Mor628
If your complaint is non-product related i.e. missing inspections, then using the RM (ISO 14971) would not be appropriate.
Depending on how your QMS system is set up, you should be raising a corrective action (CAPA) to detail any containment, corrective or preventative actions, as well as a root cause/risk analysis. (i use the term "risk analysis" loosely here as this could mean a full process FMEA or a quality engineer listing the possible outcomes from the issue.)
If you are unsure about CAPA a quick search of elsmar will give you plenty to read.
If your complaint is non-product related i.e. missing inspections, then using the RM (ISO 14971) would not be appropriate.
Depending on how your QMS system is set up, you should be raising a corrective action (CAPA) to detail any containment, corrective or preventative actions, as well as a root cause/risk analysis. (i use the term "risk analysis" loosely here as this could mean a full process FMEA or a quality engineer listing the possible outcomes from the issue.)
If you are unsure about CAPA a quick search of elsmar will give you plenty to read.
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