U.S. Department of Energy Office of Environment, Health, Safety and Security. Procedure AD-1-2A Conducting DOECAP Laboratory and TSDF Phased Audits

Transcription

1 U.S. Department of Energy Office of Environment, Health, Safety and Security Procedure AD-1-2A Conducting DOECAP Laboratory and TSDF Phased Audits Revision 1.0 Prepared By: DOECAP Operations Team Approved: Date: 2/16/2016 George E. Detsis, Manager, Analytical Services Program

2 Revision Log Revision Number Effective Date Description of Changes Section Number 0 1/5/2016 New Procedure All 1.0 2/16/2016 Major Rewrite All

3 Table of Contents 1.0 PURPOSE APPLICABILITY DESCRIPTION OF DOECAP LABORATORY AND TREATMENT, STORAGE, AND DISPOSAL FACILITY (TSDF) PHASED AUDITS Background Phase I Audit DOECAP Audit Checklists Completed in Advance Phase II Audit Modified-Scope Audit Phase III Audit Desktop Audit Phase IV Implementation LABORATORY AND TSDF PHASED AUDIT CHECKLISTS, SCHEDULING, STAFFING, AND AUDIT NOTIFICATION Modified Audit Checklists Scheduling and Staffing Laboratory and TSDF Phased Audits Phase I and II Audits Scheduling and Staffing the Audits Phase III Desktop Audits Scheduling and Staffing the Audits Audit Notification Letters for Laboratory and TSDF Phased Audits PHASE I AUDITS Phase I Audit Process Phase I Audit Expectations for the Facility PHASE II AUDIT LIMITED-SCOPE AUDIT Phase II Audit Process Phase II Audit Expectations for the Facility PHASE III AUDIT DESKTOP AUDIT Phase III Desktop Audit Preaudit Activities Phase III Desktop Audit Process Phase III Desktop Audit Expectations for the Facility Phase III Desktop Audit Report FILES AND QUALITY RECORDS Files Maintained by the DOECAP Operations Team (Not Quality Records) Quality Records ACRONYMS i

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5 1.0 PURPOSE This procedure describes various aspects of conducting Laboratory and Treatment, Storage, and Disposal Facility (TSDF) Phased Audit Process, including radiological and nonradiological TSDFs, for the United States (U.S.) Department of Energy Consolidated Audit Program (DOECAP or Program). It describes the phased DOECAP audits, staffing the audit teams, and the processes and responsibilities associated with conducting the each type of phased audit. 2.0 APPLICABILITY This procedure applies to the following personnel and entities: a. Analytical Services Program (ASP) Manager b. DOECAP Lead Auditors c. DOECAP auditors and subject matter experts d. DOECAP Operations Team e. DOECAP-audited facilities 3.0 DESCRIPTION OF DOECAP LABORATORY AND TREATMENT, STORAGE, AND DISPOSAL FACILITY (TSDF) PHASED AUDITS 3.1 Background U.S. Department of Energy (DOE) Order 435.1, Radioactive Waste Management, requires the field element manager to determine if a TSDF s services are acceptable based on an annual DOE review. The proposed revision to the DOE Order changes this requirement to a review every other year. In 2014, DOECAP initiated the TSDF Pilot as the means to prepare for this change. The TSDF Pilot s goal was to prepare the TSDFs that consistently perform well on DOCAP audits for an audit schedule that will alternate a full DOECAP audit one year with a desk audit the next year as long as the TSDF maintains good performance. DOECAP considers good performance to include a robust self-assessment program and a mature issues management program, which are demonstrated, in part, when the DOECAP findings issued to the facility are not considered significant and are quickly and completely corrected. A facility s performance on DOECAP audits determines its progress from one phase to the next. The TSDF Pilot has been so successful that in Fiscal Year 2016, DOECAP expanded it to include laboratories and changed its name to the Laboratory and TSDF Phased Audit Process. 3.2 Phase I Audit DOECAP Audit Checklists Completed in Advance The facility fills out the DOECAP audit checklists in advance, performs a selfassessment to them, and sends the completed checklists, self-identified findings, causal analyses, and corrective actions to DOECAP four weeks before the scheduled audit, along with the usual site procedures, plans, permits, etc. How completely and thoroughly the facility fills out the audit checklists, coupled with its self-assessment program, will determine the efficiency with which the facility Page 1 of 20

