U.S. Department of Energy Consolidated Audit Program DOECAP TSDF Audit Checklist: 1 Revision 2.1
Quality Assurance Management Systems Effective Date: March 7, 2017 Page 31 of 32
Audit ID: ______TSDF: ______Auditor: ______
U. S. Department of Energy
Consolidated Audit Program
Treatment, Storage, and Disposal Facilities - Checklist 1
Quality Assurance Management Systems
Revision 2.1
March 7, 2017
Audit ID: Date:Areas of Review During Audit
____QA Program ____Personal Training and Qualifications ____Design Control
____Procurement ____Instructions, Procedures, & Drawings ____Document Control
____Control of Special Processes ____Identification and Control of Items ____Control of Purchased Items/Services
____Inspection ____Test Control ____Control of Measuring & Test Equipment
____Corrective Action ____Inspection, Test, and Operating Status ____Control of Nonconforming Items
____QA Records ____Assessments ____Laboratory QA
A = Acceptable U = Unsatisfactory NA = Not Acceptable NO = Not Observed F = Finding O = Observation
Access to all referenced regulations are available at the following URL:
• https://apps.oro.doe.gov/sites/DOECAP/SitePages/Home.aspx
• http://www.access.gpo.gov/nara/cfr/cfr-table-search.html#page1
Checklist 1 was revised to NQA-1-2015 in November 2015.
NOTE:
• When audit findings are written against site-specific documents (i.e., procedures, QA plans, licenses, permits, etc.), a copy of the pertinent requirement text from that document must be attached to this checklist for retention in DOECAP files.
Item Number / Lines of Inquiry / Status / Response/Comment /
1.0 / Quality Assurance Program
1.1 / Program Management
1.1.1 / Are responsibilities for the establishment and implementation of the quality assurance program defined?
NQA-1 Requirement 1, Section 201(d)
1.1.2 / Does the facility have a documented quality assurance program that is planned, implemented, maintained, and consistent with license conditions?
NQA-1 Requirement 2, Section 100(a)
1.1.3 / Does the documented quality assurance program describe the organizational structure, functional responsibilities, levels of authority, and lines of communication for activities affecting quality?
NQA-1 Requirement 1, Section 100
1.1.4 / Does the scope of the documented quality assurance program meet the applicable quality assurance criteria as licensed by the Nuclear Regulatory Commission (NRC) or an Agreement State with the NRC?
Site-Specific Radioactive Materials License
1.1.5 / Does the organization establish and implement processes to detect and correct quality problems?
DOE Order 414.1D, Attachment 2, and NQA-1 Requirement 1, Section 201
1.1.6 / Do the controlled conditions include the use of appropriate equipment, suitable environmental conditions for accomplishing the activity, and assurance that prerequisites for the given activity have been satisfied?
NQA-1 Requirement 2, Section 100(a)
1.1.7 / Does management regularly assesses the adequacy and effective implementation of the quality assurance program?
Does the facility assess all applicable QA program elements within a two-year period?
Note: For well-established activities, the period may be extended one year at a time beyond the two-year interval based on the results of an annual evaluation of the applicable functional area and objective evidence that the functional area activities are being satisfactorily accomplished. However, the internal assessment interval may not exceed a maximum of four years.
NQA-1 Requirement 2, Section 100(c), and Requirement 18, Section 201.2
1.2
1.2.1 / Does the facility have a formal written training program that defines job qualifications and required training based on job function?
NQA-1 Requirement 2, Sections 100(a) and (b) and Section 300, RCRA, OSHA
1.2.2 / Do the training requirements include/meet environmental, health and safety, and operational requirements?
NOTE: This line of inquiry is also included in the Environmental Compliance & Permitting (EC) checklist and the Industrial & Chemical Safety (ICS) audit checklists. The QA auditor should only address this item if there are no EC and ICS auditors on the audit team.
RCRA, OSHA
1.2.3 / Is indoctrination and training commensurate with scope, complexity, importance of the activities, and the education, experience, and proficiency of the person?
NQA-1 Requirement 2, Section 200
1.2.4 / Is the person responsible for shipping of hazardous materials, radioactive materials and/or hazardous waste properly trained and qualified?
Is the vendor providing the training approved and qualified to give the training?
NOTE: This item is also included in the Transportation Management (TR) audit checklist. The QA auditor should only address this item if there is no TR auditor on the audit team.
49 CFR 172, Subpart H
1.2.5 / Does the organization maintain a program that assures personnel performing or managing activities affecting quality receive indoctrination in their job responsibilities and authority; general criteria, including applicable codes and standards, regulatory commitments, company procedures, and quality assurance program requirements?
