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7/29/2019 QMS Process Manual
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Quality Management System (QMS)
Process Manual
7/29/2019 QMS Process Manual
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QMS PROCESS MANUAL
Title: Revision Record
Approved By: Revision Date: Oct. 2, 2001
Revision Record
Date Description Change Request
Reference10/2/01 Initial release ----------
QMS Process Manual Revision Record
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QMS PROCESS MANUAL
Title: Table of Contents
Approved By: Revision Date: Oct. 2, 2001
Page i
Table of Contents
Section Title Revision Date
1.2.
3.
4.
4.14.2
4.3
5.5.1
5.25.35.4
5.5
6.
6.16.2
6.3
6.46.5
7.
7.17.2
7.3
7.47.5
7.6
7.7
7.87.9
7.10
7.117.12
7.13
7.147.15
7.16
7.17
7.187.19
Scope
QMS Process Model
QMS Process Responsibilities
QMS Documentation Processes
Document ManagementRecords Management
Manual Preparation and Maintenance
Management Responsibility Processes
QMS Planning
CommunicationsCustomer FocusRisk Management
Management Review
Resource Management Processes
Resources PlanningHuman Resources Management
Infrastructure
Work EnvironmentTraining
Product Realization Processes
Product Quality PlanningCustomer Requirements and Interface
Design and Development Planning
Requirements DefinitionProduct Design
Purchasing
Implementation
IntegrationAcceptance
Delivery and Installation
Product Servicing PlanningMaintenance
Change Management
Customer Property ControlHandling and Preservation
Monitoring and Measuring Device Control
Product Identification and Traceability
Peer ReviewTechnical Review
02 Oct 0102 Oct 01
02 Oct 01
02 Oct 01
02 Oct 0102 Oct 01
02 Oct 01
02 Oct 0102 Oct 01
02 Oct 0102 Oct 0102 Oct 01
02 Oct 01
02 Oct 01
02 Oct 0102 Oct 01
02 Oct 01
02 Oct 0102 Oct 01
02 Oct 01
02 Oct 0102 Oct 01
02 Oct 01
02 Oct 0102 Oct 01
02 Oct 01
02 Oct 01
02 Oct 0102 Oct 01
02 Oct 01
02 Oct 0102 Oct 01
02 Oct 01
02 Oct 0102 Oct 01
02 Oct 01
02 Oct 01
02 Oct 0102 Oct 01
QMS Process Manual Table of Contents
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QMS PROCESS MANUAL
Title: Table of Contents
Approved By: Revision Date: Oct. 2, 2001
Page ii
Section Title Revision Date
8.8.1
8.28.3
8.4
8.5
8.68.7
8.8
8.98.10
Measurement, Analysis, & Improvement ProcessesQA Planning
Customer SatisfactionNonconforming Product Control
QA Process Audits
QA Product Audits
QMS AuditsMeasurement
Quality Data Analysis
Corrective ActionPreventive Action
02 Oct 0102 Oct 01
02 Oct 0102 Oct 01
02 Oct 01
02 Oct 01
02 Oct 0102 Oct 01
02 Oct 01
02 Oct 0102 Oct 01
Annexes
Annex Title Revision Date
A
B
QMS Process Manual Traceability Matrix
QMS Process Manual Support Forms
02 Oct 01
02 Oct 01
QMS Process Manual Table of Contents
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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 processesneeded 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 processimprovement
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 customerinterfaces.
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 ManualTraceability Matrix) includes a traceabilitymatrix between QMS requirements and process manuals.
Annex B (QMS Support Forms) includes the support forms referenced in thedetailed process definitions.
QMS Process Manual Scope
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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 overallrelationships between management, resource management, product realization, and
measurement, analysis & improvement processes that ensure customer requirements areeffectively satisfied. Detailed interfaces are defined in later sections of this manual.
Figure 2-1 QMS Process Model
QMS Process Manual QMS Process Model
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 Realization Processes
Resources Planning
Human Resource Management
Infrastructure
Work Environment
Training
Resource Management Processes
QMS Planning
Customer Focus
Risk Management
Communications
Management Review
Management Responsibility Processes
QA Planning
Customer Satisfaction
Measurement
Corrective Action
Preventive Action
Nonconforming Product
Control
QA Product Audits
QA Process Audits
QMS Audits
Quality Data Analysis
Measurement, Analysis,
& Improvement Processes
C
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T
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M
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R
R
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Q
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A
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SF
A
C
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I
O
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Quality Management System Process Model
Product
Product
Reqts.
