QMS Process Manual

7/29/2019 QMS Process Manual

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Quality Management System (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


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


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

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QMS PROCESS MANUAL

Title: Scope


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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


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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


Maintenance

Peer Review

Technical Review

Handling and Preservation

Customer Property Control

Change Management

Product ID and Traceability

Monitoring & Measuring

Control


Resources Planning

Human Resource Management

Infrastructure

Work Environment

Training


QMS Planning

Customer Focus

Risk Management

Communications

Management Review


QA Planning

Customer Satisfaction

Measurement

Corrective Action

Preventive Action

Nonconforming Product

Control

QA Product Audits

QA Process Audits

QMS Audits


Measurement, Analysis,

& Improvement Processes

C

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S

T

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M

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Q

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A

T

I

SF

A

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Quality Management System Process Model

Product

Product

Reqts.

Document Management

Records Management Manual Preparation & Maintenance

Support Processes






Product Design

Purchasing

Implementation

Integration

Acceptance


Maintenance

Peer Review

Technical Review



Change Management



Control







Product Design

Purchasing

Implementation

Integration

Acceptance


Maintenance

Peer Review

Technical Review



Change Management



Control


Resources Planning


Infrastructure

Work Environment

Training


Resources Planning


Infrastructure

Work Environment

Training


QMS Planning

Customer Focus

Risk Management

Communications

Management Review


QA Planning


Measurement

Corrective Action

Preventive Action


Control

QA Product Audits

QA Process Audits

QMS Audits



& Improvement Processes QA Planning


Measurement

Corrective Action

Preventive Action


Control

QA Product Audits

QA Process Audits

QMS Audits



& Improvement Processes

C

U

S

T

O

M

E

R

R

E

Q

U

I

R

E

M

E

N

T

S

C

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M

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R

S

A

T

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SF

A

C

T

I

O

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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


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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


Measurement

Nonconforming Product Control

QA Process Audits

QA Product Audits

QMS Audits


QA Planning


Infrastructure

Training

Work Environment

Resources Planning



Product Design

Implementation

Integration

Acceptance

Delivery & Installation

Maintenance

Peer Review

Technical Review

Handling & Preservation



Purchasing

Change Management

Product ID & Traceability

Monitoring & Measuring Device Control



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


Measurement

Nonconforming Product Control

QA Process Audits

QA Product Audits

QMS Audits


QA Planning


Infrastructure

Training

Work Environment

Resources Planning



Product Design

Implementation

Integration

Acceptance

Delivery & Installation

Maintenance

Peer Review

Technical Review

Handling & Preservation



Purchasing

Change Management

Product ID & Traceability

Monitoring & Measuring Device Control



QMS Planning

Customer Focus

Risk Management

Communications

Management Review


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QMS PROCESS MANUAL

Title: QMS Documentation Processes


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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


4.3

DocumentManagement

4.1

RecordsManagement

4.2


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QMS PROCESS MANUAL

Title: Document Management


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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





8.6 QMS Audits

Control of

QMS Document

Development,

Distribution, and

Maintenance


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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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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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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



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QMS PROCESS MANUAL

Title: Records Management


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4.2 Records Management

Purpose:

The Records Management process provides evidence of conformity to requirements andeffective operation of the Quality Management System (QMS).


Records Management Inputs and 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





8.6 QMS Audits

Control,

Management, and

Use of QMS

Objective

Evidence

Records

ManagementProcess

4.2

RecordsManagement

Process4.2

QMS Planning5.1

Input Process





8.6 QMS Audits

Control,

Management, and

Use of QMS

Objective

Evidence


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Records Management Tasks and Responsibilities:


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


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.



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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.





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QMS PROCESS MANUAL

Title: Manual Preparation and Maintenance


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4.3 Manual Preparation and Maintenance

Purpose:

The Manual Preparation and Maintenance process establishes and maintains the QualityManagement System (QMS) requirements and process manuals.


Manual Preparation & Maintenance Inputs and 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


Process4.3


Process4.3

QMS Planning

5.1

Input Process


Control Processes




8.6 QMS Audits



Controlled

and Maintained

QMS Requirements

& Process Manuals


Process4.3


Process4.3

QMS Planning

5.1

Input Process


Control Processes




8.6 QMS Audits



Controlled

and Maintained

QMS Requirements

& Process Manuals


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Manual Preparation & Maintenance Tasks and Responsibilities:


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





HR Human Resources


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


human resources, and QA define QMS requirements, processes, and QMS interfaces.

