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   <Document>
      <DocumentName><![CDATA[DOE O 414.1B Quality Assurance]]></DocumentName>
      <DocumentId><![CDATA[DOE O 414.1B]]></DocumentId>
      <DocumentOpenDate>10/09/2003</DocumentOpenDate>
      <DocumentCloseDate>11/10/2003</DocumentCloseDate>
      <DocumentResolutionDate>02/02/2004</DocumentResolutionDate>
      <MajorComments>
         <Section>
            <SectionTitle><![CDATA[Overall Comments]]></SectionTitle>
            <SectionContent><![CDATA[Please provide your overall comments about this document.
Note: this 'paragraph' is not part of the original document.]]></SectionContent>
            <Organization>
               <OrganizationName><![CDATA[Ames Labortatory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Argonne National Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Associate Manager for Science & Technology, Richland]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Bechtel Hanford]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Bechtel Nevada]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Berkeley Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Bonneville Power Administration]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Janet Lubach]]></SourceUsername>
                  <SourceTitle><![CDATA[BPA DPC]]></SourceTitle>
                  <SourceSite><![CDATA[Bonneville Power Administration]]></SourceSite>
               </Source>
               <ApproverName><![CDATA[]]></ApproverName>
               <Comments><![CDATA[This package represents the official, consolidated comments from BPA;  
  
Consistent with Secretarial delegation Order Number 00-033.00A, dated 9/27/2002, to the Administrator and Chief Executive Officer, Bonneville Power Administration, this draft order does not apply to BPA. 

The precursor directive, Order 414.1,  Management of DOE Weapon Program & Weapon Complex, on page 12 of Appendix A,  of Delegation 0204-161 of October 7, 1996, showed that the order was not applicable to BPA;

Recommend that BPA be explicitly listed as not applicable from this current draft DOE order, 414.1B and any future orders, as BPA does not have any National Labs, nor Nuclear facilities or weapons,  and does not manufactures any products.]]></Comments>
               <Response>
                  <ResponseLevel><![CDATA[Accepted]]></ResponseLevel>
                  <ResponseContent><![CDATA[Response – Accept - Attachment 1 will be revised to delete the Bonneville Power Administration. ]]></ResponseContent>
               </Response>
               <Concurrence><![CDATA[Concur/No Comment]]></Concurrence>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Brookhaven National  Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[BWXT Pantex, LLC]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Carlsbad Area Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Carlsbad Field Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[CH2MHill]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Chicago Operations Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Critique]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Departmental Representatives Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Directives Management Team]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[DynMcDermott Petroleum Operations]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Fermi National Accelerator Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Fernald]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Fluor Hanford Inc]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Golden Field Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Grand Junction]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters CI]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters CIO]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters CN]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters CR]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters ED]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters EE]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters EH]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters EIA]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters EM]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Joni Boone]]></SourceUsername>
                  <SourceTitle><![CDATA[EM DPC]]></SourceTitle>
                  <SourceSite><![CDATA[Headquarters EM]]></SourceSite>
               </Source>
               <ApproverName><![CDATA[Sandra L. Johnson, Director, Office of Safety and Engineering, EM-5]]></ApproverName>
               <Comments><![CDATA[Linda C. Wright (SRO EM DPC) for Savannah River EM Office


Delegate GROSSO,  VINCENT  J for Westinghouse Savannah River Corp. for SR-EM
1) With the exception of the portion dealing with suspect/counterfeit parts, is it DOE's intent that any other portion of the Order be made applicable to facilities/activities already required to meet 10CFR830, Subpart A?
3) DOE O 414.1B Draft states that it cancels 414.1A.  It states that part of 414.1A is being moved to another draft (DOE M 414.1 - 1, Corrective Action Management Program). Neither document lists the Applicability section as 414.1A does.  414.1B does state that it is applicable to DOE National Nuclear Security Administration (NNSA) and Attachment 1 lists the applicability for organizations.  It does include the Office of Environment, Safety and Health.  What it does not do is state the exclusions as 414.1A did. Is there any intent for this Order to list the exclusions as 414.1A did.  It clarifies the topic and takes away any concern for interpretation.
4) If 414.1B intends to say we have to meet the requirements it is proposing, there would be several complex contract changes required. It that the intent? If so there should be an implementation period which has not been identified.
5) Will NQA-1 2000 now be the complex wide QA standard? If this order will not be released for a few months, NQA-1 2003 will be out in April. Wouldn't this be the better standard to reflect?]]></Comments>
               <Response>
                  <ResponseLevel><![CDATA[Accepted with Modification]]></ResponseLevel>
                  <ResponseContent><![CDATA[1) and 3) Response  Accept w/mod See Appl Section
4) Response  Accept w/mod  The commentator is correct in that the intent (purpose) of DOE Orders is to establish requirements for DOE organizations that must be met.  Contract changes should be minimal and in many cases may only involve reference to the new Order.  This is due to the fact that the Order changes are minor and incremental.  Many contractors do not include their detailed implementing processes in the contract, but refer to these processes in their QAP may be a contract deliverable.  Any implementation period that may be needed by a contractor to make changes to internal processes consistent with the CRD should be negotiated with the DOE Approval Authority.  This may be done as part of the routine contractor QAP revision cycle permitted under the CRD.

5) Response  Accept w/mod See Requirements Section]]></ResponseContent>
               </Response>
               <Concurrence><![CDATA[Concur/No Comment]]></Concurrence>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters FE]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters GC]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Richard Farman]]></SourceUsername>
                  <SourceTitle><![CDATA[GC DPC]]></SourceTitle>
                  <SourceSite><![CDATA[Headquarters GC]]></SourceSite>
               </Source>
               <ApproverName><![CDATA[]]></ApproverName>
               <Comments><![CDATA[Subject Matter Expert steve.duarte@hq.doe.gov
1)  If this Order is intended to apply to defense nuclear facilities, it must have a separate finding that the order is necessary for the protection of human health and the environment or safety, the fulfillment of current legal requirements, or the conduct of critical administrative functions, as specified in 42 USC 7274k.  Please contact ME-43 for details.

2)  The draft does not appear to establish requirements on members of the public that necessitate a notice and comment rulemaking.  No action by the OPI is required.

3)  The directive is a "rule" as that term is defined by the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 801-804, which requires that, when issued in final form, the directive be reported to Congress.  No action by the OPI is required.  GC
will report this directive to Congress when it is issued.]]></Comments>
               <Response>
                  <ResponseLevel><![CDATA[Accepted]]></ResponseLevel>
                  <ResponseContent><![CDATA[]]></ResponseContent>
               </Response>
               <Concurrence><![CDATA[Concur/No Comment]]></Concurrence>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters HG]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters IG]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters IN]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters LM]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters MBE]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters NA]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Diane Gillis]]></SourceUsername>
                  <SourceTitle><![CDATA[NA Directives Point of Contact]]></SourceTitle>
                  <SourceSite><![CDATA[Headquarters NA]]></SourceSite>
               </Source>
               <ApproverName><![CDATA[]]></ApproverName>
               <Comments><![CDATA[Overall Comments
Comment:  Focus remains too limited to facilities and safety and doesn't address the complete scope of work of DOE with sufficient balance.  (SME/Joel Smith, NA-121.3)

Comment:  The intent of this Order is to establish an overall management system for DOE and contractor organizations of which other management systems (i.e., DOE P 450.4, and DOE O 5480.19 for planning and conducting work as identified in Criterion 5, DOE P 450.5 for self-assessments and how that integrates into Criteria 9 and 10) need to play a significant part in the development and implementation of the overall management system.  This Order needs to strengthen how the management system it describes identifies an integrated (or "umbrella") management program that covers these other management system programs and how they are connected through the 10 criteria to create a single integrated program.  (Service Center/Bolivar - SME/Morley)]]></Comments>
               <Response>
                  <ResponseLevel><![CDATA[Accepted with Modification]]></ResponseLevel>
                  <ResponseContent><![CDATA[Response  Accept w/mod  Paragraph 1.b. will be revised to include the words all work after (QA).  The current text is in 1.a. is clear that it applies to all products and services.   The definition of work (ref. para. 7.k.) is also clear that work is a broadly defined term that covers much more than facility or safety activities.  Additional text to be added to the DOE QA Guide, G 414.1-2 may be suggested by the commentator to address these issues.

Response  accept w/mod  The DOE QA Guide, G 414.1-2 will be revised to address these issues.  DOE Orders are only permitted to include requirements and responsibilities. 

]]></ResponseContent>
               </Response>
               <Concurrence><![CDATA[Concur/No Comment]]></Concurrence>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters NE]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters NTEU]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters OA]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters OPI]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters PC-1]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters PO]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters RW]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters SC]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters SO]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Geralyn Praskievicz]]></SourceUsername>
                  <SourceTitle><![CDATA[SO DPC]]></SourceTitle>
                  <SourceSite><![CDATA[Headquarters SO]]></SourceSite>
               </Source>
               <ApproverName><![CDATA[]]></ApproverName>
               <Comments><![CDATA[

Subject Matter Expert lynne.preston@hq.doe.gov
The draft order is written incorrectly so that if interpreted literally, it would require the Office of Security and the NNSI/CTA to develop quality assurance programs that meet the criteria of the order.  The order should state that it applies only to nuclear facilities.

The applicable sections, quoted:

3.  APPLICABILITY.
a.  DOE Elements.  Except for the exclusions in paragraph 3c, this Order applies to all DOE/NNSA elements (see Attachment 1).

