One of the most frequently cited issues during FDA inspections pertains to the failure to conduct thorough investigations regarding unexplained discrepancies.
Once an investigation is conducted and findings are documented, 21 CFR 211.192 emphasizes the necessity of implementing follow-up actions to prevent the recurrence of discrepancies or product failures. Companies are obliged to assess the root causes of identified issues and implement corrective measures tailored to address these causes effectively and to reduce the risk of future violations.
The failure to conduct thorough investigations into discrepancies or failures can lead to dire consequences. When the root cause is overlooked, they risk not only regulatory ramifications but also potential harm to patients reliant on their medications.
The Path Forward: Grasp the critical importance of thorough investigations and the frameworks to improve compliance, uphold public health, and regain the trust of the communities we serve.
Common Mistakes in Deviation and Complaint Investigations –
1) Improper Root Cause Analysis include:
a) Superficial Analysis
b) Lack of Evidence
c) Relying on ineffective methods
Solutions –
1) Conduct brainstorming sessions with cross-functional teams to assess all possible root causes to identify the underlying causes of failures. It helps to develop effective corrective actions and preventative measures.
2) Utilizing established tools such as Fishbone Diagrams, 5 Whys, or FMEA ensures a thorough analysis and Document the rationale for eliminating each cause.
2) Limited Scope i.e., Investigations frequently suffer from a narrow focus that hinders comprehensive understanding:
a) Isolated Investigations
b) Neglect to examine related products or processes that might share common root causes.
Solution –
Investigations should be extended to other batches and related products to evaluate potential systemic issues. Corrective actions may need to be applied across different areas to uphold product integrity.
3) Lack of Documentation:
a) Fail to document each step of the investigation thoroughly.
b) Insufficient supporting evidence for the conclusions drawn.
Solution –
Maintain detailed records throughout the investigation process, encompassing the initial discrepancy, potential root causes considered, evidence for causation elimination, and final conclusions.
4) Enhancing Investigation Processes to rectify common mistakes and optimize investigation processes
Solutions –
1) Establish clear and detailed procedures for handling discrepancies can streamline the investigational process.
2) Create an environment where employees feel empowered to report concerns without fear of repercussion is vital.
3) Implement Comprehensive Training.
4) Continuous Monitoring and Feedback to address before they result in significant failures.
Read also:
- Deviation Management and Root Cause Analysis
- Verification of OOS Results | EDQM Guidelines
- How to Manage Deviation Backlog?
Resource Person: Bharathi Kodali