Effective Date: March 12, 2021
Expiration Date: March 12, 2026
|| TOC | ChangeHistory | Preface | Chapter1 | Chapter2 | Chapter3 | Chapter4 | Chapter5 | Chapter6 | Chapter7 | Chapter8 | AppendixA | AppendixB | AppendixC | AppendixD | AppendixE | AppendixF | AppendixG | ALL ||
4.1.1 Project Managers shall establish and execute the Project QA program that provides mission success assurance for the defined crew safety, technical, programmatic, regulatory, and other stakeholders’ objectives (e.g., do-no-harm) and that is commensurate with the program’s or project’s risk posture. Hereafter, these objectives will be referred to as mission success objectives.
4.1.2 The Project Managers shall develop the QA program that addresses the requirements herein and the following as a minimum:
a. Using risk-informed selection and use of the requirements, controls, and practices, herein, that maximize conformance of hardware attributes and process attributes considered to be critical for meeting mission success objectives. See NPR 8715.3 for the roles and responsibilities associated with requirements tailoring and safety and mission assurance (SMA) technical authority (TA).
b. Personnel safety during development as well as during the mission.
c. Consideration of relevant quality specifications, controls, and verification methods when managing technology readiness and manufacturability of designs.
d. Designs and product selections that consider supplier quality and market availability risks in designs and product selections.
e. Use of appropriate FAR and NFS clauses in contracts and purchase orders that enable effective flow-down of technical requirements and execution of GCQA functions.
f. The roles and responsibilities of those who will execute the plan.
4.1.3 The Project Manager shall:
a. Document the project quality program requirements in an SMA plan (SMAP) or a document that is referenced by the SMAP (e.g., mission assurance requirements (MAR) document), hereafter referred to as the Project QA Plan.
Note: Quality requirements considered to be of the programmatic type, as defined by NPR 7120.5, are usually contained in the program- or project-specific engineering documentation and requirements of the institutional type, as defined by NPR 7120.5, are contained in the SMAP.
b. Provide sufficient detail and organization in project QE and QA documentation to enable contracting officers (CO) and procurement authorities to fully specify the appropriate QA requirements on procurement contracts, task orders, and purchase orders (See 5.1, Requirements Flow-Down).
c. Obtain concurrence from the Center-level SMA TA for the Project QA program requirements prior to their flow-down to suppliers.
4.1.4 Critical Items and Processes Determination. Project Managers shall:
a. Manage criticality identification by:
(1) Ensuring that the method used to identify critical items and processes are controlled, documented, and communicated to suppliers and personnel responsible for executing the project QA plan (for additional information, see Criteria for use of contract quality requirements, 48 CFR § 46.203). See Appendix A for the definition of critical.
(2) Flowing down relevant requirements to suppliers when their input is necessary for identifying critical items or processes and associated technical specifications.
(3) Considering the criticality of items and processes used in mission development activities and products (e.g., consumed materials, ground support equipment, launch operations processes, aircraft modifications and maintenance, laboratory evaluation processes, test and verification processes, repair processes).
Note 1: Criticality derives from importance with respect to achieving a mission objective (e.g., crew safety, technical (engineering or science), programmatic (cost and schedule), regulatory, other stakeholders’ (hosts’ requirements)) and may be identified incrementally over the mission life cycle.
Note 2: Disseminating the assigned hardware criticality categorization (e.g., crew-safety-critical, science-critical, regulatory-critical) to project team members and suppliers may be necessary for their understanding of risk ownership and thus context for risk-based decision making.
Note 3: It is common to classify all mission hardware as crew-safety-critical or mission-critical thereby enabling use of a single set of QA requirements for all hardware developments and acquisitions. Programs and projects are cautioned to recognize the programmatic burden of resolving quality gaps for items that have been classified as critical by default but when failing to adhere to quality requirements will not create an unacceptable mission risk. This result is likely to distract resources from more important problems.
Note 4: The strategies for determining item (i.e., hardware) or process criticality should consider: i.) system-level design to determine the relationship of item failure to a catastrophic safety outcome or to mission failure due to a quality defect, and ii.) the threat a quality defect places on the project’s resources if the item is to be redesigned, rebuilt, or replaced during development to overcome a nonconformity. Common techniques for determining hardware criticality include hazard analysis, and design and process failure modes, and effects analyses (FMEAs) though these alone may not be sufficient and other objective or subjective assessment criteria may be needed.