5. Develop QMS procedures



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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.





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QMS PROCESS MANUAL

Title: Management Responsibility Processes


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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


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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 Planning Inputs and 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


Control Processes



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


Control Processes





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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Title: QMS Planning


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QMS Planning Tasks and Responsibilities:


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




HR Human Resources


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)



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Title: QMS Planning


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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


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.


5.1 Management Commitment

5.3 Quality Policy

5.4 Planning



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QMS PROCESS MANUAL

Title: Communications


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5.2 Communications

Purpose:

The Communications process ensures communication processes are established andQuality Management System (QMS) effectiveness is communicated.


Communications Inputs and Outputs:


QMS plan


QMS status data

QMS communications mechanisms

QMS communications

QMS Process Manual Communications

CommunicationsProcess

5.2


5.2

QMS Planning

5.1

Input Process


Control Processes




8.6 QMS Audits



QMS

Visibility &

Status


5.2


5.2

QMS Planning

5.1

Input Process


Control Processes




8.6 QMS Audits



QMS

Visibility &

Status


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Communications Tasks and Responsibilities:


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




HR Human Resources


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 communications records.


5.5 Responsibility, Authority, and Communication



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QMS PROCESS MANUAL

Title: Customer Focus


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5.3 Customer Focus

Purpose:

The Customer Focus process ensures customer requirements are determined and satisfiedwith the aim of improving customer satisfaction.


Customer Focus Inputs and Outputs:


QMS plan


Customer survey data

Customer requirements traceability

Customer satisfaction survey actionstatus

QMS Process Manual Customer Focus

Customer FocusProcess

5.3


5.3


Control Processes




8.6 QMS Audits



Continuous

Focus on

Customer

Requirements

and Satisfaction

QMS Planning

5.1

Input Process

Quality Data

Analysis

8.8


5.3


5.3


Control Processes




8.6 QMS Audits



Continuous

Focus on

Customer

Requirements

and Satisfaction

QMS Planning

5.1

Input Process

Quality Data

Analysis

8.8


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Customer Focus Tasks and Responsibilities:


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




HR Human Resources


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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5.2 Customer Focus



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QMS PROCESS MANUAL

Title: Risk Management


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5.4 Risk Management

Purpose:

The Risk Management process ensures project technical, cost, and schedule risks areidentified, analyzed, planned, tracked, and controlled.


Risk Management Inputs and 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


Control Processes




8.6 QMS Audits


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


Control Processes




8.6 QMS Audits


Preventive Action

8.10


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Risk Management Tasks and Responsibilities:


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




HR Human Resources


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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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.





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Title: Management Review


Page 1


Purpose:

The Management Review process ensures the Quality Management System (QMS) isreviewed at planned intervals for continued suitability, adequacy, and effectiveness.


Management Review Inputs and 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


Control Processes



8.6 QMS Audits


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


Control Processes



8.6 QMS Audits


Preventive Action

8.10


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Management Review Tasks and Responsibilities:


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



PS Product ServicingHR Human Resources


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


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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Management Review Records:

Management review schedule

Management review notice

Management review materials

Management review minutes

Management review action items.





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QMS PROCESS MANUAL

Title: Resource Management Processes


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


6.2

Training6.5

Infrastructure6.3

Work Environment6.4


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Title: Resources Planning


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.


Resources Planning Inputs and 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


6.1

QMS

Planning

5.1

Input Process


Control Processes




8.6 QMS Audits


HumanResources Mgmt.

6.2

Output Processes

Infrastructure

6.3

Work

Environment

6.4

Training

6.5


6.1


6.1

QMS

Planning

5.1

Input Process


Control Processes




8.6 QMS Audits


HumanResources Mgmt.

6.2

Output Processes

Infrastructure

6.3

Work

Environment

6.4

Training

6.5


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Resources Planning Tasks and Responsibilities:


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





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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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


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.


6.1 Provision of Resources



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Title: Human Resources Management


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.


Human Resources Management Inputs and Outputs:


Resources plan

Manager needs

Employee evaluation criteria

Employee job description

Employee recruitment and selection

Employee evaluation

QMS Process Manual Human Resources Management


Process6.2


Process6.2

Resources Planning

6.1

Input Process


Control Processes




8.6 QMS Audits


Qualified

and

Capable Staff

Selected


Process6.2


Process6.2

Resources Planning

6.1

Input Process


Control Processes




8.6 QMS Audits


Qualified

and

Capable Staff

Selected


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Human Resources Management Tasks and Responsibilities:


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


PM Product ManagementPD Product Development


HR Human ResourcesQA Quality Assurance

Human Resources Management Procedure:

1. Establish job qualifications and requirements


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


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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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.


