qualprod
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Hi everybody
In the practice of internal audits, I have seen that nonconformances detected would cause different impacts in the system,
in that case , I think it would depend of the negative impact of the non conformance to decide to write up or not the non conformity.
In detail, according to 19011 " nonconformity = non-fulfilment of a requirement".
Auditing the manufacturing process, and the documents of this process.
In this case if into a procedure there is the next line " the supervisor sends an email to quality inspector to release the product."
" the quality inspector sign off the form xxxx and release the product"
In this case, if the supervisor didn´t show the email (forgot to send it) to inspector, but inspector , without receiving the email, anyway he released the product.
Should the absence of the email the need to write up the nonconformity (email sending) or would be sufficient the inspector signature in the form XXX? and nothing to do, or to write up the nonconformity only for the absence of email as a nonconformity (non-fulfilment of a requirement)?
If we consider non-fulfilments , this is a non-fulfilment (email) , but is it a good practice to do it?
How do auditors consider this situation?
Thanks you so much
In the practice of internal audits, I have seen that nonconformances detected would cause different impacts in the system,
in that case , I think it would depend of the negative impact of the non conformance to decide to write up or not the non conformity.
In detail, according to 19011 " nonconformity = non-fulfilment of a requirement".
Auditing the manufacturing process, and the documents of this process.
In this case if into a procedure there is the next line " the supervisor sends an email to quality inspector to release the product."
" the quality inspector sign off the form xxxx and release the product"
In this case, if the supervisor didn´t show the email (forgot to send it) to inspector, but inspector , without receiving the email, anyway he released the product.
Should the absence of the email the need to write up the nonconformity (email sending) or would be sufficient the inspector signature in the form XXX? and nothing to do, or to write up the nonconformity only for the absence of email as a nonconformity (non-fulfilment of a requirement)?
If we consider non-fulfilments , this is a non-fulfilment (email) , but is it a good practice to do it?
How do auditors consider this situation?
Thanks you so much