Manufacturing and Quality

Overview

Manufacturing and Quality management share some common characteristics. All programs must develop and then execute their manufacturing and quality (M&Q) plans and strategies, including Producibility. The Government develops a Manufacturing Strategy and a Quality Strategy. The contractor develops a Manufacturing Plan and a Quality Plan.

Three important parts of execution include:

Manufacturing Management Program

A Manufacturing Management Program describes the proven manufacturing management practices. The industry standard for Manufacturing Management is SAE AS6500, ???Manufacturing Management Program.??? The Government???s implementation of SAE AS6500 is detailed in MIL-HDBK-896A, ???Manufacturing Management Program Guide.??? The PMO team should identify the appropriate contract manufacturing requirements.

AS6500 and MIL-HDBK-896A address many requirements including:

A Manufacturing Management Program provides a system to promote the timely development, production, and fielding of affordable and capable weapon systems by addressing manufacturing risks and issues throughout the program acquisition cycle. PMs of programs with a manufacturing component should ensure contractors have a robust manufacturing management system.

Manufacturing management is closely linked to the SE process and the SEP in several ways. First, the manufacturing organization should provide representation to the design function and ensure producibility and inspectability are addressed as design considerations. Manufacturing engineers should provide process capability data to the designers and compare proposed tolerances, materials, and assemblies to current capabilities. Typically, a representative from the manufacturing function must coordinate on designs, indicating the design properly takes these considerations into account. Because of this close linkage to SE, manufacturing personnel should:

Manufacturing should be a TPM for the program, and the program???s strategy for manufacturing should be contained in the program???s SEP. Typical TPMs for manufacturing include:

Quality Management Program

Quality Management describes the proven quality management practices. Example industry standards for Quality Management are SAE AS9100, ???Quality Management Systems,??? and ISO 9001, ???Quality Management Systems Requirements.??? A QMS includes all the functions involved in the determination and achievement of quality. The PMO team should identify the appropriate quality requirements per FAR 46 Quality Assurance and 52 Contract Provisions. Quality planning should include the development of a Quality Strategy (Government) and a Quality Plan (contractor).

Quality Standards (AS and ISO) that can be used by a program to focus on these specific quality areas of concern:

To ensure consistency in applying quality planning and process control, the program should establish a QMS early, ideally at Milestone A (see PM Guidebooks (forthcoming) for more information on Quality Management). The QMS should be defined and documented in the AS. Quality should be integrated into the AS an SE practice that supports the successful transition of a capability to development, then LRIP, FRP, and delivery of systems to support warfighter missions.

The primary focus of the QMS should be to ensure efficiency in processes. The program team should integrate the QMS with Statistical Process Control to eliminate defects and control variation in production.

The PM, Systems Engineer, and Lead Software Engineer should take into consideration that process capability goes beyond machine capability. The process should include the effects of change in workers, materials, fabrication methods, tooling and equipment, setup, and other conditions. Process capability data should be collected throughout process and product development.

Two more valuable tools to assist in creating quality in design are Six Sigma and Quality Function Deployment. Six Sigma techniques identify and reduce all sources of product variation ??? machines, materials, methods, measurement system, the environment and the people in the process. Quality Function Deployment is a structured approach to understanding customer requirements and translating them into products that satisfy those needs.

Quality of Design

Quality of Design focuses on the concurrent development of product and manufacturing processes, leading to a producible, testable, sustainable, and affordable product that meets defined requirements. The design phase is critical because product life cycle costs are committed at this point. The QMS should aid the transition from development to production by controlling and reducing life cycle cost by reducing complexities that are often found when quality is not integrated as a function of the design. Therefore, to achieve high-quality (product characteristics meet specification requirements), an end product should be designed so that:

The objectives of quality design efforts are to:

Quality of Conformance

Quality of Conformance is the degree to which a product or service meets or exceeds its design specifications and is free of defects or other problems that could degrade its performance. The manufacturing, processing, assembling, finishing, and review of the first article and first production units, is where failure or success in the area of quality of conformance is first measured. Any operation that causes the characteristic to be outside of the specified limits will render the configuration of the product different from that which was originally intended, and this could impact cost, schedule, and performance.

Producibility

Producibility is a design accomplishment for the relative ease of manufacturing. Like manufacturing and other system design functions, producibility is integral to delivering capability to the warfighter effectively and efficiently. Producible designs are lower risk, more cost-effective, and repeatable, which enhances product reliability and supportability. Producibility should be assessed at both a product and enterprise (i.e., organizational, prime contractor facility) level. The PM should implement producibility engineering and planning efforts early and should continuously assess the integrated processes and resources needed to successfully achieve producibility.

