CAPA Closure for a seldom produced item

I

ISODOC

#1
Can a CAPA be closed if the action that needs to be taken to correct the problem cannot be done until a new order comes in, which in this case may be months or a year away?

Thanks
 
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sagai

Quite Involved in Discussions
#2
Re: CAPA Closure

Hi !
I do not think so.
CAPA can be closed when it was verified and the effectiveness of the correction/ca/pa testified.
We also have cases when regardless we have already almost ready, the effectiveness check is in a "far" future time. These are mostly process related CAPAs, when you can not immediately check whether or not it was implemented properly, or for example internal audit findings, when due to the nature of large organization, the CAPA depends on a different team and we will not check the effectiveness till the time of the next internal audit, typically a year later.
br
Sz.
 

qusys

Trusted Information Resource
#3
Re: CAPA Closure

Can a CAPA be closed if the action that needs to be taken to correct the problem cannot be done until a new order comes in, which in this case may be months or a year away?

Thanks
However you should have a plan in place with responsibilities defined as well as due dates.
You should demonstrate a percentage progress and continual monitor and set a date for follow up to control the status.
In the successive audit we can verify if the process owner has completely closed the action , by also verifying the effectiveness:bigwave:
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#4
Re: CAPA Closure

Welcome to the Cove! :bigwave:

The answer to your question is a resounding "maybe."

Could you share what the nonconformance was for, in specific terms? We could perhaps discuss the actions taken and the various positions (arguments) for closing, closing with a plan to re-audit as soon as the next order comes in, or keep open.
 

Jim Wynne

Staff member
Admin
#5
Re: CAPA Closure

Can a CAPA be closed if the action that needs to be taken to correct the problem cannot be done until a new order comes in, which in this case may be months or a year away?

Thanks
Welcome to the Cove. :)

Why would you want to close it? More details would be good, but in general the record should be complete, including everything that happens as a result of the original NC.
 
I

ISODOC

#6
Re: CAPA Closure

We currently have over 175 CAPA's open at this time. We're having a hard time keeping up with them with the limited resources we have and more are written weekly. We are a job shop that makes tubing that are run in small batches and each one is unique (special tooling, etc.). When the job runs and the part is out of specification its written up on an NCR and we usually request a deviation from the customer. Some customers agree to the deviation request while others don't. The ones that don't accept the deviation we re-run and try to make some changes to the run to get acceptable product. It's a very dynamic environment as you can imagine. Most engineers have 7-15 CAPA's at one time. Any advice you can give would be greatly appreciated.
 

Jim Wynne

Staff member
Admin
#7
Re: CAPA Closure

We currently have over 175 CAPA's open at this time.
<snip>

That seems a bit extreme. Either your business is wildly out of control in one way or another or you're producing documentation unnecessarily, or it's some combination of the two. The problem isn't open CAs, it's too many CAs. That's the problem you need to solve.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#8
Can a CAPA be closed if the action that needs to be taken to correct the problem cannot be done until a new order comes in, which in this case may be months or a year away?
If the corrective action is job specific or product specific or customer specific, you should wait until you run the part number again, so you can assess the EFFECTIVENESS of the corrective action. Now, if the corrective action was related to a process that can be verified in a similar product, you should be able to "close" the corrective action request accordingly.

Much better than to rush a closure of a CAR, is to ensure that, indeed, the problem does not recur. When it comes to corrective action closure, assurance of implementation and effectiveness is MUCH more important than promptness.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#9
Re: CAPA Closure

<snip> That seems a bit extreme. Either your business is wildly out of control in one way or another or you're producing documentation unnecessarily, or it's some combination of the two. The problem isn't open CAs, it's too many CAs. That's the problem you need to solve.
Or - It's a relatively large company.
 
A

Al Dyer

#10
Call me an old broken 78 record, but the only one that can really close the action is the customer, internal or external.

Al...
 
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