4.1.5 Quality Data and Records Management
18.104.22.168 Project Managers shall collect, organize, and analyze data to achieve the following objectives:
a. Demonstrate quality conformance.
b. Record nonconformances over the entire mission development life cycle (for additional information, see Contract administration office responsibilities, 48 CFR § 46.104(c)). Also, see 6.3, Managing Quality Nonconformances.
c. Provide efficient traceability to and identification of material, component, and subsystem configurations and quality pedigrees for rapid identification of current levels of requirements compliance and impacts from known and emerging quality problems (e.g., GIDEP alerts, counterfeit items, fraudulent material certifications, faulty designs, and qualification failures).
d. Support the version integrity of QA products such that they are consistent with the project’s configuration management (CM) plan. For additional information, see NPR 7123.1, NASA Systems Engineering Processes and Requirements, for program and project CM requirements.
4.1.6 Personnel Credentials. The Project Manager shall include requirements in the Project QA program for personnel that achieve:
a. Personnel training or certification, in accordance with, and when required by, the applicable technical standard 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).
b. Prohibition of personnel performing QA verifications on their own work (e.g., procedures, fabrication, testing).
4.1.7 Quality Implementation Plans. The Project Manager shall include requirements in the Project QA program for development and delivery of QA implementation plans by the suppliers that:
a. Indicate how project-unique quality requirements and product, process, and verification specifications will be accommodated within or in addition to the supplier’s existing QMS. A compliance matrix is recommended for efficiently communicating the supplier’s recognition and handling of the quality requirements that have been flowed to them.
b. Communicate the intended use and sequence of manufacturing processes, tests, and inspections.
c. Communicate how the Supply Chain Risk Management requirements of Chapter 5, Supply Chain Risk Management for Mission Acquisition Items, will be met.
The technical standards adopted by NASA for quality engineering and quality assurance are listed in Table 4.1. Project managers shall include these standards and the requirements therein, or alternate equivalent technical requirements and standards in the Project QA program. These technical standards are referred to in several sections of this directive because they are relevant to a variety of product development activities (e.g., design, process development, personnel training, and quality assurance).
Table 4.1 NASA Adopted Technical Standards for Quality Engineering and Quality Assurance
|NASA-STD-5009||Nondestructive Evaluation Requirements for Fracture Critical Metallic Components|
|NASA-STD-6016||Standard Materials and Processes for Spacecraft|
|NASA-STD-8739.1||Workmanship Standard for Staking and Conformal Coating of Printed Wiring Boards and Electronic Assemblies|
|NASA-STD-8739.4||Crimping, Interconnecting Cables, Harnesses, and Wiring or IPC IPC/WHMA-A-620B-S, Space Applications Electronic Hardware Addendum to IPC/WHMA-A-620B|
|NASA-STD-8739.5||Fiber Optics Terminations, Cable Assemblies, and Installation|
|NASA-STD-8739.6||Implementation Requirements for NASA Workmanship Standards|
|NASA-STD-8739.10||Electrical, Electronic, and Electromechanical (EEE) Parts Assurance Standard|
|NASA-STD-8739.12||Metrology and Calibration|
|NASA-STD-8739.14||NASA Fastener Procurement, Receiving Inspection, and Storage Practices for NASA Mission Hardware|
|ANSI/ESD S20.20-2014||ESD Association Standard for the Development of an Electrostatic Discharge Control Program for Protection of Electrical and Electronic Parts, Assemblies, and Equipment (Excluding Electrically Initiated Explosive Devices)|
|IPC J-STD-001GS||Joint Industry Standard, Space Applications Electronic Hardware Addendum to IPC J-STD-001G Requirements for Soldered Electrical and Electronic Assemblies (Chapter 10 of IPC J-STD-001GS does not apply)|
|IPC/WHMA-A-620C-S||Space Applications Electronic Hardware Addendum to IPC/WHMA-A-620C|
|NAS 412 Revision 1||Foreign Object Damage/Foreign Object Debris (FOD) Prevention|
|SAE GEIA-STD-0005-1A||Performance Standard for Aerospace and High-Performance Electronic Systems Containing Lead-free Solder|
|SAE GEIA-STD-0005-2A||Standard for Mitigating the Effects of Tin Whiskers in Aerospace and High-Performance Electronic Systems|
|SAE AS5553C||Counterfeit Electronic Parts; Avoidance, Detection, Mitigation, and Disposition.|
|SAE AS6174A||Counterfeit Materiel, Assuring Acquisition of Authentic and Conforming Materiel|