6 moves through the phases of the Laboratory and TSDF Phased Audits. It has been shown that the most successful facilities in the Laboratory and TSDF Phased Audit Process are the ones that incorporate the DOECAP lines of inquiry into their own assessment, audit, and surveillance programs. DOECAP may require a facility to undergo a second or even a third Phase I audit before its performance with regard to the audit checklists, associated self-assessment, and current DOECAP findings are found to be acceptable. 3.3 Phase II Audit Modified-Scope Audit The facility goes through the same advance steps listed for a Phase I audit, including completing all completed checklists, and DOECAP conducts a limitedscope audit. The audit disciplines that are not included in the on-site audit are the areas where the facility demonstrated during the Phase I audit(s) that it: a. Has mature programs. b. Has incorporated the DOECAP lines of inquiry into its operational activities, assessments, and audits. c. Has adequately addressed the DOECAP findings. d. Routinely corrects other identified deficiencies in a timely manner. NOTE: The ASP Manager determines the next phase of the audit for each participating facility based on the input from the previous audit team and the DOECAP Operations Team. 3.4 Phase III Audit Desktop Audit The facility fills out the DOECAP audit checklists and provides (a) the completed audit checklists; (b) detailed documentation from its issues management system in a summary table that includes all internal and external findings since the last DOECAP audit and the associated causal analyses and corrective actions, plus all open findings from previous years; (c) a summary of any regulatory issues since the last DOECAP audit; and (d) a summary of major changes in facility operations or staffing since the last DOECAP audit. NOTE: If the Lead Auditor and audit team members determine that the facility is demonstrating deficiencies (e.g., one or more significant deficiencies or multiple deficiencies that indicate a potential programmatic breakdown) during a Phase II or Phase III audit, it could result in the ASP Manager requiring that facility to go back to a Phase I audit for its next DOECAP audit. 3.5 Phase IV Implementation Once a successful Phase III desktop audit has been performed, the ASP Manager determines if the facility warrants a Phase II audit (modified scope) or a full Phase I audit the following year. Page 2 of 20

7 4.0 LABORATORY AND TSDF PHASED AUDIT CHECKLISTS, SCHEDULING, STAFFING, AND AUDIT NOTIFICATION 4.1 Modified Audit Checklists The DOECAP Operations Team modifies the standard laboratory and TSDF audit checklists as follows: a. Add an extra column to provide room for the facility to enter its responses. b. Add a field at the beginning of each audit checklist section so that the name of the person who filled out each section and the date completed can be entered. c. Add a field at the beginning of the audit checklist so that the name and contact information for the individual at the facility who has overall accountability for the checklist can be entered In November of each year, the DOECAP Operations Team provides the revised audit checklists that have been modified as identified above to the laboratories and TSDFs that have been approved by the ASP Manager for desktop audits in that fiscal year, along with instructions on how to fill out the checklists If the audit checklists are modified after November, the DOECAP Operations Team provides the modified checklists to the laboratories and TSDFs that were approved by the ASP Manager for Phase III desktop audits during that fiscal year. 4.2 Scheduling and Staffing Laboratory and TSDF Phased Audits Phase I and II Audits Scheduling and Staffing the Audits The DOECAP Operations Team coordinates, schedules, and staffs the Laboratory and TSDF Phased Audits with the facilities and DOECAP auditors in the same manner that all other DOECAP audits are staffed Phase III Desktop Audits Scheduling and Staffing the Audits Exemption: The ASP Manager has granted an exemption for Phase III desktop audits from the DOECAP requirement for a federal employee who is also a qualified DOECAP Lead Auditor to lead the radiological TSDF audits. The ASP Manager oversees and approves the final report Phase III desktop audits are led by the DOECAP Operations Team Laboratory Lead or TSDF Lead, as appropriate Members of the DOECAP Operations Team staff all of the positions on Phase III desktop audit teams, except those positions Page 3 of 20

