OFFICIAL USE ONLY
U.S. Department of Energy Consolidated Audit Program
Laboratory Closure Checklist
Audit ID:
DOECAP Checklist: 10
Effective Date: November 2015
Rev. 3.1
Page 1 of 4
Auditor: _________________________________________________________
U. S. Department of Energy
Consolidated Audit Program
Laboratory Closure Module 10
Revision 3.1
November 2015
Use of this DOECAP checklist is authorized only if the user has satisfied the copyright restrictions associated with TNI -EL-V1-2009 and ISO 17025:2005.
DOECAP does not control or restrict the use of copyrighted standards that have been incorporated into this checklist; however , TNI and ISO do restrict use of
their standards.
OFFICIAL USE ONLY
May be exempt from public release under the Freedom of Information Act
(5 U.S.C 552), exemption number and category: Exemption #4: Commercial Proprietary
Status Key: A = Acceptable, U = Unacceptable, NA = Not Applicable, F = Finding, O = Observation
OFFICIAL USE ONLY
OFFICIAL USE ONLY
U.S. Department of Energy Consolidated Audit Program
Laboratory Closure Checklist
Audit ID:
DOECAP Checklist: 10
Effective Date: November 2015
Auditor: _________________________________________________________
Department of Energy review required before public release
Name/Org:
Date: Guidance (if applicable) Memo dated October 30, 2008 from Charles B. Lewis III to Larry Kelly, DM No 419069
Referenced regulations are accessible at the following URLs:

Audit ID:
Rev. 3.1
Page 2 of 4
http://www.p2s.com/?page_id=1526
Date:
Status Key: A = Acceptable, U = Unacceptable, NA = Not Applicable, F = Finding, O = Observation
OFFICIAL USE ONLY
OFFICIAL USE ONLY
U.S. Department of Energy Consolidated Audit Program
Laboratory Closure Checklist
DOECAP Checklist: 10
Effective Date: November 2015
Audit ID:
Auditor: _________________________________________________________
ITEM
10.1
Line of Inquiry
Status
Quality Assurance Documents
QSM Rev. 5.0, Module 2, 4.13.9. Specific closure lines of inquiry are listed below.
10.1.1
The laboratory has developed a Laboratory Closure Plan.
10.1.2
The closure plan defines the laboratory plans for waste management.
10.1.3
The Closure Plan defines laboratory plans for record archival.
10.1.4
The Closure Plan defines laboratory plans for Database Archival.
10.1.5
The Closure Plan defines laboratory organizational responsibilities for closure.
10.2
10.2.1
Documents and Records
The laboratory must have a procedure for permanent laboratory closure and disposal
of any remaining records associated with DOE analytical data.
QSM Rev. 5.0, Module 2, 4.13.9
10.2.2
Rev. 3.1
Page 3 of 4
Will documents be retained for a minimum of five years?
Status Key: A = Acceptable, U = Unacceptable, NA = Not Applicable, F = Finding, O = Observation
OFFICIAL USE ONLY
Summary of Observations/Objective
Evidence Reviewed/Audit Notes
OFFICIAL USE ONLY
U.S. Department of Energy Consolidated Audit Program
Laboratory Closure Checklist
DOECAP Checklist: 10
Effective Date: November 2015
Audit ID:
ITEM
Auditor: _________________________________________________________
Line of Inquiry
Status
TNI EL-V1M2-ISO-2009, Section 4.13.3 b)
10.2.3
All revision of Standard Operating Procedures will be archived?
Are all obsolete (outdated) documents retained for either legal or knowledge preservation
purposes are suitably marked and included in the archive?
ISO/IEC 17025:2005, Clause 4.3.2.2 d)
10.2.4
Does the laboratory have a plan to handle all accountable documents including: logbooks,
COC records, sample work sheets, bench sheets, SOPs, and other documents relating to
the sample or sample analyses, procurement of services, and generation of electronic
deliverables?
QSM Rev. 5.0, Module 2, 4.13.9
10.2.5
Does the laboratory have a plan to submit all due final data reports to clients?
DOE Site Agreements and Contracts
10.3
10.3.1
Waste Management
Are all containerized waste has been itemized?
(Refer to the requirements of QSM Rev. 5.0, Section 6.4 (Waste Management
and Disposal)
10.3.2
Rev. 3.1
Page 4 of 4
Are all liquid waste has been itemized?
Status Key: A = Acceptable, U = Unacceptable, NA = Not Applicable, F = Finding, O = Observation
OFFICIAL USE ONLY
Summary of Observations/Objective
Evidence Reviewed/Audit Notes
OFFICIAL USE ONLY
U.S. Department of Energy Consolidated Audit Program
Laboratory Closure Checklist
Audit ID:
ITEM
DOECAP Checklist: 10
Effective Date: November 2015
Auditor: _________________________________________________________
Line of Inquiry
Status
10.3.3
Is the Disposal Plan and Schedule defined?
10.3.4
Are all samples have been itemized and the disposal path has been identified?
10.3.5
Is the sample disposal plan defined?
10.3.7
Inspect RCRA Units for compliance. All inspections results will be included in the
audit report for the closure.
10.3.8
Review all waste manifests for all disposed sample. If possible, obtain copies of all
waste manifests for all disposed samples.
10.3.9
Will building security maintained until all records are archived and all waste has
been disposed?
10.4
10.4.1
Rev. 3.1
Page 5 of 4
Software Documentation
Do files of all versions of software programs exist and include dates that software was
placed into and removed from production? Do files for previously used software,
LIMS manuals, and user maintenance manuals exist? Will all software records will
be retained according to GALP requirements?
EPA 2185 “Good Automated Laboratory Practices” (As published in 1995)
Status Key: A = Acceptable, U = Unacceptable, NA = Not Applicable, F = Finding, O = Observation
OFFICIAL USE ONLY
Summary of Observations/Objective
Evidence Reviewed/Audit Notes
OFFICIAL USE ONLY
U.S. Department of Energy Consolidated Audit Program
Laboratory Closure Checklist
Audit ID:
Rev. 3.1
Page 6 of 4
Auditor: _________________________________________________________
Revision Effective
Number Date
3.1
DOECAP Checklist: 10
Effective Date: November 2015
11/2015
Reason for Revision
Added reference to DOECAP Checklist Webpage
Status Key: A = Acceptable, U = Unacceptable, NA = Not Applicable, F = Finding, O = Observation
OFFICIAL USE ONLY
Line
of
Inquiry or
Page #
First Page