Draft USDV Safety and Mission Assurance Plan DRD.pdf

1. DRD Title: Safety & Mission Assurance Plan

2. DRD No.: USDV-18 3. Data Type: 1 4. OPR: NE

5. Solicitation No.: TBD

6. Contract No.: TBD

7. Date Issued: TBD 8. Date Revised: N/A 9. DRD Category:

☐ Technical ☐ Administrative

☒ S&MA

10. Description/Use:

This Safety & Mission Assurance (S&MA) Plan shall describe the assignment of responsibility organizationally and the procedures specific to S&MA requirements as required to support the requirements of this SOW.

11. Distribution:

1 electronic copy: ISS Program Authorized Repository Program Authorized Repository Upload Notification: Contractor’s Contracting Officer

Initial Submission: Draft at Milestone 01 – Mission Concept Review (MCR); Baseline at Milestone 02 – System Requirements Review (SRR)

Submission Frequency: Updates quarterly at Program Reviews (as required)

Format: The Contractor’s format is acceptable

Interrelationship: SOW: 2.4.1, 2.4.5, 2.4.6, 3.2, 3.3

Applicable Documents: N/A

Scope: N/A

Contents: The Contractor shall provide their corporate S&MA Plans applicable to this contract related to Safety, Quality, Reliability, and Software. S&MA Plans shall demonstrate Safety and Mission Assurance is incorporated into all phases of the USDV lifecycle. The S&MA Plans shall document the key activities/tasks in each discipline supported by additional process details such as flow diagrams (where applicable), analysis tools/technologies verification and validations system/tools to monitor the effectiveness and timely response of the product assurance system.

Plans may consist of a single S&MA plan or multiple plans that address the S&MA discipline areas described in this DRD.

The S&MA plan(s) shall be accompanied with a contents summary identifying where in the plan the specific items listed in the SOW and this DRD are addressed.

1. System Safety

Defines the objectives, responsibilities, and methods to be used for overall system safety program conduct and control. It describes the integration of system safety provisions into the total program based on early implementation, planned safety certification review/process, and total program life cycle support. The level of detail in the plan directly correlates with the nature and complexity of the system safety effort required to meet program requirements and objectives. It shall provide a general description of the appropriate system safety tasks that shall become the foundation for efforts during the system definition, design, manufacture, test, and operations. The elements of the System Safety Plan shall identify the interfaces with other program activities including design, development, test, operation, continuous risk management and program control (waivers, deviations, corrective actions). While individual program characteristics may vary the emphasis for a particular effort, the system safety plan shall focus on the basic elements:

(a) Planning:

(1) Identify special safety studies that may be required during system definition or design.

(2) Personnel requirements both in terms of skills and level of effort required for the safety program during the complete system life cycle.

(3) Establish safety goals and objectives to determine the type of safety input for the overall program. The goals and objectives should be identified in the initial submittal and evaluated at the major milestone reviews.

(i) Goals shall be measurable and state what will be accomplished by performing the various safety tasks.

(ii) Goals shall be structured so that safety tasks can be selected to accomplish them.

(iii)Task results shall clearly demonstrate that the goals have been met.

(b) Organization: The program organization and system safety relationships and responsibilities shall be described along with reporting channels for this task.

The description includes any provisions for independent reporting of issues in addition to the program processes.

(c) Contracting: The identification of the relationships to other program elements, subcontractor, and supplier system safety efforts will be done.

(d) Interface/Coordination: Relationships to other program planning documentation shall be identified to assure proper coordination of activities.

(e) Requirements: Applicable requirements and their sources (programmatic, agency or other) shall be listed.

(f) Analysis: The plan shall stipulate hazard analysis methodologies and their intended application. System Safety analysis strategies shall define:

(1) Concept trade studies (Initial hazard identification and recommended design alternatives).

(2) Utilization of Hazard Analysis (HA) results in the design development and the process to assure the analysis maintains currency with the evolving system and program requirements.

(3) Inputs to test and system verification activities.

(4) Definition of operational system safety requirements:

(i) Redundancy.

