Quality Management System (QMS) Process Manual

QMS PROCESS MANUAL Title: Revision Record Approved By: Revision Record Date 10/2/01 Initial release Description Change Request Reference ---------Revision Date: Oct. 2, 2001

QMS Process Manual

Revision Record

QMS PROCESS MANUAL Title: Table of Contents Approved By: Revision Date: Oct. 2, 2001 Page i Table of Contents Section 1. 2. 3. 4. 4.1 4.2 4.3 5. 5.1 5.2 5.3 5.4 5.5 6. 6.1 6.2 6.3 6.4 6.5 7. 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9 7.10 7.11 7.12 7.13 7.14 7.15 7.16 7.17 7.18 7.19 Title Scope QMS Process Model QMS Process Responsibilities QMS Documentation Processes Document Management Records Management Manual Preparation and Maintenance Management Responsibility Processes QMS Planning Communications Customer Focus Risk Management Management Review Resource Management Processes Resources Planning Human Resources Management Infrastructure Work Environment Training Product Realization Processes Product Quality Planning Customer Requirements and Interface Design and Development Planning Requirements Definition Product Design Purchasing Implementation Integration Acceptance Delivery and Installation Product Servicing Planning Maintenance Change Management Customer Property Control Handling and Preservation Monitoring and Measuring Device Control Product Identification and Traceability Peer Review Technical Review Revision Date 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01

QMS Process Manual

Table of Contents

QMS PROCESS MANUAL Title: Table of Contents Approved By: Revision Date: Oct. 2, 2001 Page ii Revision Date 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01 02 Oct 01

Section 8. 8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8 8.9 8.10

Title Measurement, Analysis, & Improvement Processes QA Planning Customer Satisfaction Nonconforming Product Control QA Process Audits QA Product Audits QMS Audits Measurement Quality Data Analysis Corrective Action Preventive Action Annexes

Annex A B

Title QMS Process Manual Traceability Matrix QMS Process Manual Support Forms

Revision Date 02 Oct 01 02 Oct 01

QMS Process Manual

Table of Contents

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

1. Scope This Quality Management System (QMS) Process Manual defines the detailed processes needed to fully implement requirements specified in the QMS Requirements Manual. The QMS Process Manual includes: The QMS process model showing process relationships and interactions Detailed process interfaces between QMS processes The inputs needed to implement QMS processes and resultant outputs Process task and responsibility matrixes that define the interfaces between functional areas Detailed procedures that provide the implementation instructions and directions QMS process records that provide evidence of conformity and support process improvement Traceability references to the QMS Requirements Manual Support forms to assist with QMS implementation.

The QMS Process Manual is divided into the following sections: Section 1 (Scope) provides an introduction to the QMS Process Manual and its contents. Section 2 (QMS Process Model) shows overall QMS process and customer interfaces. Section 3 (QMS Process Responsibilities) identifies overall management responsibilities for QMS processes. Sections 4 through 8 includes the detailed QMS, management, resource management, product realization, and measurement, analysis, and improvement process definitions. Annex A (QMS Process Manual Traceability Matrix) includes a traceability matrix between QMS requirements and process manuals. Annex B (QMS Support Forms) includes the support forms referenced in the detailed process definitions.

QMS Process Manual

Scope

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

2. QMS Process Model Figure 2-1 shows the QMS Process Model. The QMS Process Model shows the overall relationships between management, resource management, product realization, and measurement, analysis & improvement processes that ensure customer requirements are effectively satisfied. Detailed interfaces are defined in later sections of this manual.

Quality Management System Process Model

Management Responsibility Processes
QMS Planning Customer Focus Risk Management Communications Management Review

C U S T O M E R R E Q U I R E M E N T S

Measurement, Analysis, & Improvement Processes Resource Management Processes

Resources Planning Human Resource Management Infrastructure Work Environment Training QA Planning Customer Satisfaction Measurement Corrective Action Preventive Action Nonconforming Product Control QA Product Audits QA Process Audits QMS Audits Quality Data Analysis

C U S T O M E R S A T I S F A C T I O N

Support Processes
Document Management Records Management Manual Preparation & Maintenance

Product Realization Processes Product Reqts.

Product Quality Planning Customer Requirements & Interface Design & Development Planning Product Servicing Planning Requirements Definition Product Design Purchasing Implementation Integration Acceptance Delivery and Installation Maintenance Peer Review Technical Review Handling and Preservation Customer Property Control Change Management Product ID and Traceability Monitoring & Measuring Control

Product

Figure 2-1 QMS Process Model

QMS Process Manual

QMS Process Model

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

3. QMS Process Responsibilities Figure 3-1 identifies the QMS process owners. Senior management has responsibility for ensuring processes are implemented as planned and are effective. Functional responsibilities are identified in the individual process descriptions included in this manual.

Company CompanyPresident President & &General GeneralManager Manager

QMS Planning Customer Focus Risk Management Communications Management Review

VP, VP,Product Product

VP, VP,Human Human Resources Resources

VP, VP,Quality Quality

Document Management Manual Preparation & Maintenance Records Management Corrective Action Preventive Action Customer Satisfaction Measurement Nonconforming Product Control QA Process Audits QA Product Audits QMS Audits Quality Data Analysis QA Planning

Product Quality Planning Human Resource Management Requirements Definition Infrastructure Product Design Training Implementation Work Environment Integration Resources Planning Acceptance Delivery & Installation Maintenance Peer Review Technical Review Handling & Preservation Customer Requirements & Interface Customer Property Control Purchasing Change Management Product ID & Traceability Monitoring & Measuring Device Control Design and Development Planning Product Servicing Planning

Figure 3-1 QMS Process Responsibilities

QMS Process Manual

QMS Process Responsibilities

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

4. QMS Documentation Processes QMS documentation processes define the responsibilities and tasks needed to develop, use, control, and maintain QMS documents and records. QMS documentation processes are identified below.

Document Management 4.1 Manual Preparation and Maintenance 4.3

Records Management 4.2

Figure 4-1 QMS Documentation Processes QMS documentation processes are defined in the following sections.

QMS Process Model

QMS Documentation Processes

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

4.1 Document Management Purpose: The Document Management process ensures the integrity of document preparation, distribution, maintenance, and control. QMS Process Interfaces:

Input Process
QMS Planning 5.1

Document Document Management Management Process Process 4.1 4.1

Control of QMS Document Development, Distribution, and Maintenance

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

Document Management Inputs and Outputs: Process Inputs QMS plan Contract documentation requirements QMS requirements Process Outputs Document format requirements Document masters Document backups Document listing

QMS Process Manual

Document Management

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

Document Management Tasks and Responsibilities: Process Tasks 1. Identify documents to be managed and controlled 2. Establish document format requirements 3. Maintain master list of documents 4. Approve documents prior to release 5. Provide access to approved documentation 6. Maintain documentation (masters, backups) 7. Review document management status 8. Audit document management 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

Document Management Procedure: 1. Identify documents to be managed and controlled QA identifies baseline documents to be managed and controlled including product specifications and documents, product support documents (e.g., users manual), and externally supplied documents. QA identifies support documents to be configuration controlled including plans and procedures. 2. Establish document format requirements QA establishes document format requirements in accordance with customer guidelines and requirements, when applicable. Format requirements include: Copyright information Graphics Format Cover and signature pages Revision/change record Table of contents Headers and footers Revision marks and change bars Spacing and fonts Margins

QMS Process Manual

Document Management

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

Level hierarchy of headings Listings, figures, and tables Paging Abbreviations and acronyms Glossary.

3. Maintain master list of documents QA maintains a master list of controlled documentation. The master list includes the following data. Document ID Document title Document type (plan, procedure, specification, report, manual) Document owner Document media type (hardcopy, electronic) Document location Revision date.

4. Approve documents prior to release Senior management, product management, product development, product servicing, human resources, and QA review documents for adequacy prior to release including rerelease as defined in detailed processes of this manual. 5. Provide access to approved documentation QA provides on-line (read only) access to baseline documentation at points of use. QA maintains document distribution lists and provides copies when documents (including updates) are ready for release and notification to remove obsolete copies. QA provides copies of approved documentation upon request. QA identifies obsolete documents to prevent unintended use. 6. Maintain documentation (masters, backups) QA maintains baseline documentation. QA maintains document master versions (electronic and hardcopy) in controlled library areas to protect from damage and unauthorized access. QA provides master versions for document updates when directed by the change control board (CCB). QA keeps backup (disaster) copy of controlled documentation in separate area. QA maintains document change history.

QMS Process Manual

Document Management

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

7. Review document management status Senior management reviews document management status in accordance with Management Review process. 8. Audit document management activities and products QA audits document management activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. QA ensures documents are identified and legible. Document Management Records: Document master list Document approval records Document repositories.

QMS Requirements Manual Reference: 4.2 Documentation Requirements

QMS Process Manual

Document Management

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

4.2 Records Management Purpose: The Records Management process provides evidence of conformity to requirements and effective operation of the Quality Management System (QMS). QMS Process Interfaces:

Input Process
QMS Planning 5.1

Records Records Management Management Process Process 4.2 4.2

Control, Management, and Use of QMS Objective Evidence

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

Records Management Inputs and Outputs: Process Inputs QMS plan QMS requirements QMS implementation results Process Outputs QMS identified records QMS record responsibility QMS record medium QMS record location QMS record access control QMS record retention period QMS record disposition

QMS Process Manual

Records Management

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

Records Management Tasks and Responsibilities: Process Tasks 1. Identify QMS records 2. Establish and maintain record storage areas and locations 3. Maintain QMS records integrity 4. Define QMS record retention period 5. Define QMS records disposition 6. Review records management status 7. Audit records management 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 X X

Records Management Procedure: 1. Identify QMS records QA creates and maintains the QMS records master list that identifies for each quality record the following information: QMS record name Record medium (hardcopy, electronic) QMS responsibility Storage location Retention period Disposition instructions.

2. Establish and maintain record storage area and locations QMS record owners maintain their responsible records in controlled areas to prevent record damage and inadvertent use. Read-only and check-in/check-out access controls are applied, as applicable. 3. Maintain QMS records integrity QMS record owners ensure records remain legible, readily identifiable, and retrievable. Electronic records are refreshed as needed for technology updates to prevent obsolescence.

QMS Process Manual

Records Management

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

4. Define QMS record retention period QA defines QMS record retention time. As a minimum, record retention times are for the life of the contract. 5. Define QMS records disposition QA determines how QMS records are disposed. Disposition is performed in accordance with contract instructions, as applicable. 6. Review Records Management status Senior management reviews records management status in accordance with Management Review process. 7. Audit Records Management activities and products QA audits records management activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Records Management Records: QMS records master list.

