7.

1 Product Quality Planning Purpose: The Product Quality Planning process ensures the processes needed to achieve the product are planned and developed consistent with Quality Management System (QMS) requirements. QMS Process Interfaces:

Control Processes
7.13 Change Management 4.1 Document Management 7.14 Customer Property Control 4.2 Records Management 7.17 Product ID & Traceability 7.16 Monitoring & Measuring 7.15 Handling & Preservation Device Control

Output Processes Input Process

Product ProductQuality Quality Planning Process Planning Process 7.1 7.1

Verification/Audit Processes
5.5 Management Review 8.4 QA Process Audits 8.5 QA Product Audits 8.6 QMS Audits

Product Quality Planning Inputs and Outputs: Process Inputs QMS plan Customer requirements and needs Historical data (cost and effort) Process Outputs Process, document, and resource needs Product acceptance criteria Quality objectives Product quality planning review

Product Quality Planning Tasks and Responsibilities: Process Tasks 1. Identify product requirements & quality objectives 2. Determine product processes, documents, responsibilities, and interfaces 3. Estimate product cost and effort 4. Define resources (people, tools, training) 5. Develop product schedule 6. Document product quality plan 7. Review product quality plan 8. Review product quality planning status 9. Audit product quality planning activities & products
* SM Senior Management PM Product Management PD Product Development PS Product Servicing HR Human Resources QA Quality Assurance

Task Responsibility*
SM PM PD PS HR QA

X X X X X X X

X X

X X

Product Quality Planning Procedure: 1. Identify product requirements and quality objectives Product management identifies customer needs, requirements, and interfaces. Product management establishes specific quality objectives. 2. Determine product processes, documents, responsibilities, and interfaces Product management defines the processes needed, including documentation, to design and develop, maintain, verify, validate, and control the product and provide evidence requirements are met. Processes needed include: Product Quality Planning Customer Requirements & Interface Design and development (Section 7.3 addresses design and development planning) Product Servicing (Section 7.11 addresses product servicing planning) Controls (Handling and storage, change management, monitoring and measuring device control, product identification and traceability, customer property) Verification (Peer review, technical review).

Product management ensures acceptance criteria are defined for design and development and servicing. 3. Estimate product cost and effort

Product management estimates the overall cost and effort to realize the product using historical data, where available. 4. Define resources (people, tools, training) Product management defines the resources needed to satisfy requirements and the personnel skill levels and quantity based on effort estimates. Product management identifies tool and training needs. 5. Develop product schedule Product management determines overall product activities and milestones for product realization including controls and reviews. 6. Document product quality plan Product management documents the results of product quality planning activities including objectives, responsibilities, estimates, schedules, and processes to be used. Product management updates the plan, as needed, as product realization progresses. 7. Review product quality plan Senior management, product management, product development, product servicing, human resources, and QA review the product quality plan to ensure planning is suitable to the companys method of operations. 8. Review product quality planning status Senior management reviews product quality planning status in accordance with Management Review process. 9. Audit product quality planning activities and products QA audits product quality planning activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Product Quality Planning Records: Product quality plan Product acceptance criteria Quality objectives Product quality planning review records.

QMS Requirements Manual Reference: 7.1 Product Planning

7.2 Customer Requirements and Interface Purpose: The Customer Requirements and Interface process ensures customer product requirements and communication are established. QMS Process Interfaces:

Control Processes
7.13 Change Management 7.17 Product ID & Traceability 7.15 Handling & Preservation 4.1 Document Management 4.2 Records Management

Output Processes Input Process

Customer Customer Requirements Requirements& & Interface InterfaceProcess Process 7.2 7.2

Design & Development Planning 7.3 Product Servicing Planning 7.11

Verification/Audit Processes
7.19 Technical Review 5.5 Management Review 8.4 QA Process Audits 8.5 QA Product Audits 8.6 QMS Audits

Customer Requirements & Interface Inputs and Outputs: Process Inputs Product quality plan Customer requirements Statutory requirements Process Outputs Product requirements Product requirements review Customer communications