Attachment 1.  DOE ORGANIZATIONS TO WHICH DOE O 414.1B IS APPLICABLE
This Notice is applicable to the following DOE organizations and their associated Federal field elements:  ...Office of Security...

4.  REQUIREMENTS.
a.  Quality Assurance Requirements.  Each DOE element must develop and implement a QAP...


10 CFR 830.121 states:  "Contractors conducting activities, including providing items or services, that affect, or may affect, the nuclear safety of DOE nuclear facilities must conduct work in accordance with the Quality Assurance criteria in Sec. 830.122.  But the draft order doesn't say anywhere that it is only applicable to nuclear facilities.

Please add the statement that the order applies only to nuclear facilities subject to 10 CFR 830.

I believe this is a major comment because the draft order would require headquarters offices to develop quality assurance programs, which would be impact our ability to perform our primary duties in an efficient and economic manner.

]]></Comments>
               <Response>
                  <ResponseLevel><![CDATA[Not Accepted]]></ResponseLevel>
                  <ResponseContent><![CDATA[Response  rejected  Since at least 1990, all past revisions of the QA Order have applied to the DOE headquarters and field organizations (e.g., Office of Security and the NNSI/CTA, or their predecessor organization). One purpose of a QA Program is to clearly define the work and the processes to assure that the work meets requirements.   The Office of Security (SO) performs work to certain requirements in order to achieve desired outcomes.  SO is responsible for the quality of that work.  Therefore, a QAP, or management system, is appropriate to assure SO achieves its goals.  It is also assumed the SO has well-defined work processes for its primary duties (such as how security threats are analyzed and communicated), desired outcomes, roles and responsibilities, interfaces, documents/records, and assessment methods.  These are fundamental elements of a QAP, so minimal effort should be required to comply with the Order.  The QA Criteria also include a Quality Improvement requirement.  Properly applied to the SO work processes, this criterion can uncover opportunities for improving the efficient and economic performance of your primary duties.  Several security contractors in the field (e.g., Wackenhut) have mature QAPs that may provide useful examples to SO.

]]></ResponseContent>
               </Response>
               <Concurrence><![CDATA[Concur/No Comment]]></Concurrence>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Honeywell FM&T (Kansas City Plant)]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Idaho Operations Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Idaho Operations Office-EM]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[INL - NE]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[INL-ICP-EM]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Kaiser-Hill Company, LLC]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Kansas City Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Lawrence Berkeley Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Lawrence Livermore National Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Livermore Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Los Alamos National Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Los Alamos Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[NA Service Center]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Yolanda Bolivar]]></SourceUsername>
                  <SourceTitle><![CDATA[AL DPC]]></SourceTitle>
                  <SourceSite><![CDATA[NA Service Center]]></SourceSite>
               </Source>
               <ApproverName><![CDATA[]]></ApproverName>
               <Comments><![CDATA[

Subject Matter Expert nmorley@doeal.gov
The intent of this Order is to establish an overall management system for DOE and contractor organizations of which other management systems (i.e., DOE P 450.4, and DOE O 5480.19 for planning and conducting work as identified in Criterion 5, DOE P 450.5 for self-assessments and how that integrates into Criteria 9 and 10) need to play a significant part in the development and implementation of the overall management system.  This Order needs to strengthen how the management system it describes identifies an integrated (or "umbrella") management program that covers these other management system programs and how they are connected through the 10 criteria to create a single integrated program.

]]></Comments>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[National Energy Technology Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[National Renewable Energy Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Nevada Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Oak Ridge National Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Oak Ridge Operations Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Oakland Operations Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Office of Energy Assurance]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Office of River Protection]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Ohio Field Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[OSTI]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Pacific Northwest National Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Pantex Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Portsmouth Paducah Project Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Princeton Plasma Physics Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Richland Operations Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Rocky Flats Field Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Sandia National Laboratories]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Sandia Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Savannah River EM Office]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Linda C. Wright]]></SourceUsername>
                  <SourceTitle><![CDATA[SRO EM DPC]]></SourceTitle>
                  <SourceSite><![CDATA[Savannah River EM Office]]></SourceSite>
               </Source>
               <ApproverName><![CDATA[]]></ApproverName>
               <Comments><![CDATA[

Delegate GROSSO,  VINCENT  J for Westinghouse Savannah River Corp. for SR-EM
1) With the exception of the portion dealing with suspect/counterfeit parts, is it DOE's intent that any other portion of the Order be made applicable to facilities/activities already required to meet 10CFR830, Subpart A?
3) DOE O 414.1B Draft states that it cancels 414.1A.  It states that part of 414.1A is being moved to another draft (DOE M 414.1 - 1, Corrective Action Management Program). Neither document lists the Applicability section as 414.1A does.  414.1B does state that it is applicable to DOE National Nuclear Security Administration (NNSA) and Attachment 1 lists the applicability for organizations.  It does include the Office of Environment, Safety and Health.  What it does not do is state the exclusions as 414.1A did. Is there any intent for this Order to list the exclusions as 414.1A did.  It clarifies the topic and takes away any concern for interpretation.
4) If 414.1B intends to say we have to meet the requirements it is proposing, there would be several complex contract changes required. It that the intent? If so there should be an implementation period which has not been identified.
5) Will NQA-1 2000 now be the complex wide QA standard? If this order will not be released for a few months, NQA-1 2003 will be out in April. Wouldn't this be the better standard to reflect?

]]></Comments>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Savannah River Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Southeastern Power Administration]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Southwestern Power Administration]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Stanford Linear Accelerator Center]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Stanford Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Thomas Jefferson National Accelerator Facility]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[University of California]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Wackenhut Services Inc (SRS)]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Wackenhut Services Inc. (Nevada)]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[West Valley Demonstration Project]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Western Area Power Administration]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Westinghouse Savannah River Corp.]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Westinghouse Savannah River Corp. for SR-EM]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[GROSSO,  VINCENT  J]]></SourceUsername>
                  <SourceTitle><![CDATA[Delegate]]></SourceTitle>
                  <SourceSite><![CDATA[Westinghouse Savannah River Corp. for SR-EM]]></SourceSite>
               </Source>
               <Comments><![CDATA[1) With the exception of the portion dealing with suspect/counterfeit parts, is it DOE's intent that any other portion of the Order be made applicable to facilities/activities already required to meet 10CFR830, Subpart A?
3) DOE O 414.1B Draft states that it cancels 414.1A.  It states that part of 414.1A is being moved to another draft (DOE M 414.1 - 1, Corrective Action Management Program). Neither document lists the Applicability section as 414.1A does.  414.1B does state that it is applicable to DOE National Nuclear Security Administration (NNSA) and Attachment 1 lists the applicability for organizations.  It does include the Office of Environment, Safety and Health.  What it does not do is state the exclusions as 414.1A did. Is there any intent for this Order to list the exclusions as 414.1A did.  It clarifies the topic and takes away any concern for interpretation.
4) If 414.1B intends to say we have to meet the requirements it is proposing, there would be several complex contract changes required. It that the intent? If so there should be an implementation period which has not been identified.
5) Will NQA-1 2000 now be the complex wide QA standard? If this order will not be released for a few months, NQA-1 2003 will be out in April. Wouldn't this be the better standard to reflect?]]></Comments>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[WIPP]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Y-12 (BWXT)]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Y-12 (WSI)]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Y-12 Site Office]]></OrganizationName>
            </Organization>
         </Section>
         <Section>
            <SectionTitle><![CDATA[1. Objectives]]></SectionTitle>
            <SectionContent><![CDATA[1.	OBJECTIVES.  
a.	To ensure that the quality of Department of Energy (DOE)/National Nuclear 
Security Administration (NNSA), products and services meet or exceed the 
customers' expectations.  
b.	To achieve quality assurance (QA) based upon the following principles:  
(1)	That quality can be assured and maintained through a single, integrated, 
effective quality assurance program (QAP).  
(2)	That management support for planning, organization, direction, and 
control is essential to QA.  
(3)	That performance and quality improvement require through, rigorous 
assessment and corrective action.

]]></SectionContent>
            <Organization>
               <OrganizationName><![CDATA[Ames Labortatory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Argonne National Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Associate Manager for Science & Technology, Richland]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Bechtel Hanford]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Bechtel Nevada]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Berkeley Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Bonneville Power Administration]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Brookhaven National  Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[BWXT Pantex, LLC]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Carlsbad Area Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Carlsbad Field Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[CH2MHill]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Chicago Operations Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Critique]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Departmental Representatives Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Directives Management Team]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[DynMcDermott Petroleum Operations]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Fermi National Accelerator Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Fernald]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Fluor Hanford Inc]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Golden Field Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Grand Junction]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters CI]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters CIO]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters CN]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters CR]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters ED]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters EE]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters EH]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters EIA]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters EM]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Joni Boone]]></SourceUsername>
                  <SourceTitle><![CDATA[EM DPC]]></SourceTitle>
                  <SourceSite><![CDATA[Headquarters EM]]></SourceSite>
               </Source>
               <Comments><![CDATA[Joanne Shadel (RL DPC) for Richland Operations Office
RL states: It has always been a key concept, but frequently not understood, that line management is responsible for implementing the QA Program to achieve quality in work performed.  This concept was deleted from this revision.  Recommend adding a requirement that the organizations responsible for performing the work are also responsible for achieving quality. <b> Failure to resolve this issue will jeopardize DOE's ability to accomplish policy objectives and missions. </b> <i> Jean F Schwier, Acting Deputy Manager authorizes this comment. </i>

Dixie Evans (ID-EM DPC) for Idaho Operations Office-EM
1.b.(4) - New Section, Insert "Line organizations achieve and maintain quality".  This is Quality 101.  The words were extracted from DOE O 414.1A.

