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CAPA - Extensions vs Overdue

#1
What is more important to measure-CAPAs that are overdue by original due date or the number of extensions a CAPA has? when a CAPA is extended do you measure from the new due date or the original due date? If from the new due date, how do you know how "overdue" a CAPA is?
 

Randy

Super Moderator
#2
Neither is any more important than the other, just document your decisions/justifications and move on. None of that is required anyhow so it's your cup of Hemlock, therefore if the process is burdensome, change it to what's better suited for you.
 

Tagin

Quite Involved in Discussions
#4
If from the new due date, how do you know how "overdue" a CAPA is?
I think the degree of 'overdue' is better correlated with the extent of risk exposure. Typically, the 'amount' of risk is going to increase the longer the time before the corrections & preventions are put into place. But if some process only happens once/yr or twice/yr and a correction to that process isn't implemented in 3-4 months, it may not matter, whereas a process that occurs multiple times per day or per hour have an entirely different time scale urgency.
 

Mike S.

An Early 'Cover'
Trusted
#5
IMO....

I believe living up to some kind of due date is required. The standard (AS9100) requires that you "...take specific actions when timely and effective corrective actions are not achieved."

Timely is one of those words where context matters.

If your customer issues you a CAR with a due date, be prepared for your auditor to have a problem if you don't meet that date and don't communicate with the customer about it - i.e. explain why you need more time and ask for an extension before it goes past-due. I have done this many times, sometimes asking for multiple extensions, but always being open and honest with the customer. Most customers will be understanding if you are being reasonable in your efforts. IMO it ain't overdue if the customer grants an extension. Not all CA's can effectively be completed in a few weeks or a month -- which are typical initial due dates.
 

Ninja

Looking for Reality
Trusted
#6
Like Normzone, I would look first at how the due dates are set, and whether they are realistic.
Further questions and answers would flow from there...
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#7
Setting REALISTIC deadlines for corrective action implementation is part of the issue. In some cases, the delinquency in implementing corrective actions is just a sympton of a dysfunctional corporate culture, where heads of departments don't feel they are accountable to a "lowly quality" person.

All ISO Management System Standards require top management to be aware and involved with the status of corrective actions in their organizations. If they allow chronic delinquency, they are derelict and there is very little a "lowly quality" person can do, in those cases.

One more aspect to consider: are the CAR's meaningful? Remember that CAR's should be triggered with caution, as you really want to deal with systemic, relevant issues. Sometimes, the reason for CAR's to be disregarded is the fact that too many spurious/trivial/irrelevant issues are mistakenly treated via a CAR, when, in reality, they should not.
 
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ScottK

Not out of the crisis
Staff member
Super Moderator
#8
If a CAR needs to be extended more than once it needs to be re-evaluated to determine if it's even a useful CAR. If it's not useful close with no action taken and document why.
Kind of like issuing a deviation... you do a deviation once. If it's needed again the specification or design should be reviewed.
Also - as part of the CAR evaluation process I have taken a path where if a CAR is likely to take a long time to complete it's moved into a project tracking system and the CAR is closed.
Finally - Always be prepared to to defend CARs open a long time waiting on Verification of Effectiveness... how many of us have stated VOE will take place at next production on a part that may be run once a year?
 

Ninja

Looking for Reality
Trusted
#9
I have taken a path where if a CAR is likely to take a long time to complete it's moved into a project tracking system and the CAR is closed.
That's a nice approach. I've left them in CAR for years...redefining as an improvement project would have been cleaner.
The end result is the same, but it gets it out of repeated audit questions.
 

Mike S.

An Early 'Cover'
Trusted
#10
Close the CAR and call it an improvement project can work if it is an internal CAR. Not usually for a customer-issued CAR.

I have had a customer issue a CAR with a 1 month due date -- their default standard. They take 25 days to get me the part, and I know it will take me more than 5 days to do testing and verify the complaint and, if valid, do a good RCCA, so I ask for an extension of 30 days.

Later we determine the problem is more involved than expected and I may ask for another 30 - 60 day extension. Sometimes more than once if sub-tier vendors are involved.

KEY POINT: This is always done with valid justification provided to the customer, and before it goes past-due. If you build a rapport with the customer and are trustworthy, it means a lot.
 
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