80JSC018R0007,_Applicable_Documents_2.pdf

HHP 10050

Document Management Handbook Human Health and Performance Directorate

OPEN TO JSC AND JSC CONTRACTOR EMPLOYEES & OTHER

NASA AND NASA CONTRACTOR EMPLOYEES, AS REQUIRED

CCB Controlled (HHP CB)

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Revision C

September 2014

National Aeronautics and Space Administration Lyndon B. Johnson Space Center Houston, Texas

Human Health and Performance Directorate

Document Management Handbook Document: HHP 10050 Rev C Date: 09/2014 Page: 2

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NASA APPROVAL SHEET

Document Management Handbook Health and Human Performance Directorate

PREPARED BY:

Sarah Koctar DATE Document Management Specialist Human Health and Performance Directorate

APPROVED:

Carol Coats Beal DATE Configuration Management Lead Human Health and Performance Directorate

APPROVED:

Jeffrey R. Davis, M. D. DATE Director, Human Health and Performance Directorate

NATIONAL AERONAUTICS AND SPACE ADMINISTRATION

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CHANGE HISTORY

REVISION/

CHANGE DATE AUTHORIZATION DESCRIPTION OF CHANGE

BASELINE 08/24/12 DIR HSCB 12 005 Initial Release, (published as HHPD 10050)

A 12/19/12 DIR HHPCB 12 004 Document title updated to remove duplication, document number changed to HHP 10050, updated control board to HHP CB, separated signature page to reflect contractor versus NASA signatories, modified format of Change History Log, acronym “HHPD” changed to “HHP,” acronym Document Change Notice (DCN) changed to Page Change Notice (PCN), changed font to Calibri, added missing acronyms to the acronyms list, moved Responsibility and Change authority under section 1.4, updated Figure 4 1 to reflect updates to export control process, updated section 4.3 to add sections 4.3.1 and 4.3.2, added Template to Appendix A (previously TBD), added Appendices B and C.

B 01/14/2014 HHP_CB 13 008 Document title has been updates. The entire document has been reworded to coordinate with the Industry standard of Document Management.

Information to include the integration with other roles. Document Template updated.

C 09/19/2014 HHP_CB 13 008 R1 New section added – Section 4.1. Updates to the HHP Document Template. Updates to Appendices

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TABLE OF CONTENTS

1.0 INTRODUCTION

1.1 SCOPE AND PURPOSE OF DOCUMENT MANAGEMENT

1.2 BENEFITS OF DOCUMENT MANAGEMENT

1.3 RESPONSIBILITY AND CHANGE AUTHORITY

2.0 DOCUMENTS

2.1 VERB APPLICATION

2.2 APPLICABLE DOCUMENTS

2.3 REFERENCE DOCUMENTS

3.0 PLANNING FOR DOCUMENT MANAGEMENT

3.1 SCOPE OF THE DM PROCESS

3.2 ROLES AND RESPONSIBILITIES

3.3 DM INTEGRATED PROCESS FLOW CHART

3.4 RELATIONSHIP OF DM TO OTHER FUNCTIONAL ACTIVITIES

4.0 HHP DOCUMENT MANAGEMENT PROCESS AND PROCEDURES

4.1 DOCUMENT TEMPLATE APPLICABILITY

4.2 DOCUMENT TYPES

4.3 DOCUMENT NUMBERING SYSTEM

4.4 DMMANDATORY EVALUATOR FOR HHP BOARDS

4.5 DM APPLICABLE DOCUMENT LIST

4.6 PROCESSING VIA CONTROL BOARD

4.7 DOCUMENT MARKINGS

4.8 RECORDS RETENTION

4.9 RETIREMENT AND CANCELLATION OF DOCUMENTS

5.0 DOCUMENT MANAGEMENT SHAREPOINT SITE

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APPENDICES

APPENDIX A – ACRONYMS AND ABBREVIATION

APPENDIX B – HHP DOCUMENT TEMPLATE INSTRUCTIONS

APPENDIX C – HHP DOCUMENT TEMPLATE

APPENDIX D – FORMS

LIST OF FIGURES

FIGURE 1.1 1 DM INTEGRATION FLOW CHART

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1.0 INTRODUCTION

Document Management (DM) is a process to ensure that data and information are available and usable when needed. DM comprises the activities needed to plan, develop, implement, and administer systems for the acquisition, storage, and retrieval of documentation. The guidance provided in this handbook will take precedence in the absence of a formal structure/format in the creation of a new HHP Document.

1.1 SCOPE AND PURPOSE OF DOCUMENT MANAGEMENT

This handbook documents the DM processes prescribed by HHP. The processes and procedures detailed within are designed to organize, control, and assure accessibility to HHP documents and to be used by all National Aeronautics and Space Administration (NASA) organizations participating in HHP projects and NASA contractors supporting HHP. This document provides all HHP participants with guidance on how to comply with the requirements and procedures for HHP Document Management.

