Non-Conformance Management: Steps for performing common tasks
Things you need to know
- there are two types of users:
- Standard Users, who can all record non-conformances
- Non-Conformance Administrators (NC Administrators), who can assign non-conformances, manage them, and close them
- there are two main set-up functions – Admin, which is available only to the Super Admin, and Set-Up, available to all NC Administrators, including the Super Admin
- 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 and added to
- all notifications are sent by email and listed on the NC tab, or the CAR or PAR tab, of the Summary page
- you can download the full user manual by logging in to your isoTracker demo account and clicking the Help button at the top right.
Admin: creating users
To add a user:
- click Admin at the top right and choose Manage Users
- click Create New User
- enter a username and password, both with at least six alphanumeric characters (the password is case sensitive)
- 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).
To make a user an NC Administrator, which means they can assign, manage, and close non-conformances:
- click Non-Conformance in the Administrator box on the left and move it to the box on the right
- click Submit & New at the bottom of the page
- repeat to add additional users.
Admin: creating a database of products
The products section has already been set up with a Category text box, a Size drop-down list, and a Lot No field. Note that a blank field can be entered only on the New NC page. You can change those fields if a non-conformance about a product has not been recorded, or contact us for assistance and we’ll make the changes.
To add a new product:
- click Admin at the top right and then click Products
- choose Add Products
- enter the product’s details in the relevant fields
- click Submit.
The steps for adding a process are similar.
Admin: creating a custom database
Existing databases are available for recording customers, suppliers, employees, products, processes, or “various” (a catch all for people). In addition, you can choose to create up to three custom databases, using the Others section.
To create a new database:
- click Admin at the top right, click Others, and then click the Others 1 tab
- change the name of the Others 1 database by clicking the little pen icon on the left of the name, typing in the new name, and clicking the Save option that appears
- create up to four fields (drop-down lists or text boxes); note that if you select Yes for the Blank Field option when creating a text box, this field can be populated only on the New NC page and does not hold data centrally
- click Submit.
You can now add entries to the custom database, either individually or in bulk. You can also add entries “on the fly”, when recording new non-conformances.
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, go to Set-Up > About and click the word Active in the Status column to deactivate the relevant items.
Admin: changing the name of the Non-Conformance module
If you wish to change the name of the module from Non-Conformance to another name, then do the following:
- click Admin at the top right and then click Modules
- click the pen icon on the left of the word Non-Conformance
- enter a new name for the module in the text box that opens
- click Save.
Log out of your isoTracker account and then log back in, and you’ll see that all references to Non-Conformance and NC have been changed.
Set-Up: Customizing the module
As previously mentioned, the module has been populated with content. Using the Set-Up section, you can customize existing, default settings.
To access the Set-Up section, click the Non-Conformance icon and then choose Set-Up at the top of the screen. The section includes settings such as the following:
- Number: you can create additional numbering systems
- Responsibility: determine users (other than NC administrators) who have the right to be assigned non-conformances and to manage them
- Status: change the default names of different statuses to terms familiar to you
- Action Required: determine which fields to display on the Action Required page, which is the module’s default opening page and lists active non-conformances
- Object Activate/Deactivate: re-order objects (also known as sections) by dragging and dropping them; deactivate an object by clicking its Active entry in the Status column; change the name of an object by clicking the Edit icon in the Action column and typing a new name; and add up to two new objects using the Add a New Object
Recording a non-conformance
To record a non-conformance:
- click the Non-Conformance icon at the bottom of the screen and click New NC
- select the Non-Conformance in the Number drop-down list
- select the type of entity affected by the non-conformance (Product, for example) from the About drop-down list or enter a suitable search term (Produ for example) in the Quick Search box and click Find
- in the search results, click the Click Here to Select link in the Select column, to access options in the chosen category (available products, for example); alternatively, click or Add New Product and add the details of a new product in the fields that appear (the details will then be added to the database and can be retrieved through searches)
- select an importance level for the non-conformance from the Importance drop-down list
- enter the details of the non-conformance in the Details text box
- in the Documents object, click the Upload button; you can also choose to attach an external document and wait for it to be uploaded at this point
- in the Assign To section, select Assigned from the Status drop-down list and choose an administrator or accept the default selection of Super Admin in the Assign Administrator drop-down list (note that the Assign To section is available only when an NC Administrator is recording a non-conformance; it’s not available when a standard user is recording one)
- click Submit at the bottom of the page.
The page refreshes and the status of the non-conformance appears as Assigned.
