Exhibit H - Quality Assurance Requirements.pdf

PR# * Solicitation/PO or Subcontract # *

EXHIBIT “H”

QUALITY ASSURANCE REQUIREMENTS

TABLE OF CONTENTS

QC Title Page

QC-01A QUALITY ASSURANCE PROGRAM REQUIREMENTS FOR OFF-SITE SUBCONTRACTS

(Feb 2018)

QC-03 QUALIFICATION AND CERTIFICATION OF PERSONNEL AND STAFF (Sept 2014)

QC-04 TRACEABILITY - ITEM (Jun 2011)

QC-06 CERTIFICATE OF CONFORMANCE (Feb 2018)

QC-07 MANUFACTURING, INSPECTION, MAINTENANCE, REPAIR, AND/OR TEST

PROCEDURES (Sept 2014)

QC-08A ENGINEERING EVALUATION / ANALYSIS REPORT (Jun 2011)

QC-12A CERTIFICATION OF CALIBRATION FOR SUBCONTRACTOR M&TE (Sept 2014)

QC-16 SHELF LIFE CERTIFICATIONS/STORAGE REQUIREMENTS (Jun 2011)

QC-19 FIRST ARTICLE INSPECTION/REVIEW (Jun 2011)

QC-22 CONTRACTOR'S RIGHT OF ACCESS TO SUBCONTRACTOR’S FACILITY (Visit) (Jun 2011)

QC-25 NONCONFORMANCE REPORTING (Feb 2018)

QC-26 CORRECTIVE ACTION REPORTS (Jun 2011)

QC-27 SUSPECT/COUNTERFEIT ITEMS (S/CI) (Feb 2018)

QC-28 SERIALIZATION AND MARKING (Mar 2016)

QC-29 HANDLING, RECEIVING, STORAGE, SHIPPING, AND PACKAGING (Mar 2016)

QC-34 DOCUMENTS AND RECORDS (May 2012)

QC-36 SOFTWARE QUALITY ASSURANCE (SQA) (Sept 2014)

QC-37 OTHER

QC-01A QUALITY ASSURANCE PROGRAM REQUIREMENTS FOR OFF-SITE SUBCONTRACTS

(Feb 2018)

In accordance with CONTRACTOR’s responsibilities under DOE Order 414.1D, Quality Assurance and 10 CFR 830 Subpart A, Quality Assurance Requirements, SUBCONTRACTOR’S Quality Assurance (QA) Program is required to be evaluated for the capability of providing items/services in accordance with subcontract technical and quality requirements prior to award, and is required to be approved by CONTRACTOR prior to the start of work (as further defined/controlled in the subcontract).

SUBCONTRACTOR QA Program approval documentation will be maintained on file with CONTRACTOR.

SUBCONTRACTOR will perform all work under this Subcontract in accordance with its approved QA Program and further will notify CONTRACTOR of any quality affecting changes made to its QA Program, whereupon CONTRACTOR will determine need for re-evaluation/re-approval. SUBCONTRACTOR’S QA Program shall be subject to ongoing evaluation and monitoring by CONTRACTOR and shall address configuration control of subcontract requirements, including CONTRACTOR approval of substitutions and configuration control of any provided CONTRACTOR procedures, specifications, or items.

SUBCONTRACTOR agrees to provide CONTRACTOR and/or DOE/NNSA the right and access to conduct audits of SUBCONTRACTOR’S quality systems and verify compliance with subcontract requirements as well as the right to conduct inspection and/or testing of SUBCONTRACTOR’S product to assure conformance with subcontract requirements. Any SUBCONTRACTOR proprietary processes must be specifically identified in writing in order to prevent disclosure. Unless otherwise provided for in this subcontract, SUBCONTRACTOR is responsible for including (i.e. flowing down) the quality assurance requirements of this subcontract in its lower-tier subcontracts to the extent necessary to ensure SUBCONTRACTOR’S compliance with these requirements.

It is additionally noted that this subcontract includes items and/or services that are intended to be used in support of the following applications: (as marked with an “X”):

Calibrated Instrumentation (i.e. Accredited Calibration) applications (ref. DOE/AL 56XB, DOE Development and Production Manual, Chapter 13.2, Metrology Program and/or ISO 17025, General Requirements for the Competence of Testing and Calibration Laboratories [and applicable accreditations; e.g. A2LA, NVLAP, ACLASS, DKD, etc.]).

