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Evaluation of Bearing (Effect) of a Deviation on Quality

C

class08820

#1
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
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Re: Evaluation of bearing on Quality

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?
 
C

class08820

#3
Re: Evaluation of bearing on Quality

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
 
D

Duke Okes

#4
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?
 
Z

zancky

#5
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.
 
C

Chance

#6
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?
In my company where I work currently, I do everything as posted by Duke. I made a trend for 2011 and found that 33% where variances from a single procedure. I believe the procedure needs to be re-modified. How to handle this? Any suggestion is highly appreciated.

Thanks.
 

Jim Wynne

Staff member
Admin
#7
In my company where I work currently, I do everything as posted by Duke. I made a trend for 2011 and found that 33% where variances from a single procedure. I believe the procedure needs to be re-modified. How to handle this? Any suggestion is highly appreciated.

Thanks.
33% of what? What are you describing as a "deviation"?
 
C

Chance

#8
33% of what? What are you describing as a "deviation"?
33% - recurring issue to the same process; 67% - non recurring issues
I am making a trend of the deviations (recurring process, human, non-recurring). The result shows that 33% is a recurring process deviation. I hope I made it clearer..sorry.
 

Jim Wynne

Staff member
Admin
#9
33% - recurring issue to the same process; 67% - non recurring issues
I am making a trend of the deviations (recurring process, human, non-recurring). The result shows that 33% is a recurring process deviation. I hope I made it clearer..sorry.
I think there's confusion in this thread over what's meant by "deviation." What do you mean?
 
C

Chance

#10
I think there's confusion in this thread over what's meant by "deviation." What do you mean?
Let me explain further. There is one department who asks to deviate from the process for four times consecutively. The deviation is then approved. I think I have to do something about it because it keeps happening again and again, that means the process is not stable since there are deviations everytime.
 
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