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Corrective and preventive actions

Corrective & Preventive Actions


Corrective and Preventive Actions
Corrective and Preventive Action Definitions for CDMS
These are the 4 sequential steps that a CAPA owner must complete

Initial Action Taken – Describe the first things that you did when you were
made aware of the NC. This includes the containment actions to minimize the
effect and impact of the NC.
2. Root Cause – Describe the ultimate reasons why the NC occurred. This may
not be an obvious answer. You can use the “5-Why process” to identify the
potential multiple root causes.
3. Proposed Solution – Describe actions to fix the issues and prevent
reoccurrences. These actions should address each of the potential Root Causes.
4. Solution Implemented – Describe the changes that were implemented. You
should not be making any reference to something that you are going to do or will
be done.
1.



Corrective and Preventive Actions
Creating and submitting a Corrective or Preventive action (CAPA)

• Any associate in the organization can generate/request a corrective/preventive
action in the system.
• When you create a CAPA in the system, you want to be sure to include as much
detail as necessary for the CAR Admin to understand the issue so that the CAPA can
be assigned to the correct owner.

• The CAPA system is used to address Internal Customer (site to site) complaints as
well.


Corrective and Preventive Actions
Conduct Initial Action Taken
• This step you want to state what you did when you were made aware of the
issue. After you conduct your initial actions, you should document your actions
in CDMS in the Conduct Initial Action Taken task. This step should be done right
away.
• This action should be the containment action to immediately prevent further
issue.
• Example of a reported issue (used for all slides):
• During an audit, uncontrolled documents were found in the receiving area.
• The initial action would consist of removing all of the uncontrolled documents.
• There could be more to go with this but at minimum, this is going to resolve the
immediate problem. Get the uncontrolled documents out of the area.
• You only want to enter the initial action in this task. You don’t want to include
anything more than initial action.


Corrective and Preventive Actions
Conduct Root Cause Analysis

• This is the most critical in the process. You must identify the true Root Cause
• This is where you are identifying the Root Cause of the issue, not the obvious
answer or a restatement of the issue

• The Root Cause should never list human error. This points to a person being at
fault. You must identify the process break down that caused the issue.
• Joe forgot, Joe didn’t know, Joe printed them out without a form number etc.
• Joe forgot? Why did he forget? Lack of training
• Joe didn’t know? Why didn’t he know? Lack of training
• Joe printed them without a form number.-Restatement of the issue. Do not
restate the obvious.
• The Root Cause of this issue is that Joe was not trained properly or the training
that he received was not effective.
• Why is this the Root Cause? Because if Joe had the proper training, he would
know that per ISO, all documents must be controlled.


Corrective and Preventive Actions
Conduct Solution Proposed
• This is where you state your plan to correct the issue
• This is where you will be stating what you will be doing or what you propose to
do
• We will conduct a training on document control for Joe
• This action will correct the issue for Joe but did other associates receive the
same initial training?
• In order to ensure that this issue isn’t occurring in other areas as well, should
others be retrained?
• When completing this step, ask yourself if what you are entering is going to
cancel out or take care of the Root Cause that you reported.
• If it doesn’t resolve the Root Cause and prevent recurrence, stop where you
and go back to the Root Cause to determine how you can resolve the issue.
• If multiple Root Causes were identified, link each to a proposed solution. At
least one solution per root cause.


Corrective and Preventive Actions
Conduct Solution Implemented
• This is where you are stating what you have done
• Training was held on 6/20/14 for document control
• All receiving associates were included in the training
• You should not be making any statements that reference what you will do!
• We are going to train next week-NO
• Spoke to Joe and we are going to go over the procedure-NO
• The solution has been implemented at this point and is in place. If it is not 100%
complete and in place, stop and do not complete this step.

• Provide the evidence you completed the actions, to assist the verification.


Corrective and Preventive Actions
Conduct Independent Verification

• This is where a person that is independent from the process/issue will verify the
actions
• When you are doing a verification, you are ensuring that what the CAPA owner
entered to correct the issue, was actually put in place and has resolved the issue.
• If they stated that they conducted training, you should be putting in your
verification that you reviewed the training log and found entry #ABC for Joe on
PRO-S-1234 Document Control that was conducted on 6/25/14. Then, you went
to the receiving dock and verified that all forms and documents have a document
number on them and that they are controlled.
• IF you are doing the verification and you go to the training log and there is no
evidence of training or you go to the receiving dock and you find forms with no
document control number on them, you will be entering that in your verification.
Be sure to put everything that you did to try to verify and what is preventing you
from completing that verification.
• Your job is to report the facts of whether the actions were taken and if they are
effective.


Corrective and Preventive Actions
Closing the CAPA

• The CAR Admin will close the CAPA or leave it unresolved
• After the verification, the CAR Admin receives the task to close the CAPA
• The admin will review the response from the CAPA owner as well as the results
of the independent verification

• If the admin feels that the CAR was answered effectively, they will close the
CAPA.
• The admin can close the CAPA regardless of what was reported in the
verification. They may have more information and will close based on that. They
must include comments in the admin section if they chose to close the CAPA
although the verifier indicated that all actions weren’t complete.
• If the CAR admin leaves the CAR open, it will go to the next revision and the CAR
Owner will have to start from the beginning or the Admin may escalate the issue
to the CAR Owners direct report


Thank you



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