QUALITY MANAGEMENT SYSTEM POLICIES AND PROCEDURESThe Company's quality management system is fully...

Your Company Name

PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".

Date Printed: Form Rev: Orig

QUALITY MANAGEMENT SYSTEM POLICIES AND PROCEDURES

Origination Date: XXXX Document

Identifier: QMS-00 QMS Policies and Procedures

Date: Latest Revision Date Document

Revision: Orig

Abstract: This handbook documents (your Company's) quality management system policies and procedures.

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

JENFS

Typewritten Text

REDACTED

JENFS

Typewritten Text

JENFS

Typewritten Text

Copyright © JnF Specialties, LLC. All rights reserved worldwide. https://www.quality-control-plan.com/about-us/copyright/

https://www.quality-control-plan.com/about-us/copyright/

QMS-00 Policies and Procedures

CAGE: xxxxx

Your Company Name

Rev: Orig

of 20



REVISION LOG Issue Date Comment Author

Orig

DOCUMENT CHANGE RECORD

Issue Item Reason for Change

NOTE: Company policies herein are expressed from the perspective of "As-a-Matter-of-Fact". To apply this perspective, mentally add the phrase to the beginning of each paragraph herein. Delete this note prior to release of quality handbook.

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig

of 20



TABLE OF CONTENTS Section 1: Scope...................................................................................................................................................................................................... 5 Section 2: Normative references ............................................................................................................................................................................. 5 Section 3: Terms and Definitions............................................................................................................................................................................ 5 Section 4: Context of the Organization ................................................................................................................................................................... 5 4.1 Understanding the organization and its context...................................................................................................................................................................................... 5 4.2 Understanding the needs and expectations of interested parties ............................................................................................................................................................ 5 4.3 Determining the scope of the quality management system .................................................................................................................................................................... 5

Non-Applicable Provisions of the QMS ..................................................................................................................................................................................................................................... 5 4.4 Quality management system and its processes ....................................................................................................................................................................................... 5 Section 5: Leadership.............................................................................................................................................................................................. 7 5.1 Leadership and commitment ................................................................................................................................................................................................................... 7

5.1.1 General.................................................................................................................................................................................................................................................................... 7 5.1.2 Customer focus ....................................................................................................................................................................................................................................................... 7

5.2 Policy ....................................................................................................................................................................................................................................................... 7 5.2.1 Developing the quality policy ................................................................................................................................................................................................................................ 7 5.2.2 Communicating the quality policy ......................................................................................................................................................................................................................... 7

5.3 Organizational roles, responsibilities and authorities ............................................................................................................................................................................. 7 Section 6: Planning ................................................................................................................................................................................................. 7 6.1 Actions to address risks and opportunities.............................................................................................................................................................................................. 7

6.1.1 Planning for the QMS............................................................................................................................................................................................................................................. 7 6.1.2 Planning requirements ............................................................................................................................................................................................................................................ 8

6.2 Quality objectives and planning to achieve them ................................................................................................................................................................................... 8 6.2.1 Establishing quality objectives ............................................................................................................................................................................................................................... 8 6.2.2 Achieving quality objectives .................................................................................................................................................................................................................................. 8

6.3 Planning of changes................................................................................................................................................................................................................................. 8 Section 7: Support ................................................................................................................................................................................................... 8 7.1 Resources................................................................................................................................................................................................................................................. 8

7.1.1 General.................................................................................................................................................................................................................................................................... 8 7.1.2 People ..................................................................................................................................................................................................................................................................... 8 7.1.3 Infrastructure .......................................................................................................................................................................................................................................................... 9 7.1.4 Environment for the operation of processes........................................................................................................................................................................................................... 9 7.1.5 Monitoring and measuring resources ..................................................................................................................................................................................................................... 9 7.1.5.1 General.................................................................................................................................................................................................................................................................... 9 7.1.5.2 Measurement traceability ....................................................................................................................................................................................................................................... 9 7.1.6 Organizational knowledge...................................................................................................................................................................................................................................... 9

7.2 Competence ............................................................................................................................................................................................................................................. 9 7.3 Awareness................................................................................................................................................................................................................................................ 9 7.4 Communication ..................................................................................................................................................................................................................................... 10 7.5 Documented information....................................................................................................................................................................................................................... 10

7.5.1 General.................................................................................................................................................................................................................................................................. 10 7.5.2 Creating and updating........................................................................................................................................................................................................................................... 10 7.5.3 Control of documented information ..................................................................................................................................................................................................................... 10 7.5.3.1 Documents required by QMS and International Standard ................................................................................................................................................................................... 10 7.5.3.2 Activities for control of documented information................................................................................................................................................................................................ 10

Section 8: Operation.............................................................................................................................................................................................. 10

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig

of 20



8.1 Organizational planning and control..................................................................................................................................................................................................... 10 8.2 Requirements for products and services ............................................................................................................................................................................................... 11

8.2.1 Customer communication..................................................................................................................................................................................................................................... 11 8.2.2 Determining the requirements related to products and services .......................................................................................................................................................................... 11 8.2.3 Review of requirements related to products and services .................................................................................................................................................................................... 11 8.2.3.1 Ability to meet requirements ................................................................................................................................................................................................................................ 11 8.2.3.2 Retain documented information of review........................................................................................................................................................................................................... 11 8.2.4 Changes to requirements for products and services ............................................................................................................................................................................................. 11

8.3 Design and development of products and services ............................................................................................................................................................................... 11 8.3.1 General through 8.3.6 Design and development changes .................................................................................................................................................................................... 11

8.4 Control of externally provided processes, products and services......................................................................................................................................................... 12 8.4.1 General.................................................................................................................................................................................................................................................................. 12 8.4.2 Type and extent of control.................................................................................................................................................................................................................................... 12 8.4.3 Information for external providers ....................................................................................................................................................................................................................... 12

8.5 Production and service provision .......................................................................................................................................................................................................... 12 8.5.1 Control of production and service provision........................................................................................................................................................................................................ 12 8.5.2 Identification and traceability............................................................................................................................................................................................................................... 12 8.5.3 Property belonging to Customers or external providers....................................................................................................................................................................................... 12 8.5.4 Preservation .......................................................................................................................................................................................................................................................... 12 8.5.5 Post-delivery activities ......................................................................................................................................................................................................................................... 13 8.5.6 Control of changes................................................................................................................................................................................................................................................ 13

8.6 Release of products and services........................................................................................................................................................................................................... 13 8.7 Control of nonconforming outputs........................................................................................................................................................................................................ 13

8.7.1 Identify and control nonconforming outputs........................................................................................................................................................................................................ 13 8.7.2 Retain documented information for nonconformities .......................................................................................................................................................................................... 13

Section 9: Performance evaluation........................................................................................................................................................................ 13 9.1 Monitoring, measurement, analysis and evaluation.............................................................................................................................................................................. 13

9.1.1 General.................................................................................................................................................................................................................................................................. 13 9.1.2 Customer satisfaction ........................................................................................................................................................................................................................................... 14 9.1.3 Analysis and evaluation........................................................................................................................................................................................................................................ 14

9.2 Internal audit.......................................................................................................................................................................................................................................... 14 9.2.1 Conduct internal audits at planned intervals ........................................................................................................................................................................................................ 14 9.2.2 Audit requirements ............................................................................................................................................................................................................................................... 14

9.3 Management review .............................................................................................................................................................................................................................. 14 9.3.1 General.................................................................................................................................................................................................................................................................. 14 9.3.2 Management review inputs................................................................................................................................................................................................................................... 14 9.3.3 Management review outputs................................................................................................................................................................................................................................. 15

Section 10: Improvement ........................................................................................................................................................................................ 15 10.1 General ............................................................................................................................................................................................................................................ 15 10.2 Nonconformity and corrective action ............................................................................................................................................................................................. 15

10.2.1 Required actions for nonconformities .................................................................................................................................................................................................................. 15 10.2.2 Required records for nonconformities.................................................................................................................................................................................................................. 15

10.3 Continual improvement................................................................................................................................................................................................................... 15 Appendix A: Company Processes and Applicable ISO 9001 Clauses ............................................................................................................................ 16 Appendix B: Company Processes and Applicable Documents....................................................................................................................................... 17 Appendix C: Outsourced Processes................................................................................................................................................................................ 18 Appendix D: Quality Objectives..................................................................................................................................................................................... 18 Appendix E: Identification of Key Realization Processes .............................................................................................................................................. 19

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig

of 20



Section 1: Scope (Your Company's) quality management system (QMS) policies and procedures summarize top management's stategic view to improve the QMS, enhance Customer satisfaction and assure consistent delivery of products and services that achieve conformance with Customer and applicable statutory and regulatory requirements.

Section 2: Normative references Documents that are referenced herein are indispensable and their title's are displayed in Bold Italics.

Section 3: Terms and Definitions Unless otherwise noted, the Company applies the definitions of key terms according to ISO 9001 and the QMS-16 Definitions and Abbreviations Procedure.

Section 4: Context of the Organization

4.1 Understanding the organization and its context The Company considers, monitors and reviews internal and external issues that affect its ability to achieve intended results according to the QMS-04 Management Process Procedure.

4.2 Understanding the needs and expectations of interested parties The Company considers the needs and expectations of interested parties that affect its ability to achieve intended results according to the QMS-04 Management Process Procedure.

4.3 Determining the scope of the quality management system The Company's quality management system applies to all employees within all functional areas of the business operation. The Company provides the following products and/or services: Producer/Provider of [Your text] NAICS code: [Your code(s)] SIC code: [Your code(s)] QMS policies and/or procedures outline responsibilities, methods, measurements and related performance indicators to ensure effective operation and control of the quality management system.

Non-Applicable Provisions of the QMS The Company cites no exclusions to the ISO 9001 standard. (list your exclusions to ISO 9001)

4.4 Quality management system and its processes The Company's quality management system is fully documented and implemented and is maintained as needed to meet the requirements of the Company's vision and governing policies. The Company uses a process-oriented method of management, which emphasizes the importance of:

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig

of 20



. During Management Review (see 9.3), process resources are discussed and allocated as applicable. Corrective action is taken to ensure processes achieve the desired results. Every process has at least one QMS Procedure that defines it in greater detail that may include a process map. Process maps define the details of each process, which includes

The relationship between QMS procedures and their applicable ISO 9001 clauses is shown in Appendix A. See Appendix B for applicable Company processes and documents. Outsourced processes and their controls are defined in Appendix C. See Appendix E for identification of key realization processes.

