EPA Audit of WIPP QA Program: LANL-CO WIPP QA 1-1

ASME NQA-1-1989 CHECKLIST

NQA-1 ELEMENT: No. 1 with Supplement 1S-1, Organization EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

Basic Requirements

1. Are the organizational structure, functional responsibilities, levels of 

authority and lines of communication documented for activities 

affecting quality?

Y QAPD, Revision 11, section 1.1, Organization and Quality Assurance Program; 

section 1.1.1.4, Communication and Interface Responsibilities, paragraph A; Appendix 

C, CBFO Organization, Responsibilities, and Interfaces; Appendix D, CBFO Quality 

Assurance Manager Responsibilities; Appendix E, TRU Waste Characterization and 

Certification Organizational and Individual Responsibilities

LCO-ACP-01, Revision 4, section 2.0, Scope; section 4.0, Responsibilities; section 5.0, 

Organizational Interfaces

LCO-QPD-06, Revision 2, section 2.0, Mission Description; section 3.0, Organization 

and Quality Assurance Program 

LANL-CO Organization Chart for EPA Audit, provided 6/2/2014

Key Position Descriptions, provided 6/2/2014

2. Do persons or organizations responsible for performing quality 

assurance functions have sufficient authority, access to work areas 

and organizational freedom to:

 Identify quality problems?

 Initiate, recommend, or provide solutions to quality problems 

through designated channels?

 Verify implementation of solutions?

 Assure that further processing, delivery, installation or use is 

controlled until proper disposition of a nonconformance, 

deficiency or unsatisfactory condition has occurred?

Y QAPD, Revision 11, section 1.1.1.3, QA Management, paragraphs A and B; Appendix 

D, CBFO Quality Assurance Manager Responsibilities

LCO-ACP-01, Revision 4, section 4.3, LANL-CO Quality Assurance Manager; section 

4.4, CEMRC Quality Assurance Manager; section 5.3, Quality Assurance

LCO-QPD-06, Revision 2, section 3.2, LANL-CO WIPP/RSO Program Director 

Responsibilities; section 3.4, QA Manager Responsibilities; section 3.5, Communication 

Responsibilities

LCO-MP18-1, Revision 4, section 4.0, Responsibilities; section 5.0, Procedure

Key Position Descriptions, provided 6/2/2014

3. Do persons or organizations responsible for performing quality 

assurance functions have direct access to responsible management at 

a level where appropriate action can be effected?

Y QAPD, Revision 11, section 1.1.1.3, QA Management, paragraph A.7; Appendix C, 

CBFO Organization, Responsibilities, and Interfaces

LCO-QPD-06, Revision 2, section 3.2, LANL-CO WIPP/RSO Program Director 

Responsibilities; section 3.4, QA Manager Responsibilities; section 3.5, Communication 

Responsibilities

LANL-CO Organization Chart for EPA Audit, provided 6/2/2014

LCO-MP18-1, Revision 4, section 4.0, Responsibilities; section 5.0, Procedure

4. Do persons or organizations responsible for performing quality 

assurance functions report to a management level that provides the 

required authority and organizational freedom, including sufficient 

Y QAPD, Revision 11, section 1.1.1.3, QA Management, paragraphs A.7–10 and B

LCO-QPD-06, Revision 2, section 3.2, LANL-CO WIPP/RSO Program Director 
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 1-2

independence from cost and schedule considerations? Responsibilities; section 3.4, QA Manager Responsibilities; section 3.5, Communication 

Responsibilities

LANL-CO Organization Chart for EPA Audit, provided 6/2/2014

Supplementary Requirements (1S-1)

1. Are the organizational structure and the responsibility assignments 

such that:

 Quality is achieved and maintained by those who have been 

assigned responsibility for performing work?

 Quality achievement is verified by persons or organizations not 

directly responsible for performing the work?

Y QAPD, Revision 11, section 1.1.1, Organization; section 1.1.1.2, Employees; section 

1.1.1.3, QA Management; Appendix D, CBFO Quality Assurance Manager 

Responsibilities

LCO-ACP-01, Revision 4, section 4.0, Responsibilities; section 5.0, Organizational 

Interfaces

LCO-QPD-06, Revision 2, section 3.0, Organization and Quality Assurance Program; 

section 4.0, Qualification and Training Requirements

LANL-CO Organization Chart for EPA Audit, provided 6/2/2014

Key Position Descriptions, provided 6/2/2014

2. Do the individuals or organizations responsible for establishing and 

executing a quality assurance program delegate any or all of the work

to others, and, if so, do the individuals or organizations retain 

responsibility for the quality assurance program?

Y QAPD, Revision 11, section 1.1.1.5, Delegation of Work

LCO-QPD-06, Revision 2, section 3.0, Organization and Quality Assurance Program

LCO-MP18-1, Revision 4, section 4.0, Responsibilities; section 5.0, Procedure

3. Is responsibility for the control of further processing, delivery, 

installation or operation of nonconforming items designated in 

writing?

N/A QAPD, Revision 11, section 1.1.1.3, QA Management, paragraph B.4; section 1.3.2.1, 

Documenting and Evaluating Nonconforming Items, paragraph E

4. Where more than one organization is involved in the execution of 

quality assurance activities, is the responsibility and authority of each 

organization clearly established and documented?

Y QAPD, Revision 11, section 1.1.1.4, Communication and Interface Responsibilities, 

paragraph B; Appendix C, CBFO Organization, Responsibilities, and Interfaces

LCO-ACP-01, Revision 4, section 4.0, Responsibilities; section 5.0, Organizational 

Interfaces

5. Are the external interfaces between organizations, as well as the 

internal interfaces between organizational units, documented? Are 

interface responsibilities defined and documented?

Y QAPD, Revision 11, section 1.1.1.4, Communication and Interface Responsibilities, 

paragraph B; Appendix C, CBFO Organization, Responsibilities, and Interfaces

LCO-ACP-01, Revision 4, section 4.0, Responsibilities; section 5.0, Organizational 

Interfaces

LCO-QPD-06, Revision 2, section 3.6, Interface Responsibilities

*Y: The referenced documents adequately define, describe, address or satisfy the NQA-1-1989 requirement.

N: The referenced documents do not adequately define, describe, address or satisfy the NQA-1-1989 requirement.

I: EPA requires additional information to determine if the referenced documents adequately define, describe, address or satisfy the NQA-1-1989 requirement.

 N/A: The specific NQA-1-1989 requirement is not applicable to the subject QA program.
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 2-1

ASME NQA-1-1989 CHECKLIST

NQA-1 ELEMENT: No. 2 with Supplements 2S-1, 2S-2, 2S-3 and EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

2S-4, Quality Assurance Program

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

Basic Requirements

1. Is a documented quality assurance program planned, implemented 

and maintained in accordance with NQA-1?

Y QAPD, Revision 11, section 1.1.2.1, Quality Assurance Program Documents

LCO-QP2-1, Revision 5, Establishing Quality Controls

LCO-QP2-2, Revision 5, Quality Assurance Requirements for Quality Level One 

Activities

LCO-QP2-3, Revision 5, Qualification and Training

2. Does the quality assurance program identify the activities and items 

to which it applies?

Y QAPD, Revision 11, section 1.1.2.2, Applicability of QAPD Requirements

LCO-QP2-1, Revision 5, Establishing Quality Controls

LCO-QP2-2, Revision 5, Quality Assurance Requirements for Quality Level One 

Activities

3. Does the quality assurance program provide control over activities 

affecting quality to an extent consistent with their importance?

Y QAPD, Revision 11, section 1.1.2.3, Grading Items and Activities and Applying 

Management Controls

LCO-QP2-1, Revision 5, Establishing Quality Controls

LCO-QP2-2, Revision 5, Quality Assurance Requirements for Quality Level One 

Activities

Grading for FY11 and FY12, GRD-1204-01-01-01

Grading for FY13, GRD-1301-01-01-01

Grading for FY14, GRD-1312-01-01-01

4. Was the quality assurance program established at the earliest time 

consistent with the schedule for accomplishing the activities?

Y QAPD, Revision 11, section 1.1.2.3, Grading Items and Activities and Applying 

Management Controls.

LCO-QP2-1, Revision 5, Establishing Quality Controls

LCO-QP2-2, Revision 5, Quality Assurance Requirements for Quality Level One 

Activities

Grading for FY11 and FY12, GRD-1204-01-01-01

Grading for FY13, GRD-1301-01-01-01

Grading for FY14, GRD-1312-01-01-01

5. Does the quality assurance program provide for the planning and 

accomplishment of activities affecting quality under suitably 

controlled conditions, which include the use of appropriate 

N/A QAPD, Revision 11, section 1.1.2.4, Planning Work, paragraphs E and G
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 2-2

NQA-1 ELEMENT: No. 2 with Supplements 2S-1, 2S-2, 2S-3 and EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

2S-4, Quality Assurance Program

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

equipment, suitable environmental conditions for accomplishing the 

activity and assurance that prerequisites for the given activity have 

been satisfied?

6. Does the quality assurance program provide for any special controls, 

processes, test equipment, tools and skills to attain the required 

quality and for verification of quality?

N/A QAPD, Revision 11, section 1.1.2.4, Planning Work

7. Does the quality assurance program provide for indoctrination and 

training of personnel performing activities affecting quality?

Y QAPD, Revision 11, section 1.2.2, Training Requirements, paragraph A

LCO-QP2-3, Revision 5, Qualification and Training

QA-DL-01, LANL-CO QA Distribution and Required Reading List, TRN-1406-01-01-

01, Revision 11

2013 Peer Inspector Training Attendance Record, TRN-1302-01-01-01

Training records for B. Ams, D. Guerin D, A. Heiser, D. Reed, C. Stroud

8. Does the management of the organizations implementing the quality 

assurance program regularly assess the adequacy of that part of the 

program for which they are responsible and assure its effective 

implementation?

