Reporting Failure Investigations and Process Deviations

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

This includes, but is 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.

Learning Objectives

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 deviation 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
• 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

________________________________________

COURSE AGENDA

FIRST DAY

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

Exercise: Review Attendees’ Past Experience with Failure Investigations and Process
Deviations and Expectations for the Course

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
- Common to all
- Unique to each

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

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

SECOND DAY

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)

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

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

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

THIRD DAY

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

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

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

Review the Main Points from Day One and Day 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