1.2 BENEFITS OF DOCUMENT MANAGEMENT

DM shall conduct activities according to the principles of ANSI/GEIA 859, Implementation Guide for Data Management. DM will reduce the risk of not having documentation available when and where needed. Having the correct documentation available supports better decision making, supports faster decision processes, provides current information, and facilitates collaboration among customers and suppliers. It offers a wide range of benefits that contribute to improvements, cost, schedule, performance, and support of complex engineered systems. DM shall safeguard the integrity of the documents regardless of the physical location. DM shall control the digital format and procedures necessary to exchange, index, store, and distribute or provide access to the documents.

1.3 RESPONSIBILITY AND CHANGE AUTHORITY

This document shall be prepared and maintained in accordance with SA WI 001, Human Health and Performance Directorate Master Work Instruction. The responsibility for the development of this document lies with the Business and Institutional Management Office (SA4). The Human Health and Performance Control Board (HHP CB) is the responsible authority for managing changes to this document. Proposed changes shall be submitted in accordance with the Change Request (CR) process described in JSC 28330, Human Health and Performance Directorate Configuration Control Management Plan.

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2.0 DOCUMENTS

In the event of a conflict between this document and JPR 1281.5B, Document and Data Control, referenced in Section 2.2, Applicable Documents, the requirements in JPR 1281.5B shall take precedence.

2.1 VERB APPLICATION

In the context of this document the use of the verb “shall” indicates a requirement. Use of the verb “should” or “will” does not impose a binding requirement. For example, on standards published by the American Society for Testing and Materials, requirements with “shall” is a mandatory requirement, meaning, “must”, or “have to”. “Shall” is the term denoting absolute requirements and “should” or “will” as denoting a somewhat flexible requirement.

2.2 APPLICABLE DOCUMENTS

The following documents include specifications, models, standards, guidelines, handbooks, and other special publications. The documents listed in this paragraph are applicable to the extent specified herein. Applicable documents consist of documents that contain provisions or other pertinent requirements directly related to and necessary for the performance of the activities specified by the document. Applicable documents for requirements mandated by a project, governed by SA and for SA or others, in terms of both activities and deliverables should be included in the Applicable list.

Document No. Title

ANSI/GEIA 859 Implementation Guide for Data Management

JPR 1281.5B Document and Data Control

JSC 28225 Human Health and Performance Directorate Certification of Flight Readiness (CoFR) Implementation Plan

JSC 28330F Human Health and Performance Directorate Configuration Management Plan

JWI 2190.1B JSC Export Compliance

NF 1686 Sensitive But Unclassified (SBU)

NPR 1441.1D NASA Records Retention Schedules

NPR 1600.1 NASA Security Program Procedural Requirements w/Change 2

SA WI 001 Human Health and Performance Directorate Master Work Instruction

SA WI 025 Human Health and Performance Directorate Export Control Processes

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2.3 REFERENCE DOCUMENTS

The following documents contain supplemental information to guide the user in the application of this document. These reference documents may or may not be specifically cited within the text of this document.

Document No. Title

American Society for Testing and Materials

I5 CFR 730 774 U.S. Department of Commerce Export Administration Regulations

22 CFR 120 130 U.S. Department of State International Traffic in Arms Regulations

36 CFR Parts 1220 and

Code of Federal Regulations, Chapter XII—National Archives and Records Administration

GPO 2000 Government Printing Office Style Manual 2000

JPD 2200.1 Release of JSC Scientific and Technical Information to External Audiences, latest version

JPD 1280.1A Quality Policy

JPR 1440.3C JSC Records Management Procedural Requirements

JWI 1282.1A Organizational Master List Instructions

NPD 1440.6H NASA Records Management (w/Change 5, 6/26/09)

NPR 1450.10D NASA Correspondence Management and Communications Standards and Style w/Change 2 (1/21/2011)

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3.0 PLANNING FOR DOCUMENT MANAGEMENT

3.1 SCOPE OF THE DM PROCESS

The activities described in this section are conducted very early in the Program/Project life cycle. For example, when the requirements for a new capability are being defined, the DM function captures and manages the documentation of initial requirements, any significant changes in direction, and tradeoffs made. By applying a DM perspective to these early decisions, the data will be available for later requirements traceability.

3.2 ROLES AND RESPONSIBILITIES

ROLE RESPONSIBILITY

Book Manager New Document

Work with applicable Project Manager, Configuration Management Office (CMO) and DM to identify the following:

- Configuration Control Board (CCB) of final control

- Interim approval CCBs, if applicable

- Document Numbering System to be used

- Template to be used

- Export control review planning

- Whether document will contain proprietary data Create draft document Coordinate any internal (or concurrence) reviews Coordinate editing support and/or ensure document meets quality standards Coordinate submittal through Export Control process Coordinate/ensure correct legal labels are applied to document Submit final document to applicable control board or review board Follow direction from board for any document changes Coordinate approvals Submit final electronic version to applicable personnel for publication

Book Manager Revision/PCN

Obtain official baseline electronic version from DM Formulate recommended changes Coordinate review of legal labels for applicability and updates as needed Submit Change Request (CR) containing revised document to applicable CCB

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Follow direction from board for any additional document changes Coordinate approvals Submit final electronic version to applicable personnel for publication

Document Management

Provide document numbers for HHP documents and Work Instructions (WI) upon request Develop and maintain Applicable Document List (ADL) for the HHP Directorate Quality Master List Develop and maintain the Document Tree for the HHP Directorate Participate as a mandatory evaluator on CR evaluations for the HHP Directorate to include DM specialists who support other document types such as ISSMP, HRP, etc.