(Comment submitted by R. L. Blyth, ID OPI, and approved by R. L. Green, Acting Deputy Manager, Technical Support)]]></Comments>
               <Response>
                  <ResponseLevel><![CDATA[Accepted with Modification]]></ResponseLevel>
                  <ResponseContent><![CDATA[Response  accept w/mod  The new text is an attempt to streamline the language and avoid repeating specific responsibilities or requirements found in the Order.  Two objectives (1.b. and 1.c.) from O 414.1A will be modified and reinserted as principles. 

]]></ResponseContent>
               </Response>
               <Concurrence><![CDATA[Concur/No Comment]]></Concurrence>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters FE]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters GC]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters HG]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters IG]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters IN]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters LM]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters MBE]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters NA]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Diane Gillis]]></SourceUsername>
                  <SourceTitle><![CDATA[NA Directives Point of Contact]]></SourceTitle>
                  <SourceSite><![CDATA[Headquarters NA]]></SourceSite>
               </Source>
               <Comments><![CDATA[Comment:  a. To ensure that the quality of Department of Energy (DO E)/National Nuclear Security Administration (NNSA), products and services meet or exceed the customers' requirements.  The following may be an objective but is probably not a "principle:" (1) That quality can be assured and maintained through a single, integrated, effective quality assurance program (QAP). Misspelled word - (3) That performance and quality improvement require (thorough), rigorous assessment and corrective action.  (SME/Joel Smith, NA-121.3)

Comment: 
•	The latest draft of DOE Order 414.1B, Quality Assurance, does not clearly and consistently define the relationship of this order to the QA rule. It seems to try in a couple of places (3.b(2), Applicability and 3.c(2), Exclusions and Attachment 2, first paragraph) to clarify that it only applies to work not governed by 10 CFR 830, Subpart A, Quality Assurance, yet the CRD portion of the Order calls for the use of NQA-1 for "nuclear-related hazardous activities." Also, paragraph 3.c(2), Exclusions, has similar wording: "Work that may be subject to QA regulations and the requirements of this Order should be integrated and made consistent with all requirements." In addition to NQA-1, the draft is calling for the use of standards in the development of safety software. It also includes a new section on the prevention and control of suspect/counterfeit items. If 414.1 is intended to apply only to the non safety-class and non safety-significant work in DOE facilities (both nuclear and non nuclear), the draft is now more stringent than the CFR. 
•	3 1.c (1) DOE Guide 414.1-2A will have to be re-written to match the new order. 3 1.c (3) Should read …DOE G 414.1-3. 3 3 c Facilities falling under the Price Anderson Amendments act (i.e, 10 CFR 830 Subpart A) should be excluded from this Order. 3 4.a (2) Change “as follows” to “such as”. 
•	4 4 e. Why single out S/CI as an entity? If the QA Program is working, this will be accounted for; if not, adding S/CI as a line item makes no difference. 
•	4 4.a (5) Delete this paragraph. It would be prohibitively expensive to have an independent 3rd party certify one’s QA program (e.g., a program similar to ISO 9000 certification). Alternatively, change “Uses and maintains third-party independent certification” to “Obtains an independent review.” 
•	4 5 This one item is going to spring forth a cottage industry of internal/external audits that will be not be useful and largely counter productive. 
•	7 5 This was tried once before with less than optimal results. Why does DOE think it is going to work this time, especially when adding grading a very subjective element.
•	7 6 DOE does not have adequate staff to support this activity. 
•	9 f. (2) Is QA only for ES&H and S&S not program? 
•	10 6 How are we to implement draft documents that are either, a) superceded, or b) not yet issued. 
•	10 7 h As written these definitions are not workable, they encompass the entire envelope of software in use at a facility.
(Livermore/Cyganowski - SME/Palmer)

Comment:  Section 1.a.  Within the objectives, part a, we should also include that the objective is also to "establish an effective Quality Assurance program through an effective management system."  (Sandia/Martinez - SME/Dilley)]]></Comments>
               <Response>
                  <ResponseLevel><![CDATA[Accepted with Modification]]></ResponseLevel>
                  <ResponseContent><![CDATA[[OPI Note: Many of the following comments are not related to the “Objectives” paragraph.  Where possible, they will be responded to with appropriate Order paragraph.]

Diane Gillis (NA Directives Point of Contact) for Headquarters NA
Comment: a. To ensure that the quality of Department of Energy (DO E)/National Nuclear Security Administration (NNSA), products and services meet or exceed the customers' requirements. The following may be an objective but is probably not a "principle:" (1) That quality can be assured and maintained through a single, integrated, effective quality assurance program (QAP). Misspelled word - (3) That performance and quality improvement require (thorough), rigorous assessment and corrective action. (SME/Joel Smith, NA-121.3) 

Response – accept w/mod – The new text is an attempt to streamline the language and avoid repeating specific responsibilities or requirements found in the Order.  The text will be modified to read as a principle and the typo will be corrected. 

[OPI Note: These following comments are not related to the “Objectives” paragraph.  Where possible, they will be responded to with appropriate Order paragraph on Applicability.]

Comment: b. The latest draft of DOE Order 414.1B, Quality Assurance, does not clearly and consistently define the relationship of this order to the QA rule. It seems to try in a couple of places (3.b(2), Applicability and 3.c(2), Exclusions and Attachment 2, first paragraph) to clarify that it only applies to work not governed by 10 CFR 830, Subpart A, Quality Assurance, yet the CRD portion of the Order calls for the use of NQA-1 for "nuclear-related hazardous activities." Also, paragraph 3.c(2), Exclusions, has similar wording: "Work that may be subject to QA regulations and the requirements of this Order should be integrated and made consistent with all requirements." 
In addition to NQA-1, the draft is calling for the use of standards in the development of safety software. It also includes a new section on the prevention and control of suspect/counterfeit items. If 414.1 is intended to apply only to the non safety-class and non safety-significant work in DOE facilities (both nuclear and non nuclear), the draft is now more stringent than the CFR. â€¢ 

[OPI Note: These following comments are not related to the “Objectives” paragraph.  Where possible, they will be responded to with appropriate Order paragraphs]

3 1.c (1) DOE Guide 414.1-2A will have to be re-written to match the new order. 
Response – accept – The guide is in the revision process.

3 1.c (3) Should read â€¦DOE G 414.1-3. 
Response – reject – Comment is not referencing a legitimate paragraph.

3 3 c Facilities falling under the Price Anderson Amendments act (i.e, 10 CFR 830 Subpart A) should be excluded from this Order. 
Response – Accept w/mod – This Order does not supersede 10 CFR 830, but will supplement it with specific requirements for certain work processes.  This will include S/CIs and safety software (later).

3 4.a (2) Change â€œas followsâ€ to â€œsuch asâ€. â€¢ 

Response – reject – The current text allows for flexibility by stating, “…where practicable and consistent with contractual or regulatory requirements…” 

4 4 e. Why single out S/CI as an entity? If the QA Program is working, this will be accounted for; if not, adding S/CI as a line item makes no difference. â€¢

Response – reject – The S/CI requirements are transferred from O 440.1 and the subject text simply ties the S/CI requirements to the QAP

4.a (5) Delete this paragraph. It would be prohibitively expensive to have an independent 3rd party certify oneâ€™s QA program (e.g., a program similar to ISO 9000 certification). Alternatively, change â€œUses and maintains third-party independent certificationâ€ to â€œObtains an independent review.â€ â€¢ 

Response – Accept w/mod – This form of QAP validation will be moved to paragraph 5. Responsibilities, as an optional method to supplement QAP review and approval.

4 5 This one item is going to spring forth a cottage industry of internal/external audits that will be not be useful and largely counter productive. â€¢ 7 5 This was tried once before with less than optimal results. Why does DOE think it is going to work this time, especially when adding grading a very subjective element. â€¢ 

Response -  reject – The comment is unclear as to the paragraph it applies to.

7 6 DOE does not have adequate staff to support this activity. â€¢ 

Response -  reject – The comment is unclear as to the paragraph it applies to.
 
9 f. (2) Is QA only for ES&H and S&S not program? â€¢ 

Response – Accept w/mod – QA is to applied to all work,  not just “ES&H and S&S”, however the OA organization only assesses this scope of work.

10 6 How are we to implement draft documents that are either, a) superceded, or b) not yet issued. â€¢ 

Response – Accept w/mod – The draft information was provided to assist the reviewers.  Upon issuance of the final Order, the current revisions will be listed with a note indicating that a new version is in progress.  The drafts are typically available on the DOE REVCOM website.

10 7 h As written these definitions are not workable, they encompass the entire envelope of software in use at a facility. 
Response -  reject – The definitions have already been approved by the Secretary in the DOE Implementation Plan for DNFSB Recommendation 2002-3 (Livermore/Cyganowski - SME/Palmer) 

Comment: Section 1.a. Within the objectives, part a, we should also include that the objective is also to "establish an effective Quality Assurance program through an effective management system." (Sandia/Martinez - SME/Dilley)

Response – Accept w/mod – The QAP is to understood and implemented as a management system.  1.b.(1) will be revised to add this intent.


