EPLC_OM_Manual_v . .doc

SUBJECT \* MERGEFORMAT Operations and Maintenance Manual

Version: Error! Unknown document property name. Error! Unknown document property name.

Food and Drug Administration

<Project Name & Release Version #> Enterprise Performance Life Cycle

Operations and Maintenance Manual

Document Version Number: <1.0> Document Version Date: <mm/dd/yyyy> Notes to the Author

[This document is a template of a Operations and Maintenance Manual document for a project. The template includes instructions to the author, boilerplate text, and fields that should be replaced with the values specific to the project.

· Blue italicized text enclosed in square brackets ([text]) provides instructions to the document author, or describes the intent, assumptions and context for content included in this document.

· Blue italicized text enclosed in angle brackets (<text>) indicates a field that should be replaced with information specific to a particular project.

· Text and tables in black are provided as boilerplate examples of wording and formats that may be used or modified as appropriate to a specific project. These are offered only as suggestions to assist in developing project documents; they are not mandatory formats.

When using this template, the following steps are recommended:

1. Replace all text enclosed in angle brackets (e.g., <Project Name>) with the correct field document values. These angle brackets appear in both the body of the document and in headers and footers. To customize fields in Microsoft Word (which display a gray background when selected) select File->Properties->Summary and fill in the appropriate fields within the Summary and Custom tabs.

After clicking OK to close the dialog box, update all fields throughout the document selecting Edit>Select All (or Ctrl-A) and pressing F9. Or you can update each field individually by clicking on it and pressing F9.

These actions must be done separately for any fields contained with the document’s Header and Footer.

2. Modify boilerplate text as appropriate for the specific project.

3. To add any new sections to the document, ensure that the appropriate header and body text styles are maintained. Styles used for the Section Headings are Heading 1, Heading 2 and Heading 3. Style used for boilerplate text is Body Text.

4. To update the Table of Contents, right-click on it and select “Update field” and choose the option - “Update entire table”.

5. Before submission of the first draft of this document, delete this instruction section “Notes to the Author” and all instructions to the author throughout the entire document.

VERSION HISTORY

[Provide information on how the development and distribution of the Operations and Maintenance Manual will be controlled and tracked. Use the table below to provide the version number, the author implementing the version, the date of the version, the name of the person approving the version, the date that particular version was approved, and a brief description of the reason for creating the revised version.] Version Number Implemented

By Revision

Date Approved

By Approval

Date Description of and Reason for Change

Table of Contents

61.0 EXECUTIVE SUMMARY

61.1.

BACKGROUND

61.2 Scope of Operations & Maintenance Manual

61.3 Key Stakeholders

61.4 Maintenance Contacts

61.5 Acronyms and Abbreviations

71.6 References

71.7 Policies, Directives and Procedures

72.0 PROJECT MANAGEMENT

72.1 Project Management Documentation

82.2 Risk Assessment and Management

82.3 Assumptions and Constraints

82.4 Issue and Action Management

82.5 Dependencies

82.6 Testing

82.7 Maintenance Reports

92.8 Documentation

92.9 Acceptance/Sign-off Criteria

102.10 Training

103.0 SYSTEM DETAILS

103.1 Main Functions

103.2 System Architecture & Support Requirements

113.3 Security

113.4 Storage Requirements

113.5 System Operation

113.6 System Backups

123.7 Error Conditions

133.8 System Inventory

134.0 APPLICATION INSTALLATION

134.1 First-Time Users

134.2 Access Controls

134.3 Installation

134.4 Configuration

144.5 Starting the System

144.6 Stopping the System

144.7 Suspending the System

145.0 SYSTEM MAINTENANCE PROCEDURES

145.1 Naming Conventions & Standards

145.2 Performance Verification Procedures

155.3 Maintenance Procedures

155.3.1 [MAINTENANCE PROCEDURE NAME]

156.0 SOFTWARE MAINTENANCE PROCEDURES

156.1 Consolidated Unit List [x]

156.2 [Software Unit Identifier]

156.2.1 DESCRIPTION

166.2.2 FUNCTIONS

166.2.3 INPUT

166.2.4 PROCESSING

166.2.5 DATA STRUCTURES

166.2.6 VERIFICATION PROCEDURES

166.2.7 LISTINGS

166.2.8 INTERFACES

177.0 Database Maintenance Procedure

177.1 Database Identifier

177.2 GENERAL CHARACTERISTICS

177.3 ORGANIZATION AND DETAILED DESCRIPTION

178.0 ERROR CODES

18APPENDIX A: Operations and Maintenance Manual Approval

19APPENDIX B: REFERENCES

20APPENDIX C: KEY TERMS

1.0 Executive Summary

1.1. BACKGROUND

[This section provides a high-level overview of the project/ system as well as the main business and technical objectives to which this Operations & Maintenance Manual relates. Include key areas of functionality.]

