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U. S. Department of Energy

Consolidated Audit ProgramTreatment, Storage, and Disposal Facilities - Checklist 1

Quality Assurance Management SystemsRevision 2.1

March 7, 2017Audit ID: Date:

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 of 31

Audit ID: ________________ TSDF: _______________________________________ Auditor: ________________________________

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.

http://www.access.gpo.gov/nara/cfr/cfr-table-search.html#page1

https://apps.oro.doe.gov/sites/DOECAP/SitePages/Home.aspx%20%20




Item Number Lines of Inquiry Status Response/Comment

1.0 Quality Assurance Program1.1 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 1001.1.4 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 License1.1.5 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 2011.1.6 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



Audit ID: ________________ TSDF: _______________________________________ Auditor: ________________________________Item

Number Lines of Inquiry Status Response/Comment

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 201.21.2

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, OSHA1.2.2 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, OSHA1.2.3 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 2001.2.4 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 H1.2.5 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 2011.2.6 Does the responsible organization designate those activities that require

qualification of personnel and the minimum requirements for such personnel?

NQA-1 Requirement 2, Section 3001.2.7 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 5001.2.9 Are training records for all personnel reviewed current and compliant with

regulatory requirements?

RCRA, OSHA, DOT, and NQA-1, Requirement 2, Section 5001.3

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?

1.41.4.1 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 2031.4.3 Are technical requirements specified in the procurement documents?

NQA-1 Requirement 4, Section 2021.4.4 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 2021.4.5 Do the procurement documents identify appropriate test, inspection, and

acceptance criteria for determining acceptability of the item or service?

NQA-1 Requirement 4, Section 2021.4.6 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 3001.5

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?






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).


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 1001.6.2 Are documents specifying quality requirements and changes reviewed for

adequacy and approved for release by authorized personnel?

NQA-1 Requirement 6, Section 1001.6.3 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





1.71.7.1 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 5011.7.2 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


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?






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?


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 2011.9.2 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 2011.9.3 Are records maintained as appropriate for the currently qualified personnel,

processes, and equipment of each special process?


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?






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?


1.11.1 Are characteristics to be tested and test methods to be employed specified?

NQA-1 Requirement 11, Section 1001.11.2 Are test results documented and their conformance with test requirements and

acceptance criteria evaluated?

NQA-1 Requirement 11, Section 1001.11.3 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 6001.12

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?






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 2001.12.3 Is M&TE calibrated at prescribed times or intervals and whenever the accuracy of

the equipment is suspect?

NQA-1 Requirement 12, Section 3011.12.4 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 3011.12.5 If no nationally recognized standards exist, is the basis for calibration defined and

documented?

NQA-1 Requirement 12, Section 3011.12.6 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 303.61.12.7 Have records been established and maintained to indicate calibration status and the

capability of M&TE to satisfactorily perform its intended function?


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?






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?


1.14.1 Are items that do not conform to specified requirements controlled to prevent inadvertent installation or use?

NQA-1 Requirement 15, Section 1001.14.2 Do controls provide for identification, documentation, evaluation, segregation

when practical, and disposition of nonconforming items, and for notification to affected organizations?

NQA-1 Requirement 15, Section 1001.14.3 Are nonconforming items identified by legible marking, tagging, or other methods

not detrimental to the item?

NQA-1 Requirement 15, Section 2001.14.4 Is the identification of nonconforming items made either on the item, the container,

or the package containing the item?

NQA-1 Requirement 15, Section 2001.14.5 Are nonconforming items evaluated and are recommended dispositions proposed?






1.14.6 Is further processing, delivery, installation, or use of a nonconforming item controlled pending the evaluation and an approved disposition by authorized personnel?

NQA-1 Requirement 15, Section 4011.14.7 Is the responsibility and authority for the evaluation and disposition of

nonconforming items defined?

Is responsibility for the control of further processing, delivery, installation, or use of nonconforming items designated in writing?


1.15.1 Are conditions adverse to quality defined, identified promptly and corrected as soon as practicable?

NQA-1 Requirement 16, Section 1001.15.2 In the case of a significant condition adverse to quality, is the cause of the adverse

condition determined and corrective action taken to preclude recurrence?