(ii) Reliability analyses relationship to Hazard Reports (HRs).

(iii) Technical and engineering.

(g) Safety review and certification process: The plan shall address safety review and certification processes that apply to the USDV.

(h) Risk assessment: The description of the role of system safety in the program risk management process shall address:

(1) The review of pertinent historical safety data from similar systems.

(2) The utilization of Hazard Analysis and related safety assessments. This shall include the process for recommending corrective action or alternatives to the appropriate management level for a decision to either eliminate the hazard or accept the risk.

(3) The program definition for acceptable or residual risk. If the risk management process allows for risk acceptance at varied levels, the plan shall address the role of system safety at each level and in the notification of risk acceptance to the program manager.

(i) Reporting: The implementation of the requirements for reporting System Safety activities and products shall be provided at program milestone review.

(j) Mishap investigation: The role of System Safety in the investigation, development of corrective actions and the application of lessons learned. Provisions for supporting related NASA activities in the investigation process.

(k) Data retention: Planning for the maintenance of the system safety documentation shall be identified. Data documentation shall include safety risk acceptance rationale and the associated supporting information.

2. Reliability Analysis Development and Probability Risk Assessment (PRA) Support

Plan Provide full details of reliability and PRA support organizations, plans, processes, modeling and analyses used to accomplish higher system reliability and safety to meet USDV mission needs. Also describe the approach to designing in reliability starting from the conceptual design stage and its progressive improvement throughout the life cycle of the system. Include the following:

(1) Provide details of the Contractor organizational structure of Reliability and PRA teams with reference to other organizations such as Design Engineering, Systems Engineering and others, including interactions and interfaces with those disciplines.

(2) Provide details of how the Contractor intends to perform and document a systematic review and evaluation of all Contractor reliability aspects of hardware design, development, manufacture, operation.

(3) Provide details for how single point failure(s) are identified and communicated to NASA via the ISRP

(4) Provide details of how reliability and PRA support processes are integrated into the design function to improve system/subsystem reliability by influence the design as part of the systems engineering model, risk management, and other processes, assessments and analyses.

(5) Identify ground-rules and baseline design assumptions, and planned reliability tools, including those for Probabilistic Design Analysis (PDA) and structural reliability. Identify data assumptions, attributes of the model (including level, assumed relationships, etc.), timelines modeled, and capabilities modeled. Identify the method to be utilized in verification of the models provided the Government has access to this material.

(6) Provide details on how the Contractor supports the development of the NASA ISS Program PRA.

(7) Define the scope, content, approach, ground rules and assumptions that the Contractor will utilize in the development and performance of reliability predictions and allocations for the USDV. The plan shall address the methods to be utilized along with any specific modifications to these methods. It shall also address data sources and model/data validation. The plan shall address the schedule and method for Baysian updating. The plan shall address the method for maintaining systems engineering models that are compatible with the risk model developed as part of the probabilistic risk assessment to estimate and allocate component, subsystem, and human reliability values throughout the operation of the system and new developments as they occur.

(8) Provide a roadmap of quantitative reliability assessments to support the program reliability requirements, risk evaluation and reduction efforts.

Included in this roadmap shall be an identification of tests used to anchor reliability models, to anchor reliability growth predictions, and to evaluate the effectiveness of failure mode risk mitigation achieved from design, fault detection and isolation, health management systems, and system maintenance. The quantitative reliability assessment roadmap shall also identify reliability metrics to be assessed and the details of the reliability growth modeling approach. The roadmap can reference internal contractor/vendor procedures, processes and controls including EEE parts selection and control, data sources, studies, etc.

(9) Provide process details of compliance to verification details of key Contractor reliability and PRA tasks.

(10) Document how a Contractor data collection system to support reliability and PRA performance evaluation throughout the USDV life cycle will be established and maintained.

