Image: Site Corrective Action Record Heading Overview

1. Record Status: This will outline the status of the Record. If the Record is still open, the stage that needs to be completed next will be visible beside the status name. The status will either be ‘Opened + Stage name’ (orange), or Closed (green).

2. No:. This is the system reference number for the Site Corrective Action. This number will be visible wherever the Record is displayed in the system.

3. Date: This is the Date that the Corrective Action Record was created.

4. Name: This is the name of the Corrective Action. By default, the name of the Site Corrective Action Record will be ’Site Corrective Action + Record number’ in brackets. This can be edited via the ‘Actions>Rename’ function via the Actions button.

5. Site: This is the Site for which the Corrective Action Record was raised.

6. Source: The source will outline how the Site Corrective Action was raised. If it was raised as a stand-alone Site Corrective Action via the Auditing module, the Source will be 'AuditingModule'. If the Record was raised via the Nonconformances in a Site Audit or Site Self Assessment Record, a blue hyperlink will be visible allowing you to access the Record from which this Site Corrective Action was raised. Clicking the link will bring you directly to the relevant Record, in the same browser tab. Right click on your mouse and select ‘Open link in new tab’ to stay in the main Site Corrective Action Record page.

7. Risk: This is the Risk that was selected in the ‘Corrective Action Details’ stage of the Site Corrective Action Record. The 'Risk' may appear blank if the Record was not assigned a Risk, i.e,. if the Record was created via a Site Audit Record or a Site Self Assessment Record - opened directly in the second workflow stage.

8. Actions button: You can raise various Actions via the ‘Actions’ button, such as 'Delete', 'Archive', 'Print', 'Rename', etc.

9. Related Records: If any Related Records were added via the ‘Actions’ button, they will be displayed here. Additionally, if the Site Corrective Action was raised directly from a Site Audit or a Site Self Assessment, the Record from which the Corrective Action has been raised will be linked here. Clicking on the links in this section will either open the Related Records in the system, or if it is a URL link, the page will be opened in a new tab.

10. Attachments: If any Attachments were added via the ‘Actions’ tab, they will be displayed here. Clicking on the links in this section will download the Attachments directly to your device.

11. Remove Related Records/Attachments: Click the ‘X’ button to remove any Related Records or Attachments from this Record. You will be asked to confirm your choice by clicking ‘Yes’ or ‘No’.

Image: Adding a Site Corrective Action via the 'Add Site Corrective Action' button in the Auditing Module

Image: Site Corrective Action Opened via 'Add Site Corrective Action' Button (Blank Record)

Image: Adding a Site Corrective Action via a Site Audit or Site Self Assessment Record - Tick the 'Corrective Action Box' in 'Audit Record' Workflow Stage

Image: Adding a Site Corrective Action via a Site Audit or Site Self Assessment Record - Complete the Nonconformance & Corrective Action' Workflow Stage

Image: Site Corrective Action Created via a Site Audit Record or Site Self Assessment Record

Image: Site Corrective Action Opened via 'Site Audit Record' (Pre-Populated Record). 'Responsible' not Specified for the Corrective Action in the Site Audit or Site Self Assessment Record - First Stage Still Opened.

Image: Site Corrective Action Opened via 'Site Self Assessment' (Pre-Populated Record). 'Responsible' not Specified for the Corrective Action in the Site Audit or Site Self Assessment Record - First Stage Closed.

A Site Corrective Action can have a total of 5 or more workflow stages, however, two of those will only appear if prompted by another workflow stage. Most commonly, only three workflow stages will be completed: 'Corrective Action Details', 'Corrective Action Response' and 'Review'.

For a Site Corrective Action you must complete:

1) Corrective Action Details (Raised via the Auditing Module)

1.1) Corrective Action Details (Raised from a Site Audit / Site Self Assessment Record)

2) Corrective Action Response

3) Review

4) Additional Information (Stage Dependent)

5) Additional Review (Stage Dependent)

1. Nonconformance/Requirement: Enter the details of the Nonconformance or issue that is giving rise to the Site Corrective Action. You should include as much detail as possible and ensure it relates to the specific site that you have chosen for the Record.

2. Comments/Observations: Enter any comments that you have for the Site on the Nonconformance/Requirement noted above. You could add your reasoning behind the cause for that issue.

3. Risk - Criteria: Determine the Risk Level that the Nonconformance is likely to pose by selecting a Risk Value for each criterion. There may be multiple Risk Criteria depending on the Risk Assessment Model embedded for the Auditing Module. Click here to learn more about Risk Assessments. This is a non-editable field.