Using proactive quality control and quality assurance techniques is recognized to be the most impactful quality assurance strategy for meeting programmatic mission objectives and for reducing long-term technical risks presented by quality escapes and latent defects in reworked and repaired hardware. This is referred to as “building quality in.” These techniques maximize manufacturability and leverage established quality controls as an integral part of the design phase. While the QA program will not be the source of hardware or process designs directly, the QA program will apply applicable controls and assurance techniques that result in designs that transfer readily to manufacturers, where process controls can be readily specified and for which verification methods are available and perceptive of relevant defects. Examples of the types of quality controls addressed in this section for design assurance are documentation of specifications, leveraging NASA-adopted technical standards, qualification for new processes, and supply chain risk management. Quality assurance is applied in the form of reviews or assessments of engineering documentation and manufacturing processes. This section establishes the techniques to be used; however, it does not prescribe a particular level of quality assurance surveillance. All uses of quality assurance surveillance are expected to be risk-based with priority given to safety-critical hardware and process attributes (related to crew safety objectives or to Occupational Safety and Health Administration regulatory objectives).
4.3.1 Design Considerations and Technical Specifications. In the Project QA program, the Project Manager shall address the requirements in paragraphs a. and b. and the relevant requirements in the technical standards listed in Table 4.1 to ensure the design, construction, and verification specifications are defined, documented, and can be achieved with low programmatic risk. The design, construction, and verification specifications both inform, and are derived from, the design process.
a. Design, construction, and verification specifications are documented both in engineering documentation (e.g., data sheets, technical specifications, drawings, procedures) and by reference to technical standards. Design, construction, and verification specifications are used to determine product quality conformance.
b. The design, construction, and verification specifications are specified in a manner that enables their effective flow-down to work groups and suppliers within and outside of NASA in a manner that:
(1) Maximizes efficient acquisition of parts and materials.
(2) Maximizes manufacturability.
(3) Achieves reliability objectives.
(4) Achieves item-quality conformance.
(5) Provides a basis for physical configuration verification.
Note: The limited scope of coverage by the technical standards listed in Table 4.1 is not intended to relieve programs, projects, developers, and manufacturers from adequately defining and identifying design, construction, and verification specifications. For new designs, materials, and manufacturing methods, quality engineering activities are expected to produce unique and technically applicable design, construction, and verification specifications when available technical standards are insufficient.
4.3.2 Retrievable Engineering Documentation. Project Managers shall ensure that personnel performing QE and QA functions have routine access to, and knowledge of, the design, construction, and verification specifications when necessary to perform their work.
4.3.3 Identify Verifications and Tests. The Project Manager shall ensure that the Project QA program includes the requirements in a. through d. for the use of fully developed tests and inspections to evaluate item and process quality conformance, both during production (i.e., in-process) and at the point of acceptance or certification (i.e., end-of-line).
a. Prior to production, the verifications (i.e., tests and inspections) that will be used to evaluate product or process conformance are documented (for additional information, see Contractor responsibilities, 48 CFR § 46.105.(b)).
b. The minimum qualification and verification requirements are specified in a manner that enables their effective flow down to work groups and suppliers within and outside of NASA.
c. Reporting requirements for verification results and data are defined including those applicable to the party responsible for performing the test or the verification (for additional information, see 48 CFR § 46.104(e)).
d. Personnel performing QE and QA functions have routine access to knowledge of the verifications and pass/fail criteria that are required when it is necessary for performing their work.
4.3.4 The Project Manager shall include the following requirements in the Project QA program:
a. Compliance with the following for control of Pb-free materials:
(1) Conformance by suppliers with the criteria of SAE-GEIA-STD-0005-1A and SAE-GEIA-STD-0005-2A using control level “2C.”