QMS Requirements Manual Reference: 4.2 Documentation Requirements

QMS Process Manual

Records Management

QMS PROCESS MANUAL Title: Manual Preparation and Maintenance Approved By: Revision Date: Oct. 2, 2001 Page 1

4.3 Manual Preparation and Maintenance Purpose: The Manual Preparation and Maintenance process establishes and maintains the Quality Management System (QMS) requirements and process manuals. QMS Process Interfaces:

Control Processes
4.1 Document Management 4.2 Records Management

Input Process
QMS Planning 5.1

Manual ManualPreparation Preparation and Maintenance and Maintenance Process Process 4.3 4.3

Controlled and Maintained QMS Requirements & Process Manuals

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

Manual Preparation & Maintenance Inputs and Outputs: Process Inputs QMS plan Company goals and objectives Contract requirements Manuals change requests Process Outputs QMS policy and objectives QMS requirements QMS responsibilities QMS process model QMS processes and procedures QMS records QMS manuals updates

QMS Process Model

Manual Preparation and Maintenance

QMS PROCESS MANUAL Title: Manual Preparation and Maintenance Approved By: Revision Date: Oct. 2, 2001 Page 2

QMS Process Model

Manual Preparation and Maintenance

QMS PROCESS MANUAL Title: Manual Preparation and Maintenance Approved By: Revision Date: Oct. 2, 2001 Page 3

Manual Preparation & Maintenance Tasks and Responsibilities: Process Tasks 1. Define QMS manuals structure 2. Define QMS manuals responsibilities 3. Define QMS policy and objectives 4. Define QMS requirements and processes 5. Develop QMS procedures 6. Document the QMS manuals 7. Review the QMS manuals including updates 8. Review manual preparation & maintenance status 9. Audit manual preparation & maintenance 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 X X X X X X X X X X X X X X

Manual Preparation & Maintenance Procedure: 1. Develop QMS manuals structure QA defines QMS requirements and process manuals content to ensure requirements are addresses, responsibilities and interfaces defined, and procedures are developed. 2. Define QMS manuals responsibilities Senior management identifies QMS requirements and process manual section responsibilities. 3. Define QMS policy and objectives Senior management, product management, product development, product servicing, human resources, and QA define QMS requirements and process manuals policy and objectives. 4. Define QMS requirements and processes Senior management, product management, product development, product servicing, human resources, and QA define QMS requirements, processes, and QMS interfaces. 5. Develop QMS procedures

QMS Process Model

Manual Preparation and Maintenance

QMS PROCESS MANUAL Title: Manual Preparation and Maintenance Approved By: Revision Date: Oct. 2, 2001 Page 4

Senior management, product management, product development, product servicing, human resources, and QA develop QMS procedures that provide the detailed steps and instructions to implement QMS requirements and processes. 6. Document the QMS manuals QA documents QMS requirements and process manuals. 7. Review the QMS manual including updates QA maintains the QMS requirements and process manuals under configuration control. Senior management, product management, product development, product servicing, human resources, and QA review the QMS manuals to ensure compliance to requirements, interface consistency, and completeness. QA implements changes to the QMS requirements and process manuals in accordance with the Document Management process. 8. Review manual preparation and maintenance status Senior management reviews manual preparation and maintenance status in accordance with Management Review process. 9. Audit manual preparation and maintenance activities and products QA audits manual preparation and maintenance activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Manual Preparation & Maintenance Records: QMS requirements manual QMS process manual QMS manuals change records.

QMS Requirements Manual Reference: 4.2 Documentation Requirements

QMS Process Model

Manual Preparation and Maintenance

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

5. Management Responsibility Processes QMS management responsibility processes define the responsibilities and tasks needed to ensure management commitment, a customer-focus, communications, and reviews of QMS performance and effectiveness. QMS management responsibility processes are identified below.

QMS Planning 5.1

Communications 5.2

Customer Focus 5.3

Risk Management 5.4

Management Review 5.5

Figure 5-1 Management Responsibility Processes QMS management responsibility processes are defined in the following sections.

QMS Process Manual

Management Responsibility Processes

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

5.1 QMS Planning Purpose: The QMS Planning process ensures Quality Management System (QMS) process and resource needs are planned and developed consistent with QMS requirements. QMS Process Interfaces:

Output Processes Control Processes

4.1 Document Management 4.2 Records Management

Communications 5.2 Customer Focus 5.3 Risk Management 5.4

QMS Requirements Manual

QMS QMS Planning PlanningProcess Process 5.1 5.1

Management Review 5.5 Resources Planning 6.1 Product Quality Planning 7.1 Design & Development Planning 7.3 Product Servicing Planning 7.11 QA Planning 8.1

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

QMS Planning Inputs and Outputs: Process Inputs Customer and company requirements Historical data (effort, staffing, costs) Company assets (tools, processes) Process Outputs QMS planning QMS process needs QMS effort, staffing, and cost estimates

QMS Process Manual

QMS Planning

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

QMS Planning Tasks and Responsibilities: Process Tasks 1. Identify management requirements and quality objectives 2. Define management processes and documents 3. Estimate effort, project staffing, and costs 4. Define resources (tools, training) 5. Develop management schedule 6. Document QMS plan 7. Review QMS plan 8. Review QMS planning status 9. Audit QMS 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

QMS Planning Procedure: 1. Identify management requirements and quality objectives Senior management determines and documents QMS requirements and specific quality objectives. 2. Define management processes and documents Senior management defines the processes needed to manage, review, and control QMS activities. Senior management identifies the documents needed to support overall QMS management of management, resource provisioning, product realization, and measurement, analysis, and improvement processes. Senior management defines the quality records needed to provide evidence that requirements are being met. 3. Estimate effort, project staffing, and costs Senior management estimates the management effort needed to perform management functions using historical data, where available. Senior management estimates QMS staffing and costs needed using historical data, where available. 4. Define resources (tools, training)

QMS Process Manual

QMS Planning

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

Senior management defines the resources needed to satisfy contract requirements. Senior management identifies management support tools for tracking schedule and status to plans. Senior management identifies QMS training needs. 5. Develop management schedule Senior management determines management activities, milestones, and review points. 6. Document QMS plan Senior management documents the results of planning activities including objectives, responsibilities, estimates, schedules, and processes to be used. 7. Review QMS plan Senior management, product management, product development, product servicing, human resources, and QA review the QMS plan to ensure planning output is suitable to the companys method of operations and is consistent with lower-level plans. 8. Review QMS planning status Senior management reviews QMS planning status in accordance with Management Review process. 9. Audit QMS planning activities and products QA audits QMS planning activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. QMS Planning Records: QMS plan and objectives QMS schedule QMS effort estimation records QMS staffing and cost estimation records QMS processes.

QMS Requirements Manual Reference: 5.1 Management Commitment 5.3 Quality Policy 5.4 Planning

QMS Process Manual

QMS Planning

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

5.2 Communications Purpose: The Communications process ensures communication processes are established and Quality Management System (QMS) effectiveness is communicated. QMS Process Interfaces:

Control Processes
4.1 Document Management 4.2 Records Management

Input Process
QMS Planning 5.1

Communications Communications Process Process 5.2 5.2

QMS Visibility & Status

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

Communications Inputs and Outputs: Process Inputs QMS plan Contract requirements QMS status data Process Outputs QMS communications mechanisms QMS communications

QMS Process Manual

Communications

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

Communications Tasks and Responsibilities: Process Tasks 1. Identify communications mechanisms 2. Communicate QMS effectiveness 3. Review communications status 4. Audit communications 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

Communications Procedure: 1. Identify communications mechanisms Senior management identifies the communications mechanisms for communicating QMS effectiveness. Senior management communicates status of management reviews, risks, audit, and measurement activities. Senior management identifies: Type of communications Medium QMS responsibility Customer Communication frequency.

2. Communicate QMS effectiveness Senior management communicates QMS effectiveness as planned. 3. Review communications status Senior management reviews communications status in accordance with Management Review process. 4. Audit communications activities and products QA audits communications activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Communications Records:

QMS Process Manual

Communications

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

QMS communications records.

QMS Requirements Manual Reference: 5.5 Responsibility, Authority, and Communication

QMS Process Manual

Communications

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

5.3 Customer Focus Purpose: The Customer Focus process ensures customer requirements are determined and satisfied with the aim of improving customer satisfaction. QMS Process Interfaces:

Control Processes
4.1 Document Management 4.2 Records Management

Input Process
QMS Planning 5.1 Quality Data Analysis 8.8

Customer CustomerFocus Focus Process Process 5.3 5.3

Continuous Focus on Customer Requirements and Satisfaction

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

Customer Focus Inputs and Outputs: Process Inputs QMS plan Contract requirements Customer survey data Process Outputs Customer requirements traceability Customer satisfaction survey action status

QMS Process Manual

Customer Focus

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

Customer Focus Tasks and Responsibilities: Process Tasks 1. Establish and maintain contract requirements traceability status 2. Review customer satisfaction survey status 3. Review customer focus status 4. Audit customer focus 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

Customer Focus Procedure: 1. Establish and maintain contract requirements traceability status Product management maintains the status of contract requirements throughout the product life cycle. Product management establishes a customer requirements traceability matrix. Product management updates the matrix as project phases, deliveries, and milestones are complete. 2. Review customer satisfaction survey status Senior management and product management review customer satisfaction status data and measurements provided by the Quality Data Analysis process. Senior management and product management identify action items and tracks status through completion. 3. Review customer focus status Senior management reviews customer focus status in accordance with Management Review process. 4. Audit customer focus activities and products QA audits customer focus activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Customer Focus Records: Contract requirements traceability matrix Customer satisfaction survey action status records.

QMS Process Manual

Customer Focus

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

QMS Requirements Manual Reference: 5.2 Customer Focus

QMS Process Manual

Customer Focus

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

5.4 Risk Management Purpose: The Risk Management process ensures project technical, cost, and schedule risks are identified, analyzed, planned, tracked, and controlled. QMS Process Interfaces:

Control Processes
4.1 Document Management 4.2 Records Management

Output Processes Input Process

QMS Planning 5.1

Risk RiskManagement Management Process Process 5.4 5.4

Management Review 5.5 Preventive Action 8.10

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

Risk Management Inputs and Outputs: Process Inputs QMS plan Technical, cost, and schedule uncertainties Process Outputs Risk statement Risk classification Risk prioritization Risk mitigation planning Risk status tracking

QMS Process Manual

Risk Management

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

Risk Management Tasks and Responsibilities: Process Tasks 1. Identify project risks from technical, cost, and schedule issues and constraints 2. Analyze risk impact, probability of occurrence, and timeframe 3. Classify and prioritize risks 4. Plan risk management approach 5. Track, analyze, and control risks 6. Review risk management status 7. Audit risk management 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 X X

Risk Management Procedure: 1. Identify project risks from technical, cost, and schedule issues and uncertainties Senior and product management identify risks from technical, cost, and schedule issues and uncertainties. Senior and product management record identified risks. 2. Analyze risk impact, probability of occurrence, and timeframe Senior and product management analyze each risk for impact, probability of occurrence, and timeframe. Senior and product management determine if risk: Impact is high, moderate, or low Probability of occurrence is high, moderate, or low Timeframe is near, mid, or far.

3. Classify and prioritize risks Senior and product management classify and prioritize risks. Senior and product management determine risk type (product, environment, program) and rank risks considering impact, probability of occurrence, and timeframe. 4. Plan risk management approach Senior and product management plan the risk management approach. Senior and product management assign risk responsibility by determining if risks are internal or external. QMS Process Manual Risk Management

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

Internal risks are assigned to task leads and external risks are transferred to external groups, as applicable. Risk assignees determine risk plan approach: accept, mitigate, or watch. 5. Track, analyze, and control risks Senior and product management track risks by reviewing risk status at management meetings. Senior and product management analyze risk status for effectiveness and consistency with plan. Senior and product management make decisions based on risk status. 6. Review risk management status Senior and product management review risk management status in accordance with Management Review process. 7. Audit risk management activities and products QA audits risk management activities and product in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Risk Management Records: Risk status records.