Document Management
Records Management Manual Preparation & Maintenance
Support Processes
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 Realization Processes
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 Realization Processes
Resources Planning
Human Resource Management
Infrastructure
Work Environment
Training
Resource Management Processes
Resources Planning
Human Resource Management
Infrastructure
Work Environment
Training
Resource Management Processes
QMS Planning
Customer Focus
Risk Management
Communications
Management Review
Management Responsibility Processes
QA Planning
Customer Satisfaction
Measurement
Corrective Action
Preventive Action
Nonconforming Product
Control
QA Product Audits
QA Process Audits
QMS Audits
Quality Data Analysis
Measurement, Analysis,
& Improvement Processes QA Planning
Customer Satisfaction
Measurement
Corrective Action
Preventive Action
Nonconforming Product
Control
QA Product Audits
QA Process Audits
QMS Audits
Quality Data Analysis
Measurement, Analysis,
& Improvement Processes
C
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T
O
M
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R
R
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Q
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Quality Management System Process Model
Product
Product
Reqts.
Document Management
Records Management Manual Preparation & Maintenance
Support Processes
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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 responsibilityfor ensuring processes are implemented as planned and are effective. Functional
responsibilities are identified in the individual process descriptions included in thismanual.
Figure 3-1 QMS Process Responsibilities
QMS Process Manual QMS Process Responsibilities
Company President
& General Manager
Company President
& General Manager
VP, ProductVP, ProductVP, Human
Resources
VP, Human
Resources VP, QualityVP, 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
Human Resource Management
Infrastructure
Training
Work Environment
Resources Planning
Product Quality Planning
Requirements Definition
Product Design
Implementation
Integration
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
QMS Planning
Customer Focus
Risk Management
Communications
Management Review
Company President
& General Manager
Company President
& General Manager
VP, ProductVP, ProductVP, Human
Resources
VP, Human
Resources VP, QualityVP, 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
Human Resource Management
Infrastructure
Training
Work Environment
Resources Planning
Product Quality Planning
Requirements Definition
Product Design
Implementation
Integration
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
QMS Planning
Customer Focus
Risk Management
Communications
Management Review
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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.
Figure 4-1 QMS Documentation Processes
QMS documentation processes are defined in the following sections.
QMS Process Model QMS Documentation Processes
Manual Preparationand Maintenance
4.3
DocumentManagement
4.1
RecordsManagement
4.2
Manual Preparationand Maintenance
4.3
DocumentManagement
4.1
RecordsManagement
4.2
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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:
Document Management Inputs and Outputs:
Process Inputs Process Outputs
QMS plan
Contract documentation requirements
QMS requirements
Document format requirements
Document masters
Document backups
Document listing
QMS Process Manual Document Management
Document
ManagementProcess
4.1
DocumentManagement
Process4.1
QMS Planning5.1
Input Process
Verification/Audit Processes
5.5 Management Review
8.4 QA Process Audits
8.5 QA Product Audits
8.6 QMS Audits
Control of
QMS Document
Development,
Distribution, and
Maintenance
Document
ManagementProcess
4.1
DocumentManagement
Process4.1
QMS Planning5.1
Input Process
Verification/Audit Processes
5.5 Management Review
8.4 QA Process Audits
8.5 QA Product Audits
8.6 QMS Audits
Control of
QMS Document
Development,
Distribution, and
Maintenance
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QMS PROCESS MANUAL
Title: Document Management
Approved By: Revision Date: Oct. 2, 2001
Page 2
Document Management Tasks and Responsibilities:
Process TasksTask Responsibility*
SM PM PD PS HR QA
1. Identify documents to be managed and controlled X
2. Establish document format requirements X
3. Maintain master list of documents X
4. Approve documents prior to release X X X X X X
5. Provide access to approved documentation X
6. Maintain documentation (masters, backups) X
7. Review document management status X
8. Audit document management activities and
products
X
* SM Senior Management
PM Product Management
PD Product Development
PS Product Servicing
HR Human Resources
QA Quality Assurance
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), andexternally 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 guidelinesand 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
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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 re-release 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. QAmaintains 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 andunauthorized 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.
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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 withManagement Review process.
8. Audit document management activities and products
QA audits document management activities and products in accordance with QA ProcessAudits, 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
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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 andeffective operation of the Quality Management System (QMS).
QMS Process Interfaces:
Records Management Inputs and Outputs:
Process Inputs Process Outputs
QMS plan
QMS requirements
QMS implementation results
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
Records
ManagementProcess
4.2
RecordsManagement
Process4.2
QMS Planning5.1
Input Process
Verification/Audit Processes
5.5 Management Review
8.4 QA Process Audits
8.5 QA Product Audits
8.6 QMS Audits
Control,
Management, and
Use of QMS
Objective
Evidence
Records
ManagementProcess
4.2
RecordsManagement
Process4.2
QMS Planning5.1
Input Process
Verification/Audit Processes
5.5 Management Review
8.4 QA Process Audits
8.5 QA Product Audits
8.6 QMS Audits
Control,
Management, and
Use of QMS
Objective
Evidence
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QMS PROCESS MANUAL
Title: Records Management
Approved By: Revision Date: Oct. 2, 2001
Page 2
Records Management Tasks and Responsibilities:
Process TasksTask Responsibility*
SM PM PD PS HR QA
1. Identify QMS records X
2. Establish and maintain record storage areas and
locations
X X X X X X
3. Maintain QMS records integrity X X X X X X
4. Define QMS record retention period X
5. Define QMS records disposition X
6. Review records management status X
7. Audit records management activities and products X* SM Senior Management
PM Product ManagementPD Product Development
PS Product Servicing
HR Human ResourcesQA Quality Assurance
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
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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 thelife of the contract.