In the Immediate Steps section, the following new options appear:
- Root Cause: create one or more root causes and associate them with the non-conformance
- Emails: create new emails associated with the non-conformance and send them to external email addresses
- Investigation: send investigation notifications that require replies to internal users
- Corrective Action: record the action required and ensure it’s implemented and then checked for effectiveness
- Cost: record any costs associated with the non-conformance
- Close: close the non-conformance.
Note that these options can be used in any order, or not used at all – it’s possible to close a non-conformance immediately after it has been recorded and assigned.
Recording a root cause
To record a root cause:
- click the + icon on the Root Cause object header
- enter the details of the root cause, move the number of the just recorded non-conformance in the Related NCRs section to the right, and click the Submit
The root cause is listed and assigned a unique number.
You can add multiple non-conformances and/or root causes. However, make sure that each non-conformance is related to a root cause, to ensure proper reporting.
Recording a required corrective action
To record the corrective action required to correct a non-conformance and associated root cause:
- click the + sign on the Corrective Action object header
- click the Choose a Non-Conformance Record link, select a non-conformance from the pop-up list, and click Submit; this is an important step
- click the Choose a Root Cause link, select a root cause from the pop-up list, and click Submit
- set a target date and time and enter the details of the action required
- click Submit.
The corrective action is recorded and assigned a unique number. Related non-conformances and root causes display above it.
Recording the corrective action taken
To record a corrective action that has been taken:
- open the Action Taken section by the clicking the + sign on the left
- select a completion date in the Completed By text box and enter a name
- enter the details of the action taken
- click Submit.
You can then record the effectiveness of the action taken by opening the Effectiveness section, entering the relevant details, and clicking Submit. To close the corrective action, click the big red Close button.
An alternative method for recording and closing a corrective action
A more collaborative method for recording, implementing, and checking the effectiveness of a corrective action involves sending notifications to users and then copying their replies into the relevant sections.
To do this:
- in the Corrective Action object, click the + sign next to Send a Corrective Action Notification
- select a user and click Add
- set the date and time by which a reply is required, and click Done
- enter the details of the corrective action in the Action Required text box
- click Submit.
A user who has been sent a corrective action notification can access it by opening the CAR tab on their Summary page, opening the Non-Conformance Notes listing, and clicking the relevant number. Then the user can click the Submit Reply option that appears above the relevant post, enter the details of the reply, select a completion date, attach documents if required, and click Submit.
The receiving user, most likely you, will receive a Non-Conformance Replies notification on the CAR tab of the Summary page. Click that link to view the details of the reply.
Above the reply will be an Accept/Reject button. If you’re not satisfied with a reply, click that button, select Rejected from the Action drop-down list, type in the action required, and select a new reply due date. If you are satisfied with a reply, you can select Accepted or do nothing.
Three buttons display next to the Reply Sent date:
- Copy to AR: to copy the contents of the reply to the Action Required section
- Copy to AT: to copy the contents of the reply, along with the date of completion and completed by information, to the Action Taken section
- Copy to E: to copy the contents of the reply to the Effectiveness section.
Multiple notifications can be sent to multiple users to cover all the steps of the resolution process. They can also be spaced out by selecting different required reply dates, which are then followed up with reminders. Note that this alternative method is probably more complicated but it is more cooperative and inclusive.
Closing a non-conformance
To close a non-conformance:
- scroll down to the Close object and click the + sign
- select Close from the Status drop-down list; if you did not close the corrective action, a pop-up box will alert you to this and you can click the Cancel button
- if necessary, open the corrective action object and click the red Close button (it then changes to a big green Open button)
- return to the Close object, select Close from the Status drop-down list, enter a comment if you choose, and click Submit.
The closed non-conformance is removed from the Action Required list but is still accessible from the All NC page, which is available to all NC administrators.
Reactivating a non-conformance
NC administrators and the Super Admin can choose to reactivate a closed non-conformance and view all objects associated with it. To do this:
- click the All NC icon at the top of the screen and click the Properties icon in the Action column of the relevant non-conformance
- go to the Non-Conformance Record object header and click the Click Here link on the right of Assigned To
- in the pop-up box that appears, select Reactivate from the Status drop-down list
- to assign the reactivated non-conformance, select an administrator from the Administrator drop-down list
- click Submit.
The assigned administrator will receive a Reactivated Non-Conformance notification on the NC tab of their Summary page. The non-conformance is now reopened and can be managed as before by the assigned administrator, the Super Admin, and other NC administrators.