COMPANY VISION To continually improve our processes, products and services to

t.

QUALITY POLICY ENVIRONMENTAL POLICY

To prevent production and distribution of products or waste materials that

The Company is committed to providing high quality and high value products to its Customers, a

PRACTICAL STEPS TO SUPPORT POLICIES Customer Focus:

Workplace Excellence:

Empowerment: The Company is responsible for developing a quality system that accommodates the goal of achieving Customer satisfaction. We are responsible for carefully listening to Customers and fully understanding their requirements and expectations and be as responsive as possible to those needs within the province and spirit of good business practices.

Intelligent Management: The Company makes decisions and guides operations based on facts, data and verifiable evidence whenever possible to eliminate bias and unfounded opinion wherever possible.

SEE SECTION 5 FOR DETAILS ON THESE PRACTICAL STEPS

Left blank intentionally

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig

of 20



Section 5: Leadership

5.1 Leadership and commitment

5.1.1 General The Company uses the quality management system to guide and validate its decisions and to

Management participation in the QMS is described in the QMS-04 Management Process Procedure.

5.1.2 Customer focus The Company demonstrates leadership and commitment with respect to Customer focus by ensuring the maintenance and enhancement of Customer satisfaction through

5.2 Policy

5.2.1 Developing the quality policy The Company's quality policy defines the purpose and context of the organization and its strategic direction, which includes a framework for

5.2.2 Communicating the quality policy The Company's quality policy is available to interested parties and is maintained as documented information that is

.

5.3 Organizational roles, responsibilities and authorities Assignment of responsibilities and authorities for relevant roles are communicated and understood throughout the organization according to the QMS-05 Responsibilities and Authorities Procedure to ensure the quality management system conforms to the requirements of ISO 9001. Responsible authorities confirm processes are

IMPORTANT: The quality management system is maintained at its authorized revision level until planned changes are implemented.

Section 6: Planning

6.1 Actions to address risks and opportunities

6.1.1 Planning for the QMS Planning for the quality management system includes consideration of the context of the organization and the needs and expectations of interested parties. QMS-04 Management Process Procedure is used to address associated risks and

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig

of 20



opportunities to achieve

6.1.2 Planning requirements Proportionate actions are taken to address risks and opportunities that could impact requirements that are applicable to products and services according to the QMS-13 Corrective Action Procedure. The Company integrates and implements these actions into quality management system processes (see 4.4) and evaluates their effectiveness.

6.2 Quality objectives and planning to achieve them

6.2.1 Establishing quality objectives The Company establishes and maintains documented information for quality objectives at relevant functions, levels and processes according to the QMS-04 Management Process Procedure. Quality objectives are consistent with the quality policy and are

monitored, communicated and updated as required to enhance Customer satisfaction (see Appendix D).

6.2.2 Achieving quality objectives The Company determines how to achieve its quality objectives according to

6.3 Planning of changes Changes to the quality management system are performed according to the QMS-02 Configuration Management Procedure, which considers the purpose of changes and potential consequences and

Section 7: Support

7.1 Resources

7.1.1 General The Company determines and provides the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system according to the QMS-04 Management Process Procedure, which considers

.

7.1.2 People The Company determines and provides the people necessary for the effective implementation of its quality management system and operation and control of its processes according to the QMS-04 Management Process Procedure and QMS-06 Training Procedure. Cop

yrigh

t © Jn

F Specia

lties,

LLC. A

ll righ

ts res

erved

worl

dwide

.


CAGE: xxxxx

Your Company Name

Rev: Orig

of 20



7.1.3 Infrastructure The Company determines, provides and maintains the infrastructure necessary for the operation of its processes to achieve

according to the QMS-04 Management Process Procedure.

7.1.4 Environment for the operation of processes The Company determines, provides and maintains the environment necessary for the operation of its processes to achieve

7.1.5 Monitoring and measuring resources

7.1.5.1 General The Company determines and provides resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services according to the QMS-04 Management Process Procedure, which ensures the provided resources are

7.1.5.2 Measurement traceability Measuring equipment is identified for traceability then calibrated and/or verified prior to use and safeguarded from

according to the QMS-15 Calibration Procedure.

7.1.6 Organizational knowledge The Company determines, maintains, uses and internally shares knowledge that is required to operate its processes. The Company considers the need for updating its organizational knowledge for each Customer according to the QMS-07 Proposal Development and Contract Review Procedure.

7.2 Competence The Company determines the necessary competence for Employees whose work affects the performance and effectiveness of the quality management system. The Company ensures Employee competence according to

the QMS-04

Management Process Procedure, QMS-06 Training Procedure and QMS-01 Control of Documented Information Procedure.

7.3 Awareness The Company ensures Employees and Contractors are made aware of the Company's quality policy and applicable quality objectives. In addition, Employees and Contractors are made aware of their

according to the QMS-06 Training Procedure.

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig

of 20



7.4 Communication Internal and external communications relevant to the QMS are determined that includes


7.5 Documented information

7.5.1 General The Company's quality management system includes documented information required by ISO 9001 and records necessary for the effectiveness of the quality management system.

7.5.2 Creating and updating During creation and update of documented information, the Company reviews and approves documents prior to release for

according to the QMS-02 Configuration Management Procedure. In addition, the Company determines an appropriate document format, which may include .

7.5.3 Control of documented information

7.5.3.1 Documents required by QMS and International Standard The Company controls documented information to ensure it is available and suitable for use when and where it is needed and is protected from according to the QMS-01 Control of Documented Information Procedure.

7.5.3.2 Activities for control of documented information The Company controls the distribution, access, retrieval, use, storage, preservation, legibility, revision level, retention and disposition of documented information that is maintained as evidence of conformity to

Section 8: Operation

8.1 Organizational planning and control Processes that are used to achieve compliance with requirements for deliverable products and services are suitable for their purpose and are planned according to Section 6 herein. The Company applies QMS-07 Proposal Development and Contract Review Procedure to implement the processes and QMS-02 Configuration Management Procedure to approve processes and control changes. Consequences of unintended changes are

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig

of 20



8.2 Requirements for products and services

8.2.1 Customer communication The Company communicates with its Customers by providing information relative to its products and services according to the QMS-07 Proposal Development and Contract Review Procedure and by obtaining

Additional Customer communication channels include

according to the QMS-10 Production Procedure.

8.2.2 Determining the requirements related to products and services The Company ensures that it can meet the claims for products and services it offers and ensures requirements for products and services are defined, which includes according to the QMS-07 Proposal Development and Contract Review Procedure.

8.2.3 Review of requirements related to products and services

8.2.3.1 Ability to meet requirements The Company reviews Customer requirements according to the QMS-07 Proposal Development and Contract Review Procedure before accepting a contract, which includes

8.2.3.2 Retain documented information of review The Company maintains a record for each review that includes new requirements for products and services.

8.2.4 Changes to requirements for products and services When the requirements for products and services are changed, the Company applies QMS-07 Proposal Development and Contract Review Procedure to ensure Responsible Authorities are aware of changes. Applicable documents are revised according to the QMS-02 Configuration Management Procedure.

8.3 Design and development of products and services

8.3.1 General through 8.3.6 Design and development changes The Company's design and development process ensures design activities are conducted in a controlled manner that is defined in the QMS-17 Design and Development Procedure, which includes policies for: 8.3.2 Design and development planning 8.3.3 Design and development inputs 8.3.4 Design and development controls 8.3.5 Design and development outputs 8.3.6 Design and development changes

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig

of 20



8.4 Control of externally provided processes, products and services

8.4.1 General The Company ensures that externally provided processes, products and services conform to requirements according to the QMS-08 Purchasing Procedure and QMS-09 Receiving Procedure. The Company determines the controls to be applied to externally provided processes, products and services when

The Company determines and applies criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers that is based upon according to requirements and QMS-08 Purchasing Procedure. The Company retains documented information of these activities and any necessary actions arising from the evaluations.

8.4.2 Type and extent of control The Company ensures that externally provided processes, products and services do not adversely affect the Company's ability according to the QMS-08 Purchasing Procedure and QMS-09 Receiving Procedure.

8.4.3 Information for external providers The Company ensures that mandatory requirements are according to the QMS-08 Purchasing Procedure.

8.5 Production and service provision

8.5.1 Control of production and service provision The Company implements production and services under controlled conditions according to the QMS-04 Management Process Procedure and QMS-10 Production Procedure.

8.5.2 Identification and traceability The Company uses suitable means to identify outputs when it is necessary to ensure the conformity of products and services and identifies the status of outputs with respect to

the QMS-10 Production Procedure. The Company controls the unique identification of outputs when

8.5.3 Property belonging to Customers or external providers Property used by the Company or under its control that is received from outside sources is controlled according to the QMS-10 Production Procedure.

8.5.4 Preservation The Company preserves production and service outputs to the extent necessary according to the QMS-10 Production Procedure and QMS-11 Shipping Procedure. Cop

yrigh

t © Jn

F Specia

lties,

LLC. A

ll righ

ts res

erved

worl

dwide

.


CAGE: xxxxx

Your Company Name

Rev: Orig

of 20



8.5.5 Post-delivery activities The Company meets requirements for post-delivery activities associated with the products and services according to the QMS-05 Responsibilities and Authorities Procedure.

8.5.6 Control of changes To ensure continuing conformity with requirements, the Company

according to the QMS-02 Configuration Management Procedure, QMS-10 Production Procedure and QMS-17 Design and Development Procedure.

8.6 Release of products and services In-process inspections are conducted during production and service activities according to the QMS-10 Production Procedure. Products and services are released for delivery to Customers only after

8.7 Control of nonconforming outputs

8.7.1 Identify and control nonconforming outputs The Company ensures outputs that do not conform to requirements are identified and controlled to prevent their unintended use or delivery according to the QMS-14 Control of Nonconformances Procedure. The Company takes appropriate actions based on

8.7.2 Retain documented information for nonconformities Company records describe each nonconformance and include Customer approval when applicable, actions taken and identification of Responsible Authorities.

