When (criteria) to Require a Corrective/Preventive Action? (Industry Standard?)

S

SoCalGlenn

Hello All,

What criteria do your companies use to determine when a Corrective/Preventive Action (a robust cause-analysis and preventive actions, which are then reviewed for closure by a QE) is required, for internal nonconformances? Is there such a thing as an industry standard? And who and how is the determination made to close the CAR?

I have heard the rule that a C/A is required only if the nonconformance is determined to be "major", and not if "minor". I also remember from my aerospace days that a CAR may only be required if the nonconformance is not reworkable and goes to MRB. Unfortunately, these methods don't work well for us; all NCRs magically become "minor" and everything we do is reworkable.

I am struggling to improve our NCR process at a small manufacturing company (50 employees). Our Engineering manager wants robust corrective and preventive actions on ALL nonconformances, to "kill" each issue, and prevent recurrence. I currently assign all nonconformances from Production to a responsible engineer, offer some guidance as required, and then am the single gate that all must go through to check for closure. I am trying to formulate a better process to propose, because the volume of work required for me - the sole Manufacturing/Quality Engineer - is absolutely impossible to keep-up with. I would like to steer us more towards the standard practice of only requiring CAPA when some kind of agreebale criteria is met. My workload would then be reduced, and I could spend time auditing for recurring issues, instead of ALL issues. But my main hurdle is "when do we require CA/PA for nonconformances"?

Any help is appreciated!
 
Q

QCAce

Re: When Require Corrective/Preventive Action? (Industry Standard?)

SoCalGlenn,

You are close to the answer in your question. Combine your NCR's by type, area, etc. and count up the number of each type and report them on a Pareto. Then write in your procedures that you will take corrective action on the top 2-3 types each month.

You'll find working on 1-2 issues at a time with a cross-functional team will be much more productive.

Good luck.
 
Coury Ferguson

Coury Ferguson

Moderator here to help
Trusted Information Resource
Re: When Require Corrective/Preventive Action? (Industry Standard?)

SoCalGlenn said:
Hello All,

What criteria do your companies use to determine when a Corrective/Preventive Action (a robust cause-analysis and preventive actions, which are then reviewed for closure by a QE) is required, for internal nonconformances? Is there such a thing as an industry standard? And who and how is the determination made to close the CAR?

I have heard the rule that a C/A is required only if the nonconformance is determined to be "major", and not if "minor". I also remember from my aerospace days that a CAR may only be required if the non conformance is not reworkable and goes to MRB. Unfortunately, these methods don't work well for us; all NCRs magically become "minor" and everything we do is reworkable.

I am struggling to improve our NCR process at a small manufacturing company (50 employees). Our Engineering manager wants robust corrective and preventive actions on ALL nonconformances, to "kill" each issue, and prevent recurrence. I currently assign all nonconformances from Production to a responsible engineer, offer some guidance as required, and then am the single gate that all must go through to check for closure. I am trying to formulate a better process to propose, because the volume of work required for me - the sole Manufacturing/Quality Engineer - is absolutely impossible to keep-up with. I would like to steer us more towards the standard practice of only requiring CAPA when some kind of agreebale criteria is met. My workload would then be reduced, and I could spend time auditing for recurring issues, instead of ALL issues. But my main hurdle is "when do we require CA/PA for nonconformances"?

Any help is appreciated!
Click to expand...

:topic: I have moved this post to this forum, since it is asking about Corrective/Preventative Action.

On-Topic: I don't believe there is a "Industry Standard" regarding when to initiate Corrective/Preventative Actions. What I would suggest is that you determine when a CA or PA is to be generated, and define it in the CA and PA procedure.

I have never heard of initiating a CA/PA for a defined non-conformance (Major or Minor). The organization needs to define when there will be CA and/or PA initiated. In my opinion.
 
5

50spenc

Re: When Require Corrective/Preventive Action? (Industry Standard?)

Hi SoCalGlenn,

My response is similar to Andy's. As the only EQ in a small engineering company I learn by experience that trying to tackle all of the problems whilst doing every other required task becomes too much. A Pareto Analysis of your problems will give you a better direction to address certain themes.

