AUDITING THE DOECAP WAY

1. AUDITING THE DOECAP WAY DOECAP Operations Team ASP 2012 Workshop September 2012

2. The Audit • Audit Preparation • Audit Execution • Audit Reports • Corrective Actions

3. Audit Preparation • DOECAP Requirements • Training • Required Reading • Preaudit Conference Call • Facility Documents • Review SOPs, License, Permits, PT results, and any other pertinent information

4. Audit Preparation • Check your flash drive to make sure it can be opened by other laptops • Query contracts/procurement for contract requirements (TSDF Only)

5. Audit Preparation • Review site history • Look at EDS • Query your site • Review previous finding history for trends • Save important information on flash drive • Save Draft Report on flash drive • Save your checklist on flash drive

6. Audit Preparation • Fill out as much of the checklist as possible prior to audit. • Applicable SOPs, section, person, form, etc… • Use previous checklist • Use facility documents provided • If you need something not provided contact the Operations Team.

7. Audit Execution • Be prepared • Use on-site time to audit • Build on previous audits • Audit processes and implementation • Base findings on violation of regulation or requirement • Review implementation of corrective actions from previous DOECAP audits and attempt to close these findings

8. Audit Reports • Writing Findings • One direct sentence, factual statement • the statement should be general (vs examples) and should consider the corrective action • Writing Finding Discussions • State requirement • State problem/issue • State evidence • Include, at the end, any clarifying information or mitigating factors

9. Audit Reports Writing Observations • Deviations from Best Management Practices, non-requirement-based issues, or an opportunity for improvement, which warrant attention • Clearly state the issue • Unaddressed issues that could potentially result in a future finding • Do not use the words should or shall • Must pass “so what test”

10. Audit Reports Example Finding and Discussion SH-120607-B: Suitable facilities for quick drenching or flushing of the eyes and body are not provided in the XXX building. (Priority II) (29 CFR 1910.151 (c); ABC SOP aaa, Rev. 1) 29CFR1910 requires that where the eyes or body of any person may be exposed to injurious corrosive material, suitable facilities for quick drenching or flushing of the eyes and body shall be provided within the work area for immediate emergency use. A safety shower was not available at the XXX building to provide quick drenching. Work conducted at the XXX building poses an exposure risk to injurious corrosive materials. In addition, several eyewash stations were out of service with no replacement eyewash available.

11. Audit Reports Example Finding and Discussion M1-120712-C:  Vendor requalification does not meet requirements. (Priority II) (QSAS, Rev. 2.8, Section 4.6, SOP XXX-045, Procurement Control, Rev. 4) SOP XXX-0##, Rev. # states that vendor requalification shall be conducted annually and require reissuance of the approval. A “Vendor Approval Certificate” for balance and weight certification vendor ABC was completed on July 15, 2008. XXX has not performed requalification of the vendor.

12. Audit Reports • Executive Summary • One paragraph summarizing overall area of review. • Short mention of both new and open findings (e.g. Findings were identified related to records maintenance and training). • Keep this very simple. • Do not mention closed findings • Do not mention observations

13. Executive Summary Examples Do Not: One, XXX did not describe their waste neutralization process in their waste disposal procedure. And two, XXX did not provide instruction to sample receiving personnel for opening DOE samples under a hood. XXX’s sample handling policy, stated in section A of their Chemical Hygiene Plan prohibits laboratory personnel from having direct contact with the contents of laboratory samples. DO: XXX did not have procedures for the waste neutralization process or instructions for opening DOE samples under a hood.

14. Audit Reports • Section Narratives • Short concise overview • Try to keep it to one page • Short summary, previous findings closed or opened • New findings, short explanation • Use direct sentences state the facts • Do not use flowery language-you are not writing a novel.

15. Audit Reports • Peer review • Factual Accuracy Period • Operations Team and DOE Review • Respond promptly to questions and clarifications

16. Issues Pay Attention to Details • In the Executive/Section Summary: The Radiation Protection Program is reviewed annually as required. • Finding: The Radiation Protection Program has not been reviewed annually as required.

17. Issues • In the Executive/Section Summary: The laboratory has an excellent QA program • There were eight QA findings. Eight QA findings does not reflect an excellent QA Program

18. Objective Opinions The following statements are your objective opinion, they should not be used. • The facility was clean and neat • The staff was kind and helpful • The staff was eager and dedicated

19. Corrective Actions • Will the actions fix the problem, correct the deficiency • Will the actions take into account related systems, processes and methods • Will the actions prevent the problem from reoccurring • Confirm acceptance or take appropriate action for change