Walk-throughs
- Document Control: Steps for performing common tasks
- Complaints Management: Steps for performing common tasks
- Audits Management: Steps for performing common tasks
- Non-Conformance Management: Steps for performing common tasks
- Training Management: Steps for performing common tasks
- Risk Management: Steps for performing common tasks
Non-Conformance Management: Steps for performing common tasks
Things you need to know
- there are two types of users:
- Standard Users, who can all record non-conformances
- Non-Conformance Administrators (NC Administrators), who can assign non-conformances, manage them, and close them
- there are two main set-up functions – Admin, which is available only to the Super Admin, and Set-Up, available to all NC Administrators, including the Super Admin
- 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 and added to
- all notifications are sent by email and listed on the NC tab, or the CAR or PAR tab, of the Summary page
- you can download the full user manual by logging in to your isoTracker demo account and clicking the Help button at the top right.
Admin: creating users
To add a user:
- click Admin at the top right and choose Manage Users
- click Create New User
- enter a username and password, both with at least six alphanumeric characters (the password is case sensitive)
- 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).
To make a user an NC Administrator, which means they can assign, manage, and close non-conformances:
- click Non-Conformance in the Administrator box on the left and move it to the box on the right
- click Submit & New at the bottom of the page
- repeat to add additional users.
Admin: creating a database of products
The products section has already been set up with a Category text box, a Size drop-down list, and a Lot No field. Note that a blank field can be entered only on the New NC page. You can change those fields if a non-conformance about a product has not been recorded, or contact us for assistance and we’ll make the changes.
To add a new product:
- click Admin at the top right and then click Products
- choose Add Products
- enter the product’s details in the relevant fields
- click Submit.
The steps for adding a process are similar.
Admin: creating a custom database
Existing databases are available for recording customers, suppliers, employees, products, processes, or “various” (a catch all for people). In addition, you can choose to create up to three custom databases, using the Others section.
To create a new database:
- click Admin at the top right, click Others, and then click the Others 1 tab
- change the name of the Others 1 database by clicking the little pen icon on the left of the name, typing in the new name, and clicking the Save option that appears
- create up to four fields (drop-down lists or text boxes); note that if you select Yes for the Blank Field option when creating a text box, this field can be populated only on the New NC page and does not hold data centrally
- click Submit.
You can now add entries to the custom database, either individually or in bulk. You can also add entries “on the fly”, when recording new non-conformances.
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, go to Set-Up > About and click the word Active in the Status column to deactivate the relevant items.
Admin: changing the name of the Non-Conformance module
If you wish to change the name of the module from Non-Conformance to another name, then do the following:
- click Admin at the top right and then click Modules
- click the pen icon on the left of the word Non-Conformance
- enter a new name for the module in the text box that opens
- click Save.
Log out of your isoTracker account and then log back in, and you’ll see that all references to Non-Conformance and NC have been changed.
Set-Up: Customizing the module
As previously mentioned, the module has been populated with content. Using the Set-Up section, you can customize existing, default settings.
To access the Set-Up section, click the Non-Conformance icon and then choose Set-Up at the top of the screen. The section includes settings such as the following:
- Number: you can create additional numbering systems
- Responsibility: determine users (other than NC administrators) who have the right to be assigned non-conformances and to manage them
- Status: change the default names of different statuses to terms familiar to you
- Action Required: determine which fields to display on the Action Required page, which is the module’s default opening page and lists active non-conformances
- Object Activate/Deactivate: re-order objects (also known as sections) by dragging and dropping them; deactivate an object by clicking its Active entry in the Status column; change the name of an object by clicking the Edit icon in the Action column and typing a new name; and add up to two new objects using the Add a New Object
Recording a non-conformance
To record a non-conformance:
- click the Non-Conformance icon at the bottom of the screen and click New NC
- select the Non-Conformance in the Number drop-down list
- select the type of entity affected by the non-conformance (Product, for example) from the About drop-down list or enter a suitable search term (Produ for example) in the Quick Search box and click Find
- in the search results, click the Click Here to Select link in the Select column, to access options in the chosen category (available products, for example); alternatively, click or Add New Product and add the details of a new product in the fields that appear (the details will then be added to the database and can be retrieved through searches)
- select an importance level for the non-conformance from the Importance drop-down list
- enter the details of the non-conformance in the Details text box
- in the Documents object, click the Upload button; you can also choose to attach an external document and wait for it to be uploaded at this point
- in the Assign To section, select Assigned from the Status drop-down list and choose an administrator or accept the default selection of Super Admin in the Assign Administrator drop-down list (note that the Assign To section is available only when an NC Administrator is recording a non-conformance; it’s not available when a standard user is recording one)
- click Submit at the bottom of the page.
The page refreshes and the status of the non-conformance appears as Assigned.