Provide support to the HHP Directorate to ensure correct formatting is applied to HHP specific documents and by DM specialists who apply variant templates for other document types such as ISSMP, HRP, etc.

Maintain the HHP document template and document checklist Safeguard the HHP documentation in accordance with NPR 1600.1,NASA Security Program Procedural Requirements

Configuration Management Office

(CMO)

Process document through applicable board per JSC 28330, Human Health and Performance Directorate Configuration Management Plan Control the Baseline Document Shall process CoFR documentation though the Flight Activities Control Board (FACB), in accordance with JSC 28225, Human Health and Performance Directorate (HHPD) Certification of Flight Readiness (CoFR) Implementation Plan

Project Manager – New Document

Coordinate any required reviews for the project, i.e., Preliminary Design Review (PDR), Critical Design Review (CDR), Flight Readiness Review (FRR), Functional Configuration Audit (FCA)/Physical Configuration Audit (PCA), etc.

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3.3 DM INTEGRATED PROCESS FLOW CHART

FIGURE 1.1 1 DM INTEGRATION PROCESS

3.4 RELATIONSHIP OF DM TO OTHER FUNCTIONAL ACTIVITIES

DM is a cross functional activity. The Directorate DM and Divisional DM works with Configuration Management (CM), and other related activities (Export Control, Quality Management System) as shown in Figure 1.1 1.

Directorate and Divisional DM processes each document through a review to ensure the following is accomplished:

Ensure that documentation guidelines are met (e.g., formatting, acronyms, etc. in accordance with HHP 10050), Communicate with Directorate Information Systems to ensure the development of the document structure correlates with the requirement flow downs from all Directorate and Division documentation, Document Management Handbook Document: HHP 10050 Rev C Date: 09/2014 Page: 12

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Secure and administer version control of each data object, Coordinate with appropriate CM personnel on correct version pre and post board activities, Coordinate with Export Control (EC) to ensure the data object is properly marked, and Ensure the document is placed in the appropriate library for retrieval

Directorate DM and Divisional DM will communicate to ensure that there is no duplication of work. All efforts to complete a document review shall be followed by both parties in accordance with the HHP 10050, Document Management Handbook.

4.0 HHP DOCUMENT MANAGEMENT PROCESS AND PROCEDURES

HHP DM processes and procedures shall be a closed loop system in accordance with JPR 1281.5, Document and Data Control. These processes and procedures shall provide guidance to the Book Managers (BMs), DM, CM and others who support the implementation of the requirements.

4.1 DOCUMENT TEMPLATE APPLICABILITY

All SA Directorate and Divisional documentation shall follow the guidance of the HHP document template structure (i.e., Cover Page, Change History, Signature Page, Header/Footer, 1.0 Introduction, 2.0 Documents, 3.0 the information of the document). All SA Directorate and Divisional documentation shall follow the HHP document template. The applicability of the template shall include work instructions, JSC numbered documents that relate directly with the SA Directorate, and any HHP numbered documents. Any documentation that is ISSMP, HRP, or Joint documentation is not required to follow the SA Directorate template.

4.2 DOCUMENT TYPES

The BM will be responsible for identifying the document type that has been or will be developed. The following list provides a few descriptions of potential document types.

Policy document – A policy is a statement from senior management used to guide decision making and achieve rational outcomes. Each policy document must be approved by the Directorate Chief.

Procedure – A set of instructions covering those features of operations that lend themselves to a definite or standardized procedure without loss of effectiveness.

Work Instruction (WI) – Documents that describe how to accomplish specific JSC activities needed to ensure consistent working methods and achieve the required JSC quality standard. WIs are used within one or more directorate level organizations, but do not have Center wide impact.

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Requirements document – A document that contains performance based requirements to facilitate development of individual operational requirements documents by providing a common framework and operational concept to guide their development.

Plan document – Organizational schema or method for the accomplishment of an objective.

4.3 DOCUMENT NUMBERING SYSTEM

The HHP DM Handbook authorizes the use of the HHP document numbering. These numbers are assigned to documents that are under the responsibility of the HHP directorate. DM will assign the document numbers and maintain the document number list. Those document series that have already been established with a different numbering system may continue to be used.

1. The requestor will obtain the Document Number Request Form from the CM SharePoint site. Complete the form and submit to the SA4 DM via email. The request for a document number should be made when the document is ready for board review.

2. DM will provide a document number on the HHP document request form within 2 working days of receipt.

4.4 DMMANDATORY EVALUATOR FOR HHP BOARDS

DM shall participate as a mandatory evaluator for all CRs that are processed though the HHP Boards and Panels. DM will perform minimal non technical Document Quality Assurance (DQA) to include verification of the correct HHP document template format, first time call out of acronyms in the document, Applicable Document List (ADL) properly called out documents with “shall” statements in the document, Change History log is accurate, and header/footer match the document title and revision/change.

If needed, DM will make the appropriate non technical changes to the SA Directorate and Divisional documentation that includes NASA generated or HHIMS generated documents.

