Training Management: Steps for performing common tasks
Things you need to know
- there are three types of users:
- Training Administrators (also known as Trainers), who can all create, schedule, grade, and close training events
- Standard Users, who are users internal to isoTracker; they can run training events and respond to CAPA tasks assigned to them
- Stakeholders, who are users external to isoTracker but listed in the Admin section as Customers, Suppliers, Employees or Various; they can run training events only as respondents and cannot respond to CAPA tasks
- there are two main set-up functions – in Admin, which is available only to the Super Admin, and in Set-Up, available to all Training Administrators and the Super Admin
- the module has been populated with content so that a training event can be scheduled immediately; the set-up content can of course be changed and added to
- a training event can be for users, job roles, customers, suppliers, employees, or other trainees categorized as “various”
- all notifications are sent by email and listed on the Training 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
You will need to add users to your isoTracker account in order to be able to evaluate the Training module. 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 must differ from the Super Admin’s address).
To make a user a training administrator:
- click Training 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 training administrators.
Admin: creating a database of suppliers
Your account already includes lists of suppliers and employees. These lists are used to select Respondents (who are not users in isoTracker) to perform training events. For example, you can give your list of suppliers access to training using the isoTracker Training module.
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 choose Add New Supplier
- enter the details of a supplier, including an email address
- click Submit.
You can add employees and customers in a similar way.
Set-Up: Creating courses
There are already three courses present. These were PowerPoint presentations and have been converted to video format in isoTracker.
Other formats are also supported, such as Word documents (which are converted to PDF in isoTracker), sound files in MP3 format, and links to videos hosted on third-party sites such as YouTube.
To add a course that’s saved locally:
- click the Training icon at the bottom of the page
- click Set-Up at the top of the page (this feature is available only to Training Administrators)
- click Courses and then click the + sign on the left of Add Courses
- assign a unique name in the relevant text box
- leave the Type drop-down list set to the default, All
- upload a course in a supported format using the Upload button; wait until the red button on the right changes from Abort to Delete
- click the Submit
To add a video that’s hosted on a third-party site, paste the URL where the video is located in the Paste Web Link text box and click Submit.
You can add to the list of courses, and change the order of listed courses by dragging and dropping.
Set-Up: Creating tests
Three tests with multiple choice questions are present by default.
To add a test:
- click the Training icon at the bottom of the page
- click Set-Up at the top of the page (this feature is available only to Training Administrators)
- click Tests and then click the + sign on the left of Add Tests
- enter a name for the test in the Name text box
- either accept the default settings or make new selections in the Duration and Pass Score drop-down lists
- leave the Type drop-down list on the default, All
- click the + sign next to Add Questions to open the Add New Questions page; by default, it includes five questions in the Single Answer question format, with answer boxes; you can change the answer type for all the questions at the top or change the answer type just for certain questions, using the setting to the right of each question
- enter one or more questions and answers; note that in general, each question should have a minimum of two or three answers
- remember to select the correct answers if the questions are in the Single Answer, Multiple Answer, or Yes/No Answer formats
- scroll down and click Submit.
You can add as many tests as you wish, and change the order of tests and the order of the questions they contain by dragging and dropping.
Creating a training event
To create a training event:
- click the Training icon at the bottom of the page
- click the New Training icon at the top left of the page
- select Training from the Number drop-down list and assign a title for the event
- select Users from the Type drop-down list and select isoTracker Training from the Reason drop-down list
- move the relevant individual users from the Select Users box over to the right-hand box
- specify an occurrence, start date, and release date (for example, you might leave the occurrence as Once, select a start date that’s 30 minutes away, and keep the default release date of Immediate)
- select the trainer (for example, Super Admin) from the Main Trainer drop-down list
- click Submit.
The training event now has the status of Created. On the next page, you can add courses, tests, and/or a survey, all referred to as Features. The top of the page lists the properties of the training event. Below this is the Respondents object, which lists all the trainees and their status.
To add a course to the training event:
- click the + icon on the Courses object; courses with the Type of All are listed
- select the tick box in the Action column for the course
- click the Add button below the listed courses.
The selected course is added. You can change the default notification emails that will be sent to the selected users by clicking the Default Initial email link and then making the changes.