NQA-1 Requirement 2, Sections 100(b) and 201
1.2.6 / Does the responsible organization designate those activities that require qualification of personnel and the minimum requirements for such personnel?
NQA-1 Requirement 2, Section 300
1.2.7 / Is the qualification of inspection, test, and auditor personnel certified in writing and include the information listed below?
· The employer’s name;
· Identification of the person being certified;
· Requirements for an individual to achieve the certification;
· Activities the person is certified to perform;
· Signature of the employer’s designated representative?
NQA-1, Requirement 2, Section 400
1.2.8 / Are training records complete and maintained in a formal record keeping system?
Do the indoctrination/training records include one or more of the following for (a)inspection and test personnel qualification and requalification and (b) auditor qualification and requalification:
· Attendance sheets
· Training logs
· Personnel training records
RCRA, OSHA, DOT and NQA-1, Requirement 2, Section 500
1.2.9 / Are training records for all personnel reviewed current and compliant with regulatory requirements?
RCRA, OSHA, DOT, and NQA-1, Requirement 2, Section 500
1.3
1.3.1 / Were the facility designs completed and approved as required by the applicable permits?
Were the treatment process designs completed and approved as required by applicable permits?
Were the storage and/or disposal designs completed and approved as required by applicable permits?
1.4
1.4.1 / Are applicable design bases and other requirements necessary to assure adequate quality included or referenced in documents for procurement of items and services?
NQA-1 Requirement 4, Section 100
1.4.2 / To the extent necessary, are procurement documents requiring suppliers to have a quality assurance program consistent with the applicable requirements?
Are the applicable requirements flowed down to contractors and subcontractors?
NQA-1 Requirement 4. Sections 100 and 203
1.4.3 / Are technical requirements specified in the procurement documents?
NQA-1 Requirement 4, Section 202
1.4.4 / Are the technical requirements specified, as appropriate, by reference to specific drawings, specifications, codes, standards, regulations, procedures, or instructions, including revisions thereto that describe the items or services to be furnished?
NQA-1 Requirement 4, Section 202
1.4.5 / Do the procurement documents identify appropriate test, inspection, and acceptance criteria for determining acceptability of the item or service?
NQA-1 Requirement 4, Section 202
1.4.6 / Are procurement document reviews performed by personnel who have access to pertinent information and who have an adequate understanding of the requirements and intent of the procurement documents?
NQA-1 Requirement 4, Section 300
1.5
1.5.1 / Are activities affecting quality and services prescribed by and performed in accordance with documented instructions, procedures, or drawings that include or reference appropriate quantitative or qualitative acceptance criteria for determining that prescribed activities have been satisfactorily accomplished?
NQA-1 Requirement 5, Section 100
1.5.2 / Are the activities described to a level of detail commensurate with the complexity of the activity and the need to assure consistent and acceptable results?
Note: The need for, and level of detail in, written procedures or instructions are determined based upon complexity of the task, the significance of the item or activity, work environment, and worker proficiency and capability (education, training, experience).
NQA-1 Requirement 5, Section 100
1.6
1.6.1 / Are the preparation, issue, and change of documents that specify quality requirements or prescribe activities affecting quality such as instructions, procedures, and drawings, controlled to assure the correct documents are being employed?
NQA-1 Requirement 6, Section 100
1.6.2 / Are documents specifying quality requirements and changes reviewed for adequacy and approved for release by authorized personnel?
NQA-1 Requirement 6, Section 100
1.6.3 / Are the following controls applied to documents and changes thereto:
· The identification of controlled documents;
· The specified distribution of controlled documents for use at the appropriate location;
· The identification of individuals responsible for the preparation, review, approval, and distribution of controlled documents;
· The review of controlled documents for adequacy, completeness, approval prior to distribution; and
· A method to ensure the correct documents are being used?
Are major or minor changes defined and addressed?
NQA-1 Requirement 6, Sections 200 and 301
1.7
1.7.1 / Do controls of purchased items and services provide for the following, as appropriate:
· Source evaluation and selection;
· Evaluation of objective evidence of quality furnished by the supplier;
· Source inspection;
· Audit;
· Examination of items or services upon delivery or completion to verify that the item or service being furnished complies with the procurement requirements;
· Bid evaluation;
· Control of supplier-generated documents?
NQA-1 Requirement 7, Sections 100. 300, and 501
1.7.2 / Are records established and maintained to indicate the performance of the following functions:
· Supplier evaluation and selection;
· Acceptance of items or services; and
· Supplier nonconformances to procurement document requirements, including their evaluation and disposition
NQA-1 Requirement 7, Section 800
1.8
1.8.1 / Are controls established to assure that only correct and acceptable items are used or installed?