CM/DM will provide the initiator with the redlined document. The initiator will review the redlined document to accept the non technical changes and attach the document into Bioastronautics Planning System (BPS) as part of the evaluation.

4.5 DM APPLICABLE DOCUMENT LIST

DM will perform minimal non technical Document Quality Assurance (DQA) to include verification of the following items: usage of the correct HHP document template; first time call out of acronyms in the document; proper callout of applicable documents with “shall” statements in the document (for tracking on Applicable Documents List or ADL); and accuracy of the Change History log, header, and footer information.

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4.6 PROCESSING VIA CONTROL BOARD

Flight Readiness Reviews are also critically important. Therefore, a HHP board shall document the directorate’s readiness for launch, flight, on orbit and landing activities for all visiting vehicle (VV) flights and missions, in accordance with JSC 28225, HHP Certification of Flight Readiness Implementation Plan.

For board processing of documents, CM will work with DM to insure a proper review is conducted, whether a standard or expedited review, and that a board disposition is rendered, whether in board or outside of board (OSB). Figure 1.1 1 (DM Integration Process) depicts the CCB role in this process.

4.7 DOCUMENT MARKINGS

DM shall ensure all HHP documentation is properly marked. Those markings shall include Sensitive But Unclassified (SBU), International Traffic in Arms Regulation (ITAR), or Export Administration Regulations (EAR). Document markings for ITAR and EAR shall be subject to the discretion of the Export Control Representative (ECR) as documented in SA WI 025, HHP Export Control Processes and JWI 2190.1B, JSC Export Compliance.

For information that is to be marked as SBU, the NF 1686 shall be applied on the first page of the document. In addition to the NF 1686, SBU information shall be marked as follows:

1. Mark the bottom of the front cover or first page, as applicable, and each individual page containing SBU information with a notice that includes: the caveat "SENSITIVE BUT UNCLASSIFIED (SBU);" the Designating Official (by name and/or position); the Designating Official’s organization, project or program; and date of SBU designation.

2. Mark the top of each individual page containing SBU information with the caveat

"SENSITIVE BUT UNCLASSIFIED (SBU)."

3. Materials containing specific types of SBU information (if known) shall be further marked with an applicable caveat (e.g., "SENSITIVE BUT UNCLASSIFIED (SBU) SOURCE

SELECTION INFORMATION (SII)," "SENSITIVE BUT UNCLASSIFIED (SBU) – PERSONALLY

IDENTIFIABLE INFORMATION (PII)," or “SENSITIVE BUT UNCLASSIFIED (SBU) PREDECISIONAL INFORMATION") in order to alert the reader of the type of information conveyed.

For additional information, please refer to NPR 1600.1. NPR 1600.1 shall take precedence should the information in this section conflict.

4.8 RECORDS RETENTION

HHP Directorate shall establish a Records Retention List to be consistent with NPR 1441.1, NASA Records Retention Schedule. The records retention schedule will be shared with Book Mangers so they are informed of retention requirements that may impact their products.

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4.9 RETIREMENT AND CANCELLATION OF DOCUMENTS

The HHP Directorate shall be consistent with the requirements set forth in JPR 1281.5, Document and Data Control.

A document shall be retired in the event that the document is no longer needed, or it is being combined with another document. A document shall be canceled in the event a program has been terminated and/or the document was never properly baselined. Office of Primary Responsibility (OPR) or request originators shall retire or cancel approved documents that are no longer required or are superseded by other documents using the procedures for change requests appropriate to the document under CM control. OPR and or DM shall issue a retirement or cancellation notice in the form dictated by the originating organization document control procedures. OPR or DM shall notify the Scientific and Technical Information Center (STIC) of all canceled JSC numbered documents. DM shall notify the Organizational Master List Custodian to remove the link to the Quality Management System (QMS) List.

A document shall be deleted within one year of cancellation.

5.0 DOCUMENT MANAGEMENT SHAREPOINT SITE

DM SharePoint is resource website for HHP personnel to search for directorate documentation.

Document Templates Document Native File Search

MOU/MOA

SA Directorate Documentation Baseline Index QMS Website Links Contact Information

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ACRONYMS AND ABBREVIATIONS

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ADL Applicable Document List ANSI/GEIA American National Standards Institute/Government Electronics & Information

Technology Association BM Book Manager BPS Bioastronautics Planning System CCB Configuration Control Board CDR Critical Design Review CFR Code of Federal Regulations CM Configuration Management CMO Configuration Management Office CoFR Certification of Flight Readiness CR Change Request DM Document Management DQA Document Quality Assurance EAR Export Administration Regulations ECR Export Control Representative FACB Flight Activities Control Board FCA Functional Configuration Audit FRR Flight Readiness Review GPO Government Printing Office HHP/HHP Human Health and Performance Directorate HHP CB Human Health and Performance Control Board HRP Human Research Project ITAR International Traffic in Arms Regulations JF JSC Form JPD JSC Policy Directive JPR JSC Policy Requirements JSC Johnson Space Center JWI JSC Work Instruction NASA National Aeronautics and Space Administration NF NASA Form NPD NASA Procedural Directive NPR NASA Procedural Requirements OPR Office of Primary Responsibility OSB Outside of Board PCA Physical Configuration Audit PCN Page Change Notice PDR Preliminary Design Review PII Personally Identifiable Information QMS Quality Management System SBU Sensitive But Unclassified SII Source Selection Information

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STIC Scientific and Technical Information Center TBD To Be Determined TOC Table of Contents U.S. United States VV Visiting Vehicle(s) WI Work Instruction

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HHP DOCUMENT TEMPLATE INSTRUCTIONS

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HHP DOCUMENT TEMPLATE INSTRUCTIONS

Item Description

Template The template provided in this appendix will also be made available as a separate file to be used when creating new HHP documents.

