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NPR 7120.11A
Effective Date: September 08, 2020
Expiration Date: September 08, 2025
Printable Format (PDF)

Subject: NASA Health and Medical Technical Authority (HMTA) Implementation

Responsible Office: Office of the Chief Health & Medical Officer

| TOC | Preface | Chapter1 | Chapter2 | Chapter3 | Chapter4 | Chapter5 | AppendixA | AppendixB | AppendixC | ALL |

Chapter 4. Standards and Requirements Management

4.1 HMTA Requirements Derivation

4.1.1 The LHIC CMO is delegated the authority to represent the HMTA L2 function and convey respective institutional requirements established by law, NASA policy, or other external or internal authority to program and project managers.

4.1.2 The LHIC CMO, in collaboration with other HMTA personnel, such as, CHPOs and Subject Matter Experts (SMEs) shall assess a proposed program or project architecture and their Concept of Operations for HMTA standards applicability, non-applicability, and potential HMTA standards relief (see Figure 4-1).

Figure 4.1 shows HMTA Human System Requirements Derivation
Figure 4-1. HMTA Human System Requirements Derivation

4.1.3 Following the applicability assessment, the LHIC CMO shall assist program and project managers in the development, review, and concurrence of program level human system requirements. These requirements are first instantiations of HMTA standards allocated to systems and subsystems of a proposed architecture.

4.1.4 The LHIC CMO shall maintain appropriate insight to requirements traceability to ensure program and project compliance to HMTA standards.

4.1.5 Prior to providing concurrence of baseline requirements for a program or project, the LHIC CMO shall obtain concurrence from CHMO by providing the following evidence:

a. A list of the HMTA standards identifying whether the standard is:

(1) Directly applicable as written or with modification.

(2) Not applicable.

(3) Indirectly applicable (standard will be imposed by another entity).

b. Rationale for non-applicable standards.

c. First instantiation requirements for each applicable standard.

d. Verification statements for the requirements.

4.2 Adjudication of Requests for Relief from HMTA Standards and Requirements

4.2.1 The HMTA may grant relief from standards and requirements if it is in NASA's best interest. Relief may be granted by the LHIC CMO through requesting a deviation or waiver (see Figure 4-2).

Figure 4.2 shows HMTA Flow for Adjudication of Requests for Relief
Figure 4-2. HMTA Flow for Adjudication of Requests for Relief

4.2.2 Program and project managers may submit requests for relief from HMTA standards and requirements by following the requirements tailoring process described in NPR 7120.5, NASA Space Flight Program and Project Management Requirements and the guidance given in NASA SP-2014-3705, NASA Space Flight Program and Project Management Handbook.

4.2.3 The LHIC CMO shall ensure that prior to approving or disapproving a request for relief, the following evidence is documented and considered:

a. Rationale for the waiver or deviation.

b. Risk assessment characterizing whether the request for a waiver or deviation results in a change in risk.

c. Reference to all material that provides justification supporting acceptance, including programmatic cost and schedule information.

d. List of defined risk mitigation actions/plan, including dates or development milestones for bringing program to compliance or mitigation steps closure.

e. List of all appropriate NASA organizations and SMEs involved in the review of the request for relief.

f. List of all concerns with the request that were expressed during the adjudication process.

g. Name and role of NASA management official accepting the risk and implementing requirements relief.

4.2.4 The LHIC CMO shall adjudicate the request for relief and inform the CHMO of the decision.

4.2.5 The following exceptions to the above policy for requests for relief require CHMO concurrence.

a. Changes to program requirements which increase existing risk posture.

b. Requirements representing high consequence, including:

(1) Crew survival.

(2) Life support.

(3) Abort capability.

(4) Launch escape.

(5) Crew recovery.

c. Other exceptions the CHMO has identified and communicated to the LHIC CMO.

| TOC | Preface | Chapter1 | Chapter2 | Chapter3 | Chapter4 | Chapter5 | AppendixA | AppendixB | AppendixC | ALL |
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