CAPA Management: Steps for performing common tasks

  1. there are two types of users being Standard Users, who can all log a CAPA, and CAPA Admins, who can accept a CAPA, manage it and close it.
  2. when CAPA Admin is being referred to it also applies to Super Admins of which there can be a maximum of two (2). Super Admins have Admin rights to the entire system and to all modules. In addition, they can add users which no one else can
  3. there are two main set-up functions being Admin, which is available only to Super Admins, and Set-Up, available to CAPAs Admins, who have Set-Up activated on their Permissions page
  4. the module has been populated with content so that a CAPA can be logged immediately. The set up content can of course be changed as well as added to
  5. all notifications are sent by email as well as listed on the CAPA tab of the Dashboard
  6. the full user manual can be downloaded by logging into your isoTracker demo account and selecting Help from the drop down below Super Admin (or your name) at the top right

To add a user:

  1. click Admin at the top right and choose Manage Users
  2. click Add New User
  3. enter a username with at least six alphanumeric characters and a password with at least eight alphanumeric and special characters. The password is case sensitive
  4. enter the user’s details, including first name, last name and email address (each user’s email address MUST be unique and also must differ from the Super Admin’s address)
  5. Click on Submit

Now the Permissions page automatically opens. To make that user a CAPA Admin which means that they can assign, manage and close CAPAs:

  1. click on CAPA to open the CAPA permissions and then select Admin
  2. If you don’t want the user to have access to the Set-Up function then do not select Set-Up
  3. click Submit at the bottom of the page
  4. repeat to add additional users

The products section has already been set-up with three (3) extra fields being Format (drop-down list), Screen Size (drop-down list) and Serial No. (Blank Field). Note that a Blank Field can only be entered on the New CAPA page. You can change those fields if a CAPA about a product has not been recorded. If you find that you cannot change them then please email us with what you want and we will make the changes. To add a new product:

  1. click on Admin on the top toolbar and then on Products on the left hand panel
  2. choose Add Products
  3. enter the product’s details in the relevant fields
  4. click Submit.

The process for adding a process is similar.

Customers can be parties to a CAPA, so to speed up the recording of a CAPA, you can load a pre existing list of customers either individually or in bulk. To add a new customer:

  1. click on Admin on the top toolbar and then on Customers on the left hand panel
  2. choose Add Customers
  3. enter the customer’s details, including entries in all mandatory fields
  4. click Submit.

You can reorder, deactivate and customize the mandatory fields in the Add Fields section. Note that you can delete customers only if they haven’t registered complaints. This list can be easily searched when logging a complaint.

The process for adding a supplier or an employee is similar.

As previously mentioned the module has been populated with content. Below will explain the purpose of a selection of features in the Set-Up section.

To access Set-Up, click on CAPA on the top toolbar and then choose Set-Up at the top. The key selected features are:

  • Responsibility > Assigned Users: determine who can have the right to be assigned CAPAs and to manage them if they are not CAPA Admins
  • Responsibility > Final Review Users: determine who can have the right to close CAPAs if the 2-step closure process has been activated
  • Root Cause > Fields: click on the + icon under the Action column of Analysis Method and then click on the word Active under the Status column for 3 x 5 Whys and 5 x 5 Whys to deactivate them, leaving 5 Whys, Fishbone and Others active
  • Status: change the name of the statuses to terms familiar to you
  • Action Required: determine which fields you want displayed on the Action Required page which is the list of active CAPAs and is also the module’s default opening page
  • Object Activate/Deactivate > Objects: re-order the objects, also known as sections, using drag and drop. Deactivate objects by clicking on the word Active under the Status column. Edit the name of some of the objects by clicking on the Edit icon under the Action column and then make the change. Finally, add up to 2 new objects using the Add New Object feature

To log a CAPA:

  1. click on CAPA on the top toolbar and then click New CAPA
  2. in the About drop-down list select Product, enter the search term “Micro” in the box on the right
  3. Microsoft Surface 5, Laptop, 15 in and 13 in appear, select the appropriate result by clicking on it
  4. you can select a Parties to this CAPA following the same process as in About but it is not required
  5. in the Priority drop down list select “Major”
  6. enter the details of the CAPA in the Description text box
  7. in the Documents object click on the Upload button and attach 1 external document
  8. then in the Assign To object select Assigned from the Status drop-down list and select Super Admin in the Assign To drop-down list (note that the Assign To object is only available when a CAPA Admin is recording a CAPA and is not available when a Standard User is recording one)
  9. then click on Submit at the bottom of the page.