]]></ResponseContent>
               </Response>
               <Concurrence><![CDATA[Concur/No Comment]]></Concurrence>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters NE]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Barbara Cramer]]></SourceUsername>
                  <SourceTitle><![CDATA[NE DPC]]></SourceTitle>
                  <SourceSite><![CDATA[Headquarters NE]]></SourceSite>
               </Source>
               <Comments><![CDATA[Dixie Evans (ID DPC) for Idaho Operations Office
1.b.(4) - New Section, Insert 'Line organizations achieve and maintain quality'.  This is Quality 101.  The words were extracted from DOE O 414.1A.

(Comment submitted by R. L. Blyth, ID OPI, and approved by R. L. Green, Acting Deputy Manager, Technical Support)]]></Comments>
               <Response>
                  <ResponseLevel><![CDATA[Accepted with Modification]]></ResponseLevel>
                  <ResponseContent><![CDATA[Response  Accept w/mod  The new text is an attempt to streamline the language and avoid repeating specific responsibilities or requirements found in the Order.  Two objectives (1.b. and 1.c.) from O 414.1A will be modified and reinserted as principles. ]]></ResponseContent>
               </Response>
               <Concurrence><![CDATA[Concur/No Comment]]></Concurrence>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters NTEU]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters OA]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters OPI]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters PC-1]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters PO]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters RW]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters SC]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters SO]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Honeywell FM&T (Kansas City Plant)]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Idaho Operations Office]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Karen Moses]]></SourceUsername>
                  <SourceTitle><![CDATA[ID DPC]]></SourceTitle>
                  <SourceSite><![CDATA[Idaho Operations Office]]></SourceSite>
               </Source>
               <Comments><![CDATA[1.b.(4) - New Section, Insert 'Line organizations achieve and maintain quality'.  This is Quality 101.  The words were extracted from DOE O 414.1A.

(Comment submitted by R. L. Blyth, ID OPI, and approved by R. L. Green, Acting Deputy Manager, Technical Support)]]></Comments>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Idaho Operations Office-EM]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Karen Moses]]></SourceUsername>
                  <SourceTitle><![CDATA[ID-EM DPC]]></SourceTitle>
                  <SourceSite><![CDATA[Idaho Operations Office-EM]]></SourceSite>
               </Source>
               <Comments><![CDATA[1.b.(4) - New Section, Insert "Line organizations achieve and maintain quality".  This is Quality 101.  The words were extracted from DOE O 414.1A.

(Comment submitted by R. L. Blyth, ID OPI, and approved by R. L. Green, Acting Deputy Manager, Technical Support)]]></Comments>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[INL - NE]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[INL-ICP-EM]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Kaiser-Hill Company, LLC]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Kansas City Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Lawrence Berkeley Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Lawrence Livermore National Laboratory]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Lisla Damoulos]]></SourceUsername>
                  <SourceTitle><![CDATA[LLNL Office of Contract Management DPC]]></SourceTitle>
                  <SourceSite><![CDATA[Lawrence Livermore National Laboratory]]></SourceSite>
               </Source>
               <Comments><![CDATA[

Subject Matter Expert palmer3@llnl.gov
the latest draft of DOE Order 
414.1B, Quality Assurance, does not 
clearly and consistently define the 
relationship of this order to the QA 
rule. It seems to try in a couple of 
places (3.b(2), Applicability and 
3.c(2), Exclusions and Attachment 2, 
first paragraph) to clarify that it only 
applies to work not governed by 10 
CFR 830, Subpart A, Quality 
Assurance, yet the CRD portion of 
the Order calls for the use of NQA-1 
for "nuclear-related hazardous 
activities."  Also, paragraph 3.c(2), 
Exclusions, has similar wording: 
"Work that may be subject to QA 
regulations and the requirements of 
this Order should be integrated and 
made consistent with all 
requirements." 

In addition to NQA-1, the draft is 
calling for the use of standards in the 
development of safety software. It 
also includes a new section on the 
prevention and control of 
suspect/counterfeit items. If 414.1 is 
intended to apply only to the non 
safety-class and non 
safety-significant work in DOE 
facilities (both nuclear and non 
nuclear), the draft is now more 
stringent than the CFR. 

3	1.c	(1)	DOE Guide 414.1-2A will 
have to be re-written to match the 
new order. 
3	1.c	(3)	Should read DOE G 
414.1-3. 
3	3	c	Facilities falling under the Price 
Anderson Amendments act (i.e, 10 
CFR 830 Subpart A) should be 
excluded from this Order.
3	4.a 	(2)	Change as follows to 
such as. 
4	4	e.	Why single out S/CI as an 
entity? If the QA Program is working, 
this will be accounted for; if not, 
adding S/CI as a line item makes no 
difference.
4
	4.a	(5)	Delete this paragraph. It 
would be prohibitively expensive to 
have an independent 3rd party certify 
ones QA program (e.g., a program 
similar to ISO 9000 certification). 
Alternatively, change Uses and 
maintains third-party independent 
certification to Obtains an 
independent review.
4	5		This one item is going to spring 
forth a cottage industry of 
internal/external audits that will be 
not be useful and largely counter 
productive.
7	5		This was tried once before with 
less than optimal results. Why does 
DOE think it is going to work this 
time, especially when adding 
grading a very subjective element.
7	6		DOE does not have adequate 
staff to support this activity.
9	f.	(2)	Is QA only for ES&H and S&S 
not program?  
10	6		How are we to implement draft 
documents that are either, a) 
superceded, or b) not yet issued.
10	7	h	As written these definitions 
are not workable, they encompass 
the entire envelope of software in 
use at a facility.

]]></Comments>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Livermore Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Los Alamos National Laboratory]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Yvonne Salaz]]></SourceUsername>
                  <SourceTitle><![CDATA[LANL DPC]]></SourceTitle>
                  <SourceSite><![CDATA[Los Alamos National Laboratory]]></SourceSite>
               </Source>
               <Comments><![CDATA[Subject Matter Expert mpeterson@lanl.gov
1. b. (3)Replace through with thorough]]></Comments>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Los Alamos Site Office]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Myra Garcia-Pena]]></SourceUsername>
                  <SourceTitle><![CDATA[LASO DPC]]></SourceTitle>
                  <SourceSite><![CDATA[Los Alamos Site Office]]></SourceSite>
               </Source>
               <Comments><![CDATA[

Yvonne Salaz (LANL DPC) for Los Alamos National Laboratory
Subject Matter Expert mpeterson@lanl.gov
1. b. (3)Replace through with thorough

]]></Comments>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[NA Service Center]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[National Energy Technology Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[National Renewable Energy Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Nevada Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Oak Ridge National Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Oak Ridge Operations Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Oakland Operations Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Office of Energy Assurance]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Office of River Protection]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Ohio Field Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[OSTI]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Pacific Northwest National Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Pantex Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Portsmouth Paducah Project Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Princeton Plasma Physics Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Richland Operations Office]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Joanne Shadel]]></SourceUsername>
                  <SourceTitle><![CDATA[RL DPC]]></SourceTitle>
                  <SourceSite><![CDATA[Richland Operations Office]]></SourceSite>
               </Source>
               <Comments><![CDATA[RL states: It has always been a key concept, but frequently not understood, that line management is responsible for implementing the QA Program to achieve quality in work performed.  This concept was deleted from this revision.  Recommend adding a requirement that the organizations responsible for performing the work are also responsible for achieving quality. <b> Failure to resolve this issue will jeopardize DOE's ability to accomplish policy objectives and missions. </b> <i> Jean F Schwier, Acting Deputy Manager authorizes this comment. </i>]]></Comments>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Rocky Flats Field Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Sandia National Laboratories]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Sandia Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Savannah River EM Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Savannah River Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Southeastern Power Administration]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Southwestern Power Administration]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Stanford Linear Accelerator Center]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Stanford Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Thomas Jefferson National Accelerator Facility]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[University of California]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Wackenhut Services Inc (SRS)]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Wackenhut Services Inc. (Nevada)]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[West Valley Demonstration Project]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Western Area Power Administration]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Westinghouse Savannah River Corp.]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Westinghouse Savannah River Corp. for SR-EM]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[WIPP]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Y-12 (BWXT)]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Y-12 (WSI)]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Y-12 Site Office]]></OrganizationName>
            </Organization>
         </Section>
         <Section>
            <SectionTitle><![CDATA[2. Cancellations]]></SectionTitle>
            <SectionContent><![CDATA[2.	CANCELLATIONS.  This Order cancels the following.  
a.	DOE O 414.1A, Quality Assurance, dated 9-29-99.  [NOTE:  Attachment 2, 
Safety Issue Corrective Action ProcessSupplemental Quality Requirements for 
DOE Elements, has been moved to (draft) DOE M 414.1-1, Corrective Action 
Management Program, dated XX-XX-03.]  
b.	DOE O 440.1A, Worker Protection Management for DOE Federal and 
Contractor Employees, dated 3-27-98, portions as follows:
(1)	Attachment 1, paragraph 8, Suspect and Counterfeit Item (S/CI) Controls, 
and 
(2)	Attachment 2, paragraph 22, Suspect and Counterfeit Item (S/CI) 
Controls.  
c.	Cancellation of an Order does not, by itself, modify or otherwise affect any contractual 
obligation to comply with the Order.  Canceled Orders that are incorporated by reference 
in a contract must remain in effect until the contract is modified to delete the 
requirements in the canceled Orders. 