QMS Requirements Manual Reference: 5.6 Management Review

QMS Process Manual

Risk Management

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

5.5 Management Review Purpose: The Management Review process ensures the Quality Management System (QMS) is reviewed at planned intervals for continued suitability, adequacy, and effectiveness. QMS Process Interfaces:

Control Processes
4.1 Document Management 4.2 Records Management

Output Processes Input Process

QMS Planning 5.1

Management Management Review Review Process Process 5.5 5.5

Corrective Action 8.9 Preventive Action 8.10

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

Management Review Inputs and Outputs: Process Inputs QMS plan Audit results, customer feedback, process/product conformity data, preventive & corrective action status, follow-up actions from previous reviews, QMS change impacts, improvement recommendations Process Outputs QMS process improvements Product improvements QMS resource needs

QMS Process Manual

Management Review

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

Management Review Tasks and Responsibilities: Process Tasks 1. Plan for management review 2. Prepare for management review 3. Conduct management review 4. Record and report management review results 5. Audit management review 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

Management Review Procedure: 1. Plan for management review Senior management and product management schedule the management review. Reviews are scheduled at planned intervals (e.g., quarterly). 2. Prepare for management review Senior management, product management, and QA prepare the management review package including the inputs identified above. QA arranges meeting logistics and provides notification to senior management of date, location, and time. 3. Conduct management review Senior management, product management, product development, product servicing, human resources, and QA attend the meeting as scheduled. QA leads the review of QMS performance and results. Senior management agrees and decides on QMS changes and actions including updates to QMS policy and objectives. Senior management assigns action items with due dates. 4. Record and report management review results QA prepares management review minutes and distributes to attendees. QA tracks the status of action items and verifies closure. 5. Audit management review activities and products QA audits management review activities and products in accordance with QA Process Audits and QA Product Audits processes.

QMS Process Manual

Management Review

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

Management Review Records: Management review schedule Management review notice Management review materials Management review minutes Management review action items.

QMS Requirements Manual Reference: 5.6 Management Review

QMS Process Manual

Management Review

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

6. Resource Management Processes QMS resource management processes define the responsibilities and tasks needed to ensure the resources needed to implement, maintain, and continuously improve the QMS and enhance customer requirements are provided. QMS resource management processes are identified below.

Resources Planning 6.1 Human Resources Management 6.2 Training 6.5

Infrastructure 6.3

Work Environment 6.4

Figure 6-1 Resource Management Processes QMS resource management processes are defined in the following sections.

QMS Process Manual

Resource Management Processes

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

6.1 Resources Planning Purpose: The Resources Planning process ensures Quality Management System (QMS) resource, training, work environment, and infrastructure needs are planned consistent with QMS requirements. QMS Process Interfaces:

Control Processes
4.1 Document Management 4.2 Records Management

Output Processes
Human Resources Mgmt. 6.2

Input Process
QMS Planning 5.1

Resources Resources Planning PlanningProcess Process 6.1 6.1

Infrastructure 6.3 Work Environment 6.4 Training 6.5

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

Resources Planning Inputs and Outputs: Process Inputs QMS plan Customer requirements Training documentation Historical data (effort, costs) Company infrastructure, environment Process Outputs Resources planning Resources process needs Human resources effort and cost estimates

QMS Process Manual

Resources Planning

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

Resources Planning Tasks and Responsibilities: Process Tasks 1. Identify resources provisioning requirements and quality objectives 2. Determine resources provisioning processes and documents 3. Estimate effort and costs 4. Define resources (tools, training) 5. Develop resources management schedule 6. Document resources plan 7. Review resources plan 8. Review resources planning status 9. Audit resources 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

Resources Planning Procedure: 1. Identify resources provisioning requirements and quality objectives Human resources reviews contract documentation and QMS planning results to identify resource requirements. Human resources determines and documents resource requirements and specific quality objectives. 2. Determine resources provisioning processes and documents Human resources defines the processes needed to manage, review, and control resources provisioning activities including resources planning, human resources management, infrastructure, work environment, and training. Human resources identifies the documents needed to support and manage resources. Human resources defines the quality records needed to provide evidence that requirements are being met. 3. Estimate effort and costs Human resources estimates effort and costs needed to perform resource management functions using historical data, where available. 4. Define resources (tools, training)

QMS Process Manual

Resources Planning

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

Human resources defines the resources needed to satisfy contract and company resource provisioning requirements and needs. Human resources identifies management support tools for tracking schedule and status to plans. Human resources identifies training needs. 5. Develop resources management schedule Human resources determines human resources activities and schedule points. 6. Document resources plan Human resources documents the results of planning activities including objectives, responsibilities, estimates, schedules, and processes to be used. 7. Review resources plan Senior management, product management, product development, product servicing, human resources, and QA review resources plan to ensure planning output is suitable to the companys method of operations. 8. Review resources planning status Senior management reviews resources planning status in accordance with Management Review process. 9. Audit resources planning activities and products QA audits resources planning activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Resources Planning Records: Resources plan and objectives Resources schedule Resources effort estimation records Resources cost estimation records Resources management processes.

QMS Requirements Manual Reference: 6.1 Provision of Resources

QMS Process Manual

Resources Planning

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

QMS Process Manual

Resources Planning

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

6.2 Human Resources Management Purpose: The Human Resources Management process ensures personnel performing work that affects product quality are competent on the basis of education, training, skills, and experience. QMS Process Interfaces:

Control Processes
4.1 Document Management 4.2 Records Management

Input Process
Resources Planning 6.1

Human HumanResources Resources Management Management Process Process 6.2 6.2

Qualified and Capable Staff Selected

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

Human Resources Management Inputs and Outputs: Process Inputs Resources plan Manager needs Employee evaluation criteria Process Outputs Employee job description Employee recruitment and selection Employee evaluation

QMS Process Manual

Human Resources Management

QMS PROCESS MANUAL Title: Human Resources Management Approved By: Revision Date: Oct. 2, 2001 Page 2

Human Resources Management Tasks and Responsibilities: Process Tasks 1. Establish job qualifications and requirements 2. Recruit qualified personnel 3. Select qualified personnel 4. Evaluate employee performance 5. Maintain human resource management records 6. Review human resource management status 7. Audit human resource management 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 X X X

X X X X

Human Resources Management Procedure: 1. Establish job qualifications and requirements Senior management, product management, product development, product servicing, human resources, and QA establish job qualifications and requirements. Job qualification and requirements defines the minimum skills, knowledge, and abilities needed for each position. 2. Recruit qualified personnel Human resources recruits qualified personnel. Recruitment mechanisms include newspapers, job fairs, and college interviews. 3. Select qualified personnel Senior management, product management, product development, product servicing, human resources, and QA interview candidates to be selected. Human resources develops offer package for candidates to be hired. 4. Evaluate employee performance Managers evaluate employee performance yearly using the employee performance criteria established by human resources. Managers evaluate the effectiveness of human resource management activities. Managers inform employees of the importance of their activities and their contribution to objectives.

QMS Process Manual

Human Resources Management

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

5. Maintain human resource management records Human resources maintains human resource management records. 6. Review human resources management status Senior management reviews human resources management status in accordance with Management Review process. 7. Audit human resources management activities and products QA audits human resource management activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Human Resources Management Records: Employee job description record Recruitment ads Employee interview records Employee evaluation records.

QMS Requirements Manual Reference: 6.2 Human Resources

QMS Process Manual

Human Resources Management

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

6.3 Infrastructure Purpose: The Infrastructure process defines how the infrastructure needed to achieve conformity to product requirements is determined, provided, and maintained. QMS Process Interfaces:

Control Processes
4.1 Document Management 4.2 Records Management

Input Process
Resources Planning 6.1

Infrastructure Infrastructure Process Process 6.3 6.3

Tool and Support Resources

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

Infrastructure Inputs and Outputs: Process Inputs Resources plan Product requirements Process Outputs Identified infrastructure Infrastructure status Infrastructure improvements

QMS Process Manual

Infrastructure

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

Infrastructure Tasks and Responsibilities: Process Tasks 1. Identify infrastructure 2. Monitor infrastructure 3. Maintain infrastructure 4. Review infrastructure status 5. Audit infrastructure 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

Infrastructure Procedure: 1. Identify infrastructure Product management and QA identify the infrastructure components needed to meet product requirements including: Buildings, workspace, and associated utilities Process equipment (hardware and software) Supporting services (e.g., transport, communication).

Product management and QA maintain a listing of components. 2. Monitor infrastructure Product management, human resources, and QA monitor the status of the infrastructure to assess its effectiveness. 3. Maintain infrastructure Product management and QA maintain the infrastructure. Product management and QA update the infrastructure, as needed, based on monitoring results and changes in product requirements. 4. Review infrastructure status Senior management reviews infrastructure status in accordance with Management Review process. 5. Audit infrastructure activities and products QMS Process Manual Infrastructure

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

QA audits infrastructure activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Infrastructure Records: Infrastructure component list Infrastructure monitoring records Infrastructure update records.

QMS Requirements Manual Reference: 6.3 Infrastructure

QMS Process Manual

Infrastructure

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

6.4 Work Environment Purpose: The Work Environment process defines how the work environment is determined and managed to achieve conformity to product requirements. QMS Process Interfaces:

Control Processes
4.1 Document Management 4.2 Records Management

Input Process
Resources Planning 6.1

Work WorkEnvironment Environment Process Process 6.4 6.4

Environment Supports Product Quality

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

Work Environment Inputs and Outputs: Process Inputs Resources plan Product requirements Process Outputs Identified work environment Work environment status Work environment improvements

QMS Process Manual

Work Environment

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

Work Environment Tasks and Responsibilities: Process Tasks 1. Identify work environment 2. Monitor work environment 3. Maintain work environment 4. Review work environment status 5. Audit work environment 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

Work Environment Procedure: 1. Identify work environment Product management identifies the work environment components needed to meet product requirements. Product management maintains a listing of components. 2. Monitor work environment Human resources monitors the status of the work environment to assess its effectiveness. 3. Maintain work environment Product management maintains the work environment. Product management updates the work environment, as needed, based on monitoring results and changes in product requirements. 4. Review work environment status Senior management reviews work environment status in accordance with Management Review process. 5. Audit work environment activities and products QA audits work environment activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Work Environment Records: Work environment component list

QMS Process Manual

Work Environment

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

Work environment monitoring records Work environment update records.

QMS Requirements Manual Reference: 6.4 Work Environment

QMS Process Manual

Work Environment

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

6.5 Training Purpose: The Training process defines how training needs are identified, planned, and implemented. QMS Process Interfaces:

Control Processes
4.1 Document Management 4.2 Records Management

Input Process
Resources Planning 6.1

Training Training Process Process 6.5 6.5

Skilled and Qualified QMS Personnel

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

Training Inputs and Outputs: Process Inputs Resources plan Training requirements Process Outputs Training materials Training implementation results Training improvements

QMS Process Manual

Training

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

Training Tasks and Responsibilities: Process Tasks 1. Determine training needs and types 2. Plan training 3. Develop/Acquire and maintain training materials 4. Review training plans and materials 5. Implement training plans 6. Maintain training records 7. Assess training effectiveness 8. Review training status 9. Audit training 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

Training Procedure: 1. Determines training needs and types Human resources identifies training needs and determines types of training needed. Human resources uses surveys, questionnaires, and interviews to assist in determining needs and types. 2. Plan training Human resources develops and documents a training plan that includes an implementation schedule, resource and training requirements, and support forms to be used. 3. Develop and maintain training materials Human resources develops/acquires needed training materials including presentation slides, support files and aides. Human resources maintains training materials. 4. Review training plans and materials Senior and product management, product development, product servicing, human resources, and QA review training plans and materials. 5. Implement training plans

QMS Process Manual

Training

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

Human resources implements training in accordance with schedule and the training plan. Human resources provides process and skills training to personnel. 6. Maintain training records Human resources maintains training records of personnel and training evaluation. 7. Assess training effectiveness Human resources assesses training effectiveness by analyzing student evaluation records and reviewing feedback from managers. Human resources updates training course materials based on feedback. 8. Review training status Senior management reviews training status in accordance with Management Review process. 9. Audit training activities and products QA audits training activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audit processes. Training Records: Training courses Training attendance records Training evaluation records Training course update records.

QMS Requirements Manual Reference: 6.2 Human Resources

QMS Process Manual

Training

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

7. Product Realization Processes QMS product realization processes define the responsibilities and tasks needed to define product requirements, and to design, develop, integrate, verify, accept, and maintain product. QMS product realization processes are identified below.