Section 9: Performance evaluation

9.1 Monitoring, measurement, analysis and evaluation

9.1.1 General The Company's determines methods for monitoring, measurement, analysis and evaluation to ensure valid results by defining

according to the QMS-

04 Management Process Procedure, QMS-12 Internal Auditing Procedure and QMS-01 Control of Documented Information Procedure. Cop

yrigh

t © Jn

F Specia

lties,

LLC. A

ll righ

ts res

erved

worl

dwide

.


CAGE: xxxxx

Your Company Name

Rev: Orig

of 20



9.1.2 Customer satisfaction To monitor and measure Customer satisfaction and fulfillment of expectations, the Company may collect information about:

The Company continuously monitors Customer satisfaction according to the QMS-04 Management Process Procedure.

9.1.3 Analysis and evaluation The Company evaluates according to the QMS-04 Management Process Procedure.

9.2 Internal audit

9.2.1 Conduct internal audits at planned intervals The Company conducts internal audits at planned intervals to provide information

according to the QMS-12 Internal Auditing Procedure.

9.2.2 Audit requirements The Company assigns Responsible Authorities to perform internal audits and report audit results to management according to the QMS-12 Internal Auditing Procedure.

9.3 Management review

9.3.1 General Top management reviews the Company's quality management system at planned intervals to ensure


9.3.2 Management review inputs Management review is planned and carried out according to the QMS-04 Management Process Procedure, which takes into consideration

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig

of 20



9.3.3 Management review outputs Results from management reviews include


Section 10: Improvement

10.1 General The Company determines and selects according to the QMS-04 Management Process Procedure.

10.2 Nonconformity and corrective action

10.2.1 Required actions for nonconformities When a nonconformance occurs, including complaints, the Company reacts to the nonconformance and, as applicable, takes action according to the QMS-13 Corrective Action Procedure and QMS-14 Nonconformance Control Procedure. The Company evaluates the need for action to eliminate the cause of each nonconformance to prevent recurrence or occurrence somewhere else by

The Company ensures corrective actions are appropriate to the effects of each nonconformance.

10.2.2 Required records for nonconformities The Company retains and maintains records regarding

actions according to the QMS-01 Control of Documented Information Procedure.

10.3 Continual improvement The Company continually improves the suitability, adequacy and effectiveness of the quality management system according to the QMS-04 Management Process Procedure using . Left blank intentionally

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig

of 20



Appendix A: Company Processes and Applicable ISO 9001 Clauses Process Applicable ISO 9001 Clauses Configuration Management See 8.3.1 for 8.3.6, 8.5.6 Design and Development Changes, Control of Changes (was ) Control of Documents 7.5.2, 7.5.3 Creating and Updating, Control of Documented Information (was Control of Records 7.5.2, 7.5.3 Creating and Updating, Control of Documented Information (was ) Control of Nonconformances 8.7 Control of Nonconforming Outputs (was Corrective Action 10.2 Nonconformity and Corrective Action (was ) Internal Auditing 9.2 Internal Audit (was )

Management

4.4 Quality Management System and its Processes (was ) 7.5 Documented Information (was 5.1, 5.1.1 Leadership and Commitment, General (was ) 5.1.2 Customer Focus (was ) 5.2, 5.2.1, 5.2.2 Policy, Developing the Quality Policy, Communicating the Quality Policy (was ) 6.0 Planning (was ) 5.3 Organizational Roles, Responsibilities and Authorities (was ) 5.3 Organizational Roles, Responsibilities and Authorities (was entative) 7.4 Communication (was 9.3 Management Review (was 7.1.1, 7.1.2 General, People (was 7.2 Competence (was ) 7.1.3 Infrastructure (was ) 7.1.4 Environment for the Operation of Processes (was ) See 8.3.1 for 8.3.6, 8.5.6 Design and Development Changes, Control of Changes (was ) 8.2.1 Customer Communication (was ) 8.5.1, 8.5.5 Control of Production & Service Provision, Post Delivery Support (was ) 7.1.5 Monitoring and Measuring Resources (was 9.1.1 Measurement, Analysis & Improvement: General (was ) 9.1.2 (was ) Customer Satisfaction 9.1.1 General (was 9.1.3 Analysis and Evaluation (was data) 10.1 General, Continual Improvement (was )

Production

8.1 Operational Planning and Control (was 8.5.1, 8.5.5 Control of Production and Service Provision, Post Delivery Support (was 8.5.2 Identification & Traceability (was ) 8.5.3 Property Belonging to Customers or External Providers (was ) 8.5.4 Preservation (was 8.6 Release of Products and Services (was ) 8.7 Control of Nonconforming Outputs (was

Proposal Development & Contract Review 8.2.2 Determining the Requirements Related to Products and Services (was ) 8.2.3 Review of Requirements Related to Products and Services (was

Purchasing 8.4.1, 8.4.2 General, Type and Extent of Control (was 8.4.3 Information for External Providers (was )

Receiving

8.6 Release of Products and Services (was 8.5.2 Identification & Traceability (was ) 8.5.3 Property Belonging to Customers or External Providers (was ) 8.5.4 Preservation (was ) 8.6 Release of Products and Services (was 8.7 Control of Nonconforming Outputs (was )

Shipping

8.2.2 Determining Requirements Related to Products and Services (was 8.5.1, 8.5.5 Control of Production and Service Provision, Post Delivery Support (was ) 8.5.2 Identification & Traceability (was ) 8.5.4 Preservation (was ) 8.7 Control of Nonconforming Outputs (was )

Left blank intentionally

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig

of 20



Appendix B: Company Processes and Applicable Documents

Process Applicable Company Procedures Applicable Company Records Corrective Action QMS-13 Corrective Action Corrective action records 10.2 (was )

Design & Development QMS-17 Design & Development

Realization processes and resulting product meet requirements 8.1 (was ) Design and development planning 8.3.2 (was ) Design inputs records 8.3.3 (was ) Design review records 8.3.4 (was ) Design verification records 8.3.4 (was ) Design validation records 8.3.4 (was ) Design and development outputs 8.3.5 (was ) Design change records see 8.3.1 for 8.3.6 (was )

Internal Auditing QMS-12 Internal Auditing Internal audits 9.2 (was )

Management

QMS-00 Quality Handbook QMS-01 Control of Documented Info QMS-02 Configuration Management QMS-04 Management Process Procedure QMS-05 Responsibilities & Authorities QMS-06 Training QMS-15 Calibration QMS-16 Definitions and Abbreviation

Management review minutes 9.3.1 (was ) Training records 7.2, 7.3 (was ) Calibration records 7.1.5 (was

Production QMS-10 Production QMS-14 Control of Nonconformances

Traceability records (if required) 8.5.2 (was ) Records of loss, damage or nonconformances 8.5.3 (was

) Records of release authority of inspected product 8.6 (was

) Records of first article inspection 8.6 (was ) Control of nonconformances 8.7 (was )

Proposal Development & Contract Review

QMS-07 Proposal Development & Contract Review

Contract review records 8.2.3 (was

Purchasing QMS-08 Purchasing Supplier evaluation records 8.4.1, 8.4.2 (was )

Receiving QMS-09 Receiving QMS-14 Control of Nonconformances

Records of loss, damage or nonconformances 8.5.3 (was )

Control of nonconformances 8.7 (was )

Shipping QMS-11 Shipping QMS-14 Control of Nonconformances

Records of loss, damage or nonconformances 8.5.3 (was )

Control of nonconformances 8.7 (was )

Left blank intentionally Cop

yrigh

t © Jn

F Specia

lties,

LLC. A

ll righ

ts res

erved

worl

dwide

.


CAGE: xxxxx

Your Company Name

Rev: Orig

of 20



Appendix C: Outsourced Processes The following processes are outsourced and controlled as indicated:

Appendix D: Quality Objectives

Process Quality Objective Metric

Corrective Action

Nonconformance Trend Chart

Design & Development Customer Satisfaction Rating

Internal Auditing

Internal Audit Reports

Management

Management Review Reports

Production Product Yield Rating

Proposal Development & Contract Review

Customer Satisfaction Rating

Purchasing

Management Review Reports

Receiving . Subcontractor Performance Rating

Shipping

On-Time Delivery Rating

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig

of 20



Appendix E: Identification of Key Realization Processes

C

U

S

T

O

M

E

R

Market Research

Sales

Business Plan and Objective

Management Responsibility

Key Realization Processes

Quote

RFQ

Management Review

Personnel and Skills

Equipment and Maintenance

Facilities

Infrastructure and Information Technology

Control of NCMR’s

Corrective Actions

Internal Audits

Customer Satisfaction

Policies and Directions

M

a

n

a

g

e

m

e

n

t

Product and QMS Data

Resource

Needs

A

n

a

l

y

s

i

s

a

n

d

C

U

S

T

O

M

E

R

Calibration

Product and QMS Data

Resources

Customer Complaints, Customer

Assessments, Product Returns

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig

of 20



8 Mandatory Procedures

(delete this table prior to release of quality handbook)

22 Mandatory Forms

(delete this table prior to release of quality handbook)

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Your Company Name



DOCUMENT and RECORD CONTROL


Identifier: Document and Record Control

Date: Latest Revision Date Project: Customer, Unique ID, Part Number

Document Status:

Draft, Redline, Released, Obsolete

Document Link:

Location on Server (if used)

Abstract: This procedure describes methods for controlling documents. Cop

yrigh

t © Jn

F Specia

lties,

LLC. A

ll righ

ts res

erved

worl

dwide

.

