EPA Audit of WIPP QA Program: SNL

- 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: May, 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 Q APD, Rev ision 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 Manag er Responsibilities; Appendix E, TRU Waste Characterization and Certification Organizational and Individual Responsibilities NP 1

- 1 , Rev ision 7, section 2.1, Organizational Structure; section 2.2.1 , Responsibilities ; section 2.2.2, Communication SNL

- CO Or ganization al Structure , 4/23/2013 SNL WI PP Program Description, 11/4/2011
2. Do persons or organizations responsible for performing quality assurance functions have sufficient authority, access to work areas and organizational freedom to:

 Identify quality pr oblems?

 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, Rev ision 11, section 1.1.1.3, QA Management, paragraphs A and B; Appendix D, CBFO Quality Assur ance Manager Responsibilities NP 1

- 1 , Rev ision 7, section 2.2.1.2 , SNL WIPP QA Team Responsibilitie s SNL

- CO Organization al Structure, 4/23/2013

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, Rev ision 11, section 1.1.1.3, QA Management, paragraph A.7; Appendix C, CBFO Organization, Re sponsibilities, and Interfaces NP 1

- 1 , Rev ision 7, section 2.2.1.3 , SNL WIPP QA Team Lead Responsibilities SNL

- CO Organization al Structure, 4/23/2013 SNL WIPP Program Description, 11/4 /2011
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 independence from cost and schedule considerations? Y QAPD, Rev ision 11, section 1.1.1.3, QA Mana gement, paragraphs A.7

– 10 and B NP 1

- 1 , Rev ision 7, section 2.2.1.3 , SNL WIPP QA Team Lead Responsibilities SNL

- CO Organization al Structure, 4/23/2013 SNL WIPP Program Description, 11/4/2011EPA Audit of WIPP QA Program: SNL

- CO WIPP QA 1

- 2

Supplementary Requ irements (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 organizatio ns not directly responsible for performing the work? Y QAPD, Rev ision 11, section 1.1.1, Org anization; section 1.1.1.2, Employees; section 1.1.1.3, QA Management; Appendix D, CBFO Quality Ass urance Manager Responsibilities NP 1

- 1 , Rev ision 7, section 2.1, Organizational Structure; section 2.2.1 , Responsibilities SNL

- CO Organization al Structure, 4/23/2013
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, Rev ision 11, sect ion 1.1.1.5, Delegation of Work NP 1

- 1 , Rev ision 7, section 2.2.1.3 , SNL WIPP QA Team Lead Responsibilities SNL WIPP Program Descr iption, 11/4/2011

3. Is responsibility for the control of further processing, delivery, installation or operation of nonconforming items designated in writing? Y QAPD, Rev ision 11, section 1.1.1.3, QA Management, paragraph B.4; section 1.3.2.1, Documenting a nd Evaluating N onconforming Items, paragraph E NP 1

- 1 , Rev ision 7, section 2.2.1.3 , SNL WIPP QA Team Lead Responsibilities NP 12

- 1, Revision 8, section 2.6.1, Identifying and Processing Nonconformances WIPP Receipt Inspectors, 4/8/ 20 14
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, Rev ision 11, section 1.1.1.4, Communication and Interface Responsibilities, par agraph B; Appendix C, CBFO Organization, R esponsibilities, and Interfaces SNL WIPP Program Description, 11/4/ 20 11
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, Rev ision 11, section 1.1.1.4, Communication and Interface Responsibilities , paragraph B; Appendix C, CBFO Organization, R esponsibilities, and Interfaces NP 5

- 1, Revision 6, section 2.1.1, Incorporating Uppe r Tier Requirements; Appendix A, sect ion 2.0, Implementation Actions SNL

- CO Organization al Structure, 4/23/2013 SNL WIPP Program Description, 11/4/2011
*Y: T he reference d document s adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requiremen t. N: T he reference d document s do not adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. I : EPA requires additional information to determine if t he reference d document s adequately define, describe, a ddress 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: SNL

- 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 DA TE: May, 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 docume nted quality assurance program planned, implemented and maintained in accordance with NQA

- 1? Y QAPD, Rev ision 11, section 1.1.2.1, Quality Assurance Program Documents NP 1

- 1 , Rev ision 7, Organization and QA Program SNL WIPP Program Description, 11/4/ 20 11
2. Does the quality assurance program identify the activities and items to which it applies? Y QAPD, Rev ision 11, section 1.1.2.2, Applicability of QAPD Requirements NP 1

- 1 , Rev ision 7, section 1.1 , General SNL WIPP Program Description, 11/4/ 20 11
3. Does the q uality assurance program provide control over activities affecting quality to an extent consistent with their importance? Y QAPD, Rev ision 11, section 1.1.2.3, Grading Items and Activities and Applying Management Controls NP 1

- 1 , Rev ision 7, section 1.2.1 , QA Grading SP 1

- 1, Revision 7, section 2.1, Quality Assurance (QA) Grading
4. Was the quality assurance program established at the earliest time consistent with the schedule for accomplishing the activities? Y QAPD, Rev ision 11, section 1.1.2.3, Grading Ite ms and Activities a nd Applying Management Controls SNL WIPP Program Description, 11/4/ 20 11
5. Does the quality assurance program provide for the planning and accomplishment of activities affecting quality under suitably controlled conditions, which include t he use of appropriate equipment, suitable environmental conditions for accomplishing the activity and assurance that prerequisites for the given activity have been satisfied? Y QAPD, Rev ision 11, section 1.1.2.4, Planning Work , paragraphs E and G NP 1

- 1 , R ev ision 7, section 1.2.1 , QA Grading SP 1

- 1, Revision 7, section 2.1, Quality Assurance (QA) Grading

6. Does the quality assurance program provide for any special controls, processes, test equipment, tools and skills to attain the required quality and for ve rification of quality? Y QAPD, Rev ision 11, section 1.1.2.4, Planning Work NP 1

- 1 , Rev ision 7, section 2.2.1 , Responsibilities

7. Does the quality assurance program provide for indoctrination and training of personnel performing activities affecting quality ? Y QAPD, Rev ision 11, section 1.2.2 , Training Requirements , paragraph A NP 1

- 1 , Rev ision 7, section 2.2.1.1 , SNL WIPP Managers Responsibilities NP 2

- 1 , Rev ision 9, section 1.0 , Purpose and Scope
8. Does the management of the organizations implementing the q uality assurance program regularly assess the adequacy of that part of the program for which they are responsible and assure its effective Y QAPD, Rev ision 11, section 1.1.1.3 , QA Management NP 1

- 1 , Rev ision 7, section 2.2.1.1 , SNL WIPP Man agers ResponsibilitiesEPA Audit of WIPP QA Program: SNL

- 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 DA TE: May, 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 implementation? NP 1

- 1 , Rev ision 7, section 2.2.3 , Management Assessments 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? Y QAPD, Rev ision 11, s ection 2.4.1, Qualification of Inspection and Test Personnel , paragraph A NP 2

- 1 , Rev ision 9, Appendix B , Procedures Matrix NP 4

- 1, Revision 11, section 2.3, Receipt Inspection Personnel
2. Has the responsible organi zation 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? Y QAPD, Rev ision 11, section 2.4.1, Qualification of Inspection an d Test Personnel , paragraph A NP 2

- 1 , Rev ision 9, section 2.2, Updated Qualificat ion and Training of Individuals NP 4

- 1, Revision 11, section 2.3, Receipt Inspection Personnel
3. Do personnel selected for performing inspection and test activities have the ex perience or training commensurate with the scope, complexity or special nature of the activities? Y QAPD, Rev ision 11, section 1.2.1 , Qualification Requirements , paragraph A; s ection 2.4.1 , Qualification of Inspection and Test Personnel , paragraph C NP 2

- 1 , Rev ision 9, Appendix B , Procedures Matrix Form NP 2

- 1

- 2, Receipt Inspection Training Records for C

. Camphouse , ERMS557696 , and B

. Malama , ERMS544536
4. Have provisions been made for the indoctrination of personnel regarding the technical objectives and req uirements of the applicable codes and standards and the quality assurance program elements that are to be employed? Y QAPD, Rev ision 11, section 2.4.1 , Qualification of Inspection and Test Personnel , paragraph D NP 4

- 1, Revision 11, section 2.3, Receipt In spection Personnel Form NP 2

- 1

- 1, Qualification and Training for C. Camphouse, ERMS548415, and B. Malama, ERMS557132 Form NP 2

- 1

- 2, Receipt Inspection Training Records for C

. Camphouse , ERMS557696 , and B

. Malama , ERMS544536
5. Has the need for a formal train ing program been determined? Are training activities, including on

- the

- job training, conducted to qualify personnel who perform inspections and tests? Y QAPD, Rev ision 11, section 2.4.1 , Qualification of Inspection and Test Personnel , paragraph E NP 4

- 1, R evision 11, section 2. 3, Receipt Inspection Personnel NP 2

- 1 , Rev ision 9, section 2.4, Documentation of Training Form NP 2

- 1

- 1, Qualification and Training for C. Camphouse, ERMS548415, and B. Malama, ERMS557132 Form NP 2

- 1

- 2, Receipt Inspection Training Re cords for C

. Camphouse , ERMS557696 , and B

. Malama , ERMS544536EPA Audit of WIPP QA Program: SNL

- 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 DA TE: May, 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
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 demo nstration? Y QAPD, Rev ision 11, section 2.4.1 , Qualification of Inspection and Test Personnel , paragraph F NP 2

- 1 , Rev ision 9, section 2.1.4, Verification of Employee Qualifications Form NP 2

- 1

- 1, Qualification and Training for C. Camphouse, ERMS548415, an d B. Malama, ERMS557132
7. Is the job performance of inspection and test personnel reevaluated at periodic intervals not to exceed three years? N/A

8. If it is determined at any time that the capabilities of an individual are not in accordance with the qualif ication requirements specified for the job, is that person removed from that activity until such time as the required capability has been demonstrated? N/A

9. Is a person reevaluated for a required inspection or test capability if activities have not been p erformed in his or her qualified area for a period of one year? N/A

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?

 Basi s 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 empl oyer’s designated representative who is responsible for such certification?

 Date of certification and date of certification expiration? Y QAPD, Rev ision 11, section 2.4.1 , Qualification of Inspection and Test Personnel , paragraph H NP 2

- 1 , Rev ision 9, Appe ndix C , Sample Form NP 2

- 1

- 2 Form NP 2

- 1

- 2, Receipt Inspection Training Records for C

. Camphouse , ERMS557696 , and B

. Malama , ERMS544536

11. Has the responsible organization identified any special physical characteristics needed in the performance of each acti vity, including the need for initial and subsequent physical examination? N/A

12. Does the employer establish and maintain records of personnel qualification? Y QAPD, Rev ision 11, section 2.4.1 , Qualification of Inspection and Test Personnel , paragraph J WIP P Rec eipt Inspectors, 4/8/2014EPA Audit of WIPP QA Program: SNL

- 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 DA TE: May, 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

Form NP 2

- 1

- 2, Receipt Inspection Training Records for C

. Camphouse , ERMS557696 , and B

. Malama , ERMS544536 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

2. Has the responsible organization established written procedures for the control and administration of nondestructive examin ation personnel training, examination and certification? N/A

3. Does the employer establish and maintain records of personnel qualification? N/A
Supplementary Requirements (2S

- 3) 1. Has the responsible auditing organization established the qualifications fo r audit personnel and the requirements for the use of technical specialists to accomplish the auditing of quality assurance programs? Y QAPD, Rev ision 11, section 3.2.2.4, Auditor Qualification NP 2

- 1, Revision 9 , Appendix B, Procedures Matrix N P 18

- 1, Rev ision 9, s ection 2.1.3, Qualifications

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 implementin g 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, Rev ision 11, section 3.2.2.4, Auditor Q ualification , paragraphs A

– C NP 2

- 1, Revision 9 , Appendix B, Procedures Matrix N P 18

- 1, Rev ision 9, s ection 2.1.3.1, Auditor Qualifications Form 18

- 1

- 1, Auditor Qualifications for Angela Guerin , ERMS550905

3. Does a prospective lead auditor have the capabili ty to communicate effectively, both in writing and orally? Has the lead auditor’s employer attested to these skills in writing? Y QAPD, Rev ision 11, section 3.2.2.6, Lead Auditor Qualification , paragraph B , Lead Auditor Communication Skills N P 18

- 1, Rev isi on 9, s ection 2.1.3.3, Lead Auditor Qualification, Communication Skills paragraph Form 18

- 1

- 2, Lead Auditor Qualifications for S. Davis , ERMS528392 , and M. Chavez , ERMS544910EPA Audit of WIPP QA Program: SNL

- 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 DA TE: May, 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
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 ele ments 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 associa ted components, and safety aspects of the nuclear facility?

 On

- the

- job training to include applicable elements of the audit program? Y QAPD, Rev ision 11, section 3.2.2.6, Lead Auditor Qualification , paragraph C , Lead Auditor Training N P 18

- 1, Rev ision 9, s ection 2.1.3.3, Lead Auditor Qualification, Training paragraph Form 18

- 1

- 2, Lead Auditor Qualifications for S. Davis , ERMS528392 , and M. Chavez , ERMS544910

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, Rev ision 11, section 3.2.2.6, Lead Auditor Qualificat ion , paragraph A .2, Experience N P 18

- 1, Rev ision 9, s ection 2.1.3.3, Lead Auditor Qualification, Experience paragraph Form 18

- 1

- 2, Lead Auditor Qualifications for S. Davis , ERMS528392 , and M. Chavez , ERMS544910
6. Is a prospective lead auditor required to pa ss 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, Rev ision 11, section 3.2.2.6, Lead Auditor Qualification , paragraph D , Lead Auditor Examination N P 18

- 1, Rev ision 9, s ection 2.1.3.3, Lead Auditor Qualification, Lead Auditor Examination paragraph Form 18

- 1

- 2, Lead Auditor Qualifications for S. Davis , ERMS528392 , and M. Chavez , ERMS544910
7. Do lead auditors maintain their p roficiency 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 Y QAPD, Rev ision 11, section 3.2.2.6, Lead Auditor Qualification , paragraph F , Lead Auditor Proficiency Maintenance N P 18

- 1, Rev ision 9, s ection 2.1.3.5, Maintena nce of Lead Auditor Proficiency Form 18

- 1

- 3, Maintenance of Lead Aud itor for S. Davis , ERMS560667 , and M. Chavez , ERMS560984EPA Audit of WIPP QA Program: SNL

- 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 DA TE: May, 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 auditing?