Product Planning & Requirements Establishment Processes

Product Quality Planning 7.1 Customer Requirements & Interface 7.2

Design & Development Planning 7.3

Product Servicing Planning 7.11

Product Development, Acceptance & Delivery Processes

7.4 Requirements Definition 7.5 Product Design 7.6 Purchasing 7.7 Implementation 7.8 Integration 7.9 Acceptance 7.10 Delivery and Installation

Control/Verification Processes
7.13 Change Management 7.14 Customer Property Control 7.15 Handling and Preservation 7.16 Monitoring & Measuring Device Control 7.17 Product ID & Traceability 7.18 Peer Review 7.19 Technical Review

Product Servicing Process

Maintenance 7.12

Figure 7-1 Product Realization Processes QMS product realization processes are defined in the following sections.

QMS Process Manual

Product Realization Processes

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

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

QMS Planning 5.1 Customer Requirements & Interface 7.2 Design & Development Planning 7.3 Product Servicing Planning 7.11

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

QMS Process Manual

Product Quality Planning

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

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.

QMS Process Manual

Product Quality Planning

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

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 Product Quality Planning

QMS Process Manual

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

Quality objectives Product quality planning review records.

QMS Requirements Manual Reference: 7.1 Product Planning

QMS Process Manual

Product Quality Planning

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

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

Product Quality Planning 7.1

Customer Customer Requirements Requirements& & Interface Process Interface 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

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

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 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 QMS Process Manual Customer Requirements and Interface

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

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. 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

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

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

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

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. Design and Development Planning

QMS Process Manual

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

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 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 QMS Process Manual Design and Development Planning

QMS PROCESS MANUAL Title: Design and Development Planning Approved By: Revision Date: Oct. 2, 2001 Page 4

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 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

QMS Process Manual

Requirements Definition

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

Product management, product development, product servicing, and QA review product requirements documentation for compliance, traceability, and consistency with requirements. 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 Product Design 7.5

Purchasing Purchasing Process Process 7.6 7.6

Output Process
Implementation 7.7

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:

QMS Process Manual

Acceptance

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

7.3 Design and Development

QMS Process Manual

Acceptance

QMS PROCESS MANUAL Title: Delivery and Installation Approved By: Revision Date: Oct. 2, 2001 1

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

Delivery and Installation

QMS PROCESS MANUAL Title: Delivery and Installation Approved By: Revision Date: Oct. 2, 2001 2

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

Delivery and Installation

QMS PROCESS MANUAL Title: Delivery and Installation Approved By: Revision Date: Oct. 2, 2001 3

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

Delivery and Installation

QMS PROCESS MANUAL Title: Delivery and Installation Approved By: Revision Date: Oct. 2, 2001 4

QMS Process Manual

Delivery and Installation

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

7.11 Product Servicing Planning Purpose: The Product Servicing Planning process ensures the process needed for product maintenance is 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

Product ProductServicing Servicing Planning PlanningProcess Process 7.11 7.11

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

Product Servicing Planning Inputs and Outputs: Process Inputs Product quality plan Customer requirements Historical data (effort) Process Outputs Process, document, and resource needs Product acceptance criteria Product servicing plan review

QMS Process Manual

Product Servicing Planning

QMS PROCESS MANUAL Title: Product Servicing Planning Approved By: Revision Date: Oct. 2, 2001 2

Product Servicing Planning Tasks and Responsibilities: Process Tasks 1. Identify product servicing requirements & objectives 2. Determine product servicing processes, documents, responsibilities, and interfaces 3. Estimate effort 4. Define resources (people, tools, training) 5. Develop product servicing schedule 6. Document and maintain product servicing plan 7. Review product servicing plan 8. Review product servicing planning status 9. Audit product servicing 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

Product Servicing Planning Procedure: 1. Identify product servicing requirements and quality objectives Product servicing reviews contract documentation and the product quality plan to identify product servicing requirements, including derived requirements, and specific quality objectives. 2. Determine product servicing processes, documents, responsibilities, and interfaces Product servicing defines the process needed to operate and maintain the product. Product servicing identifies the documents needed to support maintenance. Product servicing defines product acceptance criteria and the quality records needed to provide evidence that requirements are being met. Product servicing assigns responsibilities for product servicing and identifies the interfaces between different groups to ensure effective communication and clear understanding of responsibilities. 3. Estimate effort Product servicing estimates expected effort using historical data, where available. 4. Define resources (people, tools, training)

QMS Process Manual

Product Servicing Planning

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

Product servicing defines the resources needed to satisfy requirements and the personnel skill levels and quantity based on effort estimates. Product servicing identifies tool and training needs. 5. Develop product servicing schedule Product servicing determines product servicing activities, milestones, and delivery points. 6. Document and maintain product servicing plan Product servicing documents the results of planning activities including objectives, responsibilities, estimates, schedules, and process to be used. Product servicing updates the plan, as needed, as product servicing progresses. 7. Review product servicing plan Senior management, product management, product development, product servicing, human resources, and QA review the product servicing plan to ensure planning is suitable to the companys method of operations. 8. Review product servicing planning status Senior management and product management review product servicing planning status in accordance with Management Review process. 9. Audit product servicing planning activities and products QA audits product servicing planning activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Product Servicing Planning Records: Product servicing plan Product servicing schedule Product servicing estimates (effort) Product servicing plan review records.

QMS Requirements Manual Reference: 7.5 Production and Servicing

QMS Process Manual

Product Servicing Planning

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

7.12 Maintenance Purpose: The Maintenance process defines how the operated product is modified during operations. 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 Servicing Planning 7.11 Delivery & Installation 7.10

Maintenance Maintenance Process Process 7.12 7.12

Product Servicing Control

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

Maintenance Inputs and Outputs: Process Inputs Product servicing plan Operated product Process Outputs Problem and modification requests Request analysis results Product upgrades and fixes Modification verification results

QMS Process Manual

Maintenance

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

Maintenance Tasks and Responsibilities: Process Tasks 1. Record problems and modification requests 2. Analyze problems and modifications 3. Document analysis results 4. Approve modification request 5. Perform approved modifications 6. Verify modifications 7. Review maintenance status 8. Audit maintenance 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

Maintenance Procedure: 1. Record problems and modification requests Product servicing records problems and modification requests in accordance with change management procedure. 2. Analyze problems and modifications Product servicing analyzes problem/modification requests for impact to existing and interfacing systems. Product operations identifies the: Type of modification (correction, improvement, adaptation to new environment) Scope of the modification (size, cost, time) Criticality of the modification (impact on performance, safety, security).

Product servicing verifies (replicates) the problem. 3. Document analysis results Product servicing documents options based on analysis. Product servicing documents modification request, analysis results, and implementation options. Product servicing obtains approval for selected option. 4. Approve modification request

QMS Process Manual

Maintenance

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

Product servicing, product management, product development, and QA approve modification request. 5. Perform approved modifications Product servicing performs approved modifications by identifying documentation, units, and versions to be modified. Product servicing defines test and evaluation criteria, ensures complete and correct implementation, and ensures original, unmodified requirements are not affected. Product servicing documents test results. 6. Verify modifications Product servicing performs maintenance review and acceptance. Product servicing conducts reviews with authorizing groups (e.g., customers, users) and obtains approval for completion of modifications. 7. Review maintenance status Senior management and product management review maintenance status in accordance with Management Review process. 8. Audit maintenance activities and products QA audits maintenance activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Maintenance Records: Change request forms Modified product.

QMS Requirements Manual Reference: 7.5 Production and Servicing

QMS Process Manual

Maintenance

QMS PROCESS MANUAL Title: Change Management Approved By: Revision Date: Oct. 2, 2001 1

7.13 Change Management Purpose: The Change Management process ensures changes during design and development and maintenance are identified, documented, reviewed, dispositioned, implemented, and recorded. QMS Process Interfaces:

Control Processes
4.1 Document Management 4.2 Records Management

Input Process
Product Quality Plan 7.1

Change Change Management Management Process Process 7.13 7.13

Product Change Control

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

Change Management Inputs and Outputs: Process Inputs Product quality plan Change request form (Annex B) Change need Process Outputs Change request Change request status

QMS Process Manual

Change Management

QMS PROCESS MANUAL Title: Change Management Approved By: Revision Date: Oct. 2, 2001 2

Change Management Tasks and Responsibilities: Process Tasks 1. Identify change need 2. Document change need 3. Submit change request for review 4. Approve/disapprove change request 5. Implement approved change request 6. Verify and close change request 7. Review change management status 8. Audit change management 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

Change Management Procedure: 1. Identify change need Product development and product servicing identify change need and type. Change types include problems and enhancements initiated during development, testing, and maintenance. 2. Document change need Product development and product servicing document changes using the Change Request Form (Annex B). 3. Submit change request for review Product development and product servicing submit documented change request to the change review board for review. The change review board includes representatives from product management, product development, product servicing, and QA. The change review board reviews for completeness and accuracy. If acceptable, product development and product servicing assign a number and record request in status accounting records. If unacceptable, product development and product servicing return change request to initiator for the appropriate actions. 4. Approve/disapprove change request The change review board reviews change request for technical correctness, accuracy, justification, and effect of change on products already delivered. The change review

QMS Process Manual

Change Management

QMS PROCESS MANUAL Title: Change Management Approved By: Revision Date: Oct. 2, 2001 3

board approves or disapproves the change request. If approved, the change review board signs the request form and assigns responsibility for implementation. If disapproved, the change review board returns the request to initiator for the appropriate actions. Product development and product servicing record the change review boards disposition. Product management submits change request to the customer for approval where contract and customer approved baselines are affected. 5. Implement approved change request Product development and product servicing implement the approved change request per the approval directions. 6. Verify and close change request Product development and product servicing test implemented change, as appropriate, and verify all change steps are complete before closure. Product development and product servicing record the completion status. 7. Review change management status Senior management and product management review change management status in accordance with Management Review process. 8. Audit change management activities and products QA audits change management activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Change Management Records: Change request records Change request status records.

QMS Requirements Manual Reference: 7.3 Design and Development 7.5 Production and Servicing

QMS Process Manual

Change Management

QMS PROCESS MANUAL Title: Customer Property Control Approved By: Revision Date: Oct. 2, 2001 1

7.14 Customer Property Control Purpose: The Customer Property Control process defines the controls for identifying, verifying, protecting, and safeguarding customer property provided for use or incorporated into the product. QMS Process Interfaces:

Control Processes
4.1 Document Management 4.2 Records Management

Input Process
Product Quality Plan 7.1

Customer Customer Property PropertyControl Control Process Process 7.14 7.14

Control of Customer Supplied Products

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

Customer Property Control Inputs and Outputs: Process Inputs Product quality plan Contract documentation Process Outputs Identified customer property Customer property verification results Customer property status results

QMS Process Manual

Customer Property Control

QMS PROCESS MANUAL Title: Customer Property Control Approved By: Revision Date: Oct. 2, 2001 2

Customer Property Control Tasks and Responsibilities: Process Tasks 1. Identify customer property 2. Verify customer property upon receipt 3. Protect customer property 4. Monitor condition and control of customer property 5. Report lost, damaged, or unsuitable customer property 6. Review customer property control status 7. Audit customer property control 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

Customer Property Control Procedure: 1. Identify customer property Product development and servicing maintain a log of customer property received. 2. Verify customer property upon receipt Product development and servicing verify customer property upon receipt for correctness of type, condition, quantity, and completeness. Product development and servicing record the status of verified customer property. 3. Protect customer property Product development and servicing protect and safeguard customer property from damage or inadvertent use including controlling storage area access and environment. 4. Monitor condition and control of customer property Product development and servicing monitor the condition and control of customer property and record its status. 5. Report lost, damaged, or unsuitable customer property

QMS Process Manual

Customer Property Control

QMS PROCESS MANUAL Title: Customer Property Control Approved By: Revision Date: Oct. 2, 2001 3

Product development and servicing report lost, damaged, or unsuitable customer property to the customer and maintains record of correspondence and customer disposition instructions. 6. Review customer property control status Senior management and product management review customer property control status in accordance with Management Review process. 7. Audit customer property control activities and products QA audits customer property control activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Customer Property Control Records: Customer property log Customer correspondence records (customer property) Customer property receipts verification records Customer property condition status records.