8 listed below, which are staffed by other qualified DOECAP auditors or subject matter experts approved by the ASP Manager. Laboratory o Data Quality for Radiochemistry Analyses TSDF o Environmental Compliance and Permitting o Waste Operations o Radiological Control o Transportation Management DOECAP Operations Team Briefing to the Auditors A member of the DOECAP Operations Team explains the process to each auditor that commits to support a Phase III desktop audit. This explanation includes the following information: a. How the desktop audit process works. b. Date that the documentation is expected from the facility. c. Date by which the facility s documentation is expected to be available to the auditor on the File Transfer Protocol (FTP) Site provided by the DOECAP Operations Team and the assurance that the DOECAP Operations Team provides notification via as soon as the facility s documents are available, as well as providing instructions for accessing the FTP Site. d. Date by which the auditor is expected to complete his/her review of the completed audit checklist and other facility documentation (i.e., two weeks from receipt). e. How the contact information for the points of contact (POCs) at the audited facility will be provided and the expected process for the auditor to document any telephone discussions with the POCs. The facility provides the names, addresses, and telephone numbers of the POCs to the Lead Auditor, with a copy to the DOECAP Operations Team, and the Lead auditor supplies this information to the audit team. f. Description of the write-up expected from the auditor as documentation of his/her review, which includes identification of findings that cannot be closed without visual Page 4 of 20

9 verification and, therefore, must be verified closured during the next on-site audit. g. Explanation of the detailed documentation summary table that the facility is expected to provide from its issues management system. The facility s documentation must: (1) Be organized by the DOECAP audit disciplines (i.e., the six laboratory disciplines or the seven TSDF disciplines, as appropriate). (2) Include all findings from all reviews performed at the site, such as the daily, weekly, monthly, or annual walkdowns and other types of internal/external assessments, audits, and surveillances. The information for each finding must include the type and date of the surveillance/assessment/audit, status, the name of the person who evaluated the area, the corrective actions, and any updates. This information includes the findings that the facility identified when it assessed itself against the lines of inquiry in the DOECAP audit checklists. (3) Include any open findings from previous years. This includes open findings identified by other auditing entities (external findings) and open self-identified findings noted during assessments, audits, surveillances, walkthroughs, and inspections (weekly, monthly, and annual), as well as any open findings that were identified by the facility s employees. (4) List the open findings for each audit discipline on page 2 of the completed audit checklist or provide the list in a separate file that is clearly labeled (electronic file name and document title) to match it to the associated audit checklist. (5) Provide details on the causal analysis and identified corrective action(s) for each of the findings identified since the last DOECAP audit. In addition, provide the current status of each finding (i.e., open or closed). (6) Provide details on the causal analysis and identified corrective action(s) for each of the open previous findings. (7) Include closure documentation for: All findings (internal and external) that the facility closed during the past year. Page 5 of 20

10 The findings from the last DOECAP audit. Open findings from previous DOECAP audits. h. The facility must also submit the following information: A summary of any major changes in facility operations or staffing. A summary of any regulatory issues since the last DOECAP audit (e.g., fines or other penalties, Notices of Violation). i. The facility must respond to an request from the Lead Auditor the week before the audit starts by providing any documents that have been revised since the facility submitted its preaudit document package. 4.3 Audit Notification Letters for Laboratory and TSDF Phased Audits The Audit Notification Letter and checklists are sent to the facility at least three months in advance of the scheduled audit. The letter provides the following information: a. Audit dates. 5.0 PHASE I AUDITS b. A statement that the audit checklists and instructions for completing and submitting them will be provided separately. c. Notification that four weeks prior to the audit start date, the facility must provide the completed audit checklists and other requested documentation to the DOECAP Operations Team. d. A statement the Lead Auditor will send an request for revised documents one week before the start date for the audit, and the facility is expected to provide any documents (e.g., procedures, plans, completed audit checklists) that have been revised since the facility submitted its preaudit document package. A statement that some of the audit checklists contain duplicate information, which is clearly identified so that the facility can assign one or the other checklist to complete that particular section. e. Name and contact information for the DOCAP Operations Team member that the facility may contact if there are questions about how to complete the audit checklists. 5.1 Phase I Audit Process DOECAP initiates a Phase I audit as part of continuing DOECAP audits of the facility. Page 6 of 20

