FAQs for "Adding a New Deviation Report"


1. What is a Deviation Report and why is it important?
A: A Deviation Report records any instance where a process, product, or service deviates from established standards or procedures. It helps track and address deviations, ensure compliance, and improve overall quality control.


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


3. What information is required to create a Deviation Report?
A: Required information includes:

  • Deviation Number (DEV#): Unique identifier for the report.

  • Owner: Person responsible for managing the deviation.

  • Subscriber: Optional individuals who can follow progress.

  • Department: Department associated with the deviation.

  • Type: Planned or Unplanned.

  • Error Code: Predefined code categorizing the deviation.

  • Impact Assessment: Level of impact (Minor, Major, Critical).

  • Proposed Date and Time: When the deviation is expected or identified.

  • Description: Detailed explanation of the deviation.


4. How do I assign a Deviation Number (DEV#)?
A: Enter a unique DEV# during creation to ensure accurate tracking and retrieval.


5. Why is it important to assign an owner to the Deviation Report?
A: The owner ensures accountability, manages the deviation, oversees investigation, and implements corrective actions.


6. What role does a subscriber play in a Deviation Report?
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 Deviation Report?
A: Choose the relevant department from the dropdown to identify where the deviation occurred and who should resolve it.


8. What is the difference between a planned and unplanned deviation?
A: Planned deviations are approved beforehand (e.g., temporary procedural changes). Unplanned deviations are unexpected and require immediate investigation and corrective actions.


9. How do I categorize the deviation using an error code?
A: Select a predefined error code that best describes the deviation type for tracking and analysis.


10. What should I include in the impact assessment of the deviation?
A: Evaluate potential effects on product quality, safety, and compliance, categorizing as Minor, Major, or Critical to prioritize response.


11. Why is it important to enter the proposed date and time for the deviation?
A: Helps track when the deviation occurred or is expected, ensuring timely follow-up and corrective action.


12. What should be included in the description of the deviation?
A: Provide a detailed account including what happened, how it was discovered, and immediate impacts.


13. How do I document the investigation into the deviation?
A: Record findings and evidence in the "Summary of the Investigation" section to determine root cause and prevent recurrence.


14. How do I determine if a root cause has been identified?
A: After investigation, select "Yes" or "No" in the root cause section. If identified, document details in "Root Cause Assessment."


15. What is the 5-Why Analysis, and how do I use it in the Deviation Report?
A: The 5-Why Analysis identifies the root cause by repeatedly asking "Why" until the underlying issue is discovered. Enter each "Why" directly in the report prompts.


16. How do I conduct a Fishbone Analysis within the Deviation Report?
A: Use the Fishbone (cause-and-effect) diagram option to categorize and analyze potential causes contributing to the deviation.


17. What should I include in the risk assessment for implementing the deviation?
A: Document potential effects on other processes/products and any mitigation measures in the "Risk Assessment" 

section.


18. How do I document control measures for the deviation?
A: Detail actions in "Control Measures" to minimize the deviation’s impact or prevent it from affecting other areas.


19. Why is it important to enter impacted areas in the Deviation Report?
A: Helps assess the full scope of the deviation, ensuring all affected departments, processes, or products are addressed.


20. What should be included in the Quality Assurance Impact Assessment?
A: Evaluate how the deviation affects overall product/process quality, regulatory compliance, safety, and customer satisfaction.


21. How do I document conclusions and recommendations in the Deviation Report?
A: Summarize investigation findings and suggest actions to resolve the deviation and prevent recurrence.


22. What are corrective actions, and how do I document them in the Deviation Report?
A: Corrective actions fix the deviation and prevent recurrence. Record what will be done, responsible personnel, and completion timelines in the "Corrective Actions" section.


23. How do I document preventive actions in the Deviation Report?
A: Preventive actions are proactive measures to avoid similar deviations. Document steps and monitoring methods in the "Preventive Actions" section.