QMS Requirements Manual Reference: 7.3 Design and Development 7.5 Production and Servicing

QMS Process Manual

Customer Property Control

QMS PROCESS MANUAL Title: Handling and Preservation Approved By: Revision Date: Oct. 2, 2001 1

7.15 Handling and Preservation Purpose: The Handling and Preservation process preserves the conformity of product during internal processing, delivery and installation, and maintenance. QMS Process Interfaces:

Control Processes
4.1 Document Management 4.2 Records Management

Input Process
Product Quality Plan 7.1

Handling Handlingand and Preservation Preservation Process Process 7.15 7.15

Protection of Products during Development and Maintenance

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

Handling and Preservation Inputs and Outputs: Process Inputs Product quality plan Product packaging requirements Process Outputs Product and component identification Product handling controls Product packaging controls Product storage controls

QMS Process Manual

Handling and Preservation

QMS PROCESS MANUAL Title: Handling and Preservation Approved By: Revision Date: Oct. 2, 2001 2

Handling and Preservation Tasks and Responsibilities: Process Tasks 1. Maintain product identification 2. Apply handling controls 3. Preserve product to be delivered, installed, operated, and maintained 4. Protect stored product 5. Review handling and preservation status 6. Audit handling and preservation 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

Handling and Preservation Procedure: 1. Maintain product identification Product development and servicing identify product and status throughout implementation. Product development and servicing use labels, tags, travelers, and support reports to identify product condition, status, and stage of design and development and servicing. 2. Apply handling controls Product development and servicing apply handling controls to products and components to prevent damage and deterioration. Product development and servicing apply special handling and protection methods (e.g., electrostatic protection) and ensure a clean work environment. 3. Preserve product to be delivered, installed, operated, and maintained Product development and servicing preserve the product to be delivered, installed, and maintained in accordance with contract and company requirements. Product development and servicing package product to ensure product is protected during delivery/release to customers. 4. Protect stored product Product development and servicing protect stored product and components to prevent damage or inadvertent use.

QMS Process Manual

Handling and Preservation

QMS PROCESS MANUAL Title: Handling and Preservation Approved By: Revision Date: Oct. 2, 2001 3

5. Review handling and preservation status Senior management and product management review handling and preservation status in accordance with Management Review process. 6. Audit handling and preservation activities and products QA audits handling and preservation activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Handling and Preservation Records: Packaging instructions Product status and condition records Product storage areas.

QMS Requirements Manual Reference: 7.3 Design and Development 7.5 Production and Servicing

QMS Process Manual

Handling and Preservation

QMS PROCESS MANUAL Title: Monitoring & Measuring Device Control Approved By: Revision Date: Oct. 2, 2001 1

7.16 Monitoring and Measuring Device Control Purpose: The Monitoring and Measuring Device Control process ensures the validity of results of measuring equipment/software and consistency with monitoring and measurement requirements. QMS Process Interfaces:

Control Processes
4.1 Document Management 4.2 Records Management

Input Process
Product Quality Plan 7.1

Monitoring Monitoring& & Measuring Device Measuring Device Control ControlProcess Process 7.16 7.16

Control of Equipment/Software Used to Accept and Verify Products

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

Monitoring and Measuring Device Control Inputs and Outputs: Process Inputs Product quality plan Calibration devices Calibration standards Measurement software Process Outputs Calibrated/verified devices Calibration/verification traceability to standards Nonconformance actions as needed

QMS Process Manual

Monitoring & Measuring Device Control

QMS PROCESS MANUAL Title: Monitoring & Measuring Device Control Approved By: Revision Date: Oct. 2, 2001 2

Monitoring & Measuring Device Control Tasks and Responsibilities: Process Tasks 1. Calibrate measuring equipment 2. Identify calibration status 3. Safeguard and protect measuring equipment 4. Assess impacts of nonconforming measuring equipment 5. Maintain records of calibration & verification records 6. Check and control monitoring & measuring software 7. Review monitoring & measuring device control status 8. Audit monitoring & measuring device control 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

Monitoring & Measuring Device Control Procedure: 1. Calibrate measuring equipment Product development and product servicing calibrate/verify monitoring and measuring devices at specified intervals, or prior to use, against standards traceable to international or national measurement standards. Where no standards exist, the basis for calibration or verification is recorded. Product development and product servicing adjust or re-adjust calibration/verification intervals as necessary. 2. Identify calibration status Product development and product servicing identify the status of measuring devices using labels that include calibration due date, actual calibration date, and authorized person(s) performing the calibration. 3. Safeguard and protect measuring equipment Product development and product servicing safeguard measuring equipment from adjustments that would invalidate results and protects from damage and deterioration during handling, maintenance, and storage.

QMS Process Manual

Monitoring & Measuring Device Control

QMS PROCESS MANUAL Title: Monitoring & Measuring Device Control Approved By: Revision Date: Oct. 2, 2001 3

4. Assess impacts of nonconforming measuring equipment Product development and product servicing assess the impacts of previous measuring results when equipment is found not to confirm to requirements and take appropriate corrective action. Product development and product servicing implement the appropriate actions on affected equipment or product. 5. Maintain records of calibration and verification results Product development and product servicing maintain records of calibration and verification results. Records include calibration due and actual dates, calibration status and results, traceability to standards certificates, and corrective action records, as appropriate. 6. Check and control monitoring and measuring software Product development and product servicing check and control monitoring and measuring software. Product development and product servicing confirm prior to use the ability of the software to meet its intended use and re-confirm as needed. 7. Review monitoring and measuring device control status Senior management and product management review monitoring and measuring device control status in accordance with Management Review process. 8. Audit monitoring and measuring device control activities and products QA audits monitoring and measuring device control activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Monitoring & Measuring Device Control Records: Calibration/verification records Calibration standards traceability records Nonconformance action status records.

QMS Requirements Manual Reference: 7.3 Design and Development 7.5 Production and Servicing

QMS Process Manual

Monitoring & Measuring Device Control

QMS PROCESS MANUAL Title: Monitoring & Measuring Device Control Approved By: Revision Date: Oct. 2, 2001 4

QMS Process Manual

Monitoring & Measuring Device Control

QMS PROCESS MANUAL Title: Product Identification and Traceability Approved By: Revision Date: Oct. 2, 2001 1

7.17 Product Identification and Traceability Purpose: The Product Identification and Traceability process provides product identification uniqueness, traceability, and status. QMS Process Interfaces:

Control Processes
4.1 Document Management 4.2 Records Management

Input Process
Product Quality Plan 7.1

Product ProductID ID& & Traceability Traceability Process Process 7.17 7.17

Unique Product Identification & Traceability Controls

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

Product Identification and Traceability Inputs and Outputs: Process Inputs Product quality plan Product and document requirements QA evaluations and measurements Process Outputs Product & document ID uniqueness Traceability matrix definition QA evaluation and measurement status

QMS Process Manual

Product Identification and Traceability

QMS PROCESS MANUAL Title: Product Identification and Traceability Approved By: Revision Date: Oct. 2, 2001 2

Product Identification and Traceability Tasks and Responsibilities: Process Tasks 1. Define product and document ID schemes 2. Define traceability matrix format 3. Apply defined identification and traceability schemes 4. Identify product status from evaluations and measurements 5. Review product identification and traceability status 6. Audit product identification and traceability 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

Product Identification and Traceability Procedure: 1. Define product and document identification schemes Product development and servicing define product identification schemes that provide unique product, component, unit, document, baseline, and release/version identification and traceability. 2. Define traceability matrix format Product development and servicing define product traceability matrix requirements that ensure requirement, product, test, and change traceability throughout the product lifecycle. 3. Apply defined identification and traceability schemes Product development and servicing apply defined product identification and traceability schemes throughout product development and servicing. 4. Identify product status from evaluations and measurements Product development and servicing and QA identify product status from evaluations including status to defined review criteria and nonconformance status. Product development and servicing and QA maintain the status of measurement analysis results. 5. Review product identification and traceability status

QMS Process Manual

Product Identification and Traceability

QMS PROCESS MANUAL Title: Product Identification and Traceability Approved By: Revision Date: Oct. 2, 2001 3

Senior management and product management review product identification and traceability status in accordance with Management Review process. 6. Audit product identification and traceability activities and products QA audits product identification and traceability activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Product Identification and Traceability Records: Identified documents Product identification records and labels Traceability matrix QA evaluation status records QA measurement status records.

QMS Requirements Manual Reference: 7.3 Design and Development 7.5 Production and Servicing

QMS Process Manual

Product Identification and Traceability

QMS PROCESS MANUAL Title: Peer Review Approved By: Revision Date: Oct. 2, 2001 1

7.18 Peer Review Purpose: The Peer Review process defines how product is reviewed to identify defects. QMS Process Interfaces:

Control Processes
4.1 Document Management 4.2 Records Management

Input Process
Product Quality Plan 7.1 Design and Development Planning 7.3

Peer PeerReview Review Process Process 7.18 7.18

Review of Products During Development

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

Peer Review Inputs and Outputs: Process Inputs Product quality plan Design and development plan Product review criteria Process Outputs Peer review coordination Peer review notification Peer review results and actions

QMS Process Manual

Peer Review

QMS PROCESS MANUAL Title: Peer Review Approved By: Revision Date: Oct. 2, 2001 2

Peer Review Tasks and Responsibilities: Process Tasks 1. Coordinate (schedule) peer review 2. Prepare review materials and notify participants 3. Review materials to review criteria 4. Conduct peer review meeting 5. Document review results 6. Track defects to closure 7. Review peer review status 8. Audit peer review 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

Peer Review Procedure: 1. Coordinate (schedule) peer review Product development coordinates (schedules) peer review consistent with the product quality plan and design and development plan. 2. Prepare review materials and notify participants Product development prepares review materials. Preparations include preparing review materials, identifying review criteria, identifying and notifying participants, and providing review materials to participants. 3. Review materials to review criteria Product development (peers) reviews peer review material against peer review criteria and identifies product defects. 4. Conduct peer review meeting Product development conducts peer review meetings. Peer review meetings include reviewing comments from peers, reaching consensus on product defects and actions, as applicable, documenting agreed-to defects and actions, and dispositioning products. Product dispositioning includes: Accept as is No defects or actions identified Conditionally accept Product is accepted if defects are fixed Peer Review

QMS Process Manual

QMS PROCESS MANUAL Title: Peer Review Approved By: Revision Date: Oct. 2, 2001 3

Reject Product needs more work and needs to be reviewed again.

5. Document review results Product development documents peer review minutes and actions (defects). 6. Track defects to closure Product development tracks peer review defects to closure. 7. Review peer review status Senior management and product management review peer review status in accordance with Management Review process. 8. Audit peer review activities and products QA audits peer review activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Peer Review Records: Peer review schedule Peer review notification record Peer review minutes Peer review action items.

