7.6 Control of Monitoring and Measuring Equipment

Hello,

We are a class 1 device and are currently writing our QMS for the first time. I have a question about how far the "control of monitoring and testing equipment" reaches into out production process.

In our production line we utilize fully customized jigs made in house to aid in the production process. Some of these are critical to the alignment of the device so I understand that those should be covered in this procedure. Although we also use custom jigs in house only to hold the device while it cures in a UV flood system. Would the jig that is just holding the device need to be included in this procedure as well?

Any advice / info is greatly appreciated, thank you!

You may want to distinguish between a jig and a fixture. A fixture simply holds the workpiece. A jig both holds the workpiece and aligns the workpiece with tooling, thus impacting quality. I would call your tooling that holds the device while it cures a fixture, not a jig. Fixtures would not fall under 7.6 but would be addressed under a preventative maintenance program.

Miner said:

You may want to distinguish between a jig and a fixture. A fixture simply holds the workpiece. A jig both holds the workpiece and aligns the workpiece with tooling, thus impacting quality. I would call your tooling that holds the device while it cures a fixture, not a jig. Fixtures would not fall under 7.6 but would be addressed under a preventative maintenance program.

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Thank you for this clarification! It helps a lot. This brings up another question I have. So we do have a jig that is used for the purpose you defined above. This jig is designed and made in house. There is no official way to calibrate it and there is nothing that it is measuring to a specific standard (ex. measuring the separation of two parts to be a specific distance). So in order to verify and validate that the jig is working, is it okay to use historical data?

As in can we make a device with the jig and verify that it is working properly, therefore validating that the jig is 'calibrated'?

To further your example, if the jig has a spacer to separate the two parts, that spacer should have a min-max specification on size. Calibration consists of measuring that size dimension and verifying that it continues to meet the specification. Just like you would calibrate gage blocks.