I work at a hydraulic cylinder manufacturer. The company has homemade thread and ring gages in house that we are using for production that are not sent out for calibration but have a homemade master that is used to check them with once a year which does not get sent out either. I have been here 6 months and am thinking these gages and masters are a violation of ISO. Am I correct?
The short answer is yes. The intent of ISO 9001:2015’s subclause 7.1.5 is to ensure that your company determines and provides suitable resources to ensure valid and reliable monitoring and measuring results, when evaluating the conformity of your products; and 18.104.22.168’s that is to ensure that your company provides measurement traceability when it is a requirement or when your company determines it to be necessary to have confidence in the validity of the measurement results. It seems that your practice for controlling the homemade thread and ring gages cannot fully fulfill those purposes. This is how I would address the situation:
- Assign a unique identifier to each homemade thread and ring gage. Maybe you can do that through your Document Control process.
- Ensure that those gages are protected from deterioration or damage when they are not in use.
- Have the homemade master measured by a service able to provide you with reliable certified measurements. That will make that gauge traceable to national or international standards. It will also allow you to demonstrate that the piece is fit for its intended purpose. That means, you will be able to use this piece as the standard during the in-house calibration of the rest of the gages.
- Conduct an “in-house calibration” of each gage you use in production. You will need to issue an in-house calibration certificate for each one of those pieces, indicating on those documents how you achieve traceability to NIST or equivalent. If possible, identify the error for each one of those individual measurements you perform during calibration. Do not forget to include a statement indicating that the gauge was found suitable/unsuitable for use. That will demonstrate that each gage is fit for its intended purpose.
- Include ALL the gages in your calibration program. Make them subject to all the applicable provisions of your Quality System.
This approach will allow you to demonstrate that your thread and ring gages are properly controlled and maintained. If controlling those gages has not been an issue in the past, there is no guarantee that the situation will remain the same in the future. That is managing risk 😉
For more information about calibration, please see the resources here.