QC-03 QUALIFICATION AND CERTIFICATION OF PERSONNEL AND STAFF (Sept 2014)

SUBCONTRACTOR’S personnel and staff shall have the indoctrination, training, experience, qualifications and certifications necessary for the work to be performed as required by industry standards, as well as any additional requirements specified in this subcontract. Qualification and certification records shall be available for review by CONTRACTOR upon request.

QC-04 TRACEABILITY - ITEM (Jun 2011)

SUBCONTRACTOR shall have the capability of tracing items to the raw material from which the item was fabricated. All documentation and records associated with tracing items related to this subcontract shall be available for review by CONTRACTOR upon request.

QC-06 CERTIFICATE OF CONFORMANCE (Feb 2018)

SUBCONTRACTOR shall provide a Certificate of Conformance (C of C) for all items or services procured through this subcontract. Each C of C shall be from SUBCONTRACTOR and/or Manufacturer, shall identify CONTRACTOR’S subcontract number, and state that the item or service described thereon conforms in all respects with subcontract/manufacturer requirements, which may include any applicable specifications, drawings, marking requirements, part/model/serial number identification, or codes/standards that the item is certified to. Where applicable, the C of C shall identify the material by CONTRACTOR’S part/control number consistent with part number information in subcontract documents and/or CONTRACTOR’S specifications. Each C of C shall further identify any approved changes, waivers, or deviations to the item requirements and identify any requirements that have not been met, with a corresponding means/recommendation for resolving the nonconformance. Each C of C shall be signed or otherwise authenticated by an authorized person responsible for this function as described in SUBCONTRACTOR’S quality assurance program (or other representative of SUBCONTRACTOR and/or manufacturer if SUBCONTRACTOR is not required to have a quality assurance program).

SUBCONTRACTOR personnel must assure that certificates of conformance are verified for compliance with the technical and quality requirements stated in the subcontract.

QC-07 MANUFACTURING, INSPECTION, MAINTENANCE, REPAIR, AND/OR TEST

PROCEDURES (Sept 2014)

SUBCONTRACTOR shall, upon CONTRACTOR’S request, submit to CONTRACTOR for review prior to manufacturing, inspection, maintenance, repair and/or testing, written procedures, checklists, and/or travelers detailing the activity that will be performed to verify that the items being supplied or worked on conform to the requirements of this subcontract.

QC-08A ENGINEERING EVALUATION / ANALYSIS REPORT (Jun 2011)

SUBCONTRACTOR shall provide services to study, evaluate, and/or analyze a given condition as defined by CONTRACTOR within the procurement documents. SUBCONTRACTOR shall provide results of this activity in a technical reviewed, signed written report.

QC-12A CERTIFICATION OF CALIBRATION FOR SUBCONTRACTOR M&TE (Sept 2014)

For any SUBCONTRACTOR measuring and test equipment (M&TE) that provides measurement on the acceptability of CONTRACTOR items/processes and is by design required to be calibrated, SUBCONTRACTOR shall make available for CONTRACTOR’S review or provide copies, as requested, all current calibration documentation associated with SUBCONTRACTOR owned M&TE.

For SUBCONTRACTOR owned or leased M&TE used in the performance of work (or M&TE equipment owned or leased by any sub-tier SUBCONTRACTOR) that provides measurement on the acceptability of CONTRACTOR items/processes, M&TE shall be suitably marked for traceability to the calibration documentation with recalibration due dates marked on the applicable M&TE.

SUBCONTRACTOR shall maintain a user log or other documented means to identify where each calibrated M&TE device was used, including the date(s) used.

QC-16 SHELF LIFE CERTIFICATIONS/STORAGE REQUIREMENTS (Jun 2011)

SUBCONTRACTOR shall have an effective storage and age control system for items whose acceptability is limited by its age or manner of storage. Items provided with a designed shelf life must be marked or have their packaging marked with cure/manufacturing dates or expiration dates. At the time of receipt, the material shall not have less than 85% (allowing for rounding to whole months) of its shelf life remaining without prior written approval from CONTRACTOR. In lieu of product or container marking, SUBCONTRACTOR may include shelf life information on a certification document provided with the ordered material delivered to CONTRACTOR. Any applicable special storage and handling instructions shall be provided.

