Adding Visual Inspection Defects?
Step-by-step guide for creating and maintaining Visual Inspection Defects in SiCompounding.
Overview
In pharmaceutical Visual Inspection, defects are categorized as Critical, Major, or Minor, each impacting product quality and patient safety differently:
- Critical Defects — Visible particulate matter, leaks; pose the greatest risk to patient safety
- Major Defects — Gross underfill, cloudiness; impact safety or efficacy
- Minor Defects — Small scratches, label imperfections; mainly affect cosmetic quality
SiCompounding tracks and manages these defects to ensure consistent quality control and regulatory compliance.
Navigation Path
Settings → Quality Assurance → Visual Inspection Defects
Step-by-Step Instructions
1. Open FileMaker Pro
- Click the FileMaker Pro icon on your computer to launch FileMaker.
2. Access SiCompounding
- When FileMaker opens, locate the large menu bar on the left side of the window.
- Click SiCompounding (near the top of the menu).
3. Open the Pharmacy Dashboard
- In the next window, several icons will appear across the middle of the screen.
- Click Pharmacy to open the Pharmacy Dashboard.
4. Open Settings
- From the blue sidebar menu on the left side:
- Scroll to the bottom.
- Select Settings.
5. Navigate to Visual Inspection Defects
- Under Quality Assurance, select Visual Inspection Defects.
- The Visual Inspection Defects window opens, displaying a list of existing defects with their codes, types, and status.
Visual Inspection Defects Window Fields
The Visual Inspection Defects window displays the following columns:
| Column | Description |
|---|---|
| Defect | What has become defective (description or component name) |
| Code | Unique code assigned to this defect |
| Defect Type | Category of defect (Critical, Major, or Minor) |
| Status | Current status: Active or Inactive |
| Actions | Gear icon with options: Edit, Delete, Change Logs |
Creating a New Defect
-
Click the + Defect button on the right side of the window.
-
The Visual Inspection Defects popup opens. Enter data into the following fields:
Field Description Defect Name or description of the defective item/component Code Unique identifier code for this defect Details Additional details or notes about the defect -
Click Save after completing all fields.
Defect Type Categories
When creating or editing a defect, select the appropriate defect type:
| Defect Type | Impact | Examples |
|---|---|---|
| Critical | Greatest risk to patient safety | Visible particulate matter, leaks, broken seals, missing labels, wrong drug/strength |
| Major | Affects safety or efficacy | Gross underfill, cloudiness, significant discoloration, compromised functionality |
| Minor | Mainly affects cosmetic/appearance quality | Small scratches, minor label imperfections, insignificant blemishes |
Searching Visual Inspection Defects
- Use the Search bar located in the upper right corner of the window.
- Search by Code or Defect Type.
- Press Enter/Return to execute the search and display results.
Managing Defect Status
In the Visual Inspection Defects window, toggle the Status field for each defect:
- Active – The defect is available for selection during visual inspection processes.
- Inactive – The defect is hidden from selection options.
Editing, Deleting, and Viewing Change Logs
Click the Gear Icon (Actions) at the end of each defect row to access these options:
- Edit — Modify defect details. The Visual Inspection Defects popup opens. Click Save after changes.
- Delete — Opens a Deletion Confirmation dialog with two buttons:
- DELETE — Permanently deletes the defect
- CANCEL — Closes the dialog without deleting
- Change Logs — Opens the Record Modification Log window showing all changes made to the defect. Click X in the upper right corner to close.
About Pharmacy Settings
Important: The Pharmacy Settings module contains templates and default configurations and must be completed before using other areas of SiCompounding.
Within Pharmacy Settings, you can manage:
- Product Settings – Configure pharmacy products
- Facility Areas – Define physical pharmacy spaces
- Equipment – Manage pharmacy equipment
- Workflows – Set up operational workflows
- Costs and Fees – Configure pricing structures
- Lab Work – Manage laboratory operations
- COM Templates – Create compound order templates
- Notifications – Set up system notifications
- Integrations – Configure third-party integrations
- Automations – Access and review automation logs
Best Practices
- Establish clear defect definitions aligned with USP 1790 Visual Inspection guidelines.
- Use unique, consistent codes for easy reference during visual inspections.
- Categorize defects correctly (Critical, Major, Minor) to ensure appropriate product disposition.
- Include detailed descriptions to help inspectors identify defects accurately.
- Regularly review and update defects as new quality issues or product changes occur.
- Maintain audit trails through change logs to track modifications and ensure regulatory compliance.
- Train staff on defect categories and examples to ensure consistent identification and reporting.
This completes the step-by-step guide for Adding Visual Inspection Defects in SiCompounding.