(2) Extension of Pb-free controls to non-critical items when necessary to mitigate the risk of metal whisker growth on, and liberation from, a non-critical item affecting critical item performance during a mission.
b. Fasteners and fastener supplier selection comply with NASA-STD-8739.14. See NASA-STD-8739.14 for further explanation of hardware applicability.
c. Compliance with NASA-STD-8739.12 for the following:
(1) Measurements affecting safety and mission success.
(2) Calibration services providers.
4.3.5 Supplier Risk Assessment and Selection. The Project Manager shall include the following requirements in the Project QA program:
a. In addition to the requirements in NPR 8735.1, the NASA supplier assessment system (SAS; https://sas.nasa.gov) is used for supplier prescreening. Additional supply chain risk management processes may also be used such as certified or qualified supplier lists and risk assessments based on previous or current GCQA activities. This requirement cannot be flowed down to non-NASA project offices.
b. A pre-award supplier audit, assessment, survey, or equivalent, is used to evaluate supplier risk where no prior record can be referenced in SAS or in a Government or NASA Center supplier qualification or certification system, or where the prior audit, assessment, survey or GCQA records are older than three years. This requirement cannot be flowed down to non-NASA project offices.
4.3.6 Design Risk Mitigation. The Project Manager shall address the following design review considerations in the Project QA program to identify and mitigate design specifications that create manufacturability, delivery, or performance vulnerabilities:
a. The critical design and process specifications, limits, controls, acceptance criteria, and physical attributes:
(1) Are fully defined and documented in the engineering documentation.
(2) Are addressed by engineering as being complementary across system interfaces and are complementary with planned manufacturing methods, processing methods, and test conditions.
(3) Are addressed by engineering as providing the required mission hardware reliability given the materials and manufacturing methods used, including consumed materials (e.g., gasses, soldering flux, and solvents).
(4) Remain traceable to product or process qualifications (i.e., design remains qualified with accumulation of “red line” changes to engineering documentation).
(5) Provide safety margin against unexpected variations in production processes or exposures to other stress conditions during production, integration, and test (i.e., design for manufacturability).
b. The item and its constituent subassemblies, parts, and materials have a high likelihood of availability in the supply chain through original equipment manufacturers or authorized distributors.
4.4.1 The Project Manager shall include in the Project QA program, the production quality control requirements in a. through m. below:
a. Configuration controls are used to provide uninterrupted identification and traceability for manufactured or processed items and their constituent materials, parts, processes, and subassemblies, following integration into higher level assemblies.
b. Identification and traceability controls cross-reference to objective evidence of conformance (i.e., hardware quality records) including certificates of quality conformance, production history, qualification and verification results, and usage history.
c. Preservation of records traceability for QA functions (e.g., document reviews, witnessing, and inspections) to the following:
(1) The personnel who performed the function.
(2) The date the assurance work was performed.
(3) The results of the assurance work.
(4) Item marking and tagging and other configuration identifiers.
(5) Other related paper and electronic data records.
(6) Records or documents that define system configuration.
d. External (non-NASA) suppliers maintain a configuration management system that adheres to the principles of SAE EIA-649-2, Configuration Management Requirements for NASA Enterprises.
e. Record-keeping methods provide the research expediency needed to minimize programmatic impacts from known and emerging quality problems (e.g., GIDEP alerts, counterfeit items, fraudulent material certifications, faulty designs, and qualification failures).
f. Identification and marking schemes are established and implemented that provide positive methods for differentiating conforming product from nonconforming product.
g. Identification and marking requirements are flowed down to and implemented by the supplier.
h. Production instructions (i.e., work packages, travelers) provide sufficient detail to fully communicate the sequence of steps, the procedures to be used, process control specifications, first-party hold and inspection points, inspection and test methods, product design specifications, acceptance criteria, and second party hold and inspection points.
i. Production instructions are used for all manufacturing and processing operations including maintenance, rework, and repair.
j. The integration of design and manufacturing processes provide effective flow down of changes to engineering documentation (i.e., red lines).
k. Special Process Qualification. Process qualification is used to demonstrate manufacturing process capability where in-process Government surveillance, end-item inspection, or tests before or after acceptance are insufficient for mitigating the risk of accepting items with latent defects; for mitigating the risk of damaging high-value Government-furnished items; and for mitigating programmatic risk due to low process yield or production of defective product. See 6.5 for managing risks associated with process changes.
l. Preservation of Product. Hardware item quality and accumulated quality pedigree is preserved during production, operations, handling, storage, and shipping by process controls that prevent:
(1) Inadvertent damage due to unapproved operations or failure to follow procedures.
