llc. all rights reserved worldwide. - quality control plan · changes to the configuration are...

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PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Issued". Date Printed: Form Rev: Orig

QUALITY PLAN

Origination Date: (month year) Document

Identifier: Quality Plan

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

Status: Draft, Redline, Released, Obsolete

Approvals: Abstract: This document describes the quality plan for xxxxxx. Copyright © JnF Specialties, LLC. All rights reserved worldwide. https://www.quality-control-plan.com/about-us/copyright/ Copy

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Quality Plan

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REVISION LOG Issue Date Comment Author 0-0

DOCUMENT CHANGE RECORD Issue Item Reason for Change

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Quality Plan


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TABLE OF CONTENTS 1.0 General................................................................................................................................4 2.0 Scope...................................................................................................................................4 3.0 Quality Plan Inputs ...........................................................................................................4 4.0 Quality Objectives.............................................................................................................4 5.0 Responsibilities ..................................................................................................................4 6.0 Control of Documented Information .............................................................................4 7.0 Resources ...........................................................................................................................5

7.1 Provision of resources ...................................................................................................................5 7.2 Materials, products and services.................................................................................................5 7.3 People ...............................................................................................................................................5 7.4 Infrastructure and environment for the operation of processes ..........................................5 7.5 Monitoring and measuring resources .........................................................................................6

8.0 Customers and Interested Parties Communication ...................................................6 9.0 Design and Development ................................................................................................6

9.1 Design and development process ...............................................................................................6 9.2 Control of design and development changes ...........................................................................6

10.0 Externally Provided Processes, Products and Services ...........................................6 11.0 Production and Service Provision ................................................................................7 12.0 Identification and Traceability......................................................................................8 13.0 Property Belonging to Customers and External Providers .....................................8 14.0 Preservation of Outputs ................................................................................................8 15.0 Control of Nonconforming Outputs .............................................................................8 16.0 Monitoring and Measurement.......................................................................................8 17.0 Audits ................................................................................................................................9 18.0 Work Details ....................................................................................................................9 (Note: This quality plan is based upon ISO 10005:2018. Remove this note prior to release of quality plan.)

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1.0 General The quality plan defines the quality practices, resources and activities that are applicable to (your project).

2.0 Scope The quality plan is a summary of operations that are applicable to (your project).

3.0 Quality Plan Inputs The Company captures all requirements of the Customer

as part of the Proposal Development & Contract Review Procedure. Requirements are reviewed to ensure that the Company has applicable capabilities

When the requirements for products and services are changed, the Company applies to ensure Responsible

Authorities are aware of changes. Applicable documents are revised according to the Configuration Management Procedure, including this quality plan.

4.0 Quality Objectives The Company performs all quality plan functions to achieve conformance with Customer requirements. Deviations are approved by the Customer prior to implementation.

5.0 Responsibilities Responsible Authorities oversee the project to ensure issues are identified and recorded. Solutions are transmitted to and resolved by Management has empowered all employees to

The Company's Project Manager has overall responsibility for the successful execution of the project, including conformity with Customer requirements and meeting quality objectives. The Company's Quality Manager is responsible for The Customer primary contact is: [NAME] (Insert your Organization Chart if desired)

6.0 Control of Documented Information Documents are controlled according to the Documented Information Procedure to ensure the information on them is

Documents are reviewed and approved prior to release and only the latest versions are available to users. Previous versions are stamped "Superseded" and legacy documents are segregated and retained for historical purposes. Copy

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7.0 Resources Project resources are discussed and allocated during Management Review according to the Management Process Procedure.

7.1 Provision of resources The Company determines and provides the resources needed for the establishment, implementation, maintenance and continual improvement of the quality plan according to the Management Process Procedure, which considers

7.2 Materials, products and services The Company reviews Customer requirements according to the Proposal Development and Contract Review Procedure before accepting a contract, which includes

The Company pays particular attention to review of requirements that are

The Company reviews its own requirements and general/specific statutory and regulatory requirements (OSHA, CSPC, etc), and

The Company confirms requirements are stated in the contract before acceptance when the Customer

7.3 People The Company determines and provides the people necessary for the effective implementation of its quality plan and operation and control of its processes according to the Management Process Procedure and Training Procedure. The Company determines the necessary competence for Employees whose work affects the performance and effectiveness of the quality plan. The Company ensures

The Company evaluates the effectiveness of

additional training and maintains records as evidence of competence according to the Management Process Procedure, Training Procedure and Documented Information Procedure. The Company ensures Employees and Contractors are made aware of the Company's quality plan and applicable quality plan objectives. In addition, Employees and Contractors are

7.4 Infrastructure and environment for the operation of processes The Company determines, provides and maintains the infrastructure necessary for the operation of its processes to achieve conformity of products and services according to the Management Process Procedure. The Company determines, provides and maintains

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7.5 Monitoring and measuring resources The Company determines and provides resources needed to ensure

according to the Management Process Procedure, which ensures the provided resources are

Appropriate documented

information is retained and maintained according to the Documented Information Procedure as evidence of Measuring equipment is identified for traceability then calibrated and/or verified

according to the Calibration Procedure.

