Non-Conformance Management: Steps for performing common tasks

  1. the Non-Conformance (NC) module is the central register for non-conformances recorded from any module in addition to this NC module
  2. when NC 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 types of users being Standard Users, who can all record a non-conformance, and Non-Conformance Admins (NC Admins), who can assign a non-conformance, manage it and close it
  4. there are two main set-up functions being Admin, which is available only to Super Admins, and Set-Up, available to NC Admins, who have Set-Up activated on their Permissions page
  5. the module has been populated with content so that a non-conformance can be logged immediately. The set-up content can of course be changed as well as added to
  6. all notifications are sent by email as well as listed on the NC tab of the Dashboard
  7. 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 on the top toolbar 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 that of the Super Admins)
  5. Click on Submit

Now the Permissions page automatically opens. To make that user an NC Admin which means that they
can assign, manage and close non-conformances:

  1. click on Non-Conformance to open the Non-Conformance 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 NC page. You can change those fields and 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.

If you need to create a custom database, to be used in a non-conformance, that does not refer to customers, suppliers, employees, products, processes or various (a spare database of persons) then you can do so in the Others section where in fact you can create up to three (3) separate databases. To create a new database:

  1. click on Admin at the top right and then on Others 1 on the left hand panel
  2. change the name of this database from Others 1 to something else by clicking on the little pen icon on the right of the word, type in the new name and click on the Save icon that appears on the right
  3. then click on Add Fields and create up to four (4) fields which can each be either a drop-down list, a text box or a date. Note that if Yes is selected for the Blank Field option when creating a text box then this field can only be populated on the New NC page and does not hold data centrally
  4. click Submit after creating each field.

You can now add content to this custom database either individually or in bulk using the available features. Data can also be entered into the database on the fly when recording a new non-conformance.

If you do not wish for the Others 2 and Others 3 listings to appear on the About drop-down list on the New NC page, then go to Set-Up > About and click on the word Active under the Status column to deactivate those relevant items.

If you wish to change the name of the module from Non-Conformance to another name, then do the following:

  1. select the Module Order option under Super Admin (or your name) at the top right
  2. click on the pen icon on the right of the word Non-Conformance in the relevant tile
  3. enter in the text box that opens a new name for the module
  4. click on the Save icon

Log out of your isoTracker account and then log back in and see that all references to Non-Conformance and NC have been changed

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 Non-Conformance on the top toolbar and then choose Set-Up at the top. The key selected features are:

  1. Fields > Fixed Fields: you can change the listed field names
  2. Fields > New Fields: there is a default field, Importance which has its own default options which can be added to. Additional fields can be added to this list up to a total of 25
  3. Responsibility: determine who can have the right to be assigned non-conformances and to manage them if they are not NC admins
  4. Importance & Reminders: create default tasks and a “close by date” for each Importance
  5. RMA: if you have Returned Materials then this could be a useful section for you. It can be activated on your account by clicking on the word Active in Object Activate/Deactivate
  6. Status: change the name of the statuses to terms familiar to you
  7. Action Required: determine which fields you want displayed on the Action Required page which is the list of active non-conformances and is also the module’s default opening page
  8. Object Activate/Deactivate: 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 record a non-conformance:

  1. click on Non-Conformance on the top toolbar and then click New Non-Conformance
  2. select Suppliers from the About drop-down list, enter the search term “West” in the box on the right
  3. Supplier West Inc appears as a search result and select it
  4. then in the Importance drop down list select “Major”
  5. enter the details of the non-conformance in the Details text box
  6. in the Documents object click on the Upload button, attach 1 external document and wait for it to be uploaded
  7. 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 NC Admin is recording a non-conformance and is not available when a Standard User is recording one)
  8. 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:

  • Root Cause: create one or more Root Causes and associate them to this Non-Conformance
  • Correction: Use this tab to correct this Non-Conformance if it doesn’t require a CAPA
  • CAPA: Use this tab to connect to the CAPA module and record a Corrective Action and/or a Preventive Action

The following objects will also appear:

  • Emails: to send emails to external email addresses by 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
  • Corrective Action: record the action required and ensure it’s implemented and then checked for effectiveness
  • Cost: record any costs associated with this non-conformance
  • Close: to close the non-conformance.

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

To record a Root Cause:

  1. click on the Root Cause tab
  2. Select an option from the Analysis Method header
  3. enter the details of the Root Cause, and click on Submit button. See that it is listed and assigned a unique number

You can add multiple Root Causes

Use the correction tab to correct the Non-Conformance instead of recording a CAPA:

  1. click on the Correction tab
  2. the tab opens at the Action Required page
  3. enter a target date, responsibility and enter the details of the action required
  4. click on the Choose Root Cause link, below the Action Required section and above the Submit button, select a Root Cause in the pop-up and click on Submit
  5. click Submit.

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

To record the action taken for a correction:

  1. click on the green + sign on the right of Action Taken
  2. select a Completion Date and enter a name in the Completed By text box
  3. enter the details of the action taken
  4. click Submit.

You can then record the effectiveness of the action taken by opening the Effectiveness tab entering the relevant text and clicking on Submit. Then to close the correction remember to click on the red Click to Close button which is below the Effectiveness tab

Use the CAPA tab to open the CAPA module to record a Corrective Action and/or a Preventive Action:

  1. click on Record New CAPA on the CAPA tab
  2. a new browser tab opens and key information from the Non-Conformance is copied over
  3. the key information is the About section, the details, the Root Cause and a link to the Non Conformance on the Non-Conformance tab are copied over
  4. select Major in the Priority drop-down list and then at the bottom of the page assign the CAPA to the Super Admin, who is you, and then click on Submit
  5. the browser tab with the CAPA closes and you will see the key logged CAPA information on the CAPA tab in the Non-Conformance
  6. use the document titled “CAPA Management – Steps for performing common tasks” to help you with the CAPA module

To close a non-conformance:

  1. scroll down to the Close object and click the + sign
  2. If you did not close the Correction and/or have an associated CAPA in the CAPA module still open, then you will get a pop-up box telling you that the correction was not closed. Click on the Cancel button to close the Correction. We’ll leave the CAPA on its own trajectory
  3. open the correction tab and click the red Click to Close and in the pop-up click on Submit button (it 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 non-conformance is removed from the Action Required list but is still accessible from the All Non-Conformance page which is available to all NC Admins and Super Admins.

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

  1. click the All Non-Conformance button at the top and then in the Action column of the relevant non-conformance 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 Non-Conformance notification on the Non-Conformance tab of their Dashboard. The non-conformance is now reopened and can be operated as before by the assigned admin, the Super Admins and other NC Admins.

Download PDF

No credit card required.