NQA-1 Requirement 16, Section 1001.15.3 Are the identification, cause, and corrective actions for significant conditions

adverse to quality documented and reported to appropriate levels of management?

NQA-1 Requirement 16, Section 1001.15.4 Is the completion of corrective actions verified?

NQA-1 Requirement 16, Section 1001.15.5 After completion of a corrective action or a set of corrective actions, is an

effectiveness review conducted using trained and qualified personnel that can verify the corrective action/corrective action plan has been effectively implemented to prevent recurrences?

DOE Order 226.1B, Attachment 1, Paragraph 2b(3)(b)(3)





1.161.16.1 Are quality assurance records identified, generated, authenticated, maintained, and

their final disposition specified? Note: Quality assurance records furnish documentary evidence that items or activities meet specified quality requirements.

NQA-1 Requirement 17, Section 1001.16.2 Are requirements and responsibilities for records management activities

documented?

NQA-1 Requirement 17, Section 1001.16.3 Are record retention periods documented?

NQA-1 Requirement 17, Section 7001.16.4 Are records protected from damage or loss and readily retrievable?

NQA-1 Requirement 17, Sections 601 and 8001.16.5 Are databases routinely backed up and data files protected from loss?

Site QA Plan, NQA-1, Requirement 17, Section 6011.16.6 Are manual data entry steps checked for transcription and calculation errors?

Site QA Plan, NQA-1, Requirement 17, Section 3001.17

1.17.1 Are assessments performed to verify compliance to the QA program requirements, to verify that performance criteria are met, and to determine the effectiveness of the program?

NQA-1 Requirement 18, Section 1001.17.2 Are assessments performed in accordance with written procedures or checklists by

personnel who do not have direct responsibility for performing the activities being audited?






1.17.3 Are assessment results documented and reported to and reviewed by responsible management?

Is follow-up action taken where indicated?

Do assessment records include the following: Assessment plan, Assessment report, Written replies, and Record of completion of corrective action?

NQA-1 Requirement 18, Sections 100 and 8001.17.4 Do independent assessment personnel have sufficient authority and organizational

freedom to make the audit process meaningful and effective?

NQA-1 Requirement 18, Section 302 1.17.5 Is follow-up action taken to verify that corrective action has been accomplished as

scheduled?

NQA-1 Requirement 18, Section 7001.17.6 Audits of suppliers shall be performed on a triennial basis and supplemented by

annual evaluations of the supplier’s performance to determine if the regular schedule audit frequency shall be maintained or decreased or if other corrective action is required.

NQA-1 Requirement 18, Sections 200 and 202

1.18

1.18.1 For samples collected and sent to the analytical laboratory, are records independently reviewed to provide early detection and corrective action of sampling problems and concerns?

[Guidance: EPA SW-846, Chapter One, 2014]





1.18.2 Are laboratory data review and verification processes described in written procedures?

[Guidance: EPA SW-846, Chapter One, 2014]1.18.3 Are controlled data review checklists used for verification of analytical data?

[Guidance: EPA SW-846, Chapter One, 2014]1.18.4 Are data review and verification results well documented and maintained?

[Guidance: EPA SW-846, Chapter One, 2014]1.18.5 Are in-house laboratory procedures available for each laboratory method?

[Guidance: EPA SW-846, Chapter One, 2014]1.18.6 Is documentation maintained that demonstrates that instrument calibration

standards are traceable to a certified source?

[Guidance: EPA SW-846, Chapter One, 2014]1.18.7 Is in-house laboratory data reviewed and documented by an independent chemist

to ensure that data are of suitable quality for use?

[Guidance: EPA SW-846, Chapter One, 2014]1.18.8 Is documentation available to ensure that off-site independent laboratory data are

verified and that the data are of acceptable quality before being released to the customer?

[Guidance: EPA SW-846, Chapter One, 2014]1.18.9 Is documentation available to show that deionized water sources are routinely

checked to ensure they meet ASTM requirements for Type II waters?

[Guidance: EPA SW-846, Chapter One, 2014]1.18.10 Is documentation available to show that analytical balances are checked daily or

before use (whichever is greater) and that these checks are compared to established acceptance criteria?