Y QAPD, Revision 11, section 1.1.1.3, QA Management

LCO-MP18-1, Revision 4, Management Assessments

Management Assessment MA-12-01, MAR-1203-01-01-01

Management Assessment MA-12-02, MAR-1205-02-01-01

Management Assessment MA-12-03, MAR-1210-01-01-01

Management Assessment MA-12-04, MAR-1209-01-01-01

Management Assessment MA-12-05, MAR-1208-01-01-01

Management Assessment MA-12-06, MAR-1303-02-01-01

Management Assessment MA-13-01, MAR-1303-01-01-01

Management Assessment MA-13-02, MAR-1310-01-01-01

Management Assessment MA-13-03, MAR-1305-01-01-01

Management Assessment MA-13-04, MAR-1404-01-01-01

Management Assessment MA-14-01, MAR-1403-01-01-01

Supplementary Requirements (2S-1)

1. Does the responsible organization designate those activities that 

require qualified inspection and test personnel and minimum 

requirements for such personnel?

N/A QAPD, Revision 11, section 2.4.1, Qualification of Inspection and Test Personnel, 

paragraph A
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 2-3

NQA-1 ELEMENT: No. 2 with Supplements 2S-1, 2S-2, 2S-3 and EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

2S-4, Quality Assurance Program

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

2. Has the responsible organization established written procedures for 

the qualification of inspection and test personnel to assure that only 

qualified personnel are permitted to perform inspection and test 

activities?

N/A QAPD, Revision 11, section 2.4.1, Qualification of Inspection and Test Personnel, 

paragraph A

3. Do personnel selected for performing inspection and test activities 

have the experience or training commensurate with the scope, 

complexity or special nature of the activities?

N/A QAPD, Revision 11, section 1.2.1, Qualification Requirements, paragraph A; section 

2.4.1

4. Have provisions been made for the indoctrination of personnel 

regarding the technical objectives and requirements of the applicable 

codes and standards and the quality assurance program elements that 

are to be employed?

N/A QAPD, Revision 11, section 2.4.1, Qualification of Inspection and Test Personnel, 

paragraph D

5. Has the need for a formal training program been determined? Are 

training activities, including on-the-job training, conducted to qualify 

personnel who perform inspections and tests?

N/A QAPD, Revision 11, section 2.4.1, Qualification of Inspection and Test Personnel, 

paragraph E

6. Are the capabilities of a candidate for certification initially 

determined by a suitable evaluation of the candidate’s education, 

experience, training and either test results or capability 

demonstration?

N/A QAPD, Revision 11, section 2.4.1, Qualification of Inspection and Test Personnel, 

paragraph F

7. Is the job performance of inspection and test personnel reevaluated at 

periodic intervals not to exceed three years?

N/A QAPD, Revision 11, section 2.4.1, Qualification of Inspection and Test Personnel,

paragraph G

8. If it is determined at any time that the capabilities of an individual 

are not in accordance with the qualification requirements specified 

for the job, is that person removed from that activity until such time 

as the required capability has been demonstrated?

N/A QAPD, Revision 11, section 2.4.1, Qualification of Inspection and Test Personnel, 

paragraph G

9. Is a person reevaluated for a required inspection or test capability if 

activities have not been performed in his or her qualified area for a 

period of one year?

N/A QAPD, Revision 11, section 2.4.1, Qualification of Inspection and Test Personnel, 

paragraph G

10. Is the qualification of personnel certified in writing in an appropriate 

form, including:

 Employer’s name?

 Identification of person being certified?

 Activities certified to perform?

N/A QAPD, Revision 11, section 2.4.1, Qualification of Inspection and Test Personnel, 

paragraph H
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 2-4

NQA-1 ELEMENT: No. 2 with Supplements 2S-1, 2S-2, 2S-3 and EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

2S-4, Quality Assurance Program

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

 Basis used for certification, including:

– Education, experience, indoctrination and training?

– Test results, where applicable?

– Results of capability demonstration?

 Results of periodic evaluation?

 Results of physical examinations, when required?

 Signature of employer’s designated representative who is 

responsible for such certification?

 Date of certification and date of certification expiration?

11. Has the responsible organization identified any special physical 

characteristics needed in the performance of each activity, including 

the need for initial and subsequent physical examination?

N/A QAPD, Revision 11, section 2.4.1, Qualification of Inspection and Test Personnel, 

paragraph I

12. Does the employer establish and maintain records of personnel 

qualification?

N/A QAPD, Revision 11, section 2.4.1, Qualification of Inspection and Test Personnel, 

paragraph J

Supplementary Requirements (2S-2)

1. Does the quality assurance program provide for the qualification of 

nondestructive examination personnel to the American Society of 

Nondestructive Testing Recommended Practice No. SNT-TC-1A, 

issued June 1980?

N/A CBFO QAPD, Revision 11, section 2.4.2, Qualification of Nondestructive Examination 

Personnel, paragraph A

2. Has the responsible organization established written procedures for 

the control and administration of nondestructive examination

personnel training, examination and certification?

N/A QAPD, Revision 11, section 2.4.2, Qualification of Nondestructive Examination 

Personnel, paragraph B

3. Does the employer establish and maintain records of personnel 

qualification?

N/A QAPD, Revision 11, section 2.4.2, Qualification of Nondestructive Examination 

Personnel, paragraph C

Supplementary Requirements (2S-3)

1. Has the responsible auditing organization established the 

qualifications for audit personnel and the requirements for the use of 

technical specialists to accomplish the auditing of quality assurance 

programs?

Y QAPD, Revision 11, section 3.2.2.4, Auditor Qualification.

LCO-QP18-2, Revision 3, section 5.3, Lead Auditor Qualification

Lead Auditor Qualification for L. Sparks, TRN-0510-01-01-01

Quality Assurance Project Leader Qualification for L. Sparks, TRN-0502-05-01-01

Lead Auditor Maintenance of Proficiency for L. Sparks, TRN-1310-02-01-01

List of Qualified Audit Personnel, provided 6/2/2014
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 2-5

NQA-1 ELEMENT: No. 2 with Supplements 2S-1, 2S-2, 2S-3 and EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

2S-4, Quality Assurance Program

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

2. Is the competence of audit personnel developed by one or more of the 

following methods:

 Orientation to provide a working knowledge and understanding of 

NQA-1 and the auditing organization’s procedures for 

implementing audits and reporting results?

 Training programs to provide general and specialized training in 

audit performance?

 On-the-job training, guidance and counseling under the direct 

supervision of a lead auditor?

Y QAPD, Revision 11, section 3.2.2.4, Auditor Qualification, paragraphs A–C.

LCO-QP18-2, Revision 3, section 5.3, Lead Auditor Qualification

Lead Auditor Qualification for L. Sparks, TRN-0510-01-01-01

Quality Assurance Project Leader Qualification for L. Sparks, TRN-0502-05-01-01

Lead Auditor Maintenance of Proficiency for L. Sparks, TRN-1310-02-01-01

List of Qualified Audit Personnel, provided 6/2/2014

3. Does a prospective lead auditor have the capability to communicate 

effectively, both in writing and orally? Has the lead auditor’s 

employer attested to these skills in writing?

Y QAPD, Revision 11, section 3.2.2.6, Lead Auditor Qualification, paragraph B, Lead 

Auditor Communication Skills.

LCO-QP-18-2, Revision 3, section 5.3, Lead Auditor Qualification

Lead Auditor Qualification for L. Sparks, TRN-0510-01-01-01

Quality Assurance Project Leader Qualification for L. Sparks, TRN-0502-05-01-01

Lead Auditor Maintenance of Proficiency for L. Sparks, TRN-1310-02-01-01

4. Are prospective lead auditors trained, as necessary, to assure their 

competence in auditing skills, including training in the following 

areas:

 Knowledge and understanding of NQA-1 and other nuclear-related 

codes, standards, regulations and regulatory guides?

 General structure of quality assurance programs as a whole and 

applicable elements as defined by NQA-1?

 Auditing techniques of examining, questioning, evaluating and 

reporting; methods of identifying and following up on corrective 

action items; and closing out audit findings?

 Audit planning in the quality-related functions for the following 

activities: design, purchasing, fabrication, handling, shipping, 

storage, cleaning, erection, installation, inspection, testing, 

statistics, nondestructive examination, maintenance, repair, 

operation, modification of nuclear facilities or associated 

components, and safety aspects of the nuclear facility?

 On-the-job training to include applicable elements of the audit 

program?

Y QAPD, Revision 11, section 3.2.2.6, Lead Auditor Qualification, paragraph C, Lead 

Auditor Training.

LCO-QP18-2, Revision 3, section 5.3, Lead Auditor Qualification

Lead Auditor Qualification for L. Sparks, TRN-0510-01-01-01

Quality Assurance Project Leader Qualification for L. Sparks, TRN-0502-05-01-01

Lead Auditor Maintenance of Proficiency for L. Sparks, TRN-1310-02-01-01

List of Qualified Audit Personnel, provided 6/2/2014
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 2-6

NQA-1 ELEMENT: No. 2 with Supplements 2S-1, 2S-2, 2S-3 and EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

2S-4, Quality Assurance Program

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

5. Is a prospective lead auditor required to have participated in a 

minimum of five quality assurance audits within a period of time not 

to exceed three years prior to the date of qualification, one audit of 

which shall be a nuclear quality assurance audit within one year prior 

to qualification?

Y QAPD, Revision 11, section 3.2.2.6, Lead Auditor Qualification, paragraph A.2,

Experience.

LCO-QP18-2, Revision 3, section 5.3, Lead Auditor Qualification

Lead Auditor Qualification for L. Sparks, TRN-0510-01-01-01

Quality Assurance Project Leader Qualification for L. Sparks, TRN-0502-05-01-01

Lead Auditor Maintenance of Proficiency for L. Sparks, TRN-1310-02-01-01

List of Qualified Audit Personnel, provided 6/2/2014

6. Is a prospective lead auditor required to pass an examination that

evaluates his or her comprehension of and ability to apply the body 

of knowledge identified under the training requirements (listed under 

question 4 above)?

Y QAPD, Revision 11, section 3.2.2.6, Lead Auditor Qualification, paragraph D, Lead 

Auditor Examination.

LCO-QP18-2, Revision 3, section 5.3, Lead Auditor Qualification

Lead Auditor Qualification for L. Sparks, TRN-0510-01-01-01

Quality Assurance Project Leader Qualification for L. Sparks, TRN-0502-05-01-01

Lead Auditor Maintenance of Proficiency for L. Sparks, TRN-1310-02-01-01

List of Qualified Audit Personnel, provided 6/2/2014

7. Do lead auditors maintain their proficiency through one or more of 

the following:

 Regular and active participation in the audit process?

