Audits Management: Steps for performing common tasks
Things you need to know
- there are two types of users – Audit Administrators, who can all create, schedule, run, and close an audit, and Standard Users, who cannot respond to audit questions but can respond to tasks assigned to them from the CAPA features
- there are two main set-up functions – in Admin, which is available only to the Super Admin, and in Set-Up, available to all Audit Administrators and the Super Admin
- the module has been populated with content so that an audit can be scheduled immediately; the set-up content can of course be changed and added to
- an audit can be an internal audit, a product audit, a process audit, or a supplier audit; additional audit types can also be created
- all notifications are sent by email and listed on the Audits 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 Help 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 that user an audit administrator which means that they can create, schedule, run and close audits:
- click Audits 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 suppliers
Your account already includes lists of suppliers, products, and processes. These lists are used to provide the specific details about the audit type. So with your list of suppliers you can identify the supplier that is being audited in a supplier audit.
You can add to the list of suppliers as follows:
- click the Admin icon at the top right of the page
- click the Suppliers icon and then choose Add New Supplier
- enter the details of a supplier, including an email address
- click Submit.
You can add customers and employees in a similar way.
Admin: creating a database of processes
The process section has already been set-up with two (2) extra fields – Product (text box) and Location (drop-down list). You can change those fields if an audit about a process has not been logged. If you find that you cannot change them, please email us with what you want and we will make the changes.
To add a new process:
- click Admin at the top right and then click Process
- choose Add Process
- enter the details of the process in the fields available
- click Submit.
The process for adding a product is similar.
Set-Up: changing predefined audit opinions
The default audit opinions are Passed, Accepted with Improvements and Failed.
To change these options to Conforming and Non-Conforming:
- click the Audits icon at the bottom of the page
- click Set-Up at the top of the page (this feature is available only to Audit Administrators)
- click Audit Opinions, click the edit icon on the Action column of the Passed option, change it to Conforming, and click Submit
- do the same to the Failed option – change it to Non-Conforming and click Submit
- for the Accepted with Improvements option, click the delete icon on the Action column and see that it is no longer listed; note that if it is already used and the delete icon is no longer available, you can deactivate by clicking Active under the Status column – you’ll see the entry change to Inactive.
You can add to the list by using the Add Audit Opinion function. You can also change the order of entries in the opinion list by dragging and dropping.
Set-Up: Uploading a checklist
One or more checklists can be uploaded in an Excel spreadsheet and then used as in as many audits as you wish.
To add a checklist to your available checklists:
- click the Upload Checklist icon and then click the + sign next to Add Upload Checklist
- click the link on the right of the Sample File heading; this shows you the format you must follow when uploading a checklist into the Audit module of your isoTracker account (if you are having problems with this, please send us your sample file and we will upload it for you)
- enter a unique checklist name
- browse for the upload file on your desktop, select it, and click Submit; the checklist then appears and each row will have the tick box on the right column selected; if some elements are incorrect, these will be highlighted in orange and will not be uploaded when you move on to the next stage
- click Submit again
- the uploaded checklist is added to the list; click the i button to display it.
Creating an audit
To create an audit:
- click the Audits icon at the bottom of the page and then click the New Audits icon at the top left of the page
- assign a title and scope for the audit
- select an audit type – for example Internal – from the Audit Type drop-down list
- select Pass/Fail from the Scoring drop-down list
- if creating an internal audit, select the auditor from the Auditor drop-down list; this may be the Super Admin or any Audit Administrator you have created
- optionally, select an auditee from the Auditee drop-down list (which will list your isoTracker users and employees you’ve added to the Employee database in the Admin section); note that auditees do not have a role in isoTracker, so this is purely to provide a record
- select an audit date using the Calendar feature
- if you want this audit to recur, select an interval from the Recurrence drop-down list; otherwise just leave the default of No
- click Submit.
The audit is now scheduled and can be run at any time, even if the scheduled date is a long way into the future.
Once you’ve created an audit, the Audit Properties page opens. You should then add a checklist for the audit. You can create one from scratch or select a checklist that you have already uploaded and saved in isoTracker.
To select a saved checklist for the audit:
- click the + icon on the Add Questions object and click the Saved Checklist button; this opens a new tab with the list of the saved checklists
- click the red i button in the Action column to display the contents of the checklist
- when you know which checklist you want to use, click the relevant OK button in the Action column.
The tab closes and the selected checklist populates the Audit object. The order of the questions can be changed using drag and drop. The questions can be modified by selecting them under the Modify column and then clicking the Modify button at the top. They can also be deleted by doing the same in the Delete column.
