Icy Mountain
Sachem
I need some help with this one. I couldn't even come up with a good title. Here's the (redacted) finding:
Requirement: validation of specific methods & procedures (7.5.1)
Failure: Work instructions are not always followed
Evidence: ...load currents are below spec. Note this will not affect product , & subsequent Ac/dc for performance tests are validated after endurance.
Simply put, we demonstrated a test for the auditor and the reading was outside the specifications listed in the procedure. This occured shortly before our production folks left for the day so I really couldn't go back and get to the bottom of it: The next morning (after the audit is over and the auditor has left, of course) the unit in question was processed according to our non-conforming product procedures. There was nothing wrong. Further investigation (not by me, just the Team doing what they're supposed to do) found that a load cone (big resistive thing sort of like a light bulb) on the test bed had failed. The team replaced it. The unit (and the fixture) were put back through the test procedure, just like we say in our procedures. Everything was just like the specification.
How do I answer this finding? Everything worked like it is supposed to work. I think my production tech obviously gave some pretty bad answers during the audit as to what was going on or this wouldn't have generated a finding. I'll admit that I was brain dead after two days. I probably should have been quoting what comes next (fix problem, rerun tests).
Requirement: validation of specific methods & procedures (7.5.1)
Failure: Work instructions are not always followed
Evidence: ...load currents are below spec. Note this will not affect product , & subsequent Ac/dc for performance tests are validated after endurance.
Simply put, we demonstrated a test for the auditor and the reading was outside the specifications listed in the procedure. This occured shortly before our production folks left for the day so I really couldn't go back and get to the bottom of it: The next morning (after the audit is over and the auditor has left, of course) the unit in question was processed according to our non-conforming product procedures. There was nothing wrong. Further investigation (not by me, just the Team doing what they're supposed to do) found that a load cone (big resistive thing sort of like a light bulb) on the test bed had failed. The team replaced it. The unit (and the fixture) were put back through the test procedure, just like we say in our procedures. Everything was just like the specification.
How do I answer this finding? Everything worked like it is supposed to work. I think my production tech obviously gave some pretty bad answers during the audit as to what was going on or this wouldn't have generated a finding. I'll admit that I was brain dead after two days. I probably should have been quoting what comes next (fix problem, rerun tests).