Quality Assurance (QA) is the planned and systematic activities implemented in a quality system so that the quality requirements for a product or service are fulfilled. QA focuses on the entire quality system including suppliers and ultimate consumers of the product or service. It includes all activities designed to produce products and services of appropriate quality. QA begins before a product is made or before a project is even started.
Quality Control (QC) refers to the activities used during the production of a product that are designed to verify that the product meets the customer's requirement. QC focuses on the process of producing the product or service with the intent of eliminating problems that might result in defects. QC begins as the product is being produced.
This resource page will focus on the following topic areas:
- Quality Management Systems
- Product Quality Control
- Supplier Quality Management
- Quality of Design / Quality Engineering
- Quality Policy and Guidance
- Quality Tools and Checklist
Contract Quality Requirements:
- DFARS 246 – Quality Assurance https://www.acquisition.gov/dfars/part-246-quality-assurance
- DFARS 252 – Solicitation Provisions and Contract Clauses https://www.acquisition.gov/dfars/part-252-clauses
Note: Additional information, guidance, tools, and other resources, by acquisition phase, may be found in the M&Q Body of Knowledge at https://www.cto.mil/sea/mq/
- Quality Management System (QMS)
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A Quality Management System (QMS) is a clearly defined set if processes and procedure that are formalized in documents that outline processes, procedures, and responsibilities for ensuring products or services consistently meet customer and regulatory requirements.
The ISO family of documents outlines the requirements for a quality management system:
- ISO 900: Identifies the vocabulary and fundamentals for a QMS to include the seven quality management principles
- ISO 9001: Details the requirements organizations need to meet in order to meet the standard and become certified
- ISO 9002: Provides for guidance for the implementation of ISO 9001
- ISO 9004: Provides guidance for achieving sustained success through the application of a program of evaluation and continuous performance improvement
The AS 9100 family of documents provide for the requirement of a QMS within the aerospace, space, and defense industries and include:
- AS 9100: Identifies the aerospace requirements for a QMS that demonstrates an organization's ability to provide products that meet statutory and regulatory requirements
- AS9101: Identifies the requirements for auditing aviation, space, and defense organizations against the 9100 family of standards
- AS9102: Identifies the requirements for First Article Inspection to ensure that a new product or part meet all requirements through production part verification
- AS9103: Identifies the requirement to plan for and manage Key Characteristics and any variation of those characteristics
- AS9110: Identifies the requirements for a QMS at aviation maintenance organizations and is based on ISO 9001, but includes additional requirements for aviation maintenance and airworthiness
- AS9120: Identifies the requirements for a QMS at stock distributors and is based on ISO 9001 but includes additional requirements. Stock distributors include organizations that resell, distribute, and warehouse parts for aerospace industries.
- AS9131: Identifies requirements for the uniform identification, documentation, and management of nonconforming that requires formal decisions
- AS9134: Identifies the requirements for managing risk in the supply chain on both new and existing suppliers
- AS9146: Identifies the requirements for the prevention of Foreign Object Damage for organizations involved in the design, development, delivery, and post-delivery provisions for maintenance, spares, and other materials
- AS9015: Identifies the requirements for the delegation of product verification activities at an organization's suppliers
- AS5553: Identifies the requirements for the management of electrical, electronic, and electromechanical parts to avoid the introduction of counterfeit parts into any aviation, space, and defense assemblies
The QMS is used to:
- Manage product and process quality
- Reduce the cost of poor quality (scrap, rework, repair, etc.)