If you want to change the Pass Score, listed above the checklist, from the default, click the edit icon on its right, enter a lower whole number, and click Save. Note that the Pass Score has no role in isoTracker other than being a guide. The audit is now ready to be run.
Running an audit
To run an audit:
- click the Run Audit button
- on the Run Audit page, select your answer for each question from the Answer drop-down list. If Fail is selected then a comment must be entered in the Runtime Comment box that opens. Answer all the questions and click the Audit Complete button at the bottom. If the information entered is complete, click the OK button; otherwise, follow the instructions before clicking the Audit Complete button again.
Alternatively, the checklist can be extracted and saved as an Excel spreadsheet. To do this, click the Print Checklist button. When the spreadsheet opens, save it on your desktop, answer each question in the spreadsheet by entering 1 for Pass or 0 for Fail, remember to enter a Runtime Comment for a failed question, save the spreadsheet again, and then upload it back into isoTracker using the Upload Checklist function.
Once uploaded, the information entered on the spreadsheet appears in the checklist fields on the Run Audit page. Be careful as the uploaded checklist will overwrite any information already entered. Click the Audit Complete button and then click OK.
The audit now has the status “Completed” and CANNOT be changed. The Audit Complete page opens. It contains the Investigation, Non-Conformance Record, Root Cause, Corrective Action, Preventive Action, and Close Audit objects. Use these objects to resolve any issues the audit has uncovered or to close the audit.
Recording a non-conformance
To record a non-conformance:
- click the + icon on the Non-Conformance Record object header.
- questions that did not receive a perfect score are listed; select a question by selecting its checkbox in the Action column
- select an importance level – for example, Major – from the Importance drop-down list
- enter the details of the non-conformance and click the Submit
The non-conformance is now listed with the selected checklist question and an assigned number.
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, and vice versa.
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
- 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 the corrective action that’s 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 Audit 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.
As the trainer, you’ll receive an Audit Replies notification on the CAR tab of your 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 an audit
To close an audit, giving it a “Conforming” status:
- click the + icon for the Close Audit object
- select an option – for example, Conforming – from the Audit Opinion drop-down list
- enter your audit report
- optionally, click the Schedule Next calendar and select a date
- click Submit.
The audit is removed from the Action Required page and can be accessed from the All Audits page.
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
Audits Management: Steps for performing common tasks
Things you need to know
- there are two types of users – Audit Administrators, who can all create, schedule, run, and close an audit, and Standard Users, who cannot respond to audit questions but can respond to tasks assigned to them from the CAPA features
- there are two main set-up functions – in Admin, which is available only to the Super Admin, and in Set-Up, available to all Audit Administrators and the Super Admin
- the module has been populated with content so that an audit can be scheduled immediately; the set-up content can of course be changed and added to
- an audit can be an internal audit, a product audit, a process audit, or a supplier audit; additional audit types can also be created
- all notifications are sent by email and listed on the Audits 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 Help 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 that user an audit administrator which means that they can create, schedule, run and close audits:
- click Audits 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 suppliers
Your account already includes lists of suppliers, products, and processes. These lists are used to provide the specific details about the audit type. So with your list of suppliers you can identify the supplier that is being audited in a supplier audit.
You can add to the list of suppliers as follows:
- click the Admin icon at the top right of the page
- click the Suppliers icon and then choose Add New Supplier
- enter the details of a supplier, including an email address
- click Submit.
You can add customers and employees in a similar way.
Admin: creating a database of processes
The process section has already been set-up with two (2) extra fields – Product (text box) and Location (drop-down list). You can change those fields if an audit about a process has not been logged. If you find that you cannot change them, please email us with what you want and we will make the changes.
To add a new process:
- click Admin at the top right and then click Process
- choose Add Process
- enter the details of the process in the fields available
- click Submit.
The process for adding a product is similar.
Set-Up: changing predefined audit opinions
The default audit opinions are Passed, Accepted with Improvements and Failed.
To change these options to Conforming and Non-Conforming:
- click the Audits icon at the bottom of the page
- click Set-Up at the top of the page (this feature is available only to Audit Administrators)
- click Audit Opinions, click the edit icon on the Action column of the Passed option, change it to Conforming, and click Submit
- do the same to the Failed option – change it to Non-Conforming and click Submit
- for the Accepted with Improvements option, click the delete icon on the Action column and see that it is no longer listed; note that if it is already used and the delete icon is no longer available, you can deactivate by clicking Active under the Status column – you’ll see the entry change to Inactive.
You can add to the list by using the Add Audit Opinion function. You can also change the order of entries in the opinion list by dragging and dropping.
