Human Performance: Investigation root cause analysis best practices

As an industry, biotech uses a dated manufacturing model for investigations and root cause analysis. While this model has been viewed as mostly effective in the past, as well as satisfying the criteria established by regulators and customers, there are significant opportunities for improvement. The current state of investigations and root cause analysis is self-limiting to continuous improvement as well an ineffective use of limited organizational resources.

The Human Performance Workstream, have identified fourteen recommendations and eleven best practices. The analysis and key learnings contained in this report provide the context and basis for the recommendations and best practices. The information in this report should be viewed as possible solutions to address opportunities for improvement in investigations and root cause analysis, rather than an all-or-none mandate of required actions.

Properly addressing these opportunities will not only improve the velocity and effectiveness of adopting a strong human performance operating philosophy but will ultimately result in enhancing continuous improvement and organizational effectiveness.