To assess producibility on a product level, both the product and its manufacturing processes should be assessed. Manufacturing processes should be monitored and controlled, through measurement, to ensure that they can repeatedly produce accurate, high-quality products, which helps the program meet objectives for limiting process variability to a tolerable range.

The PM should ensure that the producibility program focuses on the following five elements to build and maintain a successful producibility system:

  1. Establish a producibility infrastructure:
    • Organize for producibility
    • Integrate producibility into the program???s risk management program
    • Incorporate producibility into the new product strategy
    • Employ producibility design guidelines
  2. Define manufacturing requirements early along with methods to ensure verification and validation of requirements to be met:
    • Determine Process Capability (Cp and Cpk) and Process Performance (Pp and Ppk) as appropriate
    • Understand and document company and supplier requirements and processes
    • Understand and document company and supplier requirements and processes
    • Plan for future process capabilities and performance
  3. Plan for future process capabilities and performance
    • Identify design objectives
    • Identify key characteristics of the design
    • Perform trade studies on alternative product and process designs
    • Develop a manufacturing plan
    • Perform complexity analysis
  4. Address producibility during detailed design:
    • Address producibility during detailed design:
    • Optimize manufacturing plans as the design matures
  5. Measure producibility processes, products and systems.

Quality and Producibility should be a TPM for the program, and the program???s strategy for producibility should be contained in the program???s SEP. Planned producibility engineering activities for previous and subsequent phases also should be summarized in the SEP. As a design accomplishment, producibility should be included in the SEP, mapping key design considerations into the RFP and subsequently into the contract.

Manufacturing and Quality Activities

M&Q considerations begin early in the acquisition process and continue through all acquisition phases regardless of acquisition pathway. Table 5-4 should be used as a starting point to assess appropriate activities regardless of pathway. Detailed considerations for each of the pathways are provided in the Engineering of Defense Systems Guidebook. Often M&Q activities are driven by other functional types. For example, the procuring contracting officer in developing the contract and RFP may look to M&Q personnel for Section L and M criteria. Financial personnel may ask M&Q personnel to support Government independent cost estimates, or to evaluate contractor cost proposals, or to monitor production costs. Additional information on required M&Q tasks and activities can be found at https://ac.cto.mil/maq/.

Table 5-4. M&Q Activities by Phase

Acquisition Phase Typical Manufacturing and Quality (M&Q) Activities

Materiel Solution Analysis (MSA)
  • Participate in Analysis of Alternatives (AoA) and provide inputs to the draft Capability Development Document (CDD).
  • Provide inputs to the draft Acquisition Strategy (AS) and Systems Engineering Plan (SEP), and develop Manufacturing Plan, Manufacturing Strategy, Quality Plan, and Quality Strategy.
  • Support development of the draft Request for Proposals (RFP), review contractor proposals, and support cost estimating and tracking.
  • Review and provide inputs to the Life Cycle Sustainment Plan (LCSP), Test and Evaluation Master Plan (TEMP), Integrated Master Plan (IMP) and Integrated Master Schedule (IMS).
  • Support all program and technical reviews and audits (Alternative System Review (ASR), Manufacturing Readiness Assessment (MRA), and Independent Technical Risk Assessment (ITRA)).

Technology Maturation and Risk Reduction (TMRR)

  • Participate in prototyping and design development through the Integrated Product Team (IPT) structure to identify and mitigate M&Q risks in the product to be developed in the next phase.
  • Inputs to AS, SEP, final CDD, TEMP, LCSP, IMP/IMS, and draft RFP. Develop, implement, and monitor M&Q plans.
  • Support prototype build and testing; assess manufacturing readiness (Manufacturing Readiness Level (MRL) 6).
  • Support all program and technical reviews and audits (System Requirements Review (SRR), System Functional Review (SFR), Technology Readiness Assessment (TRA), MRA, ITRA, and Preliminary Design Review (PDR)).
  • Support development of the draft RFP, review contractor proposals, and support cost estimating and tracking.

Engineering and Manufacturing Development (EMD)

  • Participate in trades, manufacturing technology, and design development activities through the IPT structure.
  • Provide inputs to the AS, SEP, Corrosion Prevention and Control (CPC), LCSP, IMP/IMS, and draft RFP. Develop, implement, and monitor M&Q plans.
  • Support build/testing and assess manufacturing readiness (MRL 7 and 8).
  • Support all program and technical reviews and audits (Critical Design Review (CDR), Technology Readiness Review (TRR), TRA, MRA, System Verification Review (SVR)/Functional Configuration Audit (FCA), Production Readiness Review (PRR), ITRA).
  • Support development of the draft RFP, review contractor proposals; support cost estimating and tracking.