- Make better decisions based on statistical and other data
- Engage in a process of continuous improvement
A Quality Management System is a requirement of ISO 9001 and AS9100. ISO 9001 can be considered the baseline QMS while AS9100 is used for developing and advanced QMS. There are many requirements in ISO 9001 and AS9100 to include:
- Leadership
- Planning
- Support
- Operation
- Performance Evaluation
- Improvement
Documentation to support the QMS include:
- Policies
- Procedures
- Quality Manual
- Training Materials
- Work Instructions
- Audit Forms
- Process Maps
- Control Plans
Guidance, Resources, and Tools
- ISO 9001 https://www.iso.org/iso-9001-quality-management.html
- AS9100 https://www.sae.org/standards/content/as9100/
- MIL-HDBK-896 Manufacturing and Quality Program
- Advanced Product Quality Planning Manual https://www.aiag.org/quality/quality-core-tools/apqp
- DCMA Instruction 309, Government Contract Quality Assurance Surveillance Plan https://www.dcma.mil/Portals/31/Documents/Policy/DCMA-INST-309.pdf
- Product Quality Control
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Quality Control is the inspection aspect of quality management and consists of inspection, testing and quality measurements that verifies that the product deliverables conform to specification, is fit for purpose and meet stakeholder’s expectations. Quality control techniques are varied and driven by the nature of the product. Product inspections and tests that are done to check whether a product meets its specification is the most obvious form of QC. The inspection and test methods used depends on the technical nature of the product being developed. These methods could include product and process inspection, First Article Inspection/First Article Testing, Production Lot Testing, Production Part Approval, Qualification Testing, and Production Qualification Testing.
First Article Inspection (FAI)/First Article Testing (FAR): FAI is a physical audit (see AS9100, AS9102 and DCMA Manual 2101-01). FAI conducted to ensure that the product meets contractual requirements and is a dimensional and qualitative inspection of a part or assembly to ensure the part or assembly fully conforms to technical drawings, specifications, customer envelope, and interface dimensions. A flow chart will be provided to validate the capability and stability of each process step. In addition, Key characteristics and critical characteristics shall be identified to ensure that they are validated during the FAI. First Article Inspections also verify production processes by examining work instructions, routing sheets, quality plans. FAIs also include reviews of in-process, acceptance testing procedures, and results. These tests may be witnessed by DCMA Quality Assurance Representatives (QAR) and/or government acquisition personnel.
Production Lot Testing: The purpose of production lot testing (PLT) is to validate quality conformance of products prior to lot acceptance. Product specialist will review the ESA testing requirements for completeness, accuracy, and applicability; coordinate any changes with the ESA; and enter the testing requirements in the material master. The test indicates that the manufacturer’s ability to create a consistent product within prescribed tolerances (quality). These tests may be witnessed by DCMA Quality Assurance Representatives (QAR) and/or government acquisition personnel.
Production Part Approval: Production Part Approval is used to accept an item from a manufacturing process. The purpose is to determine if engineering design records, functional, and specification requirements are understood and if the manufacturer's process has the capability to produce product consistently and continuously. The PPA provides the parts characteristics, part sample size, documentation, and requirements based on AF's needs for assessing the manufacturers' product. Varying degrees of requirements may be needed to demonstrate the manufacturing capability. These tests may be witnessed by DCMA Quality Assurance Representatives (QAR) and/or government acquisition personnel.
Qualification Testing: Qualification testing is a series of simulated operational, environmental, and endurance tests that prove the design "should" hold up and perform adequately in the field. There are no guarantees since the field can produce multiple environments and simultaneous stresses that are either impossible to produce in a test environment or too expensive to do in a test environment.
Production Qualification Testing: A technical test completed prior to the Full-Rate Production (FRP) decision to ensure the effectiveness of the manufacturing process, equipment, and procedures. This testing also provides data for the independent evaluation required for materiel release so the evaluator can address the materiel's adequacy with respect to the stated requirements. These tests are conducted on a number of random samples from the first production lot and are repeated if the process or design is changed significantly and when a second or alternative source is brought online.
- ISO 9001 Quality Management System (QMS) Requirements can be considered a foundational requirement for a QMS https://www.iso.org/iso-9001-quality-management.html
- AS9100 Aerospace - Model for Quality Assurance in Design, Development, Production, Installation and Servicing https://www.sae.org/standards/content/as9100/AS9100 Quality Systems - Aerospace https://www.sae.org/standards/content/as9100/
- AS9102 First Article Inspection https://www.sae.org/standards/content/as9102/
- AS9145 Aerospace Standard Advanced Product Quality Planning (APEP) and Production Part Approval Process (PPAP) https://www.sae.org/standards/content/as9145/
- DCMA-INST-302 First Article Inspection and Production Lot Testing https://www.dcma.mil/Portals/31/Documents/Policy/DCMA-INST-302.pdf https://www.dcma.mil/Portals/31/Documents/Policy/DCMA-INST-302.pdf
- DCMA-INST-324 Product Examination https://www.dcma.mil/Portals/31/Documents/Policy/DCMA-INST-324.pdf
- DCMA Manual 2102-01 Acceptance https://www.dcma.mil/Portals/31/Documents/Policy/DCMA-MAN-2101-01.pdf
- AFMC-INST 23-110 Post-Award Part Verification and Approval requirements https://static.e-publishing.af.mil/production/1/afmc/publication/afmci23-110/afmci23-110.pdf
- MIL-HDBK-61 Configuration Management Guidance https://quicksearch.dla.mil/qsDocDetails.aspx?ident_number=202239
- Process Capability and Control
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One of the major goals of manufacturing is to provide the customer with “uniform, defect free product that has consistent performance and is affordable. M&Q personnel should support the assessment of manufacturing processes in order to determine if those processes are capability and in control.
