Modifying Investigation Details

As a part of the investigation process, you can update the details of the investigation. You can add information such as the method, results, and conclusion of the investigation. You can also provide investigation approval, risk analysis details, and the conclusion arrived at after the investigation.

Before you begin:
  • The object complaint, equipment service request, or inquiry) must be in the In Process state. If the object is a Nonconformance (NC), it must be in the Review state.
  • You must be a Quality Manager, or a Complaint Investigator who owns the object.
  • You must be on the Investigation page.
See Also
Removing Investigation Requirement
  1. From the Investigation tab toolbar, click Edit.
  2. Modify the following details.
    Field Name Description
    Severity Select a severity. You can select High, Low, Medium, or Urgent.
    Location or SiteClick and select a location from the Search Results page.
    Reference Type

    This field is applicable only for NCs.

    		Select a reference type for the investigation process. You can select CAPA, External CAPA, NC, or External NC.
    Note: If the Reference Type is CAPA or External CAPA, you must attach the corresponding CAPA request or CAPA project before you complete the investigation.
    MethodClick and select an investigation method from the Structure View page.
    ResultsClick and select a result from the Structure View page.
    Conclusion CodeClick and select a conclusion code from the Structure View page.
    RationaleType the reason to select the conclusion code.
    Responsible InvestigatorClick and select a user from the Search Results page.
    Completion DateClick and select the required date. You can select today's date or a past date.
    Risk Analysis Required

    This field is applicable only for Complaints, ESRs,and Inquiries.

    		Select Yes if risk analysis must be performed. Otherwise, select No.
    Comments

    This field is applicable only for Complaints, ESRs,and Inquiries.

    		Type your comments about the risk analysis requirement.
    MalfunctionSelect Yes if you have concluded that the problem occurred due to a reported item malfunction. Otherwise, select No.
    Packaging/Labeling ProblemSelect Yes if you have concluded that the problem occurred due to a packaging or labeling issue. Otherwise, select No.
    Use ErrorSelect Yes if you have concluded that the problem occurred due to wrong usage. Otherwise, select No.
    Recommended ActionsType your recommendations based on the investigation.
    Summary DetailsType the summary of the investigation.
    Additional Information Type any additional information about the investigation and conclusion.
    Note: If you are a quality manager, you can modify only Severity and Additional Information fields.
  3. Click Done.
    The details of the investigation are updated.