Production and Deployment (P&D)

  • Participate in the Configuration Control Board (CCB) process.
  • Support Low-Rate Initial Production (LRIP) and Full-Rate Production (FRP); assess manufacturing readiness (MRL 9 and 10).
  • Support Initial and Full Operational Capability (IOC and FOC).
  • Provide inputs to the LCSP and performance based logistics Plan. Develop, implement, and monitor M&Q plans.
  • Support development of the draft RFP, review contractor proposals; and support cost estimating and tracking.

Operations and Support (O&S)

  • Support FRP decision.
  • Provide input to AS, SEP, TEMP, LCSP. Develop, implement, and monitor M&Q plans.
  • Analyze system use data such as deficiency reports, hazard reports, regulatory violations.
  • Support build and test activities, along with pre-planned product improvement and block updates.
  • Support development of the draft RFP, review contractor proposals, support cost estimating and tracking.

Assessing Manufacturing Readiness and Risk

The National Defense Authorization Act, Section 812 and DoDI 5000.85 establish policy on the requirement to address manufacturing risks over the entire life cycle of a program.

Manufacturing feasibility, processes, and risk should be assessed early in the MSA phase and continuously through the P&D phase in all acquisition programs. To ensure integration of manufacturing readiness and risk as part of design activities, the focus should be on manufacturing process reliability and producibility, and system risk reduction.

PMs should use existing manufacturing processes whenever practical to support low-risk manufacturing. When the design requires new manufacturing capability, the PM may need to consider new manufacturing technologies or process flexibility (e.g., rate and configuration insensitivity), which introduces risk. DoDI 5000.88, Section 3.6.c., defines the requirements for manufacturing processes and manufacturing risks. See DFARS (Subpart 207.105 ??? Contents of Written Acquisition Plans) for specific guidance on manufacturing actions planned by the PM to execute the approach established in the AS and to guide contractual implementation. These include:

Low-risk manufacturing readiness includes early planning and investments in producibility requirements, manufacturing process capabilities, and quality management to ensure effective and efficient manufacturing and transition to production. It also includes assessments of the industrial base. Manufacturing risk is evaluated through MRAs, which are integrated with existing program assessments throughout the acquisition life cycle. The PM should assess manufacturing readiness in the program???s earliest phase, and the assessment should be continuous. The PM should report on the program???s manufacturing readiness progress/status during each technical review, Program Support Assessment, or its equivalent, and before each milestone decision.

Successful manufacturing has many dimensions. Industry and Government have identified best practices in the following nine manufacturing risk categories. PMs should use the best practices to assess their programs early and should report on these areas during technical reviews and before acquisition milestones. Implementation of these best practices should be tailored according to product domains, complexity and maturity of critical technologies, manufacturing processes, and specific risks that have been identified throughout the assessment process. These categories should help frame the risk assessment and focus mitigation strategies:

  1. Technology and the Industrial Base: assess the capability of the national technology and industrial base to support the design, development, production, operation, uninterrupted maintenance support and eventual disposal (environmental impacts) of the system.
  2. Design: assess the maturity and stability of the evolving system design and evaluate any related impact on manufacturing readiness.
  3. Cost and Funding: examine the risk associated with reaching manufacturing cost targets.
  4. Materials: assess the risks associated with materials (including basic/raw materials, components, semi-finished parts and subassemblies).
  5. Process Capability and Control: assess the risks that the manufacturing processes may not reflect the design intent (repeatability and affordability) of key characteristics.
  6. Quality Management: assess the risks associated with management efforts to control quality and foster continuous improvement.
  7. Manufacturing Workforce (Engineering and Production): assess the required skills, certification requirements, availability, and required number of personnel to support the manufacturing effort.
  8. Facilities: assess the capabilities and capacity of key manufacturing facilities (prime, subcontractor, supplier, vendor and maintenance/repair).
  9. Manufacturing Management: assess the orchestration of all elements needed to translate the design into an integrated and fielded system (meeting program goals for affordability and availability).

As part of the manufacturing strategy development effort, the PM needs to understand the contractor/vendor business strategy and the impacts to Government risk identification and mitigation efforts, such as the Make/Buy decisions and supply chain risks assessments. Additional guidance on assessing manufacturing risks can be found in the Manufacturing Readiness Levels Guide.

Assessment and mitigation of manufacturing risk should begin as early as possible in a program???s acquisition life cycle ??? including conducting a manufacturing feasibility assessment as part of the AoA.