 Review and study of codes, standards, procedures, instructions and 

other documents related to quality assurance program and program 

auditing?

 Participation in training programs?

Y QAPD, Revision 11, section 3.2.2.6, Lead Auditor Qualification, paragraph F, Lead 

Auditor Proficiency Maintenance.

LCO-QP18-2, Revision 3, section 5.3, Lead Auditor Qualification

Lead Auditor Maintenance of Proficiency for L. Sparks, TRN-1310-02-01-01

8. Does management conduct documented annual assessments of lead 

auditors to extend their qualification, require retraining or require 

requalification?

Y QAPD, Revision 11, section 3.2.2.6, Lead Auditor Qualification, paragraph F, Lead 

Auditor Proficiency Maintenance.

LCO-QP18-2, Revision 3, section 5.3, Lead Auditor Qualification

Lead Auditor Maintenance of Proficiency for L. Sparks, TRN-1310-02-01-01

9. Are lead auditors who fail to maintain their proficiency for a period 

of two years or more required to requalify?

Y QAPD, Revision 11, section 3.2.2.6, Lead Auditor Qualification, paragraph F, Lead 

Auditor Proficiency Maintenance.

LCO-QP18-2, Revision 3, section 5.3, Lead Auditor Qualification

10. Is the employer responsible for training auditors? Y QAPD, Revision 11, section 1.1.1.1, Management, paragraph C.1.

LCO-QP18-2, Revision 3, section 4.0, Responsibilities
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 2-7

NQA-1 ELEMENT: No. 2 with Supplements 2S-1, 2S-2, 2S-3 and EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

2S-4, Quality Assurance Program

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

11. Does the responsible auditing organization select and assign 

personnel who are independent of any direct responsibility for 

performance of the activities that they will audit?

Y QAPD, Revision 11, section 3.2.2.3, Audit Team Selection, paragraph A.

LCO-QP18-1, Revision 3, section 5.2, Audit Planning and Preparation

12. Does the lead auditor, prior to commencing the audit, concur that 

assigned audit personnel collectively have experience or training 

commensurate with the scope, complexity or special nature of the 

activities to be audited?

Y QAPD, Revision 11, section 3.2.2.3, Audit Team Selection, paragraph C.

LCO-QP18-1, Revision 3, section 5.2, Audit Planning and Preparation

13. Is the employer responsible for the development and administration 

of the examination for a lead auditor? If the employer delegates this 

activity to an independent certifying agency, does the employer 

retain responsibility for the conformance of the examination and its 

administration to the NQA-1-1989 standard?

Y QAPD, Revision 11, section 3.2.2.6, Lead Auditor Qualification, paragraph D, Lead 

Auditor Examination.

LCO-QP18-2, Revision 3, section 4.0, Responsibilities

Lead Auditor Qualification for L. Sparks, TRN-0510-01-01-01

14. Does the employer establish and maintain records of personnel 

qualifications for auditors and lead auditors performing audits?

Y QAPD, Revision 11, section 3.2.2.6, Lead Auditor Qualification, paragraph D, Lead 

Auditor Examination.

LCO-QP18-2, Revision 3, section 6.0, Records

Lead Auditor Qualification for L. Sparks, TRN-0510-01-01-01

15. Does the employer certify each lead auditor as being qualified to lead 

audits, including documentation of the following by the certification:

 Employer’s name?

 Lead auditor’s name?

 Date of certification or recertification?

 Basis of qualification (i.e., education, experience, communication 

skills, training, examination, etc.)?

 Signature of employer’s designated representative who is 

responsible for such certification?

Y QAPD, Revision 11, section 3.2.2.6, Lead Auditor Qualification, paragraph E, Lead 

Auditor Certification.

LCO-QP18-2, Revision 3, section 5.2, Auditor Qualification

Lead Auditor Qualification for L. Sparks, TRN-0510-01-01-01

16. Are the records for each lead auditor maintained and updated 

annually?

Y LCO-QP18-2, Revision 3, section 5.2, Auditor Qualification

Lead Auditor Maintenance of Proficiency for L. Sparks, TRN-1310-02-01-01

Supplementary Requirements (2S-4)

1. Are personnel identified for indoctrination or training? Y QAPD, Revision 11, section 1.2.2, Training Requirements, paragraph A; section 2.4.1, 

Qualification of Inspection and Test Personnel, paragraph C

LCO-QP2-3, Revision 5, section 1.0, Purpose
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 2-8

NQA-1 ELEMENT: No. 2 with Supplements 2S-1, 2S-2, 2S-3 and EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

2S-4, Quality Assurance Program

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

QA-DL-01, LANL-CO QA Distribution and Required Reading List, TRN-1406-01-01-

01, Revision 11

2. Is the extent of indoctrination and training commensurate with the 

following:

 The scope, complexity and nature of the activity?

 The education, experience and proficiency of the person?

Y QAPD, Revision 11, section 2.4.1, Qualification of Inspection and Test Personnel, 

paragraphs C and F

LCO-QP2-3, Revision 5, section 1.0, Purpose

2013 Peer Inspector Training Attendance Record, TRN-1302-01-01-01

Training records for B. Ams, D. Guerin D, A. Heiser, D. Reed, C. Stroud

3. Are personnel indoctrinated in the following subjects as they relate to 

a particular function:

 General criteria, including applicable codes, standards and 

company procedures?

 Applicable quality assurance program elements?

 Job responsibilities and authority?

Y QAPD, Revision 11, section 1.2.2, Training Requirements, paragraphs A and B; section 

2.4.1, Qualification of Inspection and Test Personnel, paragraph C

LCO-QP2-3, Revision 5, section 5.2, Qualification and Training

2013 Peer Inspector Training Attendance Record, TRN-1302-01-01-01

Training records for B. Ams, D. Guerin D, A. Heiser, D. Reed, C. Stroud

4. Is training provided, if needed, to:

 Achieve initial proficiency?

 Maintain proficiency?

 Adapt to changes in technology, methods or job responsibilities?

Y QAPD, Revision 11, section 1.2.2, Training Requirements, paragraph A

LCO-QP18-2, Revision 3, section 4.0, Responsibilities

2013 Peer Inspector Training Attendance Record, TRN-1302-01-01-01

Training records for B. Ams, D. Guerin D, A. Heiser, D. Reed, C. Stroud

5. Do records of the implementation of indoctrination and training take 

the form of:

 Attendance sheets?

 Training logs?

 Personnel training records?

Y QAPD, Revision 11, section 1.2.2, Training Requirements, paragraph C

LCO-QP18-2, Revision 3, section 6.0, Records

2013 Peer Inspector Training Attendance Record, TRN-1302-01-01-01

Training records for B. Ams, D. Guerin D, A. Heiser, D. Reed, C. Stroud

*Y: The referenced documents adequately define, describe, address or satisfy the NQA-1-1989 requirement.

N: The referenced documents do not adequately define, describe, address or satisfy the NQA-1-1989 requirement.

I: EPA requires additional information to determine if the referenced documents adequately define, describe, address or satisfy the NQA-1-1989 requirement.

 N/A: The specific NQA-1-1989 requirement is not applicable to the subject QA program.
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 4-1

ASME NQA-1-1989 CHECKLIST

NQA-1 ELEMENT: No. 4 with Supplement 4S-1, Procurement EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

Document Control

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

Basic Requirements

1. Are procurement documents required to reference or include design 

bases or quality requirements?

Y QAPD, Revision 11, section 2.3.4, Procurement Document Requirements

LCO-MP7-1, Revision 7-AC1, sections 5.3.4 and 5.3.5, Instructions for Requestor for 

Procurement of QL1 Materials and Services and Maintaining the LANL-CO Historical 

List of QL1 Procurements; Attachment 3, Example LANL-CO Procurement Request; 

Attachment 4, LANL-CO Example Material/Service Acceptance Form

Procurement Request PC-0429249 to Fisher, ACP-1210-02-04-02

Procurement Request PC-0450072 to High Purity Standards, ACP-1305-01-04-03

Procurement Request PC-0491122 to Troemner, ACP-1405-02-04-08

2. Do procurement documents require suppliers to have a quality 

assurance (QA) program consistent with the requirements of NQA-1-

1989?

Y QAPD, Revision 11, section 2.3.4, Procurement Document Requirements, paragraph C.

LCO-MP7-1, Revision 7-AC1, Attachment 1, LANL-CO Supplier Evaluation Template. 

Henry Troemner, LLC requalification, QSL-1306-02-01-01

Mettler Toledo requalification, QSL-1208-01-01-01

High-Purity Standards requalification, QSL-1210-01-01-01

Supplier Evaluation of Michell Instruments, Inc., QSL-1312-01-01-01

Supplier Evaluation of Bruker AXS, Inc., QSL-1403-01-01-01

Supplementary Requirements (4S-1)

1. Do procurement documents include the following provisions as 

deemed necessary by the purchaser:

 Scope of work?

 Technical requirements?

 QA program requirements?

 Right of access?

 Documentation requirements?

 Requirement for documenting nonconformances?

 Spare and replacement parts?

Y QAPD, Revision 11, section 2.3.4, Procurement Document Requirements, paragraphs A–

C

LCO-MP7-1, Revision 7-AC1, section 5.3.5, Instructions for Requestor for Procurement 

of QL1 Materials and Services and Maintaining the LANL-CO Historical List of QL1 

Procurements; Attachment 3, Example LANL-CO Procurement Request

Procurement Request PC-0429249 to Fisher, ACP-1210-02-04-02

Procurement Request PC-0450072 to High Purity Standards, ACP-1305-01-04-03

Procurement Request PC-0491122 to Troemner, ACP-1405-02-04-08

2. Is the review of procurement documentation documented? Y QAPD, Revision 11, section 2.3.5, Procurement Document Review and Approval, 

paragraph B

LCO-MP7-1, Revision 7-AC1, section 5.3.11, Instructions for Reviewers for 

Procurement of QL1 Materials and Services and Maintaining the LANL-CO Historical 

List of QL1 Procurements; Attachment 3, Example LANL-CO Procurement Request; 
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 4-2

NQA-1 ELEMENT: No. 4 with Supplement 4S-1, Procurement EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

Document Control

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

Attachment 4, LANL-CO Example Material/Service Acceptance Form

Procurement Request PC-0429249 to Fisher, ACP-1210-02-04-02

Procurement Request PC-0450072 to High Purity Standards, ACP-1305-01-04-03

Procurement Request PC-0491122 to Troemner, ACP-1405-02-04-08

3. Are changes to procurement documents subject to the same degree of 

control as used in the preparation of the original documents?