QMS Process Manual

Customer Requirements and Interface

Customer Requirements & Interface Tasks and Responsibilities: Process Tasks 1. Determine product-related requirements 2. Perform contract review (including changes) 3. Establish customer communication mechanisms 4. Review customer requirements & interface status 5. Audit customer requirements & interface activities and products
* SM Senior Management PM Product Management PD Product Development PS Product Servicing HR Human Resources QA Quality Assurance

Task Responsibility*
SM PM PD PS HR QA

X X X

X X X X

X X

X X

X X

X X

Customer Requirements & Interface Procedure: 1. Determine product-related requirements Product development determines customer requirements including stated, derived, statutory, regulatory, and company requirements as applicable. Product development prepares proposal to include: Win strategy Schedules/milestones Resource needs Competitive analysis Proposal theme Financial analysis Requirements traceability to bid request.

Senior management, product management, product development, product servicing, human resources, and QA review proposal to ensure consistency with strategic plan and bid requirements, appropriateness of market analysis, development of a winning strategy, and verifying the organization has the capability and infrastructure to meet requirements. Product management maintains proposal review records. 2. Perform contract review (including changes) Senior management, product management, product development, product servicing, human resources, and QA perform contract review of product requirements before commitment to customer to ensure product requirements are defined and the organization is capable to meet requirements. Contract review is performed prior to contract acceptance to ensure consistency between the contract and proposal. Product management resolves differences between proposal and contract and maintains records of review results and applicable actions. Product management confirms undocumented requirements before acceptance. Product management coordinates document updates and notifies affected personnel for contract changes. QMS Process Manual Customer Requirements and Interface

3. Establish customer communication mechanisms Product management establishes and implements the communication mechanisms for relating product information, handling of customer feedback including complaints, and for addressing enquiries and contract orders including amendments. Product management documents customer communication mechanisms in the Product Quality Plan. 4. Review customer requirements and interface status Senior management and product management review customer requirements and interface status in accordance with Management Review process. 5. Audit customer requirements and interface activities and products QA audits customer requirements and interface activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Customer Requirements & Interface Records: Product requirements database Product requirements review results Customer correspondence records Customer complaint records.

QMS Requirements Manual Reference: 7.2 Customer Requirements & Interface

QMS Process Manual

Customer Requirements and Interface

7.3 Design and Development Planning Purpose: The Design and Development Planning process ensures the processes needed for product development are planned and developed consistent with Quality Management System (QMS) requirements. QMS Process Interfaces:

Control Processes
4.1 Document Management 7.13 Change Management 7.14 Customer Property Control 4.2 Records Management 7.16 Monitoring & Measuring 7.17 Product ID & Traceability Device Control 7.15 Handling & Preservation

Input Processes
Product Quality Planning 7.1 Customer Requirements & Interface 7.2

Design Design& & Development Development Planning PlanningProcess Process 7.3 7.3

Output Process
Requirements Definition 7.4

Verification/Audit Processes
5.5 Management Review 8.4 QA Process Audits 8.5 QA Product Audits 8.6 QMS Audits

Design and Development Planning Inputs and Outputs: Process Inputs Product quality plan Customer requirements Historical data (product and effort) Process Outputs Process, document, and resource needs Product acceptance criteria Design and development plan review

QMS Process Manual

Design and Development Planning

Design and Development Planning Tasks and Responsibilities: Process Tasks 1. Identify product requirements and quality objectives 2. Determine design and development processes, documents, responsibilities, and interfaces 3. Estimate product size and effort 4. Define resources (people, tools, training) 5. Develop product schedule 6. Document/maintain design and development plan 7. Review design and development plan 8. Review design and development planning status 9. Audit design and development planning activities and products
* SM Senior Management PM Product Management PD Product Development PS Product Servicing HR Human Resources QA Quality Assurance

Task Responsibility*
SM PM PD PS HR QA

X X X X X X X

X X

X X

X X

Design and Development Planning Procedure: 1. Identify product requirements and quality objectives Product development reviews contract documentation and the product quality plan to identify product requirements, including derived requirements, and specific quality objectives. 2. Determine design and development processes, documents, responsibilities, and interfaces Product development defines the processes needed to design, build, verify and validate the product. Processes needed include: Requirements Definition Product Design Purchasing Implementation Integration Acceptance Delivery and Installation Peer Review Technical Review.