The PM, Systems Engineer, and Lead Software Engineering technical team should consider the manufacturing readiness and manufacturing-readiness processes of potential contractors and subcontractors as a part of the source selection for major defense acquisition programs (see DFARS Subpart 215.304).

The PM, Systems Engineer, and Lead Software Engineering technical team should assess manufacturing readiness during the acquisition life cycle, as described in Table 5-5.

Table 5-5. Minimum Points (When) to Assess Manufacturing Readiness

Key Manufacturing Readiness Assessment (MRA) Points Considerations
1. Materiel Solution Analysis (MSA) Phase supporting Milestone A Decision. As part of the Analysis of Alternatives (AoA), manufacturing risks should have been assessed for each of the competing alternatives (see the Manufacturing Readiness Levels Guide for one source of specific assessment factors). Risks for the preferred system concept should be assessed and identified at this point. The overall assessment should consider:
  • Assess manufacturing feasibility and capability to produce in a lab environment.
  • Program critical technologies are ready for the Technology Maturation and Risk Reduction (TMRR) phase.
  • Required investments in manufacturing technology development have been identified.
  • Processes to ensure manufacturability, producibility, and quality are in place and are sufficient to produce prototypes.
  • Manufacturing risks and mitigation plans are in place for building prototypes.
  • Cost objectives have been established and manufacturing cost drivers have been identified; draft Key Performance Parameters (KPPs) have been identified as well as any special tooling, facilities, material handling and skills required.
  • Producibility assessment of the preferred system concept has been completed, and the industrial base capabilities, current state of critical manufacturing processes and potential supply chain sources have all been surveyed.
2. TMRR Phase supporting Milestone B and Development Request for Proposals (RFP) Release Decision. As the program approaches the Development RFP Release Decision and the Milestone B decision, critical technologies and manufacturing processes should have matured sufficiently for 2366b certification and demonstrated in a relevant environment.
  • Assess contractor???s manufacturing capability to produce in a production-relevant environment. An initial manufacturing approach has been developed.
  • Manufacturing processes have been defined and characterized, but there are still significant engineering and/or design changes in the system itself; manufacturing processes that have not been defined or that may change as the design matures should be identified.
  • The program should be nearing acceptance of a preliminary system design. Preliminary design, producibility assessments, and trade studies of technologies and components should have been completed.
  • Prototype manufacturing processes and technologies, materials, tooling and test equipment, as well as personnel skills have been demonstrated on systems and/or subsystems in a production-relevant environment.
  • Cost, yield and rate analyses have been performed to assess how prototype data compare with target objectives, and the program has in place appropriate risk reduction to achieve cost requirements or establish a new baseline, which should include design trades.
  • Producibility considerations should have shaped system development plans, and the Industrial Base Capabilities assessment (in the Acquisition Strategy for Milestone B) has confirmed the viability of the supplier base.
3. Engineering and Manufacturing Development (EMD) Phase, Critical Design Review (CDR). At the CDR the system should be sufficiently mature to start fabricating, integrating, and testing pre-production articles with acceptable risk. The product baseline describes the detailed design for production, fielding, deployment, operations, and support. The product baseline also prescribes all necessary physical (form, fit and function) characteristics and selected functional characteristics designated for production acceptance testing and production test requirements. Production should be demonstrated in a relevant environment and should consider:
  • Assess contractor???s manufacturing capability to produce in a production representative environment. An initial manufacturing approach has been developed.
  • Critical manufacturing processes that affect the product characteristics have been identified, process control plans have been developed, and the capability to meet design tolerances has been determined.
  • Detailed design is producible and assessed to be within the production budget.
  • Detailed producibility trade studies using design characteristics and related manufacturing process are completed. Materials and tooling are available to meet the pilot line schedule.
  • Long-lead procurement plans are in place; supply chain assessments are complete.
  • Verify configuration control of the initial product baseline as demonstrated by: the completion of build-to documentation for hardware and software configuration items, production models, drawings, software design specifications, materials lists, manufacturing processes, and qualification plans and procedures.
4. EMD Phase, Milestone C. A Production Readiness Review (PRR) identifies the risks of transitioning from development to production. Manufacturing is a function of production; in order to transition to production without significant risk, the program should thoroughly evaluate processes during the PRR. Production should be demonstrated on a pilot line and should consider:
  • Assess contractor???s manufacturing capability to produce on a pilot line.
  • The detailed system design is complete and stable to support Low-Rate Initial Production (LRIP).
  • Technologies are mature and proven in a production environment, and manufacturing and quality processes are capable, in control, and ready for LRIP.
  • All materials, manpower, tooling, test equipment, and facilities have been proven on pilot lines and are available to meet the planned low-rate production schedule.
  • Cost and yield and rate analyses are updated with pilot line results.
  • Known producibility risks pose no significant challenges for LRIP.
  • Supplier qualification testing and first article inspections have been completed.
  • Industrial base capabilities assessment for Milestone C has been completed and shows that the supply chain is adequate to support LRIP.
5. Production and Deployment (P&D) Phase, Full-Rate Production (FRP) Decision Review(DR). To support FRP, there should be no significant manufacturing process and reliability risks remaining. Manufacturing and production readiness results should be presented that provide objective evidence of manufacturing readiness. The results should include recommendations for mitigating any remaining low (acceptable) risk, based on assessment of manufacturing readiness for FRP, which should include (but not be limited to):
  • Assess LRIP and FRP production environments.
  • LRIP learning curves that include tested and applied continuous improvements have been assessed and validated.
  • Meeting all systems engineering and design requirements.
  • Evidence of a stable system design demonstrated through successful test and evaluation.
  • Evidence that materials, parts, manpower, tooling, test equipment, and facilities are available to meet planned production rates.
  • Evidence that manufacturing processes are capable, in control, and have achieved planned FRP objectives.
  • Plans are in place for mitigating and monitoring production risks.
  • LRIP cost targets data have been met; learning curves have been analyzed and used to develop the FRP cost model.