5. Define QMS records disposition
QA determines how QMS records are disposed. Disposition is performed in accordancewith 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 ProcessAudits, 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
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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 QualityManagement System (QMS) requirements and process manuals.
QMS Process Interfaces:
Manual Preparation & Maintenance Inputs and Outputs:
Process Inputs Process Outputs
QMS plan Company goals and objectives
Contract requirements
Manuals change requests
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
Manual Preparationand Maintenance
Process4.3
Manual Preparationand Maintenance
Process4.3
QMS Planning
5.1
Input Process
Verification/Audit Processes
Control Processes
5.5 Management Review
8.4 QA Process Audits
8.5 QA Product Audits
8.6 QMS Audits
4.1 Document Management
4.2 Records Management
Controlled
and Maintained
QMS Requirements
& Process Manuals
Manual Preparationand Maintenance
Process4.3
Manual Preparationand Maintenance
Process4.3
QMS Planning
5.1
Input Process
Verification/Audit Processes
Control Processes
5.5 Management Review
8.4 QA Process Audits
8.5 QA Product Audits
8.6 QMS Audits
4.1 Document Management
4.2 Records Management
Controlled
and Maintained
QMS Requirements
& Process Manuals
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QMS PROCESS MANUAL
Title: Manual Preparation and Maintenance
Approved By: Revision Date: Oct. 2, 2001
Page 2
QMS Process Model Manual Preparation and Maintenance
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QMS PROCESS MANUAL
Title: Manual Preparation and Maintenance
Approved By: Revision Date: Oct. 2, 2001
Page 3
Manual Preparation & Maintenance Tasks and Responsibilities:
Process TasksTask Responsibility*
SM PM PD PS HR QA
1. Define QMS manuals structure X
2. Define QMS manuals responsibilities X
3. Define QMS policy and objectives X X X X X X
4. Define QMS requirements and processes X X X X X X
5. Develop QMS procedures X X X X X X
6. Document the QMS manuals X
7. Review the QMS manuals including updates X X X X X X
8. Review manual preparation & maintenance status X
9. Audit manual preparation & maintenance activitiesand products
X
* SM Senior Management
PM Product Management
PD Product Development
PS Product Servicing
HR Human Resources
QA Quality Assurance
Manual Preparation & Maintenance Procedure:
1. Develop QMS manuals structure
QA defines QMS requirements and process manuals content to ensure requirements areaddresses, 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
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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 theQMS requirements and process manuals in accordance with the Document Managementprocess.
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 accordancewith 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
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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 toensure management commitment, a customer-focus, communications, and reviews of
QMS performance and effectiveness. QMS management responsibility processes areidentified below.
Figure 5-1 Management Responsibility Processes
QMS management responsibility processes are defined in the following sections.
QMS Process Manual Management Responsibility Processes
QMSPlanning
5.1
Communications5.2
CustomerFocus
5.3
RiskManagement
5.4
ManagementReview
5.5
QMSPlanning
5.1
Communications5.2
CustomerFocus
5.3
RiskManagement
5.4
ManagementReview
5.5
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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 andresource needs are planned and developed consistent with QMS requirements.
QMS Process Interfaces:
QMS Planning Inputs and Outputs:
Process Inputs Process Outputs
Customer and company requirements
Historical data (effort, staffing, costs)
Company assets (tools, processes)
QMS planning
QMS process needs
QMS effort, staffing, and cost estimates
QMS Process Manual QMS Planning
QMSPlanning Process
5.1
QMSPlanning Process
5.1
QMS
Requirements
Manual
Verification/Audit Processes
Control Processes
5.5 Management Review
8.4 QA Process Audits
8.5 QA Product Audits8.6 QMS Audits
4.1 Document Management4.2 Records Management
Output Processes
Communications
5.2
Customer Focus
5.3
Risk Management
5.4
Management Review
5.5
Resources Planning
6.1
Product
Quality Planning7.1
Design &
Development Planning
7.3Product
Servicing Planning
7.11
QA Planning
8.1
QMSPlanning Process
5.1
QMSPlanning Process
5.1
QMS
Requirements
Manual
Verification/Audit Processes
Control Processes
5.5 Management Review
8.4 QA Process Audits
8.5 QA Product Audits8.6 QMS Audits
4.1 Document Management4.2 Records Management
Output Processes
Communications
5.2
Customer Focus
5.3
Risk Management
5.4
Management Review
5.5
Resources Planning
6.1
Product
Quality Planning7.1
Design &
Development Planning
7.3Product
Servicing Planning
7.11
QA Planning
8.1
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QMS PROCESS MANUAL
Title: QMS Planning
Approved By: Revision Date: Oct. 2, 2001
Page 2
QMS Planning Tasks and Responsibilities:
Process TasksTask Responsibility*
SM PM PD PS HR QA
1. Identify management requirements and qualityobjectives
X
2. Define management processes and documents X
3. Estimate effort, project staffing, and costs X
4. Define resources (tools, training) X
5. Develop management schedule X
6. Document QMS plan X
7. Review QMS plan X X X X X X
8. Review QMS planning status X
9. Audit QMS planning activities and products X* SM Senior Management
PM Product Management
PD Product Development
PS Product Servicing
HR Human Resources
QA Quality Assurance
QMS Planning Procedure:
1. Identify management requirements and quality objectives
Senior management determines and documents QMS requirements and specific qualityobjectives.
