Corrective and preventive actions

These are the 4 sequential steps that a CAPA owner must complete 1. 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 “5Why 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.

Corrective & Preventive Actions

Corrective and Preventive Action Definitions for CDMS

These are the 4 sequential steps that a CAPA owner must complete

1. 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

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

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

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

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

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

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.

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