(2) Chemical and particulate contamination.
(3) Incursion of Foreign Objects Debris (FOD). The requirements of NASA-STD-6016 require suppliers to develop a FOD control plan that is consistent with the guidance found in NAS 412 Revision 1.
(4) Poor tool, fixture, and equipment controls.
(5) Nonconforming environmental controls, both of ambient and test environments.
(6) Nonconforming item handling, packaging, storage, and shipping materials and processes.
(7) Damage due to uncontrolled ESD. The technical standards in Table 4.1 define the minimum ESD sensitivity level for which a control program is required.
m. All personnel are empowered to stop work when conditions exist that pose imminent threat to human safety and to the preservation of mission hardware.
4.4.2 Production Readiness Review (PRR). PRRs are typically used to mitigate programmatic risk where production errors, due to insufficient quality controls or engineering documentation errors, are likely to create product defects. For additional information, see Appendix F for recommended entrance criteria and success criteria for PRRs that enhance the criteria in NPR 7123.1, Appendix E.
4.5.1 The Project Manager shall include the requirements in a. through l. in the Project QA program to provide assurance of quality requirements compliance during hardware production and processing.
a. Manufacturing, Verification, and Test Procedures. Manufacturing, verification, and test procedures are traceable to product and process technical specifications (i.e., attributes of the design, of process controls, of the verifications and tests, and of pass/fail criteria not otherwise specified in the design specifications).
b. First-Party Verifications. The item supplier performs the inspections and tests invoked by the technical standards in Table 4.1 and, as modified in 4.3.4., Government Mandatory Inspection Point (GMIPs) or other types of QA surveillance functions executed on behalf of the project office are not substitutes for first-party inspections and verifications.
c. First-party test and inspection results are fully traceable to the item configuration specifications, the verification requirements, the item identifications (e.g., lot number, serial number), and the details that are unique to the production flow (e.g., date, operator, production line).
d. Materials and Parts Certification. Using the verifications and tests defined in the engineering documentation, suppliers confirm that the materials and parts considered to be critical items conform with their relevant specifications and requirements prior to their installation into the next higher level of assembly.
e. Quality Conformance for Consumed Materials. Using the verifications and tests defined in the engineering documentation, suppliers confirm that the consumed materials, used when manufacturing or processing critical items, conform with their relevant specifications and requirements prior to use (e.g., gasses, flux, solvents, inks, ESD protective containers).
f. Procedures and Training for Complex Verifications. Specialized training and procedures are provided to inspectors when the verification method is nonstandard and/or depends on unique methods for product handling, using inspection equipment, or discerning defects (e.g., microstructural analyses of coupons or samples, evaluating optical coatings, nondestructive evaluation (NDE), pre-cap inspection of hybrid microcircuits).
g. Second-party In-process Surveillance of Quality Conformance. Second-party QA surveillance of suppliers’ products or processes is used during production (i.e., in-process) when the nature of the item or manufacturing processes prevent sufficient evaluation of quality conformance at the point of product acceptance (i.e., a complex item per48 CFR § 46.203). See AS9100D for requirements for subtier supplier controls. See Chapter 7 for requirements for the use of these types of verifications for GCQA (i.e., surveillance and GMIPs) by Government project offices.
Note: Second-party QA surveillance is expected to be used by customers, regardless of their place in the supply chain, for assuring critical items considered to be complex (see definition of complex item herein) or when indicated by supply chain risk. Second-party QA surveillance is not limited to Government acquirers.
h. Selection of parallel QA surveillance techniques (“insight”) versus mandatory inspection points (“oversight”), and the types of surveillance techniques, are selected based on the criticality of the product or process attribute. See 7.2.2 for requirements for using oversight approaches by the NASA Project office acquirers for assurance of product and process attributes determined to be critical for ensuring the safety of crew and operations personnel for human-rated vehicles and missions.
Note: See NFS 1846.4, Government Contract Quality Assurance, for the definitions of “insight” and “oversight.”
i. For second-party QA surveillance activities, use of a sampling plan versus inspecting 100 percent of the subject population, is based on an assessment of the likelihood of nonconformance and impact to personnel, including crew, operations personnel, production personnel, and to mission success. It is recommended that the risk assessment consider the following:
(1) Supplier inspection results.