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, andmeasurement, 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 managementfunctions 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
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QMS PROCESS MANUAL
Title: QMS Planning
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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
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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 andQuality Management System (QMS) effectiveness is communicated.
QMS Process Interfaces:
Communications Inputs and Outputs:
Process Inputs Process Outputs
QMS plan
Contract requirements
QMS status data
QMS communications mechanisms
QMS communications
QMS Process Manual Communications
CommunicationsProcess
5.2
CommunicationsProcess
5.2
QMS Planning
5.1
Input Process
Verification/Audit Processes
Control Processes
5.5 Management Review
8.4 QA Process Audits
8.5 QA Product Audits
8.6 QMS Audits
4.1 Document Management
4.2 Records Management
QMS
Visibility &
Status
CommunicationsProcess
5.2
CommunicationsProcess
5.2
QMS Planning
5.1
Input Process
Verification/Audit Processes
Control Processes
5.5 Management Review
8.4 QA Process Audits
8.5 QA Product Audits
8.6 QMS Audits
4.1 Document Management
4.2 Records Management
QMS
Visibility &
Status
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QMS PROCESS MANUAL
Title: Communications
Approved By: Revision Date: Oct. 2, 2001
Page 2
Communications Tasks and Responsibilities:
Process TasksTask Responsibility*
SM PM PD PS HR QA
1. Identify communications mechanisms X
2. Communicate QMS effectiveness X
3. Review communications status X
4. Audit communications activities and products X* SM Senior Management
PM Product Management
PD Product Development
PS Product Servicing
HR Human Resources
QA Quality Assurance
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 ProcessAudits, QA Product Audits, and QMS Audits processes.
Communications Records:
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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
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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 satisfiedwith the aim of improving customer satisfaction.
QMS Process Interfaces:
Customer Focus Inputs and Outputs:
Process Inputs Process Outputs
QMS plan
Contract requirements
Customer survey data
Customer requirements traceability
Customer satisfaction survey actionstatus
QMS Process Manual Customer Focus
Customer FocusProcess
5.3
Customer FocusProcess
5.3
Verification/Audit Processes
Control Processes
5.5 Management Review
8.4 QA Process Audits
8.5 QA Product Audits
8.6 QMS Audits
4.1 Document Management
4.2 Records Management
Continuous
Focus on
Customer
Requirements
and Satisfaction
QMS Planning
5.1
Input Process
Quality Data
Analysis
8.8
Customer FocusProcess
5.3
Customer FocusProcess
5.3
Verification/Audit Processes
Control Processes
5.5 Management Review
8.4 QA Process Audits
8.5 QA Product Audits
8.6 QMS Audits
4.1 Document Management
4.2 Records Management
Continuous
Focus on
Customer
Requirements
and Satisfaction
QMS Planning
5.1
Input Process
Quality Data
Analysis
8.8
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QMS PROCESS MANUAL
Title: Customer Focus
Approved By: Revision Date: Oct. 2, 2001
Page 2
Customer Focus Tasks and Responsibilities:
Process TasksTask Responsibility*
SM PM PD PS HR QA
1. Establish and maintain contract requirementstraceability status
X
2. Review customer satisfaction survey status X X
3. Review customer focus status X
4. Audit customer focus activities and products X* SM Senior Management
PM Product Management
PD Product Development
PS Product Servicing
HR Human Resources
QA Quality Assurance
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 traceabilitymatrix. 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 dataand 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.
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QMS PROCESS MANUAL
Title: Customer Focus
Approved By: Revision Date: Oct. 2, 2001
Page 3
QMS Requirements Manual Reference:
5.2 Customer Focus
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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 areidentified, analyzed, planned, tracked, and controlled.