Document and Record Control

CAGE: xxxxx

Your Company Name

Rev: Orig




Orig



Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



TABLE OF CONTENTS

1.0 PURPOSE OF DOCUMENT AND RECORD CONTROL...................................................................................... 4

2.0 THEORY ................................................................................................................................................................... 4

3.0 DOCUMENT TYPES................................................................................................................................................ 4

4.0 QUALITY MANUAL ............................................................................................................................................... 5

5.0 QUALITY MANAGEMENT SYSTEM PROCEDURES ........................................................................................ 5

6.0 GENERAL WORK INSTRUCTIONS...................................................................................................................... 6

7.0 INSPECTION INSTRUCTIONS .............................................................................................................................. 6

8.0 FORMS...................................................................................................................................................................... 7

9.0 EXTERNAL DOCUMENTS..................................................................................................................................... 8

10.0 PERIODIC RE-EVALUATION OF DOCUMENTS................................................................................................ 8

11.0 CONTROL OF RECORDS ....................................................................................................................................... 8

APPENDIX A: RECORD RETENTION MATRIX............................................................................................................. 10

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



1.0 PURPOSE OF DOCUMENT AND RECORD CONTROL This procedure defines the requirements for the control of documents and records within the quality management system (QMS). The Document Control Center ensures that documents are controlled so that information on them is accessible, legible and suitably maintained and obsolete documents are stamped "Superseded". The following documents are not subject to this procedure:

2.0 THEORY Documents must be controlled so that only reviewed and approved information is released and used by employees. This ensures that no mistakes are made due to the usage of obsolete information. A record is

3.0 DOCUMENT TYPES 3.1. Quality Manual: this document provides the primary Corporate Vision Statement and Governing Policies including the Quality Policy and/or Environmental Policy. It also defines top-level requirements for the quality management system and defines how the Company meets the requirements of standards such as ISO 9001. 3.2. QMS Procedures: these documents provide

3.3. General Work Instructions: these documents provide

3.4. Inspection Instructions: these documents are

3.5. Forms: these documents are Any department manager or area supervisor may develop a new form for use in their area. 3.6. Records that are created for temporary retention of miscellaneous information are

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



4.0 QUALITY MANUAL 4.1. Creating the Quality Manual The Quality Manual has been developed by top management of the Company, which includes the Company's Vision and Governing Policies. 4.2. Review and Approval The Quality Manual is reviewed and approved by top management before release. Approval is indicated by

4.3. Distribution The Quality Manual is distributed electronically through the Company's internet server. The Document Control Center may retain older hardcopies or softcopies for historical purposes, but these are

In some cases, a hardcopy of the Quality Manual may be given to an employee, department or Customer. If the document is needed for more than thirty (30) days it is marked "Released" and dated with the month and year of release by the Responsible Authority (RA). Each employee must

4.4. Change Control Any employee may request a change to the Quality Manual. Requests for changes may be made by

5.0 QUALITY MANAGEMENT SYSTEM PROCEDURES 5.1. Creating New QMS Procedures QMS procedures should be created as soft files (MS Word, etc.). It is recommended that files of a similar type

5.2. Review and Approval QMS Procedures are to be reviewed and approved by top management. At least one member of top management that is responsible for reviewing the document should be responsible for the area affected by the document. Approval is indicated by

5.3. Distribution QMS procedures are distributed electronically through the Company's internet server and/or via the intranet. The Document Control Center may retain older hardcopies or softcopies for historical purposes, but these are

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



In some cases, a hardcopy of the procedure may be given to an employee, department or Customer. If the document is needed for more than thirty (30) days it is marked "Released" and dated with the month and year of release by the Responsible Authority (RA). Each employee must

5.4. Change Control Changes to QMS procedures are performed in the same manner as the Quality Manual.

6.0 GENERAL WORK INSTRUCTIONS 6.1. Creating New Work Instructions Where necessary, work affecting quality is described by clear and complete documented work instructions that define what is required to perform specific quality related work functions. Typically, new work instructions are developed by or under the supervision of an area manager or subject matter expert. Work instructions should be created as soft files (i.e., MS Word, etc) and then submitted to the Configuration Control Board (CCB) for review and approval. Work instructions should include, as applicable:

NOTE REGARDING JOB SPECIFIC WORK INSTRUCTIONS: Engineering may develop work instructions that are specific to a given job, which are released and controlled as part of the technical documentation and subject to the controls of the Configuration Management Procedure - not this procedure. Their format may be different from general work instructions. 6.2. Review and Approval Work instructions must be reviewed and approved by the CCB. At least one member of the CCB responsible for reviewing the document should be responsible for the area affected by the document. Approval is indicated by 6.3. Distribution General work instructions are distributed electronically through the Company's internet server and/or via the intranet. The Document Control Center may retain older hardcopies or softcopies for historical purposes, but these are In some cases, a hardcopy of the work instruction may be given to an employee, department or Customer. If the document is needed for more than thirty (30) days it is marked "Released" and dated with the month and year of release by the Responsible Authority (RA). Each employee must

6.4. Change Control Changes to general work instructions are performed in the same manner as the Quality Manual. When general work instructions are changed, the revision history table is updated and the revision indicator advanced.

7.0 INSPECTION INSTRUCTIONS 7.1. Creating New Inspection Instructions

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



New inspection instructions are developed by or under the supervision of the Quality Manager using requirements from

NOTE REGARDING JOB SPECIFIC INSPECTION INSTRUCTIONS: Engineering may develop inspection instructions that are specific to a given job, which are released and controlled as part of the technical documentation and subject to the controls of the Configuration Management Procedure - not this procedure. Their format may be different from general work instructions. 7.2. Review and Approval Approval is indicated by

7.3. Distribution Inspection instructions are distributed electronically through the Company's internet server and/or intranet. The Document Control Center may retain older hardcopies or softcopies for historical purposes, but these are not available for general access. In some cases, a hardcopy of the inspection instruction may be given to an employee, department or Customer. If the document is needed for more than thirty (30) days it is marked "Released" and dated with the month and year of release by the Responsible Authority (RA). Each employee must

7.4. Change Control Any employee may request a change to inspection instructions by completing a Request for Change form and submitting it to the Quality Manager. All changes to inspection instructions go through the same review and approval as the original release. When changes are approved the revision indicator is

8.0 FORMS 8.1. Creating New Forms Forms undergo a streamlined creation and control process. Any department manager or area supervisor may develop a new form for use in their area. The form should be created in software format (MS word, Excel, etc) and then submitted to the appropriate department manager for review and approval. Forms are a special kind of document that may be

8.2. Review and Approval Forms may be reviewed and approved by the manager of the department or area primarily affected by the form. Forms do not require a signature approval; instead, the manager approving the form shall notify the Responsible Authority of the approval by providing one software copy of the form for upload onto the Company's internet server and/or intranet in the current forms directory. It is the appropriate manager's responsibility to

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



8.3. Distribution Forms are made available through the Company's internet server, intranet or Document Control Center. These may be printed and photocopied as needed. When hardcopies run out,

8.4. Change Control Any employee may submit a request for change to the appropriate area manager responsible for the form and the manager will determine if the form should be revised. Revised forms go through the same review and approval as originals but must have their revision indicator advanced.

9.0 EXTERNAL DOCUMENTS 9.1. Some external (third party) standards or specifications may be maintained on file without control provided that the revision indicator is evident somewhere in the document. This is necessary because

9.2. Third party specifications and engineering drawings, including those of the Customer, are controlled according to the QMS-02 Configuration Management Procedure. Where control of an external document is deemed necessary, they shall be made available by the Document Control Center, which shall

10.0 PERIODIC RE-EVALUATION OF DOCUMENTS The entire set of quality documentation is subject to continuous improvement. Change control documents are filed as needed to request changes or updates.

11.0 CONTROL OF RECORDS 11.1 The controls for each type of record are defined in Appendix A of this procedure.

11.2 The listed "controller" must ensure their assigned records

11.3 Records for active contracts are maintained in the quality department handling the operations. Records are removed from the active files at

11.4 The Document Control Center maintains archive files for records. Records shall be maintained a minimum of

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



11.5 Records that are discarded after retention shall be

11.6 Hardcopy records are to be stored in suitable cabinets that prevent damage or deterioration. When archived records are stored elsewhere,

11.7 Records are available for review by the Customer and copies of non-proprietary records are furnished to the Customer upon request. Non-disclosure agreements are required for non-Governmental entities.

11.8 Records are verified for

11.9 The Company does not require vendors to maintain records for the Company; instead, .

11.10 To ensure protection of records, electronic records are subject to

11.11 Local computer data that is stored on company computers must

11.12 When making corrections to written record entries, the error is

11.13 Correction fluid or correction tape is not to be used on any quality records.

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



APPENDIX A: RECORD RETENTION MATRIX

Required Record or Document Type

Company Record Controller Type Location Minimum Retention

Calibration records Calibration Form Contract review records Contract review Form Control of Nonconformances RFS Form Corrective actions RFS Form Design change records Engineering order Form Design input records Engineering order Form Design review records Engineering order Form Design validation records

Production inspection Form

Design verification records


First Article Inspection First article Form Internal audit records Internal audit Form Lost, damaged or unsuitable Customer property Customer property Form Management review meeting minutes

Management review report Form

Record of realization process Engineering order Form Record of release of product


Supplier evaluation Supplier review Form

Traceability records Production inspection Form

Training records Training record Form

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Your Company Name



MANAGEMENT PROCESS


Identifier: Management Process


Document Status:


Document Link:


Abstract: This document describes the management review process. Cop

yrigh

t © Jn

F Specia

lties,

LLC. A

ll righ

ts res

erved

worl

dwide

.

Management Process

CAGE: xxxxx

Your Company Name

Rev: Orig




0-0



Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Management Process

CAGE: xxxxx

Your Company Name

Rev: Orig



TABLE OF CONTENTS

1.0 PURPOSE................................................................................................................................................... 4

2.0 THEORY .................................................................................................................................................... 4

3.0 MANAGING AS A PROCESS.................................................................................................................. 4

4.0 PROCEDURE: MANAGEMENT REVIEW ............................................................................................. 4

5.0 PROCEDURE: MEASURING AND MONITORING PROCESS OBJECTIVES.................................... 6

6.0 PROCEDURE: INTERNAL and EXTERNAL COMMUNICATION...................................................... 7

7.0 PROCEDURE: RESOURCE MANAGEMENT........................................................................................ 9

Appendix A: Process Map .................................................................................................................................... 10

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Management Process

CAGE: xxxxx

Your Company Name

Rev: Orig



1.0 PURPOSE This document defines the Management process, including or making reference to procedures for the various activities within the Management process.

