Seeking some input/suggestions on how to incorporate data regarding product issues discovered outside the specified lifetime.
Up until now, we've been rolling these into our non-conforming product process, and issuing an NCR when these are reported. This way, data about the kinds of failures that the devices experience long-term are still recorded.
Strictly speaking, however, would these still be considered non-conformances. If the requirement is, for example, that "all moving parts last two years of use", and a device is reported to have a moving part failure after 3 years in the field, this is not technically a non-conformance, no?
Nevertheless, we'd like to still collect this data, and the NC process is a convenient way to do so (as all the data is the same). The problem is that, by documenting these as NCRs, our NC numbers no longer accurately reflect the number of units ACTUALLY failing to meet specified requirements.
Curious to know how others gather such data? Do you handle such cases as non-conformances, or do have a separate process?
Up until now, we've been rolling these into our non-conforming product process, and issuing an NCR when these are reported. This way, data about the kinds of failures that the devices experience long-term are still recorded.
Strictly speaking, however, would these still be considered non-conformances. If the requirement is, for example, that "all moving parts last two years of use", and a device is reported to have a moving part failure after 3 years in the field, this is not technically a non-conformance, no?
Nevertheless, we'd like to still collect this data, and the NC process is a convenient way to do so (as all the data is the same). The problem is that, by documenting these as NCRs, our NC numbers no longer accurately reflect the number of units ACTUALLY failing to meet specified requirements.
Curious to know how others gather such data? Do you handle such cases as non-conformances, or do have a separate process?