4. Risk - Risk Value: Use the dropdown arrow to select the Risk Value for the Risk Criterion (or Criteria). The dropdown options will depend on the Risk Values set up in the Risk Assessment Model. For the System Default Risk Assessment, you can choose from None(1), Low(2), Medium(3), High(4). The numbers observed in brackets are the Risk Value which will allow for calculations to be completed for Total Risk.

Image: Select a System Default Risk Value

5. Risk - Total Risk: The Total Risk will populate the value from the Risk Criteria Name in the Risk Assessment Model.

Overall Result: This will be a calculation of your overall Risk, taking into consideration the Ratings as set up in the Risk Assessment Model used. The overall Risk will be displayed as followed: Risk (e.g. Low, Medium, High) + Colour (Related to the Risk, e.g. blue, green, yellow, red) + Description (Related to the Risk, e.g. Intolerable Risk, etc.)

6. Risk - Attach/Link: Click ’Add Attach’ to upload an external file directly from your device which will justify your Risk Assessment. Multiple files can be attached to the Risk Assessment Criterion. Simply click the 3 dots, select your file, and click ‘Upload’.

Image: Attaching a File From an External Device

Click ‘Link’ to attach a URL that will justify the Risk you have chosen. Multiple links can be attached to the Risk Assessment Criterion. When you paste a URL link, the ‘Name’ will be automatically populated with the website name - if the URL link is long and detailed, you may see 'Loading...' in the Name. You should use the open text field to update the name of the link. Click ‘Save & Submit’ to add the Link to the Risk Assessment Criterion.

Image: Attaching a URL Link and Changing Name

7. Risk - Report: You can provide a detailed report for your justification for the Risk Values selected for each Criterion.

8. Responsible (Action): Determine who is Responsible for investigating, or 'Action' of the Nonconformance. Using the provided dropdown, you can select from a list of Employees or Site Contacts added to Master Data.

9. Responsible (Review): Determine who is Responsible for the ‘Review’ stage of the investigation. Using the provided dropdown, you can select from a list of Employees or Site Contacts added to Master Data.

10. Due Date: Establish a Date of completion for the investigation. The Due Date will be populated automatically with the Date that the Record was created. Click in the calendar icon to change the date as required.

11. Save: Click the 'Save' button to save your progress - this will create the Site Corrective Action Record and move it to the 'Actions' tab in the Corrective Actions module. Clicking the 'Save' button will not cause a signature to be added to the Record. This will allow you to return to the Corrective Action Details stage until all the sections are completed. The ‘Save’ button allows you to make as many changes as required to the Record without the system noting signatures for each change/update.

12. Save & Submit: Click ‘Save & Submit’ to save your progress and move on to the next workflow stage. If after submitting this stage you wish to make any more changes, you will need to access the stage via the ‘Edit’ button and you will be requested to note the ‘Reason for Change’. Additionally, another signature will be added to the bottom of the stage.

13. Cancel: Click ‘Cancel’ to discard any changes made to the stage, close the Record, and move back to the main Auditing module page. If the Record was not yet 'Saved' or 'Saved & Submitted', a new Record will not be created and all of your progress will be lost. If the Record was previously 'Saved' or 'Saved & Submitted', you will loose your progress, but the Record will remain in the 'Actions' tab.

Image: Completed 'Corrective Action Details' Workflow Stage

1. Signature: Once you click 'Save & Submit' closing a workflow stage, a signature is added each time.

2. Edit: To make changes to this stage, click the 'Edit' button. Once you are happy, click the 'Save & Submit' button to save your changes. At this stage, you will be asked to enter a 'Reason for Change' which will be recorded in the Audit Log of the Record. Additionally, a second signature will be added and the workflow stage will be closed and collapsed.

3. Audit Record: The next workflow stage has been enabled and expanded, ready to be completed.

Image: Workflow Stage in 'Edit' Mode - No 'Save' Button (1), Reason for Change Requested (2), Second Signature Added (3)

If a Site Corrective Action was raised from a Site Audit Record or a Site Self Assessment, and the 'Responsible' was selected for the Corrective Action, the first workflow stage - 'Corrective Action Details' will be populated and closed and the Record will be opened directly in the second workflow stage - 'Corrective Action Response'.

If the 'Responsible' was not selected for the Corrective Action, the first workflow stage - 'Corrective Action Details' will be partially populated and remain open until the required fields are populated.

The Record should be completed in the same manner as described in point 1 above, however, read below to learn about the pre-populated fields and what their source is.