 Participat ion in training programs? 8. Does management conduct documented annual assessments of lead auditors to extend their qualification, require retraining or require requalification? Y QAPD, Rev ision 11, section 3.2.2.6, Lead Audito r Qualification , paragraph F , Lead Auditor Proficiency Maintenance N P 18

- 1, Rev ision 9, s ection 2.1.3.5, Maintena nce of Lead Auditor Proficiency Form 18

- 1

- 3, Maintenance of Lead Auditor for S. Davis , ERMS560667 , and M

. Chavez , ERMS560984 Memorandum evaluat ing M. Chavez, ERMS560985
9. Are lead auditors who fail to maintain their proficiency for a period of two years or more required to requalify? Y QAPD, Rev ision 11, section 3.2.2.6, Lead Auditor Qualification , paragraph F , Lead Auditor Proficiency Maintenance N P 18

- 1, Rev ision 9, s ection 2.1.3.5, Maintenance of Lead Auditor Proficiency
10. Is the employer responsible for training auditors? Y QAPD, Revision 11, section 1.1 .1.1, Management, paragraph C.1 N P 2 .1, Rev ision 9 , section 2.0, Implementation Actions
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, Rev ision 11, section 3.2.2.3, Audit Team Selection , paragraph A N P 18

- 1, Rev ision 9, s ection 2.3.1, Performance, Preparation paragraph

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, Rev ision 11, section 3.2.2.3, Audit Team Selection , paragraph C N P 18

- 1, Rev ision 9, s ection 2.3.1, Performance, Preparation paragraph

13. Is the employer responsible for the development and administration of the examination for a lead auditor? If t he employer delegate s 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, Rev ision 11, section 3.2.2.6, Lead Auditor Qualification , paragraph D , Lead Auditor Examination N P 18

- 1, Rev ision 9, s ection 2.1.3.3, Lead Auditor Qualification, Lead Auditor Examination paragraph

14. Does the employer establish and maintain records of personnel qualifications f

or auditors and lead auditors performing audits? Y QAPD, Rev ision 11, section 3.2.2.6, Lead Auditor Qualification , paragraph D , Lead Auditor Examination N P 18

- 1, Rev ision 9, section 2.1.3.1, Auditor Qualification; s ection 2.1.3.3, Lead Auditor Qualificatio n; section 3.0, Records; Appendix A, Auditor Qualifications Example Form; Appendix B, Lead Auditor Qualifications Example Form Form 18

- 1

- 1, Auditor Qualifications for Angela Guerin , ERMS550905 , S. Davis , ERMS528392 , and M. Chavez , ERMS544910EPA Audit of WIPP QA Program: SNL

- 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 DA TE: May, 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
15. Does the empl oyer 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, experi ence, communication skills, training, examination, etc.)?

 Signature of employer’s designated representative who is responsible for such certification? Y QAPD, Rev ision 11, section 3.2.2.6, Lead Auditor Qualification , paragraph E , Lead Auditor Certification N P 18

- 1, Rev ision 9, section 2.1.3.4, Lead Auditor Certification; Appendix B, Lead Auditor Qualifications Example Form Form 18

- 1

- 1, Auditor Qualifications for S. Davis , ERMS528392 , and M. Chavez , ERMS544910

16. Are the records for each lead auditor maintaine d and updated annually? Y N P 18

- 1, Rev ision 9, s ection 2.1.3.5, Maintena nce of Lead Auditor Proficiency Form 18

- 1

- 3, Maintenance of Lead Auditor for S. Davis , ERMS560667 , and M. Chavez , ERMS560984 Supplementary Requirements (2S

- 4) 1. Are personnel identifie d for indoctrination or training? Y QAPD, Rev ision 11, section 1.2.2, Training Requirements , paragraph A ; s ection 2.4.1, Qualification of Inspection and Test Personnel , paragraph C NP 2

- 1, Revision 9, Appendix B, Procedures Matrix
2. Is the extent of indoctr ination and training commensurate with the following:

 The scope, complexity and nature of the activity?

 The education, experience and proficiency of the person? Y QAPD, Rev ision 11, section 2.4.1, Qualification of Inspection and Test Personnel , paragraphs C and F NP 2

- 1, Revision 9, section 2.1, Initial Qualification and Training of Individuals; 2.1.1, Job Description; Appendix D, Qualification and Training Flow Chart
3. Are personnel indoctrinated in the following subjects as they relate to a particular func tion:

 General criteria, including applicable codes, standards and company procedures?

 Applicable quality assurance program elements?

 Job responsibilities and authority? Y QAPD, Rev ision 11, section 1.2.2, Training Requirements , paragraphs A and B;
s ection 2.4.1, Qualification of Inspection and Test Personnel , paragraph C NP 2

- 1, Revision 9, section 2.1.2, Training Required for the Position

4. Is training provided, if needed, to:

 Achieve initial proficiency?

 Maintain proficiency?

 Adapt to changes in technology , methods or job responsibilities? Y QAPD, Rev ision 11, section 1.2.2, Training Requirements , paragraph A NP 2

- 1, Revision 9, section 2.1.2, Training Required for the Position ; section 2.2, Updated Qualification and Training of Individuals; section 2.3, Ne w or Revised Procedure TrainingEPA Audit of WIPP QA Program: SNL

- 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 DA TE: May, 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. Do records of the implementation of indoctrination and training take the form of:

 Attendance sheets?

 Training logs?

 Personnel training records? Y QAPD, Rev ision 11, section 1.2.2, Training Requirements , paragraph C NP 2

- 1, Revision 9, section 2.4, Documentation of Training

*Y: T he reference d document s adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. N: T he reference d document s do not adequately define, describe, a ddress or satisfy the NQA

- 1

- 19 89 requirement. I : EPA requires additional information to determine if t he reference d document s adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. N/A: The specific NQA

- 1

- 1989 requirement is not applicable to the subject QA p rogram

.EPA Audit of WIPP QA Program: SNL

- 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: May, 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 Requirement s NP 4

- 1, Revision 11, section 2.1.2, Technical and Quality Requirements Documentation; section 2.1.5, P rocurement Document Preparation Contract between PerkinElmer Health Sciences, Inc. and Sandia National Laboratories fo r Nexlon 300D ICP

- MS including S10Autosampler and Polyscience R ecirculator, Section I, 2/11/2013 , ERMS559544 Form No. 4

- 1

- 1, Revision 11, Procurement Review, 1000 PPM Standards for Ca, Na, Mn, Fe, B, Cs, 1 PPM ICP

- MS Standard for Cs from Government Scienti fic Source, 1/14/2014, ERMS561585
2. Do procurement documents require s uppliers 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 NP 4

- 1 , Revision 11, section 2.1.2, Technical and Quality Requirements Documentation; section 2.1.5, Pr ocurement Document Preparation SNL WI PP Program Description, 11/4/2011 Contract between PerkinElmer Health Sciences, Inc. and Sandia National Laboratories for Nexlon 300D ICP

- MS including S10Autosampler and Polyscience R ecirculator, Section I, 2/11/2013 , ERMS559544 Supplementary Requirements (4S

- 1) 1. Do procurement documents include the following provisions as deemed necessary by the p urchaser:

 Scope of work?

 Te chnical requirements?

 QA p rogram requirements?

 Right of access?

 Documentation requirements?

 Requirement for documenting nonconformances?

 Spare and replacement parts? Y QAPD, Revision 11, section 2.3.4, Procurement Docume nt Requirements, paragraphs A

– C NP 4

- 1, Revision 11, section 2.1.5, P rocurement Document Preparation Contract between PerkinElmer Health Sciences, Inc. and Sandia National Laboratories for Nexlon 300D ICP

- MS including S10Autosampler and Polyscience R ecirculator, Section I, 2/11/2013 , ERMS559 544 Contract between Boise State University and Sandia National Laboratories for Geophysical Investigation of the Shallow Subsurface, Section I, 8/11/11 , ERMS557603 , and Section II, 6/14/ 20 11
2. Is the review of procurement documentation documented? Y QAPD, Revision 11, section 2. 3.5 , Procurement Document Review and Approval, paragraph B NP 4

- 1, Revision 11, section 2.1. 6, Procurement Document ReviewsEPA Audit of WIPP QA Program: SNL

- 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: May, 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

Form No. 4

- 1

- 1, Revision 11, Procurement Review, Service Contract with PerkinElmer for Nexlon 300D ICP

- MS inc luding S10Autosampler and Polyscience Recirculator, 1/24/ 20 13 , ERMS559543
3. A re 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 Docu ment Review and Approval, paragraphs C and D NP 4

- 1, Revision 11, section 2.2, Existing Contract Change Requests
*Y: T he reference d document s adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. N: T he reference d document s do no t adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. I : EPA requires additional information to determine if t he reference d document s adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. N/A: The specifi c NQA

- 1

- 1989 requirement is not applicable to the subject QA program

.EPA Audit of WIPP QA Program: SNL

- CO WIPP QA 5

- 1 ASME NQA

- 1

- 1989 CHECKLIST
NQA

- 1 ELEMENT: No. 5, Instructions, Procedure s and Drawings EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: May, July 2014
Does the referenc e 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 d ocumented instructions, procedures or drawings? Y QAPD, Rev ision 11, section 2.1, Work Processes , paragraph A NP 5

- 1, Revision 6, section 2.1.1, Incorp orating Upper Tier Requirements SP 5

- 1, R evision 2, Engineering Drawings NP 9

- 1, Revision 9, section 2.1. 1, Analysis Plan Preparation and Approval; section 2.1.2, Analysis Plan Changes/Revisions; section 2.1. 3, Analysis Plan Implementation NP 20

- 1, Revision 5, section 1.0, Purpose and Scope Collection of Nuclear Waste Management Procedures, Activity/Project S pecific Procedures, Analysis Plans and Test Plans
2. Do the documents referenced in question 1 include or reference appropriate quantitative or qualitative acceptance criteria? Y QAPD, Rev ision 11, section 2.1.2 , Implementing Procedures , paragraph B

. 4 NP 5

- 1 , Revision 6, Appendix A, sect ion 2.0, Implementation Actions SP 12

- 32, Revision 1, section 2.5, Acceptance Criteria Supplementary Requirements

– None *Y: T he reference d document s adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requiremen t. N: T he reference d document s do not adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. I : EPA requires additional information to determine if t he reference d document s adequately define, describe, a ddress 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: SNL

- 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 D ATE: May, 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 do cuments that specify quality requirements or prescribe activities affecting quality controlled? Y QAPD, Rev ision 11, section 1.4.1, Document Preparation, Review, Approval, and Issuance ; s ection 1.4.3, Document Changes NP 6

- 2, Revision 5, section 1.0, Purpo se and Scope; appendix B, NP 6

- 2 Process Flow Chart
2. Are such documents, including changes thereto, reviewed for adequacy and approved for release by authorized personnel? Y QAPD, Rev ision 11, section 1.4.1 , Document Preparation, Review, Approval, and Issu ance , paragraphs A and J; s ection 1.4.3 , Document Changes , paragraph A NP 6

- 1, Revision 8, section 1.0, Purpose and Scope; section 2.2, Identifying the Reviewers; section 2.3, Conducting the Review; appendix B, NP 6

- 1 Process F low Chart NP 6

- 2, Revision 5, section 2.1, Is suance of a Controlled Document Document Review Package for NP 6

- 2, ERMS561678 Document Review Package for AP

- 165, ERMS560703 , ERMS560704, ERMS560705 Document Review Package for AP

- 168, ERMS561954 , ERMS561955 , ERMS561956 Document Review Pac kage for NP 17

- 1, ERMS559928 Document Review Package for NP 18

- 1, ERMS556852 , ERMS556853 Document Review Package for SP 12

- 19, ERMS554665 , ERMS554666 , ERMS554667 Document Review Package for SP 12

- 32, ERMS561935 , ERMS561936 , ERMS561937 Document Review Packa ge for TP 14

- 01, ERMS561691 , ERMS561692 , ERMS561693 Document Review Package for TP 14

- 03, ERMS561896 , ERMS561897 , ERMS561898 Supplementary Requirements (6S

- 1) 1. Are documents controlled to assure that correct and applicable documents are available at the l ocation where they are to be used? Y QAPD, Rev ision 11, section 1.4.2, Document Distribution and Use NP 6

- 2, Revision 5, section 2.1, Issuance of a Controlled Document; s ection 2.1.1, On

- Line Documents Document Review Package for NP 6

- 2, ERMS561680EPA Audit of WIPP QA Program: SNL

- 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 D ATE: May, 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

Documen t Review Package for AP

- 165, ERMS560707 and ERMS561138 Document Review Package for AP

- 168, ERMS561957 Document Review Package for NP 17

- 1, ERMS559930 Document Review Package for TP 14

- 01, ERMS556855 Document Review Package for SP 12

- 19, ERMS554669 and ERMS 561483 Document Review Package for SP 12

- 32, ERMS561940 Document Review Package for TP 14

- 03, ERMS561695 Document Review Package for NP 18

- 1, ERMS561901
2. Does the document control system provide for:

 Identification of documents to be controlled and their s pecified 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, Rev ision 11, section 1.4.1, Document Preparation, Review, Approval, and Issuance NP 6

- 1, Revision 8, section 1.0, Purpose and Scope; section 2.2, Identifying the Reviewers NP 6

