class08820
24th June 2008, 06:23 PM
Guys
I just want to ask you If QA person evaluate any deviation report what should QA evaluate/write in evaluation section I am asking becasue I have deviation report filled by production department such as Why Deviation occred Root cause and what parameter deviate from current specs so my resposibility to evaluation of bearing on quality Please let me know
Thanks in advance
Jennifer Kirley
24th June 2008, 09:06 PM
Hello, maybe if you provided a little more detail we could give a helpful answer.
Is this a proposed root cause and corrective action filed in a Corrective Action Request (CAR)?
Are you the internal auditor?
Are you the process owner receiving a CAR from Production?
What is the CAR about?
class08820
25th June 2008, 12:26 PM
Hello, maybe if you provided a little more detail we could give a helpful answer.
Is this a proposed root cause and corrective action filed in a Corrective Action Request (CAR)? NO
Are you the internal auditor? No
Are you the process owner receiving a CAR from Production? Yes
What is the CAR about? Material rejection due to problem in process and engineering replaced parts for machine and it's already describe in DEVIATION
Duke Okes
25th June 2008, 12:43 PM
GuysI just want to ask you If QA person evaluate any deviation report what should QA evaluate/write in evaluation section I am asking becasue I have deviation report filled by production department such as Why Deviation occred Root cause and what parameter deviate from current specs so my resposibility to evaluation of bearing on quality Please let me know Thanks in advance
The role of QA in a deviation request is usually:
- determine whether the deviation should be approved (e.g., what will be the effect on the customer, end user, etc.)?
- does the request require customer approval?
- if the deviation is not granted what should be done with the parts (e.g., rework, repair, scrap)?
- if corrective action has already been taken is it deemed to be sufficient?
zancky
25th June 2008, 12:59 PM
Where I'm working Yes, sure.
If there is a "deviation" they must inform me and everything must be decided toghether.
Some reasons for that:
1) is some of production involved? If yes ,You must decide/agree if it is better to sort 100%, rework, scrap or ask for a waiver. Production dept alone can not manage it.
2) who will inform the suppleir and manage his corretive/preventive actions?
3) who decide which are the inplications on controls, procedures as it doesn't happen again
4) quality dept is a service for the production. Therefore, if You are well doing Your job, they will ask Your help whenever is possible as it reduces their work.
If You are well doing Your job but they wont You away ,well I suspect they are hidding something.