QMS Requirements Manual Reference: 7.3 Design and Development

QMS Process Manual

Peer Review

QMS PROCESS MANUAL Title: Technical Review Approved By: Revision Date: Oct. 2, 2001 1

7.19 Technical Review Purpose: The Technical Review process defines how technical progress is assessed during design and development. QMS Process Interfaces:

Control Processes
4.1 Document Management 4.2 Records Management

Input Process
Product Quality Plan 7.1 Design and Development Planning 7.3

Technical TechnicalReview Review Process Process 7.19 7.19

Review of Products at End of Development Milestones

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

Technical Review Inputs and Outputs: Process Inputs Product quality plan Design and development plan Product review criteria Process Outputs Technical review decisions Technical review actions

QMS Process Manual

Technical Review

QMS PROCESS MANUAL Title: Technical Review Approved By: Revision Date: Oct. 2, 2001 2

Technical Review Tasks and Responsibilities: Process Tasks 1. Prepare review materials and agenda 2. Provide materials to participants 3. Review technical review package 4. Conduct technical reviews 5. Document technical review results 6. Track action items to closure 7. Review technical review status 8. Audit technical review 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

Technical Review Procedure: 1. Prepare review materials and agenda Product development performs technical review preparation activities. Product development identifies the resources needed to conduct the review including personnel, location, facilities, hardware, software, and tools. Product development prepares the meeting agenda. 2. Provide materials to participants Product development provides review materials to participants. 3. Review technical review package Product management, product development, product servicing, and QA review technical review package. 4. Conduct technical reviews Product development presents technical progress. Product management, product development, product servicing, and QA evaluate product development progress for completeness, compliance to requirements and standards, adherence to applicable schedules, and readiness for next activity. 5. Document technical review results

QMS Process Manual

Technical Review

QMS PROCESS MANUAL Title: Technical Review Approved By: Revision Date: Oct. 2, 2001 3

Product development documents review decisions and action items. 6. Track action items to closure Product development tracks action items to closure. 7. Review technical review status Senior management and product management review technical review status in accordance with Management Review process. 8. Audit technical review activities and products QA audits technical review activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Technical Review Records: Technical review agenda Technical review package Technical review minutes Technical review action items.

QMS Requirements Manual Reference: 7.3 Design and Development

QMS Process Manual

Technical Review

QMS PROCESS MANUAL Title: Measurement, Analysis, and Improvement Processes Approved By: Revision Date: Oct. 2, 2001 1

8. Measurement, Analysis, and Improvement Processes QMS measurement, analysis, and improvement processes define the responsibilities and tasks needed to demonstrate product conformity, ensure QMS conformity, and continually improve QMS effectiveness. QMS measurement, analysis, and improvement processes are identified below.

QA Planning 8.1

Customer Satisfaction 8.2 QA Product Audits 8.5

Nonconforming Product Control 8.3 QMS 8.6

QA Process Audits 8.4

Measurement 8.7

Quality Data Analysis 8.8

Corrective Action 8.9

Preventive Action 8.10

Figure 8-1 Measurement, Analysis, and Improvement Processes QMS measurement, analysis, and improvement processes are defined in the following sections.

QMS Process Manual Processes

Measurement, Analysis, & Improvement

QMS PROCESS MANUAL Title: QA Planning Approved By: Revision Date: Oct. 2, 2001 1

8.1 QA Planning Purpose: The QA Planning process ensures the processes needed to assess product conformance, process effectiveness, and Quality Management System (QMS) compliance are defined consistent with QMS requirements. QMS Process Interfaces:

Output Processes Control Processes

4.1 Document Management 4.2 Records Management

Customer Satisfaction 8.2 Nonconforming Product Control 8.3 QA Process Audits 8.4

Input Process
QMS Planning 5.1

QA QA Planning PlanningProcess Process 8.1 8.1

QA Product Audits 8.5 QMS Audits 8.6 Measurement 8.7 Quality Data Analysis 8.8

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

Corrective Action 8.9 Preventive Action 8.10

QA Planning Inputs and Outputs: Process Inputs QMS plan Historical data (effort, schedule) Process Outputs QA planning QA resource needs Audit acceptance criteria QA planning review

QMS Process Manual

QA Planning

QMS PROCESS MANUAL Title: QA Planning Approved By: Revision Date: Oct. 2, 2001 2

QMS Process Manual

QA Planning

QMS PROCESS MANUAL Title: QA Planning Approved By: Revision Date: Oct. 2, 2001 3

QA Planning Tasks and Responsibilities: Process Tasks 1. Identify QA scope 2. Determine QA audits 3. Estimate QA effort and schedule 4. Define resources 5. Develop QA schedule 6. Document QA plan 7. Submit and review QA plan 8. Review QA planning status 9. Audit QA 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

QA Planning Procedure: 1. Identify QA scope QA identifies the scope of QA activities to be performed by reviewing customer requirements and QMS plans. 2. Determine QA audits QA defines the product, process, and QMS audits based on plans and requirements. Audits include: Process audits (Management, resource provisioning, product, measuring, analysis, and improvement process, QA evaluation) Product audits (product and documentation evaluation) QMS audits (QMS requirements manual compliance).

QA documents audit acceptance criteria. 3. Estimate QA effort and schedule QA estimates overall effort and schedule using historical data, where available. 4. Define resources QA defines QA personnel skill levels and quantity based on effort estimates. QMS Process Manual QA Planning

QMS PROCESS MANUAL Title: QA Planning Approved By: Revision Date: Oct. 2, 2001 4

5. Develop QA schedule QA develops an audit schedule to include process, product, and QMS audit points. 6. Document QA plan QA documents the results of QA planning activities including estimates, schedules, and processes (including procedures) to be used. QA updates the plan, as needed, as QMS activities are implemented. 7. Review QA Plan QA submits QA plan for review to ensure planning is suitable to the companys method of operations. Senior management, product management, product development, product servicing, and human resources review QA Plan for completeness and consistency to requirements and other plans. QA updates plan based on review results. 8. Review QA planning status Senior management reviews QA planning status in accordance with Management Review process. 9. Audit QA planning activities and products QA audits QA Planning activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. QA Planning Records: QA plan QA audit schedule QA estimates (effort, schedule) QA plan review records.

QMS Requirements Manual Reference: 8.1 Measurement, Analysis, and Improvement - General

QMS Process Manual

QA Planning

QMS PROCESS MANUAL Title: Customer Satisfaction Approved By: Revision Date: Oct. 2, 2001 1

8.2 Customer Satisfaction Purpose: The Customer Satisfaction process monitors and analyzes customer perception of requirements being met. QMS Process Interfaces:

Control Processes
4.1 Document Management 4.2 Records Management

Output Processes
Measurement 8.7

Input Process
QA Planning 8.1

Customer Customer Satisfaction Satisfaction Process Process 8.2 8.2

Quality Data Analysis 8.8 Corrective Action 8.9 Preventive Action 8.10

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

Customer Satisfaction Inputs and Outputs: Process Inputs QA plan Customer survey form (Annex B) Customer complaint data Process Outputs Customer satisfaction surveys Customer satisfaction survey reviews

QMS Process Manual

Customer Satisfaction

QMS PROCESS MANUAL Title: Customer Satisfaction Approved By: Revision Date: Oct. 2, 2001 2

Customer Satisfaction Tasks and Responsibilities: Process Tasks 1. Perform customer satisfaction surveys 2. Review customer satisfaction survey results 3. Report customer satisfaction survey results 4. Review customer satisfaction status 5. Audit customer satisfaction 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

Customer Satisfaction Procedure: 1. Perform customer satisfaction surveys QA submits customer satisfaction survey forms to customers as scheduled. Customer satisfaction survey forms include three (3) components: satisfaction criteria, rating scale, and open questions. 2. Review customer satisfaction survey results QA reviews customer survey results for unfavorable responses. QA looks for negative responses and comments. QA analyzes customer satisfaction trends with previous surveys to identify negative trends. QA identifies action items. 3. Report customer satisfaction survey results QA reports customer satisfaction survey results to management. QA identifies action items. QA assigns actions to appropriate management personnel with due dates. QA reports review results and actions taken to the customer. 4. Review customer satisfaction status Senior management reviews customer satisfaction status in accordance with Management Review process. Senior management, product management, product development, product servicing, human resources, and QA review take the appropriate actions based on results. 5. Audit customer satisfaction activities and products

QMS Process Manual

Customer Satisfaction

QMS PROCESS MANUAL Title: Customer Satisfaction Approved By: Revision Date: Oct. 2, 2001 3

QA audits customer satisfaction activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Customer Satisfaction Records: Customer satisfaction survey records Customer satisfaction review records Customer satisfaction survey action items.

QMS Requirements Manual Reference: 8.2 Monitoring and Measurement

QMS Process Manual

Customer Satisfaction

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

8.3 Nonconforming Product Control Purpose: The Nonconforming Product Control process ensures nonconforming products are controlled to prevent unintended use or delivery. QMS Process Interfaces:

Control Processes
4.1 Document Management 4.2 Records Management

Output Processes
Measurement 8.7

Input Process
QA Planning 8.1

Nonconforming Nonconforming Product ProductControl Control Process Process 8.3 8.3

Quality Data Analysis 8.8 Corrective Action 8.9 Preventive Action 8.10

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

Nonconforming Product Control Inputs and Outputs: Process Inputs QA plan Test failures Audit nonconformities Product nonconformities/defects Process Outputs Nonconformance status Customer authorization where required

QMS Process Manual

Nonconforming Product Control

QMS PROCESS MANUAL Title: Nonconforming Product Control Approved By: Revision Date: Oct. 2, 2001 2

Nonconforming Product Control Tasks and Responsibilities: Process Tasks 1. Identify nonconforming product 2. Document nonconforming product 3. Approve/disapprove nonconformity 4. Implement and verify approved changes 5. Review nonconforming product control status 6. Audit nonconforming product control 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 X

Nonconforming Product Control Procedure: 1. Identify nonconforming product Product development, product servicing, and QA identify nonconformities during product development, product servicing, and QA audits in accordance with Change Management, Peer Review, and QA Product Audits processes. Product development, product servicing, and QA identify and control nonconforming product to prevent its unintended use, release, or delivery. 2. Document nonconforming product Product development, product servicing, and QA document nonconformities on change request forms, peer review defect lists, and QA product audit reports in accordance with Change Management, Peer Review, and QA Product Audits processes. 3. Approve/disapprove nonconformity Product management, Product development, product servicing, and QA disposition nonconformities in accordance with Change Management, Peer Review, and QA Product Audits processes. Product management, product development, product servicing, and QA consider impacts to products already released/delivered when approving or disapproving nonconformities. Product development, product servicing, and QA record disposition status. 4. Implement and verify approved changes

QMS Process Manual

Nonconforming Product Control

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

Product development, product servicing, and QA implement and verify approved changes in accordance with Change Management, Peer Review, and QA Product Audits processes. Product development, product servicing, and QA maintain status of fixes and verification activities. 5. Review nonconforming product control status Senior management and product management review nonconforming product control status in accordance with Management Review process. 6. Audit nonconforming product control activities and products QA audits nonconforming product control activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Nonconforming Product Control Records: Product nonconformity records Product nonconformity status records Customer authorization records.

QMS Requirements Manual Reference: 8.3 Control of Nonconforming Product

QMS Process Manual

Nonconforming Product Control

QMS PROCESS MANUAL Title: QA Process Audits Approved By: Revision Date: Oct. 2, 2001 1

8.4 QA Process Audits Purpose: The QA Process Audits process ensures processes effectively produce quality products. QMS Process Interfaces:

Control Processes
4.1 Document Management 4.2 Records Management

Output Processes
Measurement 8.7

Input Process
QA Planning 8.1

QA QA Process ProcessAudits Audits Process Process 8.4 8.4

Quality Data Analysis 8.8 Corrective Action 8.9 Preventive Action 8.10

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

QA Process Audits Inputs and Outputs: Process Inputs QA plan Process documents QA process audit criteria Process Outputs QA process audit results QA process audit reporting

QMS Process Manual

QA Process Audits

QMS PROCESS MANUAL Title: QA Process Audits Approved By: Revision Date: Oct. 2, 2001 2

QA Process Audits Tasks and Responsibilities: Process Tasks 1. Identify process to be audited 2. Prepare for QA process audit 3. Perform QA process audit 4. Record QA process audit findings 5. Report QA process audit results 6. Maintain QA process audit status 7. Review QA process audits status 8. Audit QA process audits 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

QA Process Audits Procedure: 1. Identify process to be audited QA identifies the process to be audited from the QA schedule. QA process audit types include management, product realization, resource provisioning, and measurement, analysis, and improvement processes. 2. Prepare for QA process audit QA prepares for QA process audit. QA coordinates the audit to be performed with the process owner. QA defines the process audit criteria to be used. Audit criteria include checks for process completeness, compliance, timeliness, expectedness, and integrity. Completeness Process tasks are completed as defined in process documentation Compliance Process is performed in accordance with its defined documentation Timeliness Process is performed when scheduled and when ready Expectedness Process outputs are produced as defined and results are expected Integrity Process inputs are defined and are correct versions/revisions.