2.0 THEORY The Company believes in “intelligent management,” which enables the Company to make decisions based on facts, data and verifiable evidence. Intelligent management reduces the need to make decisions based on personal opinion, whims or mood and ensures results of decisions are measurable.

3.0 MANAGING AS A PROCESS The Company recognizes that it has to manage processes identified in the Quality Management Policies and Procedures handbook; however, management itself must also be treated as a process. This means that management activities must have inputs, outputs, controls and reaction plans (when things do not work out as expected.) The Company must consider the results of analyses and evaluations and the outputs from management reviews to determine if there are needs or opportunities to be addressed as part of continual improvement. The process map in the Appendix of this document identifies how Management is treated as a process and provides an overview of how management is performed. Management is responsible for implementation and application of the following QMS requirements:

4.0 PROCEDURE: MANAGEMENT REVIEW 4.1 The management of the Company performs formal management review of the Quality Management System a minimum of

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Management Process

CAGE: xxxxx

Your Company Name

Rev: Orig



4.2 This review shall include

4.3 Minutes of the meetings are taken and maintained. The Management Review Report Template may be used as a guide for the records or may be completed and retained as the record. 4.4 The Management Review meeting should include analysis of the following inputs:

m

4.5 Management shall use action items or the corrective action system to take recorded actions as a result of review topics in an effort to

See the QMS-13 Corrective Action Procedure.

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Management Process

CAGE: xxxxx

Your Company Name

Rev: Orig



4.6 Management shall determine internal issues that affect its ability to achieve intended results, which may include, but are not limited to:

4.7 Management shall determine external issues that affect its ability to achieve intended results, which may include, but are not limited to:

s

ations

5.0 PROCEDURE: MEASURING AND MONITORING PROCESS OBJECTIVES 5.1 Each process identified in the Quality Management System has at least one objective. The objective is

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Management Process

CAGE: xxxxx

Your Company Name

Rev: Orig



5.2 Each process objective must be measurable in some fashion. The means of measurement are called “metrics” and the metrics are defined in the Management Review minutes. 5.3 Top management will assign goals to each process metric. 5.4 Throughout the year, assigned managers and staff will gather data according to the defined metrics. 5.5 During Management Review the data will be presented and recorded and an assessment made on whether each process succeeded in meeting its assigned goal. 5.6 When a process does not meet a goal,

5.7 The current metrics, standings, previous goal and revised goals shall be

(See section 4.0 above.) 5.8 Over time, management shall assess performance of each process against the goals

according to the QMS-13 Corrective Action Procedure.

6.0 PROCEDURE: INTERNAL and EXTERNAL COMMUNICATION 6.1 Internal communication is an important facet of the way the Company does business. By this we mean that information must be able to flow in all directions, from

The following methods are used for internal communications:

6.2 External communications that are relevant to the quality management system must

6.2.1 Confidential Company Information Company Employees must not reveal Confidential Company Information to External Parties except to the extent such disclosures are necessary

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Management Process

CAGE: xxxxx

Your Company Name

Rev: Orig



6.2.1.1 Basic Company Information Company Employees must not communicate Basic Company Information to External Parties except to the extent that such communication is part of their normal responsibilities. For example,

Only Authorized Responsible Authorities may communicate about the Company or its business, or communicate as a representative of the Company, with any of the following External Parties:

Only Authorized Responsible Authorities may communicate about the Company or its business or communicate as a representative of the Company on

6.2.1.2 Written Company Information All Written Company Information must conform to guidelines established from time to time. All Written Company Information must be approved by the appropriate Responsible Authority before it is communicated to any External Party. With respect to any Written Company Information regarding new business, clients, or other contract counterparties, or other Third Parties with a business relationship with the Company, care must be exercised to

Written Company Information regarding must also be

approved by the appropriate Responsible Authority.

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Management Process

CAGE: xxxxx

Your Company Name

Rev: Orig



7.0 PROCEDURE: RESOURCE MANAGEMENT 7.1 The management of resources is a critical component to the management activities of the Company. Resources requiring such management includes:

ation

vities

7.2 Like other management activities, resource management must . 7.3 To manage resources, top management must

7.4 During Management Review, managers shall

7.5 From that data, top management can

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Management Process

CAGE: xxxxx

Your Company Name

Rev: Orig



Appendix A: Process Map

Objective:

INPUT from other processes

Conduct Management Review Meeting according to section 4.0. Review all agenda items and current data against most current internal and external issues.

NO

.

NO

YES

continued next page…

Revise goal?

Objective met?

INPUT from other processes

MANAGEMENT

Owner:

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Management Process

CAGE: xxxxx

Your Company Name

Rev: Orig



from previous page…

NO

YES

OUT

ALL other processes

Planning, resources or controls needed?

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Your Company Name



RESPONSIBILITIES AND AUTHORITIES


Identifier: Responsibilities and Authorities


Document Status:


Document Link:


Abstract: This document describes responsibilities and authorities of Company personnel.

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Responsibilities and Authorities

CAGE: xxxxx

Your Company Name

Rev: Orig




0-0



Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



TABLE OF CONTENTS

1.0 PURPOSE................................................................................................................................................... 4

2.0 THEORY .................................................................................................................................................... 4

3.0 RESPONSIBILITIES & AUTHORITIES.................................................................................................. 4

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



1.0 PURPOSE This document provides an overview of the responsibilities and authorities for key positions within the Company.

2.0 THEORY It is important to define the responsibilities and authorities of key positions so that employees understand their work and the relationships they have with other positions within the Company.

3.0 RESPONSIBILITIES & AUTHORITIES 3.1 Operations Manager The Operations Manager is responsible for

In this capacity the Operations Manager

3.2 Quality Manager

The Quality Manager is responsible for These duties include

The Quality Manager oversees all inspection and test activities and has

The Quality Manager also

3.3 Facilities Manager

The Facilities Manager is responsible for

a3.4 Production Manager

The Production Manager is responsible for

3.5 Business Manager

The Business Manager is responsible for .

3.6 Product Managers

The Company utilizes Product Managers for the different technologies it has developed. The Product Managers are responsible for

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



Product Managers are responsible for which includes consideration for:

)

3.7 Administrative Assistant The Administrative Assistant is responsible for

3.8 Accounting Manager

The Accounting Manager is responsible for

3.9 Environmental Health & Safety Manager

The EHS Manager is responsible for

. These duties include interacting

3.10 Quality Group Staff & Inspectors (including Receiving)

The Quality Group includes all inspection personnel and is responsible for

3.11 Production Operators

Production operators include all production personnel and manufacturing equipment operators. Operators are responsible for

3.12 Internal Auditors

Internal Auditors are responsible for

3.13 Shipping Personnel

Shipping personnel are responsible for

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



3.14 Human Resources Staff

Human Resource staff is responsible for

3.15 Purchasing Staff

Purchasing staff is responsible for

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Your Company Name



PROPOSAL DEVELOPMENT AND CONTRACT REVIEW


Identifier: Proposal Development and Contract Review


Document Status:


Document Link:


Abstract: This document describes the procedures used to review contracts and develop proposals.

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Proposal Development and Contract Review

CAGE: xxxxx

Your Company Name

Rev: Orig




0-0



Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



TABLE OF CONTENTS

1.0 PURPOSE................................................................................................................................................... 4

2.0 THEORY .................................................................................................................................................... 4

3.0 PROCEDURE............................................................................................................................................. 4

4.0 PROCESS MAP.......................................................................................................................................... 5

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



1.0 PURPOSE This document defines the Proposal Development and Contract Review process including or making reference to procedures for the various activities within the process.

2.0 THEORY The Company can only meet Customer requirements by ensuring that all such requirements are obtained from the Customer, then reviewed and understood. This process ensures the suitable capture of requirements and ensures that the Company’s understanding of those requirements is communicated to the Customer prior to and through contract acceptance.

3.0 PROCEDURE When addressing Customer needs and industry trends, the Company considers

Documentation is not required for contract review and proposal development for Customers that purchase

The Company determines its capability to meet Customer requirements by: a) b)

1) ; 2)

c) ; d) ; e)

1) 2)

See Process Map.

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



4.0 PROCESS MAP

Sales and business management personnel research

NO

“No Bid” response is returned to Customer, if required.

Customer submits RFP. This is forwarded to the Company Manager that coordinates review activities with .

The RFP is reviewed for

STOP

NO NO YES

CAPABLE?

CAPABLE?


INPUT

Proposal Development & Contract Review Process

Owner: Quality objective:

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig




Technical personnel, quality and other personnel contribute their portions to the proposal.

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig




.

OUTPUT

PRODUCTION

As applicable, contract is executed by management and returned to Customer.

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Your Company Name

PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released". Date Printed:

Form Rev: Orig

PURCHASE ORDER REVIEW


Identifier: Purchase Order Review


Document Status:


Document Link:


Abstract: This document describes the work instruction for reviewing purchase order content. Cop

yrigh

t © Jn

F Specia

lties,

LLC. A

ll righ

ts res

erved

worl

dwide

.