[Guidance: ASTM E898-2013]





1.18.11 Is documentation available to show that Type 1 or equivalent check weights are reverified at least every five years?

[Guidance: ASTM E617-2013]1.18.12 Is there documentation to show that laboratory balances are recertified at least

annually by an outside vendor or from an independent third party?

[Guidance: ASTM E898-2013]1.18.13 Do analytical logbooks follow good log-keeping practice?

[Guidance: DoD/DOE Consolidated Quality Systems Manual (QSM) for Environmental Laboratories, Section 4.13, “Control of Records”; EPA Quality Assurance/Quality Control Guidance for Laboratories Performing PCR Analyses on Environmental Samples, 2004, Section 6, “Data Recording, Record Keeping, and Data Evaluation”]




Record of Revision for Checklist 1Quality Assurance Management Systems

Revision Number

EffectiveDate

Reason forRevision

Line ofInquiry

1.3.1 June 9, 2015 Changes to various references Various2.0 Section 1.1, Program Management

Item 1.1.2: Added the section identifier for Requirement 2 (Section 100(a)).

Item 1.1.3: Added the phrase “and lines of communication for activities affecting quality.” Corrected the reference from Requirement 2 to Requirement 1, Section 100.

Item 1.1.4: Revised “a State under Agreement with the NRC” to “an Agreement State with the NRC.”

Item 1.1.5: Corrected Item 1.1.6: Added the section identifier for Requirement 2

(Section 100(a)). Item 1.1.7: Added the section identifier for Requirement 2

(Section 100(c)). Added the applicable requirement shown below from the revised Requirement 18, Section 201.2, and added it to the references.

Does the facility assess all applicable QA program functional areas and 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

Section 1.1




Revision Number

EffectiveDate

Reason forRevision

Line ofInquiry

activities are being satisfactorily accomplished. However, the internal assessment interval may not exceed a maximum of four years.

NQA-1 Requirement 18, Section 201.22.0 Section 1.2, Personnel Qualification and Training

Item 1.2.1: Added the section identifiers for Requirement 2 (Sections 100(a) and (b) and Section 300).

Item 1.2.2: Added the NOTE shown below. Deleted NQA-1 from the references. Changed “&” to “and.”

NOTE: This item 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.

Item 1.2.3: Added the section identifier for Requirement 2 (Section 200).

Item 1.2.4: Added the NOTE shown below.

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.

Item 1.2.5: Added the section identifiers for Requirement 2 (Sections 100(b) and Section 201).


Item 1.2.7: New line of inquiry added as shown below due to revision of the standard. Renumbered the remaining items/lines of inquiry in this section.

Section 1,2




Revision Number

EffectiveDate

Reason forRevision

Line ofInquiry

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

Item 1.2.8: Added the NQA-1 Requirement number and section identifier (Requirement 2, Section 500). Added a second sentence to this line of inquiry due to revision of the standard and to identify the NQA-1-required training records.

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 NQA-1, Requirement 2, Section 500

2.0 Section 1.4, Procurement Item 1.4.1: Added the section identifier for Requirement 4

(Section 100). Item 1.4.2: Added the section identifiers for Requirement 4

(Section 100 and 203).

Section 1.4




Revision Number

EffectiveDate

Reason forRevision

Line ofInquiry





2.0 Section 1.5, Instructions, Procedures, and Drawings Item 1.5.1: Revised the wording to match the standard (changed

“results” to “activities” and changed “attained” to “accomplished.” Added the section identifier for Requirement 5 (Section 100).

Section 1.5

2.0 Section 1.6, Document Control Item 1.6.1: Added the section identifier for Requirement 6

(Section 100). Added a comma and removed a comma so that the text matched the standard.


Item 1.6.3: Added the section identifier for Requirement 6 (Section 200 and 301). Combined former bullets 4 and 5 so that the text matched the standard. Moved “and” to the end of the new bullet 4 and removed it from the start of bullet 5.

Section 1.6

2.0 Section 1.7, Control of Purchased Items and Services Item 1.7.1: Added the section identifiers for Requirement 7

(Sections 100, 300, and 501). Added the following phrase from Section 501 to Bullet 5: “to verify that the item or service being furnished complies with the procurement requirements.”