QA develops the audit checklist and gathers support documents needed to support the audit. 3. Perform QA process audit

QMS Process Manual

QA Process Audits

QMS PROCESS MANUAL Title: QA Process Audits Approved By: Revision Date: Oct. 2, 2001 3

QA audits the process to defined criteria. QA determines process acceptability to criteria (Yes, No, or not applicable). 4. Record QA process audit findings QA records audit findings on audit checklists. QA indicates compliance for each criterion and adds notes and comments as appropriate. QA documents process audit nonconformities found. 5. Report QA process audit results QA reports results to affected personnel and management. Audit report includes audit checklist and identifies nonconformities needing corrective action. 6. Maintain QA process audit status QA maintains records of QA process audits (checklists, reports, nonconformance data, correspondence) and updates status logs as corrective actions are addressed. 7. Review QA process audits status Senior management reviews QA process audits status in accordance with Management Review process. 8. Audit QA process audits activities and products QA audits QA process audits activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. QA Process Audits Records: QA process audit notification record QA process audit checklists QA process audit report QA process audit nonconformance records QA audit status log.

QMS Requirements Manual Reference: 8.2 Monitoring and Measurement

QMS Process Manual

QA Process Audits

QMS PROCESS MANUAL Title: QA Process Audits Approved By: Revision Date: Oct. 2, 2001 4

QMS Process Manual

QA Process Audits

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

8.5 QA Product Audits Purpose: The QA Product Audits process ensures products developed and produced conform to defined requirements and standards. QMS Process Interfaces:

Control Processes
4.1 Document Management 4.2 Records Management

Output Processes
Measurement 8.7

Input Process
QA Planning 8.1

QA QA Product ProductAudits Audits Process Process 8.5 8.5

Quality Data Analysis 8.8 Corrective Action 8.9 Preventive Action 8.10

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

QA Product Audits Inputs and Outputs: Process Inputs QA plan Product standards QA product audit criteria Process Outputs QA product audit results QA product audit reporting

QMS Process Manual

QA Product Audits

QMS PROCESS MANUAL Title: QA Product Audits Approved By: Revision Date: Oct. 2, 2001 2

QA Product Audits Tasks and Responsibilities: Process Tasks 1. Identify product to be audited 2. Prepare for QA product audit 3. Perform QA product audit 4. Record QA product audit findings 5. Report QA product audit results 6. Maintain QA product audit status 7. Review QA product audits status 8. Audit QA product audits 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

QA Product Audits Procedure: 1. Identify product to be audited QA identifies the product to be audited from the QA schedule. QA product audits include product, product documentation, and internal plans and procedures. 2. Prepare for QA product audit QA prepares for QA product audit. QA coordinates the audit to be performed with the producer/owner to ensure product is available and appropriate support is available. QA defines the product audit criteria to be used. Audit criteria include checks for product completeness, compliance, consistency, and traceability. Completeness Product is complete and includes the appropriate level of detail Compliance Product meets applicable standards and requirements Consistency Product is internally and externally consistent Traceability Product fulfills its allocated requirements.

QA develops the audit checklist and gathers support documents needed to support the audit. 3. Perform QA product audit QA audits the product to defined criteria. QA determines product acceptability to criteria (Yes, No, or not applicable).

QMS Process Manual

QA Product Audits

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

4. Record QA product audit findings QA records audit findings on audit checklists. QA indicates compliance for each criterion and adds notes and comments as appropriate. QA documents product audit nonconformities found. 5. Report QA product audit results QA reports results to affected personnel and management. Audit report includes audit checklist and identifies nonconformities needing corrective action. Product management and QA ensure product nonconformities are addressed before product release/delivery unless authorized by the customer. 6. Maintain QA product audit status QA maintains records of QA product audits (checklists, reports, nonconformance data, correspondence) and updates status logs as corrective actions are addressed. 7. Review QA product audits status Senior management reviews QA product audits status in accordance with Management Review process. 8. Audit QA product audits activities and products QA audits QA product audits activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. QA Product Audits Records: QA product audit notification record QA product audit checklists QA product audit report QA product audit nonconformance records QA audit status log.

QMS Requirements Manual Reference: 8.2 Monitoring and Measurement

QMS Process Manual

QA Product Audits

QMS PROCESS MANUAL Title: QA Product Audits Approved By: Revision Date: Oct. 2, 2001 4

QMS Process Manual

QA Product Audits

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

8.6 QMS Audits Purpose: The QMS Audits process verifies conformance to Quality Management System (QMS) requirements and effectiveness. QMS Process Interfaces:

Control Processes
4.1 Document Management 4.2 Records Management

Output Processes
Measurement 8.7

Input Process
QA Planning 8.1

QMS QMSAudits Audits Process Process 8.6 8.6

Quality Data Analysis 8.8 Corrective Action 8.9 Preventive Action 8.10

Verification Process
5.5 Management Review 8.4 QA Process Audits 8.5 QA Product Audits

QMS Audits Inputs and Outputs: Process Inputs QA planning QMS requirements manual Previous QMS performance results Process Outputs QMS audits planning QMS audits results QMS nonconformances QMS observations

QMS Process Manual

QMS Audits

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

QMS Audits Tasks and Responsibilities: Process Tasks 1. Plan QMS audit 2. Perform QMS audit 3. Report QMS audit results 4. Perform QMS audit follow-up 5. Review QMS audits status 6. Audit QMS audits 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

QMS Audits Procedure: 1. Plan QMS audits QA plans QMS audits. QA develops an audit schedule based on QMS performance results. QMS audits are performed quarterly against a subset of QMS processes with all QMS processes audited each year to ensure conformance to plans and QMS requirements manual and to verify the QMS is effectively implemented and maintained. Auditors selected are qualified to perform internal audits and are objective and impartial. QA assembles audit materials (checklists, forms) to be used to support the audit. QA coordinates audit times and dates with affected personnel and provides official notification. 2. Perform QMS audits QA performs QMS audits as planned and scheduled. QA holds an opening meeting to brief management on audit purpose, schedule, and the areas to be audited. QA audits selected processes and personnel and records results on audit logs. Audit nonconformities and observations are confirmed with audited personnel. QA holds a closing meeting to brief audit results to management. Corrective actions are assigned with due dates for audit nonconformities. 3. Report QMS audit results QA prepares and distributes the audit report. Audit report contents include audit logs, findings, nonconformities, observations, QMS processes audited, list of audited personnel and audit team. 4. Perform QMS audit follow-up

QMS Process Manual

QMS Audits

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

QA tracks the status of audit nonconformities in accordance with corrective/preventive action system. QA follows up on corrective actions, as needed, to ensure actions are effective. 5. Review QMS audits status Senior management reviews QMS audits status in accordance with Management Review process. 6. Audit QMS audits activities and products QA audits QMS Audits activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. QMS Audits Records: QMS audits plan QMS audits schedule QMS audits notification records QMS audits log QMS audits reports QMS nonconformance records QMS observations records.

QMS Requirements Manual Reference: 8.2 Monitoring and Measurement

QMS Process Manual

QMS Audits

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

8.7 Measurement Purpose: The Measurement process ensures process and product effectiveness is reviewed and analyzed. QMS Process Interfaces:

Control Processes Input Processes

Customer Satisfaction 8.2 Nonconforming Product Control 8.3 QA Process Audits 8.4 QA Product Audits 8.5 QMS Audits 8.6
4.1 Document Management 4.2 Records Management

Measurement Measurement Process Process 8.7 8.7

Output Process
Quality Data Analysis 8.8

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

Measurement Inputs and Outputs: Process Inputs Customer satisfaction data Effort and progress data Product quality data Product characteristic data Process Outputs Process status trends Process status distribution Progress variances & trends Effort variances & trends

QMS Process Manual

Measurement

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

Measurement Tasks and Responsibilities: Process Tasks 1. Perform process measurement 2. Perform product measurement 3. Perform customer satisfaction measurement 4. Review measurement status 5. Audit measurement 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

Measurement Procedure: 1. Perform process measurement QA performs process management. QA collects data from schedule, effort, and cost performance versus plans. QA analyzes data in accordance with the Quality Data Analysis process. QA reports process measurement results to senior and product management. 2. Perform product measurement QA performs product management. QA collects data from defect rates and size performance versus plans. QA analyzes data in accordance with the Quality Data Analysis process. QA reports product measurement results to senior and product management. 3. Perform customer satisfaction measurement QA performs customer satisfaction measurement. QA collects data from customer satisfaction surveys and analyzes results. QA analyzes data in accordance with the Quality Data Analysis process. QA reports customer satisfaction measurement results to senior and product management. 4. Review measurement status Senior management and product management review measurement status in accordance with Management Review process. 5. Audit measurement activities and products

QMS Process Manual

Measurement

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

QA audits measurement activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Measurement Records: Effort and progress metrics Product quality metrics Customer satisfaction metrics.

QMS Requirements Manual Reference: 8.2 Monitoring and Measurement

QMS Process Manual

Measurement

QMS PROCESS MANUAL Title: Quality Data Analysis Approved By: Revision Date: Oct. 2, 2001 1

8.8 Quality Data Analysis Purpose: The Quality Data Analysis process ensures quality data are determined, collected, and analyzed to demonstrate Quality Management System (QMS) suitability and effectiveness. QMS Process Interfaces:

Control Processes
4.1 Document Management 4.2 Records Management

Input Process
Measurement 8.7

Quality QualityData Data Analysis Analysis Process Process 8.8 8.8

Output Processes
Corrective Action 8.9 Preventive Action 8.10

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

Quality Data Analysis Inputs and Outputs: Process Inputs Customer satisfaction data Product conformance data Process conformance data Supplier performance data Process Outputs Customer satisfaction status and trends Product conformance status and trends Process performance status and trends Supplier performance status and trends Improvement opportunities

QMS Process Manual

Quality Data Analysis

QMS PROCESS MANUAL Title: Quality Data Analysis Approved By: Revision Date: Oct. 2, 2001 2

Quality Data Analysis Tasks and Responsibilities: Process Tasks 1. Analyze customer satisfaction data 2. Analyze product conformance data 3. Analyze process performance data 4. Analyze supplier performance data 5. Review quality data analysis status 6. Audit quality data analysis 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

Quality Data Analysis Procedure: 1. Analyze customer satisfaction data QA analyzes customer satisfaction survey and complaint data. QA looks for negative trends with previous results and areas contributing most to customer dissatisfaction. QA identifies opportunity areas for improvement, as applicable. 2. Analyze product conformance data QA analyzes product conformance data. QA looks at test and review results for negative trends with previous results and areas contributing most to product nonconformities. QA identifies opportunity areas for improvement, as applicable. 3. Analyze process performance data QA analyzes process performance data. QA looks at audit results for negative trends with previous results and areas contributing most to product nonconformities. QA identifies opportunity areas for improvement, as applicable. 4. Analyze supplier performance data QA analyzes supplier performance data. QA looks at supplier product and process performance for negative trends with previous results and areas contributing most to unfavorable performance. QA identifies opportunity areas for improvement, as applicable. 5. Review quality data analysis status

QMS Process Manual

Quality Data Analysis

QMS PROCESS MANUAL Title: Quality Data Analysis Approved By: Revision Date: Oct. 2, 2001 3

Senior management and product management review quality data analysis status in accordance with Management Review process. 6. Audit quality data analysis activities and products QA audits quality data analysis activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Quality Data Analysis Records: Quality data analysis records QMS improvement opportunities, as applicable.