1.2 Scope of Operations & Maintenance Manual

[This plan is created by <identify person or team authoring document> during the <Phase> of the EPLC for the purpose of providing the maintenance team the necessary information to adequately maintain the <application/ system> system. Describe the different type of activities that require maintenance, e.g. bug fixes, security updates, etc. and the priority of each type of fix or maintenance activity identified.

Describe the software, hardware, documentation and services, which are included in the Operations & Maintenance Manual. Also, list any areas specifically excluded from the project(s), such as the acquisition of hardware/software, etc.]

1.3 Key Stakeholders

[This subsection of the Operations & Maintenance Manual lists the project’s key stakeholders. Include their name, role, and contact number.]

1.4 Maintenance Contacts

[This subsection of the Operations & Maintenance Manual lists the people or departments responsible for the various maintenance activities described throughout this document. Include the name, role, department, and contact number for each person/function listed.]

1.5 Acronyms and Abbreviations

[This subsection of the Operations & Maintenance Manual defines the acronyms that are used repeatedly throughout the document. If the acronyms are listed in a separate document, reference that document’s name and location here.]

1.6 References

[This subsection of the Operations & Maintenance Manual provides a complete list of all documents and other sources of information, such as technical specifications and project documentation referenced in this document. Identify each document by its title, report number, date, author, pathname for electronic access, and publishing organization. Other sources of information, such as electronic files, should be identified using unique identifiers such as date and version number. Any deviations from referenced standards or policies should be identified and justifications should be provided.]

1.7 Policies, Directives and Procedures

[This subsection of the Operations & Maintenance Manual outlines the policies and procedures that apply to this document. Identify any external constraints or requirements placed on this document by policies, directives, or procedures.]

2.0 Project Management

[This section of the Operations & Maintenance Manual refers how the maintenance activities will be managed.]

2.1 Project Management Documentation

[This subsection of the Operations & Maintenance Manual identifies the location of the project management documents that were created and used during the development of the <application/ system> program.]

Project Management Plan

Configuration Management Plan

Quality Management Plan

Communication Plan

Risk Management Plan

Software Development Plan

Test Plans

Project Schedule

2.2 Risk Assessment and Management

[This subsection of the Operations & Maintenance Manual refers to the Risk Management Plan that defines the methods and techniques used to successfully identify and manage the project risks. Include the name, version, and location of the risk database or risk tracking system used by the development team. Also note the frequency the risks should be reviewed and the parties that need to participate in the reviews. Refer to the Risk Management Plan if applicable.]

2.3 Assumptions and Constraints

[This subsection of the Operations & Maintenance Manual describes the assumptions on which the maintenance activities are based and the constraints on project factors such as the schedule, budget, resources, software to be reused, acquired software to be incorporated, technology to be employed, and product interfaces to other products.]

2.4 Issue and Action Management

[This subsection of the Operations & Maintenance Manual specifies the procedure on how to manage issues and action items.]

2.5 Dependencies

[This subsection of the Operations & Maintenance Manual describes the systems and activities that are dependent on this system and what systems that this system and its maintenance activities are dependent on.]

2.6 Testing

[This subsection of the Operations & Maintenance Manual describes the process for testing the changes. Identify the location of the test scripts/scenarios/cases, as well as the test result documentation.]

2.7 MAINTENANCE Reports

[This subsection of the Operations & Maintenance Manual identifies the reports to be produced and frequency of distribution, including:

· Corrective actions including priorities and results

· Failure rates and maintenance activity metrics

· Reports on customer problems/satisfaction]

2.8 Documentation

[This subsection of the Operations & Maintenance Manual outlines the documentation to be produced for the maintenance effort.]

2.9 ACCEPTANCE / Sign-off Criteria

[This subsection of the Operations & Maintenance Manual specifies the acceptance of the work products/deliverables generated by the system maintenance and project related-activities. Objective criteria for determining acceptability of the work products/deliverables should be specified and representatives of the development organization and the acquiring organization should sign a formal agreement of the acceptance criteria. Any technical processes, methods, or tools required for product acceptance should be specified. Methods such as testing, demonstration, analysis, and inspection should be specified.]