The page refreshes, the status changes to Assigned and at the bottom the following tabs appear:

  • Non-Conformance: use this tab to connect to the Non-Conformance module and record one or more NCRs related to this CAPA
  • Root Cause: create one or more Root Causes and associate them to this CAPA
  • Corrective Action: record the Action Required, Action Taken and Effectiveness of a CAR and associate it with a Non-Conformance and/or a Root Cause
  • Preventive Action: record the Action Required, Action Taken and Effectiveness of a PAR and associate it with a Non-Conformance and/or a Root Cause

The following objects will also appear:

  • Emails: click on the maroon view icon to see the email that was just sent out Use this object to send further emails to external addresses by either selecting from pre-created templates or creating a new email from scratch
  • Investigation: use to record the details of your investigation and also to send Investigation notifications to internal users that require a reply
  • Payment: record any payments associated with this CAPA
  • Close: to close the CAPA

Note that these tabs and objects can be used in any order or not used at all and the CAPA can also be closed immediately after being recorded and assigned without adding any more information in it.

Perform your Root Cause Analysis using the 5 Whys methodology and then link the Root Cause to a Corrective Action. To record a Root Cause:

  1. click on the Root Cause tab and then on the Add Root Cause button
  2. Select the option of 5 Whys from the Analysis Method drop down
  3. enter the details of the 5 Whys in the boxes below. You can use less than 5 Whys or more clicking on + sign next to Add another at the bottom
  4. when you have completed your analysis click on the Record & Submit Corrective Action button at the bottom

You can add multiple Root Causes

After recording the Root Cause, the Action Required section in the Corrective Action tab opens up. Now start recording your Corrective Action:

  1. at the top you will see a pre-populated Implementation Target Date and Effectiveness Target Date which you can change
  2. in the Responsibility drop down list select Customers and see that George Brown appears below. Move them over to the right hand box
  3. enter the details of the action required
  4. click Submit.

The Corrective Action is recorded, assigned a unique number and will have the related Root Cause listed below

To record the action taken for a Corrective Action:

  1. click on the green + sign on the right of Action Taken
  2. in the Completed By drop down list select users and see that Super Admin appears below. Move them over to the right hand box
  3. select a Completion Date
  4. enter the details of the action taken
  5. click Submit.

You will see that next to the Implementation Target Date the word Completed is listed. The status of the CAPA changes to Effectiveness Check.

You can then record the effectiveness of the action taken by opening the Effectiveness tab selecting a Completed By person, a Completion Date, entering the relevant text and clicking on Submit. The status of the CAPA changes to Effectiveness Check Completed and you will also see the word Completed appears next to the Effectiveness Target Date.

The CAPA can now be closed.

To close a CAPA:

  1. scroll down to the Close object and click the + sign
  2. If you did not close the Corrective Action then you will get a pop-up box telling you that the Corrective Action was not closed. Click on the Cancel button to close the Corrective Action
  3. open the Corrective Action tab and click the red Click to Close button and in the pop-up click on Submit (it now changes to a big green Click to Open button)
  4. return to the Close object, if you wish enter a comment but this is not mandatory, and click Submit.

The closed CAPA is removed from the Action Required list but is still accessible from the All CAPAs page which is available to all CAPA Admins and Super Admins

IMPORTANT: There is a feature for having a 2-step closure of a CAPA called Final Review. If you need it please ask your isoTracker rep to activate it for you and explain how it works

CAPA Admins and Super Admins can choose to reactivate a closed CAPA, and view all tabs and objects associated with it. To do this:

  1. click the All CAPAs button at the top and then in the Action column of the relevant CAPA click on the Reactivate icon
  2. in the pop-up select a person or group from the Administrator drop down list
  3. enter a comment if you wish and click Submit.

The assigned admin(s) will receive a Reactivated CAPA notification on the CAPA tab of their Dashboard. The CAPA is now reopened and can be operated as before by the assigned admin, the Super Admins and other CAPA Admins.

  • you can record a CAPA directly from most events in the other modules using the CAPA tab and the Source event and the CAPA are linked
  • time-based task notifications within the Corrective Action and the Preventive Action tabs can be sent to users, with reminders, and their replies automatically populate the relevant section in a Corrective Action or Preventive Action
  • time-based task notifications can be used to solicit approval of an action. Electronic Signatures can be added to those approvals
  • electronic signatures can be activated for the closure of a CAPA
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