QMS Requirements Manual Reference: 8.4 Analysis of Data

QMS Process Manual

Quality Data Analysis

QMS PROCESS MANUAL Title: Corrective Action Approved By: Revision Date: Oct. 2, 2001 1

8.9 Corrective Action Purpose: The Corrective Action process ensures causes of nonconformities are eliminated to prevent recurrence. QMS Process Interfaces:

Control Processes
4.1 Document Management 4.2 Records Management

Input Processes
Quality Data Analysis 8.8 Management Review 5.5

Corrective Corrective Action ActionProcess Process 8.9 8.9

QMS Improvements

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

Corrective Action Inputs and Outputs: Process Inputs Audit results Quality data analysis results Management review results Corrective action request form (Annex B) Process Outputs Corrective action requests Corrective action status

QMS Process Manual

Corrective Action

QMS PROCESS MANUAL Title: Corrective Action Approved By: Revision Date: Oct. 2, 2001 2

Corrective Action Tasks and Responsibilities: Process Tasks 1. Review nonconformities, customer complaints, data analysis and management review results 2. Determine causes 3. Evaluate action needed to keep nonconformance from recurring 4. Determine and implement action 5. Record results 6. Review corrective action taken 7. Review corrective action status 8. Audit corrective action 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 X X X

X X X X X X X

Corrective Action Procedure: 1. Review nonconformities, customer complaints, data analysis and management review results QA and senior management identify the need for corrective action through review of test and audit nonconformities, customer complaints, data analysis and management review results. QA and senior management identify needed corrective action on the corrective action request form (Annex B). 2. Determine causes QA and senior management determine the root causes for actual nonconformities. Planning Inadequate planning Process/Procedures Process/procedures inadequately or wrongly defined; process/procedure not followed Skills Inadequate training or skills Resources Lack of tools or misuse of tools Funding Inadequate funding.

3. Evaluate action needed to keep nonconformance from recurring

QMS Process Manual

Corrective Action

QMS PROCESS MANUAL Title: Corrective Action Approved By: Revision Date: Oct. 2, 2001 3

QA and senior management assign corrective action request and determine due date. Assignees evaluate the actions needed to keep nonconformities from recurring. 4. Determine and implement action Assignee determines and implements corrective action needed. QA ensures due dates are met, coordinates extensions, and escalates actions to management when corrective action due dates continue to be exceeded. 5. Record results Assignees complete corrective action request form to include corrective action taken. QA maintains status of corrective actions. 6. Review corrective action taken QA verifies corrective actions are implemented correctly and performs a follow-up verification, if applicable to verify effectiveness. 7. Review corrective action status Senior management reviews corrective action status in accordance with Management Review process. 8. Audit corrective action activities and products QA audits corrective action activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Corrective Action Records: Corrective action request records Corrective action status log.

QMS Requirements Manual Reference: 8.5 Improvement

QMS Process Manual

Corrective Action

QMS PROCESS MANUAL Title: Preventive Action Approved By: Revision Date: Oct. 2, 2001 1

8.10 Preventive Action Purpose: The Preventive Action process ensures potential causes of nonconformity are eliminated to prevent occurrence. QMS Process Interfaces:

Control Processes
4.1 Document Management 4.2 Records Management

Input Processes
Quality Data Analysis 8.8 Management Review 5.5 Risk Management 5.4

Preventive Preventive Action ActionProcess Process 8.10 8.10

QMS Improvements

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

Preventive Action Inputs and Outputs: Process Inputs Audit results Quality data analysis results Management review results Preventive action request form (Annex B) Process Outputs Preventive action requests Preventive action status

QMS Process Manual

Preventive Action

QMS PROCESS MANUAL Title: Preventive Action Approved By: Revision Date: Oct. 2, 2001 2

Preventive Action Tasks and Responsibilities: Process Tasks 1. Review nonconformities, customer complaints, data analysis and management review results 2. Determine potential causes 3. Evaluate action needed to keep nonconformance from occurring 4. Determine and implement action 5. Record results 6. Review preventive action taken 7. Review preventive action status 8. Audit preventive action 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 X X X

X X X X X X X

Preventive Action Procedure: 1. Review nonconformities, customer complaints, data analysis and management review results QA and senior management identify the need for preventive action through review of test and audit nonconformities, customer complaints, data analysis and management review results. QA and senior management identify preventive action request on the preventive action request form (Annex B). 2. Determine potential causes QA and senior management determine the root causes for potential nonconformities. Planning Inadequate planning Process/Procedures Process/procedures inadequately or wrongly defined; process/procedure not followed Skills Inadequate training or skills Resources Lack of tools or misuse of tools Funding Inadequate funding.

3. Evaluate action needed to keep nonconformance from occurring

QMS Process Manual

Preventive Action

QMS PROCESS MANUAL Title: Preventive Action Approved By: Revision Date: Oct. 2, 2001 3

QA and senior management assign preventive action request and determine due date. Assignees evaluate the actions needed to keep nonconformities from occurring. 4. Determine and implement action Assignee determines and implements preventive action needed. QA ensures due dates are met, coordinates extensions, and escalates actions to management when preventive action due dates continue to be exceeded. 5. Record results Assignees complete preventive action request form to include preventive action taken. QA maintains status of preventive actions. 6. Review preventive action taken QA verifies preventive actions are implemented correctly and performs a follow-up verification, if applicable to verify effectiveness. 7. Review preventive action status Senior management reviews preventive action status in accordance with Management Review process. 8. Audit preventive action activities and products QA audits preventive action activities and products in accordance with QA Process Audits, QA Product Audits, and QMS Audits processes. Preventive Action Records: Preventive action request records Preventive action status log.

QMS Requirements Manual Reference: 8.5 Improvement

QMS Process Manual

Preventive Action

QMS PROCESS MANUAL Title: QMS Process Manual Traceability Matrix Approved By: Revision Date: Oct. 2, 2001 1

Annex A: QMS Requirements Manual Traceability Matrix QMS Requirements Manual Section 4.1 General Requirements 4.2 Documentation Requirements 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning 5.5 Responsibility, Authority, and Communication 5.6 Management Review 6.1 Provision of Resources 6.2 Human Resources 6.3 6.4 7.1 7.2 7.3 Infrastructure Work Environment Product Planning Customer Requirements & Interface Design and Development QMS Process Manual Section QMS Process Manual all sections 4.1 Document Management 4.2 Records Management 4.3 Manual Preparation & Maintenance 5.1 QMS Planning 5.3 Customer Focus 5.1 QMS Planning 5.1 QMS Planning 5.2 Communications 5.4 Risk Management 5.5 Management Review 6.1 Resources Planning 6.2 Human Resources Management 6.5 Training 6.3 Infrastructure 6.4 Work Environment 7.1 Product Quality Planning 7.2 Customer Requirements & Interface 7.3 Design and Development Planning 7.4 Requirements Definition 7.5 Product Design 7.7 Implementation 7.8 Integration 7.9 Acceptance 7.10 Delivery and Installation 7.13 Change Management 7.14 Customer Property Control 7.15 Handling and Preservation 7.16 Monitoring and Measuring Device Control 7.17 Product Identification & Traceability 7.18 Peer Review 7.19 Technical Review 7.6 Purchasing 7.11 Product Servicing Planning 7.12 Maintenance 7.13 Change Management 7.14 Customer Property Control

7.4 Purchasing 7.5 Production and Servicing

QMS Process Manual

QMS Process Manual Traceability Matrix

QMS PROCESS MANUAL Title: QMS Process Manual Traceability Matrix Approved By: Revision Date: Oct. 2, 2001 2 QMS Process Manual Section 7.15 Handling and Preservation 7.16 Monitoring and Measuring Device Control 7.17 Product Identification & Traceability 7.16 Monitoring and Measuring Device Control 8.1 QA Planning 8.2 Customer Satisfaction 8.4 QA Process Audits 8.5 QA Product Audits 8.6 QMS Audits 8.7 Measurement 8.3 Nonconforming Product Control 8.8 Quality Data Analysis 8.9 Corrective Action 8.10 Preventive Action

QMS Requirements Manual Section

7.6 Control of Monitoring and Measuring Devices 8.1 Measurement, Analysis, and Improvement - General 8.2 Monitoring and Measurement

8.3 Control of Nonconforming Product 8.4 Analysis of Data 8.5 Improvement

QMS Process Manual

QMS Process Manual Traceability Matrix

QMS PROCESS MANUAL Title: QMS Process Manual Support Forms Approved By: Revision Date: Oct. 2, 2001 1 Annex B: QMS Process Manual Support Forms The forms identified below are included in this annex. These forms are referenced in the QMS process manual sections. The forms are included for guidance in implementing QMS processes. B.1 B.2 B.3 B.4 Change Request Form Customer Satisfaction Survey Form Corrective Action Request Form Preventive Action Request Form

QMS Process Manual

QMS Process Manual Support Forms

QMS PROCESS MANUAL Title: QMS Process Manual Support Forms Approved By: Revision Date: Oct. 2, 2001 2

B.1 Change Request Form Change Request Form 1. Problem Enhancement 4. Date: 2. Request No: 5. Project: 3. Initiator: 6. Change Title: 7. Change Type: Major Minor 9. Affected Items/Documentation: 8. Severity (Problems): High Medium

Low

10. Change Description:

11. Change Review Board Authorization: Approve Disapprove Defer 12. Assignee for Implementation:

13. Items/Documents Changed:

14. Incorporated By:

Date:

15. Verified By: 16. Closed By: 17. Customer Approval: (if required)

Date: Date: Date:

QMS Process Manual

QMS Process Manual Support Forms

QMS PROCESS MANUAL Title: QMS Process Manual Support Forms Approved By: Revision Date: Oct. 2, 2001 3

B.2 Customer Satisfaction Survey Form Customer Satisfaction Survey Customer: Very Poor Poor Date: Rating Scale Satisfaction Criteria Ability to meet schedule Ability to control costs Quality of products Quality of services Communicates effectively with customer Keeps customer aware of quality status Responsiveness to customer problems Responsiveness to customer requests Effectiveness of correction actions Effectiveness of improvements What worked well? Ave. High Very High N/A

What areas can be improved?

General Comments:

QMS Process Manual

QMS Process Manual Support Forms

QMS PROCESS MANUAL Title: QMS Process Manual Support Forms Approved By: Revision Date: Oct. 2, 2001 4

B.3 Corrective Action Request Form Corrective Action Request Form

Requester: Request Source: Affected QMS Manual Section: Corrective Action Requested: Request Date: Request No:

Root Cause: Assigned to: Corrective Action Taken: Due Date:

Effectiveness Check:

Verified By: Follow-up By:

Corrective Action Closure Date: Date:

QMS Process Manual

QMS Process Manual Support Forms

QMS PROCESS MANUAL Title: QMS Process Manual Support Forms Approved By: Revision Date: Oct. 2, 2001 5

B.4 Preventive Action Request Form Preventive Action Request Form

Requester: Request Source: Affected QMS Manual Section: Preventive Action Requested: Request Date: Request No:

Potential Cause: Assigned to: Preventive Action Taken: Due Date:

Effectiveness Check:

Verified By: Follow-up By:

Preventive Action Closure Date: Date:

QMS Process Manual

QMS Process Manual Support Forms