Reporting Failure Investigations and Process Deviations

Who Should Attend
Because of its comprehensive content, this course will prove most valuable to personnel in research and development, manufacturing, quality assurance, and quality control laboratory, who are involved in conducting and reporting failure investigations and deviations.

This includes but not limited to directors, managers, supervisors, team leaders, and scientists from a GMP environment, needing in depth knowledge on conducting and reporting failure investigations and process deviations.

This course is designed so that you will:
Providing a step-by-step foundation for conducting failure investigations, this training course highlights FDA requirements and quality assurance overviews on how to document the results from your failure investigation. Inadequate failure investigations continue to be a major GMP deficiency cited during routine and for-cause U.S. Food and Drug Administration (FDA) inspections. The FDA recognizes that failures are a part of business but also expects comprehensive investigations, the application of scientific judgment, and learning from the experience and permanent solutions to the problems identified.

This course provides clarification on the scope of relevant guidance and the essential skills necessary to ensure compliant documentation. Attendees will examine each step of an effective investigation and learn what documentation is required along the way, perform Root Cause Analysis and explore FDA expectations regarding CAPA. Additionally, participants will learn to avoid common obstacles to success and practice conflict resolution skills. This three-day workshop outlines tips and techniques to improve failure investigations and identifies proposed corrective action which ensures successful implementation and closeout

Course Description

This continually updated course covers appropriate reporting of failure investigations and process deviations to satisfy FDA regulatory requirements. Among the topics to be discussed include: 

• Discussion on FDA expectations regarding failures and process deviations
• Exploring deviation or incident reports, nonconforming material reports; NCR (nonconformance report)
• Out-of-Specification (OOS) results and validation failures This e-mail address is being protected from spambots. You need JavaScript enabled to view it
• Examining roles, responsibilities and guidelines for documenting the investigation
• Analyzing challenges and solutions for improving the review and approval process
• Examining best practice elements of technical writing
• Examining how each component fits within the CAPA system
• Performing Root Cause Analysis using best practice, step-by-step tools
• Documenting fact-based conclusion and proposed corrective actions
• Recommending and implementing Corrective Actions Auditing the failure or process deviation investigation to ensure follow-through and completion,
• Anticipating and avoiding common barriers and obstacles

FIRST DAY

1. Review FDA Expectations for Failure Investigations and Process Deviations
Explore GMP and GXP regulations related to process failures and process deviations
Review general industry practices for failure investigations and process deviations
Discuss FDA expectations regarding failures and process deviations
Describe types of 483's issued for investigations
Review FDA enforcement activities and trends

2. Explore Different Types of Reports
Develop procedures for completing failure investigations and addressing deviations
Review deviation or incident reports
Create nonconforming material reports
Assess out-of-specification (OOS) results
Review how to solve (OOS) results
Discuss validation failures
Address change control and traceability with the reports
Review of change control categories based on risk level
Identify what information should be captured for each type of investigation

3. Examine Roles and Responsibilities when Writing Reports for Failure Investigations and Process Deviations
Develop rules for completing failure investigations and process deviations
Implement guidelines for documenting the investigation
Assign roles and responsibilities and identify what must be documented and by whom
Analyze challenges and solutions for improving the review and approval process

4. Analyze Technical Report Writing
Outline what must be documented
Discuss the various documents associated with an investigation
Examine best practice elements of technical writing
Assess the technical content and the level of detail
Exercise: Attendees will develop a draft procedure for completing failure investigations and addressing deviations

Day Two

5. Identify Key Steps for Effective Summary Report Writing
Assign each report a unique identification number to ensure traceability
Identify the main components of the report
Introduction/Summary of the Incident
Summary of Steps of Investigation (Root Cause Analysis) Conclusion/Corrective and Preventive Actions (CAPA)

6. Evaluate the Overall System for Investigating Failure and Process Deviations
Identify who should be part of an investigation team
Outline team responsibilities
Clarify how the CAPA system should function
Examine how each component fits within the CAPA system
Follow up on CAPA issues related to deviations and ensure closure

7. Investigate the Incident (Root Cause Analysis-RCA)
Define all causes: primary and secondary
Examine data with a critical eye
Evaluate common categories of root causes and contributing causes
Perform the step-by-step processes necessary to make RCA effective
Trend results
Review statistical tools
Define problem solving approaches
Document fact-based conclusion and proposed corrective actions
Exercise: Perform Root Cause Analysis on Sample Event Using Tools Acquired in Class

8. Recommend and Implement Corrective Actions
Identify key players with whom to partner
Ensure the corrective action is appropriate and realistic and verified or validated
Assess whether or not other systems are affected by the failure
Obtain and document necessary approval
Track progress and re-evaluate corrective action effectiveness
Examine FDA expectations and enforcement trends
Exercise: Critique Sample corrective action Report

Day Three

9. Audit the Failure or Process Deviation Investigation
Review key elements of the audit process
Discuss how to correct audit observations for incomplete reports
Examine the steps necessary to ensure completion of various types of investigations
Discuss various tracking systems to ensure proper follow-up
Ensure that SOPs and work instructions are updated to reflect any changes
Obtain timely approval of the investigation report

10. Avoid Common Barriers to Success
Identify common barriers and pitfalls
Brainstorm solutions to overcome obstacles
Identify tips for resolving conflicts
Exercise: Role-Play Conflict Situations Related to Investigations

11. Types of tools which can be used to determine root cause of Failures or Process Deviation Investigations
Review key investigational tools
Review how to use investigational tools
Determine which tool are appropriates
Exercise: Analyze a case study Related to Investigations and determine root cause

12. Review the Main Points from Day One, Two and Three
Identify the purpose of the report
Outline the system/process for writing reports
Highlight components of good technical reports
Review of responsibilities
Determine corrective actions
Follow-up and closure
Exercise: Quiz Questions & Wrap-Up When delivered as an in-house program, this course is fully customizable to meet the specific needs of an organization.