Y QAPD, Revision 11, section 2.3.5, Procurement Document Review and Approval, 

paragraphs C and D

LCO-MP7-1, Revision 7-AC1, section 5.3.9, Instructions for Requestor for Procurement 

of QL1 Materials and Services and Maintaining the LANL-CO Historical List of QL1 

Procurements

*Y: The referenced documents adequately define, describe, address or satisfy the NQA-1-1989 requirement.

N: The referenced documents do not adequately define, describe, address or satisfy the NQA-1-1989 requirement.

I: EPA requires additional information to determine if the referenced documents adequately define, describe, address or satisfy the NQA-1-1989 requirement.

 N/A: The specific NQA-1-1989 requirement is not applicable to the subject QA program.
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 5-1

ASME NQA-1-1989 CHECKLIST

NQA-1 ELEMENT: No. 5, Instructions, Procedures and Drawings EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

Basic Requirements

1. Are activities affecting quality prescribed by and performed in 

accordance with documented instructions, procedures or drawings?

Y QAPD, Revision 11, section 2.1, Work Processes, paragraph A

LCO-QP2-2, Revision 5, Attachment 1, Quality Assurance Requirements Checklist

Grading for FY11 and FY12, GRD-1204-01-01-01

Grading for FY14, GRD-1312-01-01-01

ACP-EXP-003, Revision 3, section 4.0, Responsibilities

LCO-QP16-1, Revision 4-AC1, section 5.4 Work Suspension

2. Do the documents referenced in question 1 include or reference 

appropriate quantitative or qualitative acceptance criteria?

Y QAPD, Revision 11, section 2.1.2, Implementing Procedures, paragraph B.4.

LCO-QP6-1, Revision 11, section 5.1.8, list of general information required in 

procedures.

ACP-EXP-003, Revision 3, section 5.2.4, Criteria for Performance Check Acceptance.

Supplementary Requirements – None

*Y: The referenced documents adequately define, describe, address or satisfy the NQA-1-1989 requirement.

N: The referenced documents do not adequately define, describe, address or satisfy the NQA-1-1989 requirement.

I: EPA requires additional information to determine if the referenced documents adequately define, describe, address or satisfy the NQA-1-1989 requirement.

 N/A: The specific NQA-1-1989 requirement is not applicable to the subject QA program.
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 6-1

ASME NQA-1-1989 CHECKLIST

NQA-1 ELEMENT: No. 6 with Supplement 6S-1, Document Control EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A*

Applicable Procedure and Paragraph; Additional Objective Evidence

Basic Requirements

1. Are the preparation, issue and change of documents that specify 

quality requirements or prescribe activities affecting quality 

controlled?

Y QAPD, Revision 11, section 1.4.1, Document Preparation, Review, Approval, and 

Issuance; section 1.4.3, Document Changes

LCO-QPD-04, Revision 8, section 1.0, Purpose

LCO-QP6-1, Revision 11, Controlled Document Development, Change, and Revision

LCO-QP6-2, Revision 11, Controlled Document Review and Approval

LCO-QP6-3, Revision 11, Document Control and Distribution

2. Are such documents, including changes thereto, reviewed for 

adequacy and approved for release by authorized personnel?

Y QAPD, Revision 11, section 1.4.1, Document Preparation, Review, Approval, and 

Issuance, paragraphs A and J; section 1.4.3, Document Changes, paragraph A

LCO-QPD-04, Revision 8, section 4.2, Controlled Document Review and Approval

ACP-EXP-003, Revision 3, cover page

LCO-QPD-04, Revision 7 review package

Supplementary Requirements (6S-1)

1. Are documents controlled to assure that correct and applicable 

documents are available at the location where they are to be used?

Y QAPD, Revision 11, section 1.4.2, Document Distribution and Use

LCO-QPD-04, Revision 8, section 4.0, Documents

LCO-QP6-3, Revision 11, Document Control and Distribution

2. Does the document control system provide for:

 Identification of documents to be controlled and their specified 

distribution?

 Identification of personnel, positions or organizations responsible 

for preparing, reviewing, approving and issuing documents?

 Review of documents for adequacy, completeness and correctness 

prior to approval and issuance?

Y QAPD, Revision 11, section 1.4.1, Document Preparation, Review, Approval, and 

Issuance

LCO-QPD-04, Revision 8, section 4.0, Documents

LCO-QP6-1, Revision 11, section 1.0, Purpose; section 4.0, Responsibilities

LCO-QP6-2, Revision 11, section 4.0, Responsibilities; paragraph 5.13, Instructions for 

Reviewer

LCO-QP6-3, Revision 11, section 4.0, Responsibilities

3. Are major changes to documents reviewed and approved by the same 

organization that performed the original review and approval, or is 

another organization specifically designated to review and approve 

the major change?

Y QAPD, Revision 11, section 1.4.3, Document Changes, paragraph A

LCO-QP6-2, Revision 11, paragraph 5.2, Instructions for Originator and Manager

Review Package for INV-SP-03, Revision 10

Review Package for INV-SP-03, Revision 11 

Review Package for LCO-QPD-04, Revision 7

Review Package for LCO-QPD-04, Revision 8
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 6-2

NQA-1 ELEMENT: No. 6 with Supplement 6S-1, Document Control EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A*

Applicable Procedure and Paragraph; Additional Objective Evidence

Review Package for LCO-QP2-1, Revisions 0 and 5

4. Does the organization reviewing major changes to documents have 

access to pertinent background data or information upon which to 

base its approval?

Y QAPD, Revision 11, section 1.4.1, Document Preparation, Review, Approval, and 

Issuance, paragraph D

LCO-QP6-2, Revision 11, paragraph 5.11, Instructions for Originator

Demonstration of document review request, demonstrated 7/23/2014

5. Are minor changes to documents defined (i.e., those changes that do 

not require a review as a major change)? Are the persons who can 

authorize a minor change clearly delineated?

Y QAPD, Revision 11, section 1.4.3, Document Changes, paragraphs C and E

LCO-QP6-1, Revision 11, section 5.5, Administrative Changes to Controlled 

Documents; paragraph 5.5.1, Instructions for Manager

LCO-QP6-2, Revision 11, paragraph 5.3, Instructions for Originator and Manager

LCO-QP16-1, Revision 4-AC1, Conditions Adverse to Quality

*Y: The referenced documents adequately define, describe, address or satisfy the NQA-1-1989 requirement.

N: The referenced documents do not adequately define, describe, address or satisfy the NQA-1-1989 requirement.

I: EPA requires additional information to determine if the referenced documents adequately define, describe, address or satisfy the NQA-1-1989 requirement.

 N/A: The specific NQA-1-1989 requirement is not applicable to the subject QA program.
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 7-1

ASME NQA-1-1989 CHECKLIST

NQA-1 ELEMENT: No. 7 with Supplement 7S-1, Control of EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

Purchased Items and Services

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

Basic Requirements

1. Does the control of purchased items and services provide for:

 Source evaluation and selection (as applicable)?

 Evaluation of objective evidence of quality furnished by the 

supplier?

 Source inspection or audit?

 Examination of items or services upon delivery or completion?

Y QAPD, Revision 11, section 2.3.2, Supplier Selection; section 2.3.3, Proposal/Bid 

Evaluation; section 2.3.7.1, Source Verification; section 2.3.7.2, Receiving Inspection

LCO-MP7-1, Revision 7-AC1, sections 5.1.3–5.1.6, Instructions for QA Manager for 

Development and Maintenance of the LANL-CO Qualified Supplier List; section 

5.3.18–5.3.20, Instructions for Peer Inspector for Procurement of QL1 Materials and 

Services and Maintaining the LANL-CO Historical List of QL1 Procurements

Henry Troemner, LLC requalification, QSL-1306-02-01-01

Mettler Toledo requalification, QSL-1208-01-01-01

High-Purity Standards requalification, QSL-1210-01-01-01

Material Acceptance Form for PC-0429249, ACP-1210-02-04-02

Material Acceptance Form for PC-0450072, ACP-1305-01-04-03

Material Acceptance Form for PC-0491122, ACP-1405-02-04-08

Supplementary Requirements (7S-1)

1. Does procurement planning determine the following:

 What is to be accomplished?

 Who is to accomplish it?

 How it is to be accomplished?

 When it is to be accomplished?

Y QAPD, Revision 11, section 2.3.1, Procurement Planning Requirements

LCO-MP7-1, Revision 7-AC1, Attachment 3, Example LANL-CO Procurement 

Request; Attachment 4, LANL-CO Example Material/Service Acceptance Form

Procurement Request and Material Acceptance Form for PC-0429249, ACP-1210-02-

04-02

Procurement Request and Material Acceptance Form for PC-0450072, ACP-1305-01-

04-03

Procurement Request and Material Acceptance Form for PC-0491122, ACP-1405-02-

04-08

2. Does procurement planning provide for the integration of:

 Procurement document preparation, review and change control?

 Selection of procurement sources?

 Bid evaluation and award?

 Purchaser control of supplier performance?

 Verification (surveillance, inspection or audit) activities by the 

purchaser, including notification for hold and witness points?

 Control of nonconformances?

Y QAPD, Revision 11, section 2.3.1, Procurement Planning Requirements, paragraphs

C.1–9

LCO-MP7-1, Revision 7-AC1, Attachment 3, Example LANL-CO Procurement 

Request; Attachment 4, LANL-CO Example Material/Service Acceptance Form

LANL-CO Qualified Supplier List, Updated 7/24/2014

Procurement Request and Material Acceptance Form for PC-0429249, ACP-1210-02-

04-02
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 7-2

NQA-1 ELEMENT: No. 7 with Supplement 7S-1, Control of EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

Purchased Items and Services

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

 Corrective action?

 Acceptance of item or service?

 Quality assurance records?

Procurement Request and Material Acceptance Form for PC-0450072, ACP-1305-01-

04-03

Procurement Request and Material Acceptance Form for PC-0491122, ACP-1405-02-

04-08

3. Are the measures for evaluation and selection of procurement 

sources documented? Do they include one or more of the following:

 Evaluation of the supplier’s history, including current capability, 

of providing an identical or similar product that performs 

satisfactorily in actual use?

