Corrective /Preventative/Rectification actions

wayne.wilson7

Involved In Discussions
#1
Hi All,

I have just had a software update this last week and for some reason our non-conformance screen now has four categories

1. Reason for non-conformances
2. Root Cause.
3. Rectification.
4. Corrective action.

Previously and as per 8.5.2 and 8.5.3 we had

1. Reason for non-conformances (what's wrong).
2. Root Cause (reason why its wrong).
3. Corrective action (how can we put it right).
4. Preventative action (how can we prevent it happening again).

Would appreciate some feed back as Im' not convinced the update is the correct way

Regards

Wayne
 
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PaulJSmith

#2
Not sure what software you're using, but in general terms, Preventive Action is not a part of a Non-Conformance process. Once you have a Non-Con, it's a bit late to try to prevent it.
 

Jim Wynne

Staff member
Admin
#3
Hi All,

I have just had a software update this last week and for some reason our non-conformance screen now has four categories

1. Reason for non-conformances
2. Root Cause.
3. Rectification.
4. Corrective action.

Previously and as per 8.5.2 and 8.5.3 we had

1. Reason for non-conformances (what's wrong).
2. Root Cause (reason why its wrong).
3. Corrective action (how can we put it right).
4. Preventative action (how can we prevent it happening again).

Would appreciate some feed back as Im' not convinced the update is the correct way

Regards

Wayne
It seems like "rectification" is an odd way of saying "correction." This is part of, but different from, "corrective action." Correction is the immediate remedy and might include containment, rework, or other disposition of nonconforming material. Corrective action, on the other hand, would also include prevention of recurrence.
 
M

mmagargee

#4
It looks like the update removed preventive action from your corrective action, which everyone here agrees is a good thing. So could rectification refer to "containment"? In other words, preventing the nonconforming product from being shipped before you have a chance to fix the processes responsible?

BTW, you didn't say what kind of software was updated. Was it someone in your company who updated a custom workflow, or did the CAPA software vendor update his package? The answer should direct you to which source to ask for clarification, since the state "rectification" is very fuzzy.
 

John Broomfield

Staff member
Super Moderator
#5
Hi All,

I have just had a software update this last week and for some reason our non-conformance screen now has four categories

1. Reason for non-conformances
2. Root Cause.
3. Rectification.
4. Corrective action.

Previously and as per 8.5.2 and 8.5.3 we had

1. Reason for non-conformances (what's wrong).
2. Root Cause (reason why its wrong).
3. Corrective action (how can we put it right).
4. Preventative action (how can we prevent it happening again).

Would appreciate some feed back as Im' not convinced the update is the correct way

Regards

Wayne
Wayne,

Looks like your software house finally got the memo.

CAPA thinking had people stopping recurrence of nonconformity instead of doing preventive action.

Does your corrected software include risk assessment and risk treatment modules?

Does it help drive preventive action from FMEA, data analysis, setting new objectives, management reviews and planning?

John
 

wayne.wilson7

Involved In Discussions
#6
Thanks for the response All,

Seems this is still unclear and everyone's interpretation seems a little different.

The update was to our own manufacturing software that is owned by 5 sub-contract manufacturers.

I will try to explain why the software was developed b the 5 companies.
All the companies are no bigger than 40 employees and wanted a MRP system that works easier for Sub-contract machine shops (all companies work to customer print no design etc.) There is only 50 companies in the UK running the software but its becoming more and more popular.

Through All my BSi audits against rev c od 9100 the three auditors have been very impressed with the system but I don't want a change or wording in the NCR screen to trip us up. We had the screen designed so we could catch the ROOT, Corrective action and the preventative action all in one document.

Once the ROOT has been established the corrective action is to put right the non-con if possible or apply for concessions etc, the preventative is how we stop it happening again.

Would it be better if the section was labelled Rectification/Corrective and the last as Preventative??

Thanks

Wayne
 

somashekar

Staff member
Super Moderator
#7
Wilson,
We must unlearn first before learning.
CA and PA are two distinct improvement aspects
CA for a detected nonconformity
PA for potential nonconformity
When you apply a CA, the recurrence of the detected nonconformity has to be arrested.
This is the CA effectiveness.
PA starts with determining the potential nonconformity, and preventing it from happening.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#8
You can call these actions anything you want as long as you are clear on the definitions. Semantics can be painful, but words do have meanings.
however, the main point being made here is that Corrective Action and Preventive Action are two unrelated series of events. Those who have written the standard realize that they have done a poor job of deliniating what they intended and are planning to change this in the next version. Admittedly this confusion comes primarily from those who 'interpret' the standard incorrectly...

Corrective Action begins when a nonconformance (to the standard or to product requirements) is detected. Steps taken during Corrective Action include correcting the Nonconformance, determing the cause, taking Corrective Action to prevent reoccurrence and remediation of nonconforming material that may be in inventory or at Customers.

Preventive Action begins whenever you decide it will help Prevent a non conformance from occuring in the first place. Actions include risk assessment FMEA, SPC, 5S, visual workplace, error proofing, even training. Many Lean methods are Preventive Actions...

Corrective and Preventive action should NOT be on the same record since they are NOT the same thing.
 
S

somebodyelse

#10
You do not know how many times I tried to get this distinction through to our Lead Internal Auditor. It finally came to the point where I had to choose someone else to be the Lead Auditor. That person still insists that CA involves CA/PA.
 
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