QMS Process Interfaces:
Risk Management Inputs and Outputs:
Process Inputs Process Outputs
QMS plan
Technical, cost, and scheduleuncertainties
Risk statement
Risk classification
Risk prioritization
Risk mitigation planning
Risk status tracking
QMS Process Manual Risk Management
Risk Management
Process
5.4
Risk Management
Process
5.4
QMS Planning
5.1
Input ProcessManagement Review
5.5
Output Processes
Verification/Audit Processes
Control Processes
5.5 Management Review
8.4 QA Process Audits
8.5 QA Product Audits
8.6 QMS Audits
4.1 Document Management4.2 Records Management
Preventive Action
8.10
Risk Management
Process
5.4
Risk Management
Process
5.4
QMS Planning
5.1
Input ProcessManagement Review
5.5
Output Processes
Verification/Audit Processes
Control Processes
5.5 Management Review
8.4 QA Process Audits
8.5 QA Product Audits
8.6 QMS Audits
4.1 Document Management4.2 Records Management
Preventive Action
8.10
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QMS PROCESS MANUAL
Title: Risk Management
Approved By: Revision Date: Oct. 2, 2001
Page 2
Risk Management Tasks and Responsibilities:
Process TasksTask Responsibility*
SM PM PD PS HR QA
1. Identify project risks from technical, cost, andschedule issues and constraints
X X
2. Analyze risk impact, probability of occurrence, and
timeframe
X X
3. Classify and prioritize risks X X
4. Plan risk management approach X X X X X X
5. Track, analyze, and control risks X X
6. Review risk management status X X
7. Audit risk management activities and products X* SM Senior Management
PM Product Management
PD Product Development
PS Product Servicing
HR Human Resources
QA Quality Assurance
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 issuesand 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 productmanagement determine risk type (product, environment, program) and rank risksconsidering 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.
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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 andconsistency 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 withManagement 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
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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) isreviewed at planned intervals for continued suitability, adequacy, and effectiveness.
QMS Process Interfaces:
Management Review Inputs and Outputs:
Process Inputs Process Outputs
QMS plan
Audit results, customer feedback,process/product conformity data,
preventive & corrective action status,
follow-up actions from previousreviews, QMS change impacts,
improvement recommendations
QMS process improvements
Product improvements
QMS resource needs
QMS Process Manual Management Review
Management
Review
Process
5.5
Management
Review
Process
5.5
QMS Planning
5.1
Input ProcessCorrective Action
8.9
Output Processes
Verification/Audit Processes
Control Processes
8.4 QA Process Audits
8.5 QA Product Audits
8.6 QMS Audits
4.1 Document Management4.2 Records Management
Preventive Action
8.10
Management
Review
Process
5.5
Management
Review
Process
5.5
QMS Planning
5.1
Input ProcessCorrective Action
8.9
Output Processes
Verification/Audit Processes
Control Processes
8.4 QA Process Audits
8.5 QA Product Audits
8.6 QMS Audits
4.1 Document Management4.2 Records Management
Preventive Action
8.10
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QMS PROCESS MANUAL
Title: Management Review
Approved By: Revision Date: Oct. 2, 2001
Page 2
Management Review Tasks and Responsibilities:
Process TasksTask Responsibility*
SM PM PD PS HR QA
1. Plan for management review X X
2. Prepare for management review X X X
3. Conduct management review X X X X X X
4. Record and report management review results X
5. Audit management review activities and products X* SM Senior Management
PM Product Management
PD Product Development
PS Product ServicingHR Human Resources
QA Quality Assurance
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 changesand 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 thestatus 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.
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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
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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 toensure the resources needed to implement, maintain, and continuously improve the QMS
and enhance customer requirements are provided. QMS resource management processesare identified below.
Figure 6-1 Resource Management Processes
QMS resource management processes are defined in the following sections.
QMS Process Manual Resource Management Processes
ResourcesPlanning
6.1
Human ResourcesManagement
6.2
Training6.5
Infrastructure6.3
Work Environment6.4
ResourcesPlanning
6.1
Human ResourcesManagement
6.2
Training6.5
Infrastructure6.3
Work Environment6.4
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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:
Resources Planning Inputs and Outputs:
Process Inputs Process Outputs
QMS plan
Customer requirements
Training documentation
Historical data (effort, costs)
Company infrastructure, environment
Resources planning
Resources process needs
Human resources effort and cost
estimates
QMS Process Manual Resources Planning
ResourcesPlanning Process
6.1
ResourcesPlanning Process
6.1
QMS
Planning
5.1
Input Process
Verification/Audit Processes
Control Processes
5.5 Management Review
8.4 QA Process Audits
8.5 QA Product Audits
8.6 QMS Audits
4.1 Document Management4.2 Records Management
HumanResources Mgmt.
6.2
Output Processes
Infrastructure
6.3
Work
Environment
6.4
Training
6.5
ResourcesPlanning Process
6.1
ResourcesPlanning Process
6.1
QMS
Planning
5.1
Input Process
Verification/Audit Processes
Control Processes
5.5 Management Review
8.4 QA Process Audits
8.5 QA Product Audits
8.6 QMS Audits
4.1 Document Management4.2 Records Management
HumanResources Mgmt.