- 2, Revision 5, section 1.0, Purpose and Scope; section 2.1, Issuance of a Controll ed Document; section 2

- 1

- 1, On

- Line Documents; append ix B, NP 6

- 2 Process Flow Chart Document Review Package for NP 6

- 2, ERMS561680 Document Review Package for AP

- 165, ERMS560707 and ERMS561138 Document Review Package for AP

- 168, ERMS561957 Document Review Package for NP 17

- 1, ERMS559930 Document Review Package for TP 14

- 01, ERMS556855 Document Review Package for SP 12

- 19, ERMS554669 and ERMS561483 Document Review Package for SP 12

- 32, ERMS561940 Document Review Package for TP 14

- 03, ERMS561695 Document Rev iew Package for NP 18

- 1, ERMS561901
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, Rev ision 11, section 1.4.3, Document Changes , paragraph A NP 6

- 1, Revision 8, section 2.2, Identifying the Reviewers

4. Does the organization reviewing major changes to documents have access to pertinent background data or information upon which to ba se its approval? Y QAPD, Rev ision 11, section 1.4.1, Document Preparation, Review, Approval, and Issuance , paragraph D NP 6

- 1, Revision 8, section 2.3 Conducting the Review
5. Are minor changes to documents defined (i.e., those changes that do Y QAPD, Rev ision 11, section 1.4.3, Document Changes , paragraphs C and EEPA Audit of WIPP QA Program: SNL

- CO WIPP QA 6

- 3

NQA

- 1 ELEMENT: No. 6 with Supplement 6S

- 1, Document Control EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad D ATE: May, 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 not require a review as a major change) ? Are the persons who can authorize a minor change clearly delineated? NP 6

- 1, Revision 8, section 2.2, Ident ifying the Reviewers

*Y: T he reference d documen t s adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. N: T he reference d document s do not adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. I : EPA requires additional information to determine if t he r eference d document s adequately define, describe, a ddress 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: SNL

- 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: May, 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 Parag raph; 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; sectio n 2.3.7.2, Receiving Inspection NP 4

- 1, Rev ision 11, section 2.1.3, Supplier Selection; section 2.3.2, Evaluation of Service Provider/Supplier; sec tion 2.3.3, Evaluation of Items Form No. 4

- 1

- 1, Revision 11, Procurement Review, Service Contract with PerkinElmer for Nexlon 300D ICP

- MS including S10 Autosampler and Po lyscience Recirculator, 1/24/2013 , ERMS559543 ISO

- 9001 Certification, Procurement Package for Omega Engineering, Inc. Omega S

Beam Load Cell, Record

- in

- Progress, observed 7/22/2014 Supplementary Requirements (7S

- 1) 1. Does procurement plan ning 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, Rev ision 11, section 2.3.1 , Pr ocurement Planning Requirements NP 4

- 1, Revision 11, section 2.1.2, Techni cal and Quality Requirements Documentation; section 2.1.5, Procurement Do cument Preparation Form No. 4

- 1

- 1, Revision 11, Procurement Review, Service Contract with PerkinElmer for Nexlon 300D ICP

- MS including S10Autosampler and Polyscience Recirculator, 1/2 4/ 20 13 , ERMS559543
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?

 Corrective action?

 Acceptance of item or service?

 Quality assurance records? Y QAPD, Rev ision 11, section 2.3.1 , Procurement Planning Requirements, paragraphs C.1

– 9 NP 4

- 1, Revision 11, section 2.1.2, Technical and Quality Requirements Documentation; section 2.1.3, Supplier Selection; section 2.1.4, Bid Evaluation Criteria, Plan and Proposal; section 2.1.5, Procurem ent Document Preparation; section 2.1.6, Procurement Document Reviews; section 2.2, Existing Contract Change Requests; section 2.3.1, Acceptance of Procurements (Receipt Inspections); section 2.3.2, Evaluation of Service Provider/Supplier; sec tion 2.3.3, E valuation of Items Form No. 4

- 1

- 1, Revision 11, Procurement Review, Service Contract with PerkinElmer for Nexlon 300D ICP

- MS including S10Autosampler and Polyscience Recirculator, 1/24/ 20 13 , ERMS559543EPA Audit of WIPP QA Program: SNL

- 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: May, 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 Parag raph; Additional Objective Evidence
3. Are the measures for evaluation and selection of proc urement 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 qualit y 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 qua lity assurance program? Y QAPD, Rev ision 11, section 2.3.2 , Supplier S election, paragraphs A, C and D NP 4

- 1, Revision 11, se ction 2.1.3, Supplier Selection Quality Levels for WIPP Activities

- FY14 (Approved Suppliers List), downloaded 4/24/2014 ISO

- 9001 Certification, Procurement Package for Omega Engineering, Inc. Omega S

Beam Load Cell, Record

- in

- Progress, observed 7/22/2014

4. Are the following items considered in bid evaluations:

 Technical considerations?

 Quality assurance requirements?

 Supplier’s perso nnel?

 Supplier’s production capability?

 Supplier’s past performance?

 Alternates?

 Exceptions? Y QAPD, Rev ision 11, section 2.3.3 , Proposal/Bid Evaluation NP 4

- 1, Revision 11, section 2.1.4, Bid Evaluat ion Criteria, Plan and Proposal

5. Are the following ite ms 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 doc ument information exchange between purchaser and supplier?

 Establishing the extent of source surveillance and inspection activities? Y QAPD, Rev ision 11, section 2.3.6 , Supplier Performance Evaluation, paragraphs A

– F Quality Levels for WIPP Activities

- FY 14 (Approved Suppliers List), downloaded 4/24/2014 ISO

- 9001 Certification, Procurement Package for Omega Engineering, Inc. Omega S

Beam Load Cell, Record

- in

- Progress, observed 7/22/2014EPA Audit of WIPP QA Program: SNL

- 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: May, 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 Parag raph; Additional Objective Evidence
6. Are verification activities of the supplier’s quality performance pla nned, verified and documented by qualified personnel? Y QAPD, Rev ision 11, section 2.3.4 , Procurement Document Requirements, paragraph C.4 ISO

- 9001 Certification, Procurement Package for Omega Engineering, Inc. Omega S

Beam Load Cell, Record

- in

- Progress, o bserved 7/22/2014 Form No. 4

- 1

- 2, Revision 11, Procurement Review, Geophysical Investigation of the Shallow Subsurface by Boise State University, 3/6/2013, ERMS559674
7. Are supplier

- generated documents controlled, handled and approved in accordance with est ablished methods? Y QAPD, Rev ision 11, section 2.3.4 , Procurement Document Requirements, paragraph C.5
8. Are measures established, implemented and documented to control changes to procurement documents? Y QAPD, Rev ision 11, section 2.3.5 , Procurement Docume nt Review and Approval, paragraph A NP 4

- 1, Revision 11, section 2.2, Existing Contract Change Requests
9. Are methods established for the acceptance of an item or service being furnished by a supplier? Y QAPD, Rev ision 11, section 2.3.7 , Acceptance of Items or Services, paragraph A NP 4

- 1, Revision 11, section 2.3.1, Acceptance of Procurements (Receipt Inspections); section 2.3.2, Evaluation of Service Provider/Supplier; section 2.3.3, Evaluation of Items Form No. 4

- 1

- 2, Revision 11, Receipt Inspection, 1000 PPM Standards for Ca, Na, Mn, Fe, B, Cs, 1 PPM ICP

- MS Standard for Cs from Government Scientific Source, 1/23/2014, ERMS561586 Form No. 4

- 1

- 2, Revision 11, Procurement Review, Geophysical Investigation of the Shallow Subsurface by Boise State University, 3/6 /2013, ERMS559 674
10. Is the supplier required to verify that the item or service being furnished complies with the procurement requirements? Y QAPD, Rev ision 11, section 2.3.7 , Acceptance of Items or Services, paragraph B Form No. 4

- 1

- 2, Revision 11, Rec eipt Inspection, 1000 PPM Standards for Ca, Na, Mn, Fe, B, Cs, 1 PPM ICP

- MS Standard for Cs from Government Scientific Source, 1/23/2014, ERMS561586
11. Are one or more of the following methods used to accept an item or related services from a supplier:

 Suppl ier certificate of conformance?

 Source verification?

 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. Y QAPD, Rev ision 11, section 2.3.7.1, Source V erification; section 2.3.7.2, Receiving Inspection; section 2.3.7.3, P ost

- installation Testing; section 2.3.7.4 , Supplier Certificate of Conformance NP 4

- 1, Revision 11, section 2.3.1, Acceptance of Procurements (Receipt Inspections); section 2.3.2, Evalua tion of Service Provider/Supplier; sec tion 2.3.3, Evaluation of Items NP 18

- 1, Revision 9, section 2.1.2, Other Requirements Form No. 4

- 1

- 2, Revision 11, Receipt Inspection, 1000 PPM Standards for Ca, Na,EPA Audit of WIPP QA Program: SNL

- 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: May, 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 Parag raph; Additional Objective Evidence

Mn, Fe, B, Cs, 1 PPM ICP

- MS Standard for Cs from Go vernment Scientific Source, 1/23/2014, ERMS561586
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, Rev ision 11, section 2.3.7.1 , Source Verification, paragraph C NP 4

- 1, Revision 11, section 2.3.1, Acceptance of Procurements (Receipt Inspections); section 2.3.2, Evaluati on of Service Provider/Supplier NP 18

- 1, Revision 9, section 2.1.2, Other Requirements Form No. 4

- 1

- 2, Revision 11, Procurement Review, Geophysical Investigation of the Shallow Subsurface by Boise State University, 3/6/2013, ERMS559674
13. Do the purc haser and supplier have documented methods for disposition of items and services that do not meet procurement document requirements? Y QAPD, Rev ision 11, section 2.3.8 , Cont rol of Supplier Nonconformances NP 4

- 1, Revision 11, section 2.3.1, Acceptance of P rocurements (Receipt Inspections); section 2.3.2, Evaluation of Service Provider/Supplier; section 2.3.3, Evaluation of Items; section 2.3.5, Item or Services Received Does Not Meet Requirements
14. Do the methods in question 13 contain provisions for:

 Evalua tion 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., use

as
- is or repair) and technical ju stification?

 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
r equirements or purchaser

- approved documents are addressed in NQA

- 1

- 1989, Supplement 7S

- 1, paragraph 9(b). Y QAPD, Rev ision 11, section 2.3.8 , Cont rol of Supplier Nonconformances NP 4

- 1, Revision 11, section 2.3.1, Acceptance of Procurements (Receipt Inspec tions); section 2.3.2, Evaluation of Service Provider/Supplier; section 2.3.3, Evaluation of Items; section 2.3.5, Item or Services Received Does Not Meet Requirements

*Y: T he reference d document s adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. N: T he reference d document s do not adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. I : EPA requires additional information to determine if t he reference d document s adequately define, describe, a ddress 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: SNL

- CO WIPP QA 8

- 1 ASME NQA

- 1

- 1989 CHECKLIST
NQA

- 1 ELEMENT: No. 8 with Supplement 8S

- 1, Identification and EPA AUDITORS: L. Bender, P. Kelly, K. Dar low, K. Lindblad DATE: May, July , Dec 2014

Control of Items 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. Ar e controls established to assure that only correct and accepted items are used or installed? Y QAPD, Rev ision 11, section 2.1.3 , Item Identification and Control, paragraph B NP 13

- 1, Revision 7, section 2.2, Samples, Standards and Chemicals Identification; section 2.3, Conditions Adverse to Quality or Significant Conditions Adverse to Quality Samples and Standards; section 3.0 , Records NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test Plan Flowchart SP 13

- 1, Revision 5, section 2.3 , Samp le Identification/Initiating Chain of Custody; section 2.6 , Sample Archiving/Storage/Disposition ; Appendix A, Form Number : SP 13

- 1

- 1 , Chain of Custody SNL WIPP QA Surveillance IS

- 14

- 04, ERMS 562299 NP 20

- 2, Revision 10, Appendix A, Requirements for SNL

- WIPP Scientific Notebooks; Appendix B, Laboratory Scientific Notebook Technical and QA Review Checklist; Appendix C, Field Scientific Notebook Technical and QA Review Checklists TP 03

- 01, Revision 3, section 4.4, Data

- Acquisition Plan TP 08

- 02, Revision 0, sec tion 1 .0, Purpose and Scope; section 2 .0 , Experimental Process Description; section 4 .0, Data Quality Control; section 5. 0, Equipment
2. Is identification required to be maintained either on the items or in documents traceable to the items, or in a manner th at assures that identification is established and maintained? Y QAPD, Rev ision 11, section 2.1.3 , Item Identification and Control, paragraphs A and B.1 NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test Plan Flowchart Limited Calibration Certificate, Document No: 56013_11622752, 4/2/2013, ERMS599801 Limited Calibration Certificate, Document No: 56013_11596366, 3/31/2014, ERMS561916 Supplementary Requirements (8S

- 1) 1. Are items of production (e.g., batch, lot, component, part) identified f rom initial receipt and fabrication of the items up to and including installation and use? Y QAPD, Rev ision 11, section 2.1.3 , Item Identification and Control, paragraph B.1 NP 13

- 1, Revision 7, section 2.2, Samples, Standards and Chemicals Identification; section 2.3, Conditions Adverse to Quality or Significant Conditions Adverse to Quality Samples and Standards; section 2.4, Use, Handling, Storing, and ShippingEPA Audit of WIPP QA Program: SNL

- CO WIPP QA 8

- 2

NQA

- 1 ELEMENT: No. 8 with Supplement 8S

- 1, Identification and EPA AUDITORS: L. Bender, P. Kelly, K. Dar low, K. Lindblad DATE: May, July , Dec 2014

Control of Items Does the reference document adequately define, describe, address or satisfy the following: Y, N, I, N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