]]></SectionContent>
            <Organization>
               <OrganizationName><![CDATA[Ames Labortatory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Argonne National Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Associate Manager for Science & Technology, Richland]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Bechtel Hanford]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Bechtel Nevada]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Berkeley Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Bonneville Power Administration]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Brookhaven National  Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[BWXT Pantex, LLC]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Carlsbad Area Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Carlsbad Field Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[CH2MHill]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Chicago Operations Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Critique]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Departmental Representatives Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Directives Management Team]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[DynMcDermott Petroleum Operations]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Fermi National Accelerator Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Fernald]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Fluor Hanford Inc]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Golden Field Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Grand Junction]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters CI]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters CIO]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters CN]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters CR]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters ED]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters EE]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters EH]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters EIA]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters EM]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters FE]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters GC]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters HG]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters IG]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters IN]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters LM]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters MBE]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters NA]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Diane Gillis]]></SourceUsername>
                  <SourceTitle><![CDATA[NA Directives Point of Contact]]></SourceTitle>
                  <SourceSite><![CDATA[Headquarters NA]]></SourceSite>
               </Source>
               <Comments><![CDATA[Comment:  Section 2.a. Reference DOE O 470.2B rather than draft DOE M 414.1-1. Section 2. of DOE O 470.2B identifies that it cancels Attachment 2 of DOE O 414.1A.  (Service Center/Bolivar - SME/Morley & Sandia/Martinez - SME/Dilley)]]></Comments>
               <Response>
                  <ResponseLevel><![CDATA[Accepted with Modification]]></ResponseLevel>
                  <ResponseContent><![CDATA[Response – Accept w/mod – The new text will be removed. DOE Order O 470.2b incorrectly cancelled Attachment 2 of DOE O 414.1A.   The full DOE Corrective Action Management Program requirements will be reinserted as an attachment to the new QA Order. The draft Manual will not be issued. ]]></ResponseContent>
               </Response>
               <Concurrence><![CDATA[Concur/No Comment]]></Concurrence>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters NE]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters NTEU]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters OA]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters OPI]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters PC-1]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters PO]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters RW]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters SC]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters SO]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Honeywell FM&T (Kansas City Plant)]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Idaho Operations Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Idaho Operations Office-EM]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[INL - NE]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[INL-ICP-EM]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Kaiser-Hill Company, LLC]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Kansas City Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Lawrence Berkeley Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Lawrence Livermore National Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Livermore Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Los Alamos National Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Los Alamos Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[NA Service Center]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Yolanda Bolivar]]></SourceUsername>
                  <SourceTitle><![CDATA[AL DPC]]></SourceTitle>
                  <SourceSite><![CDATA[NA Service Center]]></SourceSite>
               </Source>
               <Comments><![CDATA[

Subject Matter Expert nmorley@doeal.gov
Section 2.a.  Reference DOE O 470.2B rather than draft DOE M 414.1-1.  Section 2. of DOE O 470.2B identifies that it cancels Attachment 2 of DOE O 414.1A.

]]></Comments>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[National Energy Technology Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[National Renewable Energy Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Nevada Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Oak Ridge National Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Oak Ridge Operations Office]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Jennifer Hamilton]]></SourceUsername>
                  <SourceTitle><![CDATA[OR DPC]]></SourceTitle>
                  <SourceSite><![CDATA[Oak Ridge Operations Office]]></SourceSite>
               </Source>
               <Comments><![CDATA[This Major Issue is submitted by the ORO Subject Matter Expert and concurred in by Assistant Manager Environment, Safety, and Health.

Paragraph 2.a. 	Moving DOE O 414.1A Attachment 2 to a draft directive means that it is not in effect until issuance.  Please reissue the content of DOE O 414.1A Attachment 2 as a Notice until DOE M 414.1-1 is issued. (Major issue criterion: Accomplish policy objectives and mission)]]></Comments>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Oakland Operations Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Office of Energy Assurance]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Office of River Protection]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Ohio Field Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[OSTI]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Pacific Northwest National Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Pantex Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Portsmouth Paducah Project Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Princeton Plasma Physics Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Richland Operations Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Rocky Flats Field Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Sandia National Laboratories]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Sandia Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Savannah River EM Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Savannah River Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Southeastern Power Administration]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Southwestern Power Administration]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Stanford Linear Accelerator Center]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Stanford Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Thomas Jefferson National Accelerator Facility]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[University of California]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Wackenhut Services Inc (SRS)]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Wackenhut Services Inc. (Nevada)]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[West Valley Demonstration Project]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Western Area Power Administration]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Westinghouse Savannah River Corp.]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Westinghouse Savannah River Corp. for SR-EM]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[WIPP]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Y-12 (BWXT)]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Y-12 (WSI)]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Y-12 Site Office]]></OrganizationName>
            </Organization>
         </Section>
         <Section>
            <SectionTitle><![CDATA[3. Applicability]]></SectionTitle>
            <SectionContent><![CDATA[3.	APPLICABILITY.  
a.	DOE Elements.  Except for the exclusions in paragraph 3c, this Order applies to 
all DOE/NNSA elements (see Attachment 1).  


b.	Site/Facility Management Contractors.  
(1)	Except for the exclusions in paragraph 3c, the Contractor Requirements 
Document (CRD), Attachment 2, sets forth requirements of this Order that 
will apply to site/facility management contractors whose contracts include 
the CRD.  
(2)	This CRD must be included in site/facility management contracts that 
require or involve responsibility for work or operations at DOE sites or 
facilities.  This includes work that may take place outside the physical 
boundaries of a DOE facility or work performed by suppliers and 
subcontractors in support of operations.  Contractor compliance with the 
CRD will be required to the extent set forth in the CRD.  Contractors 
conducting activities or providing items or services that affect or may 
affect nuclear safety at DOE nuclear facilities must conduct work in 
accordance with the QA requirements of Title 10, Code of Federal 
Regulations (CFR) 830, Subpart A (the QA Rule).  
(3)	This Order does not automatically apply to other than site/facility 
management contractors.  Any application of requirements of this Order to 
other than site/facility management contractors will be communicated 
separately from this Order.  
(4)	Secretarial Officers (SOs) are responsible for telling contracting officers 
which site/facility management contractors are affected by this Order.  
Once notified, contracting officers are responsible for incorporating the 
CRD into the contracts of affected site/facility management contractors 
via the laws, regulations and DOE directives clause of the contracts.  
(5)	As the laws, regulations, and DOE directives clause of site/facility 
management contracts states, regardless of the performer of the work, 
site/facility management contractors with a CRD incorporated into their 
contracts are responsible for compliance with the requirements of the 
CRD.  
(a)	Affected site/facility management contractors are responsible for 
flowing down the requirements of this CRD to subcontractors at 
any tier to the extent necessary to ensure the site/facility 
management contractors' compliance with the requirements.  
(b)	Contractors must not flow down requirements to subcontractors 
unnecessarily or imprudently.  That is, contractors will
1	ensure that they and their subcontractors comply with the 
requirements of the CRD and
2	incur only costs that would be incurred by a prudent person 
in the conduct of competitive business.  
c.	Exclusions.   
(1)	This Order does not apply to the DOE/NNSA Naval Reactors Program in 
accordance with Executive Order 12344, statutorily prescribed by Public 
Law 98-525 [42 United States Code (U.S.C.) 7158, note].  
(2)	This Order does not apply to any work that is subject to the requirements 
imposed by QA regulations of DOE, the U.S. Nuclear Regulatory 
Commission, or any other Federal agency.  Work that may be subject to 
QA regulations and the requirements of this Order should be integrated 
and made consistent with all requirements.  [See QAP integration 
requirement, paragraph 4a(4).]

]]></SectionContent>
            <Organization>
               <OrganizationName><![CDATA[Ames Labortatory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Argonne National Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Associate Manager for Science & Technology, Richland]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Bechtel Hanford]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Bechtel Nevada]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Berkeley Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Bonneville Power Administration]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Brookhaven National  Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[BWXT Pantex, LLC]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Carlsbad Area Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Carlsbad Field Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[CH2MHill]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Chicago Operations Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Critique]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Departmental Representatives Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Directives Management Team]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[DynMcDermott Petroleum Operations]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Fermi National Accelerator Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Fernald]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Fluor Hanford Inc]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Golden Field Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Grand Junction]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters CI]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters CIO]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters CN]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters CR]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters ED]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters EE]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters EH]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters EIA]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters EM]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Joni Boone]]></SourceUsername>
                  <SourceTitle><![CDATA[EM DPC]]></SourceTitle>
                  <SourceSite><![CDATA[Headquarters EM]]></SourceSite>
               </Source>
               <Comments><![CDATA[Linda C. Wright (SRO EM DPC) for Savannah River EM Office


Delegate GROSSO,  VINCENT  J for Westinghouse Savannah River Corp. for SR-EM
2) 414.1A , Section 3, titled "Applicability" second section d. titled "Other Quality Requirements"  states; "Some portions of DOE work are subject to regulation by quality assurance requirements for the NRC, and NRC Agreement State, the Environmental Protection Agency, DOE (10CFR830.120), or other government agencies.  This Order applies to those portions of the work that are not so regulated. Will this exemption still be permitted under the new order?



Joanne Shadel (RL DPC) for Richland Operations Office
RL states: The DOE QA Rule applies to nuclear/radiological facilities whereas the Order (414.1) applies to non-nuclear activities.  DOE O 414.1B incorporates the suspect/counterfeit items (S/CI) requirements that are presently in DOE O 440.1, Worker Safety, with an apparent plan to delete the S/CI requirements from 440.  As presently written in 414.1B and since the QA Rule does not address S/CI, DOE will no longer have S/CI requirements for nuclear/radiological facilities/activities.  Recommend either incorporating S/CI requirements into the QA Rule or making changes to the Order that make it clear that the S/CI requirements apply to nuclear/radiological facilities/activities. <b> Failure to resolve this issue will jeopardize DOE's ability to accomplish policy objectives and missions. </b> <i. Jean F Schwier, Acting Deputy Manager authorizes this comment. </i>

Dixie Evans (ID-EM DPC) for Idaho Operations Office-EM
3.b.(4) - Change 'telling' to 'notifying'.  Information of this significance should be transmitted formally.

