Welcome to Isolocity's Support

What is a Non-Conformance Report (NCR) and why is it important?

• A Non-Conformance Report (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 ensuring that issues are promptly addressed to prevent recurrence.

How do I start creating a new NCR in the Isolocity system?

• To create a new NCR, log in to the Isolocity system, navigate to the "CAPA" sub-menu, and select "Non-Conformance Reports." Then, click on "Create a Non-Conformance Report" to begin the process.

What information do I need to provide when creating an NCR?

• You need to provide:

  • NCR Number: A unique identifier for the report.

  • Owner: The person responsible for managing the NCR.

  • Subscriber: Optional individuals who can follow the NCR's progress.

  • Department: The department associated with the non-conformance.

  • Source: The origin of the non-conformance (Internal, Supplier, Customer).

  • Error Code: A predefined code categorizing the non-conformance.

  • Product ID and Lot Number: If applicable, details about the affected product.

  • Quantity: The amount of the affected product.

  • Description: A detailed explanation of the non-conformance.

How do I assign an NCR Number?

• The NCR Number is a required field that uniquely identifies the report within the system. You must enter this number when creating the NCR to ensure accurate tracking and retrieval.

Why should I assign an owner to the NCR?

• Assigning an owner ensures that a specific individual is accountable for the NCR. The owner is responsible for managing the report, overseeing the investigation, and ensuring corrective actions are implemented.

What role does a subscriber play in an NCR?

• Subscribers can follow the progress of the NCR but cannot make changes. They stay informed about updates and developments related to the non-conformance, which helps maintain transparency and effective communication.

How do I select the department associated with the NCR?

• You can select the relevant department from a dropdown menu during the NCR creation process. Associating the NCR with a specific department helps identify where the non-conformance occurred and who should be involved in resolving it.

How do I determine the source of the non-conformance?

• The source of the non-conformance can be internal, supplier-related, or customer-related. Identifying the correct source helps in understanding the root cause and deciding on the appropriate corrective actions.

What should be included in the description of the non-conformance?

• The description should provide a detailed account of the issue, including what happened, how the non-conformance was discovered, what was affected, and any immediate impacts. This information is essential for a thorough investigation and resolution.

How do I categorize the non-conformance using an error code?

• Select an appropriate error code from a predefined list that best describes the type of non-conformance. This helps categorize the issue for better tracking and analysis, aiding in the prevention of similar issues in the future.

Why is it important to enter the quantity of the affected product?

• Documenting the quantity of the affected product helps assess the severity and scale of the non-conformance, which is vital for determining the necessary corrective actions and potential impact on production or inventory.

How do I document immediate actions taken in response to the non-conformance?

• Immediate actions should be recorded in the "Immediate Action" section of the NCR. This might include steps like stopping production, isolating affected products, or notifying relevant stakeholders.

What is the significance of entering the product ID and lot number in the NCR?

• Entering the product ID and lot number helps trace the specific items affected by the non-conformance, which is crucial for targeted investigations and ensuring that the issue is fully resolved.

How do I select the severity of the non-conformance?

• The severity of the non-conformance can be selected based on its impact on the product, process, or customer. Options typically include categories like "Critical," "Major," and "Minor," which help prioritize the issue and allocate resources accordingly.

What should I do if a Corrective Action Report (CAR) is required?

• If a CAR is needed, indicate this by selecting the "grey button" located in the top section of the NCR. This will trigger the process for creating a CAR to address the root cause and implement preventive measures.

How do I choose the disposition for the non-conformance?

• The disposition involves deciding what will be done with the affected products or processes. Options may include rework, scrap, return to supplier, or other actions. This decision should be documented in the NCR.

How do I document short-term and long-term corrective actions?

• Short-term and long-term corrective actions should be recorded in their respective sections of the NCR. Short-term actions address the immediate issue, while long-term actions focus on preventing recurrence.

What is the process for escalating an NCR to a Corrective Action?

• If further action is needed, you can escalate the NCR to a Corrective Action by clicking the appropriate option in the report. This links the NCR to a more detailed corrective action plan.

How do I create a Deviation Report from an NCR?

• If necessary, you can create a Deviation Report directly from the NCR by selecting the "Create Deviation Report" option. This is useful for documenting approved deviations from standard procedures that arose from the non-conformance.

How do I save and close the NCR?

• After completing all necessary fields and ensuring accuracy, click "Save & Close" to finalize the NCR. This action locks the report and saves it in the system for future reference.

Can I add additional notes or comments to the NCR?

• Yes, additional notes or comments can be added to the NCR in the "Comments" section. This is useful for providing extra context or documenting any additional observations during the resolution process.

What should I do if I need to reopen a closed NCR?

• If new information arises or further action is required, you can reopen the NCR by accessing the report and selecting the "Reopen" option. This allows you to update the report and continue addressing the issue.

How do I track the activity and updates on an NCR?

• The activity tracker in the NCR module shows all actions taken on the report, including updates, changes, and user actions. This ensures transparency and allows for easy monitoring of the NCR's progress.

What are the final steps after closing an NCR?

• After closing an NCR, review the report to ensure that all actions have been completed and documented. The final step may include generating a report for management review or auditing purposes.

How do I ensure that the NCR process is effective in preventing future non-conformances?

• Regularly review closed NCRs to identify trends or recurring issues. Use this information to improve processes, update training, and implement preventive measures across the organization to reduce the likelihood of similar non-conformances in the future.