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

2. 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

3. 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

4. FY15 – Organic Finding on Balance Calibration Checks
M 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 , Table; TNI EL-V1M2-2009, Section b; Procedure XXXXXX, Revision 6.5, Section ; Procedure XXXX, Revision 5.4, Section 20.3.1)

5. 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 , Table; TNI EL-V1M2-2009, Section b; Procedure XXXXX, Revision 6.6, Section )

6. 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

7. 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