11 5.1.2 A facility that is under consideration for approval to join the voluntary Laboratory and TSDF Phased Audit Program and receive a Phase I audit must agree to the following during discussions with the DOECAP Operations Team regarding the facility s willingness to participate in this effort: a. Integrate the lines of inquiry from the DOECAP laboratory or TSDF audit checklists, as appropriate, into the facility s assessment, audit, and surveillance programs. b. Ensure that the facility s auditors/subject matter experts fill out the audit checklists completely and thoroughly as they conduct the internal assessments, audits, and surveillances. c. For each line of inquiry in the audit checklists, the facility s written response must be clear with regard to how the facility validated compliance with that requirement. Each response must list (a) the date completed, (b) the activity performed, (c) identification of the associated documentation (e.g., inspection report, procedure, etc.) and the date that it was issued, and (d) the name and title of the person who performed the activity so that the DOECAP auditor can more easily verify the information provided. d. Ensure that the name and contact information for the facility s staff member who has overall responsibility for each audit checklist is entered on the front cover of that checklist. If the DOECAP auditor has questions about the contents of the audit checklist, the auditor s starting point is to contact the identified staff member. e. Ensure that the names, addresses, and telephone numbers of any other POCs identified for the DOECAP audit disciplines are provided to the Lead Auditor, with a copy to the DOECAP Operations Team. The Lead Auditor will provide the contact information to the audit team. f. Perform a final review of all completed audit checklists and selfidentified issues prior to submitting them to the DOECAP Operations Team to ensure that: The audit checklists have been correctly and completely filled out. Duplication among the audit checklists is clearly identified, and there is no duplication of self-identified issues. The open findings for each audit discipline are either listed on page 2 of the completed audit checklist or provided in a separate file that is clearly labeled (electronic file name and document title) to match it to the associated audit checklist The Audit Notification Letter and modified, blank audit checklists are sent to the facility at least three months in advance of the scheduled audit, and Page 7 of 20

12 the preaudit process is conducted like any other regular DOECAP audit. The DOECAP Operations Team provides the facility with instructions on how to fill out the audit checklists The Lead Auditor, assisted by the DOECAP Operations Team (if requested), holds a conference call with the audited facility s personnel to ensure they have a clear understanding of how the Laboratory and TSDF Phased Audit Process works, including how to fill out the checklists, how to manage self-identified findings, what documentation to submit to the DOECAP Operations Team, and when the documentation is due, etc The week before the audit start date, the Lead Auditor sends an to the facility requesting any documents (e.g., procedures, plans, completed audit checklists) that have been revised since the facility submitted its preaudit document package to the DOECAP Operations Team Phase I audits are conducted like other on-site DOECAP audits Phase I audit reports are processed in the same manner as regular DOECAP audit reports. 5.2 Phase I Audit Expectations for the Facility Each modified audit checklist section provides fields for the facility to enter the name of the auditor/subject matter expert who filled out that section and the date completed The response for each audit checklist line of inquiry must list (a) the date completed, (b) the activity performed, (c) identification of the associated documentation (e.g., inspection, report, procedure, etc.) and the date it was issued, and (d) the name and title of the person who performed the activity so that the DOECAP auditor can more easily verify the information provided The name and contact information for the facility s staff member who has overall responsibility for each audit checklist must be identified on the front cover of that checklist. If the DOECAP auditor has questions about the contents of the audit checklist, the auditor s starting point is to contact the identified staff member The facility must review all completed audit checklists and ensure their overall quality and continuity prior to submitting them to DOECAP The names, addresses, and telephone numbers of any other POCs identified for the DOECAP audit disciplines must be provided to the Lead Auditor, with a copy to the DOECAP Operations Team. The Lead Auditor will provide the contact information to the audit team The facility must provide detailed documentation from its issues management system. This documentation must: Page 8 of 20

13 a. Be organized by the DOECAP audit disciplines (i.e., the six laboratory disciplines or the seven TSDF disciplines, as appropriate). b. Include all findings from all reviews performed at the site, such as the daily, weekly, monthly, or annual walkdowns and other internal/ external assessments, audits, and surveillances. This information must include the type and date of surveillance/assessment/audit, status, the name of the person who evaluated the area, the corrective actions, and any updates. This information includes findings that the facility identified when it assessed itself against the lines of inquiry in the DOECAP audit checklists. c. Include any open findings from previous years. This includes open findings identified by other auditing entities (external findings) and open self-identified findings noted during assessments, audits, surveillances, walkthroughs, and inspections (weekly, monthly, and annual), as well as any open findings that were identified by the facility s employees. d. List the open findings for each audit discipline on page 2 of the completed audit checklist or provide it in a separate file that is clearly labeled (electronic file name and document title) to match it to the associated audit checklist. e. Provide details on the causal analysis and identified corrective action(s) for each of the findings identified since the last DOECAP audit. In addition, provide the current status of each issue (i.e., open or closed). f. Provide details on the causal analysis and identified corrective action(s) for each of the open previous findings. g. Include closure documentation for: All findings (internal and external) that the facility closed during the past year. The findings from the last DOECAP audit. Open findings from previous DOECAP audits The facility must also provide the following information: A summary of any major changes in facility operations or staffing. A summary of any regulatory issues since the last DOECAP audit (e.g., fines or other penalties, Notices of Violation) In addition to the usual preaudit document package (e.g., procedures, plans, permits), the facility must electronically provide the other requested documentation (listed above) to the DOECAP Operations Team four weeks before the start of the audit. Page 9 of 20

