AS9100 Clause 8.2.3.C Monitoring and Measurement and 8.5.2 Requirements

B

bigbirdy

#1
Hi to all,
Bigbirdy needs your help again! My question is about section 8.2.3.C Monitoring and Measurement. The requirement is stated as.

“Determine if the process nonconformity is limited to a specific case or whether it could have affected other processes or products”

:bigwave: My question is, is this related to section 8.5.2.i. corrective action requirement i. ?

“Determining if additional nonconforming product exists based on the causes of the nonconformities and taking further action when required.”

:bigwave: The intent of these two requirements, are they same? Any suggestion how to best approach these requirements.

Thanks a lot!
 
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J

Jason PCSwitches

#2
Re: Question 8.2.3.C Monitoring and measurement and 8.5.2 requirements

Hi to all,
Bigbirdy needs your help again! My question is about section 8.2.3.C Monitoring and Measurement. The requirement is stated as.

“Determine if the process nonconformity is limited to a specific case or whether it could have affected other processes or products”

:bigwave: My question is, is this related to section 8.5.2.i. corrective action requirement i. ?

“Determining if additional nonconforming product exists based on the causes of the nonconformities and taking further action when required.”

:bigwave: The intent of these two requirements, are they same? Any suggestion how to best approach these requirements.

Thanks a lot!
What you need to do is 1st evaluate the initial NC. 2nd determine if the NC or the cause of the NC could have had any affect on anything else.

So if you had a bad part produced, did any of the lot get supplied internally/externally? If so what have you done to contain & control the escapement? If not have you properly isolated the NC product?

Have you looked at the process that produced the NC? Was it related to inspection, machinery, etc? Once determined have you properly addressed the cause to ensure other product has not & will not experience an NC related to the original cause.

See you may notice NC product at a given phase, but it is possible that NC product may have escaped further down your line. The standard is requiring that you not only look at the immediate NC, but take it as far as you can go to ensure nothing has gotten past that initial point of awareness.
 
B

bigbirdy

#3
Re: Question 8.2.3.C Monitoring and measurement and 8.5.2 requirements

@ Jason PCswithces thank you very much.

That is how we intended to approach 8.2.3 Monitoring and measuring processes but do we need to document this approach ( I.E. CAR form,work instruction or procedure)?

Thanks again
 
J

Jason PCSwitches

#4
Re: Question 8.2.3.C Monitoring and measurement and 8.5.2 requirements

@ Jason PCswithces thank you very much.

That is how we intended to approach 8.2.3 Monitoring and measuring processes but do we need to document this approach ( I.E. CAR form,work instruction or procedure)?

Thanks again

You don't necessarily need a documented procedure, one is not required at least, but you need to show objective evidence of the actions you take & demonstrate that your methods are properly communicated and understood.

How you chose to do this is entirely up to your organization. Do whatever works/adds value to YOUR organization. I caution you to think on this as many try to simply comply to the standard instead of applying the standard!!
 
B

bigbirdy

#5
Re: Question 8.2.3.C Monitoring and measurement and 8.5.2 requirements

8.2.3 is monitoring and measurement of the process and 8.5.2 is corrective action. The requirements that i mentioned above are new to AS9100C standard.

8.5.2 Corrective action calls out for documented procedure. I wonder if changing our CAR form to include an extra step for checking the extent of escapement enough to satisfy the intent of the requirements 8.5.2.i and 8.2.3.c?

Thanks.
 
H

Hodgepodge

#6
Re: Question 8.2.3.C Monitoring and measurement and 8.5.2 requirements

8.2.3 is monitoring and measurement of the process and 8.5.2 is corrective action. The requirements that i mentioned above are new to AS9100C standard.

8.5.2 Corrective action calls out for documented procedure. I wonder if changing our CAR form to include an extra step for checking the extent of escapement enough to satisfy the intent of the requirements 8.5.2.i and 8.2.3.c?

Thanks.
A form can’t always be everything for everybody. A corrective action report is a record that is sufficient to show an investigation was made and that actions were taken. The problem, cause, and corrective action statements should be succinct, however, for a form to be large enough to cover every corrective action, it would need expandable ranges for all the free form text you might need. An investigation might lead down many possible paths, the corrective action report isn’t intended to be the paper you keep your notes on. It is the final document that wraps it up.

The format for investigating and implementing corrective actions is what is important. There may be more than one problem. There may be more than one root cause. Team members should keep notes and all problems should be traced to their roots. PRI has a really good root cause tutorial. The format is great. A form can help you to remember to address all the “required” items but often times they can be limiting. Beware of forms with spaces only big enough for small problems. The format is what is important. I would go so far as to say you don’t even need a form as long as you have a good report. Check out the PRI tutorial here. (I've also attached a copy) If you apply the principles and action items and take good notes, you’ll have all you need. When you are done, you may find you need more than one of your corrective action forms for documenting all the root causes you have uncovered.
 

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Big Jim

Super Moderator
#7
Re: Question 8.2.3.C Monitoring and measurement and 8.5.2 requirements

8.2.3 is monitoring and measurement of the process and 8.5.2 is corrective action. The requirements that i mentioned above are new to AS9100C standard.

8.5.2 Corrective action calls out for documented procedure. I wonder if changing our CAR form to include an extra step for checking the extent of escapement enough to satisfy the intent of the requirements 8.5.2.i and 8.2.3.c?

Thanks.
Your corrective action procedure needs to address 8.5.2 i.
 
B

bigbirdy

#8
Re: Question 8.2.3.C Monitoring and measurement and 8.5.2 requirements

@ Big Jim, Jason PCswitches and Hodgepodge Thank you very much!
 
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