2.10 Training

[This subsection of the Operations & Maintenance Manual specifies the training needed to ensure that necessary skill levels in sufficient numbers are available to successfully conduct the system maintenance activities. The training schedule should include the types of training to be provided, numbers of personnel to be trained, entry and exit criteria for training, and the training method; for example, lectures, consultations, mentoring, or computer-assisted training. The training should include both technical and managerial skills.]

3.0 SYSTEM Details

3.1 Main Functions

[This subsection of the Operations & Maintenance Manual provides details of the system as well as its major functions

· Identification number(s)

· Title(s)

· Abbreviation(s)

· Version number(s)

· Release number(s).

· Project Owner

· Department responsible

· System name

· System category, e.g. Software, Network, etc

· Operational status, e.g. Operational, In development, Special conditions]

3.2 SYSTEM Architecture & Support Requirements

[This subsection of the Operations & Maintenance Manual describes the relationships among the system, subsystems, networks, communications, etc. Include explanatory diagrams where appropriate.

Identify the environment(s) and the types of equipment used with the system, as well as any specific maintenance related to the equipment and the environment. Include any special configuration requirements for the various pieces of equipment; refer to the System Inventory section of this document if applicable. Identify the items in the environment required to currently support the system and into the future.]

3.3 Security

[This subsection of the Operations & Maintenance Manual describes the security considerations associated with the system. Include any special security functions or concerns, as well as the name, version, and location of all the security related documentation created during the course of the project. Also include any information/disclaimers about unauthorized usage of the system and making unauthorized copies of data, software etc. Describes the process for protecting unauthorized access to the system.]

3.4 Storage Requirements

[This subsection of the Operations & Maintenance Manual identifies current and future storage requirements as well as the parameters for estimating the future requirements.]

3.5 System Operation

[This section of the Operations & Maintenance Manual identifies the parameters in which the system operates under normal circumstances.

Hours of Operation/Availability

· Normal Hours of Operation

· Regularly Schedule Maintenance Periods

Data Processing Routines

· Normal Data Processing Hours

· When is data received by the system?

· From where is the data received?

· How is the data populated into the system?

· Auto-download?

· Scripts (names, versions, & location)

· Who (what group) monitors the data-loading functions?

· What is the expected time for the data to populate?]

3.6 System Backups

[This section of the Operations & Maintenance Manual outlines the following information regarding system backups:

· Frequency and types (incremental vs. complete)

· Media used (tapes)

· Storage Requirements of media (on-site vs. off-site, retention periods, etc.)

· Group responsible for performing and monitoring backups.

· Procedure for recovering backed up data.

· Is the system part of a SAN (Storage Area Network)? If so, include relevant information.]

3.7 Error Conditions

[This subsection of the Operations & Maintenance Manual identifies all error messages produced by the system. Include an identification number, error description, and recommended course of action. If the list of Error Codes is large, place it in an Appendix.]

3.8 System Inventory

[This subsection of the Operations & Maintenance Manual identifies the software components of this application. If this list is stored within another system or document, you may refer to that here. If not, the following tables can be used as a guide.]

Software Modules

Database Modules

Scripts/ Automated Functions (not noted above)

System Related Software (Operating System, Compilers, etc.)

4.0 Application Installation

4.1 First-Time Users

[Enter specific instructions that may be unique to first-time users of the system or provide a reference to where it is stored.]

4.2 Access Controls

[Enter information describing required access controls and privileges necessary for proper system installation or provide a reference to where it is stored.]

4.3 Installation

[Enter information describing specific installation procedures or provide a reference to where it is stored.]

4.4 Configuration

[Enter information describing default and custom configuration, configuration options, and their associated definitions or provide a reference to where it is stored.]

4.5 Starting the System

[Enter information describing how to properly start the system or provide a reference to where it is stored.]

4.6 Stopping the System

[Enter information describing how to properly stop the system or provide a reference to where it is stored.]

4.7 Suspending the System

[Enter information describing how to properly suspend the system or provide a reference to where it is stored.]

5.0 SYSTEM Maintenance Procedures

[This section of the Operations & Maintenance Manual describes the procedures used to maintain the system.]