14 5.2.9 The week before the audit begins, the facility must respond to the request from the Lead Auditor by providing any documents (e.g., procedures, plans, completed audit checklists) that have been revised since the facility submitted its preaudit package to the DOECAP Operations Team. 6.0 PHASE II AUDIT LIMITED-SCOPE AUDIT 6.1 Phase II Audit Process Phase II audits are implemented as part of continuing DOECAP audits of the selected facilities If the Phase I audit was successful, the facility may be considered for a Phase II audit. The audit disciplines that are not included in the on-site audit are the areas where the facility demonstrated during the Phase I audit(s) that it has mature programs, has incorporated the DOECAP lines of inquiry into the assessments, audits, and surveillances of those programs, and it corrects identified findings in a timely manner The DOECAP Operations Team, after consultation with auditors and Lead Auditors who have participated in audits at the facilities being considered, proposes to the ASP Manager for approval the names of the facilities that are determined to be eligible for a Phase II audit and the proposed scope for each audit The ASP Manager has final approval authority regarding selection of facilities for Phase II audits. NOTE: If the DOECAP Operations Team is unable to find a qualified auditor or subject matter expert to staff one of the audit disciplines for a scheduled audit. In such cases, the DOECAP Operations Team notifies the ASP Manager, and he determines whether to cancel the audit or proceed with a limited-scope audit. Such audits are not considered part of the Laboratory and TSDF Phased Audit Process Lessons learned from the Phase I audit are incorporated into the approach for a Phase II audit The Audit Notification Letter and modified, blank audit checklists are sent to the facility at least three months in advance of the scheduled audit, and the preaudit process is conducted the same as regular DOECAP audits. The DOECAP Operations Team provides the facility with instructions on how to fill out the audit checklists The facility must submit the requested documentation from its issues management system organized by the DOECAP audit disciplines (i.e., the six laboratory disciplines or the seven TSDF disciplines, as appropriate). Page 10 of 20

15 6.1.8 The facility may elect to continue using the audit checklists that it completed for the Phase I audit; however, in such cases, the facility must: a. Incorporate, using redline, the changes to the lines of inquiry shown in the new audit checklists that are provided by the DOECAP Operations Team each year. b. Ensure all new entries made to the audit checklists include (a) the date completed, (b) the activity performed, (c) identification of the associated documentation (e.g., inspection, report, procedure, etc.) and the date it was issued, and (d) the name and title of the person who performed the activity. An example entry is shown below. 1/22/2016: Inspected the aisle space and drum stacking in Waste Storage Building 3. Acceptable. [Inspection Report 242, dated 1/26/2016; John Dillinger, Waste Operations Manager] The Lead Auditor, assisted by the DOECAP Operations Team (if requested), holds a conference call with the audited facility s personnel to ensure they have a clear understanding of how the Laboratory and TSDF Phased Audit Process works, including how to fill out the checklists, how to manage self-identified findings, what documentation to submit to the DOECAP Operations Team, and when the documentation is due, etc The week before the audit start date, the Lead Auditor sends an to the facility requesting any documents (e.g., procedures, plans, audit checklists) that have been revised since the facility submitted its preaudit document package Phase II audits are conducted like other on-site DOECAP audits Phase II audit reports are processed in the same manner as a regular DOECAP audit report. 6.2 Phase II Audit Expectations for the Facility As noted above for Phase I audits, the facility is expected to integrate the audit checklist lines of inquiry into its assessments, audits, and surveillances, and its personnel must fill out the audit checklists as they conduct these internal reviews The facility must enter the name and contact information on the front cover of the audit checklist for the facility s staff member who has overall responsibility for that checklist. If the DOECAP auditor has questions about the contents of the audit checklist, the auditor s starting point is to contact the identified staff member The facility must review all completed audit checklists and ensure their overall quality and continuity prior to submitting them to DOECAP. Page 11 of 20