Samples and Standards; Appendix A, NP 13

- 1 Sample Control Process Flowchart SP 13

- 1, Revision 5, section 2.3 , Sample Identification/Initiating Chain of Custody; section 2.6 , Sample Archiving/Storage/Disposition ; Appendix A, Form Number : SP 13

- 1

- 1 , Chain of Custody SNL WIPP QA Surveillance IS

- 14

- 04, ERMS 562299
2. Does the required identification relat e an item to the applicable design or other pertinent specifying documents? N/A

3. Is physical identification used to the maximum extent possible? Y QAPD, Rev ision 11, section 2.1.3, Item Identification and Control, paragraph B.2 NP 13

- 1, Revision 7, sectio n 2.2, Samples, Standards and Chemicals Identification; section 2.4, Use, Handling, Storing, and Shipping Samples and Standards; section 2.5, Samples and Standards Storage/Archiving
4. Are identification markings applied using materials and methods that prov ide a clear and legible identification and do not detrimentally affect the function or service life of the item? Y QAPD, Rev ision 11, section 2.1.3 , Item Identification and Control, paragraphs B.2.a

– b NP 13

- 1, Revision 7, section 2.2, Samples, Standards an d Chemicals Identification; section 2.4, Use, Handling, Storing, and Shipping Samples and Standards; section 2.5, Samples and Standards Storage/Archiving
5. Are identification markings required to be transferred to each part of an identified item when it is subdivided? Y QAPD, Rev ision 11, section 2.1.3 , Item Identification and Control, paragraph B.2.c NP 13

- 1, Revision 7, section 2.2, Samples, Standards and Chemicals Identification; section 2.5, Samples and Standards Storage/Archiving SP 13

- 1, Revision 5, se ction 2.3 , Sample Identification/Initiating Chain of Custody; section 2.6 , Sample Archiving/Storage/Disposition ; Appendix A, Form Number : SP 13

- 1

- 1 , Chain of Custody SNL WIPP QA Surveillance IS

- 14

- 04, ERMS 562299
6. Are limited

- life items (e.g., o

- rings) requ ired to be identified to preclude their use when the shelf life or operating life has expired? Y QAPD, Rev ision 11, section 2.1.3 , Item Identification and Control, paragraph A NP 13

- 1, Revision 7, section 2.2, Samples, Standards and Chemicals Identificatio n; section 2.5, Samples and Standards Storage/Archiving NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test Plan Flowchart TP 03

- 01, Revision 3, section 4 , Experimental Process Rationale and DescriptionEPA Audit of WIPP QA Program: SNL

- CO WIPP QA 8

- 3

NQA

- 1 ELEMENT: No. 8 with Supplement 8S

- 1, Identification and EPA AUDITORS: L. Bender, P. Kelly, K. Dar low, K. Lindblad DATE: May, July , Dec 2014

Control of Items 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. Have provisions been established fo r maintaining control of item identification consistent with the planned duration and conditions of storage, including:

 Provisions for maintenance or replacement of markings and identification records due to damage during handling or aging?

 Protection of i dentification markings on items subject to excessive deterioration due to environmental exposure?

 Provisions for updating existing plant records? Y QAPD, Rev ision 11, section 2.1.5 , Handling, Storage, and Shipping, paragraph E NP 13

- 1, Revision 7, section 2.2, Samples, Standards and Chemicals Identification; section 2.3, Conditions Adverse to Quality or Significant Conditions Adverse to Quality Samples and Standards; section 2.4, Use, Handling, Storing, and Shipping Samples and Standards; section 2.5, Sampl es and Standards Storage/Archiving NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test Plan Flowchart TP 03

- 01, Revision 3, section 4.4, Data

- Acquisition Plan TP 08

- 02, Revision 0, section 1 .0, Purpose and Scope; section 2 .0 , Experimental Process Description; section 4 .0, Data Quality Control; section 5. 0, Equipment SP 13

- 1, Revision 5, section 2.3 , Sample Identification/Initiating Chain of Custody; section 2.6 , Sample Archiving/Storage/Disposition ; Appendix A, Form Number : SP 13

- 1

- 1 , Chain of Custody SNL WIPP QA Surveillance IS

- 14

- 04, ERMS 562299
*Y: T he reference d document s adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. N: T he reference d document s do not adequately define, describe, a ddress or satisfy the N QA

- 1

- 1989 requirement. I : EPA requires additional information to determine if t he reference d document s adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. N/A: The specific NQA

- 1

- 1989 requirement is not applicable to the subje ct QA programEPA Audit of WIPP QA Program: SNL

- 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: May, July 2014 Does the reference document adequately define, describe, address or sat isfy the following: Y, N, I, N/A* Applicable Procedure and Paragraph; Additional Objective Evidence Basic Requirements 1. A re processes affecting the quality of items or services controlled? Y QAPD, Revision 11, section 2.1.2, Implementing Procedures, parag raph A NP 1

- 1, Revision 7, section 2.2.1.1, SNL WIPP Managers Responsibilities NP 5

- 1, Revision 6, section 2.1.1, Incorporating Upper Tier Requirements NP 20

- 1, Revision 5, section 2.1, General Requirements
2. Are special processes, such as welding, heat tre ating and nondestructive examination, performed by qualified personnel? N/A

3. Are special processes performed in accordance with qualified procedures? N/A
Supplementary Requirement s (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 NP 1

- 1, Revision 7, section 2.2.1.1, SNL WIPP Managers Responsibilities NP 20

- 1, Revision 5, section 2.1, General Requirements

2. Is each special process performed in accordance with appropriate instructions, which include or reference procedure, personnel and equipment qualification requirements? N/A

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

4. Do the special process procedures or instructions speci fy or reference applicable codes and standards, including acceptance criteria for the process? N/A

5. Are records maintained for the currently qualified personnel, processes and equipment of each special process? N/A

*Y: T he reference d document s adequate ly define, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. N: T he reference d document s do not adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. I : EPA requires additional information to determine if t he reference d d ocument s adequately define, describe, a ddress 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: SNL

- CO WIPP QA 10

- 1 ASME NQA

- 1

- 1989 CHECKLIST
NQA

- 1 ELEMENT: No. 10 with Supplement 10S

- 1, Inspectio n EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: May, 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
Ba sic Requirements 1. Are inspections preplanned? Y QAPD, Revision 11, section 2.4.3.1, I nspection Planning, paragraph A NP 4

- 1, Revision 11, section 2.1.1 , Initiating a Procurement Action
2. Are the characteristics to be inspected and the inspection methods to be employed specified? Y QAPD, Revision 11, section 2.4, Insp ection and Testing, paragraph A NP 4

- 1, Revision 11, section 2.3.1, Acceptance of Procurements (Receipt Inspections); Form NP 4

- 1

- 1, Procurement Review; Form NP 4

- 1

- 2, Receipt Inspection Form No. 4

- 1

- 1, Revision 11, Procurement Review, 1000 PPM Standards for Ca, Na, Mn, Fe, B, Cs, 1 PPM ICP

- MS Standard for Cs from Government Scientific Source, 1/14/2014, ERMS561585 Form No. 4

- 1

- 2, Revision 11, Receipt Inspection, 1000 PPM Standards for Ca, Na, Mn, Fe, B, Cs, 1 PPM ICP

- MS Standard for Cs from Government Scientific Source, 1/14/2014, ERMS56158 6
3. Are the inspections documented? Y QAPD, Revision 11, section 2.4, Insp ection and Testing, paragraph A NP 4

- 1, Revision 11, section 2.3.1 , Acceptance of Procu rements (Receipt Inspections) ; Form NP 4

- 1

- 2 , Receipt Inspection Form No. 4

- 1

- 2, Revision 11, Receipt Inspection, 1000 PPM Standards for Ca, Na, Mn, Fe, B, Cs, 1 PPM ICP

- MS Standard for Cs from Government Scientific Source, 1/14/2014, ERMS56158 6
4. Are the a cceptance inspections performed by persons who are other than those who performed or directly supervised the work being inspected? Y QAPD, Revision 11, section 2.4, Insp ection and Testing, paragraph A NP 4

- 1, Revision 11, section 2.3.1 , Acceptance of Procu rements (Receipt Inspections) WIPP Receipt Inspectors, 4/8/2014 Form No. 4

- 1

- 2, Revision 11, Receipt Inspection, 1000 PPM Standards for Ca, Na, Mn, Fe, B, Cs, 1 PPM ICP

- MS Standard for Cs from Government Scientific Source, 1/14/2014, ERMS56158 6 Supplement ary Requirement s (10S

- 1) 1. Do i nspection personnel not report directly to the immediate supervisors who were responsible for the work being inspected ? Y QAPD, Revision 11, section 2.4, Insp ection and Testing, paragraph A NP 4

- 1, Revision 11, section 2.3.1 , Acceptance of Procurements (Receipt Inspections) WIPP Receipt Inspectors, 4/8/2014EPA Audit of WIPP QA Program: SNL

- CO WIPP QA 10

- 2

NQA

- 1 ELEMENT: No. 10 with Supplement 10S

- 1, Inspectio n EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: May, 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. Are inspection personnel qualified to perform the assigned inspection task? Y QAPD, Revision 11, section 2.4.1, Qualification of Inspection and Test Personnel; section 2.4. 2, Qualification of Nonde structive Examination Personnel NP 4

- 1, Revision 11, section 2.3.1 , Acceptance of Procurements (Receipt Inspections) WIPP Receipt Inspectors, 4/8/2014 Form NP 2

- 1

- 2, Receipt Inspection Training Records for C

. Camphouse , ERMS557696 , and B

. Malama , ERMS544536
3. Are inspection hold points established and documented? Y QAPD, Revision 11, section 2.4.3.2 , Inspection Hold Points NP 4

- 1, Revision 11, section 2.1.5 , Procurement Document Preparation
4. Is the consent to waive specified hold poi nts documented prior to continuation of work beyond the hold point? N/A

5. Is the planning for inspection activities documented? Does this documentation identify characteristics, methods and acceptance criteria and provide for recording objective evidence o f inspection results? Y QAPD, Revision 11, section 2.4.3.1, I nspection Planning, paragraph A NP 4

- 1, Revision 11, section 2.3.2 , Evaluation of Service Provider/Supplier ; section 2.3.3 , Evaluation of Items ; section 2.3.4 , Item or Services Received Meets Req uirements
6. If sampling is used to verify acceptability of a group of items, is the sampling procedure based on a recognized standard practice? N/A

7. Is inspection of items in process or under construction performed? Note : Both inspection and process moni toring shall be provided when control is inadequate without both. N/A

8. Do final inspections include a records review of the results and resolution of nonconformances identified by prior inspections? N/A

9. Are modifications, repairs or replacements of item s performed subsequent to final inspection required to be reinspected or retested, as appropriate, to verify acceptability? N/A

10. Do inspection records identify the following:

 Item inspected?

 Date of inspection?

 Inspector?

 Type of observation?

 Results or a cceptability?

 Reference to information on action taken in connection with nonconformances? Y QAPD, Revision 11, section 2. 4.3.6, Inspection Documentation NP 4

- 1, Revision 11, Form NP 4

- 1

- 2, Receipt Inspection Form No. 4

- 1

- 2, Revision 11, Receipt Inspection , 1000 PPM Standards for Ca, Na, Mn, Fe, B, Cs, 1 PPM ICP

- MS Standard for Cs from Government Scientific Source, 1/14/2014, ERMS56158 6 Form No. 4

- 1

- 2, Revision 11, Receipt Inspection, Geophysical Investigation of the Shallow Subsurface by Boise State Univer sity , 3/6/2013, ERMS559674EPA Audit of WIPP QA Program: SNL

- CO WIPP QA 10

- 3 *Y: T he reference d document s adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. N: T he reference d document s do not adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. I : EP A requires additional information to determine if t he reference d document s adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. N/A: The specific NQA

- 1

- 1989 requirement is not applicable to the subject QA programEPA Audit of WIPP QA Program: SNL

- CO WIPP QA 11

- 1 ASME NQA

- 1

- 1989 CHECKLIST
NQA

- 1 ELEMENT: No. 11 with Supplements 11S

- 1 and 11S

- 2, Test EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: May, July , Dec 2014

Contro l 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 tests that are required to verify conformance of an item or computer program to specified requirement s and to demonstrate satisfactory performance for s ervice planned and executed? Y QAPD, Revision 11, section 2.4.4, Test Requirements; section 6.4.1, Basic Requirements for Software Procurement; section 6.6.2.4, Testing Phase NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test Plan Flowcha rt TP 03

- 01, Revision 3, section 4.4 , Data

- Acquisition Plan TP 08

- 02, Revision 0, section 1 .0, Purpose and Scope; section 2 .0 , Experimental Process Description; section 4 .0, Data Quality Control; section 5. 0, Equipment
2. Are the characteristics to be tested and test methods to be employed specified? Y QAPD, Revision 11, section 2.4.4.1, Test Planning; section 2.4.4.2, Test Documentation; section 6.4.1, Basic Requirements of Software Procurement; section 6.6.2.4, Testing Phase NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test Plan Flowchart SP 12

- 5, Revision 2, section 2.5, Solonist Brand Water

- Level Sounder Field Check TP 03

- 01, Revision 3, section 4.4 , Data

- Acquisition Plan TP 08

- 02, Revision 0, section 1 .0, Purpose and Scope; section 2 .0 , Experimental Process Description; section 4 .0, Data Quality Control; section 5. 0, Equipment
3. Are test results documented and their conformance with acceptance criteria evaluated? Y QAPD, Revision 11, section 2.4.4.3, Test Results; section 6.4.1, Basic Req uirements of Software Procurement; section 6.6.2.4, Testing Phase, paragraph E NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test Plan Flowchart SP 12

- 5, Revision 2, section 2.5, Solonist Brand Water

- Level Sounder Field Check Supplementa ry Requirement s (11S

- 1) 1. Are the test requirements and acceptance criteria provided or approved by the organization responsible for the design of the item to be tested? Y QAPD, Revision 11, section 2.4.4, Test Requirements NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test Plan Flowchart SP 12

- 5, Revision 2, section 2.5, Solonist Brand Water

- Level Sounder Field Check TP 03

- 01, Revision 3, section 4.4 , Data

- Acquisition Plan TP 08

- 02, Revision 0, section 1 .0, Purpose and Scope; section 2 .0 , Experimental Process Description; section 4 .0, Data Quality Control; section 5. 0, EquipmentEPA Audit of WIPP QA Program: SNL

- CO WIPP QA 11

- 2

NQA

- 1 ELEMENT: No. 11 with Supplements 11S

- 1 and 11S

- 2, Test EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: May, July , Dec 2014

Contro l 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. Do the test procedures include or reference the following, as applicable:

 Calibrated instrumentation?