QC-19 FIRST ARTICLE INSPECTION/REVIEW (Jun 2011)

When requested by CONTRACTOR, SUBCONTRACTOR shall demonstrate, to CONTRACTOR’S satisfaction, before the start of fabrication of any production lot of items, that the first article conforms to the requirements of this subcontract. SUBCONTRACTOR shall obtain CONTRACTOR’S written approval/authorization of the first article before proceeding with the production of the remaining items.

The manufacturer shall identify this article as the "first article".

QC-22 CONTRACTOR'S RIGHT OF ACCESS TO SUBCONTRACTOR’S FACILITY (Visit) (Jun

2011)

CONTRACTOR reserves the right to send its representatives to visit SUBCONTRACTOR'S facilities, on a non-resident basis, for surveillance and survey/audit purposes, to assure/verify SUBCONTRACTOR'S conformance to the technical requirements of this subcontract, including test and inspection requirements, and all applicable quality assurance requirements. Such personnel shall be allowed full access to: (1) witness all operations/tests involved in the performance of this subcontract; and (2) survey/audit all records pertaining to the subcontract. Reasonable advance notice (minimum 24 hours), in writing, will be provided to SUBCONTRACTOR prior to any such visits. SUBCONTRACTOR shall flow down this requirement for CONTRACTOR'S right of access to all lower-tier subcontractors and suppliers.

QC-25 NONCONFORMANCE REPORTING (Feb 2018)

SUBCONTRACTOR shall evaluate and notify CONTRACTOR of each nonconformance against items and services that do not meet procurement document requirements within three (3) working days of discovery. This includes, but is not limited to, nonconformance with documentation requirements and technical or material requirements, including situations where an item may be restored so as to function unimpaired, but it does not meet the original subcontract/design requirement. Notice of a nonconformance shall consist of a written description of the nonconformance and when available, an assessment of the cause and the proposed disposition/corrective action, including technical justifications for any proposed Use-As-Is or Repair dispositions. In cases where the SUBCONTRACTOR proposes a Use-As-Is or Repair disposition, the disposition of the nonconformance will be approved by CONTRACTOR with corresponding disposition implementation verified. Such Use-As-Is or Repair nonconformance documentation will be supplied by SUBCONTRACTOR to CONTRACTOR via N3B

Form 2178, Conduct of Engineering Subcontractor Deviation Disposition Request (SDDR) or other formal/controlled method and all records of nonconformance shall be maintained by the SUBCONTRACTOR. SUBCONTRACTOR shall allow for the return of any materials determined by CONTRACTOR to be nonconforming as a result of CONTRACTOR’S receipt inspection.

QC-26 CORRECTIVE ACTION REPORTS (Jun 2011)

SUBCONTRACTOR shall provide a written acknowledgement within five (5) working days of receipt of a request for corrective action from CONTRACTOR. SUBCONTRACTOR shall respond in writing within 30 days, with actual corrective actions taken or planned. Prior to implementation, such actions will be evaluated and approved by CONTRACTOR to ensure corrective actions have been/will be effectively implemented.

QC-27 SUSPECT/COUNTERFEIT ITEMS (S/CI) (Feb 2018)

(a) A suspect item is one in which there is an indication by visual inspection, testing, or other information that it may not conform to established Government or industry-accepted specifications or national consensus standards. A counterfeit item is a suspect item that is a copy or substitute, without legal right or authority to do so, or one whose material, performance, or characteristics are knowingly misrepresented by the vendor, supplier, distributor, or manufacturer.

(b) SUBCONTRACTOR warrants that all items, including their subassemblies, components, and parts, tendered to CONTRACTOR shall be genuine (i.e., not counterfeit), new and unused, and conform to the requirements of this subcontract, without substitution unless otherwise provided for within this subcontract or approved in writing by CONTRACTOR prior to delivery.