In the Immediate Steps section, the following new options appear:
- Root Cause: create one or more root causes and associate them with the non-conformance
- Emails: create new emails associated with the non-conformance and send them to external email addresses
- Investigation: send investigation notifications that require replies to internal users
- Corrective Action: record the action required and ensure it’s implemented and then checked for effectiveness
- Cost: record any costs associated with the non-conformance
- Close: close the non-conformance.
Note that these options can be used in any order, or not used at all – it’s possible to close a non-conformance immediately after it has been recorded and assigned.
Recording a root cause
To record a root cause:
- click the + icon on the Root Cause object header
- enter the details of the root cause, move the number of the just recorded non-conformance in the Related NCRs section to the right, and click the Submit
The root cause is listed and assigned a unique number.
You can add multiple non-conformances and/or root causes. However, make sure that each non-conformance is related to a root cause, to ensure proper reporting.
Recording a required corrective action
To record the corrective action required to correct a non-conformance and associated root cause:
- click the + sign on the Corrective Action object header
- click the Choose a Non-Conformance Record link, select a non-conformance from the pop-up list, and click Submit; this is an important step
- click the Choose a Root Cause link, select a root cause from the pop-up list, and click Submit
- set a target date and time and enter the details of the action required
- click Submit.
The corrective action is recorded and assigned a unique number. Related non-conformances and root causes display above it.
Recording the corrective action taken
To record a corrective action that has been taken:
- open the Action Taken section by the clicking the + sign on the left
- select a completion date in the Completed By text box and enter a name
- enter the details of the action taken
- click Submit.
You can then record the effectiveness of the action taken by opening the Effectiveness section, entering the relevant details, and clicking Submit. To close the corrective action, click the big red Close button.
An alternative method for recording and closing a corrective action
A more collaborative method for recording, implementing, and checking the effectiveness of a corrective action involves sending notifications to users and then copying their replies into the relevant sections.
To do this:
- in the Corrective Action object, click the + sign next to Send a Corrective Action Notification
- select a user and click Add
- set the date and time by which a reply is required, and click Done
- enter the details of the corrective action in the Action Required text box
- click Submit.
A user who has been sent a corrective action notification can access it by opening the CAR tab on their Summary page, opening the Non-Conformance Notes listing, and clicking the relevant number. Then the user can click the Submit Reply option that appears above the relevant post, enter the details of the reply, select a completion date, attach documents if required, and click Submit.
The receiving user, most likely you, will receive a Non-Conformance Replies notification on the CAR tab of the Summary page. Click that link to view the details of the reply.
Above the reply will be an Accept/Reject button. If you’re not satisfied with a reply, click that button, select Rejected from the Action drop-down list, type in the action required, and select a new reply due date. If you are satisfied with a reply, you can select Accepted or do nothing.
Three buttons display next to the Reply Sent date:
- Copy to AR: to copy the contents of the reply to the Action Required section
- Copy to AT: to copy the contents of the reply, along with the date of completion and completed by information, to the Action Taken section
- Copy to E: to copy the contents of the reply to the Effectiveness section.
Multiple notifications can be sent to multiple users to cover all the steps of the resolution process. They can also be spaced out by selecting different required reply dates, which are then followed up with reminders. Note that this alternative method is probably more complicated but it is more cooperative and inclusive.
Closing a non-conformance
To close a non-conformance:
- scroll down to the Close object and click the + sign
- select Close from the Status drop-down list; if you did not close the corrective action, a pop-up box will alert you to this and you can click the Cancel button
- if necessary, open the corrective action object and click the red Close button (it then changes to a big green Open button)
- return to the Close object, select Close from the Status drop-down list, enter a comment if you choose, and click Submit.
The closed non-conformance is removed from the Action Required list but is still accessible from the All NC page, which is available to all NC administrators.
Reactivating a non-conformance
NC administrators and the Super Admin can choose to reactivate a closed non-conformance and view all objects associated with it. To do this:
- click the All NC icon at the top of the screen and click the Properties icon in the Action column of the relevant non-conformance
- go to the Non-Conformance Record object header and click the Click Here link on the right of Assigned To
- in the pop-up box that appears, select Reactivate from the Status drop-down list
- to assign the reactivated non-conformance, select an administrator from the Administrator drop-down list
- click Submit.
The assigned administrator will receive a Reactivated Non-Conformance notification on the NC tab of their Summary page. The non-conformance is now reopened and can be managed as before by the assigned administrator, the Super Admin, and other NC administrators.
Walk-throughs
- Document Control: Steps for performing common tasks
- Complaints Management: Steps for performing common tasks
- Audits Management: Steps for performing common tasks
- Non-Conformance Management: Steps for performing common tasks
- Training Management: Steps for performing common tasks
- Risk Management: Steps for performing common tasks