8.0 Customers and Interested Parties Communication The Company treats Customer and interested party communication as an important

The following communication methods are used within the Management process:

.

9.0 Design and Development The Design and Development Procedure ensures that design activities are conducted in a controlled manner. Where applicable, the Company specifies

9.1 Design and development process The Company's design and development process ensures design activities are conducted in a controlled manner that is defined in the Design and Development Procedure.

9.2 Control of design and development changes When the requirements for products and services are changed, the Company applies the Proposal Development and Contract Review Procedure to ensure

10.0 Externally Provided Processes, Products and Services Purchasing is treated as a process within the Company's quality plan, which is defined in the Purchasing Procedure. The Company accepts responsibility for the quality of products and services that are purchased from Suppliers including Customer designated sources.

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Quality Plan


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The Company does not use Customer verification as evidence of effective control of quality by the Supplier.

11.0 Production and Service Provision The sequence and interaction of processes has been determined and are controlled by specific work details. Workmanship standards are

Corrective actions are controlled according to the Corrective Action Procedure to ensure

The Company plans and carries out processes that include assurances that:

The engineering drawings and technical documentation provide the requirements for all deliverables and services. In all cases, this includes

Incoming materials are inspected according to the Receiving Procedure to ensure

In-process inspections are conducted to ensure

Once all operations are complete, work undergoes

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12.0 Identification and Traceability All products are identified throughout their product life cycle, which is fully defined in the Production Procedure. Other identification and traceability requirements are defined in

13.0 Property Belonging to Customers and External Providers Customer property is suitably identified to prevent unintended use and the Customer's name is indicated on the property or related paperwork. If the property is designated by the Customer for a specific use or order,

Customer property is controlled according to the Production Procedure, contract requirements and applicable property and/or facility agreements.

14.0 Preservation of Outputs The Company prepares instructions for

The instructions are detailed in the applicable job documentation and

general rules are defined in the Production Procedure.

15.0 Control of Nonconforming Outputs All work that is found to be nonconforming against specified requirements are identified, documented, segregated (if possible), evaluated and dispositioned to prevent unintended use or delivery. Necessary actions are taken to

The process of controlling

nonconformances is fully defined in the Nonconformances Procedure.

16.0 Monitoring and Measurement The Company measures the output of the production process according to Customer requirements. Monitoring and Measurement includes:

Measuring equipment is controlled according to the Calibration Procedure.

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17.0 Audits Internal quality audits are conducted to ensure

The internal audit process is fully

defined in the Internal Auditing Procedure.

18.0 Work Details (Guidance Note: Tailor this section to address key elements of the project. A definable feature of work is a task that is separate and distinct from other tasks, has separate control requirements and may be identified by different trades or disciplines, or it may be work by the same trade in a different environment. This list should be agreed upon during the management meeting.) (Guidance Note: For instance - list each work element in "bullet format" from your Contract or Request for Quote/Proposal.) Remove the above guidance notes prior to release of the quality plan. Copyright © JnF Specialties, LLC. All rights reserved worldwide. https://www.quality-control-plan.com/about-us/copyright/

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Page 1 of 7 PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released". Date Printed: Form Rev: Orig

CONFIGURATION MANAGEMENT PROCEDURE

Origination Date: XXXX

Document Identifier:

Configuration Management Procedure



Document Link: Location on Server (if used)

Abstract: This document describes configuration management procedures. Copyright © JnF Specialties, LLC. All rights reserved worldwide. https://www.quality-control-plan.com/about-us/copyright/ Copy

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Configuration Management

Procedure


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Procedure


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TABLE OF CONTENTS 1.0 PURPOSE........................................................................................................................... 4 2.0 THEORY ............................................................................................................................ 4 3.0 CONFIGURATION DOCUMENTATION........................................................................ 4 4.0 CONFIGURATION CONTROL BOARD (CCB) ............................................................. 5 5.0 CONFIGURATION CHANGE CONTROL ...................................................................... 5 6.0 SUBCONTRACTOR AND VENDOR CHANGES .......................................................... 7 7.0 PRODUCT AND TEST SOFTWARE CONTROL ........................................................... 7