Image: Site Corrective Actions Opened via a Site Audit/Site Self Assessment Record

Image: Site Corrective Action Record Opened via a Site Audit/Site Self Assessment Record and the 'Responsible' was Selected (Opened in 'Corrective Action Response' Stage; 'Corrective Action Details' Stage Closed)

Image: Site Corrective Action Record Opened via a Site Audit/Site Self Assessment Record and the 'Responsible' was not Selected (Opened in 'Corrective Action Details' Stage)

1. Source: This is a link to the Auditing Record for which the Site Corrective Action was raised. Clicking on the link will bring you directly to the Record.

2. Risk: The Risk will not be populated as it has not been completed for the Site Corrective Action yet. If the Site Corrective Action Record has been opened in the 'Corrective Action Response' workflow stage, it will remain blank once the Record is closed. If the Site Corrective Action Record has been opened in the 'Corrective Action Details' workflow stage, you will be required to complete the Risk Assessment before a Record can be 'Saved' or 'Saved&Submitted'.

3. Related Records: This will display the Related Record from which the Site Corrective Action Record was raised. It will also show the Risk of the Related Record and what workflow stage it is currently in. Clicking on the hyperlink will open the Related Record in its current workflow stage. You can click the 'X' button if you wish to remove the Related Record. If you choose this option, this Site Corrective Action Record will also be removed from the Related Records section of that Audit Record (relationship between the Records will be removed).

4. Nonconformance / Requirement: The 'Nonconformance / Requirement' is pulled directly from the 'Nonconformance & Corrective Action' workflow stage of the Related Record. This is the name of the Checklist Requirement that a Corrective Action was raised for. In a Site Corrective Action Record, this is a fully editable open text field which will allow you to add more information regarding the requirement.

5. Comments / Observations: The 'Comments / Observations' is pulled directly from the 'Nonconformance & Corrective Action' workflow stage of the Related Record. This is the 'Comments / Observations' section of the Checklist Requirement, which is also present in the 'Comments / Observations' of the Nonconformance workflow. In a Site Corrective Action, this is a fully editable open text field which will allow you to add more information regarding the requirement.

Image: 'Nonconformance/Requirement' and 'Comments/Observations' Source

6. Risk: The 'Risk' will not be populated for a Site Corrective Action Record created from a Site Audit or a Site Self Assessment. If you click 'Edit' in that workflow stage, you will be required to complete the Risk Assessment, otherwise you will not be able to save any other changes made to the stage.

7. Responsible (Action): The Responsible (Action) is pre-populated with the name of the person selected as 'Responsible' in the 'Nonconformance & Corrective Action' workflow stage of the Record for which this Site Corrective Action was created. This will also cause the Site Corrective Action Record to have a completed and closed 'Corrective Action Details' stage. However, if a 'Responsible' was not selected, the 'Corrective Action Detail' workflow stage will remain open and the Responsible (Action) can be selected manually by clicking the dropdown arrow.

To select or re-select the 'Responsible (Action), click on the dropdown arrow to display the Employees and Sites Master Data. Use the dropdown arrows to expand the required folders and source the Responsible (Action). Once you have sourced your Responsible (Action), click on their name until a gray background appears and click 'Select' to add them to the Record.

Image: Responsible (Action) Source

Image: Select the Responsible (Action)

8. Responsible (Review): The Responsible (Review) will always be pre-populated with the name of the 'Auditor' added in the Auditing Programme for which the Auditing Record was created. If needed, this can be changed to someone else in the 'Site Corrective Action Record'.

To re-select the 'Responsible (Review)', click on the dropdown arrow to display the Employees and Sites Master Data. Use the dropdown arrows to expand the required folders and source the Responsible (Review). Once you have sourced your 'Responsible (Review)', click on their name until a gray background appears and click 'Select' to add them to the Record.

Image: Responsible (Review) Source

Image: Re-select the Responsible (Review)

9. Due Date: The Date is auto-populated with the Due Date entered in the related Site Audit or Site Self Assessment Record. This is a fully editable field - click the calendar icon to make the required changes, if needed.

Image: Re-selecting the Due Date

The second workflow stage of the Site Corrective Action is called 'Corrective Action Response'. This section gives the audited Site an opportunity to respond to the raised Corrective Action(s). When this stage is opened, the contact selected as 'Responsible (Action)' in the previous stage will receive an email notification (if an Alert has been set up in the Alerts module), notifying them that they must now complete this stage. The named Site should complete the full workflow stage as described below.

Image: Completed 'Corrective Action Response' Workflow Stage

1. Investigation/Root Cause Analysis: Complete a short overview of the investigation conducted concerning the Corrective Action raised for your Site.

2. Corrective Action: Outline the details of the Actions that have been taken by your Site to correct the situation for the Nonconformance raised for your Site.

3. Prevention Action: Outline the details of any Preventative Actions that will be set up to prevent the issue from re-occurring in the future.