Document Number

Document numbers are obtained from the Document Management office. JSC Document numbers are obtained from the Scientific & Technical Information Center (STIC).

NOTE: The “HHP” designated is used rather than “HHP” so that file names can be created using the document number.

Cover Availability category and a distribution limitation label(s) are applied to the cover prior to publication. Other notes are added when necessary, such as ITAR statements. The cover requires a verification statement at the bottom of the page. The document number is placed in the top right corner of the cover page; however, it does not have to include the revision letter or number since that information is already on the page near the date. See the HHP Document Template for more information.

Approvals Page(s)

Usually includes signature of author and at least one approver. The number of preparers and approvers on the signature page may change for different documents. Some documents may include a concurrence signature line. The originating organization’s directorate office determines level of approval for HHP numbered documents. The approving authority may remain at directorate level or be delegated to a lower level.

Page Change Notice (PCN)

PCNs are used instead of regular Approval pages when making minor editorial changes to a document. The entire document is released with the changed pages incorporated, which are identified with change bars. The cover page and the change history page will be updated to indicate a PCN.

Foreword (Optional) (Written by someone other than author) or preface (written by author). May contain both, in which case they should be on separate pages.

Revision Log Shows change history, including references to any applicable authority for making changes, such as Board Directive(s). Document baseline does not change with a PCN (ex: Revision A document stays as a Rev. A but shows a PCN in the log – “Ch #1”).

Table of Contents

(TOC)

Includes headings in document down to level three or four (i.e., 1.1.1, 1.1.1.1). Separate lists of tables and figures follow the main contents list. Number the TOC with numbers, beginning with “1.0.”

Acronyms and Abbreviations

Acronyms and uncommon abbreviations are spelled out at first use and presented in a list.

Acronyms are not generally defined in tables and figures. The acronyms and abbreviations list is located in the Appendix A.

Section 2.0 Documents listed in the Applicable Documents and Reference Documents sections reference the appropriate Revision and Change (this does not include the Revision and Change numbers of the Applicable and Reference Documents, this is just a verification of the version) that applies to the primary document. Citations for these documents should be spelled out in the body of the document with the document number and title at first mention. Thereafter, just the document number will suffice.

Fonts and Styles

Standard Body Text is 12pt Calibri, left justified. Font size in tables and figures may be reduced to save space. Heading styles are described in Appendix C of this template.

Running header

The header will include the document number, document title, date, page number, document version, and Human Health and Performance Directorate. The header on the title page will only show the document number.

Footer On each footer “Verify that this is the correct version before use” Appendix Appendices are listed in the Table of Contents References/ Bibliography

(Optional) May be included in separate sections or chapters of document body.

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HHP DOCUMENT TEMPLATE

Document Management Handbook Document: HHP 10050 Rev C Date: 09/2014 Page: 22

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Document Title Human Health and Performance Directorate (may substitute division, office or project title)

[Select applicable label(s) from JSC Document Availability and Distribution List]

CCB Controlled (assigned Board Acronym)

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BASIC or Revision/Version

Date

National Aeronautics and Space Administration Lyndon B. Johnson Space Center Houston, Texas

Leave this section blank for any special notes, such as an ITAR note, whether a PCN is being published, if the document is approved electronically, etc.

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DOCUMENT APPROVAL SHEET

Document Title

Delete extra signature lines (and page) if not needed.

PREPARED BY:

Preparer Name DATE Author Title/Org

APPROVED:

Approver Name DATE Approver Title/Org

APPROVED:

Approver Name DATE Approver Title/Org

APPROVED:

Approver Name DATE Approver Title/Org

NATIONAL AERONAUTICS AND SPACE ADMINISTRATION

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CHANGE HISTORY

REVISION/

CHANGE DATE AUTHORIZATION DESCRIPTION OF CHANGE

Initial Release

##/##/## Directive # Initial Release

A ##/##/## Directive or Action # Explanation of updates

Ch. 1 ##/##/## Directive or Action # Explanation of updates

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Section Page

1.0 INTRODUCTION................................................................................................................ X

1.1 PURPOSE .......................................................................................................................... X

1.2 SCOPE............................................................................................................................... X

1.3 PRECEDENCE .................................................................................................................... X

1.4 RESPONSIBILITY AND CHANGE AUTHORITY..................................................................... X

2.0 DOCUMENTS.................................................................................................................... X

2.1 VERB APPLICATION .......................................................................................................... X

2.2 APPLICABLE DOCUMENTS................................................................................................ X

2.3 REFERENCE DOCUMENTS ................................................................................................ X

3.0 LEVEL 1 HEADING............................................................................................................. X

3.1 LEVEL 2 HEADING............................................................................................................. X

3.1.1 LEVEL 3 HEADING............................................................................................................. X

3.1.1.1 LEVEL 4 HEADING............................................................................................................. X

APPENDIX A – Title.......................................................................................................................... X APPENDIX B – Title .......................................................................................................................... X

List of TABLES

TABLE 4.1 1 TABLE TITLE ............................................................................................................. X

List of Figures

Figure 3.1 1 Figure Title .............................................................................................................. X

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1.0 INTRODUCTION

1.1 PURPOSE

Insert Purpose here.