6.2 Human Resources



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Title: Infrastructure


Page 1

6.3 Infrastructure

Purpose:

The Infrastructure process defines how the infrastructure needed to achieve conformity toproduct requirements is determined, provided, and maintained.


Infrastructure Inputs and Outputs:


Resources plan

Product requirements

Identified infrastructure

Infrastructure status

Infrastructure improvements

QMS Process Manual Infrastructure

InfrastructureProcess

6.3


6.3

Resources

Planning

6.1

Input Process


Control Processes




8.6 QMS Audits



Tool

and

Support

Resources


6.3


6.3

Resources

Planning

6.1

Input Process


Control Processes




8.6 QMS Audits



Tool

and

Support

Resources


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Infrastructure Tasks and Responsibilities:


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





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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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.


6.3 Infrastructure



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QMS PROCESS MANUAL

Title: Work Environment


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.


Work Environment Inputs and Outputs:


Resources plan


Identified work environment

Work environment status

Work environment improvements

QMS Process Manual Work Environment

Work EnvironmentProcess

6.4


6.4

Resources Planning

6.1

Input Process


Control Processes






Environment

Supports

Product

Quality


6.4


6.4

Resources Planning

6.1

Input Process


Control Processes






Environment

Supports

Product

Quality


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Work Environment Tasks and Responsibilities:


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





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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Work environment monitoring records

Work environment update records.


6.4 Work Environment



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Title: Training


Page 1

6.5 Training

Purpose:

The Training process defines how training needs are identified, planned, andimplemented.


Training Inputs and 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


Control Processes




8.6 QMS Audits



Skilled

and

Qualified

QMS Personnel

TrainingProcess

6.5

TrainingProcess

6.5

Resources Planning

6.1

Input Process


Control Processes




8.6 QMS Audits



Skilled

and

Qualified

QMS Personnel


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Title: Training


Page 2

Training Tasks and Responsibilities:


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




HR Human Resources


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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Title: Training


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, QAProduct Audits, and QMS Audit processes.

Training Records:

Training courses

Training attendance records

Training evaluation records

Training course update records.


6.2 Human Resources



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QMS PROCESS MANUAL

Title: Product Realization Processes


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


7.3


7.11

Maintenance7.12


Maintenance7.12






Device Control








Device Control





7.5 Product Design

7.6 Purchasing

7.7 Implementation

7.8 Integration

7.9 Acceptance





7.5 Product Design

7.6 Purchasing

7.7 Implementation

7.8 Integration

7.9 Acceptance




Product Planning &

Requirements Establishment

Processes


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Title: Product Quality Planning


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.


Product Quality Planning Inputs and 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





8.6 QMS Audits

Control Processes


7.14 Customer Property Control7.17 Product ID & Traceability

7.15 Handling & Preservation


4.2 Records Management7.16 Monitoring & Measuring

Device Control


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


Interface7.2

Output Processes





8.6 QMS Audits





8.6 QMS Audits

Control Processes






Device Control

Control Processes






Device Control


7.3

Product

Servicing Planning

7.11


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Product Quality Planning Tasks and Responsibilities:


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




HR Human Resources


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:



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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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


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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Quality objectives

Product quality planning review records.


7.1 Product Planning



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Title: Customer Requirements and Interface


Page 1

7.2 Customer Requirements and Interface

Purpose:

The Customer Requirements and Interface process ensures customer productrequirements and communication are established.


Customer Requirements & Interface Inputs and Outputs:


Product quality plan

Customer requirements

Statutory requirements


Product requirements review

Customer communications

QMS Process Manual Customer Requirements and Interface


Interface Process7.2



Product Quality

Planning

7.1

Input Process


Control Processes


7.17 Product ID & Traceability






8.6 QMS Audits



Design &

Development Planning7.3

Output Processes


7.11





Product Quality

Planning

7.1

Input Process


Control Processes


7.17 Product ID & Traceability






8.6 QMS Audits



Design &

Development Planning7.3

Output Processes


7.11


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Title: Customer Requirements and Interface


Page 2

Customer Requirements & Interface Tasks and Responsibilities:


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




Documents

QMS Process Manual