Extent of Condition Joe Pardue Operations Team Lead and Laboratory Lead DOECAP Operations Team ASP Workshop 2016 September 21, 2016

Extent of Condition The presence of similar condition across the organization. Mark Paradies, TapRooT, Changing the Way the World Solves Problems. Extent of conditions evaluations are usually conducted after the root cause has been established to determine if additional actions are required to address the risk of additional failures or non-conformances

Root Cause and Corrective Action DOECAP audited facilities are required to develop root causes for all findings that are issued The root cause is to determine the causal factors that resulted in a non-compliant or unacceptable issue Laboratories are also requested to evaluate extent of condition determinations to determine if the same non-compliant or unacceptable issue occurred in other areas of the facility

FY15 – Organic Finding on Balance Calibration Checks M2-150625-A: The laboratory does not use standard check weights that bracket the expected mass range for balance calibration checks. (Priority II) (QSM, Version 5.0, Module 2, Section 5.5.13.1, Table; TNI EL-V1M2-2009, Section 5.5.13.1b; Procedure XXXXXX, Revision 6.5, Section 11.2.1; Procedure XXXX, Revision 5.4, Section 20.3.1)

FY-16 Inorganic Finding on Balance Calibration Checks M3-16XXXX-B: The laboratory does not use standard check weights that bracket the expected mass range for balance calibration checks. (Priority II) (QSM, Version 5.0, Module 2, Section 5.5.13.1, Table; TNI EL-V1M2-2009, Section 5.5.13.1b; Procedure XXXXX, Revision 6.6, Section 11.2.1.1)

Extent of Condition The two findings were issued on consecutive years and were issue for the same failure The causal analysis and corrective action were focused on the area of the laboratory related to the finding and did not address all areas of the laboratory As a result, a second finding issued dealing with the same issue, resulting in the development of a corrective action

Extent of Condition The examples that have been presented are very straight forward The audited facilities area strongly encouraged to evaluate the causal analysis and the planned corrective for extent of conditions The DOECAP review of planned corrective actions should consider extent of conditions