16 6.2.4 The facility may elect to complete new, blank audit checklists for each DOECAP audit. In such cases, the facility must enter the name of the auditor/subject matter expert who filled out each section and the date completed in the fields that are provided at the beginning of each audit checklist section The facility may elect to continue using the audit checklists that it completed for the successful Phase I audit; however, the facility must: a. Incorporate, using redline, the changes to the lines of inquiry shown in the new audit checklists that are provided by the DOECAP Operations Team each year. b. Ensure all new entries made to the audit checklists include (a) the date completed, (b) the activity performed, (c) identification of the associated documentation (e.g., inspection, report, procedure, etc.) and the date issued, and (d) the name and title of the person who performed the activity. An example entry is shown below. 1/22/2016: Inspected the aisle space and drum stacking in Waste Storage Building 3. Acceptable. [Inspection Report 242, dated 1/26/2016; John Dillinger, Waste Operations Manager] The facility must provide detailed documentation from its issues management system. The documentation must: a. Be organized by the DOECAP audit disciplines (i.e., the six laboratory disciplines or the seven TSDF disciplines, as appropriate). b. Include all findings from all reviews performed at the site, such as the daily, weekly, monthly, or annual walkdowns and other internal/ external assessments, audits, and surveillances. This information must include the type and date of surveillance/assessment/audit, status, the name of the person who evaluated the area, the corrective actions, and updates. This information includes the findings that the facility identified when it assessed itself against the lines of inquiry in the DOECAP audit checklists. c. Include any open findings from previous years. This includes open findings identified by other auditing entities (external findings) and open self-identified findings noted during assessments, audits, surveillances, walkthroughs, and inspections (weekly, monthly, and annual), as well as any open findings that were identified by the facility s employees. d. List the open findings for each audit discipline on page 2 of the appropriate completed audit checklist or provide them in a separate file that is clearly labeled (electronic file name and document title) to match it to the associated audit checklist. Page 12 of 20

17 e. Provide details on the causal analysis and identified corrective action(s) for each of the findings identified since the last DOECAP audit. In addition, provide the current status of each finding (i.e., open or closed). f. Provide details on the causal analysis and identified corrective action(s) for each of the open previous findings. g. Include closure documentation for: All findings (internal and external) that the facility closed during the past year. Findings from the last DOECAP audit. Open findings from previous DOECAP audits The facility must also provide the following information: A summary of any major changes in facility operations or staffing. A summary of any regulatory issues since the last DOECAP audit (e.g., fines or other penalties, Notices of Violation) In addition to the usual preaudit document package (e.g., procedures, plans, permits), the facility must provide the other requested documentation (listed above) to the DOECAP Operations Team four weeks before the start of the audit The week before the audit begins, the facility must respond to the request from the Lead Auditor by providing any documents (e.g., procedures, plans, audit checklists) that have been revised since the facility submitted its preaudit package to the DOECAP Operations Team. 7.0 PHASE III AUDIT DESKTOP AUDIT NOTE: The process described in this section is considered tentative, and it is subject to review and revision based on lessons learned from implementing the first desktop audit during Phase III Desktop Audit Preaudit Activities Facilities that successfully complete both the Phase I and/or Phase II audits are candidates for a Phase III desktop audit. DOECAP intends to alternate a desktop audit with a modified or full, on-site audit for those facilities that reach Phase III and that maintain good audit performance Each year in October, the DOECAP Operations Team, after consultation with auditors and Lead Auditors who have participated in audits at the facilities being considered, provides recommendations to the ASP Page 13 of 20