To add a test to the training event:
- click the + icon on the Tests object; tests with the Type of All are listed
- select the tick box under the Action column for the course
- click the Add button below the listed tests
- use the Run Tests drop-down list to specify when the test must run (for example, After Training Courses)
- choose an interval or accept the default selection of Immediately
- choose whether to display results to respondents at the question level; Yes is selected by default
- if required, click the Default Follow-up email link so you can change the notification emails that will be sent.
To select a certificate to be issued to respondents who obtain a pass score:
- click the + icon on the Certificate object; by default, three certificates are listed
- select one of the certificates in the Action column
- click the Complete button at the bottom of the page.
The training event now has the status of Awaiting. Relevant notification emails will be sent to the chosen respondents.
Running a training event
To run a training event:
- log in as one of the respondents of the event, opening the Summary page
- click the Training tab on the Summary page and, under the Scheduled Course heading, click the link to the training event
- the course opens; if it’s a video, you’ll need to start it and, once it has completed, click the Complete button at the bottom of the page
- the next page will be properties page of the Training Event opened at the Tests object
- open the test for the training by clicking the Run Training icon in the Action column for the listed test
- on the Test page, answer each question and then click the Complete button at the bottom of the page.
The page immediately shows which questions were answered correctly and which were answered incorrectly. Further down, it displays the total score achieved and the required pass score, and specifies whether the respondent has passed or failed.
As soon as the first respondent has completed the event, the Investigation, Non-Conformance Record, Root Cause, Corrective Action, and Preventive Action objects appear.
When all the respondents have completed the training event, the status changes to Completed and the Close Event object appears. Corrective and preventive action (CAPA) features can now be used or the event can be closed.
Note that certificates will be issued to respondents who have passed only once the event is closed.
Recording a non-conformance
To record a non-conformance:
- click the + icon on the Non-Conformance Record object header
- select an importance level – for example, Minor – from the Importance drop-down list
- enter the details of the non-conformance and click the Submit
The non-conformance is listed and assigned a unique 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 action taken for a corrective action
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 a training event
To close a training event:
- click the + icon for the Close Event object
- enter a comment in the text box
- leave the Occurrence drop-down list set to Select
- click Submit.
The training event is removed from the Action Required page and can be accessed from the All Events page. Also, the Respondents who have passed the event will be emailed their Certificate. The result for all Respondents will also be recorded and listed in Set-Up > Training Record.
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
Training Management: Steps for performing common tasks
Things you need to know
- there are three types of users:
- Training Administrators (also known as Trainers), who can all create, schedule, grade, and close training events
- Standard Users, who are users internal to isoTracker; they can run training events and respond to CAPA tasks assigned to them
- Stakeholders, who are users external to isoTracker but listed in the Admin section as Customers, Suppliers, Employees or Various; they can run training events only as respondents and cannot respond to CAPA tasks
- there are two main set-up functions – in Admin, which is available only to the Super Admin, and in Set-Up, available to all Training Administrators and the Super Admin
- the module has been populated with content so that a training event can be scheduled immediately; the set-up content can of course be changed and added to
- a training event can be for users, job roles, customers, suppliers, employees, or other trainees categorized as “various”
- all notifications are sent by email and listed on the Training 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
You will need to add users to your isoTracker account in order to be able to evaluate the Training module. 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 must differ from the Super Admin’s address).
To make a user a training administrator:
- click Training 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 training administrators.
Admin: creating a database of suppliers
Your account already includes lists of suppliers and employees. These lists are used to select Respondents (who are not users in isoTracker) to perform training events. For example, you can give your list of suppliers access to training using the isoTracker Training module.
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 choose Add New Supplier
- enter the details of a supplier, including an email address
- click Submit.
You can add employees and customers in a similar way.
Set-Up: Creating courses
There are already three courses present. These were PowerPoint presentations and have been converted to video format in isoTracker.
Other formats are also supported, such as Word documents (which are converted to PDF in isoTracker), sound files in MP3 format, and links to videos hosted on third-party sites such as YouTube.
To add a course that’s saved locally:
- click the Training icon at the bottom of the page
- click Set-Up at the top of the page (this feature is available only to Training Administrators)
- click Courses and then click the + sign on the left of Add Courses
- assign a unique name in the relevant text box
- leave the Type drop-down list set to the default, All
- upload a course in a supported format using the Upload button; wait until the red button on the right changes from Abort to Delete
- click the Submit
To add a video that’s hosted on a third-party site, paste the URL where the video is located in the Paste Web Link text box and click Submit.
You can add to the list of courses, and change the order of listed courses by dragging and dropping.