(Comments submitted by R.L. Blyth, ID OPI, and approved by R.L. Green, Acting Deputy Manager, Technical Support)

Subject Matter Expert tom.wright@em.doe.gov
3.c.2 Excusion statement "This Order does not apply to any work that is subject to the requirements imposed by QA regulations of DOE, ..." is contradictory to the intent of the Order.  The "DOE" reference must be removed or reworded to clarify the intent of the phrase.]]></Comments>
               <Response>
                  <ResponseLevel><![CDATA[Accepted with Modification]]></ResponseLevel>
                  <ResponseContent><![CDATA[Linda C. Wright (SRO EM DPC) for Savannah River EM Office Delegate GROSSO, VINCENT J for Westinghouse Savannah River Corp. for SR-EM 2) 414.1A , Section 3, titled "Applicability" second section d. titled "Other Quality Requirements" states; "Some portions of DOE work are subject to regulation by quality assurance requirements for the NRC, and NRC Agreement State, the Environmental Protection Agency, DOE (10CFR830.120), or other government agencies. This Order applies to those portions of the work that are not so regulated. Will this exemption still be permitted under the new order?

Response  Accept w/mod  The text will be clarified to make the following points:  This Order does not supersede DOE regulations or external regulations regarding QAPs.  Where multiple QAP requirements exist, this Order requires that they be integrated so that effective and efficient management systems are established.  This Order does include requirements that apply to certain types of work that may be conducted under a QAP established for regulatory compliance (i.e., Suspect/Counterfeit Items Protection).  These activity-specific requirements do not affect the regulatory QAP requirements.  This is consistent with our current practice for other work activities, such as nuclear facility maintenance, which is subject to the DOE QA rule, yet the detailed requirements are defined in an Order.   [OPI NOTE: These comments were copied from the Overall Comments section of REVCOM] 

Linda C. Wright (SRO EM DPC) for Savannah River EM Office Delegate GROSSO, VINCENT J for Westinghouse Savannah River Corp. for SR-EM 

4)	With the exception of the portion dealing with suspect/counterfeit parts, is it DOE's intent that any other portion of the Order be made applicable to facilities/activities already required to meet 10CFR830, Subpart A? 
Response  Accept w/mod Section - The text will be clarified to make the following points:  This Order does not supersede DOE regulations or external regulations regarding QAPs.  Where multiple QAP requirements exist, this Order requires that they be integrated so that effective and efficient management systems are established.  This Order does include requirements that apply to certain types of work that may be conducted under a QAP established for regulatory compliance (i.e., Suspect/Counterfeit Items Protection).  These activity-specific requirements do not affect the regulatory QAP requirements.  This is consistent with our current practice for other work activities, such as nuclear facility maintenance, which is subject to the DOE QA rule, yet the detailed requirements are defined in an Order.   

5)	DOE O 414.1B Draft states that it cancels 414.1A. It states that part of 414.1A is being moved to another draft (DOE M 414.1 - 1, Corrective Action Management Program). Neither document lists the Applicability section as 414.1A does. 414.1B does state that it is applicable to DOE National Nuclear Security Administration (NNSA) and Attachment 1 lists the applicability for organizations. It does include the Office of Environment, Safety and Health. What it does not do is state the exclusions as 414.1A did. Is there any intent for this Order to list the exclusions as 414.1A did. It clarifies the topic and takes away any concern for interpretation. 

Response  Accept w/mod  The text will be clarified to make the following points:  This Order does not supersede DOE regulations or external regulations regarding QAPs.  Where multiple QAP requirements exist, this Order requires that they be integrated so that effective and efficient management systems are established.  This Order does include requirements that apply to certain types of work that may be conducted under a QAP established for regulatory compliance (i.e., Suspect/Counterfeit Items Protection).  These activity-specific requirements do not affect the regulatory QAP requirements.  This is consistent with our current practice for other work activities, such as nuclear facility maintenance, which is subject to the DOE QA rule, yet the detailed requirements are defined in an Order.   

Joanne Shadel (RL DPC) for Richland Operations Office RL states: The DOE QA Rule applies to nuclear/radiological facilities whereas the Order (414.1) applies to non-nuclear activities. DOE O 414.1B incorporates the suspect/counterfeit items (S/CI) requirements that are presently in DOE O 440.1, Worker Safety, with an apparent plan to delete the S/CI requirements from 440. As presently written in 414.1B and since the QA Rule does not address S/CI, DOE will no longer have S/CI requirements for nuclear/radiological facilities/activities. Recommend either incorporating S/CI requirements into the QA Rule or making changes to the Order that make it clear that the S/CI requirements apply to nuclear/radiological facilities/activities. Failure to resolve this issue will jeopardize DOE's ability to accomplish policy objectives and missions. 

Response  Accept w/mod  The text will be clarified to make the following points:  This Order does not supersede DOE regulations or external regulations regarding QAPs.  Where multiple QAP requirements exist, this Order requires that they be integrated so that effective and efficient management systems are established.  This Order does include requirements that apply to certain types of work that may be conducted under a QAP established for regulatory compliance (i.e., Suspect/Counterfeit Items Protection).  These activity-specific requirements do not affect the regulatory QAP requirements.  This is consistent with our current practice for other work activities, such as nuclear facility maintenance, which is subject to the DOE QA rule, yet the detailed requirements are defined in an Order.   

Dixie Evans (ID-EM DPC) for Idaho Operations Office-EM 3.b.(4) - Change 'telling' to 'notifying'. Information of this significance should be transmitted formally. (Comments submitted by R.L. Blyth, ID OPI, and approved by R.L. Green, Acting Deputy Manager, Technical Support) 

Response -  Accept

Subject Matter Expert tom.wright@em.doe.gov 3.c.2 Excusion statement "This Order does not apply to any work that is subject to the requirements imposed by QA regulations of DOE, ..." is contradictory to the intent of the Order. The "DOE" reference must be removed or reworded to clarify the intent of the phrase.

Response  Accept w/mod  The text will be clarified to make the following points:  This Order does not supersede DOE regulations or external regulations regarding QAPs.  Where multiple QAP requirements exist, this Order requires that they be integrated so that effective and efficient management systems are established.  This Order does include requirements that apply to certain types of work that may be conducted under a QAP established for regulatory compliance (i.e., Suspect/Counterfeit Items Protection).  These activity-specific requirements do not affect the regulatory QAP requirements.  This is consistent with our current practice for other work activities, such as nuclear facility maintenance, which is subject to the DOE QA rule, yet the detailed requirements are defined in an Order.   The DOE QA rule includes a maintenance requirement that is supplemented by detailed requirements in an Order.    
]]></ResponseContent>
               </Response>
               <Concurrence><![CDATA[Concur/No Comment]]></Concurrence>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters FE]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters GC]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Richard Farman]]></SourceUsername>
                  <SourceTitle><![CDATA[GC DPC]]></SourceTitle>
                  <SourceSite><![CDATA[Headquarters GC]]></SourceSite>
               </Source>
               <Comments><![CDATA[

Subject Matter Expert laura.fullerton@hq.doe.gov
Comments provided by email.

]]></Comments>
               <Response>
                  <ResponseLevel><![CDATA[Accepted with Modification]]></ResponseLevel>
                  <ResponseContent><![CDATA[See GC comment and OPI response in Attachment 3]]></ResponseContent>
               </Response>
               <Concurrence><![CDATA[Concur/No Comment]]></Concurrence>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters HG]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters IG]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters IN]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters LM]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters MBE]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters NA]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Diane Gillis]]></SourceUsername>
                  <SourceTitle><![CDATA[NA Directives Point of Contact]]></SourceTitle>
                  <SourceSite><![CDATA[Headquarters NA]]></SourceSite>
               </Source>
               <Comments><![CDATA[Comment:  Contractors conducting activities or providing items or services that affect or may affect nuclear safety at (the word in the Rule is "of") DOE nuclear facilities must conduct work in accordance with the QA requirements of Title 10, Code of Federal Regulations (CFR) 830, Subpart A (the QA Rule).  Seems like this statement should be reserved for the contract and not be included in this directive: 2 incur only costs that would be incurred by a prudent person in the conduct of competitive business.  (SME/Joel Smith, NA-121.3)

Comment:  
•	3. b. (5) (b)"Contractors must not flow down requirements to subcontractors unnecessarily or imprudently." - Vague 
•	3. b. (5) (b) 1."ensure that they and their subcontractors comply with the requirements of the CRD and" 
•	3. b. (5) (b) 2."Incur costs that would be incurred by a prudent person in the conduct of competitive business." - requirements should be "SMART" (simple, measurable, achievable, realistic, time-bound) if you want to be able to trace and track effective implementation. How would someone measure "prudent" in the conduct of "competitive business"?
(Los Alamos/Griego - SME Peterson)

Comment:  Paragraph c(2) states that this order does not apply to any work subject to DOE QA regulations. Isn't this order by definition a DOE QA regulation?  The wording implies that DOE has placed itself in a catch-22 and should be re-worded to make the intent clear.  (Los Alamos/Griego - SME/Baker) 

Comment:  Section 3.c., 2nd Sentence.  Delete this sentence.  This sentence does not identify exclusions and does not make sense for an exclusion section. (Sandia/Martinez - SME/Dilley)]]></Comments>
               <Response>
                  <ResponseLevel><![CDATA[Accepted with Modification]]></ResponseLevel>
                  <ResponseContent><![CDATA[Comment: Contractors conducting activities or providing items or services that affect or may affect nuclear safety at (the word in the Rule is "of") DOE nuclear facilities must conduct work in accordance with the QA requirements of Title 10, Code of Federal Regulations (CFR) 830, Subpart A (the QA Rule). Seems like this statement should be reserved for the contract and not be included in this directive: 2 incur only costs that would be incurred by a prudent person in the conduct of competitive business. (SME/Joel Smith, NA-121.3) 

Response  Accept w/mod  The text will be clarified to make the following points:  This Order does not supersede DOE regulations or external regulations regarding QAPs.  Where multiple QAP requirements exist, this Order requires that they be integrated so that effective and efficient management systems are established.  This Order does include requirements that apply to certain types of work that may be conducted under a QAP established for regulatory compliance (i.e., Suspect/Counterfeit Items Protection).  This is consistent with our current practice for other work activities, such as nuclear facility maintenance.   The DOE QA rule includes a maintenance requirement that is supplemented by detailed requirements in an Order.    