Is the identification maintained on the item or in documents traceable to the item, or in a manner which assures that identification is established and maintained?
NQA-1 Requirement 8, Section 100
1.8.2 / Are items having limited calendar or operating life or cycles identified and controlled to preclude use of items whose shelf life or operating life has expired?
NQA-1 Requirement 8, Section 302
1.9
1.9.1 / Are special processes controlled by instructions, procedures, drawings, checklists, travelers, or other appropriate means and include or reference procedure, personnel, and equipment qualification requirements?
NQA-1 Requirement 9, Section 201
1.9.2 / Do the conditions necessary for accomplishment of the special process include proper equipment, controlled parameters of the process, specified environment, and calibration requirements?
NQA-1 Requirement 9, Section 201
1.9.3 / Are records maintained as appropriate for the currently qualified personnel, processes, and equipment of each special process?
NQA-1 Requirement 9, Section 400
1.10
1.10.1 / Are required inspections verifying conformance of an item or activity to specified requirements or continued acceptability of items in service planned and executed?
NOTE: RCRA inspections are covered in the Waste Operations checklist.
NQA-1 Requirement 10, Section 100
1.10.2 / Are periodic inspections (e.g., in-service inspections) or surveillances of structures, systems, or components planned and executed to ensure the continued performance of their required functions?
NQA-1 Requirement 10, Section 700
1.10.3 / Are inspection results documented, and do the inspection records identify the following:
· Item inspected;
· Date of inspection;
· Inspector;
· Type of observation;
· Results or acceptability; and
· Reference to information on action taken in connection with nonconformances?
NQA-1 Requirement 10, Section 800
1.11
1.11.1 / Are characteristics to be tested and test methods to be employed specified?
NQA-1 Requirement 11, Section 100
1.11.2 / Are test results documented and their conformance with test requirements and acceptance criteria evaluated?
NQA-1 Requirement 11, Section 100
1.11.3 / Are test records established and maintained to indicate the ability of the item to satisfactorily perform its intended function or to meet its documented requirements, including computer program test procedures and records in accordance with Subpart 2.7, “Quality Assurance Requirements for Computer Software for Nuclear Facility Applications”?
NQA-1 Requirement 11, Sections 400 and 600
1.12
1.12.1 / Are tools, gages, instruments, and other measurement and test equipment used for activities affecting quality controlled, calibrated at specified periods, adjusted, and maintained to required accuracy limits?
NQA-1 Requirement 12, Section 100
1.12.2 / Is the selection of M&TE based on the type, range, accuracy, and tolerance needed to accomplish the required measurements for determining conformance to specified requirements?
NQA-1 Requirement 12, Section 200
1.12.3 / Is M&TE calibrated at prescribed times or intervals and whenever the accuracy of the equipment is suspect?
NQA-1 Requirement 12, Section 301
1.12.4 / Is the calibration made against and traceable to certified equipment or reference standards having known valid relationships to nationally recognized standards, or to international standards known to be equivalent to and verified against corresponding nationally recognized standards?
NQA-1 Requirement 12, Section 301
1.12.5 / If no nationally recognized standards exist, is the basis for calibration defined and documented?
NQA-1 Requirement 12, Section 301
1.12.6 / Is M&TE suitably marked, tagged, labeled, or otherwise identified to indicate calibration status and establish traceability to calibration records?
NQA-1 Requirement 12, Section 303.6
1.12.7 / Have records been established and maintained to indicate calibration status and the capability of M&TE to satisfactorily perform its intended function?
NQA-1 Requirement 12, Section 401
1.13
1.13.1 / Is the status of inspection and test activities identified either on the item or in documents traceable to the items where it is necessary to assure that required inspections and tests are performed and to ensure that items which have not passed the required inspections and tests are not inadvertently installed, used, or operated?
NQA-1 Requirement 14, Section 100
1.13.2 / Is status maintained through indicators, such as physical location and tags, markings, shop travelers, stamps, inspection records, operating documents, quality records, or other suitable means?
Do the status indicators also provide for indicating the operating status of systems and components of the nuclear facility, such as by tagging valves and switches, to prevent inadvertent operation?
NQA-1 Requirement 14, Section 100
1.14
1.14.1 / Are items that do not conform to specified requirements controlled to prevent inadvertent installation or use?
NQA-1 Requirement 15, Section 100
1.14.2 / Do controls provide for identification, documentation, evaluation, segregation when practical, and disposition of nonconforming items, and for notification to affected organizations?