 Supplier’s current quality records supported by documented 

qualitative and quantitative information that can be objectively 

evaluated?

 Supplier’s technical and quality capability as determined by a 

direct evaluation of its facilities and personnel and the 

implementation of its quality assurance program?

Y QAPD, Revision 11, section 2.3.2, Supplier Selection, paragraphs A, C and D

LCO-MP7-1, Revision 7-AC1, sections 5.1.3–5.1.7, Instructions for QA Manager for 

Development and Maintenance of the LANL-CO Qualified Supplier List; Attachment 1,

LANL-CO Supplier Evaluation Template

Henry Troemner, LLC requalification, QSL-1306-02-01-01

Mettler Toledo requalification, QSL-1208-01-01-01

High-Purity Standards requalification, QSL-1210-01-01-01

4. Are the following items considered in bid evaluations:

 Technical considerations?

 Quality assurance requirements?

 Supplier’s personnel?

 Supplier’s production capability?

 Supplier’s past performance?

 Alternates?

 Exceptions?

N/A QAPD, Revision 11, section 2.3.3, Proposal/Bid Evaluation

5. Are the following items considered in a supplier’s performance 

evaluation:

 Establishing an understanding between purchaser and supplier of 

the provisions and specifications of the procurement documents?

 Requiring the supplier to identify planning techniques and 

processes to be used in fulfilling procurement document 

requirements?

 Reviewing supplier documents that are generated or processed 

during activities fulfilling procurement requirements?

 Identifying and processing necessary change information?

 Establishing a method of document information exchange between 

purchaser and supplier?

Y QAPD, Revision 11, section 2.3.6, Supplier Performance Evaluation, paragraphs A–F

LCO-MP7-1, Revision 7-AC1, Attachment 3, Example LANL-CO Procurement 

Request

Procurement Request PC-0429249 to Fisher, ACP-1210-02-04-02

Procurement Request PC-0450072 to High Purity Standards, ACP-1305-01-04-03

Procurement Request PC-0491122 to Troemner, ACP-1405-02-04-08
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 7-3

NQA-1 ELEMENT: No. 7 with Supplement 7S-1, Control of EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

Purchased Items and Services

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

 Establishing the extent of source surveillance and inspection 

activities?

6. Are verification activities of the supplier’s quality performance 

planned, verified and documented by qualified personnel?

N/A QAPD, Revision 11, section 2.3.4, Procurement Document Requirements, paragraph

C.4

7. Are supplier-generated documents controlled, handled and approved 

in accordance with established methods?

Y QAPD, Revision 11, section 2.3.4, Procurement Document Requirements, paragraph

C.5

LCO-MP7-1, Revision 7-AC1, Attachment 3, Example LANL-CO Procurement 

Request; Attachment 4, LANL-CO Example Material/Service Acceptance Form

Calibration Certificates for PC-0491122, ACP-1405-02-04-08

8. Are measures established, implemented and documented to control 

changes to procurement documents?

Y QAPD, Revision 11, section 2.3.5, Procurement Document Review and Approval, 

paragraph A

LCO-MP7-1, Revision 7-AC1, section 5.3.9, Instructions for Requestor for 

Procurement of QL1 Materials and Services and Maintaining the LANL-CO Historical 

List of QL1 Procurements

9. Are methods established for the acceptance of an item or service 

being furnished by a supplier?

Y QAPD, Revision 11, section 2.3.7, Acceptance of Items or Services, paragraph A

LCO-MP7-1, Revision 7-AC1, section 5.3.18–5.3.20, Instructions for Peer Inspector for 

Procurement of QL1 Materials and Services and Maintaining the LANL-CO Historical 

List of QL1 Procurements

Material Acceptance Form for PC-0429249, ACP-1210-02-04-02

Material Acceptance Form for PC-0450072, ACP-1305-01-04-03

Material Acceptance Form for PC-0491122, ACP-1405-02-04-08

10. Is the supplier required to verify that the item or service being 

furnished complies with the procurement requirements? 

Y QAPD, Revision 11, section 2.3.7, Acceptance of Items or Services, paragraph B

LCO-MP7-1, Revision 7-AC1, Attachment 3, Example LANL-CO Procurement 

Request; Attachment 4, LANL-CO Example Material/Service Acceptance Form

Calibration Certificates for PC-0491122, ACP-1405-02-04-08

Certificate of Analysis for PC-0429249, ACP-1210-02-04-02

Certificate of Analysis for PC-0450072, ACP-1305-01-04-03

11. Are one or more of the following methods used to accept an item or 

related services from a supplier:

 Supplier certificate of conformance?

 Source verification?

Y QAPD, Revision 11, section 2.3.7.1, Source Verification; section 2.3.7.2, Receiving 

Inspection; section 2.3.7.3, Post-installation Testing; section 2.3.7.4, Supplier 

Certificate of Conformance

LCO-MP7-1, Revision 7-AC1, section 5.3.18–5.3.20, Instructions for Peer Inspector for 
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 7-4

NQA-1 ELEMENT: No. 7 with Supplement 7S-1, Control of EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

Purchased Items and Services

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

 Receiving inspection?

 Post-installation test?

Note: Specific requirements for each of the above are addressed in 

NQA-1-1989, Supplement 7S-1, paragraph 8.2.

Procurement of QL1 Materials and Services and Maintaining the LANL-CO Historical 

List of QL1 Procurements

Material Acceptance Form for PC-0429249, ACP-1210-02-04-02

Material Acceptance Form for PC-0450072, ACP-1305-01-04-03

12. Are one or more of the following methods used to accept purchased 

services:

 Technical verification of data produced?

 Surveillance and/or audit of the activity?

 Review of objective evidence for conformance to the procurement 

document requirements, such as certifications or stress reports?

Y QAPD, Revision 11, section 2.3.7.1, Source Verification, paragraph C

LCO-MP7-1, Revision 7-AC1, section 5.3.18–5.3.20, Instructions for Peer Inspector for 

Procurement of QL1 Materials and Services and Maintaining the LANL-CO Historical 

List of QL1 Procurements

Material Acceptance Form for PC-0491122, ACP-1405-02-04-08

2013 Peer Inspector Training Attendance Record, TRN-1302-01-01-01

13. Do the purchaser and supplier have documented methods for 

disposition of items and services that do not meet procurement 

document requirements?

Y QAPD, Revision 11, section 2.3.8, Control of Supplier Nonconformances

LCO-MP7-1, Revision 7-AC1, Attachment 3, Example LANL-CO Procurement 

Request

Procurement Request PC-0429249 to Fisher, ACP-1210-02-04-02

Procurement Request PC-0450072 to High Purity Standards, ACP-1305-01-04-03

Procurement Request PC-0491122 to Troemner, ACP-1405-02-04-08

14. Do the methods in question 13 contain provisions for:

 Evaluation of nonconforming items?

 Submittal of a nonconformance notice to the purchaser by the 

supplier as directed by the purchaser? (See note below.) Does this 

submittal include the supplier-recommended disposition (e.g., useas-is or repair) and technical justification? 

 Purchaser’s disposition of the supplier’s recommendation?

 Verification of the implementation of the disposition

 Maintenance of records of supplier-submitted nonconformances?

Note: Specific requirements for nonconformances to the procurement 

requirements or purchaser-approved documents are addressed in 

NQA-1-1989, Supplement 7S-1, paragraph 9(b).

Y QAPD, Revision 11, section 2.3.8, Control of Supplier Nonconformances

LCO-MP7-1, Revision 7-AC1, Attachment 3, Example LANL-CO Procurement 

Request

Procurement Request PC-0429249 to Fisher, ACP-1210-02-04-02

Procurement Request PC-0450072 to High Purity Standards, ACP-1305-01-04-03

Procurement Request PC-0491122 to Troemner, ACP-1405-02-04-08

*Y: The referenced documents adequately define, describe, address or satisfy the NQA-1-1989 requirement.

N: The referenced documents do not adequately define, describe, address or satisfy the NQA-1-1989 requirement.

I: EPA requires additional information to determine if the referenced documents adequately define, describe, address or satisfy the NQA-1-1989 requirement.

 N/A: The specific NQA-1-1989 requirement is not applicable to the subject QA program.
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 9-1

ASME NQA-1-1989 CHECKLIST

NQA-1 ELEMENT: No. 9 with Supplement 9S-1, Control of Processes EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

Basic Requirements

1. Are processes affecting the quality of items or services controlled? Y QAPD, Revision 11, section 2.1.2, Implementing Procedures, paragraph A

LCO-QPD-04, Revision 8, section 4.0, Documents

LCO-QP9-1, Revision 5, section 5.1, Analysis Plans; section 5.2, Standard Analyses

ACP-IMP-003, Revision 5, section 5.1, ACRSP Test Plans; section 5.2, ACRSP Task 

Implementation Plan

INV-SP-03, Revision 11, Requests for Quality Level 1 Inventory Information

QA Index of Quality Assurance Controlled Documents, 5/16/2014

2. Are special processes, such as welding, heat treating and 

nondestructive examination, performed by qualified personnel?

N/A QAPD, Revision 11, section 2.1.4, Special Processes, paragraph B

3. Are special processes performed in accordance with qualified 

procedures?

N/A QAPD, Revision 11, section 2.1.4, Special Processes, paragraph B

Supplementary Requirements (9S-1)

1. Are processes controlled by instructions, procedures, drawings, 

checklists, travelers or other appropriate means? Are process 

parameters controlled and specified environmental conditions 

maintained?

Y QAPD, Revision 11, section 2.1.4, Special Processes, paragraph B

LCO-QP9-1, Revision 5, section 5.1, Analysis Plans; section 5.2, Standard Analyses

ACP-IMP-003, Revision 5, section 5.1, ACRSP Test Plans; section 5.2, ACRSP Task 

Implementation Plan

QA Index of Quality Assurance Controlled Documents 5/16/2014

2. Is each special process performed in accordance with appropriate 

instructions, which include or reference procedure, personnel and 

equipment qualification requirements?

N/A QAPD, Revision 11, section 2.1.4, Special Processes, paragraph B

3. Do the special process procedures or instructions include conditions 

necessary for accomplishment of the process, including proper 

equipment, controlled process parameters and calibration 

requirements?

