FAQs for "Adding a New Complaint"


1. What is the purpose of adding a new complaint in the Isolocity system?
A: Adding a new complaint documents and manages customer complaints effectively. It helps track the complaint, investigate the issue, and implement corrective actions to prevent recurrence, ensuring customer satisfaction and regulatory compliance.


2. How do I begin creating a new complaint report?
A: Navigate to the CAPA sub-menu, select "Complaints," and click "Create a Complaint Report" to start.


3. What information is required to create a complaint report?
A: Required information includes:

  • Complaint Number: Unique identifier for the complaint.

  • Date of Complaint: Date the complaint was received.

  • Part ID and Error Code: Specific identifiers for the product or process.

  • Complainant’s Details: Full name, address, phone number, and email.

  • Batch/Lot Number: If applicable, the batch or lot number related to the complaint.


4. How do I enter the complaint number?
A: Enter a unique complaint number in the designated field during creation.


5. Why is it important to enter the date of the complaint?
A: It allows tracking of timeliness in resolving complaints and ensures resolution within a reasonable timeframe.


6. What should I do if the complaint involves a specific part?
A: Select the Part ID from the dropdown to associate the complaint with the relevant part.


7. How do I select the error code for the complaint?
A: Choose an error code from the predefined list that categorizes the type of complaint.


8. How do I record the complainant's details?
A: Enter the full name, address, phone number, and email in the designated fields for proper communication and follow-up.


9. What is the significance of the batch/lot number in a complaint report?
A: Allows traceability and helps in taking corrective actions for the specific batch, important in industries like pharmaceuticals or food production.


10. How do I indicate if the strain was purchased at a store?
A: For cannabis products, select "Yes" or "No" in the relevant section.


11. What should I do if the complaint is related to a product sold at a store?
A: Enter the store’s name and location to help determine the point of sale and investigate related issues.


12. How do I add comments from the complainant?
A: Enter additional comments in the "Comments" section to provide context for the investigation.


13. How do I assign an owner to the complaint report?
A: Select the responsible individual in the "Owner" field. The owner will manage and oversee resolution.


14. Can I add subscribers to the complaint report?
A: Yes, subscribers are notified of updates but cannot make changes to the report.


15. How do I upload files associated with the complaint?
A: Use the "Upload Files" option to attach images, documents, or other supporting evidence.


16. What steps should I take if an investigation is needed?
A: Indicate "Yes" for investigation and document the process, including immediate actions and results.


17. How do I document immediate actions taken in response to the complaint?
A: Record urgent actions, such as stopping production or isolating affected products, in the "Immediate Actions" section.


18. How do I categorize the complaint?
A: Categorize by severity: Critical, Major, Minor, or No Risk to prioritize response.


19. How do I enter the root cause of the complaint?
A: Identify and document the root cause in the "Root Cause" section to prevent recurrence.


20. What should I do if CAPA is needed?
A: Select "Yes" to document corrective and preventive actions, including process or product changes.


21. How do I document the impact of the complaint on other processes?
A: Record effects on other processes in "Impact on Other Processes" to assess broader implications.


22. What should I do if the part related to the complaint was returned?
A: Indicate "Yes" and examine the part as part of the investigation.


23. How do I track the status of the complaint report?
A: Use the activity log to see all actions, updates, assignments, and resolutions.


24. How do I ensure that a reply is sent to the complainant?
A: Select "Yes" in the "Reply Sent to Complainant" section to maintain good customer relations.


25. What are the final steps in completing a complaint report?
A: Review for accuracy, ensure all required fields are completed, and click "Save & Close" to finalize. Escalate for further action if necessary.