Product development identifies the documents needed to support design and development. Product development defines product acceptance criteria and the quality records needed to provide evidence products and activities meet requirements. Product

QMS Process Manual

Design and Development Planning

development assigns responsibilities for design and development and identifies the interfaces between different groups to ensure effective communication and clear understanding of responsibilities. 3. Estimate product size and effort Product development estimates the size of the product (e.g., document pages, function points, lines of code) using historical data, where available. Product development estimates effort based on size estimate and historical data, where available. 4. Define resources (people, tools, training) Product development defines the resources needed to satisfy requirements and the personnel skill levels and quantity based on effort estimates. Product development identifies tool and training needs. 5. Develop product schedule Product development determines project design and development activities, milestones, and product delivery points. 6. Document and maintain design and development plan Product development documents the results of planning activities including objectives, responsibilities, interfaces, estimates, schedules, and processes/procedures to be used. Product development updates the plan, as needed, as design and development progresses. 7. Review design and development plan Senior management, product management, product development, product servicing, human resources, and QA review design and development plan to ensure planning is suitable to the companys method of operations. 8. Review design and development planning status Senior management and product management review design and development planning status in accordance with Management Review process. 9. Audit design and development planning activities and products QA audits design and development planning activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Design and Development Planning Records: Design and development plan

QMS Process Manual

Design and Development Planning

Design and development schedule Product development estimates (product, effort).

QMS Requirements Manual Reference: 7.3 Design and Development

QMS Process Manual

Design and Development Planning

QMS PROCESS MANUAL Title: Requirements Definition Approved By: Revision Date: Oct. 2, 2001 Page 1

7.4 Requirements Definition Purpose: The Requirements Definition process defines how product requirements are determined and allocated to configuration items. QMS Process Interfaces:

Control Processes
7.13 Change Management 7.17 Product ID & Traceability 7.15 Handling & Preservation 4.1 Document Management 4.2 Records Management

Input Processes
Design and Development Planning 7.3 Customer Requirements & Interface 7.2

Requirements Requirements Definition Definition Process Process 7.4 7.4

Output Process
Product Design 7.5

Verification/Audit Processes
7.18 Peer Review 7.19 Technical Review 5.5 Management Review 8.4 QA Process Audits 8.5 QA Product Audits 8.6 QMS Audits

Requirements Definition Inputs and Outputs: Process Inputs Design and development plan Contract requirements Process Outputs Product allocated requirements Requirements traceability Requirements review results

QMS Process Manual

Requirements Definition

QMS PROCESS MANUAL Title: Requirements Definition Approved By: Revision Date: Oct. 2, 2001 Page 2

Requirements Definition Tasks and Responsibilities: Process Tasks 1. Analyze intended use of system 2. Identify requirements 3. Identify top-level configuration items 4. Allocate requirements to configuration items 5. Evaluate requirements to review criteria 6. Document product requirements 7. Review product requirements documentation 8. Review requirements definition status 9. Audit requirements definition activities and products
* SM Senior Management PM Product Management PD Product Development PS Product Servicing HR Human Resources QA Quality Assurance

Task Responsibility*
SM PM PD PS HR QA

X X

X X X X X X X X

X X

X X X

Requirements Definition Procedure: 1. Analyze intended use of system Product development analyzes the intended use of the product to be developed. 2. Identify requirements Product development identifies the functions and capabilities of the product and applicable business, organizational, and user requirements. Product development identifies applicable safety, security, human factors, interface, operations, and maintenance requirements and any design constraints and qualification requirements. 3. Identify top-level configuration items (hardware, software) Product development identifies items of hardware, software, and manual operations. 4. Allocate requirements to identified configuration items Product development allocates requirements to configuration items 5. Evaluate product requirements to review criteria Product development reviews product requirements using the following criteria:

QMS Process Manual

Requirements Definition

QMS PROCESS MANUAL Title: Requirements Definition Approved By: Revision Date: Oct. 2, 2001 Page 3

Traceability Traceability to customer requirements Consistency Consistency with customer requirements Compliance Compliance with customer requirements and standards Appropriateness Appropriateness of requirements definition methods and standards used Testability Measurability of requirements Feasibility Feasibility of purchasing, design, operations, and maintenance.