N/A QAPD, Revision 11, section 2.1.4, Special Processes, paragraph B

4. Do the special process procedures or instructions specify or reference 

applicable codes and standards, including acceptance criteria for the 

process?

N/A QAPD, Revision 11, section 2.1.4, Special Processes, paragraph B

5. Are records maintained for the currently qualified personnel, 

processes and equipment of each special process?

N/A QAPD, Revision 11, section 2.1.4, Special Processes, paragraph B; section 1.2.2, 

Training Requirements, paragraph C

*Y: The referenced documents adequately define, describe, address or satisfy the NQA-1-1989 requirement.
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 9-2

N: The referenced documents do not adequately define, describe, address or satisfy the NQA-1-1989 requirement.

I: EPA requires additional information to determine if the referenced documents adequately define, describe, address or satisfy the NQA-1-1989 requirement.

 N/A: The specific NQA-1-1989 requirement is not applicable to the subject QA program.
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 12-1

ASME NQA-1-1989 CHECKLIST

NQA-1 ELEMENT: No. 12 with Supplement 12S-1, Test Equipment EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

Basic Requirements

1. Is the measuring and test equipment used for activities affecting 

quality:

 Controlled?

 Calibrated?

 Adjusted to maintain accuracy within specified limits?

Y QAPD, Revision 11, section 2.4.6, Use and Control of M&TE, paragraphs A and D

ACP-IMP-004, Revision 5, section 1.0, Purpose

ACP-EXP-003, Revision 3, Balance Performance Check

ACP-EXP-005, Revision 4, Thermometer Calibration and Performance Check

ACP-EXP-006, Revision 4, UV-VIS-NIR Spectrophotometer Calibration and 

Performance Check

ACP-EXP-011, Revision 3-ACI, Inductively Coupled Plasma-Mass Spectrometry

ACSRP Scientific Notebook No. ICP-MS 4, ACP-1312-05-09-01, 5/21/2013–

10/31/2013, pages 1–24

Supplementary Requirements (12S-1)

1. Is the selection of measuring and test equipment controlled to assure 

that such items are of proper type, range, accuracy and tolerance to 

accomplish the function of determining conformance to specified 

requirements?

Y QAPD, Revision 11, section 2.4.3.1, Inspection Planning, paragraphs A.7 and A.8; 

section 2.4.4.1, Test Planning, paragraph C

ACP-IMP-003, Revision 5, section 2.1.2, Research Approach

LCO-QP9-1, Revision 5, section 5.1, Analysis Plans; section 5.2, Standard Analyses

LANL-CO Material/Service Acceptance and Quality Level Determination for 

Procurement Request CEMRC 01/10/2012 to Eckert & Ziegler Analytics for LSC 

Calibration Standards (C-14; H-3 and Background), ACP-1205-03-04-01, 3/27/2012

ICP-MS Iridium Standard, High Purity Standards Lot No. 1307214, ACP-1305-03-12-

15, 5/7/2013

ICP-MS Thorium Standard, High Purity Standards Lot No. 1234128, ACP-1305-03-12-

16, 5/7/2013

Procurement Request PC-0455212 to High Purity Standards for Multiple Standards for 

ICP-MS and IC Analysis and LANL-CO Material/Service Quality Level Determination 

Form, ACP-1309-02-04-01, 4/23/2013

Interference Check Solution A (ICP-MS-ICS 3, solution A) Standard for ICP-MS, High 

Purity Standards Lot No. 1405548, ACP-1406-01-12-95, 4/15/2014

Calibration standard-modified (ICP-MSCS-M) for ICP-MS, High Purity Standards Lot 

No. 1328419, ACP-1406-01-12-97, 4/15/2014
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 12-2

NQA-1 ELEMENT: No. 12 with Supplement 12S-1, Test Equipment EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

2. Is the measuring and test equipment calibrated at prescribed 

intervals?

Y QAPD, Revision 11, section 2.4.7, Calibration, paragraph A

ACP-EXP-003, Revision 3, section 1.0, Purpose 

ACP-EXP-005, Revision 4, ACP-EXP-005, Revision 4, section 5.1, Maintenance of 

NIST-Traceable Thermometers 

ACP-EXP-006, Revision 4, section 1.0, Purpose 

ACP-IMP-004, Revision 5, Attachment 1, ACRSP M&TE Data Sheet Instructions and 

Form

List of Measuring and Test Equipment, provided 6/2/2014

M&TE Data Sheet for Digital Hygro/Thermometer with Timer, DHT34 Control 

Company, S/N: 122454202, ACP-1301-02-12-35, 10/10/2012

ICP-MS Iridium Standard, High Purity Standards Lot No. 1307214, ACP-1305-03-12-

15, 5/7/2013

Working Document Cover Sheet, Liquid Scintillation System, Beckman LS6500, ACP0502-11-12-04, 10/11/2004

3. Is the measuring and test equipment calibrated to nationally 

recognized standards? If not, are the bases for calibration 

documented?

Y QAPD, Revision 11, section 2.4.7, Calibration, paragraph B

ACP-EXP-003, Revision 3, section 5.1, Calibration of Balances

ACP-EXP-005, Revision 4, section 5.1, Maintenance of NIST-Traceable Thermometers

ACP-IMP-004, Revision 5, Attachment 1, ACRSP M&TE Data Sheet Instructions and 

Form

ACSRP Scientific Notebook No. ICP-MS 4, ACP-1312-05-09-01, 5/21/2013–

10/31/2013, pages 1–24

M&TE Data Sheet for Pu-242 Standard Reference Material, NIST, Lot No. 721-Pu242, 

ACP-1104-01-12-16, 3/10/2011

ICP-MS Iridium Standard, High Purity Standards Lot No. 1307214, ACP-1305-03-12-

15, 5/7/2013

ICP-MS Thorium Standard, High Purity Standards Lot No. 1234128, ACP-1305-03-12-

16, 5/7/2013
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 12-3

NQA-1 ELEMENT: No. 12 with Supplement 12S-1, Test Equipment EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

4. Are the method and interval of calibration for each item defined? Y QAPD, Revision 11, section 2.4.6, Use and Control of M&TE, paragraphs A and D; 

section 2.4.7, Calibration, paragraph C

ACP-IMP-004, Revision 5, section 5.1, Control and Documentation of M&TE, 

paragraph 5.1.3; section 5.2, Tracking and Calibration of M&TE, paragraph 5.2.2; 

Attachment 1, ACRSP M&TE Data Sheet Instructions and Form

ACP-EXP-003, Revision 3, section 5.1, Calibration of Balances

Working Document Cover Sheet, Liquid Scintillation System, Beckman LS6500, ACP0502-11-12-04, 10/11/2004

M&TE Data Sheet for Digital Hygro/Thermometer with Timer, DHT34 Control 

Company, S/N: 122454202, ACP-1301-02-12-35, 10/10/2012

LSC Standard Set B, Eckert & Ziegler Lot Nos. 90474, 90475, 90476, ACP-1205-04-

12-07, 3/21/2012

Beckman Multi-Purpose Liquid Scintillation Counter, System ID No. 477965, labeled: 

“Performance Check-Prior to Use, 1/5/12”, observed 7/24/2014 in CEMRC Laboratory, 

Room 151

Varian Cary 5000 UV/VIS/NIR Spectrometer S/N: ELO6113131, labeled: “Frequency 

of Performance Check-Monthly” and Maintenance Log, observed 7/24/2014 in CEMRC

Laboratory, Room 151

ACRSP ICP-MS Model 7500, S/N: JP51201393 (also showing S/N: 211306), labeled: 

“Calibrate Prior to Use”, observed 7/24/2014 in CEMRC Laboratory, Room 151

5. When measuring and test equipment is found to be out of calibration, 

is the validity of previous inspections or test results, as well as the 

acceptability of items previously inspected or tested, evaluated?

Y QAPD, Revision 11, section 2.4.6, Use and Control of M&TE, paragraph F

ACP-IMP-004, Revision 5, section 5.3, Evaluation of Out-of-Calibration Equipment, 

paragraph 5.3.1

ACP-EXP-005, Revision 4, section 5.2, Working Thermometer Performance Check, 

paragraph 5.2.5

ACP-EXP-003, Revision 3, section 5.2.4, Criteria for Performance Check Acceptance

M&TE Data Sheet for Inductively Coupled Plasma-Mass Spectrometer, S/N: 

JP51201393; M&TE Data Sheet for Software, ACP-0706-03-12-48, 5/10/2007

6. Is calibration not required for commercial devices (e.g., rulers, tape 

measures, levels), if normal commercial equipment provides

adequate accuracy?

Y QAPD, Revision 11, section 2.4.5, Monitoring, Measuring, Testing, and Data 

Collection Equipment

ACP-IMP-004, Revision 5, Attachment 1, ACRSP M&TE Data Sheet Instructions and 

Form
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 12-4

NQA-1 ELEMENT: No. 12 with Supplement 12S-1, Test Equipment EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

7. Is measuring and test equipment properly handled and stored to 

maintain accuracy?

Y QAPD, Revision 11, section 2.4.6, Use and Control of M&TE, paragraph G

ACP-IMP-004, Revision 5, section 5.1, Control and Documentation of M&TE, 

paragraph 5.1.2; Attachment 1, ACRSP M&TE Data Sheet Instructions and Form

M&TE Data Sheet for Digital Hygro/Thermometer with Timer, DHT34 Control 

Company, S/N: 122454202, ACP-1301-02-12-35, 10/10/2012

M&TE Data Sheet for Pu-242 Standard Reference Material, NIST, Lot No. 721-Pu242, 

ACP-1104-01-12-16, 3/10/2011

8. Are records maintained and equipment suitably marked to indicate 

calibration status?

Y QAPD, Revision 11, section 2.4.6, Use and Control of M&TE, paragraphs D and E

ACP-IMP-004, Revision 5, section 5.1, Control and Documentation of M&TE, 

paragraph 5.1.3; section 5.2, Tracking and Calibration of M&TE, paragraph 5.2.2; 

Attachment 1, ACRSP M&TE Data Sheet Instructions and Form

ACP-EXP-003, Revision 3, section 5.1, Calibration of Balances; section 6.0, Records

ACP-EXP-005, Revision 4, section 6.0, Record Requirements

ACP-EXP-006, Revision 4, section 6.0, Record Requirements

Visual confirmation of markings on equipment, Liquid Scintillation System, Beckman 

LS6500, System ID 474965, observed 7/24/2014 in CEMRC Laboratory, Room 151

Visual confirmation of expiration date labels, ICP-MS Standard Solutions or dilutions 

thereof stored in fume hood, on open laboratory bench or in laboratory glove box, 

observed 7/24/2014 in CEMRC Laboratory, Room 151

*Y: The referenced documents adequately define, describe, address or satisfy the NQA-1-1989 requirement.