(1) SUBCONTRACTOR shall ensure (as applicable) that malicious software (and hardware) is prevented from entering into their supply chain for items/services to be provided to

CONTRACTOR.

(c) SUBCONTRACTOR further warrants that all components, parts, materials, and supplies incorporated into CONTRACTOR’S facilities or equipment by SUBCONTRACTOR, during performance of work at LANL or fork for N3B, shall be genuine, new and unused, and original-equipment-manufacturer items, without substitution unless otherwise provided for within this subcontract or approved by CONTRACTOR in writing as suitable for the intended purpose prior to use.

(1) If SUBCONTRACTOR discovers any S/CI items or S/CI conditions of concern for items in use (including SUBCONTRACTOR owned items) or in the process of being installed at LANL, SUBCONTRACTOR shall temporarily segregate/control the items and immediately notify CONTRACTOR. CONTRACTOR will make subsequent notifications concerning CONTRACTOR owned items in accordance with CONTRACTOR’S S/CI procedures and provide SUBCONTRACTOR direction as to S/CI disposition. For SUBCONTRACTOR owned items with S/CI concerns (e.g. tools, scaffolding, hoisting, lifting, and rigging equipment, etc.), CONTRACTOR will provide direction to SUBCONTRACTOR up to and including the removal of such items from the LANL site.

(d) As part of the foregoing warranties, SUBCONTRACTOR also certifies that all labels and/or trademarks or logos affixed, or designed to be affixed; to items supplied or delivered to CONTRACTOR, and to certifications, affirmations, information, or documentation related to the authenticity and quality of items supplied or delivered to CONTRACTOR under this subcontract, are genuine.

(e) Falsification of information or documentation may constitute criminal conduct; accordingly, SUBCONTRACTOR grants CONTRACTOR the right to temporarily segregate items, and related paperwork, that are suspected to be S/CI, pending a determination by National Nuclear Security Administration (NNSA) or Department of Energy (DOE) officials whether the segregated items should be impounded as evidence.

(1) In the event NNSA/DOE directs CONTRACTOR to impound the segregated items, no liability shall be asserted or enforceable against CONTRACTOR, NNSA, or DOE because of the impoundment, all such liability being expressly waived by SUBCONTRACTOR or any person claiming any right or interest under this subcontract in the impounded items.

(2) CONTRACTOR shall incur no liability for failure to return impounded items to

SUBCONTRACTOR and does not assume any liability for loss or damage to the items impounded or temporarily segregated pursuant to this clause regardless of the circumstances under which said loss or damage may have occurred, and whether the impounded or temporarily segregated items are in CONTRACTOR’S possession or under its control.

(f) Nothing in this clause shall limit CONTRACTOR’S right to reject S/CI, and related paperwork, as nonconforming, to deny payment for such items, to return such items to SUBCONTRACTOR once NNSA/DOE has released the items, or to assert other remedies provided under this subcontract or by law.

QC-28 SERIALIZATION AND MARKING (Mar 2016)

The manufacturer shall serialize parts, components, assemblies, and subassemblies as required by drawings, specifications, and this subcontract. The manufacturer’s serial number control system shall ensure that the same serial number is not used more than once. Associated quality documents (e.g.

test/inspection reports, certification documents) shall refer to any applicable serial numbers/lot numbers of the items; serial numbers/lot numbers are required to be directly marked on items or, if not feasible, the item shall be indirectly identified (e.g. tagged) with serial number/lot number.

QC-29 HANDLING, RECEIVING, STORAGE, SHIPPING, AND PACKAGING (Mar 2016)

SUBCONTRACTOR shall control the handling, receiving, storage, cleaning, packaging, shipping, and preservation of items to prevent damage or loss and to minimize deterioration. Such activities shall include as applicable, the appropriate controls for items categorized as Level A, B, C, or D per ASME NQA-1 2008/2009a, Part II, Subpart 2.2. This includes items being provided by SUBCONTRACTOR to

CONTRACTOR as well as any items being provided by CONTRACTOR to SUBCONTRACTOR.

