Q
Hi there,
in our last audit we had a major non-conformity in our CAPA process and one part was "The CAPA form is signed and released by the QM-responsible in both cases (Remark by QMLady: one person in QM signed as CAPA responsible and as quality management responsible). A deputy rule for responsibilities and signatures is not available."
I already tried to answer this part of our major NC but our auditors were not happy. I referred to our job descriptions where every job has a defined deputy.
Has anybody an idea what our auditors could expect? Do they want a matrix? Has anybody an example I could look at to get an idea?
Thank you very much for your help in advance.
QMLady
in our last audit we had a major non-conformity in our CAPA process and one part was "The CAPA form is signed and released by the QM-responsible in both cases (Remark by QMLady: one person in QM signed as CAPA responsible and as quality management responsible). A deputy rule for responsibilities and signatures is not available."
I already tried to answer this part of our major NC but our auditors were not happy. I referred to our job descriptions where every job has a defined deputy.
Has anybody an idea what our auditors could expect? Do they want a matrix? Has anybody an example I could look at to get an idea?
Thank you very much for your help in advance.
QMLady