N: The referenced documents do not adequately define, describe, address or satisfy the NQA-1-1989 requirement.

I: EPA requires additional information to determine if the referenced documents adequately define, describe, address or satisfy the NQA-1-1989 requirement.

 N/A: The specific NQA-1-1989 requirement is not applicable to the subject QA program.
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 16-1

ASME NQA-1-1989 CHECKLIST

NQA-1 ELEMENT: No. 16, Corrective Action EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

Basic Requirements

1. Are conditions adverse to quality identified promptly and corrected 

as soon as practical?

Y QAPD, Revision 11, section 1.3.3.3, Conditions Adverse to Quality, paragraph B; 

section 1.3.3.7, Corrective Action Follow-up; section 1.3.3.9, Quality Trending, 

paragraph B

LANL-CO Finding Report FR-13-01, CAQ-1305-01-01-01

LANL-CO Finding Report FR-13-02, CAQ-1312-01-01-01

Email from L. Sparks to P. Kelly, re: FR closure times, 7/24/2014

See EPA Concern No. LANL-CO-QA-2014-01C

2. In the case of a significant condition adverse to quality, is the cause 

of the condition determined and corrective action taken to preclude 

recurrence?

Y QAPD, Revision 11, section 1.3.3.4, Significant Conditions Adverse to Quality; section 

1.3.3.5, Corrective Action Planning, paragraphs C and D

LCO-QP16-1, Revision 4-AC1, section 5.2, Processing Conditions Adverse to Quality, 

paragraph 5.2.3

LANL-CO Finding Report FR-13-02, CAQ-1312-01-01-01

3. Are the identification, cause and corrective action for significant 

conditions adverse to quality documented and reported to appropriate

levels of management?

Y QAPD, Revision 11, section 1.3.3.4, Significant Conditions Adverse to Quality, 

paragraph B

LCO-QP16-1, Revision 4-AC1, section 5.2, Processing Conditions Adverse to Quality, 

paragraph 5.2.7

Email from A. Heiser to N. Elkins, et. al., re: Finding Report FR-13-02 Regarding 

ACRSP data, with Attachment CAQ-1312-01-01-01.pdf, 12/18/2013

4. Is follow-up action taken to verify implementation of corrective 

action?

Y QAPD, Revision 11, section 1.3.3.7, Corrective Action Follow-up

LCO-QP16-1, Revision 4-AC1, section 5.2, Processing Conditions Adverse to Quality, 

paragraph 5.2.12

LANL-CO Finding Report FR-13-01, CAQ-1305-01-01-01

LANL-CO Finding Report FR-13-02, CAQ-1312-01-01-01

Supplementary Requirement – None 

*Y: The referenced documents adequately define, describe, address or satisfy the NQA-1-1989 requirement.

N: The referenced documents do not adequately define, describe, address or satisfy the NQA-1-1989 requirement.

I: EPA requires additional information to determine if the referenced documents adequately define, describe, address or satisfy the NQA-1-1989 requirement.

 N/A: The specific NQA-1-1989 requirement is not applicable to the subject QA program.
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 17-1

ASME NQA-1-1989 CHECKLIST

NQA-1 ELEMENT: No. 17 with Supplement 17S-1, QA Records EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

Basic Requirements

1. Are records that furnish documentary evidence of quality specified, 

prepared and maintained?

Y QAPD, Revision 11, section 1.5, Records, paragraph A

LCO-QPD-04, Revision 8, section 5.3, Record Identification and Classification

LCO-QP17-1, Revision 12, section 5.0, Procedure

2. Are quality assurance records legible, identifiable and retrievable? Y QAPD, Revision 11, section 1.5.2, Generating QA Records, paragraph B; section 1.5.3, 

Indexing QA Records, paragraphs B and C

LCO-QP17-1, Revision 12, section 5.1, Record Submittal, paragraph 5.1.1; section 5.2, 

Receipt and Processing of QA Records, paragraph 5.2.11; section 5.5, Record Retrieval

3. Are quality assurance records protected against damage, 

deterioration or loss?

Y QAPD, Revision 11, section 1.5.6, Storage, Preservation, Safekeeping, and Disposition 

of QA Records, paragraph A

LCO-QP17-1, Revision 12, section 5.2, Receipt and Processing of QA Records

LCO-QPD-04, Revision 8, section 5.4, Record Handling; section 5.7, Record Storage 

Facility

4. Are the requirements and responsibilities established and 

documented for the transmittal, distribution, retention, maintenance 

and disposition of quality assurance records?

Y QAPD, Revision 11, section 1.5.3: Indexing QA Records; section 1.5.5, Receiving QA 

Records; section 1.5.6, Storage, Preservation, Safekeeping, and Disposition of QA 

Records

LCO-QP17-1, Revision 12, section 4.0, Responsibilities; section 5.1, Record Submittal; 

section 5.2, Receipt and Processing of QA Records; section 5.5, Record Retrieval

LCO-QPD-04, Revision 8, section 5.4, Record Handling; section 5.7, Record Storage 

Facility; section 5.9, Disposition of QA Records

Supplementary Requirements (17S-1)

1. Has a quality assurance records system been established? Y QAPD, Revision 11, section 1.5.1, Document Changes, paragraph A

LCO-QPD-04, Revision 8, section 5.1, Record System

2. Is the quality assurance records system defined, implemented and 

enforced in accordance with written procedures, instructions or other 

documentation?

Y QAPD, Revision 11, section 1.5.1, Document Changes, paragraph A

LCO-QPD-04, Revision 8, section 5.1, Record System

LCO-QP17-1, Revision 12, Record Management

3. Do the applicable design specifications, procurement documents, test 

procedures, operational procedures or other documents specify the 

quality assurance records to be generated, supplied or maintained by 

the facility?

Y QAPD, Revision 11, section 1.5.2, Generating QA Records, paragraph A

LCO-QP17-1, Revision 12, section 5.0, Procedure

LCO-MP7-1, Revision 7-AC1, Attachment 3, LANL-CO Procurement Request
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 17-2

NQA-1 ELEMENT: No. 17 with Supplement 17S-1, QA Records EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

LCO-QP6-1, Revision 11, section 5.1, Developing Quality and Management 

Procedures, paragraph 5.1.8; section 5.1, Developing Project-Specific Procedures, 

paragraph 5.2.7

ACP-IMP-003, Revision 5, section 5.1, ACRSP Test Plans, paragraph 5.1.1; section 

5.2, ACRSP Task Implementation Plans, paragraph 5.2.1

ACP-IMP-005, Revision 3, section 6.0, Record Requirements

4. Are quality assurance records required to be legible, accurate and 

complete?

Y QAPD, Revision 11, section 1.5.2, Generating QA Records, paragraph B

LCO-QP17-1, Revision 12, section 5.1, Record Submittal, paragraph 5.1.7

5. Are documents considered to be valid quality assurance records only 

if stamped, initialed or signed and dated by authorized personnel, or 

otherwise authenticated?

Y QAPD, Revision 11, section 1.5.2, Generating QA Records, paragraph D

LCO-QPD-04, Revision 8, section 5.4, Record Handling

6. Are the quality assurance records indexed? Does the indexing system 

include record retention times and the location of the record within 

the quality assurance record system?

Y QAPD, Revision 11, section 1.5.3, Indexing QA Records

LCO-QPD-04, Revision 8, section 5.6, Record Filing System

LCO-QP17-1, Revision 12, Appendix A, Examples of File Designators; Attachment 1,

Example LANL-CO Record Submittal System Entry Screen and Instructions

RSS and RTS demonstration, 7/23/2014

7. Are quality assurance records distributed, handled and controlled in 

accordance with written procedures?

Y QAPD, Revision 11, section 1.5.2, Generating QA Records, paragraph C; section 1.5.6, 

Storage, Preservation, Safekeeping, and Disposition of QA Records, paragraph A

LCO-QP17-1, Revision 12, section 5.2, Receipt and Processing of QA Records, 

paragraph 5.2.23; section 5.5, Record Retrieval

LCO-QPD-04, Revision 8, section 5.4, Record Handling; section 5.7, Record Storage 

Facility

8. Do quality assurance records provide sufficient information to permit 

identification between the record and the items or activities to which 

it applies?

Y QAPD, Revision 11, section 1.5.3, Indexing QA Records, paragraph C

LCO-QPD-04, Revision 8, section 5.6, Record Filing System

LCO-QP17-1, Revision 12, Appendix A, Examples of File Designators

9. Are quality assurance records classified as either lifetime or 

nonpermanent?

Y QAPD, Revision 11, section 1.5.4, Classifying QA Records, paragraph A

LCO-QPD-04, Revision 8, section 5.3, Record Identification and Classification.

10. Is the retention time for nonpermanent quality assurance records 

established in writing?

N/A QAPD, Revision 11, section 1.5.4, Classifying QA Records, paragraph D

11. Are quality assurance records corrected in accordance with 

procedures that provide for appropriate review or approval by the 

Y QAPD, Revision 11, section 1.5.7, Correcting Information in QA Records

LCO-QP17-1, Revision 12, section 5.4, Supplementing or Correcting Existing QA 
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 17-3

NQA-1 ELEMENT: No. 17 with Supplement 17S-1, QA Records EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

originating organization? Does the correction include the date and 

the identification of the person authorized to issue such correction?

Records

12. Does the individual or organization responsible for receiving quality 

assurance records provide protection from damage or loss during the 

time that the records are in their possession?

Y QAPD, Revision 11, section 1.5.5, Receiving QA Records

LCO-QP17-1, Revision 12, section 5.0, Procedure; section 5.1, Record Submittal, 

paragraph 5.1.1

13. Does each organization responsible for the receipt of quality 

assurance records designate a person or organization responsible for 

receiving the records?

Y QAPD, Revision 11, section 1.5.5, Receiving QA Records

LCO-QP17-1, Revision 12, section 5.2, Receipt and Processing of QA Records

14. Does the receipt control system include:

 A method for designating the required records?