6.2
Output Processes
Infrastructure
6.3
Work
Environment
6.4
Training
6.5
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QMS PROCESS MANUAL
Title: Resources Planning
Approved By: Revision Date: Oct. 2, 2001
Page 2
Resources Planning Tasks and Responsibilities:
Process TasksTask Responsibility*
SM PM PD PS HR QA
1. Identify resources provisioning requirements andquality objectives
X
2. Determine resources provisioning processes and
documents
X
3. Estimate effort and costs X
4. Define resources (tools, training) X
5. Develop resources management schedule X
6. Document resources plan X
7. Review resources plan X X X X X X
8. Review resources planning status X
9. Audit resources planning activities and products X* SM Senior Management
PM Product Management
PD Product Development
PS Product ServicingHR Human Resources
QA Quality Assurance
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 resourcerequirements and specific quality objectives.
2. Determine resources provisioning processes and documents
Human resources defines the processes needed to manage, review, and control resourcesprovisioning 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 thequality 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)
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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 trainingneeds.
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 tothe 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 ProcessAudits, 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
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QMS PROCESS MANUAL
Title: Resources Planning
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Page 4
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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 thataffects product quality are competent on the basis of education, training, skills, and
experience.
QMS Process Interfaces:
Human Resources Management Inputs and Outputs:
Process Inputs Process Outputs
Resources plan
Manager needs
Employee evaluation criteria
Employee job description
Employee recruitment and selection
Employee evaluation
QMS Process Manual Human Resources Management
Human ResourcesManagement
Process6.2
Human ResourcesManagement
Process6.2
Resources Planning
6.1
Input Process
Verification/Audit Processes
Control Processes
5.5 Management Review
8.4 QA Process Audits
8.5 QA Product Audits
8.6 QMS Audits
4.1 Document Management4.2 Records Management
Qualified
and
Capable Staff
Selected
Human ResourcesManagement
Process6.2
Human ResourcesManagement
Process6.2
Resources Planning
6.1
Input Process
Verification/Audit Processes
Control Processes
5.5 Management Review
8.4 QA Process Audits
8.5 QA Product Audits
8.6 QMS Audits
4.1 Document Management4.2 Records Management
Qualified
and
Capable Staff
Selected
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QMS PROCESS MANUAL
Title: Human Resources Management
Approved By: Revision Date: Oct. 2, 2001
Page 2
Human Resources Management Tasks and Responsibilities:
Process TasksTask Responsibility*
SM PM PD PS HR QA
1. Establish job qualifications and requirements X X X X X X
2. Recruit qualified personnel X
3. Select qualified personnel X X X X X X
4. Evaluate employee performance X X X X X X
5. Maintain human resource management records X
6. Review human resource management status X
7. Audit human resource management activities and
products
X
* SM Senior Management
PM Product ManagementPD Product Development
PS Product Servicing
HR Human ResourcesQA Quality Assurance
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 qualificationand 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 performancecriteria 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.
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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 QAProcess 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
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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 toproduct requirements is determined, provided, and maintained.
QMS Process Interfaces:
Infrastructure Inputs and Outputs:
Process Inputs Process Outputs
Resources plan
Product requirements
Identified infrastructure
Infrastructure status
Infrastructure improvements
QMS Process Manual Infrastructure
InfrastructureProcess
6.3
InfrastructureProcess
6.3
Resources
Planning
6.1
Input Process
Verification/Audit Processes
Control Processes
5.5 Management Review
8.4 QA Process Audits
8.5 QA Product Audits
8.6 QMS Audits
4.1 Document Management
4.2 Records Management
Tool
and
Support
Resources
InfrastructureProcess
6.3
InfrastructureProcess
6.3
Resources
Planning
6.1
Input Process
Verification/Audit Processes
Control Processes
5.5 Management Review
8.4 QA Process Audits
8.5 QA Product Audits
8.6 QMS Audits
4.1 Document Management
4.2 Records Management
Tool
and
Support
Resources
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QMS PROCESS MANUAL
Title: Infrastructure
Approved By: Revision Date: Oct. 2, 2001
Page 2
Infrastructure Tasks and Responsibilities:
Process TasksTask Responsibility*
SM PM PD PS HR QA
1. Identify infrastructure X X
2. Monitor infrastructure X X
3. Maintain infrastructure X X X
4. Review infrastructure status X
5. Audit infrastructure activities and products X* SM Senior Management
PM Product Management
PD Product Development
PS Product ServicingHR Human Resources
QA Quality Assurance
Infrastructure Procedure:
1. Identify infrastructure
Product management and QA identify the infrastructure components needed to meetproduct 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 toassess 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
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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
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QMS PROCESS MANUAL
Title: Work Environment
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Page 1
6.4 Work Environment
Purpose:
The Work Environment process defines how the work environment is determined andmanaged to achieve conformity to product requirements.