 Appropriate equipment?

 Trained personnel?

 Condition of the t est equipment and the test item?

 Suitable environmental conditions?

 Provisions for data acquisition? Y QAPD, Revision 11, section 2.4.4.1, Test Planning NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test Plan Flowchart SP 12

- 5, Revision 2 , section 2.5, Solonist Brand Water

- Level Sounder Field Check TP 03

- 01, Revision 3, section 4.4 , Data

- Acquisition Plan TP 08

- 02, Revision 0, section 1 .0, Purpose and Scope; section 2 .0 , Experimental Process Description; section 4 .0, Data Quality Control; s ection 5. 0, Equipment
3. Are test results documented and evaluated by a responsible authority to assure that test requirements have been satisfied? Y QAPD, Revision 11, section 2.4.4.3, Test Results NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendi x B, Test Plan Flowchart SP 12

- 5, Revision 2, section 2.5, Solonist Brand Water

- Level Sounder Field Check TP 03

- 01, Revision 3, section 4.4 , Data

- Acquisition Plan TP 08

- 02, Revision 0, section 1 .0, Purpose and Scope; section 2 .0 , Experimental Process Descr iption; section 4 .0, Data Quality Control; section 5. 0, Equipment
4. Do the tests records identify the following:

 Item tested?

 Date of test?

 Tester or data recorder?

 Type of observation?

 Results and acceptability?

 Action taken in connection with any deviatio ns noted?

 Person evaluating the test results? Y QAPD, Revision 11, section 2.4.4.2, Test Documentation NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test Plan Flowchart SP 12

- 5, Revision 2, section 2.5, Solonist Brand Water

- Level Sounder Field Check Field Check for a Solonist Brand Electric Sounder (1,000 feet), ERMS558471

Supplementary Requirement s (11S

- 2) 1. Are test requirements and acceptance criteria provided or approved by the organization responsible for the design or use of the comp uter program to be tested? Y QAPD, Revision 11, section 6.6.2.4, Testing Phase, paragraph A NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test Plan Flowchart SP 12

- 5, Revision 2, section 2.5, Solonist Brand Water

- Level Sounder Field Check TP 03

- 01, Revision 3, section 4.4 , Data

- Acquisition Plan TP 08

- 02, Revision 0, section 1 .0, Purpose and Scope; section 2 .0 , Experimental Process Description; section 4 .0, Data Quality Control; section 5. 0, Equipment
2. Are required tests controlled, includi ng verification tests, hardware integration test s and/or in

- use tests? Y QAPD, Revision 11, section 6.6.2.4, Testing Phase, paragraph A NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test PlanEPA Audit of WIPP QA Program: SNL

- CO WIPP QA 11

- 3

NQA

- 1 ELEMENT: No. 11 with Supplements 11S

- 1 and 11S

- 2, Test EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: May, July , Dec 2014

Contro l Does the reference document adequately define, describe, address or satisfy the following: Y , N, I, N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

Flowchart SP 12

- 5, Revision 2, section 2.5, So lonist Brand Water

- Level Sounder Field Check TP 03

- 01, Revision 3, section 4.4 , Data

- Acquisition Plan TP 08

- 02, Revision 0, section 1 .0, Purpose and Scope; section 2 .0 , Experimental Process Description; section 4 .0, Data Quality Control; section 5. 0, Equip ment
3. Do test procedures or plans specify the following, as applicable:

 Required tests and test sequence?

 Required ranges of input parameters?

 Identification of the stages at which testing is required?

 Criteria for establishing test cases?

 Requirements for testing logic branches?

 Requirements for hardware integration?

 Anticipated output values?

 Acceptance criteria?

 Reports, records, standard formatting and conventions? Y QAPD, Revision 11, section 6.4.1, Basic Requirements for Software Procurement NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test Plan Flowchart TP 03

- 01, Revision 3, section 4.4 , Data

- Acquisition Plan TP 08

- 02, Revision 0, section 1 .0, Purpose and Scope; section 2 .0 , Experimental Process Description; section 4 .0, Data Quali ty Control; section 5. 0, Equipment

4. Are test results documented? Y QAPD, Revision 11, section 6.6.2.4, Testing Phase, paragraph E NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test Plan Flowchart TP 03

- 01, Revision 3, section 4.4 , Data

- Ac quisition Plan TP 08

- 02, Revision 0, section 1 .0, Purpose and Scope; section 2 .0 , Experimental Process Description; section 4 .0, Data Quality Control; section 5. 0, Equipment Field Check for a Solonist Brand Electric Sounder (1,000 feet), ERMS558471 Well H

- 9bR Video Log, ERMS558348 Experimental Determination of Lead Solubility in the Carbonate Systems to High Ionic Strengths: A Pitzer Model Description, ERMS561907
5. Are verification test results evaluated by a responsible authority to assure that test require ments have been satisfied? Y QAPD, Revision 11, section 6.7.1, Basic Requirements, paragraph B; section 6.7.2.5, Testing NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test Plan Flowchart SP 12

- 5, Revision 2, section 2.5, Solonist Brand Wa ter

- Level Sounder Field Check TP 03

- 01, Revision 3, section 4.4 , Data

- Acquisition Plan TP 08

- 02, Revision 0, section 1 .0, Purpose and Scope; section 2 .0 , ExperimentalEPA Audit of WIPP QA Program: SNL

- CO WIPP QA 11

- 4

NQA

- 1 ELEMENT: No. 11 with Supplements 11S

- 1 and 11S

- 2, Test EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: May, July , Dec 2014

Contro l Does the reference document adequately define, describe, address or satisfy the following: Y , N, I, N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

Process Description; section 4 .0, Data Quality Control; section 5. 0, Equipment

6. Do verifi cation test records identify each of the following:

 Computer program tested?

 Computer hardware used?

 Test equipment and calibrations, where applicable?

 Date of test?

 Tester or data recorder?

 Simulation models used, where applicable?

 Test problems?

 Results and acceptability?

 Action taken in connection with any deviations noted?

 Person evaluating the test results? Y QAPD, Revision 11, section 6.6.2.4, Testing Phase, paragraph E NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test Plan Flowchar t SP 12

- 5, Revision 2, section 2.5, Solonist Brand Water

- Level Sounder Field Check Field Check for a Solonist Brand Electric Sounder (1,000 feet), ERMS558471 Well H

- 9bR Video Log, ERMS558348 Experimental Determination of Lead Solubility in the Carbonate Sy stems to High Ionic Strengths: A Pitzer Model Description, ERMS561907

7. Do in

- use test results identify each of the following:

 Computer program tested?

 Computer hardware used?

 Test equipment and calibrations, where applicable?

 Date of test?

 Tester or data r ecorder?

 Acceptability? Y QAPD, Revision 11, section 6.6.2.4, Testing Phase, paragraph E NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test Plan Flowchart SP 12

- 5, Revision 2, section 2.5, Solonist Brand Water

- Level Sounder Field Check Fi eld Check for a Solonist Brand Electric Sounder (1,000 feet), ERMS558471

*Y: T he reference d document s adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. N: T he reference d document s do not adequately define, describe, a ddress o r satisfy the NQA

- 1

- 1989 requirement. I : EPA requires additional information to determine if t he reference d document s adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. N/A: The specific NQA

- 1

- 1989 requirement is not applicab le to the subject QA program

.EPA Audit of WIPP QA Program: SNL

- CO WIPP QA 12

- 1 ASME NQA

- 1

- 1989 CHECKLIST

NQA

- 1 ELEMENT: No. 12 with Supplement 12S

- 1, Control of EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: May, July , Dec 2014

Measuring and Test Equipment
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?

 Calib rated?

 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 NP 12

- 1, Revision 8, s ection 2.1, Use of M&TE; section 2.2 , Control of M&TE; section 2.2.3 , Maintenance of M&TE Ca libration Record for Troll Pressure Transducer Model 700, Serial Number 148736, Calibration Procedure SP

- 12

- 32, Revision 1; Mensor S/N 611334

– Calibration Due 6/14/2014; Temperature Probe S/N 307172

- Calibration Due 3/31/2015; record dated May 12, 2014 S andia National Laboratories Scientific Notebook , Balance Calibration Log Book Balance Calibration Records, Leslie Kirkes, 6/13/ 20 13, Balance Nos. Mettler PM 4000, AT 4000 and Mettler Toledo AT 261 Supplementary Requirement s (12S

- 1) 1. Is the selection of me asuring 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, pa ragraphs A.7 and A.8; section 2.4.4.1, Test Planning, paragraph C NP 12

- 1, Revision 8, s ection 2.1.4 , Recording the Use of M&TE NP 20

- 1, Revision 5, Test Plans NP 20

- 2, Revision 10, Scientific Notebooks TP 03

- 01, Revision 3, Test Plan for Testing of Wells at the WIPP Site SP 12

- 5, Revision 2, Depth

- to

- Water Measurement Using a Solonist Brand Electric Sounder Field Check for a Solonist Brand Electric Sounder (1,000 feet), ERMS558471 TP 08

- 02, Rev ision 0, Test Plan, Iron, Lean, Sulfide and EDTA Solubilities
2. Is the measuring and test equipment calibrated at prescribed intervals? Y QAPD, Revision 11, section 2.4.7, Calibration, paragraph A NP 12

- 1, Revision 8, s ection 2.3.1, Calibration Service Provider Responsibilities; section 2.5, Establishing Calibration Se rvice
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 NP 12

- 1, Revision 8, s ection 1.2, Scope; s ection 2.1, U se of M&TE; section 2.2 , Control of M&TE; section 2.2.3 , Maintenance of M&TE
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;EPA Audit of WIPP QA Program: SNL

- CO WIPP QA 12

- 2 NQA

- 1 ELEMENT: No. 12 with Supplement 12S

- 1, Control of EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: May, July , Dec 2014

Measuring and Test Equipment
Does the reference document adequately define, describe, address or satisfy the following: Y, N, I, N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

section 2.4.7, Calibration, par agraph C NP 12

- 1, Revision 8, s ection 2.3.1, Calibration Service Provider Responsibilities; section 2.5, Establishing Calibration Service TP 08

- 02, Rev ision 0, Test Plan, Iron, Lean, Sulfide and EDTA Solubilities Sandia National Laboratories Scientific Not ebook, ICP

- AES Logbook

- 2, November 2006iii
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 QAP D, Revision 11, section 2.4.6, Use and Control of M&TE, paragraph F NP 12

- 1, Revision 8, s ection 2.6.1, Identifying and Processing Nonconformances Calibration Record for Troll Pressure Transducer Model 700, S/N: 148736, Calibration Procedure SP

- 12

- 32, Revi sion 1; Mensor S/N: 611334

– Calibration Due 6/14/2014; Temperature Probe S/N: 307172

- Calibration Due 3/31/2015; records dated May 12, 2014 and May 28, 2014
6. Is calibration not required for commercial devices (e.g., rulers, tape measures, levels), if nor mal commercial equipment provides adequate accuracy? Y QAPD, Revision 11, section 2.4.5 , Monitoring, Measuring, Testing, and Data Collection Equipment NP 12

- 1, Revision 8, s ection 1.0, Purpose and Scope; section 2.4, Check Standard; section 2.5, Establishi ng Calibration Service
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 NP 12

- 1, Revision 8, s ection 2.1, Use of M&TE; section 2.2 , Control of M&TE
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 NP 12

- 1, Revision 8, s ection 2.0, Implementation Actions; section 2.3, Obtaining Calibratio n Services; section 3.0, Records SP 17

- 1, Revision 8, R ecords Center Operations Visual c onfirmation of t ag o ut for FLUM E System Data Acquisition System, Tag No. 820, 10/13/ 20 13 , observed 7/22/2014 Visual confirmation of markings to indicate calibration st atus: Weights S/N: 34855 and Thermometer CPC 6000, observed 7/22/ 2014
*Y: T he reference d document s adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. N: T he reference d document s do not adequately define, describe, a ddress or s atisfy the NQA

- 1

- 1989 requirement. I : EPA requires additional information to determine if t he reference d document s adequately define, describe, a ddress 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: SNL

- CO WIPP QA 13

- 1 ASME NQA

- 1

- 1989 CHECKLIST
NQA

- 1 ELEMENT: No. 13 with Supplement 13S

- 1, Handling, Storage EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: May , July , Dec 2014

and Shipping Does the reference document adequate ly define, describe, address or satisfy the following: Y, N, I, N/A* Applicable Procedure and Paragraph; Additional Objective Evidence Basic Requirements 1. Are handling, storage, cleaning, packaging, shipping and preservation of items controlled to prevent damage or loss and to minimize deterioration? Y QAPD, Revision 11, section 2.1.5 , Handling, Storage and Shipping NP 13

- 1, Revision 6, section 1.0 , Purpose and Scope ; section 2.4 , Use, Handling, Storing, and Shipping Samples and Standards ; section 2.5 , Sam ples and Standards Storage/Archiving SP 13

- 1, Revision 5, section 2.3 , Sample Identification/Initiating Chain of Custody; section 2.6 , Sample Archiving/Storage/Disposition ; Appendix A, Form Number : SP 13