Process capability and control is a requirement of AS6500 Manufacturing Management Program standard, AS9100 quality standards, AS9003 Variation Management of Key Characteristics, and AS9138 Quality Management Systems Statistical Product Acceptance Requirements. These standards require a process control plan to describe activities that will demonstrate process capabilities. Process capability clarifies the inherent process variability of a given characteristic or process. A capability study is used to assess the ability of a process to meet a drawing/specification requirement. Typical measures include process capability (Cp/Cpk) and process performance (Pp/Ppk); X bar and R charts; control charts; and other statistical analysis tools.
Process Capability and Control: Requires an analysis of the risks that the manufacturing processes are able to reflect the design intent (repeatability and affordability) of key characteristics.
Process Capability (Cp) is a statistical analysis or measurement of a process’s capacity or ability to produce product that meets specifications and to manufacture parts repeatedly within technical specifications. Depending on the stage of the process and the method used to calculate the standard deviation or sigma value, we can calculate Cp (Process Capability), Cpk (Process Capability Index), or Pp (Preliminary Process Capability), and Ppk (Preliminary Process Capability Index) to determine how our process is operating.
Process control is a way to monitor, manage, and manipulating manufacturing processes to produce uniform, defect-free products. Process control requires the management of process variables, the identification and management of product deviations from technical requirements, and the modification of process to ensure future production processes perform as expected.
Process Capability and Control Guidance, Tools, and other Resources
- ISO 9001 Quality Management System (QMS) Requirements can be considered a foundational requirement for a QMS https://www.iso.org/iso-9001-quality-management.html
- AS9100 Aerospace - Model for Quality Assurance in Design, Development, Production, Installation and Servicing https://www.sae.org/standards/content/as9100/
- AS6500, Manufacturing Management Program https://www.sae.org/standards/content/as6500/
- DoD MRL Interactive Users Guide, Process Capability and Control Thread https://dodmrl.com/
- Supplier Quality Management
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Supply chain quality management is the process of developing and executing a supplier quality program that ensures that products are delivered on-time, to the right place, in the right count and condition, at the agreed upon price in time to meet the customers’ requirements (production). A supply chain can be defined as the flow of material from a source to a destination. The Association for Operations Management (APICS) defines supply chain management (SCM) as the "design, planning, execution, control, and monitoring of supply chain activities with the objective of creating net value, building a competitive infrastructure, leveraging worldwide logistics, synchronizing supply with demand and measuring performance globally."
Supplier quality management begins early in product design and development and continues throughout the life cycle of the system or product. Supplier quality goes beyond lowest price to include identifying “best value” subcontractors and vendors that have a history of providing quality products and services, with low nonconformance rates and rapid response to problems.
- ISO 9001 Quality Management System (QMS) Requirements can be considered a foundational requirement for a QMS https://www.iso.org/iso-9001-quality-management.html
- AS9100 Aerospace - Model for Quality Assurance in Design, Development, Production, Installation and Servicing https://www.sae.org/standards/content/as9100/
- DCMA-INST-219 Supplier Risk Management
- DISA Supplier Performance Rating System https://www.sprs.csd.disa.mil/
- AS9134 Supply Chain Management Guidelines https://www.sae.org/standards/content/as9134/
- Supply Chain Management Handbook https://scmh.iaqg.org/
- Quality of Design / Quality Engineering
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Quality of design or quality by design is a deliberate and structured process for designing, developing and producing new products or improved products in a way to ensure customer satisfaction. When the contractor is designing the product, they should involve a concurrent engineering team approach that includes subject matter experts from design, materials, manufacturing, quality, reliability, sustainment, etc., in order to ensure that the product being developed achieves both design and manufacturing efficiency while meeting customer requirements.
