Maybe these will be new and fresh to you, although we’ve posted about them over the decades. Perhaps you’ve never heard of them. So I’ll give it a shot.
If your nonconformance has an occurrence rate (even if it is small), then you can - and should - use a control chart to track to rate. (I use them to track all defects and determine when a CA needs to be initiated as well). The control chart will reliably and definitively tell you if the CA has eliminated or reduced the occurrence rate. This is mostly used for physics related defects, but not exclusively... The type of control chart will depend on the process and type of data available...there is no one size fits all control chart.
If your nonconformance is a one time or rare human behavior based defect then you need to use logic, knowledge and data. You need to know and understand the process(es) used by the people doing the job (not just what is written in the procedure). There must be actual data/objective evidence of what happened. You – and others – must understand how mistakes and errors happen and how to prevent them or at least make them very difficult to do. Then you need to think about the corrective action – will it actually work? Sometimes you can test it. Sometimes it’s a thought experiment. Audits can also tell you if the new process is being followed…
Ensuring or confirming the effectiveness of corrective actions is not a remote, sit on your duff behind your computer kind of thing. At least not yet. maybe some day.
If your nonconformance has an occurrence rate (even if it is small), then you can - and should - use a control chart to track to rate. (I use them to track all defects and determine when a CA needs to be initiated as well). The control chart will reliably and definitively tell you if the CA has eliminated or reduced the occurrence rate. This is mostly used for physics related defects, but not exclusively... The type of control chart will depend on the process and type of data available...there is no one size fits all control chart.
If your nonconformance is a one time or rare human behavior based defect then you need to use logic, knowledge and data. You need to know and understand the process(es) used by the people doing the job (not just what is written in the procedure). There must be actual data/objective evidence of what happened. You – and others – must understand how mistakes and errors happen and how to prevent them or at least make them very difficult to do. Then you need to think about the corrective action – will it actually work? Sometimes you can test it. Sometimes it’s a thought experiment. Audits can also tell you if the new process is being followed…
Ensuring or confirming the effectiveness of corrective actions is not a remote, sit on your duff behind your computer kind of thing. At least not yet. maybe some day.