 A method for identifying records received?

 Procedures for receipt and inspection of incoming records?

 A method for submittal of completed records to the storage 

facility?

Y QAPD, Revision 11, section 1.5.5, Receiving QA Records

LCO-QPD-04, Revision 8, section 5.3, Record Identification and Classification

LCO-QP17-1, Revision 12, section 5.2, Receipt and Processing of QA Records, 

paragraphs 5.2.1, 5.2.2, 5.2.10, 5.2.21 and 5.2.26

15. Is the receipt control system structured to permit a current and 

accurate assessment of the status of quality assurance records during 

the receiving process?

Y QAPD, Revision 11, section 1.5.5, Receiving QA Records

LCO-QP17-1, Revision 12, section 5.2, Receipt and Processing of QA Records

Records filing demonstration, 7/23/2014

16. Prior to storage of quality assurance records, was a written storage 

procedure prepared and responsibility assigned for enforcing its 

requirements? Does the storage procedure include each of the 

following:

 A description of the storage facility?

 The filing system to be used?

 A method for verifying that the records received are in agreement 

with the transmittal document and that the records are legible?

 A method of verifying that the records are those designated (see 

No. 14 above)?

 The rules governing access to and control of the files?

 A method for maintaining control of and accountability for records 

removed from the storage facility?

 A method for filing supplemental information and disposing of 

superseded records (see No. 11 above)?

Y QAPD, Revision 11, section 1.5.6, Storage, Preservation, Safekeeping, and Disposition 

of Records, paragraph A

LCO-QPD-04, Revision 8, section 5.7, Record Storage Facility; section 5.6, Record 

Filing System

LCO-QP17-1, Revision 12, section 5.2, Receipt and Processing of QA Records, 

paragraphs 5.2.2, 5.2.11 and 5.2.27; section 5.4, Supplementing or Correcting Existing 

QA Records; section 5.5, Record Retrieval

17. Are quality assurance records stored in a manner approved by the 

organizations responsible for storage, including the following:

Y QAPD, Revision 11, section 1.5.6, Storage, Preservation, Safekeeping, and Disposition 

of Records
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 17-4

NQA-1 ELEMENT: No. 17 with Supplement 17S-1, QA Records EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

 Provisions in the storage arrangements to prevent damage from 

moisture, temperature and pressure?

 Records firmly attached in binders or placed in folders or 

envelopes for storage in steel file cabinets or on shelving in 

containers?

 Provisions for special processed records (such as radiographs, 

photographs, negatives and microfilm) to prevent damage from 

excessive light, stacking, electromagnetic fields and temperature?

LCO-QPD-04, Revision 8, section 5.7, Record Storage Facility

Tour of record storage room, 7/23/2014

18. Have measures been established to preclude the entry of 

unauthorized personnel into the storage area?

Y QAPD, Revision 11, section 1.5.6.1, Records Disposition, paragraph J

LCO-QPD-04, Revision 8, section 5.7, Record Storage Facility

Tour of record storage room, 7/23/2014

19. Have measures been taken to provide for replacement, restoration or 

substitution of lost or damaged records?

Y QAPD, Revision 11, section 1.5.6.1, Records Disposition, paragraph K

LCO-QPD-04, Revision 8, section 5.7, Record Storage Facility

LCO-QP17-1, Revision 12, section 5.3, Submitting Records to be Filed in Existing 

Record Packages

20. Are records stored in a facility that minimizes the risk of damage or 

destruction from the following:

 Natural disasters such as winds, floods or fires?

 Environmental conditions such as high and low temperatures and 

humidity?

 Infestation of insects, mold or rodents?

Y QAPD, Revision 11, section 1.5.6, Storage, Preservation, Safekeeping, and Disposition 

of Records

Tour of record storage room, 7/23/2014

21. Are quality assurance records stored in single or dual storage 

facilities?

Y (single) QAPD, Revision 11, section 1.5, Records

LCO-QPD-04, Revision 8, section 5.7, Record Storage Facility

22. Does the design and construction of a single record storage facility 

meet the following criteria:

 Reinforced concrete, concrete block, masonry or equal 

construction?

 Floor and roof with drainage control (if a floor drain is provided, a 

check valve (or equal) is included)?

 Doors, structure and frames, and hardware designed to comply 

with the requirements of a minimum 2-hour fire rating?

 Sealant applied over walls as a moisture or condensation barrier?

 Surface sealant on the floor providing a hard-wear surface to 

minimize concrete dusting?

N/A QAPD, Revision 11, section 1.5.6.1, Records Disposition, paragraph E
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 17-5

NQA-1 ELEMENT: No. 17 with Supplement 17S-1, QA Records EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

 Foundation sealant and provisions for drainage?

 Forced air circulation with filter system?

 Fire protection system?

 Only those penetrations used exclusively for fire protection, 

communication, lighting or temperature/humidity control are 

allowed (all penetrations are sealed or dampered to comply with 

the minimum 2-hour fire protection rating)?

23. Were the construction details of the quality assurance records storage 

facility reviewed for adequacy of protection of contents by a person 

who is competent in the technical field of fire protection and fire 

extinguishing?

N/A QAPD, Revision 11, section 1.5.6.1, Records Disposition, paragraph F

24. Does the design and construction of an alternative single record 

storage facility meet the following criteria:

 2-hour fire rated vault meeting National Fire Protection 

Association (NFPA) 232-1986 or NFPA 232AM-1986 or both?

 2-hour fire rated Class B file containers meeting the requirements 

of NFPA 232-1986 or NFPA 232AM-1986 or both?

 2-hour fire rated file room meeting the requirements of NFPA 232-

1986 or NFPA 232AM-1986 or both, with the following 

provisions:

– Early warning fire detection and automatic fire suppression 

capability with electronic supervision at a constantly attended 

central station?

– Records storage in fully-enclosed metal cabinets?

– Adequate access and aisle ways?

– Prohibition in the room of work not directly associated with 

record storage or retrieval?

– Prohibition in the room of smoking, eating or drinking?

– 2-hour fire rated dampers or doors in all boundary 

penetrations?

Y QAPD, Revision 11, section 1.5.6.1, Records Disposition, paragraph G

LCO-QPD-04, Revision 8, section 5.7, Record Storage Facility

25. When temporary storage of quality assurance records is required by 

an organization’s procedures, are the records stored in a 1-hour fire 

rated container? Do these procedures specify the maximum allowable

time limit for temporary storage? Does the container bear a UL label 

(or equivalent) certifying 1-hour fire protection, or is it certified by a 

person competent in the technical field of fire protection?

Y QAPD, Revision 11, section 1.5.6.1, Records Disposition, paragraph I

LCO-QPD-04, Revision 8, section 5.7, Record Storage Facility

Tour of laboratory offices, 7/24/2014
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 17-6

NQA-1 ELEMENT: No. 17 with Supplement 17S-1, QA Records EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

26. If storage at dual facilities for each quality assurance record is 

provided, are the facilities at locations sufficiently remote from each 

other to eliminate the chance of exposure to a simultaneous hazard? 

Although dual storage facilities are not required to satisfy the 

requirements of a single storage facility, are all other requirements of 

this standard met?

N/A QAPD, Revision 11, section 1.5.6.1, Records Disposition, paragraph H

27. Does the storage system provide for retrieval of information in 

accordance with planned retrieval times, based on the record type?

Y QAPD, Revision 11, section 1.5.3, Indexing QA Records, paragraph B

LCO-QPD-04, Revision 8, section 5.8, Record Tracking System; section 5.9, 

Disposition of QA Records

LCO-QP17-1, Revision 12, section 5.5 Record Retrieval

RSS and RTS demonstration, 7/23/2014

28. Is a list maintained designating those personnel who shall have 

access to quality assurance files?

QAPD, Revision 11, section 1.5.6.1, Records Disposition, paragraph J

LCO-QPD-04, Revision 8, section 5.7, Record Storage Facility

Memo to the Quality Assurance File, QAM-13-04, 3/25/2013

Posted records access list, observed 7/23/2014

29. Are records maintained by a supplier at its facility or other location 

accessible to the purchaser or its designated alternate (e.g., the 

owner)?

N/A QAPD, Revision 11, section 2.3.4, Procurement Document Requirements, paragraph C

30. Are records accumulated at various locations, prior to transfer, made 

accessible to the owner directly or through the procuring 

organization?

N/A QAPD, Revision 11, section 2.3.4, Procurement Document Requirements, paragraph C

31. Does the custodian of quality assurance records inventory the 

submittals, acknowledge receipt, and process these records in 

accordance with NQA-1?

Y QAPD, Revision 11, section 1.5.6, Storage, Preservation, Safekeeping, and Disposition 

of Records, paragraph A; section 1.5.5, Receiving QA Records

LCO-QP17-1, Revision 12, section 5.2, Receipt and Processing of QA Records

Records filing demonstration, 7/23/2014

32. Are the records storage and maintenance requirements of regulatory 

agencies followed in determining final disposition of quality 

assurance records?

Y QAPD, Revision 11, section 1.5.6.1, Records Disposition, paragraph L

LCO-QPD-04, Revision 8, section 5.9, Disposition of QA Records
EPA Audit of WIPP QA Program: LANL-CO WIPP QA 17-7

NQA-1 ELEMENT: No. 17 with Supplement 17S-1, QA Records EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: June–July 2014

Does the reference document adequately define, describe, address or 

satisfy the following:

Y, N, I, 

N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

33. Are the supplier’s nonpermanent records disposed of only if the 

applicable conditions listed below are satisfied:

 Items are released for shipment, a Code Data Report is signed or a 

Code Symbol Stamp is affixed?

 Regulatory requirements are satisfied?

 Operational status permits?

 Warranty consideration is satisfied?

 Purchaser’s requirements are satisfied?

N/A QAPD, Revision 11, section 1.5.6.1, Records Disposition, paragraph L

*Y: The referenced documents adequately define, describe, address or satisfy the NQA-1-1989 requirement.

N: The referenced documents do not adequately define, describe, address or satisfy the NQA-1-1989 requirement.

I: EPA requires additional information to determine if the referenced documents adequately define, describe, address or satisfy the NQA-1-1989 requirement.

 N/A: The specific NQA-1-1989 requirement is not applicable to the subject QA program.