The role of manufacturing in this process is to "influence the design for producibility," which is the relative ease of fabrication and assembly. A better way to look at it is below:
Quality by Design is a component of the systems engineering process and an integral part of product and process verification and validation. It changes the way manufacturers approach all process design, process qualification, and process verification through the entire lifecycle of the product.
- DoD Producibility and Manufacturability Engineering Guide https://www.cto.mil/wp-content/uploads/2024/06/DoD-Producibility-and-Manufacturability-2024.pdf
- Continuous Process Improvement - Lean - Six Sigma - Theory of Constraints
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The role of the program manager (PM) is to direct the development, production, and initial deployment of a new defense system. This must be done within limits of cost, schedule, and performance, and as approved by the program manager's acquisition executive. The CPI tools outlined in this chapter can be used to support the achievement of these capabilities. A program manager should be able to:
- Define quality and identify the various forms and structures associated with quality
- Describe a few of the more significant quality initiatives
- Identify several continuous process improvement tools
- Describe the connection between quality and reliability/maintainability (R&M)
- Describe how quality can be addressed in contract language
Major techniques used in a CPI program include:
- Lean: Focuses on eliminating waste or muda
- Six Sigma: Focuses on variation and the reduction of variation on Key and Critical Characteristics
- Theory of Constraints: Focuses on bottlenecks and the flow of material
- Note: Each of these techniques requires many pages of description, and there is a lot of material available on the web for each of them.
- Lean
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The term “Lean” was coined by Womack, Jones and Roos in “The Machine that Changed the World” to describe the Toyota Production System (TPS). They found that “Lean production” is different from craft and mass production. Toyota, using lean production, is able to reduce cost by eliminating waste, which reduces flow time and increase efficiency. Toyota has identified the seven forms of waste as:
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Excess Transportation
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Excess Inventory
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Excess Motion
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Excess Waiting
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Over-Production
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Over-Processing
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Defects
The Toyota Production System (TPS) focuses on five basic practices:-
The use of standard/stable processes (work instructions)
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The use of continuous improvement (Kaizen)
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The use of Just-om-Time inventories
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A focus on customer satisfaction
Resources:- ISO 9001 Quality Management System (QMS) Requirements can be considered a foundational requirement for a QMS https://www.iso.org/iso-9001-quality-management.html
- AS9100 Aerospace - Model for Quality Assurance in Design, Development, Production, Installation and Servicing https://www.sae.org/standards/content/as9100/
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The Machine that Changed the World by Womack, Jones and Roos which can be found at any bookstore
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What is Lean https://www.lean.org/explore-lean/what-is-lean/
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- Six Sigma
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While Lean focuses on eliminating waste to improve, six sigma reduces waste by focusing on the reduction of variation, especially on key or critical characteristics. Six Sigma is the disciplined methodology of defining, measuring, analyzing, improving and controlling the quality in every one of the Company’s products, processes and transactions-with the ultimate goal of virtually eliminating all defects. The main tool for achieving six sigma is DMAIC:
- Define what is important to the customer
- Measure how well you are currently doing
- Analyze what is wrong and where variation occurs
- Improve by addressing root causes of problems
- Control to hold the gains made
DMAIC uses the Deming Cycle (Plan, Do, Check, Act) to focus their attention and by using a multitude of QA/QA tools to help them do this, to include but not limited to:
- Cause and Effect Diagram
- Check Sheet
- Flow Chart
- Histogram
- Pareto Chart
- Run Chart
- Scatter Diagram
- Affinity Diagram
- Arrow Chart
- Matrix Diagram
- Process Decision Program Chart
- Relations Diagram
- Tree Diagram, and many other tools
- Theory of Constraints (TOC)
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Theory of Constraints (TOC) s a systems thinking process that helps organizations improve by identifying and eliminating bottlenecks in their processes. All organizations and systems have constraints or bottlenecks that causes the organization to lose productivity and efficiency. TOC uses a five-step problem solving methodology to identify and correct the bottleneck.