Product development records requirements review results. 6. Document product requirements Product development documents product requirements to include, as appropriate: Requirements states and modes Functional capability requirements Business, enterprise, and user requirements Safety and security requirements Human factors requirements Operational and maintenance requirements External interface requirements Environmental requirements Design constraints Qualification requirements Computer resource requirements Quality factors Internal data requirements Installation data requirements Physical requirements Training, logistics requirements Packaging requirements Configuration item identification Rationale for requirements allocation Product requirements allocation matrix.

7. Review product requirements documentation Product management, product development, product servicing, and QA review product requirements documentation for compliance, traceability, and consistency with requirements.

QMS Process Manual

Requirements Definition

QMS PROCESS MANUAL Title: Requirements Definition Approved By: Revision Date: Oct. 2, 2001 Page 4

8. Review requirements definition status Senior and product management, product development, product servicing, human resources, and QA review requirements definition status in accordance with Management Review and Technical Review processes. 9. Audit requirements definition activities and products QA audits requirements definition activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Requirements Definition Records: Product requirements documentation Requirements review minutes and action items.

QMS Requirements Manual Reference: 7.3 Design and Development

QMS Process Manual

Requirements Definition

QMS PROCESS MANUAL Title: Product Design Approved By: Revision Date: Oct. 2, 2001 Page 1

7.5 Product Design Purpose: The Product Design process defines how the product will be built. QMS Process Interfaces:

Control Processes
7.13 Change Management 7.17 Product ID & Traceability 7.15 Handling & Preservation 4.1 Document Management 4.2 Records Management

Input Processes
Design and Development Planning 7.3 Requirements Definition 7.4

Output Processes

Product Product Design DesignProcess Process 7.5 7.5

Purchasing 7.6 Implementation 7.7

Verification/Audit Processes
7.18 Peer Review 7.19 Technical Review 5.5 Management Review 8.4 QA Process Audits 8.5 QA Product Audits 8.6 QMS Audits

Product Design Inputs and Outputs: Process Inputs Design and development plan Requirements documentation Process Outputs Product design Product design traceability Product design review results

QMS Process Manual

Product Design

QMS PROCESS MANUAL Title: Product Design Approved By: Revision Date: Oct. 2, 2001 Page 2

Product Design Tasks and Responsibilities: Process Tasks 1. Transform requirements into top-level architecture 2. Refine design components into lower level units 3. Evaluate design to review criteria 4. Document product design 5. Review product design documentation 6. Review product design status 7. Audit product design activities and products
* SM Senior Management PM Product Management PD Product Development PS Product Servicing HR Human Resources QA Quality Assurance

Task Responsibility*
SM PM PD PS HR QA

X X

X X X X X X

X X

X X X

Product Design Procedure: 1. Transform product requirements into a top-level architecture Product development transforms configuration item requirements into an architecture that defines its top-level structure and components ensuring all requirements are allocated to components. Product development produces a top-level design for external interfaces to configuration items, and a top-level database design. 2. Refine design components into lower levels units Product development performs detailed design for each component of the configuration items. Product development refines components into lower levels containing units that can be implemented to ensure requirements are allocated from components to units. Product development produces a detailed interface design that defines interfaces external to the configuration item, between components, and units and ensures interface design is detailed to permit implementation without further documentation. Product development produces a detailed database design. 3. Evaluate product design to review criteria Product development reviews the product design using the following criteria: Traceability Traceability to product requirements Consistency Consistency with product requirements Compliance Compliance with customer requirements and standards Appropriateness Appropriateness of design methods and standards used

QMS Process Manual

Product Design

QMS PROCESS MANUAL Title: Product Design Approved By: Revision Date: Oct. 2, 2001 Page 3

Feasibility Feasibility of purchasing, implementation, testing, operations, and maintenance.

Product development records design review results. 4. Document product design Product development documents product design to include: Component and unit design definitions Database design and user interface design decisions Design rationale Database design External and internal and interface design Product design allocation matrix.

