Why is it so hard to close out the CAPAs ?

John Broomfield

Leader
Super Moderator
Re: Why is ii so hard to close out the CAPAs ?

Yes! Both! :bighug:

I guess I'm frustrated because the problems are tough to define, tough to fix and not getting enough attention (in my humble opinion). CARs pile up, and more CARs pile on top of them (okay, there are only a dozen of them, but they seem like a swarm of bees).

I don't WANT to rush them, but I'm starting to feel pressed and wondering if I'm doing something wrong, or if this is just a tough slog for everybody who cares about getting things down right.

SimpleIsGood,

You mentioned difficulty in defining the problem and I am sensing that corrective action is not confined to the vital few nonconformities.

This may help: https://needs2cash.wordpress.com/2014/02/03/how-to-define-a-problem/

It could be that some of the nonconformities are currently worthy of correction only.

John
 

TPMB4

Quite Involved in Discussions
I always thought that the supplier can't close out a CAR if it came from the customer. You send off the 8D or other reporting format with the RCA, permanent corrective actions verification of the actions made and validation of it to the customer with any supporting evidence. This then should get fully reviewed and often they have their own scoring system so it isn't one guy saying yeah or nay according to whim.

Of course with the various design change procedures operated I guess you are saying you get to the proposed corrective action stage and are trying to get it approved so you can complete the CAR process. Engineering change orders, etc. As mentioned above you can't close it out until it is complete even if that means you have a whole swarm of them waiting to be closed. Just need to keep track of them and where in the process they are or what is the hold up/other process you are waiting for.
 

TWA - not the airline

Trusted Information Resource
In my experience if you allow CAPAs to stay open until all actions have been taken, procedures implemented, designs and processes changed and everything verified and validated then people lose the focus on "getting it done" and rather get used to having CAPAs open until everyone forgets about them. For almost anybody working on a CAPA this comes on top of the usual work load and therefore if the due date is not set and monitored like the rest of the daily tasks typically is, the CAPA will always come at the end of the queue.
I do understand that there is a dangerous tendency to close out CAPAs using boilerplate statements and w/o any meaningful actions taken if you put pressure on people with fixed due dates. However, in my opinion such a behavior is at least also a result of the company culture and not only of strict procedures that do not leave the room for meaningful actions (which I agree will typically take longer than some weeks). Or, to put it the other way round, in a company that really cares about quality you'll always find a way to do the right things even if you have to write a memo that explains why in that case you did not follow your procedures...
My :2cents:
 
S

SimpleIsGood

In my experience if you allow CAPAs to stay open until all actions have been taken, procedures implemented, designs and processes changed and everything verified and validated then people lose the focus on "getting it done" and rather get used to having CAPAs open until everyone forgets about them ... My :2cents:

:applause:

Yes. This is part of the problem.

I went back and re-read our CAPA procedure. According to our auditor-approved procedure:

  1. Quality opens CARs/PARs
  2. Managers and Supervisors evaluate the problems in THEIR areas and propose a corrective action
  3. Quality approves the corrective action or asks for a new suggested action
  4. Once approved by Quality, Managers and Supervisors then take action
  5. When Quality has evidence the action was taken (not necessarily that the action was effective), we can close it out.
Getting a response to the CAR, and completing corrective action each get up to 30-days or a red flag is thrown on the play.

Seems to me like we might be skipping a thorough validation step in there toward the end. On the other hand, if everyone is well aware of the problem and sensible corrective action has been taken, you would think we would notice the issue coming back from the dead.

I see one issue as procedural. The other is what our Japanese friends might call Sincere Mind. With a Sincere Mind, you almost don't need a procedure at all. Without a Sincere Mind, no procedure in the world will provide consistently good results.
 
R

Reg Morrison

Once approved by Quality, Managers and Supervisors then take action
When Quality has evidence the action was taken (not necessarily that the action was effective), we can close it out.

Getting a response to the CAR, and completing corrective action each get up to 30-days or a red flag is thrown on the play.
Comparing your procedure against the requirements of ISO 9001:2008, it is missing the effectiveness-check step. So, "auditor-approved" or not, it does not fulfill the requirements of the ISO 9001 standard.

