily required that this be done by a third party. If you have internal capability and certified / traceable measurement equipment to calibrate with, you can do it yourself. All such calibrations need to be traceable to national / international standards. For example, if you have hand held measurement tools (calipers, micrometers), you can calibrate them with a set of certified gauge blocks. This reduces the need for external calibration.
Calibration / verification of test equipment is a huge and target rich environment for ISO 9001 audits. Make sure your system is up to snuff and covers all of the equipment (and all the requirements in 7.6). Make sure there are work instructions covering calibration of equipment that you verify in-house.
The Calibration Conumdrum
All Quality management system standards uniformly have requirements for controlling the equipment and devices used to measure, verify, test, and accept product and monitor the processes used to achieve specified results. As a third party auditor it seems like almost everyone misses something. It’s almost unavoidable. Clearly it’s because this process is generally referred to as “calibration” and the mental image it invokes is associated primarily with things like micrometers, depth gages, and comparators. The process is often much more complicated, addressing appropriate consideration for gages, thermostats, software, jigs, timers, CMM’s etc. Controlling monitoring and measuring devices must, therefore, include multiple aspects.
What are some of the features of a good calibration management process?
- Identifying equipment
- Defining frequencies
- Indicating status of equipment
- Alternate methods of “control”
- What to include in the procedure
- Certificates of calibration
- Outsourcing calibration services
- Storage and preservation
- Recall programs and contingency plans
Whether implemented manually or electronically, calibration control is crucial for a management systems success. There are as9100 software calibration systems designed to manage and simplify control of calibration requirements including repair, maintenance and recall. Some may also manage tests/inspections that must be done on a periodic basis such as a monthly inspection. When determining whether your system will be manual or electronic, it is always wise to first know your own capabilities, manpower, and processes. Do you know where your system stands?