5. Review product design documentation Product management, product development, product servicing, and QA review product design documentation for compliance, traceability, and consistency with requirements. 6. Review product design status Senior and product management, product development, product servicing, human resources, and QA review product design status in accordance with Management Review and Technical Review processes. 7. Audit product design activities and products QA audits product design activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Product Design Records: Product design documentation Product design review minutes and action items.

QMS Requirements Manual Reference: 7.3 Design and Development

QMS Process Manual

Product Design

QMS PROCESS MANUAL Title: Purchasing Approved By: Revision Date: Oct. 2, 2001 Page 1

7.6 Purchasing Purpose: The Purchasing process ensures procured and subcontracted products conform to specified requirements. QMS Process Interfaces:

Control Processes
7.13 Change Management 7.17 Product ID & Traceability 7.15 Handling & Preservation 4.1 Document Management 4.2 Records Management

Input Processes
Design and Development Planning 7.3

Purchasing Purchasing Process Process 7.6 7.6

Output Process
Implementation 7.7

Product Design 7.5

Verification/Audit Processes
7.19 Technical Review 5.5 Management Review 8.4 QA Process Audits 8.5 QA Product Audits 8.6 QMS Audits

Purchasing Inputs and Outputs: Process Inputs Design and development plan Supplier historical and performance data Supplier selection criteria Supplier product and documents Process Outputs Qualified suppliers selected Supplier requirements Supplier performance review Supplier product verification and acceptance

QMS Process Manual

Purchasing

QMS PROCESS MANUAL Title: Purchasing Approved By: Revision Date: Oct. 2, 2001 Page 2

Purchasing Tasks and Responsibilities: Process Tasks 1. Perform supplier selection 2. Develop purchasing documentation 3. Review purchasing documentation 4. Review supplier technical performance 5. Verify supplier product 6. Maintain supplier results and records 7. Review purchasing status 8. Audit purchasing activities and products
* SM Senior Management PM Product Management PD Product Development PS Product Servicing HR Human Resources QA Quality Assurance

Task Responsibility*
SM PM PD PS HR QA

X X X X X X

X X

Purchasing Procedure: 1. Perform supplier selection Product development selects qualified suppliers and subcontractors by establishing selection criteria and evaluating suppliers/subcontractors proposal, capabilities, and other factors. Selection criteria include costs, ability to meet schedule, historical performance, and quality system capability. 2. Develop purchasing documentation Product development prepares and negotiates a contract that addresses requirements including cost and schedule of the product to be delivered and proprietary, usage, ownership, warranty, licensing rights, as appropriate. Purchasing documents describe the product to be purchased including: Requirements for approval or qualification of product, procedures, processes, equipment and personnel QMS requirements, where applicable.

3. Review purchasing documentation Product management, product development, and QA review purchasing documentation prior to release for adequacy. 4. Review supplier technical performance

QMS Process Manual

Purchasing

QMS PROCESS MANUAL Title: Purchasing Approved By: Revision Date: Oct. 2, 2001 Page 3

Product development reviews supplier/subcontractor performance including reviews of supplier performance to plans and technical performance to plans. 5. Verify supplier products Product development verifies supplier/subcontractor products at the supplier/subcontractor facility by witnessing factory acceptance testing, when specified in the purchasing documentation. Supplier/subcontractor product is reviewed upon receipt for correctness of type, damage, completeness (including documentation), and functionality, where appropriate. Product development records verification results. 6. Maintain supplier results and records Product development maintains purchasing records including supplier selection, purchasing documentation, and negotiation records. Product development maintains monitoring and verification records. 7. Review purchasing status Senior management and product management review the status of purchasing activities in accordance with the Management Review process. 8. Audit purchasing activities and products QA audits purchasing activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Purchasing Records: Supplier selection records Subcontracts/purchase orders Supplier review records Supplier product verification records.