- 1

- 1 , Chain of Custody SNL WIPP QA Surveillance IS

- 14

- 04, ERMS 562299 Supplementary Requirement s (13S

- 1) 1. Are the handling, storage and shipping of items conducted in accordance with established work and inspection instructions, drawings, specifications, shipment instructions or other pertinent documents o r procedures specified for use in conducting the activity? Y QAPD, Revision 11, section 2.1.5, Handling, Storage and Shipping, paragraph A NP 13

- 1, Revision 6, section 2.4, Use, Handling, Storing, and Shipping Samples and Standards SP 13

- 1, Revision 5, sec tion 2.3 , Sample Identification/Initiating Chain of Custody; section 2.6 , Sample Archiving/Storage/Disposition ; Appendix A, Form Number : SP 13

- 1

- 1 , Chain of Custody SP 13

- 2, Revision 4, section 2.5, Core Logging SNL WIPP QA Surveillance IS

- 14

- 04, ERMS 56229 9
2. When required for particular items, are special equipment (such as containers, shock absorbers and accelerometers), and special protective environments (such as inert gas atmosphere, specific moisture content levels and temperature levels) specified and provided and their existence verified? Y QAPD, Revision 11, section 2.1.5, Handling, Storage and Shipping, paragraph s D

– D.1 NP 13

- 1, Revision 6, section 2.4, Use, Handling, Storing, and Shipping Samples and Standards SP 13

- 1, Revision 5, section 2.3 , Samp le Identification/Initiating Chain of Custody; section 2.6 , Sample Archiving/Storage/Disposition ; Appendix A, Form Number : SP 13

- 1

- 1 , Chain of Custody NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test Plan Flowchart TP 03

- 01, Revision 3, section 3, Purpose and Scope; section 4.4, Data

- Acquisition Plan Form NP 18

- 1

- 4, Limited Scope Surveillance Report of Core Sample Logging and Management, IS 13

- 01, ERMS558716EPA Audit of WIPP QA Program: SNL

- CO WIPP QA 13

- 2

NQA

- 1 ELEMENT: No. 13 with Supplement 13S

- 1, Handling, Storage EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: May , July , Dec 2014

and Shipping Does the reference document adequate ly define, describe, address or satisfy the following: Y, N, I, N/A* Applicable Procedure and Paragraph; Additional Objective Evidence

Form NP 18

- 1

- 4, Limited Scope Surveillance Report of Control of Samples and Stan dards/Chain of Custody, IS 14

- 04, ERMS562299 SNL WIPP QA Surveillance IS

- 14

- 04, ERMS 562299
3. When required for critical, sensitive, perishable or high

- value articles, are specific procedures for handling, storage, packaging, shipping and preservation used? Y QAPD, Revision 11, section 2.1.5, Handling, Storage and Shipping, paragraph B NP 13

- 1, Revision 6, section 2.4, Use, Handling, Storing, and Shipping Samples and Standards SP 13

- 1, Revision 5, section 2.3 , Sample Identification/Initiating Chain of Custody ; section 2.6 , Sample Archiving/Storage/Disposition ; Appendix A, Form Number : SP 13

- 1

- 1 , Chain of Custody NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test Plan Flowchart TP 03

- 01, Revision 3, section 3, Purpose and Scope; section 4.4, D ata

- Acquisition Plan SNL WIPP QA Surveillance IS

- 14

- 04, ERMS 562299
4. Are special

- handling tools and equipment u sed and controlled as necessary to ensure safe and adequate handling? Y QAPD, Revision 11, section 2.1.5, Handling, Storage and Shipping, paragrap h D. 2 NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test Plan Flowchart TP 03

- 01, Revision 3, section 3, Purpose and Scope; section 4.4, Data

- Acquisition Plan
5. Are special

- handling tools and equipment inspected and tested in accordance wi th procedures and at specified time intervals to verify that the tools and equipment are adequately maintained? Y QAPD, Revision 11, section 2.1.5, Handling, Storage and Shipping, paragraph D.3 NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B , Test Plan Flowchart TP 03

- 01, Revision 3, section 3, Purpose and Scope; section 4.4, Data

- Acquisition Plan
6. Are operators of special

- handling and lifting equipment experienced or trained in the use of the equipment? Y QAPD, Revision 11, section 2.1.5, Ha ndling, Storage and Shipping, paragraph D.4 NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test Plan Flowchart TP 03

- 01, Revision 3, section 3, Purpose and Scope; section 4.4, Data

- Acquisition Plan
7. Are instructions for marking and labelin g for packaging, shipment, handling and storage of items established as necessary to adequately identify, maintain, and preserve the item s , including indication of the Y QAPD, Revision 11, section 2.1.5, Handling, Storage and Shipping, paragraph C NP 13

- 1, Revision 6, section 2.2 , Samples, Standards and Chemicals IdentificationEPA Audit of WIPP QA Program: SNL

- CO WIPP QA 13

- 3

NQA

- 1 ELEMENT: No. 13 with Supplement 13S

- 1, Handling, Storage EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: May , July , Dec 2014

and Shipping Does the reference document adequate ly define, describe, address or satisfy the following: Y, N, I, N/A* Applicable Procedure and Paragraph; Additional Objective Evidence presence of special environment s or the need for special controls? SP 13

- 1, Revision 5, section 2.3 , Sample Identification/Initiating Chain of Custody; section 2.6 , Sample Archiving/ Storage/Disposition ; Appendix A, Form Number : SP 13

- 1

- 1 , Chain of Custody NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test Plan Flowchart SNL WIPP QA Surveillance IS

- 14

- 04, ERMS 562299
*Y: T he reference d document s adequately define, de scribe, a ddress or satisfy the NQA

- 1

- 1989 requirement. N: T he reference d document s do not adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. I : EPA requires additional information to determine if t he reference d document s adeq uately define, describe, a ddress 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: SNL

- CO WIPP QA 14

- 1 ASME NQA

- 1

- 1989 CHECKLIST
NQA

- 1 ELEMENT: No. 14, Inspection, Test and Operating Status EPA AU DITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: May, July , Dec 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 status of inspection and test activities identified either on the item or documents traceable to the item, in order to assure that (1) required inspections and tests are performed and (2) items that have not passed the required inspec tions and tests are not inadvertently installed, used or operated? Y QAPD, Revision 11, section 2.1.3 , Item Identification and Control, paragraph s B.4 and B.5 SP 1

- 1, Revision 7, section 2, Implementation Actions; Appendix A, WIPP QA Grading Process Flowch art; Appendix B, QA Grading Determination, Form SP 1

- 1

- 1 NP 5

- 1, Revision 6, section 2.3, Preparation, Review, and Approval of Implementing Procedures and Revisions; section 2.6, Compliance with Implementing Procedures; Appendix A, NP and SP Guidance; Appe ndix B, Form NP 5

- 1

- 1, Procedure History and Review/Approval; Appendix C, NP 5

- 1 Process Flow Chart Form NP 2

- 1

- 2, Receipt Inspection Training Records for C

. Camphouse , ERMS557696 , and B

. Malama , ERMS544536 SP 12

- 5, Revision 2, section 2.5, Solonist Brand Water

- Level Sounder Field Check Field Check for a Solonist Brand Electric Sounder (1,000 feet), ERMS558471 NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test Plan Flowchart TP 08

- 02, Revision 0, Iron, Lean, Sulfide and EDTA Solubilities
2. Is the status maintained through indicators, such as physical location, tags, markings, shop travelers, stamps, inspection records or other suitable means? Y QAPD, Revision 11, section 2.1.3, Item Identification and Control, paragraph B.5 NP 12

- 1, Revision 8, section 2.3, Obtaining Calibration Services; section 2.6, M&TE Nonconformances Visual c onfirmation of t ag o ut for FLUM E System Data Acquisition System, Tag No. 820, 10/13/ 20 13 , observed 7/22/2014 Visual confirmation of markings to indicate calibration status: Weights S/N: 34855 and Thermometer CPC 6000, observed 7/22/ 2014
3. Is the authority for application and removal of tags, markings, labels and stamps specified? Y QAPD, Revision 11, section 2.1.3, Item Identification and Control, paragraph B.5 NP 12

- 1, Revision 8, section 2.3, Obtaining Calibration Services; section 2.6, M&TE Nonconformances
4. Are status indicators provided for indicating the operating status of systems and components of the nuclear facility to prevent their inadvertent operation? Y QA PD, Revision 11, section 2.1.5, Handling, Storage and Shipping, paragraph F NP 12

- 1, Revision 8, section 2.3, Obtaining Calibration Services; section 2.6, M&TE Nonconformances NP 13

- 1, Revision 7, section 2.2, Samples, Standards and Chemicals Identificatio n; section 2.5, Samples and Standards Storage/ArchivingEPA Audit of WIPP QA Program: SNL

- CO WIPP QA 14

- 2 NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test Plan Flowchart TP 03

- 01, Revision 3, section 4, Experimental Process Rationale and Description Visual c onfirmation of t ag o ut for FLUM E System Data Acquisition System, Tag No. 820, 10/13/ 20 13 , observed 7/22/2014 Visual confirmation of markings to indicate calibration status: Weights S/N: 34855 and Thermometer CPC 6000, observed 7/22/ 2014 Supplementary Requirements

– None *Y: T he reference d document s adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. N: T he reference d document s do not adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. I : EPA requires additional information to determine if t he reference d document s adequately define, describe, a ddress 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: SNL

- CO WIPP QA 15

- 1 ASME NQA

- 1

- 1989 CHECKLIST
NQA

- 1 ELEMENT: No. 15 with Supplement 15S

- 1, Control of EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: May, July 2014

Nonconforming Items Does the reference document adequately define, describe, address or satisfy the following: Y, N, I, N/A* Applicable Procedur e and Paragraph; Additional Objective Evidence Basic Requirements 1. Are items that do not conform to specified requirements controlled to prevent inadvertent installation or use? Y QAPD, Revision 11, section 1.3.2.4 , Segregating Nonconforming Items, paragr aph A NP 13

- 1, Revision 7, section 2.2, Samples, Standards and Chemicals Identification; section 2.3, Conditions Adverse to Quality or Significant Conditions Adverse to Quality Samples and Standards; section 2.4, Use, Handling, Storing, and Shipping Sample s and Standards; section 2.5, Samples and Standards Storage/Archiving; Appendix A, NP 13

- 1 Sample Control Process Flowchart; Appendix B, NP 13

- 1 Standard Control Process Flowchart NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test Plan Fl owchart TP 03

- 01, Revision 3, section 3, Purpose and Scope; section 4.4, Data

- Acquisition Plan SP 13

- 1, Revision 5, Chain of Custody
2. Are controls provided for identification, documentation, evaluation, segregation ( when practical ) and disposition of nonco nforming items, and for notification to affected organizations? Y QAPD, Revision 11, section 1.3.2.1 , Documenting and Evaluating Nonconforming Items ; section 1.3.2.2 , Identifying Nonconforming Items or Data ; section 1.3.2.3, Reporting Nonconformances; sect ion 1.3.2.4: Segregating Nonconforming Items ; section 1.3.2.5 , Disposition of Nonconforming Items or Data NP 13

- 1, Revision 7, section 2.2, Samples, Standards and Chemicals Identification; section 2.3, Conditions Adverse to Quality or Significant Condition s Adverse to Quality Samples and Standards; section 2.4, Use, Handling, Storing, and Shipping Samples and Standards; section 2.5, Samples and Standards Storage/Archiving; Appendix A, NP 13

- 1 Sample Control Process Flowchart; Appendix B, NP 13

- 1 Standard Co ntrol Process Flowchart NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test Plan Flowchart TP 03

- 01, Revision 3, section 3, Purpose and Scope; section 4.4, Data

- Acquisition Plan SP 13

- 1, Revision 5, Chain of Custody Supplementary Requirem ent s (15S

- 1) 1. Are nonconforming items identifi ed by marking, tagging or other methods that shall not adversely affect the end use of the item? Y QAPD, Revision 11, section 1.3.2.2 , Identifying Nonconforming Items or Data, paragraph A NP 13

- 1, Revision 7, s ection 2.2, Samples, Standards and Chemicals Identification;EPA Audit of WIPP QA Program: SNL

- CO WIPP QA 15

- 2

NQA

- 1 ELEMENT: No. 15 with Supplement 15S

- 1, Control of EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: May, July 2014

Nonconforming Items Does the reference document adequately define, describe, address or satisfy the following: Y, N, I, N/A* Applicable Procedur e and Paragraph; Additional Objective Evidence

section 2.3, Conditions Adverse to Quality or Significant Conditions Adverse to Quality Samples and Standards; section 2.5, Samples and Standards Storage/Archiving; Appendix A, NP 13

- 1 Sample Con trol Process Flowchart; Appendix B, NP 13

- 1 Standard Control Process Flowchart NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test Plan Flowchart TP 03

- 01, Revision 3, section 3, Purpose and Scope; section 4.4, Data

- Acquisition Plan SP 17

- 1, Revision 8, Records Center Operations SP 13

- 1, Revision 5, Chain of Custody Visual confirmation of Tag Out for FLUM E System Data Acquisition System, Tag No. 820, 10/13/2013, observed 7/22/2014
2. Is the identification of nonconforming items legible and e asily recognizable? Y QAPD, Revision 11, section 1.3.2.2, Identifying Nonconforming Items or Data, paragraph A NP 13

- 1, Revision 7, section 2.2, Samples, Standards and Chemicals Identification; section 2.3, Conditions Adverse to Quality or Significant Cond itions Adverse to Quality Samples and Standards; section 2.5, Samples and Standards Storage/Archiving; Appendix A, NP 13

- 1 Sample Control Process Flowchart; Appendix B, NP 13

- 1 Standard Control Process Flowchart NP 20

- 1, Revision 5 , Appendix A , Test Plan C ontent; Appendix B, Test Plan Flowchart TP 03

