2. 2
Current QAPD (Revision 3)
• Issued July 28, 2016 (Effective October 1, 2016)
• Changed Lab QA Program QRL N/A to QRL 4 (to indicate that Lab/site
specific requirements apply to the work activity and no additional FCT
QA requirements need to be applied)
• Changed Appendix E and corresponding Table 4 to add QRL 4
QAPD Reviewed Annually For Any Needed Changes
QAPD (Revision 4)
• Currently in progress
May 23, 2017
Quality Assurance Program Document
(QAPD) and Supporting Documents
3. 3
QA POCs have performed assessment and support activities at
their laboratories (this is an ongoing effort)
• Working with Work Package Managers and Project Personnel
– Support QRL Assignments
– Other support as requested
FCT FY 16 – 17 QA Program Assessments / Audits:
• Oak Ridge: QA Audit, February 2016 (Canister Design Project)
– Program in compliance with NQA-1 procedures
• Savannah River: QA Review / Assessment, January 2017
– Program in compliance with FCT QAPD
FCT Remaining FY 17 QA Program Assessments:
• Argonne, QA Review / Assessment planned for week of July 10, 2017
• Additional Labs (TBD)May 23, 2017
Quality Assurance Activities
FY 2016 - 2017
Editor's Notes
List issues or observations from the assessments Performed by the TIO for FCT:
The assessment found that there were many work packages where the activities specified in the work scope section appeared to have no correlation to a milestone and/or there were no milestones/deliverables to address the work scope activities.
A large percentage of the work package data dictionaries do not specify where or whom to send the milestone/deliverable.
The review found that there was very little indication that resources required to implement the applicable QA requirements of the QAPD and associated costs were identified in the overall budget of the work packages.
Most work packages were found to not contain QA requirements from the QAPD or QA requirements from DOE Order 414.1 or 10 CFR 830.
Work packages were also found to not contain information that would suggest or require that objective evidence is to be maintained of the performance of the work performed.
The assessment found that none of the Work packages with milestones designated as N/A had specified that the deliverable was to be submitted with a Document Cover Sheet and supporting documentation was to be provided.
The Assessment determined that the QRL’s were found to be designated for all milestones and the QRL designation could be flowed down to subcontractors because the QRL was specified in the work package.
Work packages, where it was apparent there was University collaboration, did not specify any specify QAPD requirements in the work package or specify that contractual documents were required to contain QRLs, applicable FCT QAPD requirements or laboratory QA requirements in the contractual documents.
Some Universities contracts have not had QA requirements specified or flowed down to the University as required by the AFCI QAPD.
Milestone M3501030104 for WP IN1015010301 did not receive an ITR due to confusion on the “completion” of the milestone.
There were two laboratories where instrumentation was found to be not calibrated.
Formal surveillance and assessments directly related to FCR&D activities at ORNL have not been performed. (checklist item 1.6.8) in the last year.
Some research activities are at a point where the need for formalized procedures or research plans may be necessary to ensure consistency of the work performed. (checklist item 1.6.12).
Some instruments/equipment were found to be outside the calibration period. Although no FCR&D work was performed on these instruments/equipment while they were outside their calibration period, the process to ensure instrumentation/equipment is calibrated warrants attention.
Software development will need more formal Software QA and V&V as the development progresses.
Some laboratory notebooks were found to be behind in entries into the notebooks and there are areas for improvement that may need to be addressed concerning maintaining order and control for the laboratory notebooks in some areas.
The areas of laboratory notebooks, records, calibration of equipment and test planning were found to need formal documentation
No formal documentation existed for performing Technical and Peer Reviews therefore deliverables were not receiving a peer review by procedure that meets requirements of Appendix C of the QAPD?
Laboratory notebooks need to be controlled and efforts made to record the data within the laboratory notebooks to ensure data is not being lost for one of a kind experiments/tests
List issues or observations from the assessments Performed by the TIO for FCT:
The assessment found that there were many work packages where the activities specified in the work scope section appeared to have no correlation to a milestone and/or there were no milestones/deliverables to address the work scope activities.
A large percentage of the work package data dictionaries do not specify where or whom to send the milestone/deliverable.
The review found that there was very little indication that resources required to implement the applicable QA requirements of the QAPD and associated costs were identified in the overall budget of the work packages.
Most work packages were found to not contain QA requirements from the QAPD or QA requirements from DOE Order 414.1 or 10 CFR 830.
Work packages were also found to not contain information that would suggest or require that objective evidence is to be maintained of the performance of the work performed.
The assessment found that none of the Work packages with milestones designated as N/A had specified that the deliverable was to be submitted with a Document Cover Sheet and supporting documentation was to be provided.
The Assessment determined that the QRL’s were found to be designated for all milestones and the QRL designation could be flowed down to subcontractors because the QRL was specified in the work package.
Work packages, where it was apparent there was University collaboration, did not specify any specify QAPD requirements in the work package or specify that contractual documents were required to contain QRLs, applicable FCT QAPD requirements or laboratory QA requirements in the contractual documents.
Some Universities contracts have not had QA requirements specified or flowed down to the University as required by the AFCI QAPD.
Milestone M3501030104 for WP IN1015010301 did not receive an ITR due to confusion on the “completion” of the milestone.
There were two laboratories where instrumentation was found to be not calibrated.
Formal surveillance and assessments directly related to FCR&D activities at ORNL have not been performed. (checklist item 1.6.8) in the last year.
Some research activities are at a point where the need for formalized procedures or research plans may be necessary to ensure consistency of the work performed. (checklist item 1.6.12).
Some instruments/equipment were found to be outside the calibration period. Although no FCR&D work was performed on these instruments/equipment while they were outside their calibration period, the process to ensure instrumentation/equipment is calibrated warrants attention.
Software development will need more formal Software QA and V&V as the development progresses.
Some laboratory notebooks were found to be behind in entries into the notebooks and there are areas for improvement that may need to be addressed concerning maintaining order and control for the laboratory notebooks in some areas.
The areas of laboratory notebooks, records, calibration of equipment and test planning were found to need formal documentation
No formal documentation existed for performing Technical and Peer Reviews therefore deliverables were not receiving a peer review by procedure that meets requirements of Appendix C of the QAPD?
Laboratory notebooks need to be controlled and efforts made to record the data within the laboratory notebooks to ensure data is not being lost for one of a kind experiments/tests