Purchase Order Review

CAGE: xxxxx

Your Company Name

Rev: Orig


Form Rev: Orig


0-0



Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig


Form Rev: Orig

1 Quality Group -- The reviewer determines the need for, and if justified,

-- Complete the Used-On and Contract# sections on the cover page of the PO Used-On = J/N or Program Acronym; Contract# = P.O.#

-- Check-off 2 Quality Group -- Forward Requisition to Document Control for

.-- Check mark the appropriate field in the "Type of Certs" section; multiple

types of Certs may be required. -- Verify Raw Material Requirements are recorded on Requisitions, except

for

-- Suppliers should be evaluated according to the Supplier Evaluation -- Determine if a Supplier has been designated by the Customer - notify

Purchasing when a sole-source Supplier is designated by the Customer -- Initial and date (should be Mo/Day) the Requisition in the "Approved By"

field and forward it to the Purchasing Group. -- Add known QA requirements to the requisition for entry on the PO; such as

-- may not be expired for rubber products; -- may not be expired for epoxy products

IF THEN 2.1 Older Revision

Supply Required -- Contact the applicable Project Engineer and process the Requisition

2.2 Requisition is marked "Under Revision"

--

--

2.3 A Raw Material

Requirement is not Specified

-- Specify a Raw Material Requirement on the Requisition. -- A Material Note Number is not

2.4 Deviation to drawing is noted on Requisition such as "Less Note"

Validate each exception by examination of

2.5 Order is for production Copy the PO to Drafting with comment to produce drawing A/R;

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig


Form Rev: Orig

activity without reference to engineering

drawing

This provision is not applicable to

3 Quality Group Add provisions for any one or combination of the following to the Requisition or P.O. when justified: --

--

-- l -- --

--

--

--

--

--

--

-- --

-- --

--

-- ion--

--

4 Quality Group

Relative to the procurement of software, the reviewer determines the need for, and if justified, adds to the procurement document provisions for any one or combination of the following: --

--

--

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig


Form Rev: Orig

--

--

--

--

5 Discrepancy in Requisition or P.O.

-- Return to Purchasing Group for correction(s)

5.1 Supplier Quality Requirements applies

-- Attach prepared original to Requisition or P.O. -- Copy to R&I

5.2 P.O. requires additional conditions related to

supplier

-- Record supplier related add-on text to Requisition or P.O. --

IF THEN

5.2.1 P.O. requires additional conditions related to in-

house processing

Record add-on text to Requisition or P.O. and forward to User

5.2.2 Requisition or P.O. Ok --

--

--

6 Quality Group Forward Supplier Evaluation to the Supplier; perform required follow-up routines.

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Your Company Name



PURCHASING


Identifier: Purchasing


Document Status:


Document Link:


Abstract: This document describes the purchasing process. Cop

yrigh

t © Jn

F Specia

lties,

LLC. A

ll righ

ts res

erved

worl

dwide

.

Purchasing

CAGE: xxxxx

Your Company Name

Rev: Orig




0-0



Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Purchasing

CAGE: xxxxx

Your Company Name

Rev: Orig



TABLE OF CONTENTS

1.0 PURPOSE................................................................................................................................................... 4

2.0 THEORY .................................................................................................................................................... 4

3.0 PROCEDURE: SUPPLIER EVALUATION AND SELECTION............................................................. 4

4.0 PROCESSING REQUISITIONS AND PURCHASE ORDERS ............................................................... 5

5.0 OTHER PURCHASING RULES............................................................................................................... 6

6.0 PROCESS MAP.......................................................................................................................................... 8

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Purchasing

CAGE: xxxxx

Your Company Name

Rev: Orig



1.0 PURPOSE This document defines the Purchasing process including or making reference to procedures for the various activities within the process. Note: this procedure applies to suppliers of products or providers of services that directly affects the quality of our products or services. Suppliers that provide office and maintenance supplies, furniture, grounds keeping services, etc. are not subject to the controls of this procedure.

2.0 THEORY The purchase of materials that go into our products or services that help us produce products affects everything we make. As a result, it is important to monitor and control the quality of both products and services that we receive as well as the suppliers of such products and services.

3.0 PROCEDURE: SUPPLIER EVALUATION AND SELECTION 3.1 All suppliers of product related materials or services must be evaluated unless these suppliers are:

3.2 Supplier evaluation is conducted by following the format on the Supplier Evaluation Form. 3.3 The Supplier Evaluation Form ensures that all new suppliers are

. 3.4 Once approved through the Supplier Evaluation Form, the Quality Manager will update the Approved Supplier List. 3.5 The following ratings apply to suppliers: • RESTRICTED:

• CONDITIONAL:

• UNRESTRICTED: . • DOCK-TO-STOCK:

3.6 Once entered into the Approved Supplier List, suppliers are rated

3.7 Using incoming (receiving) inspection results for product suppliers and employee feedback on service providers, the Quality Manager will determine if the Supplier should be increased in rating to

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Purchasing

CAGE: xxxxx

Your Company Name

Rev: Orig



3.8 Using the results from combination of the following functions for product suppliers, the Quality Manager will determine if the Supplier should be increased in rating to

3.9 For suppliers providing product, incoming inspection results are recorded on the Subcontractor Performance Rating Spreadsheet, which

3.10 If a new Supplier rates

3.11 If any Supplier rates

3.12 If items are returned to any Supplier using a Material Shipper, the Quality Manager will

3.13 Any Supplier may be de-rated to

3.14 Management may override

3.15 During management review, the entire Approved Supplier List is subject to

4.0 PROCESSING REQUISITIONS AND PURCHASE ORDERS 4.1 During review of each requisition, the Quality Group will determine if a Supplier or special process has

4.2 Responsible Authorities take into consideration the potential impact of externally provided processes, products and services on the Company's ability to consistently meet customer and applicable statutory and regulatory requirements. Particular attention is paid to

4.3 Responsible Authorities ensure the adequacy of requirements prior to their communication to a Supplier, which includes:

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Purchasing

CAGE: xxxxx

Your Company Name

Rev: Orig



. 4.4 When appropriate, the purchase order defines

4.5 As applicable, purchase order information includes: a)

b) c)

d) requirements relative to: - d - e)

l f)

ed) g)

4.6 The requirements for delegation are defined when the Company delegates inspection verification to a Supplier. The Approved Supplier List is used to 4.7 When the Company or its Customer needs to perform verification activities at a Supplier facility, the Purchase Order 4.8 See the process map herein. 4.9 Emergency Purchasing Authority: The Company will authorize the shift foreman and/or the maintenance foreman emergency purchase authority for the procurement of supplies, parts and materials outside the normal plant operating schedule. In such cases, the Purchasing department will

5.0 OTHER PURCHASING RULES 5.1 In all instances, the Purchasing Department will strive for

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Purchasing

CAGE: xxxxx

Your Company Name

Rev: Orig



5.2 Any employee of the Purchasing Department that has any financial or other interest in a supplier company, either directly or through any member of his/her immediate family, shall

5.3 The acceptance by purchasing personnel of gifts or gratuities from suppliers is 5.4 The acceptance of items intended for the purpose of advertisement and bearing the name of the Supplier is

5.5 The Purchasing department will cooperate with Customer-related activities and

5.6 The Purchasing department will not, in any way,

5.7 The Company will abide by all Government clauses or other statutory or regulatory requirements as referenced by the order, contract or other requirements document.

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Purchasing

CAGE: xxxxx

Your Company Name

Rev: Orig



6.0 PROCESS MAP

Purchasing Process Owner:

Quality objective:

YES NO

Employee obtains Requisition and .

Notify employee and resolve issues.

Employee submits Requisition to

Purchasing reviews Requisition to see if .

NO

OK?

.


INPUT

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Purchasing

CAGE: xxxxx

Your Company Name

Rev: Orig




Approved Suppliers available?

NO

PO is submitted to supplier. PO Log is updated.

OUT OUT OUT

To Purchasing

Receiving

Buyer reviews Company and Customer Approved Supplier List.

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Your Company Name



PRODUCTION PROCEDURE


Identifier: Production


Document Status:


Document Link:


Abstract: This document describes the production process. Cop

yrigh

t © Jn

F Specia

lties,

LLC. A

ll righ

ts res

erved

worl

dwide

.

Production Procedure

CAGE: xxxxx

Your Company Name

Rev: Orig




0-0



Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



TABLE OF CONTENTS

1.0 PURPOSE................................................................................................................................................... 4

2.0 THEORY .................................................................................................................................................... 4

3.0 PROBLEM RESOLUTION ....................................................................................................................... 4

4.0 PROCEDURE: PRODUCTION DOCUMENTATION............................................................................. 4

5.0 PRODUCT IDENTIFICATION................................................................................................................. 5

6.0 PROCEDURE: PRODUCT HANDLING.................................................................................................. 5

7.0 PROCEDURE: PRESERVATION............................................................................................................. 5

8.0 PROCEDURE: CUSTOMER PROPERTY CONTROL............................................................................ 6

9.0 PROCEDURE: VALIDATION OF PROCESSES..................................................................................... 7

10.0 PROCEDURE: INSPECTION AND TEST OF PRODUCT ..................................................................... 7

11.0 PROCEDURE: SHELF LIFE EXTENSION - Subject to Customer Review and/or Approval ................. 9

12.0 PROCESS MAP........................................................................................................................................ 10

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



1.0 PURPOSE This document defines the overall production process and includes or makes reference to the procedures necessary for the process. NOTE: The production process includes all QC inspections and tests within it. Quality is not a separate process.

2.0 THEORY Production operations or tasks must be conducted under controlled conditions to ensure product quality. By this we mean: • • • •

3.0 PROBLEM RESOLUTION All employees are instructed to immediately notify a Responsible Authority (RA) whenever a process or product related problem occurs that cannot be corrected according to

It is understood that the appropriate responsible authority will occasionally not be available for support; in that event,

• • • • • • •

4.0 PROCEDURE: PRODUCTION DOCUMENTATION 4.1 All revision controlled production documents are

. 4.2 In addition to this process procedure, additional production documentation may be required for a given order or production operation. Where required, these are

4.3 Such documentation includes the and when applicable,

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



4.4 Records that are created for temporary retention of miscellaneous information are

5.0 PRODUCT IDENTIFICATION 5.1 Product is identified in shop areas by any of the following methods:

5.2 Lot traceability or individual serialization of parts is

5.3 Bad (nonconforming) product that has failed an inspection or test and cannot be reworked to comply with requirements is See the QMS-14 Control of Nonconformances. 5.4 Any parts or product not marked with a tag are

5.5 IDENTIFICATION OF TRANSFER CONTAINERS 5.5.1 Whenever a portion of chemical is transferred from its original container to a smaller temporary container,

5.5.2 Whenever a portion of chemical is transferred from its original container to a smaller permanent container,

6.0 PROCEDURE: PRODUCT HANDLING 6.1 Work instructions and/or training will 6.2 In all cases, Operators are . 6.3 The Company provides suitable safety and personal protection equipment for handling hazardous or toxic materials. Operators are

7.0 PROCEDURE: PRESERVATION Preservation can include

according to the QMS-11 Shipping Procedure.