(2) Acquirer inspection results.
(3) Hazard analysis controls/mitigation.
(4) Failure modes and effects analysis controls/mitigation.
(5) Design complexity.
(6) Technology maturity.
(7) Process maturity.
(8) Contractor quality system controls and ability to leverage statistical process control (SPC) data.
(9) Metrics related to contractor past performance.
(10) Probabilistic risk assessment.
j. QA surveillance plan(s) (QASP) are used to document how acquirers (e.g., Government project offices, prime contractors) will conduct second-party, in-process QA surveillance, both for activities that do and do not require mandatory approval (i.e., Mandatory Inspection Point (MIP)) to proceed to the next production step. Suppliers' QASPs may be stand-alone documents or contained in the quality implementation plan or in QMS documentation. For Government project offices preparing QASPs, see https://sma.nasa.gov/sma-disciplines/quality for QASP work aids.
Note: Technical and programmatic information is expected to mature in specificity over the life of the project as the technical specification values become known through design approvals, as schedules solidify, and as the supply chain is established through subcontracts and other lower-tier procurements. Therefore, surveillance plans and GCQA Statements of Work are also expected to mature and be refined over the life of the project.
k. The standard second-party QA surveillance functions are the following:
(1) Documentation review. Documentation review assures that procurement and engineering documentation and other types of controlling documentation are traceable to requirements and provide process controls. Examples of documentation that may be included in this type of surveillance activity are:
(a) Part or material certification.
(b) Manufacturing procedures.
(c) Purchase orders.
(2) Process and Test Witnessing. Production process witnessing and test witnessing is used to confirm that the supplier is successfully employing the critical process controls, verifications, and tests defined by engineering documentation.
(3) Review of Production Records. Review of production records, including test data, to provide confidence that production followed the approved procedures, that controls were achieved, and that the supplier’s verifications determined the product to be conforming. Examples of records that may be included in this type of surveillance activity are:
(a) Receiving inspection acceptance.
(b) Results for tests required by the technical standards in Table 4.1 and the engineering documentation.
(c) Connector mate and demate log.
(d) Pressure cycles log.
(4) Inspection. Direct product examination by a quality engineer, quality specialist, or relevant subject matter expert on behalf of the project involves physical inspection, measurement, or test of the production item to ensure conformity to technical requirements. Examples of inspections that may be included in this type of surveillance activity are:
(a) The inspection requirements defined in the standards in Table 4.1.
(b) 100 percent of the bonding test coupons for structural composites.
(c) Component workmanship prior to integration into higher levels of assembly (i.e., pre-closure).
(d) Component quality pre- and post-environmental test.
(e) Repaired printed wiring assemblies.
(f) Items prior to packaging for shipment out of the facility.
(5) Quality Conformance Testing and NDE. In addition to the NDE used to verify product conformance, the project may choose to require product testing or NDE, performed by NASA or a NASA-identified test facility, prior to the point of item acceptance or certification (for additional information, see Contract Quality Requirements, General, 48 CFR § 46.201.(c)).
4.5.2 Product Acceptance. The Project Manager shall include product acceptance process and data delivery requirements in the Project QA program including a. through d.
a. The data the project will use for certifying the quality conformance of mission hardware items (i.e., materials, parts, subassemblies, and components) are specified and include:
(1) Parts and materials conformance certifications.
(2) Records of successful completion of all required inspections and tests including incoming inspections, GMIPs, and acceptance tests.
(3) Statement of as-built configuration’s traceability to requirements.
(4) Record of and resolutions for, all departures from requirements (e.g., deviations, waivers, variances).
(5) Record of all item and process nonconformances and their associated remedial actions (i.e., rework, repair, replace).
(6) Record of non-conformance dispositions of use-as-is and any residual configuration or qualification traceability gaps.
(7) Record of agreement between the Government and the prime contractor for acceptance of nonconforming items (for additional information, see Nonconforming supplies or services, 48 CFR § 46.407.(b).(2)). This requirement applies for production at all levels of the supply chain.
(8) Statement of life left for limited life items.
(9) As-built bill of materials for subassemblies (e.g., parts and materials list).