18 Manager regarding facilities that are determined to be eligible to receive a Phase III desktop audit The ASP Manager makes the final selection of the facilities will receive a Phase III desktop audit and notifies the DOECAP Operations Team The Audit Notification Letter and modified, blank audit checklists are sent to the facility at least three months in advance of the scheduled audit, and the preaudit process is conducted the same as regular DOECAP audits. The DOECAP Operations Team provides the facility with instructions on how to fill out the audit checklists The facility may elect to continue using the audit checklists that it completed for the successful Phase I audit; however, the facility must: a. Incorporate, using redline, the changes to the lines of inquiry shown in the new audit checklists that are provided by the DOECAP Operations Team each year. b. Ensure all new entries made to the audit checklists after the Phase I audit entries include (a) the date completed, (b) the activity performed, (c) identification of the associated documentation (e.g., inspection, report, procedure, etc.) and the date it was issued, and (d) the name and title of the person who performed the activity. An example entry is shown below. 1/22/2016: Inspected the aisle space and drum stacking in Waste Storage Building 3. Acceptable. [Inspection Report 242, dated 1/26/2016; John Dillinger, Waste Operations Manager] The Lead Auditor (if requested) holds a conference call with the audited facility s personnel to ensure they have a clear understanding of how the Laboratory and TSDF Phased Audit Process works, including how to fill out the audit checklists, how to manage self-identified findings, what documentation to submit to the DOECAP Operations Team, when the documentation is due, etc. 7.2 Phase III Desktop Audit Process When the facility submits the completed audit checklists and other documentation, the DOECAP Operations Team s Document Coordinator notifies the Lead Auditor Below is an overview of the steps involved in the process for Phase III desktop audits from the point that the facility s documents are received by the DOECAP Operations Team. The entire process is expected to take approximately ten weeks. a. The Lead Auditor performs a quick review of the audit checklists for updates and changes. Page 14 of 20

19 NOTE: If the Lead Auditor identifies that small adjustments are needed in the completed audit checklists, he/she contacts the audited facility by telephone and requests the change. If more extensive changes are needed, the Lead Auditor follows up the telephone call with a letter signed by the ASP Manager that requests the identified changes within one week. b. The Lead Auditor holds a conference call with the auditors to ensure that everyone understands what will be provided to them, as well as their deliverables and the due date. c. The Lead Auditor notifies the DOECAP Operations Team s Document Coordinator that the audit checklists and other documents are acceptable. d. The Document Coordinator notifies the audit team members that the documents are available on the DOECAP contractor s FTP Site and provides access instructions. The audit team has two weeks to review the documents and provide their deliverables to the Lead Auditor. e. The auditors must review all of their assigned documentation. If an auditor has questions, he or she can call the identified facility POC(s) for the area being evaluated. The facility provides the names, addresses, and telephone numbers of the POCs to the Lead Auditor, with a copy to the DOECAP Operations Team. The Lead auditor supplies this information to the audit team. f. The Lead Auditor compiles the draft report and coordinates its review by the audit team. g. The Lead Auditor provides the draft report to the audited facility for a factual accuracy review. The audited facility has one week (five business days) to perform a factual accuracy review and provide comments to the Lead Auditor. h. The Lead Auditor addresses the comments provided by the facility, which includes an notification to the facility manager/director with the status of each comment (i.e., accepted or not accepted). i. The Lead Auditor provides the draft report to the Document Coordinator to enter into the DOECAP Operations Team s review process. j. The DOECAP Operations Team reviews and processes the audit report and submits it to the DOECAP Task Manager for review. k. The DOECAP Task Manager submits the draft report to the ASP Manager for approval. l. The ASP Manager reviews the report and approves it, with requested changes or as written. Page 15 of 20

20 7.2.3 The Lead Auditor ensures that the previous DOECAP findings which cannot be verified as closed without visual observation of the physical circumstances are documented in the audit report so that they can be verified as closed during the next on-site DOECAP audit of the facility. 7.3 Phase III Desktop Audit Expectations for the Facility The facility is expected to integrate the audit checklist lines of inquiry into its assessment, audit, and surveillance programs, and its personnel fill out the audit checklists as they conduct these internal reviews The facility must ensure that the name of the auditor/subject matter expert who completed or updated each section of the audit checklist and the date completed are provided for every audit checklist that is completed If facility elects to continue using the audit checklists that it completed for the successful Phase I audit, the facility must: a. Incorporate, using redline, the changes to the lines of inquiry shown in the new audit checklists that are provided by the DOECAP Operations Team each year. b. Ensure all new entries made to the audit checklists after the Phase I audit entries include (a) the date completed, (b) the activity performed, (c) identification of the associated documentation (e.g., inspection, report, procedure, etc.) and the date it was issued, and (d) the name and title of the person who performed the activity. An example entry is shown below. 1/22/2016: Inspected the aisle space and drum stacking in Waste Storage Building 3. Acceptable. [Inspection Report 242, dated 1/26/2016; John Dillinger, Waste Operations Manager] The facility must ensure that the name and contact information for the facility staff member who has overall responsibility for the audit checklist is identified on the front cover of that checklist. If the DOECAP auditor has questions about the contents of the audit checklist, the auditor s starting point is to contact the identified staff member The facility must review all completed audit checklists and ensure their overall quality and continuity prior to submitting them to the DOECAP Operations Team The facility must provide the names, addresses, and telephone numbers of the POCs identified for each DOECAP audit discipline to the Lead Auditor, with a copy to the DOECAP Operations Team. The Lead auditor supplies this information to the audit team. Page 16 of 20