Item 1.7.2: New line of inquiry from Requirement 7, Section

Section 1.7




Revision Number

EffectiveDate

Reason forRevision

Line ofInquiry

800, “Records.”2.0 Section1.8, Identification and Control of Items

Item 1.8.1: Added the section identifier for Requirement 8 (Section 100). Split the line of inquiry into two questions.


Section 1.8

2.0 Section 1.9, Control of Special Processes Item 1.9.1: Added the section identifier for Requirement 9

(Section 201). Item 1.9.2: Added the section identifier for Requirement 9

(Section 201). Added a comma to match the text in the standard. Item 1.9.3: Added the section identifier for Requirement 9

(Section 400). Added a comma to match the text in the standard.

Section 1.9

2.0 Section 1.10, Inspection Item 1.10.1: Added the section identifier for Requirement 10

(Section 100). Item 1.10.2: Added a new line of inquiry for Requirement 10,

Section 700, “Inspections During Operations.”

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?


Item 1.10.2: Added the new line of inquiry shown below for Requirement 10, Section 800, “Records.”

Are inspection results documented, and do the inspection records identify the following:

Section 1.10




Revision Number

EffectiveDate

Reason forRevision

Line ofInquiry

Item inspected; Date of inspection; Inspector; Type of observation; Results or acceptability; and Reference to information on action taken in connection

with nonconformances?


2.0 Section 1.11, Test Control Section 1.11.1: Added the section identifier for Requirement 11

(Section 100) Section 1.11.2: Added the section identifier for Requirement 11

(Section 100) Section 1.11.3: Added the section identifiers for Requirement 11

(Sections 400 and 600). Added the following phrase to invoke the software quality assurance requirements in Subpart 2.7 because they are invoked by Requirement 11, Section 400 and 602 “and records in accordance with Subpart 2.7, “Quality Assurance Requirements for Computer Software for Nuclear Facility Applications.”

Section 1.11

2.0 Section 1.12, Control of Measuring and Test Equipment (M&TE) Item 1.12.1: Added the section identifier for Requirement 12



Section 1.12




Revision Number

EffectiveDate

Reason forRevision

Line ofInquiry

(Section 301). Changed “time periods or usage” to “times or intervals” to match the standard.

Item 1.12.4: Added the section identifier for Requirement 12 (Section 301). Added the text shown in bold below to make the line of inquiry match the standard.

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?

Item 1.12.5: Added the section identifier for Requirement 12 (Section 301). Added the word “defined” to match the standard.

Item 1.12.6: Added the section identifier for Requirement 12 (Section 303.6). Added the text shown in bold below to make the line of inquiry match the standard.

Is M&TE suitably marked, tagged, labeled, or otherwise identified to indicate calibration status and establish traceability to calibration records?

Item 1.12.7: Added the section identifier for Requirement 12 (Section 401). Changed “measuring and test equipment” to “M&TE.” Changed “their” to “its” to match the standard.

2.0 Section 1.13, Inspection, Test, and Operating Status Item 1.13.1: Added the section identifier for Requirement 14

(Section 100). Changed “assure” to “ensure” and added a comma to match the standard.

Item 1.13.2: Added the section identifier for Requirement 14

Section 1.13




Revision Number

EffectiveDate

Reason forRevision

Line ofInquiry

(Section 100). Added the words “shop travelers, stamps, inspection records” to match the standard. Added the following sentence to this line of inquiry to match the standard:

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?

2.0 Section 1.14, Control of Nonconforming Items Item 1.14.1: Added the section identifier for Requirement 15







(Section 402). Split the line of inquiry into two sentences. Added “installation” to the second sentence to match the standard.

Section 1.14

2.0 Section 1.15, Corrective Action Item 1.15.1: Added the section identifier for Requirement 16

(Section 100). Changed “practical” to “practicable” to match the standard. Merriam-Webster defines “practicable” as “capable of being put into practice or of being done or accomplished.”

Section 1.15




Revision Number

EffectiveDate

Reason forRevision

Line ofInquiry

Item 1.15.2: Added the section identifier for Requirement 16 (Section 100). Added the following introductory phrase to match the standard: “In the case of a significant condition adverse to quality.” Moved the second sentence to Item 1.15.5.