4. Completion Date: Use the calendar icon to select the Date that the Corrective Action was completed. This is automatically populated with the Date that the stage was opened but can be changed by clicking on the calendar icon.

5. Supporting Documents: Click the ‘Add File’ button on the far right hand side of the page to attach an external Document directly from your device which may support your Corrective Action Response details. Click the three dots, select the file directly from your device, add a short description of the file’s contents, and click ‘Upload’.

6. Supporting Documents: The file will then be displayed in the Supporting Documents section along with the original file name and the provided file description. Clicking on the hyperlink will prompt the system to download the file. Multiple Supporting Documents can be uploaded to this workflow stage. To delete a Supporting Document click the 'X' button and confirm your choice in the pop-up window.

Image: Adding a Supporting Document

7. Save: Click ‘Save’ to save your progress. This will allow you to return to the Corrective Action Response stage until all of the required sections are completed. The ‘Save’ button allows you to make as many changes as required to the Record without the system noting signatures for each change/update.

8. Save & Submit: Click 'Save & Submit' when you are happy to close this workflow stage and move on to the next workflow stage of the Site Corrective Action Record - 'Review'. When you 'Save & Submit' a workflow stage, a signature is added and the stage is collapsed, allowing for the next workflow stage to open.

9. Cancel: Click the 'Cancel' button if you wish to discard your progress and return to the main Auditing module page. If the Record was not yet 'Saved' or 'Saved & Submitted', a new Record will not be created and all of your progress will be lost. If the Record was previously 'Saved' or 'Saved & Submitted', you will loose your progress, but the Record will remain in the 'Actions' tab.

Image: Workflow Stage in 'Edit' Mode - No 'Save' Button (1), Reason for Change Requested (2), Second Signature Added By Another User (3)

In most cases, the 'Review' stage will be the last workflow stage of the Site Corrective Action Record. Two more stages may open if this stage is completed and the Decision has been selected as 'Additional Details Required'. In that case, an 'Additional Information' workflow stage will open afterwards, also prompting an 'Additional Review' stage to open.

Please see below for the outlined exampled and prompted additional workflow stages.

Image: Completed 'Review' Workflow Stage

1. Report: Here you should review the Site's Corrective Action Responses and complete a Review Report for the Site to review.

2. Decision: Click the dropdown arrow to select a Decision for the Site’s Corrective Action Response.

Image: Decision Dropdown Options

2.1. Additional Information Required: Choose this option if you require additional information from this Site in order to close the Site Corrective Action Record. This option can be chosen multiple times (Via 'Additional Review' workflow stage), until all necessary information has been submitted by the Site. If you choose this option, the 'Additional Information' workflow stage will be opened next.

2.2. Closed - Approved: Choose this option if you wish to close this Site Corrective Action and Approve the Corrective Action.

2.3. Closed - Not Approved: Choose this option if you would like to close this Site Corrective Action but do not wish to Approve the Corrective Action.

2.4. Closed - Dropped: Choose this option if you wish to Close this Corrective Action and take no further action.

2.5. Closed - Not Concluded: Choose this option if you can’t come to an agreed conclusion for the Site’s Corrective Action and want to close it.

3. Save: Click ‘Save’ to save your progress. This will allow you to return to the 'Review' stage until all of the information is completed. The ‘Save’ button allows you to make as many changes as required to the Record without the system noting signatures for each change/update.

4. Save & Submit: Click ‘Save & Submit’ to save your progress and close out the Site Corrective Action Record. Once you submit this stage, the Record will be moved from the ‘Actions’ to the ‘Complete’ tab in the Corrective Actions module. If after submitting this stage you wish to make any more changes, you will need to access the Record in the ‘Complete’ tab and click the ‘Edit’ button for your required stage. You will be requested to note the ‘Reason for Change’. Additionally, another signature will be added to the bottom of the stage.

If you chose the 'Additional Information Required' decision, the next workflow stage, 'Additional Information' will open.

5. Cancel: Click ‘Cancel’ to discard any changes made to this worklfow stage, close the Record, and move back to the main Auditing module page.  

Image: Completed 'Additional Information' Workflow

1. Report: The Site contact will use the 'Report' section to respond to your Additional Information request.

2. Supporting Documents: If any Supporting Documents were requested, they should be attached here by the Site contact. Click here for details on attaching a Supporting Document.

3. Save: Click 'Save' to save your progress but do not move on to the next workflow stage.

4. Save & Submit: Click 'Save & Submit' to open the next workflow stage - 'Additional Review'.

5. Cancel: Click the 'Cancel' button to discard changes and return to the main Auditing Module page.

Image: Completed 'Additional Review' Workflow Stage

The 'Additional Review' workflow stage should be completed in the same manner as the 'Review' workflow stage.