How to handle CAR (Corrective Action Request) Scope vs. Timely Response

Hello,

Apologies if this has been discussed already (I made sure I looked through as many related posts as possible) and also for the length, but I'm at a loss and looking for some input:

After performing a year-end review of CAR trends, it has been shown that our corrective actions are not being addressed in a timely manner.

Some details on our current method...

CARs in our CAPA system have four possible states: Active, Completed, Closed and Late.
- Active: the CAR has been submitted and approved as a valid CAR, is not Late and is being worked on.
- Completed: Containment, root cause and corrective action have stated as being completed by the process owner, and the CAR has been submitted to QA for review.
- Closed: QA has performed the follow-up activities and has found the actions to be effective.
- Late: The containment, root cause and/or corrective action has not been completed and forwarded to QA by the due date. A CAR goes from Active to Late automatically when the due date has been passed without the required info.

We set the due date for CARs 30 days out. If it's critical, it can be shortened. If it's determined after assignment of the CAR that the problem is deep and the plan and the fix will take longer than 30 days, the owner of the CAR is to identify this fact before the CAR is due, and to request a project sheet. In this sheet, they are required to identify the elements that have to be part of any CAR (containment, root cause and corrective action) as well as identify the milestones that will be carried out to complete the CAR. Each milestone must have a due date and an owner, and needs to be approved by QA before the project is accepted for use. Once the project is accepted (in that if it is carried out as defined, it will satisfy the CAR), the CAR is moved to the Completed state, as per the definition above. The reason we do this is that it makes no sense to have the CAR show Late when the original due date is passed; the project sheet now contains the new agreed-upon dates.

Please note that at this time, the CAR is Completed, not Closed, as follow-up is not yet done.

So...my question (finally!). Is this a reasonable method to use when I know or have been informed that the fix is going to take more than 30 days? I've seen other procedures in other companies that dictate writing a CAR for that late CAR and state that the due date is the due date, no arguments - but I can't see the value in that.

How do other groups do this? What is your method when you've assigned a CAR with a due date, and the owner comes back to you 29 days later saying "Man, this is a lot bigger than we imagined. I need an extension/project"? This has been abused in the past when managers realized they could use it to circumvent the process. They treat it like a "Get Out Of Jail Free" card (no Qwality Kop jokes please, you know what I mean).

Thanks for reading, sorry it's so long, but I really value your input.

Re: How to handle CAR scope vs. timely response

IMHO having an arbitrary, inflexible "due date" for a CAR just creates problems. Some issues take longer to analyze and correct than others. Having a separate "project sheet" for longer CAR's doesn't seem beneficial. Why not just extend the due date?

What you are really looking for is progress. What progress is being made and when it completion expected? If you have good follow up and guidance by QA on CARs you should have little difficulty.

In the past, I have worked where the extended due date had to have backup data as to why (ex. to fix the problem, we had to order a new parts that delivery is 45 to 60 days out). The plant manager had to approve all extended due dates during the weekly CAR review. I liked this process.

PS: I was lucky he was a former Quality Manager and did not rubber stamp request.

gbcqc said:

In the past, I have worked where the extended due date had to have backup data as to why (ex. to fix the problem, we had to order a new parts that delivery is 45 to 60 days out). The plant manager had to approve all extended due dates during the weekly CAR review. I liked this process.

PS: I was lucky he was a former Quality Manager and did not rubber stamp request.

Click to expand...

Thanks. At what point did you accept a request to extend? Did you allow it on, say, the last day before the CAR was due? I am also trying to decide on what to do if a detailed corrective action plan is submitted within the allowed period, but no evidence of implementation is seen by the due date.

Mikishots said:

Thanks. At what point did you accept a request to extend? Did you allow it on, say, the last day before the CAR was due? I am also trying to decide on what to do if a detailed corrective action plan is submitted within the allowed period, but no evidence of implementation is seen by the due date.

Click to expand...

Since the CARs were discussed each week, we kind of knew ahead if there might be a problem with the due date. The CAR team did a quick presentation on where they were at and any issues that may be happening.

There was the due date when the CAR was completed with root cause and corrective action plan. Then the followup date to see that the CAR was in place and working as planned. There were times that the corrective action just did not work and we had to go back and keep the CAR open to do more studies and find plan B.