Item 1.15.5: Moved the second sentence from Item 1.15.2 to become a new line of inquiry Item 15.5.5 because it is from a DOE Order rather than NQA-1. Revised the text to match the DOE Order. Added the reference. The new line of inquiry reads as follows:

After completion of a corrective action or a set of corrective actions, is an effectiveness review conducted using trained and qualified personnel that can verify the corrective action/corrective action plan has been effectively implemented to prevent recurrences?

DOE Order 226.1B, Attachment 1, Paragraph 2b(3)(b)(3)2.0 1.16, Quality Assurance Records




Item 1.16.4: Added the section identifier for Requirement 17 (Sections 601 and 800).

Section 1.16




Revision Number

EffectiveDate

Reason forRevision

Line ofInquiry

Item 1.16.5: Added the NQA-1 Requirement number and the section identifier (Requirement 17, Section 601).

Item 1.16.6: Added the NQA-1 Requirement number and the section identifier (Requirement 17, Section 300).

2.0 1.17, Assessments and Audits Item 1.17.1: Added the section identifier from Requirement 18

(Section 100). Added the bold text shown below to match the standard.

Are assessments performed to verify compliance to the QA program requirements, to verify that performance criteria are met, and to determine the effectiveness of the program?

Item 1.17.2: Added the section identifier from Requirement 18 (Section 100).

Item 1.17.3: Added the section identifier from Requirement 18 (Sections 100 and 800). Added the third sentence as shown below from Section 800.

Do assessment records include the following: Assessment plan, Assessment report, Written replies, and Record of completion of corrective action?



Item 1.17.6: Added a new line of inquiry for vendor/supplier audits as shown below.

Section 1.17




Revision Number

EffectiveDate

Reason forRevision

Line ofInquiry

Audits of suppliers shall be performed on a triennial basis and supplemented by annual evaluations of the supplier’s performance to determine if the regular schedule audit frequency shall be maintained or decreased or if other corrective action is required.

NQA-1 Requirement 18, Sections 200 and 2022.0 1.18, Laboratory QA

Item 1.18: Added the note shown below.

NOTE: On-site laboratory quality requirements are usually identified in the DOE contract, RCRA permit, other site permits, state-specific requirements, EPA methods used by the laboratory, Land Disposal Restrictions, and consensus standards invoked by the site’s QAP/laboratory QAP, which may include ASTM (e.g., ASTM E898, ASTM E617, ASTM D 1193-1999), NIST (e.g., NIST Handbook 44), ISO/IEC, TNI, etc. Therefore, the lines of inquiry (LOIs) provided below are general and are not linked to specific requirements documents (although many of the LOIs were developed using the guidance contained in EPA SW-846, Chapter One, dated July 2014).

Item 18.1.1: Changed the requirement reference to a guidance reference. Added “2014” to EPA SW-846, Chapter One.



Item 18.1.4: Changed the requirement reference to a guidance

Section 1.18




Revision Number

EffectiveDate

Reason forRevision

Line ofInquiry

reference. Added “2014” to EPA SW-846, Chapter One. Item 18.1.5: Changed “SOPs” to “procedures.” Item 18.1.6: Changed the requirement reference to a guidance

reference. Added “2014” to EPA SW-846, Chapter One. Item 18.1.7: Item 18.1.8: Changed the requirement reference to a guidance

reference. Added “2014” to EPA SW-846, Chapter One. Item 18.1.9: Changed the requirement reference to a guidance

reference. Item 18.1.10: Added the year to ASTM E898-2013. Changed

the requirement reference to a guidance reference. Item 18.1.11: Added the year to ASTM E898-2013. Removed

the hyphen from “reverified.” Changed the requirement reference to a guidance reference.

Item 18.1.12: Changed the requirement reference to a guidance reference. Deleted the reference to ASTM E898-1988.

Item 18.1.13: Changed the requirement reference to guidance references from DoD/DOE and the EPA.

2.1 March 7, 2017 Removed Official Use Only Designation




Notes:

lines of inquiry - p2s€¦ · web viewnqa-1 requirement 18, section 700 1.17.6 audits of...

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