Handling, storage, and shipping of items shall be conducted in accordance with established work and inspection instructions, drawings, specifications, shipment instructions, or other pertinent documents or procedures specified for use in conducting the activity. Items shall be packaged according to size, manufacturer, dimensional and manufacturer lot or heat number. Packages shall be closed and labeled in a manner that identifies the item, dimensions and weight (where applicable), SUBCONTRACTOR’S and/or manufacturer’s name, and CONTRACTOR’S subcontract number. Non-conforming packages may be returned to SUBCONTRACTOR at SUBCONTRACTOR’S expense.

QC-34 DOCUMENTS AND RECORDS (May 2012)

Any documents and records required to be submitted by SUBCONTRACTOR to CONTRACTOR are identified in this subcontract, including any dates/times for submittal. SUBCONTRACTOR shall retain records resulting from subcontract performance for 5 years from final payment, unless otherwise specified by applicable law. Disposition of Subcontractor maintained records after the specified retention times are at the discretion of the SUBCONTRACTOR.

QC-36 SOFTWARE QUALITY ASSURANCE (SQA) (Sept 2014)

SUBCONTRACTOR shall take all necessary precautions to ensure that malicious software is prevented from entering into their supply chain for items/services to be provided to CONTRACTOR.

SUBCONTRACTOR shall maintain records for all computer software which will identify and state the software engineering activities used to manage the software life cycle activities (based upon a consensus SQA standard; e.g. ASME NQA-1, ISO/IEC/IEEE 12207 or equivalent Contractor specific standard) required for the purchased software items/products or services, and these records shall be made available for CONTRACTOR’S review upon request. The software life cycle activities will be identified, testable, and controlled, including: requirements, design, user implementation, acceptance testing, verification, validation, problem reporting, corrective action, software configuration management, and in-use testing processes used for the software item/products or services to be purchased.

The Subcontractor shall include or otherwise make available for review at Contractor’s request, the following activities and associated documentation that are marked with an X, as appropriate and graded for the software being used or developed:

1. Software Project Management Plan and/or Software Quality Assurance Plan to include but not be limited to:

a) Roles & responsibilities for the project team, including software design verification.

b) Interface controls including responsibilities for design interfaces, related procedures, and any necessary interface controls between Subcontractor and Contractor.

c) Identification of documents (including baseline documents) needing to be controlled and/or maintained as records

2. Software Risk Management Plan (to include; identification of potential risks, analysis and prioritizing of risks, impact and mitigation of risks)

3. Software Configuration Management documentation

a) Include establishment of a software baseline no later than the completion of the software validation process

b) Changes subsequent to establishment of the software baseline are traceable to software requirements, approved, documented, and added to the baseline so that the baseline defines the most recently approved software configuration

4. Applicable Subcontractor sub-tier supplier evaluation documentation and sub-tier software procurement documentation providing evidence of incorporation and verification of applicable procurement quality requirements

a) Commercial Grade Dedication plan, as applicable

5. Software Requirements which are identified, testable, controlled, and documented

a) Requirements document or specification

b) Requirements traceability matrix

6. Software Design Documentation

a) Model or algorithm

b) Design description/components

c) Programmer’s reference manual

7. Software hazard analysis documentation

a) Hazard analysis including identification and analysis of hazards with potential to defeat a safety function

b) Mitigation (or elimination) strategies for identified hazards (at the software system and component level as applicable)

8. Verification and Validation (V&V)

a) V&V document (e.g. test plan/test cases) that describes methods used in developing and validating the software (including acceptance criteria) and controls and documents V&V activities

b) V&V report (e.g. results) that demonstrates requirements are met

c) User Instructions

9. Problem Reporting and Corrective Action (communicate as necessary with N3B)

a) Supplier notification of defects, new releases, or other operational impacts to software users

b) Subcontractor/Supplier provide mechanism for software users to report defects and request operational assistance

10. Training and Qualification

a) Subcontractor personnel Training and Qualification records associated with the design and development of software

b) Subcontractor provided training to Contractor personnel in the use and evaluation of purchased software

QC-37 OTHER

(a) GENERAL: Acceptance Criteria for the acceptance of work and Items are defined in the statement of work and/or technical specification sections in exhibit D Scope of Work and Technical Specifications for Off-Site Analytical Laboratory Services.

