Click here to view the "Adding a Deviation Report" Video
Note: Some fields may be missing or labeled differently in your database if your Admin has customized the Deviations Report.
Customizing your Deviation Report
To customize a field in your Deviation Report, hover next to the field name and click the pencil icon. This lets you change the label to better suit your organization’s needs.
Your Deviation Report can also be customized within Team Settings. For more information,
click here.
Within Team Settings, you can:
- Change the module name and icon
- Update e-signature settings
- Modify the abbreviation in the list view
- Hide or require specific fields
Can't customize the Deviation Report? That's because your not an Admin. See Isolocity's User Permissions, here.
Creating a Deviation Report
Step #1
Click here to access the "CAPA" sub-menu.
Step #2
Click "Deviations".
Step #3
Click "Create Report".
Step #4
Complete the "Administrative Details" section by completing the following fields:
- Report #
- Target Completion Date
Step #5
Complete the "Owners and Subscribers" section by completing the following fields:
- Owners (those who can edit the report)
- Subscribers (those who can only view the report)
- Process Owners
- QA Reviewers
Step #6
Complete the "Part A - Description (Initiator)" section by completing the following fields:
- Type
- Error Code
- Impact Assessment
- Proposed Date
- Proposed Time
- Description
- Investigation Summary by Quality Assurance
Step #7
Click "Create Report" to save your progress.
Step #8
Complete the Root Cause Analysis by completing the following fields:
- Root Cause Determined?
- Root Cause Assessment
- Perform a 5-Why Analysis and/or Fishbone Analysis
Step #9
Complete the "Part B - Assessment and Control (Initiator)" section by completing the following fields:
- Is PFMEA?
- Is HACCP?
- Description of Risk Assessment
- Control Measures
- Impacted Areas
- Quality Assurance Impact Assessment
- Conclusion and Recommendation
- Corrective Actions
- Preventative Actions
Step #10
Complete the "Part C - Approval (Quality and Process Owner)" section by completing the following fields:
- All action items complete with support documents attached?
- Approval Expiration Date
- Process Owner Approval
- Quality Inspector Approval
- Disposition
- Additional Comments
Step #11
Click here to download a PDF of your report.