Set-Up: Creating tests
Three tests with multiple choice questions are present by default.
To add a test:
- click the Training icon at the bottom of the page
- click Set-Up at the top of the page (this feature is available only to Training Administrators)
- click Tests and then click the + sign on the left of Add Tests
- enter a name for the test in the Name text box
- either accept the default settings or make new selections in the Duration and Pass Score drop-down lists
- leave the Type drop-down list on the default, All
- click the + sign next to Add Questions to open the Add New Questions page; by default, it includes five questions in the Single Answer question format, with answer boxes; you can change the answer type for all the questions at the top or change the answer type just for certain questions, using the setting to the right of each question
- enter one or more questions and answers; note that in general, each question should have a minimum of two or three answers
- remember to select the correct answers if the questions are in the Single Answer, Multiple Answer, or Yes/No Answer formats
- scroll down and click Submit.
You can add as many tests as you wish, and change the order of tests and the order of the questions they contain by dragging and dropping.
Creating a training event
To create a training event:
- click the Training icon at the bottom of the page
- click the New Training icon at the top left of the page
- select Training from the Number drop-down list and assign a title for the event
- select Users from the Type drop-down list and select isoTracker Training from the Reason drop-down list
- move the relevant individual users from the Select Users box over to the right-hand box
- specify an occurrence, start date, and release date (for example, you might leave the occurrence as Once, select a start date that’s 30 minutes away, and keep the default release date of Immediate)
- select the trainer (for example, Super Admin) from the Main Trainer drop-down list
- click Submit.
The training event now has the status of Created. On the next page, you can add courses, tests, and/or a survey, all referred to as Features. The top of the page lists the properties of the training event. Below this is the Respondents object, which lists all the trainees and their status.
To add a course to the training event:
- click the + icon on the Courses object; courses with the Type of All are listed
- select the tick box in the Action column for the course
- click the Add button below the listed courses.
The selected course is added. You can change the default notification emails that will be sent to the selected users by clicking the Default Initial email link and then making the changes.
To add a test to the training event:
- click the + icon on the Tests object; tests with the Type of All are listed
- select the tick box under the Action column for the course
- click the Add button below the listed tests
- use the Run Tests drop-down list to specify when the test must run (for example, After Training Courses)
- choose an interval or accept the default selection of Immediately
- choose whether to display results to respondents at the question level; Yes is selected by default
- if required, click the Default Follow-up email link so you can change the notification emails that will be sent.
To select a certificate to be issued to respondents who obtain a pass score:
- click the + icon on the Certificate object; by default, three certificates are listed
- select one of the certificates in the Action column
- click the Complete button at the bottom of the page.
The training event now has the status of Awaiting. Relevant notification emails will be sent to the chosen respondents.
Running a training event
To run a training event:
- log in as one of the respondents of the event, opening the Summary page
- click the Training tab on the Summary page and, under the Scheduled Course heading, click the link to the training event
- the course opens; if it’s a video, you’ll need to start it and, once it has completed, click the Complete button at the bottom of the page
- the next page will be properties page of the Training Event opened at the Tests object
- open the test for the training by clicking the Run Training icon in the Action column for the listed test
- on the Test page, answer each question and then click the Complete button at the bottom of the page.
The page immediately shows which questions were answered correctly and which were answered incorrectly. Further down, it displays the total score achieved and the required pass score, and specifies whether the respondent has passed or failed.
As soon as the first respondent has completed the event, the Investigation, Non-Conformance Record, Root Cause, Corrective Action, and Preventive Action objects appear.
When all the respondents have completed the training event, the status changes to Completed and the Close Event object appears. Corrective and preventive action (CAPA) features can now be used or the event can be closed.
Note that certificates will be issued to respondents who have passed only once the event is closed.
Recording a non-conformance
To record a non-conformance:
- click the + icon on the Non-Conformance Record object header
- select an importance level – for example, Minor – from the Importance drop-down list
- enter the details of the non-conformance and click the Submit
The non-conformance is listed and assigned a unique 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 action taken for a corrective action
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 a training event
To close a training event:
- click the + icon for the Close Event object
- enter a comment in the text box
- leave the Occurrence drop-down list set to Select
- click Submit.
The training event is removed from the Action Required page and can be accessed from the All Events page. Also, the Respondents who have passed the event will be emailed their Certificate. The result for all Respondents will also be recorded and listed in Set-Up > Training Record.
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