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



7.1 Operators will employ

7.2 Operators will employ

7.3 Operators will employ . 7.4 Operators will employ

7.5 FOD: Foreign Object Damage and Detection: Work instructions and training methods ensure that handling and preservation practices reduce the introduction of foreign objects (FOD) into products. 7.6 Marking and labeling including 7.7 Special handling for hazardous materials

8.0 PROCEDURE: CUSTOMER PROPERTY CONTROL The Company identifies, verifies, protects and safeguards customer property provided for use or incorporation into products and services. When property is lost, damaged or otherwise found to be unsuitable for use, the Company documents findings and reports to the customer. 8.1 Customer Property (Property) means

Hardware property includes:

8.1.1 8.1.2 8.1.3

8.1.4 8.2 All Customer furnished property shall be inspected by Receiving Inspection upon receipt according to the QMS-09 Receiving Procedure. Any nonconformities or shortages

8.3 Property shall be identified as such with an indication of the Customer name and/or work order # on the parts or packaging. As practical, this material shall

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



8.4 Sensitive material, as defined by the Customer, shall

8.5 Property will only be used as instructed or required by Customer contract and will not

8.6 Customer provided equipment shall be subject to

8.7 Quality shall investigate and report to the Customer

8.8 Requirements for the control of Property shall be flowed down to Company subcontractors when applicable.

9.0 PROCEDURE: VALIDATION OF PROCESSES 9.1 Unless otherwise specified by engineering requirements, the form named Design Validation-Verification is used to record results of validation and verification activities. 9.2 Provisions for validation and verification includes: •

• •

• •

10.0 PROCEDURE: INSPECTION AND TEST OF PRODUCT The Company determines what needs to be monitored and measured and the methods for

10.1 Receiving inspection is performed according to the QMS-09 Receiving Procedure. 10.2 First Article Inspection 10.2.1 First article inspections are

10.2.2 The Company will utilize the Customer provided First Article Inspection Report to record First Article inspection results when provided.

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



10.2.3 Where not provided, the Company will utilize

10.2.4 Complete the first article inspection form according to its format and submit to CCB. 10.2.5 Calibrated tools shall be used for first article inspection; however, non-calibrated measurement and test equipment (M&TE) under the following conditions: 1) 2)

10.2.6

10.2.7

10.3 In Process Inspections 10.3.1 In-process inspection is performed by Operators

10.3.2 In-process inspections are performed

10.3.3 Calibrated tools shall be used for in-process inspection; however, non-calibrated measurement and test equipment (M&TE) may under the following conditions: 1) 2)

10.3.4 . 10.3.5

10.3.6 Any item failing in-process inspection must be processed according to the QMS-14 Control of Nonconformances. 10.4 Final Inspection 10.4.1 Final inspection is performed . 10.4.2 100% sampling is required for final inspection unless

10.4.3 Calibrated tools shall be used for final inspection; however, non-calibrated measurement and test equipment (M&TE) may under the following conditions: 1) 2)

10.4.4 Complete the production inspection form according to its format. 10.4.5 Any item that exhibits “infant mortality” during inspection shall

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



10.4.6 Any item failing final inspection must be processed according to the QMS-14 Control of Nonconformances.

11.0 PROCEDURE: SHELF LIFE EXTENSION - Subject to Customer Review and/or Approval 11.1 Items that are subject to expiration may

under

production conditions; for instance: 11.1.1

11.1.2 .

11.1.3 11.1.4

11.2 Chemicals that are purchased or prepared by the chem-lab are exempt from . 11.3 Raw material components whose shelf life has been extended must display

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



12.0 PROCESS MAP

Production Process Owner:

Quality objective: ents.

NO YES

Job Sheet provided from Contracts to .

PURCHASING

Next Page


INPUT

rials

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig




Based on production schedule, .

Products Products Subassembly

Process Build Assembly

Process TEST FAIL TEST

To QMS-14

STOP

FAIL

Next Page

Final QC

Final QC

continued next page… Cop

yrigh

t © Jn

F Specia

lties,

LLC. A

ll righ

ts res

erved

worl

dwide

.


CAGE: xxxxx

Your Company Name

Rev: Orig




B C

Products OUTPUT OUTPUT

ALL TO APPROPRIATE FILE:

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Your Company Name



SHIPPING PROCESS


Identifier: Shipping


Document Status:


Document Link:


Abstract: This document describes the shipping process.

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Shipping

CAGE: xxxxx

Your Company Name

Rev: Orig




0-0



Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Shipping

CAGE: xxxxx

Your Company Name

Rev: Orig



TABLE OF CONTENTS

1.0 PURPOSE................................................................................................................................................... 4

2.0 THEORY .................................................................................................................................................... 4

3.0 PROCEDURE: PACKAGING AND SHIPPING ...................................................................................... 4

4.0 PROCESS MAP.......................................................................................................................................... 5

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Shipping

CAGE: xxxxx

Your Company Name

Rev: Orig



1.0 PURPOSE This document defines the Shipping process including product packaging activities.

2.0 THEORY The final packaging and arrangement of shipping is critical to the quality of product as received by the Customer; as a result, the Company

3.0 PROCEDURE: PACKAGING AND SHIPPING See Process Map.

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Shipping

CAGE: xxxxx

Your Company Name

Rev: Orig



4.0 PROCESS MAP

Shipping Process Owner:

Quality objective:

NO OK?

.

YES Revise

Next Page


INPUT

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Shipping

CAGE: xxxxx

Your Company Name

Rev: Orig




.

NO OK?

YES

Shipping staff affixes all labels and finalizes all shipping paperwork.

Output

Output

To Customer

To File

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Your Company Name



INTERNAL AUDITING


Identifier: Internal Auditing


Document Status:


Document Link:


Abstract: This document describes the procedure used to audit the quality management system. Cop

yrigh

t © Jn

F Specia

lties,

LLC. A

ll righ

ts res

erved

worl

dwide

.

Internal Auditing

CAGE: xxxxx

Your Company Name

Rev: Orig




0-0



Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Internal Auditing

CAGE: xxxxx

Your Company Name

Rev: Orig



TABLE OF CONTENTS

1.0 PURPOSE................................................................................................................................................... 4

2.0 THEORY .................................................................................................................................................... 4

3.0 INTERNAL AUDITING PROCEDURE ................................................................................................... 4

4.0 PROCESS MAP.......................................................................................................................................... 6

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Internal Auditing

CAGE: xxxxx

Your Company Name

Rev: Orig



1.0 PURPOSE This document provides details and procedures for the internal auditing process. NOTE: At this time, only quality system audits are conducted. When environmental system or other audits are implemented, this procedure will be amended to include rules for additional audits.

2.0 THEORY Internal auditing of a Company’s quality system is critical for maintaining good processes and documentation and for identifying areas for improvement opportunity.

3.0 INTERNAL AUDITING PROCEDURE The Resonsible Authority takes into consideration the importance of each audited process, changes in the Company and results of previous audits when planning audit frequency, requirements, methods, responsibilities and reporting. 3.1 Internal quality audits are conducted by

.

3.2 Audit requirements include those of ISO 9001 and the Company’s quality system documents as well as requirements of Customers or regulatory authorities, as applicable. 3.3 Auditors may not be independent of the area being audited; therefore,

3.4 Minimum auditor training requirements are as follows: •

• 3.5 The Quality Manager plans audits according to

3.6 The Quality Manager maintains the Internal Audit Schedule that records . 3.7 Using the Internal Audit Report, the Lead Auditor will

3.8

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Internal Auditing

CAGE: xxxxx

Your Company Name

Rev: Orig



3.9 The internal audit according to the QMS-13 Corrective Action Procedure as necessary to address

3.10 During the corrective action effectiveness review, the results of actions taken to address audit findings are evaluated. 3.11 The completed Internal Audit Report is then returned to the Quality Manager for logging and the Internal Audit Schedule is updated. 3.12 Copies of the completed audit report are sent to the appropriate managers of the areas audited to report the findings and results. In this way, and in conjunction with the submission of corrective action requests,

3.13 The results of internal audits are also gathered and summarized on the Audit Trend Analysis Chart (generated by the Internal Audit Schedule) for review by top management during management review according to the QMS-04 Management Process Procedure and

3.14 In all cases, auditees are

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Internal Auditing

CAGE: xxxxx

Your Company Name

Rev: Orig



4.0 PROCESS MAP

OK?

Internal Auditing Process Owner:

Quality objective: .

INPUT from other processes:

Quality Manager (QM) selects

Auditors conduct audit in following stages: o

o

o

o

QM schedules audits according to

Findings / Observations?

YES NO

Record findings

YES

MANAGEMENT

Quality Manager updates audit schedule

OUTPUT o o o

NO

Finalize audit report

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Your Company Name



DEFINITIONS AND ABBREVIATIONS


Identifier: Definitions and Abbreviations


Document Status:


Document Link:


Abstract: This document describes definitions and abbreviations used by the Company.

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Definitions and Abbreviations

CAGE: xxxxx

Your Company Name

Rev: Orig




0-0



Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



TABLE OF CONTENTS

1.0 PURPOSE................................................................................................................................................... 4

2.0 ABBREVIATIONS .................................................................................................................................... 4

3.0 DEFINITIONS (GLOSSARY)................................................................................................................... 4

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



1.0 PURPOSE This document provides the accepted definitions and abbreviations for terms used by the Company.

2.0 ABBREVIATIONS • ATP: Acceptance Test Procedure • CCB: Configuration Control Board • DR: Data Review • IHS: Inherently Stable • IS: “is” or “as found” • ISO: International Organization for Standardization • M&TE: Measurement and Test Equipment • MCD: Manufacturing Control Document • MRB: Material Review Board • NCP: Nonconforming Product • NCR: Nonconformance Report • QA: Quality Assurance • QC: Quality Control • QTP: Qualification Test Procedure • QTR: Qualification Test Report • R&D: Research and Development • RA: Responsible Authority • REA: Responsible Engineering Authority • RFCA: Request for Corrective Action • RFP: Request for Price/Proposal • RFS: Request for Support • RQA: Responsible Quality Authority • RTV: Return to Vendor • SAE: Society of Automotive Engineers • SB (also S/B): “should be”

3.0 DEFINITIONS (GLOSSARY) ACCEPTANCE The formal assent to ownership by the Customer or an authorized agent of a supply (document, product, service, etc.) and recognition that it conforms to contractual requirements. ACCESSIBILITY The feature of design and installation that permits quick and easy admission (for performance of visual and manipulative maintenance) to the area in which a failure has been traced.

