Nonconformance, Corrective and Preventive Action Procedure(s)?

C

CATERAF

#1
Hi,

I'm currently trying to get my company ready for certification, but having had no experience with anything QA-related before, i'm easily confused. :confused:

I have read through dozens of posts about combining corrective and preventive procedures. No problem there - i can see how they link.

My question is about nonconformance, corrective AND preventive action.
Can you combine all three into one procedure?

For example, you have a nonconformance, then you need to correct for that and then you put systems in place that prevent the nonconformance from reoccuring. Is it therefore suitable to combine all three procedures into the one?

At the same time though can corrective and preventive actions stem from anything other than a nonconformance...?? I had thought they could, but then everytime I think about a reason for 'correcting' something, it's because something didn't conform. i.e., design nonconformance, product nonconformance, audit nonconformance, etc. Also, you would only put a preventive system in place to *stop* a problem occurring. Wouldn't this then have stemmed from knowledge of a problem, thereby stemming from a nonconformance somewhere along the line?

I suppose this all links together to form the question of; doesn't nonconformance tie in with corrective and preventive actions and therefore all can be whacked in together in the same procedure??

Any advice or suggestions are very much appreciated!
 
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K

krichmond0306

#3
Hi,

I'm currently trying to get my company ready for certification, but having had no experience with anything QA-related before, i'm easily confused. :confused:

I have read through dozens of posts about combining corrective and preventive procedures. No problem there - i can see how they link.

My question is about nonconformance, corrective AND preventive action.
Can you combine all three into one procedure?

For example, you have a nonconformance, then you need to correct for that and then you put systems in place that prevent the nonconformance from reoccuring. Is it therefore suitable to combine all three procedures into the one?

At the same time though can corrective and preventive actions stem from anything other than a nonconformance...?? I had thought they could, but then everytime I think about a reason for 'correcting' something, it's because something didn't conform. i.e., design nonconformance, product nonconformance, audit nonconformance, etc. Also, you would only put a preventive system in place to *stop* a problem occurring. Wouldn't this then have stemmed from knowledge of a problem, thereby stemming from a nonconformance somewhere along the line?

I suppose this all links together to form the question of; doesn't nonconformance tie in with corrective and preventive actions and therefore all can be whacked in together in the same procedure??

Any advice or suggestions are very much appreciated!

I'm not sure how helpful my advice or thoughts would be but in my opinion NCs, CAs and PAs should ALWAYS be combined into one system, Root Cause Analysis. The problem I have where I work is that we are good at identifying NCs and correcting them but often fail to follow up with PAs. Which negates all the CA work you did. All three are components of a a Root Cause Analysis Process and for it to be complete and successful you can not excluding any of them.

Again that is my opinion, I definitely not an expert.
 
C

CATERAF

#4
Thanks for your responses!

...in my opinion NCs, CAs and PAs should ALWAYS be combined into one system, Root Cause Analysis. The problem I have where I work is that we are good at identifying NCs and correcting them but often fail to follow up with PAs. Which negates all the CA work you did. All three are components of a a Root Cause Analysis Process and for it to be complete and successful you can not excluding any of them.
I agree Krichmond0306 - how can you have CA without the NC? It just struck me that all the terminology says CAPA but there isn't much about the actual 'nonconformance' procedure. I hadn't heard it termed 'Root Cause Analysis' but after looking it up that's pretty much what it is!

I just wondered if other companies often included them together or separately and for what reason?

Also, I came across a certified company who had combined all three so I know that it *can* be done, but whether that is advisable is a different matter...
 

Jim Wynne

Staff member
Admin
#5
I'm currently trying to get my company ready for certification, but having had no experience with anything QA-related before, i'm easily confused. :confused:
I have lots of experience with QA, but I'm also easily confused, so don't worry about it. :D

I have read through dozens of posts about combining corrective and preventive procedures. No problem there - i can see how they link.

My question is about nonconformance, corrective AND preventive action.
Can you combine all three into one procedure?

For example, you have a nonconformance, then you need to correct for that and then you put systems in place that prevent the nonconformance from reoccuring. Is it therefore suitable to combine all three procedures into the one?

At the same time though can corrective and preventive actions stem from anything other than a nonconformance...?? I had thought they could, but then everytime I think about a reason for 'correcting' something, it's because something didn't conform. i.e., design nonconformance, product nonconformance, audit nonconformance, etc. Also, you would only put a preventive system in place to *stop* a problem occurring. Wouldn't this then have stemmed from knowledge of a problem, thereby stemming from a nonconformance somewhere along the line?

I suppose this all links together to form the question of; doesn't nonconformance tie in with corrective and preventive actions and therefore all can be whacked in together in the same procedure??

Any advice or suggestions are very much appreciated!
How or whether you combine these things is a matter of preference. ISO 9001 expects you to differentiate between CA and PA, with the former being the result of a nonconformity and the latter being intended to prevent nonconformity before it happens. The confusing part is that CA includes PA--preventing recurrence--but you're not allowed to count it as PA. You can apply the same actions to other products or processes and count that as PA, however.

