Missing Investigation Findings and Follow-Up in Records


Novo Nordisk A/S
Issued on:
Inspection Dates:
27 Apr 2023 to 04 May 2023
Hallas Alle, DK-4400 Kalundborg, Denmark
  • Prabhu P Raju
  • Unnee Ranjan
  • Mikhail Ovanesov
  • Sergey Akimov

Detailed Analysis

Key Observations

  • The observation highlights a systemic deficiency in document management, specifically regarding the handling and documentation of complaints. It points to an overarching need for enhanced procedures, training, and oversight to ensure that investigations are thoroughly conducted and properly documented, particularly in assessing the associated risks and trend analysis.

Possible Root Cause :

  • Lack of a standardized complaint investigation procedure that mandates the documentation of detailed investigation findings, including assessment for trends and necessary follow-up actions.
  • Insufficient training of personnel handling complaints leading to inadequate documentation and investigation of complaints.
  • Inadequate quality oversight to ensure that each complaint is thoroughly investigated, and findings are comprehensively documented.
  • Lack of proper tools or systems for trend analysis which results in missing abnormal trends and rates of occurrence.
  • Ineffective communication between departments involved in the product quality complaint lifecycle, resulting in missing or incomplete information.

Corrective Action:

  • Develop or revise standard operating procedures (SOPs) for handling complaints to include detailed steps for documenting investigations, decisions for not performing investigations, and follow-ups.
  • Implement a training program focused on complaint handling for staff involved in the complaint process to ensure they understand the importance and methodology of thorough investigation documentation.
  • Establish regular quality oversight mechanisms, such as routine audits or reviews of complaint files, to ensure all required information is captured and appropriately acted upon.
  • Introduce or enhance technology solutions for trend analysis to automatically flag batches with recurring issues for further investigation.

Preventive Action

  • Institute a continuous training program on complaint management, emphasizing the criticality of detailed documentation and the rationale behind investigation decisions.
  • Upgrade or maintain IT systems to support robust trend analysis capabilities for early detection of quality issues.
  • Strengthen inter-departmental communication and collaboration through regular meetings or integrated management systems to ensure complete information flow during complaint management.
  • Review and update the documentation process as part of the CAPA system regularly to incorporate improvements and changes in regulatory requirements.
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