21 7.3.8 The facility must review all completed audit checklists and ensure their overall quality and continuity prior to submitting them to the DOECAP Operations Team The facility must provide detailed documentation from its issues management system. This documentation must: a. Be organized by the DOECAP disciplines (i.e., the six laboratory disciplines or the seven TSDF disciplines, as appropriate). b. Include all findings from all reviews performed at the site, such as the daily, weekly, monthly, or annual walkdowns and other internal/ external assessments, audits, and surveillances. This information must include the type and date of surveillance/assessment/audit, status, person who evaluated the area, the corrective actions, and any updates. This information includes the findings that the facility identified when it assessed itself against the lines of inquiry in the DOECAP audit checklists. c. Include any open findings from previous years. This includes open findings identified by other auditing entities (external findings) and open self-identified findings noted during assessments, audits, surveillances, walkthroughs, and inspections (weekly, monthly, and annual), as well as any open findings that were identified by the facility s employees. d. List the open findings for each audit discipline either on page 2 of the completed audit checklist or provide them in a separate file that is clearly labeled (electronic file name and document title) to match it to the associated audit checklist. e. Provide details on the causal analysis and identified corrective action(s) for each of the findings identified since the last DOECAP audit. In addition, provide the current status of each finding (i.e., open or closed). f. Provide details on the causal analysis and identified corrective action(s) for each of the open previous findings. g. Include closure documentation for the following: All findings (internal and external) that the facility closed during the past year. The findings from the last DOECAP audit. Open findings from previous DOECAP audits. Page 17 of 20

22 7.3.9 The facility must also provide the following information: a. A summary of any major changes in facility operations or staffing. b. A summary of any regulatory issues since the last DOECAP audit (e.g., fines or other penalties, Notices of Violation). 7.4 Phase III Desktop Audit Report The DOECAP Operations Team obtains the ASP Manager s approval of the Phase III desktop audit report format and any proposed changes thereto The DOECAP Operations Team maintains the Phase III desktop audit report template as one of the official DOECAP report templates. 8.0 FILES AND QUALITY RECORDS See DOECAP Procedure AD-1-6, DOECAP Quality Records and Program Documents, for more information on DOECAP quality records and other Program documents. 8.1 Files Maintained by the DOECAP Operations Team (Not Quality Records) The DOECAP Operations Team maintains the following files and information related to implementation of this procedure that are not quality records: a. Drafts of letters, reports, checklists, etc. b. Laboratory and TSDF Phased Audit schedules for the current fiscal year, since these schedules are living documents that require frequent revision. c. Preaudit information package from audited facilities, including completed audit checklists. d. DOECAP preaudit documentation package developed by the DOECAP Operations Team. e. Audited facility CAPs. f. Contact information on the following the DOECAP participants while they are active in the Program: Laboratory and TSDF Lead Auditors. Laboratory and TSDF auditors. Laboratory and TSDF auditors-in-training. Laboratory and TSDF subject matter experts. Laboratory and TSDF audit observers. g. Audited facilities physical address, telephone number, and contact information for the designated facility POC while the facility is active in the Program. Page 18 of 20

23 8.2 Quality Records 9.0 ACRONYMS The following quality records are developed during implementation of this procedure: a. New and revised laboratory and TSDF audit checklists (blank). b. Modified laboratory and TSDF audit checklists (blank) used for the Laboratory and TSDF Phased Audits Process. c. Signed audit notification letters. d. Final audit plans. e. Completed Audit Evaluation forms. f. Completed Audit Cost forms. g. Completed attendance forms for the audit opening meeting and exit meeting. h. Auditor notes submitted in hard copy to the DOECAP Operations Team. i. Completed DOECAP audit checklists submitted by the DOECAP auditors and the audited laboratories and TSDFs. j. DOE-approved audit reports with signed cover letters. ASP DOE DOECAP FTP POC SharePoint EDS TSDF U.S. Analytical Services Program U.S. Department of Energy U.S. Department of Energy Consolidated Audit Program File Transfer Protocol point of contact SharePoint Electronic Data System treatment, storage, and disposal facility United States Page 19 of 20

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