QMS Requirements Manual Reference: 7.4 Purchasing

QMS Process Manual

Purchasing

QMS PROCESS MANUAL Title: Implementation Approved By: Revision Date: Oct. 2, 2001 Page 1

7.7 Implementation Purpose: The Implementation process builds, tests, and reviews product units and components. QMS Process Interfaces:

Control Processes
4.1 Document Management 7.13 Change Management 7.14 Customer Property Control 4.2 Records Management 7.16 Monitoring & Measuring 7.17 Product ID & Traceability Device Control 7.15 Handling & Preservation

Input Processes
Design and Development Planning 7.3

Product Design 7.5

Implementation Implementation Process Process 7.7 7.7

Output Process
Integration 7.8

Verification/Audit Processes
7.18 Peer Review 7.19 Technical Review 5.5 Management Review 8.4 QA Process Audits 8.5 QA Product Audits 8.6 QMS Audits

Implementation Inputs and Outputs: Process Inputs Design and development plan Design documentation Implementation review criteria Process Outputs Product units and components Unit and component traceability Implementation test and review results

QMS Process Manual

Implementation

QMS PROCESS MANUAL Title: Implementation Approved By: Revision Date: Oct. 2, 2001 Page 2

Implementation Tasks and Responsibilities: Process Tasks 1. Develop units and components 2. Generate unit & component test cases, procedures 3. Execute unit and component test procedures 4. Document units and components and test results 5. Evaluate units and components to review criteria 6. Review implementation status 7. Audit implementation activities and products
* SM Senior Management PM Product Management PD Product Development PS Product Servicing HR Human Resources QA Quality Assurance

Task Responsibility*
SM PM PD PS HR QA

X X X X X X

X X

Implementation Procedure: 1. Develop units and components Product development develops units and components in accordance with the approved design. Product development codes instructions and data definitions, adapts reusable component and non-developmental items to software, as applicable, builds and populates databases and data files, and traces requirements to units and components. Product development procures needed product, as applicable. 2. Generate unit and component test cases and procedures Product development generates test cases to identify test inputs including nominal, boundary, and erroneous values. Product development creates test procedures that specify the actions necessary to initiate, execute, stop, and handle anomalies, as appropriate, and ensure all inter-unit data flows are traversed for component test. 3. Execute unit and component test procedures Product development performs unit and component testing by executing the tests to include comparing actual to expected results, analyzing results, identifying faults, and performing regression testing, as needed. 4. Document units and components and test results Product development documents implementation results in engineering notebooks including the implemented product (e.g., code lists or pointer to source file) and test plan, cases, procedures, and results.

QMS Process Manual

Implementation

QMS PROCESS MANUAL Title: Implementation Approved By: Revision Date: Oct. 2, 2001 Page 3

5. Evaluate units and components to review criteria Product development reviews units and components using the following criteria: Traceability Traceability to product requirements and design Consistency Consistency with requirements, design, and other units/components Compliance Compliance with customer requirements and standards Appropriateness Appropriateness of implementation methods and standards used Feasibility Feasibility of integration, operations, and maintenance.

Product development records implementation review results. 6. Review implementation status Senior and product management, product development, product servicing, human resources, and QA review implementation status in accordance with Management Review and Technical Review processes. 7. Audit implementation activities and products QA audits implementation activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Implementation Records: Unit and component test documentation and results Engineering notebooks Unit and component traceability matrix Implementation review minutes and action items.

QMS Requirements Manual Reference: 7.3 Design and Development

QMS Process Manual

Implementation

QMS PROCESS MANUAL Title: Integration Approved By: Revision Date: Oct. 2, 2001 Page 1

7.8 Integration Purpose: The Integration process defines how product units and components are integrated into the final product. QMS Process Interfaces:

Control Processes
4.1 Document Management 7.13 Change Management 7.14 Customer Property Control 4.2 Records Management 7.16 Monitoring & Measuring 7.17 Product ID & Traceability Device Control 7.15 Handling & Preservation

Input Processes
Design and Development Planning 7.3 Implementation 7.7

Integration Integration Process Process 7.8 7.8

Output Process
Acceptance 7.9

Verification/Audit Processes
7.18 Peer Review 7.19 Technical Review 5.5 Management Review 8.4 QA Process Audits 8.5 QA Product Audits 8.6 QMS Audits

Integration Inputs and Outputs: Process Inputs Design and development plan Units and components Process Outputs Integrated units and components Integration test and review results

QMS Process Manual

Integration

QMS PROCESS MANUAL Title: Integration Approved By: Revision Date: Oct. 2, 2001 Page 2