Set-Up: Uploading a checklist
One or more checklists can be uploaded in an Excel spreadsheet and then used as in as many audits as you wish.
To add a checklist to your available checklists:
- click the Upload Checklist icon and then click the + sign next to Add Upload Checklist
- click the link on the right of the Sample File heading; this shows you the format you must follow when uploading a checklist into the Audit module of your isoTracker account (if you are having problems with this, please send us your sample file and we will upload it for you)
- enter a unique checklist name
- browse for the upload file on your desktop, select it, and click Submit; the checklist then appears and each row will have the tick box on the right column selected; if some elements are incorrect, these will be highlighted in orange and will not be uploaded when you move on to the next stage
- click Submit again
- the uploaded checklist is added to the list; click the i button to display it.
Creating an audit
To create an audit:
- click the Audits icon at the bottom of the page and then click the New Audits icon at the top left of the page
- assign a title and scope for the audit
- select an audit type – for example Internal – from the Audit Type drop-down list
- select Pass/Fail from the Scoring drop-down list
- if creating an internal audit, select the auditor from the Auditor drop-down list; this may be the Super Admin or any Audit Administrator you have created
- optionally, select an auditee from the Auditee drop-down list (which will list your isoTracker users and employees you’ve added to the Employee database in the Admin section); note that auditees do not have a role in isoTracker, so this is purely to provide a record
- select an audit date using the Calendar feature
- if you want this audit to recur, select an interval from the Recurrence drop-down list; otherwise just leave the default of No
- click Submit.
The audit is now scheduled and can be run at any time, even if the scheduled date is a long way into the future.
Once you’ve created an audit, the Audit Properties page opens. You should then add a checklist for the audit. You can create one from scratch or select a checklist that you have already uploaded and saved in isoTracker.
To select a saved checklist for the audit:
- click the + icon on the Add Questions object and click the Saved Checklist button; this opens a new tab with the list of the saved checklists
- click the red i button in the Action column to display the contents of the checklist
- when you know which checklist you want to use, click the relevant OK button in the Action column.
The tab closes and the selected checklist populates the Audit object. The order of the questions can be changed using drag and drop. The questions can be modified by selecting them under the Modify column and then clicking the Modify button at the top. They can also be deleted by doing the same in the Delete column.
If you want to change the Pass Score, listed above the checklist, from the default, click the edit icon on its right, enter a lower whole number, and click Save. Note that the Pass Score has no role in isoTracker other than being a guide. The audit is now ready to be run.
Running an audit
To run an audit:
- click the Run Audit button
- on the Run Audit page, select your answer for each question from the Answer drop-down list. If Fail is selected then a comment must be entered in the Runtime Comment box that opens. Answer all the questions and click the Audit Complete button at the bottom. If the information entered is complete, click the OK button; otherwise, follow the instructions before clicking the Audit Complete button again.
Alternatively, the checklist can be extracted and saved as an Excel spreadsheet. To do this, click the Print Checklist button. When the spreadsheet opens, save it on your desktop, answer each question in the spreadsheet by entering 1 for Pass or 0 for Fail, remember to enter a Runtime Comment for a failed question, save the spreadsheet again, and then upload it back into isoTracker using the Upload Checklist function.
Once uploaded, the information entered on the spreadsheet appears in the checklist fields on the Run Audit page. Be careful as the uploaded checklist will overwrite any information already entered. Click the Audit Complete button and then click OK.
The audit now has the status “Completed” and CANNOT be changed. The Audit Complete page opens. It contains the Investigation, Non-Conformance Record, Root Cause, Corrective Action, Preventive Action, and Close Audit objects. Use these objects to resolve any issues the audit has uncovered or to close the audit.
Recording a non-conformance
To record a non-conformance:
- click the + icon on the Non-Conformance Record object header.
- questions that did not receive a perfect score are listed; select a question by selecting its checkbox in the Action column
- select an importance level – for example, Major – from the Importance drop-down list
- enter the details of the non-conformance and click the Submit
The non-conformance is now listed with the selected checklist question and an assigned number.
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, and vice versa.
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
- 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 the corrective action that’s 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 Audit 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.
As the trainer, you’ll receive an Audit Replies notification on the CAR tab of your 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 an audit
To close an audit, giving it a “Conforming” status:
- click the + icon for the Close Audit object
- select an option – for example, Conforming – from the Audit Opinion drop-down list
- enter your audit report
- optionally, click the Schedule Next calendar and select a date
- click Submit.
The audit is removed from the Action Required page and can be accessed from the All Audits page.
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