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Procedure


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1.0 PURPOSE This procedure defines the requirements for the management of the configuration of products produced by the Company's configuration management activities include the following:

The following are not governed by this control procedure:

2.0 THEORY Part configuration includes a variety of aspects of a given part, including

and more. Because a given product may change over its life, typically due to design improvement activities or Customer requirements, it is important to maintain control and records regarding changes. This procedure has been developed based on practices defined in

3.0 CONFIGURATION DOCUMENTATION 3.1. The current configuration of a given part is identified through applicable technical documents. These may include, but are not limited to:

ls

3.2. All such technical documents are developed and approved by the Responsible Authority, which are then controlled according to this procedure. (See section 4.0) 3.3. Configuration documents and Customer intellectual property received by the Company are forwarded to Project personnel are responsible for the production of configuration controlled documents that meet the requirements of C

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4.0 CONFIGURATION CONTROL BOARD (CCB) 4.1. The Responsible Authority (RA) that authorized the original document and the Quality Manager serve as the baseline Configuration Control Board, which has full authority and responsibility for MRB actions approved by the CCB that affect configuration may

4.2. CCB responsibilities include:

.

5.0 CONFIGURATION CHANGE CONTROL 5.1. Evaluation of a change in configuration for a deliverable item takes into consideration

Typically, this includes such areas of concern as

5.2. All associated changes and affected hardware items or computer programs are included on the Change Order form. The evaluation by the CCB includes

Redlined technical documents may be used if


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Procedure


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5.3. Types of Configuration Change Changes to the configuration are implemented after approval of engineering changes, deviations or waivers. The definition for each is as follows: 5.3.1. Engineering Change:

5.3.2. Deviation:

5.3.3. Waiver:

5.4. Change Classification Changes in configuration are classified by the CCB as either Class I or Class II. The change classification assigned by the CCB is entered on the Change Order, which serves as the document to describe the proposed change and to record CCB decisions relating to the change. Proposed Class I engineering changes are submitted to

5.4.1. Class I Changes The engineering change is classified as Class I when it affects one or more of the following:

t Non-technical contractual provisions are affected, such as, but not limited to:

o o o o o

5.4.2. Class II Changes Any change that does not fall within the Class I definition is a Class II change. Class II changes are implemented

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5.5. Change Implementation 5.5.1. The Responsible Authority verifies that changes have been incorporated into affected units and that the associated configuration status records have been revised. The Responsible Authority asserts that changes have

5.5.2. Superseded revision levels of electronic documents are stored in a controlled access server file and superseded hardcopies, when available, are stored in open-access files. Superseded documents may be used by direction of the Responsible Authority using

5.5.3. Proposed Class I engineering changes are approved by the CCB and are submitted to the Customer in the form of a Change Order (CO) or as required by contract. A Class I Engineering Change is not implemented until

5.6. Document approval is indicated by any of the following methods:

6.0 SUBCONTRACTOR AND VENDOR CHANGES 6.1. Supplier and vendor requests for change are controlled according to

7.0 PRODUCT AND TEST SOFTWARE CONTROL Revision control is


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NUMBER: DATE: RFS#: PERSON REQUESTING

CHANGE ORDER: CLASS I II PERSON WRITING CHANGE ORDER:

CHANGE ORDER

Page of HOLD PO'S PENDING APPROVAL

YES NO

YES NO

EXISTING SERVICES

AFFECTED YES NO

TITLE: CURRENT REV:

DOC#: CHANGE REV TO:

USED ON:

FIRST ARTICLE DESIGN VALIDATION:

YES NO

PRODUCT S/N(s) or LOT#(s) AFFECTED

REASON FOR CHANGE:

:

:

DISPOSITION OF EXISTING SERVICES MRB ACCEPT N/A

RE-INSPECT

Effectivity/Release Date: CUSTOMER APPROVAL/CONCURRENCE:

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

CONTROL OF NONCONFORMANCES

Origination Date: XXXX Document

Identifier: Control of Nonconformances




Abstract: This document describes procedures for control of nonconformances. Copyright © JnF Specialties, LLC. All rights reserved worldwide. Co

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TABLE OF CONTENTS 1.0 PURPOSE................................................................................................................................................... 4

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

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

4.0 DISPOSITIONS.......................................................................................................................................... 6

5.0 CUSTOMER DISPOSITION AUTHORITY............................................................................................. 7

6.0 PROCESSING SCRAP .............................................................................................................................. 7


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1.0 PURPOSE This document defines and makes reference to the procedures necessary for the control of nonconforming items.