I highly support Bev D's sound advice and only deem the issue fixed and closed with supporting evidence that the problem HAS been put to rest.
 

Marc

Fully vaccinated are you?
Leader
There was a somewhat similar post on the Elsmar Cove LinkedIn group. I'm copying my reply here for the heck of it.
Why is it so hard to close out the CAPAs ?
First off, when a corrective action is started in response to a request for corrective action, a plan and timeline should be set for each stage of that specific corrective action. This is not the same as setting a specific timeline for all corrective actions because each corrective action will be different. That is why I said setting up such a timeline (such as in a procedure) is not realistic. I have seen corrective actions completed in a day or two, whilst others took over a year. For example, replacement or new equipment may be necessary in some instances. In such cases that in its self can delay (or even stop) the progress of a corrective action for reasons such as getting appropriations ($$$) for the equipment.

Some companies do set up "standard" due dates, but it is not realistic to do so. The important thing is for each corrective action to be tracked for continuing progress. Some corrective actions may, for example, take a longer time to verify effectiveness of so are open longer on that aspect alone. Others can be verified as effective more quickly.

What you are describing is *very* typical in my experience. In some (many) companies it is difficult to get management support, not to mention the support of employees on the floor (discipline issues). I have had reasonable success by having a tracking system which is maintained with deadlines appropriate to each specific corrective action. When a deadline is missed "traceable" notices such as emails are sent to the appropriate people (notice I say "people" because typically there are more than one person involved). Failure to follow through can also be fed into internal meetings and ultimately management review.

The unfortunate part is that there are companies which I call "bad personality" companies which are difficult to get things done in and there is a lack of (for example) management support. Ideally everyone will do their job, part of which is (for example) to report their progress or other aspects of their company's corrective action procedure(s)/system.

I have been retained by companies to "clean up" their corrective actions, typically in response to an external audit finding. I set up a tracking system if there isn't one and used "escalation" when a goal isn't met - That is to say if someone does not meet their deadline their supervisor or manager is contacted. Sometimes this leads to an internal meeting as to why the corrective action isn't being followed through on.

Some aspects can be hard to address such as employees not completing required forms or reporting their actions. Again, in a company which I call a "bad personality" company, there is little or no discipline in some areas such as things as simple as completing forms. In such companies they are effectively letting employees do what they want without regard to what the employee's job responsibilities are. If employees do not "take the corrective action seriously" there is an internal discipline problem. I would speak with upper management about the issue. It is not unusual for the person assigned the responsibility to track and follow through on corrective actions to be given the responsibility, but not the authority, to enforce follow through by employees.

As a consultant, in my past several times I have "quit" over their giving me the responsibility but no authority. I went to the person who hired me and I was always persuaded not to quit but it was always on the condition that if I said something had to be done by someone it would be done. That said, as a consultant my reputation is based upon success. I will be blamed for failure (which is always the reason I give if I "quit" a project for a company).

The bottom line is there has to be realistic times set for each phase of each individual corrective action and there has to be a solid tracking mechanism with an escalation path when deadlines are not met without good reason for a delay.
 

John Broomfield

Leader
Super Moderator
:applause:

Yes. This is part of the problem.

I went back and re-read our CAPA procedure. According to our auditor-approved procedure:

  1. Quality opens CARs/PARs
  2. Managers and Supervisors evaluate the problems in THEIR areas and propose a corrective action
  3. Quality approves the corrective action or asks for a new suggested action
  4. Once approved by Quality, Managers and Supervisors then take action
  5. When Quality has evidence the action was taken (not necessarily that the action was effective), we can close it out.
Getting a response to the CAR, and completing corrective action each get up to 30-days or a red flag is thrown on the play.

Seems to me like we might be skipping a thorough validation step in there toward the end. On the other hand, if everyone is well aware of the problem and sensible corrective action has been taken, you would think we would notice the issue coming back from the dead.

I see one issue as procedural. The other is what our Japanese friends might call Sincere Mind. With a Sincere Mind, you almost don't need a procedure at all. Without a Sincere Mind, no procedure in the world will provide consistently good results.

...and leadership results in the Sincere Mind.
 
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