Assessing Industrial Capabilities

DFAR 207.105, Contents of Written Acquisition Plans, provides guidance on manufacturing actions planned by the PM to execute the approach established in the AS and to guide contractual implementation.

Current legislation and policies governing industrial base capabilities are intended to ensure that:

PMs should be interested in three broad risk areas from an industrial base perspective that go beyond classical supply chain considerations:

The ability of the industrial base to respond to near-term readiness, or to meet surge and mobilization requirements, has deteriorated as our industrial base continues to shrink. This has diminished the likelihood of competition and contributed to the emergence of production bottlenecks at many points.

Industrial Capability Analysis

When the DoD is in danger of losing industrial capabilities because a supplier (plant, industry, company, etc.) is going out of business, merging with another company, or being bought out, the program should perform an analysis. The analysis addresses the following issues:

Industrial Capabilities Planning

Industrial Capabilities Planning should address current and future status of unique manufacturing capabilities. The planning should:

Products and Tasks

Product Tasks
10-18-1: Develop producibility planning and strategy inputs
  1. Obtain the technical data package for the subject acquisition.
  2. Evaluate the system design and identify areas of producibility risk.
  3. Develop producibility enhancements to risk areas and implement in the system design.
  4. Establish producibility technical performance measures (TPM).
  5. Review producibility risks at technical reviews and audits.
  6. Document program planning and strategy for producibility in the program???s systems engineering plan (SEP).
10-18-2: Assess quality management systems (QMS)
  1. Identify quality management requirements in accordance with system acquisition documents.
  2. Obtain the facility???s quality management system (QMS) documentation.
  3. Identify QMS requirements that can affect producibility.
  4. Obtain facility manufacturing plans and quality assurance/control process documentation.
  5. Document adherence to producibility requirements in the quality manual, procedures, and work instructions.
  6. Verify or invalidate implementation during test, inspections, quality audits and management reviews.
  7. Document results in the QMS production and quality records.
10-18-3: Statistical process control (SPC) study results
  1. Identify statistical process control (SPC) requirements in accordance with system acquisition documents.
  2. Obtain the facility???s SPC plan and related documentation.
  3. Assess the application and effectiveness of SPC for producibility impacts at the facility.
  4. Identify process variability and verify critical processes are ???in control???.
  5. Conduct process capability (Co) and process performance (Cpk) studies, and calculate the amount of defective material produced.
  6. Provide SPC study results to the decision maker.
10-18-4: Manufacturing readiness assessment (MRA) results
  1. Develop the program plans for assessment of manufacturing readiness.
  2. Perform manufacturing readiness assessments and determine manufacturing readiness level.
  3. Identify manufacturing and producibility risks resulting from immature manufacturing processes.
  4. Submit manufacturing readiness assessment (MRA) results to decision maker.

Source: AWQI eWorkbook

Resources

Key Terms

Source:
DAU ACQuipedia
DAU Glossary

Policy and Guidance

DAU Training Courses

DAU Tools

Media

DAU Communities of Practice

On this page

  1. Overview
  2. Quality in Design
  3. Assessing Manufacturing Readiness and Risk
  4. Resources
Back to top