Quality
Quality Overview
Logging a Quality Event
3min
A Quality Event is an occurrence that causes a product or process to deviate from accepted standards or specifications. To log a new quality event, select Quality Dashboard under Quality from the main horizontal menu.
From the Quality Dashboard, select the Quality Events tab.
Click the + Event button. Select Deviations from the dropdown if you want to record an instance of a departure from standard procedures, instructions, or specifications. Select Non-Conformance from the dropdown to record a unit or batch that doesn't meet specified criteria or standards.
If you selected Deviations from the dropdown, follow these steps. If you selected Non-Conformance, skip to the next section, labeled Logging Non-Conformance.
1
Deviations
Deviation Report
- Under Deviation Initiated Date, select the date that the deviation is being reported from the dropdown calendar.
- Under Originator Name, type the name of the person reporting the deviation.
- Under Deviation Due Date, select the date by which all activities related to resolving the deviation should be completed from the dropdown calendar.
- Under Department, type the name of the department in which the deviation occurred.
- Under Date of Occurrence, select the date on which the deviation was observed from the dropdown calendar.
- Under Deviation Type, choose whether the deviation was Planned or Unplanned.
- Under Product / Material / Process Description, enter all of the details related to the deviation, then select the associated SOP from the dropdown list in the field below it.
- Enter the ID Number of the affected product or material.
- Enter the number of units affected in the Quantity Affected field.
Description of the Event
- In this section, describe what happened during the deviation in detail.
- To extend or condense the height of the text box, click in the bottom right corner of the text box, hold down, then drag the box to your desired height.
Immediate Corrective Action
- In this section, use the text box to describe the corrective actions that should be taken to resolve the deviation.
- To extend or condense the height of the text box, click in the bottom right corner of the text box, hold down, then drag the box to your desired height.
- Under Completed by Date, select the date in which all corrective actions should be completed from the dropdown calendar.
Classification (completed by QA)
- If you are a QC-level user, you will have the option to choose the classification of the deviation. Select Minor, Major, or Critical.
- Under Completed by Date, select the date that the deviation was classified by QC from the dropdown calendar.
Save your progress by clicking Save, or continue the process of logging the event by clicking Next. Click Exit to leave the page without saving.
2
Investigation
Investigation Team
- Click the +Add Team Member button to begin adding members to the investigation team. For each member, enter their Department, Name, and Position.
- Add more team members by clicking the +Add Team Member button again to add more rows.
Investigation Details
- In this section, add the details of the investigation into the text box.
Root Cause Analysis
- Enter the Root Cause Analysis, or the most probable root cause(s) into the text box.
- Under Completed by Date, select the date on which the analysis was entered from the dropdown calendar.
Save your progress by clicking Save, or continue the process of logging the event by clicking Next. Click Exit to leave the page without saving.
3
CAPA (Corrective Action & Preventative Action)
Corrective Actions
- Click the +Add Action button to begin adding actions to the corrective actions list. For each action, enter the Action, Responsible Person, Target Due Date, and Completion Date.
- Add more corrective actions by clicking the +Add Action button again to add more rows. Corrective Action Summary
- In this section, add a summary of the corrective actions being taken to fix the deviation into the text box. Effectiveness Check Reference
- In this section, add a description of how you will determine whether or not the corrective actions have remediated the deviation.
- Click the +Upload box to add any supporting document files.
- Under Completed by Date, select the date on which the effectiveness check was entered from the dropdown calendar. Approvals
- Enter the Department Management Approval Date from the dropdown calendar.
- Enter the QA Approval Date from the dropdown calendar.
Preventative Actions
- Repeat the steps from the Corrective Actions section above, this time adding actions and details in relation to all preventative actions that should be implemented to prevent the deviation from happening again.
Click the + Event button, then select Non-Conformance from the dropdown.
1
Non-Conformance
Deviation Report
- Under Initiated Date, select the date that the deviation is being reported from the dropdown calendar.
- Under Originator Name, type the name of the person reporting the deviation.
- Under Due Date, select the date by which all activities related to resolving the deviation should be completed from the dropdown calendar.
- Under Department, type the name of the department in which the deviation occurred.
- Under Date of Occurrence, select the date on which the deviation was observed from the dropdown calendar.
- Under Non-Conformance Type, select the type of non-conformance that occurred from the list.
- Under Product / Material / Process Description, enter all of the details related to the non-conformance, then select the associated SOP from the dropdown list in the field below it.
- Under Specifications, select First, Second, or Third.
- Enter the ID Number of the affected product or material.
- Enter the number of units affected in the Quantity Affected field.
Description of Non-Conformance
- In this section, describe the non-conformance in detail.
- To extend or condense the height of the text box, click in the bottom right corner of the text box, hold down, then drag the box to your desired height.
Immediate Corrective Action
- In this section, use the text box to describe the corrective actions that should be taken to resolve the deviation.
- To extend or condense the height of the text box, click in the bottom right corner of the text box, hold down, then drag the box to your desired height.
- Under Completed by Date, select the date in which all corrective actions should be completed from the dropdown calendar.
Classification (completed by QA)
- If you are a QC-level user, you will have the option to choose the classification of the deviation. Select Minor, Major, or Critical.
- Under Completed by Date, select the date that the deviation was classified by QC from the dropdown calendar.
Save your progress by clicking Save, or continue the process of logging the event by clicking Next. Click Exit to leave the page without saving
2
Investigation
Investigation Team
- Click the +Add Team Member button to begin adding members to the investigation team. For each member, enter their Department, Name, and Position.
- Add more team members by clicking the +Add Team Member button again to add more rows.
Investigation Details
- In this section, add the details of the investigation into the text box.
Root Cause Analysis
- Enter the Root Cause Analysis, or the most probable root cause(s) into the text box.
- Under Completed by Date, select the date on which the analysis was entered from the dropdown calendar.
Save your progress by clicking Save, or continue the process of logging the event by clicking Next. Click Exit to leave the page without saving.
3
CAPA
Corrective Actions
- Click the +Add Action button to begin adding actions to the corrective actions list. For each action, enter the Action, Responsible Person, Target Due Date, and Completion Date.
- Add more corrective actions by clicking the +Add Action button again to add more rows. Corrective Action Summary
- In this section, add a summary of the corrective actions being taken to fix the deviation into the text box. Effectiveness Check Reference
- In this section, add a description of how you will determine whether or not the corrective actions have remediated the deviation.
- Click the +Upload box to add any supporting document files.
- Under Completed by Date, select the date on which the effectiveness check was entered from the dropdown calendar. Approvals
- Enter the Department Management Approval Date from the dropdown calendar.
- Enter the QA Approval Date from the dropdown calendar.
Preventative Actions
- Repeat the steps from the Corrective Actions section above, this time adding actions and details in relation to all preventative actions that should be implemented to prevent the deviation from happening again.
If anything in this non-conformance report needs to be changed, click Initiate Change Request. This will open a form where the change request can be submitted for review.
Updated 17 Feb 2024
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