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



ASSEMBLY A combination of two or more related subassemblies or parts designed to perform a specific function and capable of disassembly. AUDIT A systematic and independent examination to determine whether quality activities and related results comply with planned arrangement and whether these arrangements are implemented effectively and are suitable to achieve objectives. AUDIT NONCONFORMANCE Major Nonconformance - a) The absence or systemic breakdown of the Process Control and/or Quality Management system, or b) Any non-conformance where the effect impacts or has the potential to impact the integrity of the product. Minor Nonconformance - Any single system failure or lapse in conformance with the applicable standard or audit criteria. BAILED PROPERTY Any material, components, tools and equipment, premises, intellectual property, personal data, supplies, jigs, dies, gages, fixtures, molds, patterns and other items furnished directly or indirectly by the Buyer and used by the Company to perform work against the Buyer's purchase order. CALIBRATION Comparison of two instruments or measuring devices, one of which is a standard of known accuracy, to detect, correlate, report or eliminate by adjustment any discrepancy in accuracy of the instrument or measuring device being compared with the standard. CATALOG ITEM

CERTIFICATE OF CONFORMANCE

. CERTIFICATION

CHANGE

CHANGE REQUEST

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



TRAINING

UNIT (SOFTWARE)

UNIT (HARDWARE)

UNSCHEDULED MAINTENANCE

VALIDATION TESTING

VALIDATION OF A PROCESS

VERIFICATION

VERSION

WAIVER A written authorization to use or release a product that does not conform to the specified requirements. WORK

WORKMANSHIP Proficiency related only to a hardware operation or process undertaken by an individual.

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Your Company Name



DESIGN AND DEVELOPMENT


Identifier: Design and Development


Document Status:


Document Link:


Abstract: This document describes the procedures used to design and develop products or services.

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Design and Development

CAGE: xxxxx

Your Company Name

Rev: Orig




0-0



Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



TABLE OF CONTENTS 1.0 PURPOSE................................................................................................................................................... 4 2.0 THEORY .................................................................................................................................................... 4 3.0 DESIGN & DEVELOPMENT PROCEDURE .......................................................................................... 4 4.0 PROCESS MAP.......................................................................................................................................... 7

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



1.0 PURPOSE This document provides details on the Design and Development process.

2.0 THEORY The Company performs new product research and development (R&D). Controlling the design and development activity ensures that product designs meet all requirements and that parts produced are adequate as a result of the design.

3.0 DESIGN & DEVELOPMENT PROCEDURE

3.1 General The responsible engineering authority (REA) for design and development is assigned by the Plant Manager. Design and development personnel from various business groups may include

Design and development planning outputs are recorded in the applicable Design Review or correspondence to the Customer and are controlled according to the QMS-02 Configuration Management Procedure.

3.2 Design and development planning The Company considers the following conditions when determining the stages and controls for design and development:

.

3.3 Design and development inputs The Company considers the following conditions when it determines requirements essential for the specific types of products and services to be designed and developed:

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



The Company determines that design and development inputs are

3.4 Design and development controls The Company applies controls to the design and development process to ensure that:

ned

3.5 Design and development outputs The Company ensures that design and development outputs:

The Company retains records for design and development outputs.

3.6 Design and development changes The Company identifies, reviews and controls changes made during or subsequent to the design and development of products and services to the extent necessary to ensure that there is no adverse impact on conformity to requirements. The Company retains records for:

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



See Process Map.

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig



4.0 PROCESS MAP

Design and Development Process Owner:

Quality objective:

YES

Engineer reviews all design documents for adequacy.

OK? NO YES


Design

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.


CAGE: xxxxx

Your Company Name

Rev: Orig




REA approves design documents.

OK? NO YES

.

.

OUTPUT

PRODUCTION

Design Verification Design Validation

.

.

OK? NO YES

Restart process at appropriate step!

Design Validation

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Document Name or ID

CAGE: xxxxx

Your Company Name

Rev: Orig

Page 1 of 4 This document may not be disclosed or reproduced in whole or in part without prior written

permission from a representative of the Company with the authority to grant such permission.

Contract Review Program Name: Program Source: Internal Customer External Customer RFP#: Contract Type: Commercial Gov R&D Customer: Contract#: Contract Type: Customer Name: Program Manager: Company Funded, Account#: Job #: PO Number:

---

---------------------------------------------------------------------------------------------------------- Risk Planning

Identical ----------------------------------------------------------------------------------------------------------

COMMENTS: Analysis Made By: Reviewed By: Date: Date:

Form Rev: Orig

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Document Name or ID

CAGE: xxxxx

Your Company Name

Rev: Orig



Compliance Matrix-1 (Program Name - Contract - Revision)

x x

Specification Name – Number – Revision

Form Rev: Orig

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Document Name or ID

CAGE: xxxxx

Your Company Name

Rev: Orig



Compliance Matrix-2 (Program Name - Contract - Revision)

Form Rev: Orig

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Document Name or ID

CAGE: xxxxx

Your Company Name

Rev: Orig



Work Breakdown Structure

Form Rev: Orig

Check-off each item that is completed

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Your Company Name

(YOUR COMPANY NAME) PROPRIETARY INFORMATION Page 1 of 6

MANAGEMENT REVIEW REPORT


Identifier: Name, Number, Unique ID

Date: Latest Revision Date Document

Status: Draft, Redline, Released, Obsolete

Document Link:


Abstract: This document provides the management review report.

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Document Name or ID

CAGE: xxxxx

Your Company Name

Rev: Orig



CREATION LOG Issue Date Comment Author

0-0

REVISION RECORD


Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Document Name or ID

CAGE: xxxxx

Your Company Name

Rev: Orig



Please complete each section - this form may used as the final report or used as a template to type and publish more formal Management Review Meeting records. At all stages, management must consider

Date of Review: Recorded by:

In Attendance:

NAME TITLE

Absent:

NAME TITLE

ITEM 1: Review of the Quality Policy for current adequacy and the need for changes to it. Review the Quality Policy to ensure it still represents the Company’s goals.

The Company is committed to

Quality Policy reviewed and accepted as is.

ITEM 2: Internal audit results.

ITEM 3: Status of MR System corrective actions.

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Document Name or ID

CAGE: xxxxx

Your Company Name

Rev: Orig



ITEM 4: Review of resources needed to maintain and improve the effectiveness of the quality management system.

ITEM 5: Review the effectiveness of current training programs and

ITEM 6: Review of Suppliers and

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Document Name or ID

CAGE: xxxxx

Your Company Name

Rev: Orig



ITEM 7: Review of quality objectives, data and goals. Review the current Quality Objectives as outlined in the Quality Manual and modify goals accordingly.

Process Quality Objective Data Metric Current Standing

Goal

Management

Corrective Action

.

Internal Auditing


Purchasing

Receiving

ITEM 8: Discuss Customer feedback and complaints not already discussed as part of the NCR system review.

ITEM 9: Discuss the overall performance of the quality system, any changes to the Company that may affect the quality system or

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Document Name or ID

CAGE: xxxxx

Your Company Name

Rev: Orig



ITEM 10: Note other recommendations for management to demonstrate

ITEM 11. Note follow-up activities from prior Management Review issues.

ITEM 12. Set date for next Management Review:

ITEM 13. NCR’s FILED AT THIS MEETING:

Line Item Corrective? Nature of Issue

1

2

3

4

5

6

ITEM 14. OTHER ACTION ITEMS ASSIGNED:

Action Item Assigned to: Required Response Date

ITEM 15. ITEMS FOR FOLLOW-UP AT NEXT MEETING:

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Your Logo Shaded Area for Administrative Use Form Rev: Orig

REQUEST FOR SUPPORT

Nonconformance Continuous Improvement Opportunity Calculated Risk Release

SUBCONTRACTOR: _________________________ DATE RECEIVED: _________________________

RFS#: SHEET _____ OF _____

Traveler#: Op#: Quantity Received: Job Number: Item Name: Description: ID S/B Spec#, Para# & IS Condition w/Quantity &Dimension Affected # Discrepant

Dwg/Spec: Part#:

Part# Rev: Lot or S/N:

Responsible Engr. Authority – Date Responsible Engr. Authority – Date Quality - Date Referee - Date

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

(Your Company Name)

QUALITY SYSTEM EVALUATION

Company Name: Street Address:

City: State: Zip: Phone No: Fax No:

GENERAL INFORMATION

Quality Program Representative: ___________________ Title:____________

Does the above have other responsibilities? Yes___ No___

If yes, explain:_______________________________________________________

Describe/List Company's major products/services:__________________________

___________________________________________________________________

Plant/Facility Area _______________________ Mfg. Area_______________

Quality System:

Does your Company have a Quality Control Manual? Yes___ No___

If yes, indicate Features that are

:

Form Rev: Orig

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

Specification(s) to which your Company works? ___________________________

___________________________________________________________________

Does your Company have a Material Review Board (MRB)?_______________

If yes,

Has your Quality System

Government Quality Surveillance? Yes___ No___

If yes,

Can you furnish a Certificate of Analysis or Certificate of Conformance if requested? Yes___ No___

Can/Will you respond to

If yes,

BUYER USE ONLY BELOW LINE

_______________________________________________________________

APPROVAL STATUS: Conditionally Approved _____ Approved______

On-site Survey Required _____ Disapproved _____ Vendor Code________

: _________________________________________________________ _________________________________________________________________________________________________________________________________________________________________________________________________________

_________________________________________________________________________________________________________________________________________________________________________________________________________

Form Rev: Orig

Copyri

ght ©

JnF Spe

cialtie

s, LL

C. All r

ights

reserv

ed w

orldw

ide.

QUALITY MANAGEMENT SYSTEM POLICIES AND PROCEDURESThe Company's quality management system is fully...

Documents

Transcript of QUALITY MANAGEMENT SYSTEM POLICIES AND PROCEDURESThe Company's quality management system is fully...