1.2 SCOPE

Insert Scope here.

1.3 PRECEDENCE

In the event of a conflict between this document and the documents referenced in Section 2.1, Applicable Documents, the requirements listed in the Applicable Documents will take precedence.

1.4 RESPONSIBILITY AND CHANGE AUTHORITY

This document is prepared and maintained in accordance with insert governing document here.

The responsibility for the development of this document lies with insert responsible organization here. [CCB statement]

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2.0 DOCUMENTS

2.1 VERB APPLICATION

In the context of this document the use of the verb “shall” indicates a requirement. Use of the verb “should” or “will” does not impose a binding requirement. For example, on standards published by the American Society for Testing and Materials, requirements with “shall” is a mandatory requirement, meaning, “must”, or “have to”. “Shall” is the term denoting absolute requirements and “should” or “will” as denoting a somewhat flexible requirement.

2.2 APPLICABLE DOCUMENTS

The following documents include specifications, models, standards, guidelines, handbooks, and other special publications. The documents listed in this paragraph are applicable to the extent specified herein. Applicable documents consist of documents that contain provisions or other pertinent requirements directly related to and necessary for the performance of the activities specified by the document.

Document No. Title

Sample Text Sample Text

2.3 REFERENCE DOCUMENTS

The following documents contain supplemental information to guide the user in the application of this document. These reference documents may or may not be specifically cited within the text of this document.

Document No. Title

Sample Text Sample Text

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3.0 LEVEL 1 HEADING

Insert Body Text here (optional).

3.1 LEVEL 2 HEADING

Insert Body Text here.

TABLE TITLE GOES ABOVE THE TABLE.

TABLE 3.1 1 TABLE TITLE

Table text 12pt/centered/bold Table text 12pt/centered/bold

Table text 12pt Table text 12pt

FIGURE CAPTION GOES BELOW THE FIGURE.

Insert Figure above caption

Figure 3.1 1 Figure Caption

List Bullet Level 1

- List Bullet Level 2

List Bullet Level 3

1. Numbered List Level 1

A. Numbered List Level 2

1) Numbered List Level 3

a. Numbered List Level 4

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APPENDIX A ACRONYMS AND ABBREVIATIONS

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Verify that this is the correct version before use.

A ACRONYM Acronym Description

B ACRONYM Acronym Description

B ACRONYM Acronym Description

C ACRONYM Acronym Description

C ACRONYM Acronym Description

C ACRONYM Acronym Description

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FORMS

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FORM 1 EXAMPLE HHP DOCUMENT NUMBER REQUEST FORM

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FORM 2 SBU INSTRUCTIONS

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Form 3 SBU Form

JSC 17773

Revision D

Preparing Hazard Analyses for JSC Ground Operations

Safety and Test Operations Division

March, 2011

National Aeronautics and Space Administration

Foreword

This document provides general instructions for preparing hazard analyses for JSC ground equipment and operations. It contains a checklist to help the user to anticipate, identify, evaluate, and control typical hazards associated with ground operations; basic forms and instructions for preparing a hazard analysis. Reference links are also included for several hazard assessment techniques that will be useful in preparing a hazard analysis.

The document is intended to be an instruction document and is not a requirements document. It provides general information on how to prepare a hazard analysis to comply with JSC hazard analysis requirements in Chapter 2.3 of JPR 1700.1, “JSC Safety and Health Handbook” or JSC 20483, “JSC Committee for the Protection of Human Subjects, Guidelines for Investigators Proposing Research for Space Flight and Related Investigations (aka CPHS Redbook). It also provides references to assist the user in selecting the appropriate hazard evaluation tool(s), but it is not intended to be a comprehensive tutorial on risk identification and assessment techniques.

If you have any comments or suggestions for this document, please contact the Chief, Safety and Test Operations Division, mail code NS.

Approval:

___Original Signed By______ David T. Loyd Chief, Safety and Test

Operations Division

Change Record

Rev. Date Originator/Phone Description

A

B

C December

Dan L. Clem/483-4272 Revised document in plain English.

Updated examples and methodologies.

D March, Dan L. Clem/483-4272 Updated document to meet guidelines. Added clarifications throughout the document.

Removed obsolete appendices.

Added links to resource documents in section 14 and as used in the document. Added Safe Plan of Action.

Admin November

Dan L. Clem/483-4272 Updated cross references and links to JPR 1700.1.

