Welcome to Isolocity's Support

What is a Deviation Report and why is it important?

• A Deviation Report is a document used to record any instance where a process, product, or service deviates from established standards or procedures. It is important because it helps in tracking and addressing deviations, ensuring compliance, and improving overall quality control.

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

• To start creating a new Deviation Report, log in to the Isolocity system, navigate to the "CAPA" sub-menu, and select "Deviation Reports." From there, click on "Create a Deviation Report" to begin the process.

What information is required to create a Deviation Report?

• You need to provide:

  • Deviation Number (DEV#): A unique identifier for the deviation report.

  • Owner: The person responsible for managing the deviation.

  • Subscriber: Optional individuals who can follow the progress of the deviation report.

  • Department: The department associated with the deviation.

  • Type: The type of deviation (Planned or Unplanned).

  • Error Code: A predefined code categorizing the deviation.

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

  • Proposed Date and Time: The date and time the deviation is expected or was identified.

  • Description: A detailed explanation of the deviation.

How do I assign a Deviation Number (DEV#)?

• The Deviation Number is a required field that uniquely identifies the report within the system. Enter this number in the designated field during the report creation process to ensure accurate tracking and retrieval.

Why is it important to assign an owner to the Deviation Report?

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

What role does a subscriber play in a Deviation Report?

• Subscribers can follow the progress of the Deviation Report but cannot make changes. They are kept informed about updates and developments, ensuring transparency and effective communication.

How do I select the department associated with the Deviation Report?

• Select the relevant department from a dropdown menu during the report creation process. Associating the deviation with a specific department helps identify where the deviation occurred and who should be involved in resolving it.

What is the difference between a planned and unplanned deviation?

• A planned deviation is a deviation that is known and approved before it occurs, usually for a specific reason, such as a temporary change in procedures. An unplanned deviation is unexpected and occurs without prior approval, requiring immediate investigation and corrective actions.

How do I categorize the deviation using an error code?

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

What should I include in the impact assessment of the deviation?

• The impact assessment should evaluate the deviation’s potential effects on product quality, safety, and compliance. Categorize the impact as Minor, Major, or Critical to help prioritize the response and allocate resources effectively.

Why is it important to enter the proposed date and time for the deviation?

• Documenting the proposed date and time helps track when the deviation was identified or is expected to occur. This information is crucial for timely follow-up and ensuring that corrective actions are implemented promptly.

What should be included in the description of the deviation?

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

How do I document the investigation into the deviation?

• Document the investigation in the "Summary of the Investigation" section. Include details about what was investigated, the findings, and any evidence collected. This step is critical for understanding the root cause and preventing recurrence.

How do I determine if a root cause has been identified?

• After conducting the investigation, indicate whether a root cause has been determined by selecting "Yes" or "No" in the relevant section. If a root cause is identified, document it in detail in the "Root Cause Assessment" section.

What is the 5-Why Analysis, and how do I use it in the Deviation Report?

• The 5-Why Analysis is a method used to identify the root cause of a problem by asking "Why" multiple times until the underlying cause is discovered. You can perform this analysis directly in the report by following the prompts and entering each "Why" as you progress.

How do I conduct a Fishbone Analysis within the Deviation Report?

• A Fishbone Analysis, also known as a cause-and-effect diagram, helps categorize potential causes of a problem. You can initiate this analysis in the report by clicking the appropriate option and filling out the diagram to explore all possible causes of the deviation.

What should I include in the risk assessment for implementing the deviation?

• The risk assessment should consider the potential effects of implementing the deviation on other processes or products. Document any risks identified and the measures needed to mitigate them in the "Risk Assessment" section.

How do I document control measures for the deviation?

• Control measures should be detailed in the "Control Measures" section. These are actions taken to minimize the deviation's impact on other areas of the system or prevent it from affecting other processes or products.

Why is it important to enter impacted areas in the Deviation Report?

• Entering impacted areas helps assess the deviation's full scope, ensuring that all affected departments, processes, or products are considered during the investigation and corrective action process.

What should be included in the Quality Assurance Impact Assessment?

• The Quality Assurance Impact Assessment should evaluate how the deviation affects the overall quality of the product or process. This includes considering compliance with regulatory standards, product safety, and customer satisfaction.

How do I document conclusions and recommendations in the Deviation Report?

• The conclusions and recommendations section should summarize the investigation’s findings and suggest actions to address the deviation and prevent future occurrences. This section provides a clear path forward for resolving the issue.

What are corrective actions, and how do I document them in the Deviation Report?

• Corrective actions are steps taken to fix the deviation and prevent it from happening again. Document these actions in the "Corrective Actions" section, including what will be done, who is responsible, and the timeline for completion.

How do I document preventive actions in the Deviation Report?

• Preventive actions are proactive measures taken to prevent similar deviations in the future. Record these actions in the "Preventive Actions" section, detailing the steps to be implemented and how they will be monitored for effectiveness.