Comment: • 3. b. (5) (b)"Contractors must not flow down requirements to subcontractors unnecessarily or imprudently." - Vague • 3. b. (5) (b) 1."ensure that they and their subcontractors comply with the requirements of the CRD and" • 3. b. (5) (b) 2."Incur costs that would be incurred by a prudent person in the conduct of competitive business." - requirements should be "SMART" (simple, measurable, achievable, realistic, time-bound) if you want to be able to trace and track effective implementation. How would someone measure "prudent" in the conduct of "competitive business"? (Los Alamos/Griego - SME Peterson) 

Response  Accept w/Mod  This text is provided by the Departments Directives Management team in accordance with M 251.1, and the latest version must be used as provided. 

Comment: Paragraph c(2) states that this order does not apply to any work subject to DOE QA regulations. Isn't this order by definition a DOE QA regulation? The wording implies that DOE has placed itself in a catch-22 and should be re-worded to make the intent clear. (Los Alamos/Griego - SME/Baker) 

Response  Accept w/mod  The text will be clarified to make the following points:  This Order does not supersede DOE regulations or external regulations regarding QAPs.  Where multiple QAP requirements exist, this Order requires that they be integrated so that effective and efficient management systems are established.  This Order does include requirements that apply to certain types of work that may be conducted under a QAP established for regulatory compliance (i.e., Suspect/Counterfeit Items Protection).  This is consistent with our current practice for other work activities, such as nuclear facility maintenance.   The DOE QA rule includes a maintenance requirement that is supplemented by detailed requirements in an Order.    


Comment: Section 3.c., 2nd Sentence. Delete this sentence. This sentence does not identify exclusions and does not make sense for an exclusion section. (Sandia/Martinez - SME/Dilley)

Response  Accept w/mod  The text will be clarified to make the following points:  This Order does not supersede DOE regulations or external regulations regarding QAPs.  Where multiple QAP requirements exist, this Order requires that they be integrated so that effective and efficient management systems are established.  This Order does include requirements that apply to certain types of work that may be conducted under a QAP established for regulatory compliance (i.e., Suspect/Counterfeit Items Protection).  This is consistent with our current practice for other work activities, such as nuclear facility maintenance.   The DOE QA rule includes a maintenance requirement that is supplemented by detailed requirements in an Order.    
]]></ResponseContent>
               </Response>
               <Concurrence><![CDATA[Concur/No Comment]]></Concurrence>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters NE]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Barbara Cramer]]></SourceUsername>
                  <SourceTitle><![CDATA[NE DPC]]></SourceTitle>
                  <SourceSite><![CDATA[Headquarters NE]]></SourceSite>
               </Source>
               <Comments><![CDATA[Dixie Evans (ID DPC) for Idaho Operations Office
3.b.(4) - Change 'telling' to 'notifying'.  Information of this significance should be transmitted formally.

(Comments submitted by R.L. Blyth, ID OPI, and approved by R.L. Green, Acting Deputy Manager, Technical Support)]]></Comments>
               <Response>
                  <ResponseLevel><![CDATA[Accepted with Modification]]></ResponseLevel>
                  <ResponseContent><![CDATA[Response  This text is provided by the Departments Directives Management (ME-43) team in accordance with M 251.1, and must be used as provided. The latest version from ME-43 will be used.

]]></ResponseContent>
               </Response>
               <Concurrence><![CDATA[Concur/No Comment]]></Concurrence>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters NTEU]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters OA]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters OPI]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters PC-1]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters PO]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters RW]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters SC]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Headquarters SO]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Honeywell FM&T (Kansas City Plant)]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Idaho Operations Office]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Karen Moses]]></SourceUsername>
                  <SourceTitle><![CDATA[ID DPC]]></SourceTitle>
                  <SourceSite><![CDATA[Idaho Operations Office]]></SourceSite>
               </Source>
               <Comments><![CDATA[3.b.(4) - Change 'telling' to 'notifying'.  Information of this significance should be transmitted formally.

(Comments submitted by R.L. Blyth, ID OPI, and approved by R.L. Green, Acting Deputy Manager, Technical Support)]]></Comments>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Idaho Operations Office-EM]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Karen Moses]]></SourceUsername>
                  <SourceTitle><![CDATA[ID-EM DPC]]></SourceTitle>
                  <SourceSite><![CDATA[Idaho Operations Office-EM]]></SourceSite>
               </Source>
               <Comments><![CDATA[3.b.(4) - Change 'telling' to 'notifying'.  Information of this significance should be transmitted formally.

(Comments submitted by R.L. Blyth, ID OPI, and approved by R.L. Green, Acting Deputy Manager, Technical Support)]]></Comments>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[INL - NE]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[INL-ICP-EM]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Kaiser-Hill Company, LLC]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Dan Mayfield]]></SourceUsername>
                  <SourceTitle><![CDATA[Kaiser-Hill DPC]]></SourceTitle>
                  <SourceSite><![CDATA[Kaiser-Hill Company, LLC]]></SourceSite>
               </Source>
               <Comments><![CDATA[Two comments from QA Program Manager
1. Scope and Applicability Conflicts within the Document and 10 CFR 830 Subpart A.  
This directive explicitly excludes “… work that is subject to the requirements imposed by QA regulations of DOE…” (DOE 414.1B 3(c) (2)), but addresses the same scope as 10 CFR 830 Subpart A for activities that affect DOE nuclear facilities.  It then imposes requirements in excess of or in conflict with the regulation:
A. The directive imposes specific standards for use for nuclear-related hazard and non-nuclear activities; whereas 10 CFR 830.121 (b) (3) directs the use of  “…voluntary consensus standards in its development and implementation, where practicable and consistent with contractual and regulatory requirements (emphasis added)…”.  Thus a 10 CFR 830-compliant QAP could be in violation of the draft directive should the contractor choose other standards.  The selection of standards for nuclear-related work directly conflicts with the exclusion cited above.
B. The directive requires the contractor to integrate its quality or management systems requirements with:
(1) the DOE Corrective Actions Manual DOE M 414.1-1 (Draft), when previous versions of that document have only applied to DOE; this would have the effect of imposing a specific corrective action process on the contractor rather that may not meet the 10 CFR 830 Subpart A requirements
(2) Office of Civilian Radioactive Waste Management requirement RW-0333P, when that document applies to nuclear-related activities (see above) and NOT to all DOE sites (RW-0333P is for Yucca Mountain-related activities)

2. Scope and Applicability Conflicts with Other DOE Directives

This directive requires the consideration of quality guidance that includes DOE G440.1-6 Implementation Guide for Use with Suspect/Counterfeit Items Requirements of DOE O 440.1… . The definitions of ‘suspect/counterfeit’ and ‘defective material’ in the guide conflict with those contained in DOE M 231.1, Environment, Safety, and Health Reporting.  


These comments address issues that preclude or hamper the Department’s ability to accomplish its objectives and missions because multiple, overlapping jurisdictional issues for quality systems applications could lead to systematic weakness and failures in the quality programs of contractors and thus their mission achievement.]]></Comments>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Kansas City Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Lawrence Berkeley Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Lawrence Livermore National Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Livermore Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Los Alamos National Laboratory]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Yvonne Salaz]]></SourceUsername>
                  <SourceTitle><![CDATA[LANL DPC]]></SourceTitle>
                  <SourceSite><![CDATA[Los Alamos National Laboratory]]></SourceSite>
               </Source>
               <Comments><![CDATA[Subject Matter Expert mpeterson@lanl.gov
3. b. (5) (b)"Contractors must not 
flow down requirements to subcontractors unnecessarily or 
imprudently."  
- Vague

3. b. (5) (b) 1."ensure that they and 
their subcontractors comply with the 
requirements of the CRD and"
3. b. (5) (b) 2."Incur costs that would 
be incurred by a prudent person in 
the conduct of competitive business."  
- requirements should be "SMART"  
(simple, measurable, achievable, 
realistic, time-bound) if you want to 
be able to trace and track effective 
implementation. How would someone measure "prudent" in the conduct of "competitive business"?

