Welcome to Isolocity's Support

What is an Out of Specification (OOS) Report and why is it important?

• An Out of Specification (OOS) Report is a formal document used to record and investigate any test results or measurements that fall outside predefined specifications. The OOS process is crucial for maintaining product quality, ensuring compliance with regulatory standards, and preventing the release of non-conforming products.

How do I start creating an OOS Report in the Isolocity system?

• To create an OOS Report, log in to the Isolocity system, navigate to the "CAPA" sub-menu, and select "Out of Specification Reports." Then, click on "Create an OOS Report" to begin the process.

What information is required to create an OOS Report?

• The required information includes:

  • OOS Number: A unique identifier for the report.

  • Date Requested: The date the OOS investigation was initiated.

  • Batch Number: The batch associated with the OOS event.

  • Owners: Individuals responsible for managing the OOS.

  • Subscribers: Optional individuals who can follow the OOS progress.

  • Impact Assessment: The potential impact of the OOS event.

  • Sample Name and ID: Information about the sample that failed specification.

  • COA Number: The Certificate of Analysis number related to the OOS.

  • Error Code: A predefined code categorizing the OOS.

  • Description of Laboratory Investigation: Detailed findings from the lab investigation.

Why is the OOS Number important?

• The OOS Number is a unique identifier that tracks the OOS report within the system. It is essential for referencing and retrieving the report throughout the investigation and resolution process.

How do I document the date the OOS was requested?

• Enter the date when the OOS investigation was initiated in the "Date Requested" field. This helps track the timeline of the investigation and ensures timely follow-up and resolution.

What should I include in the Impact Assessment?

• The Impact Assessment should detail the potential effects of the OOS event on product quality, patient safety, and regulatory compliance. This assessment helps determine the severity of the issue and guides decision-making during the investigation.

How do I assign owners to the OOS Report?

• Owners can be assigned by clicking on the "Add Owners" option. Owners are responsible for managing the OOS investigation, coordinating corrective actions, and ensuring the report is completed and approved.

What is the role of subscribers in an OOS Report?

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

How do I upload associated files to the OOS Report?

• You can upload relevant files, such as laboratory results or photographs, by clicking on the "Upload Files" option in the OOS Report. These files provide supporting evidence and additional context for the investigation.

How do I document the sample information in an OOS Report?

• Enter the sample name, sample ID, and COA number in the designated fields. This information is crucial for identifying the specific sample that failed to meet specifications and for tracking the investigation results.

How do I categorize the OOS using an error code?

• Select an appropriate error code from a predefined list that best describes the nature of the OOS event. Categorizing the OOS helps in analyzing trends and implementing preventive measures to reduce future occurrences.

What should be included in the description of the laboratory investigation?

• The description should provide detailed findings from the laboratory investigation, including any tests conducted, observations made, and potential causes identified. This section is critical for understanding why the sample did not meet specifications.

How do I determine if an assignable cause was found?

• After conducting the laboratory investigation, indicate whether an assignable cause was found by selecting "Yes" or "No" in the relevant section. If a cause is identified, it should be documented in detail.

What should I do if recommended actions are needed?

• If recommended actions are required to address the OOS event, document these actions in the "Recommended Actions" section. This might include corrective actions, additional testing, or process changes to prevent recurrence.

How do I finalize and approve the OOS Report?

• After completing all necessary fields and ensuring accuracy, click "Approve" to finalize the report. This step will add your e-signature with a date and time stamp, officially closing the investigation.

Can I add additional comments to the OOS Report?

• Yes, additional comments can be added in the "Comments" section. This is useful for providing extra context, observations, or notes that may not fit into the structured fields of the report.

How do I determine if further testing is required?

• Assess whether additional testing is necessary based on the initial investigation results. Document any further testing plans, including the number of tests, laboratories involved, and expected outcomes.

How do I handle situations where the test results are still out of specification after further testing?

• If the results remain out of specification, document the outcome and consider escalating the issue to a Corrective Action, Change Control, or Deviation Report. This step ensures that appropriate measures are taken to address the underlying issue.

What is the process for closing the OOS investigation?

• To close the OOS investigation, ensure that all actions have been completed and documented. The final approval and e-signature by the department manager will close the report, ensuring all required steps have been followed.

How do I reopen an OOS Report if new information becomes available?

• If new information arises that affects the OOS investigation, you can reopen the report by selecting the "Reopen" option. This allows you to update the report and continue the investigation as needed.

What are the final steps after closing an OOS Report?

• After closing the OOS Report, review it to ensure completeness and accuracy. The report may be used for auditing purposes, management review, or regulatory submission, depending on the severity and nature of the OOS event.

How do I ensure that the OOS process effectively prevents future occurrences?

• Regularly review closed OOS Reports to identify patterns or recurring issues. Use these insights to refine processes, update training, and implement preventive measures across the organization to reduce the likelihood of future OOS events.

How do I escalate an OOS Report to a Corrective Action or other related reports?

• If necessary, you can escalate the OOS Report to a Corrective Action, Change Control, or Deviation Report by selecting the appropriate option. This links the OOS report to a more detailed investigation and resolution process.

What is the role of the activity tracker in the OOS Report?

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

How do I manage the impact of an OOS event on other processes or products?

• Assess and document any potential impacts on other processes or products in the "Impact Assessment" section. This helps ensure that the full scope of the OOS event is understood and that all affected areas are addressed.