TOC is called a Thinking process asks three questions that are essential to improvement:
- What needs to be changed
- What should it be changed to
- What action will cause the change
TOC Metrics identify three measures that are used to measure performance and guide management decisions:-
Throughput
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Investment
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Operating Expenses
TOC follows a five-step process called focusing steps:-
Identify the bottleneck
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Exploit the bottleneck
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Subordinate everything else to the bottleneck
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Elevat the bottleneck
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Repeat the above steps with the next bottleneck
- Quality Resources and Guidance
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Note: All AS documents can be obtained at https://www.sae.org/standards/content/as9100/
- AS9100 Quality Management System (QMS) - Requirements for Aviation, Space, and Defense Organizations
- AS9110 QMS Requirements for Aviation Maintenance Organizations
- AS9120 QMS Requirements for Aviation, Space, and Defense Distributors
- AS9101 Requirements for Conducting Audits if Aviation, Space, and Defense Quality Management Systems
- AS9102 Aerospace First Article Inspection Requirements
- AS9103 QMS Variation Management of Key Characteristics
- AS9115 QMS Requirements for Aviation, Space, and Defense Organizations - Deliverable Software
- AS9117 Delegated Product Release Verification (DPRV)
- AS9131 QMS Nonconformity Data Definition and Documentation
- AS9132 Data Matrix Quality Requirements for Parts Marking
- AS9133 Qualification Procedure for Aerospace Standard Parts
- AS9138 QMS Statistical Product Acceptance Requirements
- AS9145 Requirements for Advanced Product Quality Planning (APSP) and Production Part Approval Process (PPAP)
- AS9146 Foreign Object Damage (FOD) Program
- AS9162 Aerospace Operator Self-Verification Programs
- DCMA-INST-309 Government QA Surveillance Planning https://www.dcma.mil/Portals/31/Documents/Policy/DCMA-INST-309.pdf
- DCMA-INST-322 Quality System Audit https://www.dcma.mil/Portals/31/Documents/Policy/DCMA-INST-322.pdf
- DCMA-INST-323 Data Collection and Analysis https://www.dcma.mil/Portals/31/Documents/Policy/DCMA-INST-323.pdf
- DCMA-INST-1201 Corrective Action Process https://www.dcma.mil/Portals/31/Documents/Policy/DCMA-INST-1201.pdf
- DCMA-MAN-2101 Acceptance https://www.dcma.mil/Portals/31/Documents/Policy/DCMA-MAN-2101-01.pdf
- Quality Tools and Checklist
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- ISO 9001 Quality Management System (QMS) Requirements can be considered a foundational requirement for a QMS https://www.iso.org/iso-9001-quality-management.html
- AS9100 Aerospace - Model for Quality Assurance in Design, Development, Production, Installation and Servicing https://www.sae.org/standards/content/as9100/
- AS9100, Audit Checklist conduct an internet search
- DAU Government ISO 9001, QMS Audit Checklist conduct an internet search
- Interactive MRL Users Guide (Checklist) for the Quality thread https://dodmrl.com/
- Assessment of Manufacturing Risks and Readiness, DI-SESS-81974 https://www.dodmrl.com/DI-SESS-81974.pdf
- Manufacturing and Quality Assurance Status Report DI-QCIC-82323 https://quicksearch.dla.mil/qsDocDetails.aspx?ident_number=283861
- Quality Status Report DI-MGMT-82186 https://quicksearch.dla.mil/Transient/F12A20A94C444BD8BEF292F9CDD768E4.pdf
- Quality Program Plan (QPP) DI-QCIC-81722 conduct an internet search
- Quality Management System (QMS) DI-MGMT-82184 https://quicksearch.dla.mil/qaDocDetails.aspx?ident_number=282795
- Quality Engineering Inspection Requirements and Equipment List DI-QCIC-80756A http://everyspec.com/DATA-ITEM-DESC-DIDs/DI-QCIC/DI-QCIC-80756_51827/
- Quality Assurance Program Plan DI-QCIC-81794 https://quicksearch.dla.mil/Transient/F9EB0B17A38B46D8BBCFF4A780C4C34C.pdf
- Quality Assurance Provisions (QAP) DI-SESS-80789A https://quicksearch.dla.mil/Transient/714F8563B8344EED93944605B22366E5.pdf
- Critical to Customer Assessment conduct an internet search
- Critical to Quality Tree conduct an internet search