FAQs for "Adding a New Non-Conformance Report (NCR)"


1. What is a Non-Conformance Report (NCR) and why is it important?
A: An NCR is a formal document used to identify, track, and resolve deviations from standard procedures, product specifications, or regulatory requirements. It is crucial for maintaining quality control and preventing recurrence of issues.


2. How do I start creating a new NCR in the Isolocity system?
A: Log in to Isolocity, navigate to the CAPA sub-menu, select "Non-Conformance Reports," and click "Create a Non-Conformance Report" to begin.


3. What information do I need to provide when creating an NCR?
A: Required information includes:

  • NCR Number: Unique identifier for the report.

  • Owner: Person responsible for managing the NCR.

  • Subscriber: Optional individuals who can follow progress.

  • Department: Department associated with the non-conformance.

  • Source: Origin of the issue (Internal, Supplier, Customer).

  • Error Code: Predefined code categorizing the non-conformance.

  • Product ID and Lot Number: If applicable.

  • Quantity: Amount of affected product.

  • Description: Detailed explanation of the non-conformance.


4. How do I assign an NCR Number?
A: Enter a unique NCR Number during creation to ensure accurate tracking and retrieval.


5. Why should I assign an owner to the NCR?
A: The owner ensures accountability, manages the NCR, oversees investigations, and implements corrective actions.


6. What role does a subscriber play in an NCR?
A: Subscribers can follow progress but cannot make changes. They stay informed of updates for transparency and communication.


7. How do I select the department associated with the NCR?
A: Choose the relevant department from the dropdown during creation to identify where the non-conformance occurred.


8. How do I determine the source of the non-conformance?
A: Sources can be Internal, Supplier, or Customer. Correct identification helps determine root cause and appropriate corrective actions.


9. What should be included in the description of the non-conformance?
A: Include what happened, how it was discovered, affected items, and immediate impacts for a thorough investigation.


10. How do I categorize the non-conformance using an error code?
A: Select a predefined error code that best describes the type of non-conformance for tracking and future prevention.


11. Why is it important to enter the quantity of the affected product?
A: It helps assess the severity and scale of the non-conformance for corrective action planning.


12. How do I document immediate actions taken in response to the non-conformance?
A: Record urgent steps like stopping production or isolating products in the "Immediate Action" section.


13. What is the significance of entering the product ID and lot number in the NCR?
A: Helps trace specific affected items for targeted investigations and resolution.


14. How do I select the severity of the non-conformance?
A: Choose based on impact on product, process, or customer. Options typically include Critical, Major, or Minor.


15. What should I do if a Corrective Action Report (CAR) is required?
A: Click the grey button at the top of the NCR to trigger a CAR for root cause investigation and preventive measures.


16. How do I choose the disposition for the non-conformance?
A: Decide what to do with affected products (e.g., rework, scrap, return to supplier) and document in the NCR.


17. How do I document short-term and long-term corrective actions?
A: Record short-term actions for immediate resolution and long-term actions to prevent recurrence.


18. What is the process for escalating an NCR to a Corrective Action?
A: Click the escalate option in the NCR to link it to a detailed corrective action plan.


19. How do I create a Deviation Report from an NCR?
A: Use the "Create Deviation Report" option to document approved deviations that arose from the non-conformance.


20. How do I save and close the NCR?
A: Click "Save & Close" after completing all fields to finalize and store the NCR in the system.


21. Can I add additional notes or comments to the NCR?
A: Yes, use the "Comments" section for extra context or observations during resolution.


22. What should I do if I need to reopen a closed NCR?
A: Access the report and select "Reopen" to update and continue addressing the issue.


23. How do I track the activity and updates on an NCR?
A: The activity tracker shows all actions, updates, and user changes for transparency and monitoring.


24. What are the final steps after closing an NCR?
A: Review to ensure all actions are complete and documented. Reports can be generated for management review or audits.


25. How do I ensure the NCR process is effective in preventing future non-conformances?
A: Regularly review closed NCRs for trends, update processes, provide training, and implement preventive measures to reduce recurrence.