Welcome to Isolocity's Support

What is the purpose of adding a new complaint in the Isolocity system?

• The purpose of adding a new complaint in the Isolocity system is to document and manage customer complaints effectively. This process helps in tracking the complaint, investigating the issue, and implementing corrective actions to prevent recurrence, ultimately ensuring customer satisfaction and regulatory compliance.

How do I begin creating a new complaint report?

• To begin creating a new complaint report, navigate to the CAPA sub-menu in the Isolocity system. Click on the "Complaints" section and then select "Create a Complaint Report" to initiate the process.

What information is required to create a complaint report?

• The required information includes:

  • Complaint Number: A unique identifier for the complaint.

  • Date of Complaint: The date when the complaint was received.

  • Part ID and Error Code: Specific identifiers for the product or process related to the complaint.

  • Complainant’s Details: Full name, address, phone number, and email of the complainant.

  • Batch/Lot Number: If applicable, the batch or lot number related to the complaint.

How do I enter the complaint number?

• The complaint number is a required field that uniquely identifies each complaint. Enter this number in the designated field during the report creation process.

Why is it important to enter the date of the complaint?

• The date of the complaint is crucial for tracking purposes. It allows the organization to monitor the timeliness of the complaint resolution process and ensures that the complaint is addressed within a reasonable timeframe.

What should I do if the complaint involves a specific part?

• If the complaint involves a specific part, select the Part ID from the dropdown menu provided in the complaint report form. This ensures that the complaint is accurately associated with the relevant part.

How do I select the error code for the complaint?

• The error code should be selected from a predefined list that categorizes the nature of the complaint. This helps in identifying the type of issue reported and facilitates a more targeted investigation and resolution process.

How do I record the complainant's details?

• Enter the complainant’s full name, address, phone number, and email address in the designated fields. Accurate entry of this information is essential for communication and follow-up regarding the complaint.

What is the significance of the batch/lot number in a complaint report?

• The batch/lot number is particularly important in industries like pharmaceuticals or food production, where traceability is crucial. Entering this number allows the organization to track the specific batch associated with the complaint and take appropriate corrective actions if needed.

How do I indicate if the strain was purchased at a store?

• For complaints involving cannabis products, you will need to indicate whether the strain was purchased at a store by selecting "Yes" or "No" in the relevant section of the report.

What should I do if the complaint is related to a product sold at a store?

• If the complaint involves a product sold at a store, enter the store’s information, including the name and location, in the appropriate section of the complaint report. This information helps in determining the point of sale and investigating any related issues.

How do I add comments from the complainant?

• Any additional comments or details provided by the complainant should be entered in the "Comments" section of the complaint report. This information can provide valuable context for the investigation.

How do I assign an owner to the complaint report?

• To assign an owner, click on the "Owner" field and select the individual responsible for managing the complaint. The owner will be notified of any updates and will oversee the resolution process.

Can I add subscribers to the complaint report?

• Yes, you can add subscribers who will be notified of any changes or updates to the report. Subscribers can follow the progress of the complaint but cannot make changes to the report.

How do I upload files associated with the complaint?

• You can upload any relevant files, such as images or documents, by clicking on the "Upload Files" option in the complaint report. These files can provide additional evidence or information related to the complaint.

What steps should I take if an investigation is needed?

• If an investigation is required, indicate this by selecting "Yes" in the relevant section of the report. You will then need to describe the investigation process, including any immediate actions taken and the results of the investigation.

How do I document immediate actions taken in response to the complaint?

• Immediate actions taken should be recorded in the "Immediate Actions" section. This might include steps such as stopping production, isolating affected products, or contacting the complainant for further information.

How do I categorize the complaint?

• The complaint should be categorized based on its severity and impact, using options such as "Critical," "Major," "Minor," or "No Risk." This categorization helps prioritize the complaint and determine the appropriate level of response.

How do I enter the root cause of the complaint?

• The root cause of the complaint should be identified and entered in the "Root Cause" section of the report. This analysis helps prevent similar issues from occurring in the future by addressing the underlying cause.

What should I do if CAPA is needed?

• If corrective and preventive actions (CAPA) are needed, select "Yes" in the relevant section. You will then need to document the actions taken, including any changes to processes or products to prevent recurrence.

How do I document the impact of the complaint on other processes?

• If the complaint affected other processes, describe the impact in the "Impact on Other Processes" section. This information is important for understanding the broader implications of the issue and ensuring that all affected areas are addressed.

What should I do if the part related to the complaint was returned?

• If the part was returned, indicate this by selecting "Yes" in the relevant section of the report. Returned parts should be examined as part of the investigation to help identify the cause of the complaint.

How do I track the status of the complaint report?

• The status of the complaint report can be tracked through the activity log, which records all actions taken on the report, including updates, assignments, and resolutions.

How do I ensure that a reply is sent to the complainant?

• Ensure that a reply is sent by selecting "Yes" in the "Reply Sent to Complainant" section. This step is important for maintaining good customer relations and closing the feedback loop.

What are the final steps in completing a complaint report?

• The final steps include reviewing the entire report for accuracy, ensuring that all required fields are completed, and clicking "Save & Close" to finalize the report. If the complaint leads to further action, ensure that it is escalated appropriately.