Joe Pardue Operations Team Lead and Laboratory Lead DOECAP Operations Team ASP Workshop 2016 September 21 2016 1 Extent of Condition The presence of similar condition across the organization ID: 539728
Download Presentation The PPT/PDF document "Extent of Condition" is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
Slide1
Extent of Condition
Joe PardueOperations Team Lead and Laboratory LeadDOECAP Operations TeamASP Workshop 2016September 21, 2016
1Slide2
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-conformances2Slide3
Root Cause and Corrective Action
DOECAP audited facilities are required to develop root causes for all findings that are issuedThe root cause is to determine the causal factors that resulted in a non-compliant or unacceptable issueLaboratories 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 facility3Slide4
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) 4Slide5
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)5Slide6
Extent of Condition
The two findings were issued on consecutive years and were issue for the same failureThe 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 action6Slide7
Extent of Condition
The examples that have been presented are very straight forwardThe audited facilities area strongly encouraged to evaluate the causal analysis and the planned corrective for extent of conditionsThe DOECAP review of planned corrective actions should consider extent of conditions
7Slide8
8