(b) In reference to QC-01A QUALITY ASSURANCE PROGRAM REQUIREMENTS FOR OFF-SITE

SUBCONTRACTS and Exhibit D Section 3.3 the SUBCONTRACTOR shall submit their

Laboratory Quality Assurance Program/Plan (LQAP) to the CONTRACTOR for approval, prior to start of work.

The SUBCONTRACTOR will perform all work under this subcontract in accordance with its CONTRACTOR approved LQAP.

The SUBCONTRACTOR shall notify the CONTRACTOR of any changes made to the CONTRACTOR approved SUBCONTRACTOR’s LQAP. SUBCONTRACTORS LQAP shall be subject to ongoing evaluation and monitoring by the CONTRACTOR.

The SUBCONTRACTOR shall perform audits of their work to ensure compliance to the SUBCONTACTORS QA Program: the SUBCONTRACTOR will supply copies of these reports to the CONTRACTOR during the project when requested. All final reports will be turned over as a project record. Exhibit D Section 3.5.

(c) In reference to QC-03 QUALIFICATION AND CERTIFICATION OF PERSONNEL AND STAFF and pursuant to Exhibit D Sections 2.7, 3.7.1, and 3.15.3 the SUBCONTRACTOR personnel shall meet the minimum requirements of the contract.

(d) In Reference to QC-04 TRACEABILITY – ITEM and Pursuant to Exhibit D Sections 3.8.2 through

3.8.4 and 4.6.2 all Standards and reference material shall be traceable and well documented as defined.

(e) In Reference to QC-06 CERTIFICATE OF CONFORMANCE and pursuant to Exhibit D Section

5.2.2.2 each Case Narrative shall include a signed statement affirming that the analytical work and data package have been reviewed and are in compliance with the requirements of the Scope of Work.

(f) In Reference to QC-07 MANUFACTURING, INSPECTION, MAINTENANCE, REPAIR, AND/OR

TEST PROCEDURES and pursuant to Exhibit D Sections 3.13, 3.15.8, and 4.6.11.1 the SUBCONTRACTOR shall provide upon request instrument maintenance, repair logs, calibration and recertification logs if an instrument performance exceed acceptance criteria prior to being brought back into service.

(g) In reference to QC-08A ENGINEERING EVALUATION / ANALYSIS REPORT and pursuant to

Exhibit H Sections, 4.2 and 5.0 the SUBCONTRACTOR shall provide analytical services and analysis reports consisting of two (2) parts: The Analytical Electronic Data Deliverable (EDD) and the Analytical Data Package in the form of a searchable PDF with bookmarks. The Levels/Stages are defined in Exhibit D the Scope of Work. A complete data deliverable shall include the Transmittal/Status Sheet found in Attachment I. The Transmittal/Status Sheet will be the issues tracking form. Each complete data deliverable will be assessed within the following five (5) categories.

1. Reviewed- Work may proceed.

2. Reviewed- Revise and resubmit. Work may not proceed subject to incorporation of indicated comments.

3. Reviewed. Revise and resubmit. Work may not proceed.

4. Reject. Submittal does not meet requirements. Resubmit.

5. Permission to proceed not required.

Corrections to EDDs requiring more than 48 hours shall be addressed with a formal corrective action plan to be submitted within four (4) days of formal request as per Exhibit D Section 5.1.4. Analytical Data resubmittal requirements are in Exhibit D Section 5.3.3.

The SUBCONTRACTOR shall not cancel any analysis because of Holding Time issue without prior notification of the CONTRACTOR STR pursuant to Exhibit D 3.11.5.

If catastrophic instrument failure occurs and specified analytical technique cannot be used the SUBCONTRACTOR shall contact the CONTRACTOR for approval for the use of an alternate analytical technique. If the proposed alternate technique will not yield results suitable to the end use of the data, instructions for shipment of samples or sample splits to another SUBCONTRACTOR will be provided by the CONTRACTOR pursuant to Exhibit D Section 4.2.4.3.

(h) In reference to QC-12A CERTIFICATION OF CALIBRATION FOR SUBCONTRACTOR M&TE and pursuant to Exhibit D Sections 3.8, 4.1.2, 4.2.1, and 4.6.3.3. Certification and Traceability of Measuring and Testing Equipment (M&TE) all pipet and balance identifications specified on all Analytical Batch preparation bench sheets or logs shall be traceable to the respective calibration log and calibration certificates containing the stamp of the accrediting body.