3. Software S&MA Plan The Contractor’s Software S&MA Plan (SSMAP) shall describe the Safety, Quality Assurance, Reliability, Verification and Validation, Independent Verification and Validation, Certification, and Configuration Management activities for all computer software programs including the software portion of the firmware and complex electronic devices. The Contractor shall describe an approach to safety critical software in accordance with NASA- STD-8719.13C, NASA Software Safety Standard. The Contractor’s SSMAP shall also describe implementation of a Software Quality Management System in accordance with AS9115, Quality Management Systems – Requirements for Aviation, Space and Defense Organizations - Deliverable Software (Supplement to AS9100) and an IEEE 730-2014, Standard for Software Quality Assurance Processes, compliant Software Assurance Plan. The

Contractor’s software assurance plan shall use NASA-STD-8739.8 section 6, 7.1, 7.2, 7.3, 7.4, and 7.5 as a guide.

These SSMAP activities shall provide evaluations of the software lifecycle, including patches and updates, and assess the resulting software and associated documentation to assure compliance with Contractor requirements and applicable software development plans, as well as conformance to software safety and software assurance requirements.

The SSMAP activities shall also assure standards and procedural controls are established and implemented; audits, evaluations, and reviews are accomplished; procedures are followed;

and all assurance activities are performed as scheduled.

The SSMAP shall address Verification and Validation (V&V) and show how Contractor Software Assurance will collect and maintain records during the V&V efforts and provide objective evidence to NASA. The Contractor’s SSMAP shall ensure verification and validation activities satisfy functional, performance, and other requirements and that each phase of the development process has been performed and yields the right products.

The Contractor’s plan shall ensure products requiring certification in accordance with Contractor software development plan meet the following prerequisites:

1. Verification the products were developed and supported according to an approved process.

2. Verification all software products are present, complete, current, and controlled and no open nonconformances exist which are safety or mission critical.

3. Validation the software products meet all the appropriate requirements including safety and reliability requirements.

4. Validation the software products meet the requirements contained in a joint integration verification and test plan.

The Contractor’s SSMAP shall address if third-party IV&V is to be performed for USDV, and if so, provide a description of what IV&V is planned.

The SSMAP shall also describe the following aspects in accordance with NASA-STD- 8739.8:

(a) Software Documentation.

(b) Software Problem Reporting and Corrective Action.

(c) Software Risk Management.

(d) Software Assurance Program Metrics.

(e) Software Assurance Records.

(f) Training.

(g) Software Security Assurance.

4. Quality Assurance The Contractor’s Quality plan shall describe the Contractor’s internal quality requirements, Quality organization including structure of management interfaces, and quality methods employed to ensure product and service quality. The Quality Plan shall also describe the philosophy and approach for implementation of the planned quality activities, including details of responsibilities and controls. This may reference the Contractor’s current Quality System Manual, procedures, and work instructions, such as by an outline, cross-reference matrix, etc. The Contractor shall provide access to their Quality System Manual and first-tier procedures for review by NASA.

a) Contractor documented quality management system shall meet the intent of each element of the SAE AS9100.

b) As a minimum, the subparagraphs below shall be addressed by the present documented quality management system or subsequent submittal of a quality plan to include details of responsibilities and controls to adequately describe the specific quality assurance activities related to hardware being procured:

1) Customer Quality Requirements – include hardware specific and application-specific (i.e., iterative developments, astronaut training, product transportation, and mission operations support) quality requirements imposed by contract or component/equipment specification (i.e., traceability requirements, specific inspection points, specific quality activities including Government surveillance and inspection processing).

2) Responsibilities – describe which Contractor organizations are responsible to perform the applicable quality management system activities.

3) Article, Material, and Service Controls – describe the level of article, material, and service control including traceability requirements invoked by the Contractor for the articles, materials, and/or services used in or performed as part of the hardware design and maintenance criteria, including how quality is assured for each material, part, assembly, and/or service performed.

4) Procurement – For all types of materials/parts/components the Contractor purchases include the quality management system requirements used for various acquisition types (e.g., systems, parts, materials, special processes);

design and construction quality control requirements; the level of control exercised over the suppliers including how suppliers are approved, monitored, and maintained with controls for supplier nonconformances processing; and how externally sourced materials and products are certified as conforming prior to integration into systems.