2.0 THEORY Items that have failed inspections or tests or that in any way does not meet requirements are considered “nonconformances”. Such items must be controlled to ensure they are not accidentally delivered or used. The Company’s system ensures that nonconformances are identified when found and are segregated, investigated and dispositioned. Corrective and/or preventive actions are taken to ensure nonconformances do not reoccur.

3.0 GENERAL PROCEDURE 3.1 “Nonconformance” is any item made by the Company or raw material used by the Company or returned from the Customer that does not meet: •

3.2 Nonconforming items must be withheld pending

3.3 All employees are empowered to

3.4 Upon discovery of a nonconforming item, an employee may

3.5 When an employee cannot bring the item into conformance through immediate rework, the employee shall

3.6 3.7 The employee shall

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3.8 The employee shall

3.9 Upon receipt of the RFS, the Quality representative will

3.10 Quality will then

3.11 If the nonconforming item is ascertained or estimated to be the fault of a Supplier, Quality may

3.12 Quality will also

3.13 The RFS shall then be

3.14 The MRB consists of the following managers, at a minimum: •

3.14.1 MRB Qualification A Material Review Board member must: 1)

3.15 In the event of a non-unanimous decision, the Plant Manager shall

3.16 The Company shall provide

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4.0 DISPOSITIONS 4.1 Dispositions are classified as Major, Minor or None. 4.1.1 Major:

4.1.2 Minor:

4.1.3 None:

4.2 MRB dispositions may include, but are not limited to: 4.2.1 Clarification

4.2.2 Conditional Acceptance

4.2.3 Non-Deliverable

4.2.4 Notification It is possible that

4.2.5 Precautionary The MRB may determine that a Request for Support was prepared because of

4.2.6 Repair (Non-Standard and Standard)

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4.2.7 Request for Waiver/Deviation

4.2.8 Return to Supplier (Receiving Inspection)

4.2.9 Rework (Non-Standard and Standard)

4.2.10 Scrap

5.0 CUSTOMER DISPOSITION AUTHORITY 5.1 Major: A Waiver/Deviation disposition is subject to Customer approval. 5.2 RTV and Scrap dispositions are 5.3 Minor: Conditional Accept and Non-Standard Rework/Repair dispositions are

5.4 Scrap, RTV or Standard Rework dispositions are . 5.5 None:

6.0 PROCESSING SCRAP 6.1 Nonconforming items dispositioned as scrap are

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6.2

6.3

6.4


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Your Logo Use other side for additional information Shaded Area for Administrative Use Only Form Rev: Orig

NONCONFORMANCE REPORT Nonconformance Continuous Improvement Opportunity Calculated Risk Release

SUBCONTRACTOR:_________________________ DATE RECEIVED: _________________________

NCR#: SHEET _____ OF _____ Punch #: Bldg#: Quantify: Job Number:

Item Name: Description: ID S/B Spec#, Para#, & IS Condition w/Quantity &Dimension Affected # Discrepant Dwg/Spec:

Part#: Part# Rev: Reserved:

P.O.#: Qty Inspected:

Area: Date:

Inspector: Unit Cost Project Name:

Measurement Machine Personnel Material Method Environment/Design Send-to/Date: Critical Impact to Schedule or Contract: Yes No

Disposition Instructions

ACN Orientation Yes No Supplement Yes No CAR: Yes No CAR Sent: Yes No CLASSIFICATION MRB Disposition

MAJOR MINOR NONE

Material Review Board Acceptance

Project Engineer/Date Your Authority Name/Date QC/Date Referee/Date

Rework/Repair Operator Rework/Repair Date Rework Inspector/Date Customer/Date:

Rework Time: --- Rework QC Time: Sum of Time Consumed by MRB: ACN=Advance Change Notice; CAR=Corrective Action Request; RTV=Return to Vendor; Supplement=Add to Existing Procedure


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CORRECTIVE AND PREVENTIVE ACTION


Identifier: Corrective and Preventive Action




Abstract: This document describes the procedures used to correct and prevent nonconformities. Copyright © JnF Specialties, LLC. All rights reserved worldwide. Co

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

3.0 PROCEDURE: INTERNAL REPORTS .................................................................................................... 4

4.0 PROCEDURE: INVESTIGATION & CORRECTIVE ACTION REQUESTS (ICAR’s) ........................ 5

5.0 PROCESS MAP.......................................................................................................................................... 6


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1.0 PURPOSE This document provides details and procedures for the process governing the discovery, reporting, resolution and recording of actions taken to correct or prevent nonconformities.