QMS Process Interfaces:
Work Environment Inputs and Outputs:
Process Inputs Process Outputs
Resources plan
Product requirements
Identified work environment
Work environment status
Work environment improvements
QMS Process Manual Work Environment
Work EnvironmentProcess
6.4
Work EnvironmentProcess
6.4
Resources Planning
6.1
Input Process
Verification/Audit Processes
Control Processes
5.5 Management Review
8.4 QA Process Audits
8.5 QA Product Audits8.6 QMS Audits
4.1 Document Management
4.2 Records Management
Environment
Supports
Product
Quality
Work EnvironmentProcess
6.4
Work EnvironmentProcess
6.4
Resources Planning
6.1
Input Process
Verification/Audit Processes
Control Processes
5.5 Management Review
8.4 QA Process Audits
8.5 QA Product Audits8.6 QMS Audits
4.1 Document Management
4.2 Records Management
Environment
Supports
Product
Quality
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QMS PROCESS MANUAL
Title: Work Environment
Approved By: Revision Date: Oct. 2, 2001
Page 2
Work Environment Tasks and Responsibilities:
Process TasksTask Responsibility*
SM PM PD PS HR QA
1. Identify work environment X
2. Monitor work environment X
3. Maintain work environment X
4. Review work environment status X
5. Audit work environment activities and products X* SM Senior Management
PM Product Management
PD Product Development
PS Product ServicingHR Human Resources
QA Quality Assurance
Work Environment Procedure:
1. Identify work environment
Product management identifies the work environment components needed to meetproduct 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 thework 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
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QMS PROCESS MANUAL
Title: Work Environment
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Page 3
Work environment monitoring records
Work environment update records.
QMS Requirements Manual Reference:
6.4 Work Environment
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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, andimplemented.
QMS Process Interfaces:
Training Inputs and Outputs:
Process Inputs Process Outputs
Resources plan
Training requirements
Training materials
Training implementation results
Training improvements
QMS Process Manual Training
TrainingProcess
6.5
TrainingProcess
6.5
Resources Planning
6.1
Input Process
Verification/Audit Processes
Control Processes
5.5 Management Review
8.4 QA Process Audits
8.5 QA Product Audits
8.6 QMS Audits
4.1 Document Management
4.2 Records Management
Skilled
and
Qualified
QMS Personnel
TrainingProcess
6.5
TrainingProcess
6.5
Resources Planning
6.1
Input Process
Verification/Audit Processes
Control Processes
5.5 Management Review
8.4 QA Process Audits
8.5 QA Product Audits
8.6 QMS Audits
4.1 Document Management
4.2 Records Management
Skilled
and
Qualified
QMS Personnel
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QMS PROCESS MANUAL
Title: Training
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Page 2
Training Tasks and Responsibilities:
Process TasksTask Responsibility*
SM PM PD PS HR QA
1. Determine training needs and types X
2. Plan training X
3. Develop/Acquire and maintain training materials X
4. Review training plans and materials X X X X X X
5. Implement training plans X
6. Maintain training records X
7. Assess training effectiveness X
8. Review training status X
9. Audit training activities and products X* SM Senior Management
PM Product Management
PD Product Development
PS Product Servicing
HR Human Resources
QA Quality Assurance
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 determiningneeds 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
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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, QAProduct 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
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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 defineproduct requirements, and to design, develop, integrate, verify, accept, and maintain
product. QMS product realization processes are identified below.
Figure 7-1 Product Realization Processes
QMS product realization processes are defined in the following sections.
QMS Process Manual Product Realization Processes
Product QualityPlanning
7.1
CustomerRequirements & Interface
7.2
Design &Development Planning
7.3
ProductServicing Planning
7.11
Maintenance7.12
Product ServicingProcess
7.13 Change Management
7.14 Customer Property Control
7.15 Handling and Preservation
7.16 Monitoring & Measuring
Device Control
7.17 Product ID & Traceability7.18 Peer Review
7.19 Technical Review
Control/VerificationProcesses
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
Product Development,Acceptance
& Delivery Processes
Product Planning &
Requirements Establishment
Processes
Product QualityPlanning
7.1
CustomerRequirements & Interface
7.2
Design &Development Planning
7.3
ProductServicing Planning
7.11
Maintenance7.12
Product ServicingProcess
Maintenance7.12
Product ServicingProcess
7.13 Change Management
7.14 Customer Property Control
7.15 Handling and Preservation
7.16 Monitoring & Measuring
Device Control
7.17 Product ID & Traceability7.18 Peer Review
7.19 Technical Review
Control/VerificationProcesses
7.13 Change Management
7.14 Customer Property Control
7.15 Handling and Preservation
7.16 Monitoring & Measuring
Device Control
7.17 Product ID & Traceability7.18 Peer Review
7.19 Technical Review
Control/VerificationProcesses
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
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
Product Development,Acceptance
& Delivery Processes
Product Planning &
Requirements Establishment
Processes
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QMS PROCESS MANUAL
Title: Product Quality Planning
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Page 1
7.1 Product Quality Planning
Purpose:
The Product Quality Planning process ensures the processes needed to achieve theproduct are planned and developed consistent with Quality Management System (QMS)
requirements.