- 01, Revision 3, section 3, Purpose and Scope; section 4.4, Data

- Acquisition Plan SP 17

- 1, Revision 8, Records Center Operations SP 13

- 1, Revision 5, Chain of Custody Visual confirmation of Tag Out for FLUM E Sy stem Data Acquisition System, Tag No. 820, 10/13/2013, observed 7/22/2014
3. Are nonconforming items segregated, when practical, by placing them in a clearly identified and designated hold area until properly dispositioned? Y QAPD, Revision 11, section 1.3.2 .4, Segregating Nonconforming Items, paragraph B NP 13

- 1, Revision 7, section 2.4, Use, Handling, Storing, and Shipping Samples and Standards; section 2.5, Samples and Standards Storage/Archiving; section 2.6, Samples and Standards Disposition; Appendix A, NP 13

- 1 Sample Control Process Flowchart; Appendix B, NP 13

- 1 Standard Control Process Flowchart NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test PlanEPA Audit of WIPP QA Program: SNL

- CO WIPP QA 15

- 3

NQA

- 1 ELEMENT: No. 15 with Supplement 15S

- 1, Control of EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: May, July 2014

Nonconforming Items Does the reference document adequately define, describe, address or satisfy the following: Y, N, I, N/A* Applicable Procedur e and Paragraph; Additional Objective Evidence

Flowchart TP 03

- 01, Revision 3, section 3, Purpose and Scope; section 4.4, Data

- Acqu isition Plan
4. Are nonconforming items dispositioned in accordance with documented procedures? Y QAPD, Revision 11, section 1.3.2.5, Disposition of Nonconforming Items or Data, paragraph A NP 13

- 1, Revision 7, section 2.2, Samples, Standards and Chemicals I dentification; section 2.3, Conditions Adverse to Quality or Significant Conditions Adverse to Quality Samples and Standards; section 2.4, Use, Handling, Storing, and Shipping Samples and Standards; section 2.5, Samples and Standards Storage/Archiving; App endix A, NP 13

- 1 Sample Control Process Flowchart; Appendix B, NP 13

- 1 Standard Control Process Flowchart NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test Plan Flowchart TP 03

- 01, Revision 3, section 3, Purpose and Scope; section 4.4, D ata

- Acquisition Plan
5. Is further processing, delivery, installation or use of a nonconforming item controlled pending an evaluation and an approved disposition by authorized personnel? Y QAPD, Revision 11, section 1.3.2.4, Segregating Nonconforming Items, paragraph A ; section 1.3.2.5, Disposition of Nonconforming Items or Data, paragraph A NP 13

- 1, Revision 7, section 2.3, Conditions Adverse to Quality or Significant Conditions Adverse to Quality Samples and Standards; section 2.4, Use, Handling, Storing, a nd Shipping Samples and Standards; section 2.5, Samples and Standards Storage/Archiving; Appendix A, NP 13

- 1 Sample Control Process Flowchart; Appendix B, NP 13

- 1 Standard Control Process Flowchart NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Append ix B, Test Plan Flowchart TP 08

- 02, Revision 0, section 1 .0, Purpose and Scope; section 2 .0 , Experimental Process Description; section 4 .0, Data Quality Control; section 5. 0, Equipment
6. Are the responsibility and authority for the evaluation and dispositio n of nonconforming items defined? Y QAPD, Revision 11, section 1.3.2.1, Documenting and Evaluating Nonconforming Items, paragraph E NP 13

- 1, Revision 7, section 2.3, Conditions Adverse to Quality or Significant Conditions Adverse to Quality Samples and Sta ndards; section 2.4, Use, Handling, Storing, and Shipping Samples and Standards; section 2.5, Samples and Standards Storage/Archiving; Appendix A, NP 13

- 1 Sample Control Process Flowchart; Appendix B, NP 13

- 1 Standard Control Process Flowchart NP 20

- 1, Rev ision 5 , Appendix A , Test Plan Content; Appendix B, Test PlanEPA Audit of WIPP QA Program: SNL

- CO WIPP QA 15

- 4

NQA

- 1 ELEMENT: No. 15 with Supplement 15S

- 1, Control of EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: May, July 2014

Nonconforming Items Does the reference document adequately define, describe, address or satisfy the following: Y, N, I, N/A* Applicable Procedur e and Paragraph; Additional Objective Evidence

Flowchart TP 08

- 02, Revision 0, section 1 .0, Purpose and Scope; section 2 .0 , Experimental Process Description; section 4 .0, Data Quality Control; section 5. 0, Equipment SP 17

- 1, Revision 8, Reco rds Center Operations SP 13

- 1, Revision 5, Chain of Custody
7. Do the personnel performing evaluations to determine disposition of nonconforming items have:

 Demonstrated competence in the specific area they are evaluating?

 An adequate understanding of the re quirements?

 Access to pertinent background information? Y QAPD, Revision 11, section 1.3.2.5, Disposition of Nonconforming Items or Data, paragraph A NP 20

- 1, Revision 5 , Appendix A , Test Plan Content; Appendix B, Test Plan Flowchart TP 08

- 02, Revision 0, section 1 .0, Purpose and Scope; section 2 .0 , Experimental Process Description; section 4 .0, Data Quality Control; section 5. 0, Equipment
8. Is the final disposition (e.g., use

- as
- is, reject, repair, rework) of nonconforming items identified and documented? Y QAPD, Revision 11, section 1.3.2.5, Disposition of Nonconforming Items or Data, paragraph B NP 13

- 1, Revision 7, section 2.3, Conditions Adverse to Quality or Significant Conditions Adverse to Quality Samples and Standards; section 2.4, Use, Handling, Sto ring, and Shipping Samples and Standards; section 2.5, Samples and Standards Storage/Archiving; Appendix A, NP 13

- 1 Sample Control Process Flowchart; Appendix B, NP 13

- 1 Standard Control Process Flowchart
9. Is the technical justification for the acceptabili ty of a nonconforming item, dispositioned repair, or use

- as
- is documented? Y QAPD, Revision 11, section 1.3.2.5, Disposition of Nonconforming Items or Data, paragraph C NP 13

- 1, Revision 7, section 2.3, Conditions Adverse to Quality or Significant Conditio ns Adverse to Quality Samples and Standards; section 2.4, Use, Handling, Storing, and Shipping Samples and Standards; section 2.5, Samples and Standards Storage/Archiving; Appendix A, NP 13

- 1 Sample Control Process Flowchart; Appendix B, NP 13

- 1 Standard C ontrol Process Flowchart SP 17

- 1, Revision 8, Records Center Operations
10. Are nonconformances to design requirements, specifically those dispositioned for use

- as
- is or repair, subjected to design control measures commensurate with those applied to the origi nal design? Y QAPD, Revision 11, section 1.3.2.5, Disposition of Nonconforming Items or Data, paragraph D NP 13

- 1, Revision 7, section 2.3, Conditions Adverse to Quality or Significant Conditions Adverse to Quality Samples and Standards; section 2.4, Use, Handling, Storing, and Shipping Samples and Standards; section 2.5, Samples and Standards Storage/Archiving; Appendix A, NP 13

- 1 Sample Control Process Flowchart; Appendix B, NP 13

- 1 Standard Control Process FlowchartEPA Audit of WIPP QA Program: SNL

- CO WIPP QA 15

- 5

NQA

- 1 ELEMENT: No. 15 with Supplement 15S

- 1, Control of EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: May, July 2014

Nonconforming Items Does the reference document adequately define, describe, address or satisfy the following: Y, N, I, N/A* Applicable Procedur e and Paragraph; Additional Objective Evidence

Documentation Package, CAR IS

- 13

- 08

- CA R

- 01, ERMS561398 Corrective Action Verification , CAR IS

- 13

- 08

- CAR

- 01, ERMS561401 SP 17

- 1, Revision 8, Records Center Operations SP 13

- 1, Revision 5, Chain of Custody
11. Is an accepted deviation documented on as

- built records? Y QAPD, Revision 11, section 1.3 .2.5, Disposition of Nonconforming Items or Data, paragraph D.1 NP 13

- 1, Revision 7, section 2.3, Conditions Adverse to Quality or Significant Conditions Adverse to Quality Samples and Standards; section 2.4, Use, Handling, Storing, and Shipping Samples an d Standards; section 2.5, Samples and Standards Storage/Archiving; Appendix A, NP 13

- 1 Sample Control Process Flowchart; Appendix B, NP 13

- 1 Standard Control Process Flowchart SP 17

- 1, Revision 8, Records Center Operations SP 13

- 1, Revision 5, Chain of Cus tody
12. Are repaired or reworked items reexamined in accordance with applicable procedures and with the original acceptance criteria, unless the nonconforming item disposition has established alternate acceptance criteria? Y QAPD, Revision 11, section 1.3.2. 5, Disposition of Nonconforming Items or Data, paragraph E NP 13

- 1, Revision 7, section 2.4, Use, Handling, Storing, and Shipping Samples and Standards; section 2.5, Samples and Standards Storage/Archiving; section 2.6, Samples and Standards Disposition; A ppendix A, NP 13

- 1 Sample Control Process Flowchart; Appendix B, NP 13

- 1 Standard Control Process Flowchart SP 17

- 1, Revision 8, Records Center Operations SP 13

- 1, Revision 5, Chain of Custody
*Y: T he reference d document s adequately define, describe, a dd ress or satisfy the NQA

- 1

- 1989 requirement. N: T he reference d document s do not adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. I : EPA requires additional information to determine if t he reference d document s adequately defi ne, describe, a ddress 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: SNL

- 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: May, 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 advers e to quality identified promptly and corrected as soon as practical? Y QAPD, R evision 11 , s ection 1.3.3.3 , Conditions Adverse to Quality , paragraph B;
s ection 1.3.3.7 , Corrective Action Follow

- up ; s ection 1.3.3.9 , Quality Trending , paragraph B NP 16

- 1, Rev ision 6, section 2.2.2, Corrective Action Plan: Response and Response Evaluation to a Corrective Action; section 2.3, Stop Work; Appe ndix E; Appendix F; Appendix G Documentation Package, CAR W

- 13

- 05 , ERMS560433

– ERMS56043 5 ; CAR W

- 13

- 12 , in

- process provided 5/8/2014 ; CAR W

- 14

- 05 , in

- process provided 5/8/2014 Documentation Package, CARs April 2013 to April 2014 , 4/15/2014 2. In the case of a significant condition adverse to quality, is the cause of the condition determined and corrective action taken to preclud e recurrence? Y QAPD, R evision 11 , s ection 1.3.3.4 , Significant Conditions Adverse to Quality ; s ection 1.3.3.5 , Corrective Action Planning , paragraphs C and D NP 16

- 1, Revision 6, section 2.2.2, Corrective Action Plan: Response and Response Evaluation to a Corrective Action; section 2.4, Recurring Conditions Adverse to Quality; section 2.5, Trend Analysis Documentation Package, CAR W

- 13

- 05, ERMS560433

– ERMS56043 5; CAR W

- 13

- 12, in

- process provided 5/8/2014; CAR W

- 14

- 05, in

- process provided 5/8/2014 Documenta tion Package, CAR s April 2013 to April 2014, 4/15/2014 3. Are the identification, cause and corrective action for significant conditions adverse to quality documented and reported to appropriate levels of management? Y QAPD, R evision 11 , s ection 1.3.3.4 , Sig nificant Conditions Adverse to Quality , paragraph B NP 16

- 1, Revision 6, section 2.2, Processing Conditions Adverse to Quality and Significant Conditions Adverse to Quality; section 2.2.1 Initiation of a Corrective Action Request; section 2.2.2, Corrective Action Plan: Response and Response Evaluation to a Corrective Action; section 2.2.3, Follow

- up Verification and Closure of a Corrective Action Request; section 2.3, Stop Work; App endix E; Appendix F; Appendix G Documentation Package, CAR W

- 13

- 05, ERMS5604 33

– ERMS56043 5; CAR W

- 13

- 12, in

- process provided 5/8/2014; CAR W

- 14

- 05, in

- process provided 5/8/2014 Documentation Package, CAR s April 2013 to April 2014, 4/15/2014 4. Is follow

- up action taken to verify implementation of corrective action? Y QAPD, R evision 1 1 , s ection 1.3.3.7 , Corrective Action Follow

- up NP 16

- 1, Revision 6, section 2.2.3, Follow

- up Verification and Closure of a Corrective Action Request; section 2.2.4 Partial Verification of Corrective Actions; Appendix GEPA Audit of WIPP QA Program: SNL

- CO WIPP QA 16

- 2

NQA

- 1 ELEMENT: No. 16, Corrective Action EPA AUDITORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: May, 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

Documentation Package, CAR W

- 13

- 05, ERMS560433

– ERMS56043 5; CAR W

- 13

- 12, in

- process provided 5/8/2014; CAR W

- 14

- 05, in

- process provided 5/8/2014 Documentation Package, CAR s April 2013 to April 2014, 4/15/2014 Supplementary Requirement

– None *Y: T he reference d document s adequately defi ne, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. N: T he reference d document s do not adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. I : EPA requires additional information to determine if t he reference d document s adequately define, describe, a ddress 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: SNL

- CO WIPP QA 17

- 1 ASME NQA

- 1

- 1989 CHECKLIST
NQA

- 1 ELEMENT: No. 17 with Supplement 17S

- 1, Q uality EPA AUDI TORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: May, July 201 4

Assurance Records Does the reference document adequately define, describe, address or satisfy the following: Y, N, I, N/A* Applicable Procedure and Paragraph; Additional Objective Evid ence Basic Requirements 1. Are records that furnish documentary evidence of quality specified, prepared and maintained? Y QAPD, Rev ision 11, section 1.5 , Records, paragraph A NP 17

- 1 , Rev ision 9 , Records SP 17

- 1, Revision 8, Records Center Operations
2. Are quality assurance records legible, identifiable and retrievable? Y QAPD, Rev ision 11, section 1.5.2 , Generating QA Records, paragraph B ; s ection 1.5.3 , Indexing QA Records, paragraphs B and C NP 17