Contents

1 WHO SHOULD FOLLOW THIS DOCUMENT?

2 WHAT IS A HAZARD ANALYSIS?

3 WHEN IS A HAZARD ANALYSIS REQUIRED?

4 WHEN TO START A HAZARD ANALYSIS

5 JOB HAZARD ANALYSIS (JHA) AND SAFE PLAN OF ACTION (SPA)

6 PROCEDURE FOR DOING A HAZARD ANALYSIS

7 ASSIGNING A RAC

8 CONTENTS OF A HAZARD ANALYSIS

9 FORMAT FOR A HAZARD ANALYSIS

10 REVIEW AND APPROVAL OF A HAZARD ANALYSIS

11 CONTROLLING OR ELIMINATING THE HAZARDS THAT ARE IDENTIFIED

12 TRACKING HAZARDS

13 HOW OFTEN MUST THE HAZARD ANALYSIS BE REVIEWED?

14 REFERENCES TO USE WHILE DOING A HAZARD ANALYSIS

APPENDIX A - COMPARISON OF HAZARD ANALYSIS TECHNIQUES

APPENDIX B – JOB HAZARD ANALYSIS (JHA)

APPENDIX C – EXAMPLE HAZARD ANALYSIS

APPENDIX D – SAFE PLAN OF ACTION

1 Who should follow this document?

You should follow this document if your work at JSC falls within the scope of the JSC Safety & Health Handbook JPR 1700.1, Chapter 2.3 to create a hazard analyses for JSC ground operations or the CPHS Redbook for human research.

2 What is a hazard analysis?

It will be necessary to become familiar with a few simple terms so you can understand a hazard analysis.

Hazard – A hazard is any credible condition or exposure that could potentially cause harm to personnel, damage to property or the environment, or mission failure.* For example, wearing loose clothing in close proximity to rotating equipment is a hazard. A checklist which covers most of the hazards experienced at JSC is provided in NS-STO-CH01, General Hazard Identification Checklist.

*It is important to understand that all potential hazards must be identified when performing a hazard analysis. Failure to include potential hazards that are inherently controlled is a common mistake when preparing the hazard analysis. For example, assume you wish to perform a test on an aluminum bracket which has been designed to have 100% rounded edges. It is reasonable to assume that sharp edges would not be a hazard because they have already been “designed” out. However, the potential for sharp edges still remains, and should be considered in the hazard analysis nonetheless. This is because other factors such as incorrect machining (failure to remove sharp edges/burrs, etc.) or improper handling (creation of sharp edges when dropped, crushed, etc.) could still potentially expose workers to a sharp edge. In this instance, proper design, handling, and inspection of the bracket are controls used to protect against potential exposure to sharp edges, and should therefore be included in the hazard analysis. Another way to think about this is to ask which hazards could be present in a system if no precautions had been taken to eliminate or control them.

Hazard Control – Hazard controls are measures taken to eliminate a hazard or reduce the likelihood that a hazard will result in a harmful event. Hazard controls are the design features, procedures, and personal protective equipment used in a system to remove hazards altogether or reduce the likelihood that a mishap can occur. In the above example, a cover placed over the rotating equipment, or a written procedure which prohibits loose clothing, are examples of hazard controls.

System – A system is any combination of equipment, resources, personnel, and procedures needed to perform an operation. Systems can range in complexity from very simple to extremely complex. For example, the people, processes and equipment needed to maintain and operate a grinding wheel station used to sharpen tools is a relatively simple operation, whereas the people, processes and equipment used to remove and service the Space Shuttle main engines is an extremely complex operation – but, nonetheless they are both systems.

Hazard Analysis – A hazard analysis is an organized method for identifying hazards and hazard controls used in a system at any point in its life cycle.

Simply put, the hazard analysis lists each potentially harmful event that could credibly occur in a system, the worst-case result for each event, and all the measures that are taken to prevent or reduce the likelihood of its occurrence.

3 When is a hazard analysis required?

You must do a hazard analysis if your operation falls under the requirements of OSHA -29 CFR 1910.119, “Process Safety Management”*, or as required by Chapter 2.3, paragraph 5 of JPR 1700.1 (current version), “JSC Safety and Health Handbook.”

* See 29 CFR 1910.119 for specific chemicals and quantities that fall under these requirements. NOTE: JSC/Houston does not currently maintain any processes which are subject to the Process Safety Management regulation. However, specific processes at WSTF are subject to this regulation. See WSTF Standard Instruction 25SW-0005 for applicability of PSM hazard analysis requirements and associated WSTF processes which must adhere to the PSM regulation.

4 When to start a hazard analysis You should start your hazard analysis in the early design stages and add to it as design and operational details are available. Adding hazard controls to a system during its initial design phase is usually less expensive and more effective than adding controls after the system is built. It is still possible to perform a hazard analysis on an existing system, but it is likely to cost more and not work as well.

5 Job Hazard Analysis (JHA) and Safe Plan of Action (SPA) JHAs are required for hazardous jobs per Chapter 2.3 of JPR 1700.1 (current version), “JSC Safety and Health Handbook.” SPAs or equivalent are required as a part of certain JHAs as described in the same chapter. Appendix B lists the steps and format for a JHA, which follows the format and methodology of OSHA pamphlet 3071, “Job Hazard Analysis.” Appendix C provides an example hazard analysis. Appendix D lists the steps and suggest format for an SPA.