QMS Process Interfaces:
Product Quality Planning Inputs and Outputs:
Process Inputs Process Outputs
QMS plan
Customer requirements and needs
Historical data (cost and effort)
Process, document, and resource needs
Product acceptance criteria
Quality objectives
Product quality planning review
QMS Process Manual Product Quality Planning
Product Quality
Planning Process
7.1
Product Quality
Planning Process
7.1
QMS
Planning
5.1
Input Process
CustomerRequirements &
Interface7.2
Output Processes
Verification/Audit Processes
5.5 Management Review
8.4 QA Process Audits
8.5 QA Product Audits
8.6 QMS Audits
Control Processes
7.13 Change Management
7.14 Customer Property Control7.17 Product ID & Traceability
7.15 Handling & Preservation
4.1 Document Management
4.2 Records Management7.16 Monitoring & Measuring
Device Control
Design &Development Planning
7.3
Product
Servicing Planning
7.11
Product Quality
Planning Process
7.1
Product Quality
Planning Process
7.1
QMS
Planning
5.1
Input Process
QMS
Planning
5.1
Input Process
CustomerRequirements &
Interface7.2
Output Processes
Verification/Audit Processes
5.5 Management Review
8.4 QA Process Audits
8.5 QA Product Audits
8.6 QMS Audits
Verification/Audit Processes
5.5 Management Review
8.4 QA Process Audits
8.5 QA Product Audits
8.6 QMS Audits
Control Processes
7.13 Change Management
7.14 Customer Property Control7.17 Product ID & Traceability
7.15 Handling & Preservation
4.1 Document Management
4.2 Records Management7.16 Monitoring & Measuring
Device Control
Control Processes
7.13 Change Management
7.14 Customer Property Control7.17 Product ID & Traceability
7.15 Handling & Preservation
4.1 Document Management
4.2 Records Management7.16 Monitoring & Measuring
Device Control
Design &Development Planning
7.3
Product
Servicing Planning
7.11
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QMS PROCESS MANUAL
Title: Product Quality Planning
Approved By: Revision Date: Oct. 2, 2001
Page 2
Product Quality Planning Tasks and Responsibilities:
Process TasksTask Responsibility*
SM PM PD PS HR QA
1. Identify product requirements & quality objectives X
2. Determine product processes, documents,
responsibilities, and interfaces
X
3. Estimate product cost and effort X
4. Define resources (people, tools, training) X
5. Develop product schedule X
6. Document product quality plan X
7. Review product quality plan X X X X X X
8. Review product quality planning status X
9. Audit product quality planning activities & products X* SM Senior Management
PM Product Management
PD Product Development
PS Product Servicing
HR Human Resources
QA Quality Assurance
Product Quality Planning Procedure:
1. Identify product requirements and quality objectives
Product management identifies customer needs, requirements, and interfaces. Productmanagement 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.
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Title: Product Quality Planning
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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 productrealization 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
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Title: Product Quality Planning
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Page 4
Quality objectives
Product quality planning review records.
QMS Requirements Manual Reference:
7.1 Product Planning
QMS Process Manual Product Quality Planning
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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 productrequirements and communication are established.
QMS Process Interfaces:
Customer Requirements & Interface Inputs and Outputs:
Process Inputs Process Outputs
Product quality plan
Customer requirements
Statutory requirements
Product requirements
Product requirements review
Customer communications
QMS Process Manual Customer Requirements and Interface
CustomerRequirements &
Interface Process7.2
CustomerRequirements &
Interface Process7.2
Product Quality
Planning
7.1
Input Process
Verification/Audit Processes
Control Processes
7.13 Change Management
7.17 Product ID & Traceability
7.15 Handling & Preservation
7.19 Technical Review
5.5 Management Review
8.4 QA Process Audits
8.5 QA Product Audits
8.6 QMS Audits
4.1 Document Management
4.2 Records Management
Design &
Development Planning7.3
Output Processes
ProductServicing Planning
7.11
CustomerRequirements &
Interface Process7.2
CustomerRequirements &
Interface Process7.2
Product Quality
Planning
7.1
Input Process
Verification/Audit Processes
Control Processes
7.13 Change Management
7.17 Product ID & Traceability
7.15 Handling & Preservation
7.19 Technical Review
5.5 Management Review
8.4 QA Process Audits
8.5 QA Product Audits
8.6 QMS Audits
4.1 Document Management
4.2 Records Management
Design &
Development Planning7.3
Output Processes
ProductServicing Planning
7.11
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QMS PROCESS MANUAL
Title: Customer Requirements and Interface
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Page 2
Customer Requirements & Interface Tasks and Responsibilities:
Process TasksTask Responsibility*
SM PM PD PS HR QA
1. Determine product-related requirements X X X X X X
2. Perform contract review (including changes) X X X X X X
3. Establish customer communication mechanisms X
4. Review customer requirements & interface status X X
5. Audit customer requirements & interface activities
and products
X
* SM Senior Management
PM Product Management
PD Product Development