5) Milestone Reviews – describe how the Contractor’s quality system supports milestone reviews.

6) Configuration Assurance – describe how the configuration of the hardware build is compared and verified to the approved design baseline drawings and specifications. Describe how the configuration of Government Furnished Property/Equipment is maintained.

7) Special Process Controls – describe special process controls implemented for in-house processes and, if applicable, for sub-tier supplier processes.

8) Inspection and Test (describe who is be responsible to perform inspections to include any restrictions) – include: how the quality of purchased items is validated at receiving inspection or at sub-tier suppliers’ facilities, specific in-process (manufacturing) inspections performed, details of final inspection, functional and environmental test monitoring details, and pre-ship inspections.

When applicable, provisions shall be included for development of site quality plans for major end item test and flight test.

9) Nonconforming Product (Material Review Board Process) - describe the process of convening a nonconforming product material review board to disposition nonconforming product using a defined board of qualified personnel including Contractor quality assurance personnel and customer representatives. MRB limitations within the Performance Work Statement (PWS) and membership qualification shall be defined. An MRB membership listing shall be submitted within the quality plan or by contract letter.

10) Flight Operations, Refurbishment, and Reuse – when applicable, describe how the Contractor’s quality assurance system is implemented for flight operations, refurbishment, and reuse.

11) Record Retention – for those records not delivered to NASA, specify which records are required to be kept, who keeps them, for how long, and how they are to be dispositioned at the end of the retention period, and/or as specified in the contract.

12) Hazard Analysis - Assure that work authorizing documentation includes inspection verifications for any hardware developed by the Contractor that is traceable to any specific hazard analysis.

13) Verification of Key Characteristics - Assure that the verification of Key Characteristics associated with hazards (catastrophic or critical) involving Critical Items are verified by personnel independent of those performing the work (e.g., Quality Assurance)

14) The SMA plan shall identify the suppliers compliance with personnel training and certification requirements in accordance with, and when required by, the applicable technical standards for the work being performed (e.g., manufacturing, test, inspection), prior to performing that work (e.g., calibration, soldering, electrical harness installation, nondestructive evaluation, process witnessing, product inspection).

15) Training and Certification - Assure that personnel performing operations or inspections are properly trained and/or certified, (e.g., electronic workmanship, welding, soldering, non-destructive evaluation, leak testing) and maintain their proficiency.

The Contractor’s Quality Plan shall also describe their approach to:

1. Quality Workmanship Standards to be used

2. Metrology and Calibration

3. Foreign Object Debris Control

4. EEE Parts Control

5. Electrostatic Discharge Control

6. Limited Life Items

7. Configuration Management System

8. Processes and Products

9. Counterfeit Clauses

a. Guarantee of Product Source(s)

b. Test and Inspection Requirements

c. Product Impoundment and Financial Responsibility

10. Government Source Inspection (GSI)

11. Government Right of Access

12. Limited Operating Life Items

13. Non-destructive Inspection (NDI)/Non-destructive Test (NDT) Certification

14. Nonconformance Approval

The Contractor’s plan shall address how the requirements in SOW Paragraph X.X.X will be met to provide NASA audit schedules, audit reports, and As Build Configuration Lists for the

USDV.

5. The NASA Advisory and GIDEP Problem Data Sharing and Utilization Program

Documentation and Reporting Implementation Plan The GIDEP implementation plan shall describe how Contractor and sub-tier implementation procedures are accomplished for NASA Advisories, GIDEP Notices and other Notices are prepared and responded to in accordance with NASA Policies and GIDEP Operations Manual.

The GIDEP implementation plan shall describe how NASA Advisories, GIDEP Notices and other Notices are prepared and responded to in accordance with NASA Policies and GIDEP Operations Manual. The plan will address the following:

a. Contractor initiated GIDEP Notices shall:

1. Address essential detail required identifying problem types and/or manufacture’s name, special requirements and environments, the problem situation (condition) and cause, actions taken and recommendation. Such data shall be restricted to objective, factual information.

