Abstract: | Many current audit programs are very good at determining the compliance issues at a site, but are less successful in developing long-term compliance solutions. One method for addressing these issues is the use of root cause analysis techniques. These techniques allow the facility to identify and focus on permanent solutions to compliance issues. The authors note the following: Conducting a root cause analysis is not a substantial burden on the audit team or the facility. Most information is already collected during the audit, but is not being used. Looking at the overview pattern of the root cause analysis can provide a picture of the maturity of your audit program. Pareto charts are excellent methods to convey the results of your analysis. They show both the trends of analysis and help highlight the most significant root causes. |