You should worry less about the form of the documentation and more about dealing conscientiously with nonconforming things and doing what you can to prevent those things from happening in the first place.
 

qusys

Trusted Information Resource
#6
Hi,

I'm currently trying to get my company ready for certification, but having had no experience with anything QA-related before, i'm easily confused. :confused:

I have read through dozens of posts about combining corrective and preventive procedures. No problem there - i can see how they link.

My question is about nonconformance, corrective AND preventive action.
Can you combine all three into one procedure?

For example, you have a nonconformance, then you need to correct for that and then you put systems in place that prevent the nonconformance from reoccuring. Is it therefore suitable to combine all three procedures into the one?

At the same time though can corrective and preventive actions stem from anything other than a nonconformance...?? I had thought they could, but then everytime I think about a reason for 'correcting' something, it's because something didn't conform. i.e., design nonconformance, product nonconformance, audit nonconformance, etc. Also, you would only put a preventive system in place to *stop* a problem occurring. Wouldn't this then have stemmed from knowledge of a problem, thereby stemming from a nonconformance somewhere along the line?

I suppose this all links together to form the question of; doesn't nonconformance tie in with corrective and preventive actions and therefore all can be whacked in together in the same procedure??

Any advice or suggestions are very much appreciated!
I do not understand you are speaking about three procedures. Usually they are two that I have seen combined but clear in their different scope: corrective actions and preventive actions.
Consider that there is also the control of non conforming product but the scope is different from the two mentioned.
All of three shall be documented as per ISO 9001 requirements.:bigwave:
 

RoxaneB

Super Moderator
Super Moderator
#7
Here's the stance that I've taken in the past...

A Nonconformance is a discrepancy. It is typically associated with either Product or Process.

The documented procedure for Nonconformances included initiating the Nonconformance form and the following:
  • Triggers for identifying Product-related nonconformances (e.g., physical deformities, chemical composition deviations, etc.)
  • Triggers for identifying Process-related nonconformances (e.g., unscheduled downtime > XX minutes, etc.)
  • Options for addressing Product-related nonconfomrances - rework, scrap, downgrade, etc.
  • Options for addressing Process-related nonconformances (e.g., correction, corrective action)

At this point, the procedure for Corrective Action would be linked in - referencing our Nonconformance form and completing the Corrective Action (e.g., root cause, action plan, verification plan) portions.

Our Preventive Action procedure linked into data analysis, trend review, planning, Opportunities for Improvement, 5S and several other aspects that were in place to prevent nonconformances (both product and process) from occurring.
 
R

RMain

#8
Three seperate procedures. Nonconformance captures the day to day bumps in the road (Usually Product/Methods Related) and offers a methodolgy to address the issue with a disposition, and confirm the dispositions effectiveness. Corrective action is to address trends of nonconformances you do not have to create a Corrective Action for every Nonconformance. Under Special incidences a Corrective Action may be raised to address a System Nonconformance or a Serious /Costly (Time/Cost/Customer) Incident a one off as opposted to a trend. The Preventive Action addresses a forseable concern before it becomes a Nonconcormace / Trend and/or System breakdown. Three seperate procedure for three seperate conditions. Don't be fooled into thinking that confirming the effectivity / result of a nonconformance's disposition is a corrective action because it may have been effective for this perticular incident but if it continues in the future there is reason to raise a Corrective Action based on a trend of incidents unrelated because they occured at different times over the year.
 

SATHYABALARAMAN

Involved In Discussions
#9
I hope everyone understands what is CA & PA. Let me give an example.

Problem: Headache

Correction: Taking a tablet / Applying Vicks or any balm to stop the ache. (Immediate action)

CA: Going to doctor, examine, Diagnosis of the disease & taking treatment so that headache will not reoccur.

PA: You cannot take PA for head ache, coz it already occurred, whatever action taken would be CA.

Then PA is like Vaccination. When there is any spread of disease in 1 place/country, we take vaccination to avoid it before it hits our place.

Apply the same theory to workplace.
 
K

krichmond0306

#10
I hope everyone understands what is CA & PA. Let me give an example.

Problem: Headache

Correction: Taking a tablet / Applying Vicks or any balm to stop the ache. (Immediate action)

CA: Going to doctor, examine, Diagnosis of the disease & taking treatment so that headache will not reoccur.

PA: You cannot take PA for head ache, coz it already occurred, whatever action taken would be CA.

Then PA is like Vaccination. When there is any spread of disease in 1 place/country, we take vaccination to avoid it before it hits our place.

Apply the same theory to workplace.
Good analogy, I go back to my experience with 8D, which I thought was a great tool because it captured it all in one report structure (NC reporting, containment/corrective actions, and how it was going to be prevented in the future). We treating the 8D report as a formal document and if any of the "D"s were not done it could not be closed out either internally or externally.
 
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