2. Names of responsible individuals and organizations that may be contacted for further technical details.

3. How contractor initiated GIDEP Notices that are of general concern will be coordinated with NASA-JSC Advisory Coordinator, and how the Contractor or its sub-tier contractor will complete the appropriate GIDEP Form and submit to GIDEP, in accordance with the GIDEP Operations Manual.

4. How the contractor will collaborate with the NASA-JSC Center Advisory Coordinator to generate and coordinate NASA Advisories utilizing the NASA Advisory Reporting System (NARS).

Note: NARS will coordinate the NASA concurrence (i.e., legal and export control) in accordance with NASA policies.)

5. How the contractor will respond to the NASA Advisory, Notices and Alerts, Distribution and Response Tracking System (NANADARTS), https://nanadarts.nasa.gov/ to NASA Advisories, GIDEP and other Notices with one of the following categories:

a. No Usage,

b. Usage with No Impact along with rationale/justification for continued usage/corrective action

c. Usage with Impact including rationale/justification and corrective/preventive action.

6. How the contractor shall keep NASA Program and Center Advisory Coordinator informed of open, on-going investigations, counterfeit, undetermined or suspected usage.

7. Follow-up reports on results of investigations, analyses, etc. may be extended beyond the allowed working days for the initial report upon request to https://nanadarts.nasa.gov/. NASA Advisory. GIDEP, and other Notices may be closed out if no corrective action required; and

8. No response required on NASA Advisory, GIDEP, and other Notices distributed by NANADARTS as ‘Information Only’ unless usage is identified.

9. Cost data shall be gathered and provided upon request. This data may be used in support of criminal investigations.

10. Contracted initiated GIDEP Notice – The proposed GIDEP Notice will be coordinated with the NASA-JSC Advisory Coordinator as defined in the GIDEP implementation plan.

11. Should the situation arise of immediate urgency and there is insufficient time to process a GIDEP Notice, a NASA Advisory may be utilized with the pre-coordination of the NASA-JSC Coordinator. Subsequently, the Contractor shall follow-up with the appropriate GIDEP Notice, as necessary, in accordance with the GIDEP Policies for dissemination to all GIDEP participants.

The contractor shall ensure a procedure is in place to support all NASA Advisory and GIDEP information to include:

2. Documentation of the current implementation procedures and NASA Advisory and GIDEP policies.

3. B. Procedures to ensure released NASA Advisory and GIDEP information is gathered, tracked, reviewed, captured and retained in a contractor electronic database for applicability to ensure factual investigation and reporting of suspect parts.

4. Logistics parts tracking, tagging, segregation, and retention of suspect parts or material in the custody of the Contractor pending final disposition instructions from the Contracting Officer or Contracting Officer Technical Representative with concurrence from the NASA-JSC Advisory/GIDEP Coordinator.

The Contractors’ format is acceptable for their internal implementation plan. GIDEP Notices are to be prepared on the appropriate GIDEP form in accordance with the GIDEP Manual and Policies and Procedures. NASA Advisories are to be coordinated with the NASA-JSC Advisory Coordinator utilizing NARS. The contractor’s format is acceptable for providing the task management, control, and tracking status, provided it includes all the necessary information (NASA Advisory/GIDEP Notice number, disposition status, part numbers affected, the system affected, a risk analysis along with a mitigation plan for acceptance of, continued usage, and/or corrective/preventive action).

The contractor shall ensure a procedure is in place to support all NASA Advisory and GIDEP information to include:

1. Documentation of the current implementation procedures and NASA Advisory and GIDEP policies.

2. B. Procedures to ensure released NASA Advisory and GIDEP information is gathered, tracked, reviewed, captured and retained in a contractor electronic database for applicability to ensure factual investigation and reporting of suspect parts.

3. Logistics parts tracking, tagging, segregation, and retention of suspect parts or material in the custody of the Contractor pending final disposition instructions from the Contracting Officer or Contracting Officer Technical Representative with concurrence from the NASA-JSC Advisory/GIDEP Coordinator.

Remarks: N/A

Maintenance: N/A

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