6 Procedure for doing a hazard analysis The specific steps for doing a hazard analysis depends on the hazard analysis technique(s) used. Some hazard analyses are done by a single safety analyst or engineers, while others are done by teams. Many times, a team approach is best because of the synergy of the team in identifying hazards.

The general steps for doing a hazard analysis are:

1. Determine who will provide input and review for developing the hazard analysis. Include those with direct knowledge of the research or testing to be performed, equipment, its operation and design, and the hazards associated with the system. This will include:

Designers Maintenance personnel Construction personnel Operations personnel Principle investigators Safety personnel Any others who might have knowledge of the system

2. Determine the best hazard analysis technique to use. You may use any of the techniques listed below or any other technique as required by the complexity of your system. It is important to choose an analytical technique that will identify all the hazards in the system being analyzed. For example, a FMEA is not the best choice for a system involving human interaction because it only considers hardware failures, and not the interaction between personnel, equipment or environment. Other techniques, such as the What-If Analysis, are available which consider these factors. Conversely, a FMEA is excellent for identifying individual system components that could create a hazardous condition if they were to unexpectedly fail.

There are many hazard analysis techniques available (see Section 13).

Consulting safety personnel on the decision of which technique to use will help you chose the most effective analytical tool for your situation.

Here are some of the more common hazard analysis techniques used at JSC.

Appendix A lists the descriptions, uses, advantages, and disadvantages of these techniques:

What-If Analysis Hazard and Operability Study (HAZOP) Failure Mode and Effects Analysis (FMEA) Fault Tree Analysis Event Tree Analysis Probabilistic Risk Assessment

3. Conduct the hazard analysis by:

Breaking the system into subsystems Identifying hazards with each subsystem Identifying hazards at subsystem interfaces Determining the worst credible mishap, if all controls failed Determining the Risk Assessment Code (RAC) for the event with no controls Determining what controls are in place Determining the worst credible event with all the existing controls in place Determining the RAC with all controls in place Determining if any further work is required based on the RAC Determining how the presence of the hazard control will be verified Writing the report

7 Assigning a RAC Use the RAC matrix and descriptions in chapter 2.3, paragraph 2.3.9 of JPR 1700.1, “JSC Safety and Health Handbook.” This process is used to assign a RAC code both before and after controls are implemented.* To use the matrix:

a. Find the “consequence” or the worst-case outcome of a mishap from the hazard along the left side of the matrix.

b. Find the “likelihood” that you expect the mishap to occur across the top of the matrix. The qualitative definitions are usually preferred and the probabilities are merely added as an example.

c. Find the RAC in the box where the “consequence” and “likelihood” cross.

d. Use the table after the matrix to determine what action to take based on the

RAC.

*It is important to note that the likelihood code must be reduced following implementation of controls, but the “consequence” code will remain the same. [This is because the worst-case outcome for a particular hazard does not change after controls are in place, only the probability of its occurrence.] For example a hazard assigned a RAC code of IB1 before controls can be reduced to IE4 after controls (likelihood can be reduced from B to E), but cannot be reduced to IIE5 (consequence of event cannot be reduced from I to II).

8 Contents of a hazard analysis As a minimum, your hazard analysis must contain:

a. The system’s name and location.

b. The hazards of the system and their causes. Include hazards from human factors as well. You must also consider hazards of interfaces between systems, and interfaces between the equipment and the facility.

c. The consequence of each hazard if it were to cause a mishap. For example, death, major injury, minor injury, or estimated property damage and dollar amount.

d. Any existing engineering or administrative controls for each hazard.

e. Proposed engineering or administrative controls for each hazard, if the existing controls are inadequate.

f. Verification methods for each control to explain how the presence of each control will be confirmed (e.g., review of procedures, inspections, etc.).

g. What would happen if the engineering or administrative controls were to fail.

h. A qualitative evaluation of the possible safety and health effects before and after the controls are in place.

i. Who was on the team that did the hazard analysis.

j. When the system was last analyzed.

k. A qualitative evaluation of the risk before and after the hazard controls are in place. This is the risk that management will have to accept.

9 Format for a hazard analysis The format of the hazard analysis can vary depending on the analysis technique used. However, it must contain the items called out in Paragraph 7. A sample hazard analysis is included in Appendix C. You can find more examples at:

http://www6.jsc.nasa.gov/safety/hazard/index.htm.

10 Review and approval of a hazard analysis You can find the required approvals in paragraph 2.3.8, chapter 2.3, of JPR 1700.1.

11 Controlling or eliminating the hazards that are identified You must use at least one of the steps shown below to eliminate or control all the hazards that were identified in the hazard analysis:

a. Eliminate or minimize the hazard through use of engineering (design) controls, such as substitution for less hazardous materials and equipment, use of guards and interlocks, and isolation of hazards from personnel and equipment, where feasible.

b. If it is not feasible to eliminate or minimize the hazard through use of engineering controls, then the hazard potential must be mitigated by administrative controls or personal…