5.1 Naming Conventions & Standards

[This subsection of the Operations & Maintenance Manual describes rules and conventions used within the system, such as:

· Naming conventions

· GUI standards

· Coding standards]

5.2 Performance Verification Procedures

[This subsection of the Operations & Maintenance Manual describes the procedures used to verify the system’s performance.]

5.3 Maintenance Procedures

[This subsection of the Operations & Maintenance Manual describes the maintenance procedures, e.g. verification methods, and other procedures necessary to maintain the system input/output components. Provide a separate subsection heading for each procedure.]

5.3.1 [MAINTENANCE PROCEDURE NAME]

[This subsection of the Operations & Maintenance Manual provides a maintenance procedure identifier (i.e. unique number) for reference in the remainder of the document. Describe the step-by-step procedures for performing each task.]

6.0 Software Maintenance Procedures

[This section of the Operations & Maintenance Manual describes the specific software maintenance procedures. Provide a separate subsection heading for each procedure.]

6.1 Consolidated Unit List [x]

[This subsection of the Operations & Maintenance Manual provides a decomposition of the system into lower level subsystems, modules, programs, etc. These components are further identified and described in the following subsections.]

6.2 [Software Unit Identifier]

[This subsection of the Operations & Maintenance Manual provides a software maintenance procedure identifier (i.e. unique number) for reference in the remainder of the document.]

6.2.1 DESCRIPTION

[This subsection of the Operations & Maintenance Manual describes the step-by-step activities for performing the procedure.]

6.2.2 FUNCTIONS

[This subsection of the Operations & Maintenance Manual describes the function(s) that will be performed by the software maintenance procedure.]

6.2.3 INPUT

[This subsection of the Operations & Maintenance Manual provides a list of all of the data inputs used by this software unit and what is required for the software maintenance procedure.]

6.2.4 PROCESSING

[This subsection of the Operations & Maintenance Manual describes what the software unit performs on the data input in order to generate the expected output, and what changes, if any, would result from the software maintenance procedure.]

6.2.5 DATA STRUCTURES

[This subsection of the Operations & Maintenance Manual describes the data structures used by the software unit and what changes, if any, would result from the software maintenance procedure.]

6.2.6 VERIFICATION PROCEDURES

[This subsection of the Operations & Maintenance Manual describes what will be verified and how it will be verified when the software maintenance procedure is performed.]

6.2.7 LISTINGS

[This subsection of the Operations & Maintenance Manual provides a list of the components that make up the software maintenance procedure.]

6.2.8 INTERFACES

[This subsection of the Operations & Maintenance Manual describes what software interfaces are used and/or impacted as a result of performing the software maintenance procedure.]

7.0 DATABSE MAINTENANCE PROCEDURE

[This section of the Operations & Maintenance Manual describes the procedures used to maintain the database(s) used by the system. Provide a separate subsection heading for each database procedure.]

7.1 Database Identifier

[This subsection of the Operations & Maintenance Manual provides a maintenance procedure identifier (i.e. unique number) for reference in the remainder of the document. Describe the general characteristics, organization and description for each procedure and database.]

7.2 GENERAL CHARACTERISTICS

[This subsection of the Operations & Maintenance Manual describes the unique features of the database maintenance procedure to be performed and its expected outcome.]

7.3 ORGANIZATION AND DETAILED DESCRIPTION

[This subsection of the Operations & Maintenance Manual provides a detailed description of the database structure.]

8.0 ERROR CODES

[This appendix of the Operations & Maintenance Manual provides a list of the Error Codes mentioned in subsection 5.4, Error Conditions.]

APPENDIX A: Operations and Maintenance Manual Approval

The undersigned acknowledge that they have reviewed the <Project Name> Operations and Maintenance Manual and agree with the information presented within this document. Changes to this Operations and Maintenance Manual will be coordinated with, and approved by, the undersigned, or their designated representatives.

Signature:

Date:

Print Name:

Title:

APPENDIX B: REFERENCES

[Insert the name, version number, description, and physical location of any documents referenced in this document. Add rows to the table as necessary.]

The following table summarizes the documents referenced in this document.

APPENDIX C: KEY TERMS

The following table provides definitions and explanations for terms and acronyms relevant to the content presented within this document.

Template Version 2.0 (Last Modified on Mar 27, 2009)

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Revision Date: Error! Unknown document property name.

EPLC_Operations_and_Maintenance_Manual_Template.doc