Thanks to everyone for their input and advice - it's given me some ideas to investigate.

Mikishots said:

Thanks. At what point did you accept a request to extend? Did you allow it on, say, the last day before the CAR was due? I am also trying to decide on what to do if a detailed corrective action plan is submitted within the allowed period, but no evidence of implementation is seen by the due date.

Click to expand...

I thought the deadline for a CAR should be set at the first incident review stage- if it looks complex then give a longer reasonable date for completion, if the CAR overruns this date- then this is a quality metric of "date exceeded by X months" Occassionally it may be reasonable to extend the date- but adequate justification has to be documented, and this can't be a routine occurrence. I think noting how many months the CAR has exceeded the expected closure date really helps to focus some folk with getting a move on with things.

Further to your earlier post, I only use OPEN and CLOSED for tracking, after all it is either completed or not, but I do like the way you can track different stages using your method.

Best wishes

Timely response = without undue delay
What is undue due to... ?
Ignorance
Ignoring
Looking at everything through a microscope
Always using hammer and so NC comes up again and using hammer again
Not using appropriate technology
Lack of resources
.
..
...
So if there are many CAR's that are late, then this set needs a CAR ...
To find one of the above as the root cause... and let this CAR not become late

It's always struck as funny that people think that 'timely' is - or can be made to be - bound to a specific length of time.

the poster who referred to 'progress' over completion date is spot on.

I think it's important to remember that actions that prevent reocurrence can take a long time and are effected by the complexity of the Problem in determining the causal mechanism(s), lead times for procuring any necessarry items for the solution such as equipment, instruments, software, fixtures, etc., and the time it takes to deploy, test/validate and finally launch the solution. All of this is without prioritzation and resource availability - which must be managed 'appropriately' per ISO...I have worked on many projects that have taken more than 2 years to get to that final solution. and I've worked on problems that took 2 days.

I do recognize that Problem Solving has phases:
containment - should we shut down shipments and/or the process itself; can we screen for and rework the Problem: this is usually referred to as a 'tournequet' for obvious reasons.
countermeasure or short term solution: this is usually described as a bandaid.
remediation - how do we 'clean up' past records or already built and shipped parts etc.
and finally, the corrective action implementation that prevents reocurrence. that must be verified, validated and deployed...

I alsways recommend dates for these interim actions. It shows progress and a committment to really solving the problem...I've never had an auditor problem with this approach.

Bev D said:

It's always struck as funny that people think that 'timely' is - or can be made to be - bound to a specific length of time.

the poster who referred to 'progress' over completion date is spot on.

I think it's important to remember that actions that prevent reocurrence can take a long time and are effected by the complexity of the Problem in determining the causal mechanism(s), lead times for procuring any necessarry items for the solution such as equipment, instruments, software, fixtures, etc., and the time it takes to deploy, test/validate and finally launch the solution. All of this is without prioritzation and resource availability - which must be managed 'appropriately' per ISO...I have worked on many projects that have taken more than 2 years to get to that final solution. and I've worked on problems that took 2 days.

I do recognize that Problem Solving has phases:
containment - should we shut down shipments and/or the process itself; can we screen for and rework the Problem: this is usually referred to as a 'tournequet' for obvious reasons.
countermeasure or short term solution: this is usually described as a bandaid.
remediation - how do we 'clean up' past records or already built and shipped parts etc.
and finally, the corrective action implementation that prevents reocurrence. that must be verified, validated and deployed...

I alsways recommend dates for these interim actions. It shows progress and a committment to really solving the problem...I've never had an auditor problem with this approach.

Click to expand...

With respect to interim action dates, the database I've set up does exactly that, captured as key event fields that need to be completed and submitted as part of the CAR. The CAR cannot be closed until all key events have been completed, works well IF THEY ARE DONE ON TIME.

I've come to the conclusion that I'm going to need more support from the people up top. No matter what kind of rules, methods and requirements I can come up with to close CARs effectively, they are useless if there is no accountability imposed on the respondents and stakeholders. They don't get done because the people responsible for these chronically late CARs have the "Who's gonna make me? I've got my own job to do" mentality.

Enough to make a grown man cry.