I set myself two other rules as well as the Pareto approach 1. theme up problem solving where the CAPA has shown to of previously failed and 2. where the COPQ is extremely high (your Engineering Manager might like that one).

Maybe your justification for revising your approach the Engineering Manager might be does he want sticking plasters and firefighting or does he want to fix the root causes. Hope this helps.

Spencer
 
SteelMaiden

SteelMaiden

Super Moderator
Trusted Information Resource
Please don't think of this as nit-picky, but are you talking about when to generate a request for corrective action?

You decide when or if to generate a corrective (or preventive) action once you have investigated a cause, and evaluated the 1) problem, 2) risk and liability, 3) costs involved, 4) benefits, (and maybe some other things that my feeble brain is not thinking of right now)

But, this is one of my pet peeves, people bringing me a problem and telling me they have a corrective action. I expect someone bringing me a corrective action to hand me over a list of things they (or an assignee) will be doing, along with the projected completion dates. I do not expect a list of things that they perceive as needing "fixed".
 
M

Mike S.

Happy to be Alive
Trusted Information Resource
What do you really want to accomplish? What is the company’s goal? In a real world, priorities must be established. It might be great to answer every call on the first ring, but is that a priority worth the expense to do it?

I don’t require written CA for every NC. Sometimes the spec is so tight that even with a good process, execution, and equipment, there will be a few percent fallout, and the company consciously decided that is acceptable. Also, if the issue is relatively minor, isolated, and/or can be corrected on-the-spot, I do not ask for written NC. But, if the issue is repetitive or I think it has a good chance of being repetitive, expensive, dangerous or otherwise “major” I require a written CA from the responsible manager.

As mentioned above, a Pareto could also help to guide where your finite resources should be looking so you get the proverbial biggest bang for the buck.
 
S

SoCalGlenn

Thank you all very much. This is exactly what I need to hear!

Since it sounds like you all focus mainly on recurring issues, does this mean that engineers can close-out their own NCRs at your company?

Thanks much,
Glenn
 
Coury Ferguson

Coury Ferguson

Moderator here to help
Trusted Information Resource
SoCalGlenn said:
Thank you all very much. This is exactly what I need to hear!

Since it sounds like you all focus mainly on recurring issues, does this mean that engineers can close-out their own NCRs at your company?

Thanks much,
Glenn
Click to expand...

Well, our Corrective Action system is defined that there is a Corrective Action Board, which includes persons from Quality, Engineering, Production, and Purchasing. The Board has the authority to close out Corrective Actions, delete Corrective Actions that are not valid, and to extend corrective action due dates if needed, but that is not all that the board does. We meet once a month to review all/any Corrective Actions that have been generated. The Board also has the authority to generate Preventative Actions. But, that is our system and it works for our organization. This may not work for someone else's Organization.
 
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5

50spenc

Glenn,

I think the answer to your question lies in your faith in the person completing the CAPA.

My experience in a small company was that people just went out and fixed the problem which in some cases is great, but some didn't really address the route causes properly (mainly because their problem solving skills were not developed). Where I was unsure about the engineer I reviewed it with the engineer responsible and used it as an opportunity to develop their skills.

The other alternative if you have time is do it as a team approach, get all the members together and review all the CAPA. This takes time but it also means that other team members experience can contribute to the issue.

It basically comes down to how you think you should balance your time against the risk of other peoples comptences.

Spencer
 
M

Mike S.

Happy to be Alive
Trusted Information Resource
SoCalGlenn said:
Thank you all very much. This is exactly what I need to hear!

Since it sounds like you all focus mainly on recurring issues, does this mean that engineers can close-out their own NCRs at your company?

Thanks much,
Glenn
Click to expand...

We have several QE’s. If a QE requests formal (written) RC/CA he can do it in one of two ways: 1. Request a less formal RC/CA response on the same NC form that was created to disposition the discrepant parts. In this case, the QE is the sole approver and no one else is involved and no new paperwork is generated. 2. For more serious matters a formal CAR is issued by another, higher level QE, and it gets much wider visibility. A special form is used, and it is tracked by the formal CAR system. This same higher-level CAR is issued for audit findings and customer complaints. The original issuing QE and the higher-level QE both approve the response before closing the CAR, and the Dept. Mgr. and sometimes even his boss is the CAR recipient.
 
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