(10) Photographs for subassemblies and components prior to permanent seal of their enclosure or installation into the next higher level of assembly when they can no longer be inspected.
(11) Shipping and handling instructions.
(12) Terms and conditions for exercising applicable warranties (for additional information, see 48 CFR § 46.7, Warrantees).
Note: See Appendix E for additional data deliverables that may be required of suppliers of critical items.
b. The applicability of the acceptance requirements is defined for development and qualification units.
c. Product certification and Government acceptance requirements are flowed down to external suppliers for use with their subtier suppliers (for additional information, see Subcontracts, 48 CFR § 46.405).
d. Processes are established for collecting, delivering, and retaining objective evidence of item or process conformance by the project and by the supplier (e.g., end item data package, Acceptance Data Package (ADP)). For additional information, see Contract administration office responsibilities and Contractor responsibilities, 48 CFR §§ 46.104(c), 105.(4).
4.5.3 Product Acceptance Data Package Review. The Project Manager shall include in the Project QA program that ADP reviews are used to ensure that the documentation contains records of, or traceability to, objective evidence of product conformance, risks that have not been fully mitigated, and accepted nonconformances and requirement waivers. ADP reviews are conducted with a level of rigor that is commensurate with the items complexity, criticality, and known risks and issues associated with nonconformances and waivers. Highly integrated systems may require formal project-level, multidisciplinary reviews in order to certify or accept the hardware. A QA review of quality documentation and records may be sufficient for less complex items.
4.6.1 Project Managers shall include the quality requirements in a. through c. in the Project QA program to assure quality controls are used and quality conformance is sustained during integration and test (I&T) processes.
a. Assembly and Test Procedures. Assembly and test procedures are traceable to product and process technical specifications (i.e., attributes of design and process control; types of verifications and tests planned for use and their associated conditions and pass/fail criteria).
b. First-Party Inspections and Verifications. The required inspections and tests that are applicable during I&T are performed by the system integrator (e.g., post-install connector inspections). These inspections may also be used for second-party QA surveillance.
c. QA surveillance plan(s) are used to document how in-process QA surveillance will be performed, both for activities that do and do not require project QA signature (i.e., sign-off) to proceed to the next I&T or production step (e.g., MIP). Typical QA surveillance functions during I&T are the following:
(1) Integration of components into higher levels of assembly.
(2) Removals of components from higher levels of assembly.
(3) 100 percent final connector mates at box level and above.
(4) Handling operations involving mission systems and subsystems involving lifts, moves, or preparation for storage or shipping.
(5) Identification and segregation of nonconforming materials and items.
4.6.2 The Project Manager shall provide QA requirements for evaluating test readiness in the Project QA program including those in a. through l. below.
a. Safety procedures are evaluated for completeness.
b. Test procedures are evaluated for completeness.
c. Personnel have adequate training and instructions to execute the procedures.
d. Environmental controls are defined and can be achieved.
e. Mechanisms are in place to limit access to the test area to only required and essential personnel.
f. Mechanisms are in place to ensure cables are grounded to remove static charge prior to connector mating.
g. Mechanisms are in place to ensure connectors are not mis-mated.
h. Test software has been determined to be safe prior to use.
i. Methods are in place for reporting test anomalies.
j. Methods for record keeping are used that accumulate quality conformance data with traceability per 4.4.1.b.
k. Methods for record keeping are used that ensure that mandatory quality verifications are performed prior to moving to the next step.
l. Mechanisms are in place to properly secure hardware to prevent damage during movement and testing.
4.6.3 The Project Manager shall include requirements for physical configuration audits in the Project QA program to ensure persistent traceability of the processed and integrated hardware with design specifications and requirements.
4.7.1 Project Managers shall include the quality requirements in a. through c. in the Project QA program to assure quality controls are used and quality conformance is sustained during launch and mission initiation operations.
a. Process qualification, personnel training, and/or process rehearsals are used to mitigate risks when using new or non-standard processes.
b. First-Party Inspections and Verifications. Quality controls and verifications are defined for launch preparations and execution. Typically, these quality controls are defined and executed by the launch process provider (e.g., commercial, Space Launch Services Program) with the Project QA function participating in a supporting or surveillance role.
c. The QA surveillance plan(s) are used to document how in-process QA surveillance will be performed for launch and mission initiation operations.
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