AS9100D and the monitoring and measuring resources requirement
AS9100 REV D Section 7.1.5 is all about the how you look after measuring devices, calibration and measurement traceability. It's not a massive change from the previous standard but what does it mean and what do you have to do? The Clause is essentially the same as the ISO9001:2015 clause it is based on but does carry some useful additional clarification and must do items as additional steps. From this section forward the AS9100D standard does start to add more to your list of requirements.
Firstly, you need to ensure that you have the resources required to carry out the measurements required by your operation. For instance, if you must weigh things do you have scales that are accurate enough to meet your specification? If you must measure a diameter or length, do you have a device that is capable of repeatably and reliably measuring this to the required tolerances? What about temperature? Moisture? And so on. You need the right tool for the job.
Now that you have the right tool for the job do you have a program in place to maintain the devices to ensure that they are still fit for purpose. This typically means you need some form maintenance plan for your devices, and you need to keep this documented information as evidence that you have been doing what you say, and the equipment does indeed meet the specification requirements.
Resources also include people. That means you do need to think have you got the right people (and enough!) with the right skills to be able to do the tasks we are adding to our QMS. Where you outsource this work you need to also be able to prove that those you outsource to also have the required resources in place.
As an Organisation you need to determine the amount of measurement traceability that is required and on what devices it is required on, the standard won't stipulate that for you. Drivers for the traceability may be regulatory requirements, international standards (ISO / NIST) customer requirements, industry standards (especially around safety) or organisational requirements. There needs to be a process to establish and manage this traceability to ensure that a device is in calibration or has been verified while in use. That means you must be able to identify the item easily and link that to the ability to prove calibration or measurement traceability.
In fact, there is a requirement for the organisation to remove from operation any device that is damaged, suspected of giving a false reading or out of calibration. As part of this, you need to be able to trace the parts that have been tested/manufactured with this device back to its last known good state which the date of the last calibration would typically be. This should form part of your thinking when you are working out how frequently you should be recalibrating items and what your maintenance/inspection routines would be for them.
The AS9100D standard has a requirement for you to create a process (and maintain that process) to be able to recall any of your monitoring or measurement equipment that requires calibration or verification. That means you need to know where it is, who has it and prove that you can recall it when you need to as part of meeting the clause.
Strange as it sounds, not all companies have a documented register of their items that need calibration or maintenance or are used in the monitoring or measurement processes. AS9100D stipulated that you must have this in place. Further than that it does stipulate exactly what you need to have in that register – equipment type, a unique identification of the item, location, calibration / verification method, the frequency of these activities and the acceptance criteria,
Documenting the calibration status of the device and track when it is due to be recalibrated can be tricky if you have a large (or even a small) number of devices and perhaps only 1 or 2 of a specific type that you just can't take out of operation. Organisations typically use some form of database to manage this and hope that people review it. This is a great example of where the MANGO system can help where it can both track your devices, hold all the maintenance records, the device history and alert you in advance of when work needs doing.
You should visually identify the devices that are calibrated by using a label showing the calibrated condition, there is no set standard for this but something like the one shown here is typically used as it gives all the information required.
The AS9100D standard for aviation, space and defence also highlights a requirement that the calibration or verification of any equipment use din the monitoring and measuring processes must be carried out under suitable environmental conditions. These would typically be defined under the standard that you are working to when calibrating or verifying the equipment and should be documented as part of the certification that the work has been done. That means doing the calibration in the spare office rather than a temperature or humidity controlled lab may not be an option!
Safeguard from adjustment
If your device can be adjusted, you know that someone in your organisation is going to adjust it. The standard requires you to safeguard against this happening. This may include lock nuts, tamper proof labels, lock wires and many more options. As part of your maintenance routine, you should be checking these are still in place. Again, if they are in doubt you need to track back to the last known good state and question all products the item has been used on.
Increasingly software is used in measurement systems, you must then, also verify that the software is performing as expected and giving the correct result. It should fall inside your calibration program. You will also need to think about verification of any software as well in terms of proving that the software produces the results that you expect so ensuring you have a well documented test, validation and verification process is critical.
The calibration element of the organisation is frequently one of the tricky ones when it comes to determining what is required. It is good to document your rationale for the decisions that you make. Contract external calibration specialists who can take care of the tricky units and document procedures for any internal calibration work that you do. Finally get a system that will control, track & remind you of what is and isn't calibrated, what needs to be done and what has been done so you can demonstrate historical records.
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