- 1 , Rev ision 9, section 2.1, Identification and Creation o f Records; section 2.4 Supplementing, Changing, or Correcting Records; se ction 2.5, Retrieval of Records SP 17

- 1, Revision 8, section 2.1, Processing QA Records/Record Packages
3. Are quality assurance records protected against damage, deterioration or loss? Y QAPD, Rev ision 11, section 1. 5.6 , Storage, Preservation, Safekeeping, and Disposition of QA Records, paragraph A NP 17

- 1 , Rev ision 9, section 2.2, Temporary Protection of In

- Process Documents; section 2.3.1, Non

- paper Media Records SP 17

- 1, Revision 8, section 2.2, Storing and Protecting QA Records
4. Are the requirements and responsibilities established and documented for the transmittal, distribution, retention, maintenance and disposition of quality assurance records? Y QAPD, Rev ision 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 NP 17

- 1 , Rev ision 9 , Records SP 17

- 1, Revisi on 8, Records Center Operations Supplementary Requirements (17S

- 1) 1. Has a quality assurance records system been established? Y QAPD, Rev ision 11, section 1. 5.1 , Document Changes, paragraph A NP 17

- 1 , Rev ision 9 , Records SP 17

- 1, Revision 8, Records Center Operations
2. Is the quality assurance records system defined, implement ed and enforced in accordance with written procedures, instructions or other documentation? Y QAPD, Rev ision 11, section 1.5.1 , Document Changes, paragraph A NP 17

- 1 , Rev ision 9 , Records SP 17

- 1, Revision 8, Records Center Operations
3. Do the applicable d esign specifications, procurement documents, test procedures, operational procedures or other documents specify the quality assurance records to be generated, supplied or maintained by Y QAPD, Rev ision 11, section 1 .5.2 , Generating QA Records , paragraph A NP 17

- 1 , Revision 9, section 2.1 , Identification and Creation of RecordsEPA Audit of WIPP QA Program: SNL

- CO WIPP QA 17

- 2

NQA

- 1 ELEMENT: No. 17 with Supplement 17S

- 1, Q uality EPA AUDI TORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: May, July 201 4

Assurance Records Does the reference document adequately define, describe, address or satisfy the following: Y, N, I, N/A* Applicable Procedure and Paragraph; Additional Objective Evid ence the facility? All NPs and SPs cited in this report , section 3.0, Records
4. Are quality assurance records required to be legible, accurate and complete? Y QAPD, Rev ision 11, section 1. 5 .2 , Generating QA Records, paragraph B NP 17

- 1 , Rev ision 9, section 2.1 , Identification and Creation of Records SP 17

- 1, Revision 8, section 2.1, Processing QA Records/Record Packages
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, Rev ision 11, section 1.5. 2 , Generating QA Records, paragraph D NP 17

- 1 , Rev ision 9, section 2.1, Identification and Creation of Records SP 17

- 1, Revision 8 , section 2.1, Processing QA Records/Record Packages
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, Rev ision 11, section 1.5.3 , Indexing QA Records NP 17

- 1 , Rev ision 9, section 2.1 , Identification and Creation of Records SP 17

- 1, Revision 8, section 2.1, Processing QA Records/Record Packages NP 17

- 1, Revision 9, Appendix B, Form Number 17

- 1

- 2
7. Are quality assurance records distributed, handled and controlled in accordance with written procedures? Y QAPD, Rev ision 11, section 1. 5.2 , Generating QA Records, paragraph C ; s ection 1.5.6 , Storage, Preservation, Safekeeping, and Disposition of QA Records, paragraph A NP 17

- 1 , Rev isi on 9 , Records SP 17

- 1, Revision 8, Records Center Operations
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, Rev ision 11, section 1. 5.3 , Ind exing QA Records, paragraph C NP 17

- 1 , Rev ision 9, section 2.1 Identification and Creation of Records SP 17

- 1, Revision 8, section 2.1, Processing QA Records/Record Packages NP 17

- 1, Revision 9, Appendix B, Form Number 17

- 1

- 2
9. Are quality assurance records classified as either lifetime or nonpermanent? Y QAPD, Rev ision 11, section 1.5 .4 , Classifying QA Records, paragraph A NP 17

- 1 , Rev ision 9, section 2.1 Identification and Creation of Records SP 17

- 1, Revision 8, section 2.1, Processing QA Records/Record P ackages
10. Is the retention time for nonpermanent quality assurance records established in writing? N/A

11. Are quality assurance records corrected in accordance with procedures that provide for appropriate review or approval by the originating organization? D oes the correction include the date and the identification of the person authorized to issue such correction? Y QAPD, Rev ision 11, section 1.5.7 , Corre cting Information in QA Records NP 17

- 1, Revision 9, section 2.4, Supplementing, Changing, or Correcting Records SP 17

- 1, Revision 8, section 2.1, Processing QA Records/Record Packages Form No. 4

- 1

- 1, Revision 11, Procurement Review, Service Contract withEPA Audit of WIPP QA Program: SNL

- CO WIPP QA 17

- 3

NQA

- 1 ELEMENT: No. 17 with Supplement 17S

- 1, Q uality EPA AUDI TORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: May, July 201 4

Assurance Records Does the reference document adequately define, describe, address or satisfy the following: Y, N, I, N/A* Applicable Procedure and Paragraph; Additional Objective Evid ence

PerkinElmer for Nexlon 300D ICP

- MS including S10Autosampler and Polyscience Recirculator, 1/24/2013, ERMS 559543
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, Rev ision 11, section 1.5.5 , Receiving QA Records NP 17

- 1, Revision 9, section 2.2, Temporary Protection of In

- Process Documents; section 2.3.1, Non

- paper Media Records SP 17

- 1, Revision 8, Records Center Operations
13. Does each organization responsible for the receipt of quality assurance records designate a per son or organization responsible for receiving the records? Y QAPD, Rev ision 11, section 1.5.5 , Receiving QA Records NP 17

- 1, Revision 9, section 1.0, Purpose and Scope SP 17

- 1, Revision 8, section 1.0, Purpose and Scope
14. Does the receipt control system inc lude:

 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, Rev ision 11, section 1.5 .5 , Receiving QA Records SP 17

- 1, Revision 8, section 2.1, Processing QA Records/Record Packages; section 2.2, Storing and Protecting QA Records

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, Rev ision 11, section 1.5.5 , Receiving QA Records NP 17

- 1, Revision 9, section 2.1, Identification and Creation of Records SP 17

- 1, Revision 8, section 2.1, Processing QA Records/Record Packages; secti on 2.2, Storing and Protecting QA Records
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 descr iption 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 Y QAPD, Rev ision 11, section 1. 5.6 , Storage, Preservation, Safekeeping, and Disposition of Records, paragraph A NP 17

- 1, Revision 9, section 2.1, Identification and Creation of Records SP 17

- 1, Revision 8, section 2.1, Processing QA Reco rds/Record Packages; section 2.2, Storing and Protecting QA RecordsEPA Audit of WIPP QA Program: SNL

- CO WIPP QA 17

- 4

NQA

- 1 ELEMENT: No. 17 with Supplement 17S

- 1, Q uality EPA AUDI TORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: May, July 201 4

Assurance Records Does the reference document adequately define, describe, address or satisfy the following: Y, N, I, N/A* Applicable Procedure and Paragraph; Additional Objective Evid ence superseded records ( see No. 11 above)? 17. Are quality assurance records stored in a manner approved by the organizations responsible for storage, including the following:

 Provisions in the storage arrangements to prevent damage f rom 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, negati ves and microfilm) to prevent damage from excessive light, stacking, electromagnetic fields and temperature? Y QAPD, Rev ision 11, section 1.5.6 , Storage, Preservation, Safekeeping, and Dispos ition of Records SP 17

- 1, Revision 8, section 2.2, Storing and Pr otecting QA Records

18. Have measures been established to preclude the entry of unauthorized personnel into the storage area? Y QAPD, Rev ision 11, section 1.5. 6.1 , Records Disposition, paragraph J SP 17

- 1, Revision 8, section 2.2, Storing and Protecting QA Re cord s 19. Have measures been taken to provide for replacement, restoration or substitution of lost or damaged records? Y QAPD, Rev ision 11, section 1.5.6. 1 , Records Disposition, paragraph K NP 17

- 1, Revision 9, section 2.1, Identification and Creation of Reco rds SP 17

- 1, Revision 8, section 2.1, Processing QA Records/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 s uch as high and low temperatures and humidity?

 Infestation of insects, mold or rodents? Y QAPD, Rev ision 11, section 1.5.6 , Storage, Preservation, Safekeep ing, and Disposition of Records SP 17

- 1, Revision 8, section 2.2, Storing and Protecting QA Records

21. Are quality assurance records stored in single or dual storage facilities? Y QAPD, Rev ision 11, section 1.5 , Records NP 17

- 1, Revision 9, section 2.1, Identification and Creation of Records SP 17

- 1, Revision 8, section 2.1, Processing QA Records/Record Pa ckages; section 2.2, St oring and Protecting QA Records Description of Dual Storage Facilities, prov ided 5/8/ 2014
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 N/AEPA Audit of WIPP QA Program: SNL

- CO WIPP QA 17

- 5

NQA

- 1 ELEMENT: No. 17 with Supplement 17S

- 1, Q uality EPA AUDI TORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: May, July 201 4

Assurance Records Does the reference document adequately define, describe, address or satisfy the following: Y, N, I, N/A* Applicable Procedure and Paragraph; Additional Objective Evid ence 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 a pplied over walls as a moisture or condensation barrier?

 Surface sealant on the floor providing a hard

- wear surface to minimize concrete dusting?

 Foundation sealant and provisions for drainage?

 Forced air circulation with filter system?

 Fire protection sys tem?

 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 constr uction 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

24. Does the design and construction of an alt ernative 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 su pervision 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 smoki ng, eating or drinking?

– 2

- hour fire rated dampers or doors in all boundary penetrations? N/AEPA Audit of WIPP QA Program: SNL

- CO WIPP QA 17

- 6

NQA

- 1 ELEMENT: No. 17 with Supplement 17S

- 1, Q uality EPA AUDI TORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: May, July 201 4

Assurance Records Does the reference document adequately define, describe, address or satisfy the following: Y, N, I, N/A* Applicable Procedure and Paragraph; Additional Objective Evid ence
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 thes e 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, R ev ision 11, section 1.5. 6.1 , Records Disposition, paragraph I SP 17

- 1, Revision 8, section 2.2, Storing and Protecting QA Records

26. If storage at dual facilities for each quality assurance record is provided, are the facilities at locations sufficiently rem ote 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? Y QAPD, Rev ision 11, section 1.5. 6.1 , Records Disposition, paragraph H SP 17

- 1, Revision 8, section 2.2, Storing and Protecting QA Records Description of Dual St orage Facilities, provided 5/8// 2014

27. Does the storage system provide for retrieval of information in accordance with planned retrieval times, based on the record type? Y QAPD, Rev ision 11, section 1. 5.3 , Indexing QA Records, paragraph B SP 17

- 1, Revision 8, section 2.1, Processing QA Records/Record Packages; section 2.2, Storing and Protecting QA Records
28. Is a list maintained designating those personnel who shall have access to quality assurance files? Y QAPD, Rev ision 11, section 1.5.6 .1 , Records Disposition, paragraph J SP 17

- 1, Revision 8, section 2.2, Storing and Protecting QA Records Memorandum from Paul Shoema ker to WIPP Records Center, re: Approved Access List for SNL WIPP Records Center and SNL WIPP Proprietary and Privileged Records, 1/28/2013 , ERMS559128
29. Are records maintained by a supplier at its facility or other location accessible to the purchaser or i ts designated alternate (e.g., the owner)? Y QAPD, Rev ision 11, section 2. 3.4 , Procurement Document Requirements, paragraph C NP 4

- 1, Revision 11, section 2.1.7, Budget/Procurement Specialist Processing; section 3.0, Records
30. Are records accumulated at va rious locations, prior to transfer, made accessible to the owner directly or through the procuring organization? N/A

31. Does the custodian of quality assurance records inventory the submittals, acknowledge receipt, and process these records in accordance wi th NQA

- 1? Y QAPD, Rev ision 11, section 1.5.6 , Storage, Preservation, Safekeeping, and Disposition of Records, paragraph A ; section 1.5.5 , Receiving QA Records SP 17

- 1, Revision 8, section 2.1, Processing QA Records/Record Packages Form NP 17

- 1

- 2, Records S ubmittal, Receipt Inspection Training for C. Camphouse, ERMS558195 Form NP 17

- 1

- 2, Records Submittal, Receipt Inspection Training for B. Malama,EPA Audit of WIPP QA Program: SNL

- CO WIPP QA 17

- 7

NQA

- 1 ELEMENT: No. 17 with Supplement 17S

- 1, Q uality EPA AUDI TORS: L. Bender, P. Kelly, K. Darlow, K. Lindblad DATE: May, July 201 4

Assurance Records Does the reference document adequately define, describe, address or satisfy the following: Y, N, I, N/A* Applicable Procedure and Paragraph; Additional Objective Evid ence

E RMS554701

32. Are the records storage and maintenance requirements of regulatory agencies followed in determining final disposition of quality assurance records? Y QAPD, Rev ision 11, section 1.5 .6.1 , Records Disposition, paragraph L NP 17

- 1, Revision 9, section 2.1, Identification and Creation of Records SP 17

- 1, Revision 8, section 2.1, Processing QA Records/Record Packages
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 satisfi ed?

 Operational status permits?

 Warranty consideration is satisfied?

 Purchaser’s requirements are satisfied? N/A

*Y: T he reference d document s adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. N: T he reference d document s do n ot adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. I : EPA requires additional information to determine if t he reference d document s adequately define, describe, a ddress or satisfy the NQA

- 1

- 1989 requirement. N/A: The specif

ic NQA

- 1

- 1989 requirement is not applicable to the subject QA program

.