Subject Matter Expert mcbaker@lanl.gov Paragraph c(2) states that this order does not apply to any work subject to DOE QA regulations. Isn't this order by definition a DOE QA regulation? The wording implies that DOE has placed itself in a catch-22 and should be re-worded to make the intent clear.]]></Comments>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Los Alamos Site Office]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Myra Garcia-Pena]]></SourceUsername>
                  <SourceTitle><![CDATA[LASO DPC]]></SourceTitle>
                  <SourceSite><![CDATA[Los Alamos Site Office]]></SourceSite>
               </Source>
               <Comments><![CDATA[

Yvonne Salaz (LANL DPC) for Los Alamos National Laboratory
Subject Matter Expert mpeterson@lanl.gov
3. b. (5) (b)"Contractors must not 
flow down requirements to subcontractors unnecessarily or 
imprudently."  
- Vague

3. b. (5) (b) 1."ensure that they and 
their subcontractors comply with the 
requirements of the CRD and"
3. b. (5) (b) 2."Incur costs that would 
be incurred by a prudent person in 
the conduct of competitive business."  
- requirements should be "SMART"  
(simple, measurable, achievable, 
realistic, time-bound) if you want to 
be able to trace and track effective 
implementation. How would someone measure "prudent" in the conduct of "competitive business"?

Subject Matter Expert mcbaker@lanl.gov Paragraph c(2) states that this order does not apply to any work subject to DOE QA regulations. Isn't this order by definition a DOE QA regulation? The wording implies that DOE has placed itself in a catch-22 and should be re-worded to make the intent clear.

]]></Comments>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[NA Service Center]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[National Energy Technology Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[National Renewable Energy Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Nevada Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Oak Ridge National Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Oak Ridge Operations Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Oakland Operations Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Office of Energy Assurance]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Office of River Protection]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Ohio Field Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[OSTI]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Pacific Northwest National Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Pantex Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Portsmouth Paducah Project Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Princeton Plasma Physics Laboratory]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Richland Operations Office]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Joanne Shadel]]></SourceUsername>
                  <SourceTitle><![CDATA[RL DPC]]></SourceTitle>
                  <SourceSite><![CDATA[Richland Operations Office]]></SourceSite>
               </Source>
               <Comments><![CDATA[RL states: The DOE QA Rule applies to nuclear/radiological facilities whereas the Order (414.1) applies to non-nuclear activities.  DOE O 414.1B incorporates the suspect/counterfeit items (S/CI) requirements that are presently in DOE O 440.1, Worker Safety, with an apparent plan to delete the S/CI requirements from 440.  As presently written in 414.1B and since the QA Rule does not address S/CI, DOE will no longer have S/CI requirements for nuclear/radiological facilities/activities.  Recommend either incorporating S/CI requirements into the QA Rule or making changes to the Order that make it clear that the S/CI requirements apply to nuclear/radiological facilities/activities. <b> Failure to resolve this issue will jeopardize DOE's ability to accomplish policy objectives and missions. </b> <i. Jean F Schwier, Acting Deputy Manager authorizes this comment. </i>]]></Comments>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Rocky Flats Field Office]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Tom Lukow]]></SourceUsername>
                  <SourceTitle><![CDATA[RFFO DPC]]></SourceTitle>
                  <SourceSite><![CDATA[Rocky Flats Field Office]]></SourceSite>
               </Source>
               <Comments><![CDATA[The RFFO SME provided the following evaluation of the Contractor's comment and concurs in part with the Major Comment 

â€¢	As far as the comments go, I disagree with the first statement regarding scope and applicability under Comment #1.  
   The application of the Order versus the Rule isnâ€™t confusing as I read the draft Order.  The same requirements apply to all work. Itâ€™s a matter of grading their application (nuclear vs. non-nuclear) and then what can be enforced under the Rule.

â€¢	I do agree that it goes on to impose additional requirements in excess or conflict with the regulation.
   Part A â€“ I do agree with this statement, the language should include a statement along the lines of â€œsuch asâ€ when referring to the identified national consensus standards.

â€¢	I agree with the statement as written under Part B.  The way the paragraph starts out it talks about applying national consensus standards under 1. a. (2), but then goes on to (e) which makes DOE M414.1-1, OCRWM RW-0333P and the others appear mandatory. It looks like something is missing from this paragraph {between 2 (a-d) and (e)} as it is currently written. 

Both this major comment and the suggested comment have been reviewed by the Manager, RFFO and he has provided concurrence by E:Mail to the RFFO DPC.

Dan Mayfield (Kaiser-Hill DPC) for Kaiser-Hill Company, LLC
Two comments from QA Program Manager
1. Scope and Applicability Conflicts within the Document and 10 CFR 830 Subpart A.  
This directive explicitly excludes â€œâ€¦ work that is subject to the requirements imposed by QA regulations of DOEâ€¦â€ (DOE 414.1B 3(c) (2)), but addresses the same scope as 10 CFR 830 Subpart A for activities that affect DOE nuclear facilities.  It then imposes requirements in excess of or in conflict with the regulation:
A. The directive imposes specific standards for use for nuclear-related hazard and non-nuclear activities; whereas 10 CFR 830.121 (b) (3) directs the use of  â€œâ€¦voluntary consensus standards in its development and implementation, where practicable and consistent with contractual and regulatory requirements (emphasis added)â€¦â€.  Thus a 10 CFR 830-compliant QAP could be in violation of the draft directive should the contractor choose other standards.  The selection of standards for nuclear-related work directly conflicts with the exclusion cited above.
B. The directive requires the contractor to integrate its quality or management systems requirements with:
(1) the DOE Corrective Actions Manual DOE M 414.1-1 (Draft), when previous versions of that document have only applied to DOE; this would have the effect of imposing a specific corrective action process on the contractor rather that may not meet the 10 CFR 830 Subpart A requirements
(2) Office of Civilian Radioactive Waste Management requirement RW-0333P, when that document applies to nuclear-related activities (see above) and NOT to all DOE sites (RW-0333P is for Yucca Mountain-related activities)

2. Scope and Applicability Conflicts with Other DOE Directives

This directive requires the consideration of quality guidance that includes DOE G440.1-6 Implementation Guide for Use with Suspect/Counterfeit Items Requirements of DOE O 440.1â€¦ . The definitions of â€˜suspect/counterfeitâ€™ and â€˜defective materialâ€™ in the guide conflict with those contained in DOE M 231.1, Environment, Safety, and Health Reporting.  


These comments address issues that preclude or hamper the Departmentâ€™s ability to accomplish its objectives and missions because multiple, overlapping jurisdictional issues for quality systems applications could lead to systematic weakness and failures in the quality programs of contractors and thus their mission achievement.

Dan Mayfield (Kaiser-Hill DPC) for Kaiser-Hill Company, LLC
Two comments from QA Program Manager
1. Scope and Applicability Conflicts within the Document and 10 CFR 830 Subpart A.  
This directive explicitly excludes “… work that is subject to the requirements imposed by QA regulations of DOE…” (DOE 414.1B 3(c) (2)), but addresses the same scope as 10 CFR 830 Subpart A for activities that affect DOE nuclear facilities.  It then imposes requirements in excess of or in conflict with the regulation:
A. The directive imposes specific standards for use for nuclear-related hazard and non-nuclear activities; whereas 10 CFR 830.121 (b) (3) directs the use of  “…voluntary consensus standards in its development and implementation, where practicable and consistent with contractual and regulatory requirements (emphasis added)…”.  Thus a 10 CFR 830-compliant QAP could be in violation of the draft directive should the contractor choose other standards.  The selection of standards for nuclear-related work directly conflicts with the exclusion cited above.
B. The directive requires the contractor to integrate its quality or management systems requirements with:
(1) the DOE Corrective Actions Manual DOE M 414.1-1 (Draft), when previous versions of that document have only applied to DOE; this would have the effect of imposing a specific corrective action process on the contractor rather that may not meet the 10 CFR 830 Subpart A requirements
(2) Office of Civilian Radioactive Waste Management requirement RW-0333P, when that document applies to nuclear-related activities (see above) and NOT to all DOE sites (RW-0333P is for Yucca Mountain-related activities)

2. Scope and Applicability Conflicts with Other DOE Directives

This directive requires the consideration of quality guidance that includes DOE G440.1-6 Implementation Guide for Use with Suspect/Counterfeit Items Requirements of DOE O 440.1… . The definitions of ‘suspect/counterfeit’ and ‘defective material’ in the guide conflict with those contained in DOE M 231.1, Environment, Safety, and Health Reporting.  


These comments address issues that preclude or hamper the Department’s ability to accomplish its objectives and missions because multiple, overlapping jurisdictional issues for quality systems applications could lead to systematic weakness and failures in the quality programs of contractors and thus their mission achievement.]]></Comments>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Sandia National Laboratories]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Sandia Site Office]]></OrganizationName>
            </Organization>
            <Organization>
               <OrganizationName><![CDATA[Savannah River EM Office]]></OrganizationName>
               <Source>
                  <SourceUsername><![CDATA[Linda C. Wright]]></SourceUsername>
                  <SourceTitle><![CDATA[SRO EM DPC]]></SourceTitle>
                  <SourceSite><![CDATA[Savannah River EM Office]]></SourceSite>
               </Source>
               <Comments><![CDATA[

Delegate GROSSO,  VINCENT  J for Westinghouse Savannah River Corp. for SR-EM
2) 414.1A , Section 3, titled "Applicability" second section d. titled "Other Quality Requirements"  states; "Some portions of DOE work are subject to regulation by quality assurance requirements for the NRC, and NRC Agreement State, the Environmental Protection Agency, DOE (10CFR830.120), or other government agencies.  This Order applies to those portions of the work that are not so regulated. Will this exemption still be