Integration Tasks and Responsibilities: Process Tasks 1. Integrate units and components 2. Develop integration test cases and procedures 3. Test integrated product 4. Document integration test results 5. Evaluate integrated product to review criteria 6. Review integration status 7. Audit integration activities and products
* SM Senior Management PM Product Management PD Product Development PS Product Servicing HR Human Resources QA Quality Assurance

Task Responsibility*
SM PM PD PS HR QA

X X X X X X

X X

Integration Procedure: 1. Integrate units and components Product development integrates units and components as they become available. 2. Develop integration test cases and procedures Product development develops integration test cases and procedures. 3. Test integrated product Product development tests integrated product as aggregates are developed. Product development ensures each aggregate satisfies requirements of the product and the product is fully integrated at the end of integration. 4. Document integration test results Product development documents the results of integration test. 5. Evaluate integrated product to review criteria Product development evaluates integrated products using the following criteria: Traceability Traceability to product requirements Consistency Consistency with requirements and completeness of test coverage Compliance Compliance with customer requirements and standards Appropriateness Appropriateness of test standard and methods used Integration

QMS Process Manual

QMS PROCESS MANUAL Title: Integration Approved By: Revision Date: Oct. 2, 2001 Page 3

Feasibility Feasibility of acceptance testing, operations, and maintenance.

Product development records integration review results. 6. Review integration status Senior and product management, product development, product servicing, human resources, and QA review integration status in accordance with Management Review and Technical Review processes. 7. Audit integration activities and products QA audits integration activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Integration Records: Integration test documentation and results Integration review minutes and action items.

QMS Requirements Manual Reference: 7.3 Design and Development

QMS Process Manual

Integration

QMS PROCESS MANUAL Title: Acceptance Approved By: Revision Date: Oct. 2, 2001 Page 1

7.9 Acceptance Purpose: The Acceptance process defines how the final product is tested and reviewed to ensure requirements are met. QMS Process Interfaces:

Control Processes
4.1 Document Management 7.13 Change Management 7.14 Customer Property Control 4.2 Records Management 7.16 Monitoring & Measuring 7.17 Product ID & Traceability Device Control 7.15 Handling & Preservation

Input Processes
Design and Development Planning 7.3 Integration 7.8

Acceptance Acceptance Process Process 7.9 7.9

Output Process
Delivery & Installation 7.10

Verification/Audit Processes
7.19 Technical Review 5.5 Management Review 8.4 QA Process Audits 8.5 QA Product Audits 8.6 QMS Audits

Acceptance Inputs and Outputs: Process Inputs Design and development plan Integrated product Process Outputs Acceptance test documentation Acceptance test results Acceptance review results

QMS Process Manual

Acceptance

QMS PROCESS MANUAL Title: Acceptance Approved By: Revision Date: Oct. 2, 2001 Page 2

Acceptance Tasks and Responsibilities: Process Tasks 1. Develop acceptance test cases and procedures 2. Execute tests 3. Document test results 4. Prepare and distribute acceptance test report 5. Evaluate final product to acceptance review criteria 6. Review acceptance status 7. Audit acceptance activities and products
* SM Senior Management PM Product Management PD Product Development PS Product Servicing HR Human Resources QA Quality Assurance

Task Responsibility*
SM PM PD PS HR QA

X X X X X X

X X

Acceptance Procedure: 1. Develop acceptance test cases and procedures Product development develops test cases and procedures for performing acceptance testing to include: Test setup Test inputs (include boundary and erroneous values for test inputs) Test execution (steps) Test acceptance criteria Test anomaly management Requirements satisfied.

2. Execute tests Product development executes tests in accordance with test procedures. Product development follows test step sequence, reviews test execution results to criteria, and notes inconsistencies and anomalies. 3. Document test results Product development documents results of acceptance testing. Product development identifies PASS/FAIL for each test step and processes anomalies (problems). Product development performs retests as needed. 4. Prepare and distribute acceptance test report

QMS Process Manual

Acceptance

QMS PROCESS MANUAL Title: Acceptance Approved By: Revision Date: Oct. 2, 2001 Page 3

Product development prepares and distributes the acceptance test report. The acceptance test report includes the following: Test results overview and assessment Detailed test results Problems found Test logs.