(i) In Reference to QC-16 SHELF LIFE CERTIFICATIONS/STORAGE REQUIREMENTS and pursuant to Exhibit D Sections 3.3.1.6, 3.8.2, 3.10.5, 3.10.6, and 4.6.1. Control of Standards and Storage requirements and SUBCONTRACTOR LQAP.

The SUBCONTRACTOR LQAP shall address facilities and equipment, including a description of security procedures, sample storage practices, chemical safety data sheets, and a list of equipment available at the laboratory.

The SUBCONTRACTOR shall have SOPs that require daily temperature monitoring (on all business days) for refrigerated sample storage areas and the corrective action that will be initiated if a measurement falls outside the required range.

(j) In reference to QC-19 FIRST ARTICLE INSPECTION/REVIEW and pursuant to Exhibit D

Section 2.2.1 the CONTRACTOR shall review the first complete deliverable submittal defined in Exhibit D Section 5.0 to verify all requirements have been met prior to authorization to proceed.

(k) In reference to QC-22 CONTRACTOR'S RIGHT OF ACCESS TO SUBCONTRACTOR’S

FACILITY and pursuant to Exhibit D Section 3.5.4 the CONTRACTOR retains the right to visit the SUBCONTRACTOR facility. This includes the review of raw data including but not limited to logbooks, bench sheets, calibration records, continuing calibration verification samples (CCV), continuing calibration blanks (CCB), interference check samples (ICS), initial calibration verification samples (ICV), and initial calibration blanks (ICB), RAD spectra, ICSA from metals analysis, instrument printouts and other related documentation as well as physical locations and areas of the facility. Reasonable advanced notice (minimum 24 hours) in writing shall be provided to the SUBCONTRACTOR prior to a visit.

(l) In reference to QC-25 NONCONFORMANCE REPORTING and pursuant to Exhibit D Section

3.8.6 the SUBCONTRACTOR shall notify the Contractor of any nonconformance that may significantly impact the scope of this contract and of a magnitude as to warrant a Corrective Action within three (3) working days.

(m) In reference to QC-26 CORRECTIVE ACTION REPORTS and pursuant to Exhibit D Sections

3.14 and 3.4.2 the Contractor may request that the SUBCONTRACTOR provide a Corrective Action Report for Out of Control events such as failed proficiency, loss of one or more accreditations, or systematic analytical failures associated with analytical services provided to the CONTRACTOR.

(n) In reference to QC-29 HANDLING, RECEIVING, STORAGE, SHIPPING, AND PACKAGING and pursuant to Exhibit D Section 3.10.4 the SUBCONTRACTOR shall notify the CONTRACTOR immediately of any anomalies noted during the sample receiving process

The SUBCONTRACTOR is responsible for including (i.e., flowing down) the quality and technical requirements of this subcontract to its Secondary-SUBCONTRACTOR to the extent necessary to ensure SUBCONTRACTOR’s compliance with the requirements pursuant to Exhibit D Section 2.4.2 SDDR Form.

(o) In reference to QC-28 SERIALIZATION and pursuant to Exhibit D Section 5.0 all

SUBCONTRACTOR submitted Deliverables shall have a unique Sample Delivery Group (SDG) ID based on the CONTRACTOR COC.

(p) In reference to QC34 DOCUMENTS AND RECORDS and pursuant to Exhibit D Section 3.13 requirement the SUBCONTRACTOR shall maintain a case file containing all documents and records for the period of the contract AND for a period of no less than 5 years post contract.

(q) In reference to QC-36 SOFTWARE QUALITY ASSURANCE and pursuant to Exhibit D Section

3.15 requirements the SUBCONTRACTOR shall be responsible for following Good Automated Laboratory Practices.

(r) GENERAL: Other applicable requirements not addressed in this attachment may also apply;

depending on the type of work being performed and the industries standard for these requirements.

(s) GENERAL: The SUBCONTRACTOR shall practice the principles of As Low As Reasonably Achievable (ALARA) to the extent practical for the work performed.