Product development distributes the test report for review and approval. 5. Evaluate final product to acceptance review criteria Product development evaluates the final product using the following criteria: Traceability Traceability to product requirements Test coverage Test coverage of requirements of the product Compliance Compliance to requirements and standards Conformance Conformance to expected results Feasibility Feasibility of operations and maintenance.

Product development records evaluation results. 6. Review acceptance status Senior and product management, product development, product servicing, human resources, and QA review acceptance status in accordance with Management Review and Technical Review processes. 7. Audit acceptance activities and products QA audits acceptance activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Acceptance Records: Acceptance test documentation Acceptance test results Acceptance review results.

QMS Requirements Manual Reference: 7.3 Design and Development

QMS Process Manual

Acceptance

QMS PROCESS MANUAL Title: Acceptance Approved By: Revision Date: Oct. 2, 2001 Page 4

7.10 Delivery and Installation Purpose: The Delivery and Installation process defines how the accepted product is delivered, installed, and transitioned to maintenance. QMS Process Interfaces:

Control Processes
4.1 Document Management 7.13 Change Management 7.14 Customer Property Control 4.2 Records Management 7.16 Monitoring & Measuring 7.17 Product ID & Traceability Device Control 7.15 Handling & Preservation

Input Processes
Design and Development Planning 7.3 Acceptance 7.9

Delivery Delivery& & Installation Process Installation Process 7.10 7.10

Output Process
Maintenance 7.12

Verification/Audit Processes
5.5 Management Review 8.4 QA Process Audits 8.5 QA Product Audits 8.6 QMS Audits

Delivery and Installation Inputs and Outputs: Process Inputs Design and development plan Accepted product Product support documents & materials Process Outputs Operator instructions Installation instructions Installation and turnover results

QMS Process Manual

Acceptance

QMS PROCESS MANUAL Title: Acceptance Approved By: Revision Date: Oct. 2, 2001 Page 5

Delivery and Installation Tasks and Responsibilities: Process Tasks 1. Define needed methods and resources 2. Develop installation procedures 3. Generate operations guide 4. Ensure readiness of target environment 5. Verify test and support documentation completeness 6. Deliver and install product 7. Complete turnover and acceptance 8. Review delivery & installation status 9. Audit delivery & installation activities & products
* SM Senior Management PM Product Management PD Product Development PS Product Servicing HR Human Resources QA Quality Assurance

Task Responsibility*
SM PM PD PS HR QA

X X X X X X X X X X

Delivery and Installation Procedure: 1. Define needed methods and resources Product development defines the methods and resources needed for delivery and installation. 2. Develop installation procedures Product development defines the installation procedures to be used including macros and scripts needed to support installation, as applicable. 3. Generate operations guide Product development generates the operations guide to support operations including instructions for startup, shutdown, restoration, backup, performance monitoring, database administration, and security, as needed. 4. Ensure readiness of target environment Product development ensures the target environment is ready for installation. Product development assesses the adequacy and readiness of the target environment, corrects inadequacies in the target environment, and configures the target environment. 5. Verify test and support documentation completeness

QMS Process Manual

Acceptance

QMS PROCESS MANUAL Title: Acceptance Approved By: Revision Date: Oct. 2, 2001 Page 6

Product development ensures product has successfully completed all tests and support materials, documentation are available. 6. Deliver and install product Product development delivers and installs the product in the target environment. Product development packages and delivers the product, notifies users of delivery and installation plans and activities, and conducts user training, as required. Product development installs the product by: Configuring the application environment (e.g., libraries, hardware devices, permissions, users) Building the target environment Loading data and software Testing installation and report/resolve problems.

7. Complete turnover and acceptance Product development performs turnover and acceptance activities. Product development executes acceptance tests in target environment documenting results and resolves problems. Product development coordinates turnover and customer acceptance. 8. Review delivery and installation status Senior management and product management review delivery and installation status in accordance with Management Review process. 9. Audit delivery and installation activities and products QA audits delivery and installation activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Delivery and Installation Records: Operations guide Installation procedures Installation and turnover records.

QMS Requirements Manual Reference: 7.3 Design and Development

QMS Process Manual

Acceptance