2.0 THEORY Corrective action is taken to correct nonconformities, which could be product defects found during production, errors found in documents, equipment problems or problems related to how the Company performs functions in its processes. “Corrective action” is simply the “fix” that corrects the problem. Whenever we take corrective action we also attempt to prevent the problem from recurring, which is known as “preventive action”. There are times when preventive action is a standalone activity, specifically when reporting a problem that does not exist at the moment but could exist if something isn’t done. Having a formal system to record and resolve both existing and potential problems ensures that these problems do not occur or reoccur, thereby improving our products, processes and work environment.

3.0 PROCEDURE: INTERNAL REPORTS 3.1 The Company utilizes a Request for Support (RFS) form to record

3.2 ALL employees are empowered with the ability to report sources of problems and nonconformances. 3.3 3.4 3.5 see Process Map. 3.6

3.7 3.8

3.9 In addition to corrective action efforts, management shall

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3.10 The management review process shall

3.11 Where product is suspected of a nonconformance, the Company shall

4.0 PROCEDURE: INVESTIGATION & CORRECTIVE ACTION REQUESTS (ICAR’s) 4.1 Any purchasing agent may

4.2

4.3 Failure of a Supplier to respond to an ICAR or to respond with an insufficient action plan


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5.0 PROCESS MAP

o

OUTPUT

an best

resolve the issue.

RFS is closed in log

RFS Admin reviews log and reports for trends and overdue RFS’s. RFS Admin reports these results to management.

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Your Logo INVESTIGATION AND CORRECTIVE ACTION

REQUEST ICAR Responsible Supplier:

Customer: Part# Applicable Customer P.O or Job # Customer CA or corresponding documentation received? Y N Number: Date Opened: Step 3. Due: Date ICAR closed: Closed By: Raw Material affected # Ht# P.O # ______________________________________________________________________________ 1. Champion: Team Members: 2. Problem Description: ______________________________________________________________________________ 3.

______________________________________________________________________________ 5.

9. Congratulate the Team!


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DESIGN AND DEVELOPMENT


Identifier: Design and Development




Abstract: This document describes the procedures used to design and develop products or services. Copyright © JnF Specialties, LLC. All rights reserved worldwide.

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Design and Development

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TABLE OF CONTENTS 1.0 PURPOSE................................................................................................................................................... 4 2.0 THEORY .................................................................................................................................................... 4 3.0 DESIGN & DEVELOPMENT PROCEDURE .......................................................................................... 4 4.0 PROCESS MAP.......................................................................................................................................... 5 Copyright © JnF Specialties, LLC. All rights reserved worldwide.

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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 The responsible engineering authority (REA) for design and development is

See process map. Copyright © JnF Specialties, LLC. All rights reserved worldwide.

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4.0 PROCESS MAP

YES

?

NO

NO YES

Design Planning Design Planning

INPUT

Engineer oversees creation of, as

OK? NO YES

continued next page…

Design


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PROPRIETARY

Production of project.

.

OK? NO YES

To

STOP

OUTPUT

PRODUCTION

Design Verification Design Validation

.

.

OK? NO YES

Design Validation

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DOCUMENT CONTROL


Identifier: Document Control




Abstract: This document describes procedures for controlling documents. Copyright © JnF Specialties, LLC. All rights reserved worldwide. Co

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TABLE OF CONTENTS 1.0 PURPOSE.................................................................................................................................................................. 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


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1.0 PURPOSE This procedure defines the requirements for the control of documents within the quality management system (QMS). The scope of this procedure is to control documents specifically defined in section 3.0. 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: • Engineering documents; including drawings, specifications and job-specific work instructions (see the

Configuration Management Procedure) • Personal notes • Records • Signs and labels • Test equipment software programs • Third party reference materials (owner’s manuals, encyclopedias, buyer’s guides, etc.)

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.

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 international standards such as ISO 9001. 3.2. QMS Procedures: these documents provide additional detail for certain procedures where such detail is required. The Quality Manual includes references to the applicable QMS procedures. 3.3. General Work Instructions: these documents provide machine-level or task-level details on what is required to perform specific work. These are typically specific to a department or work step. These do not include job-specific work instructions that are made part of the engineering documents and controlled via other procedures (see 1.0 above.) 3.4. Inspection Instructions: these documents are developed by or under the supervision of the Quality Manager using requirements from the applicable engineering drawings and/or technical documentation. 3.5. Forms: these documents are produced by a streamlined creation and control process. 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 not required to be maintained or controlled, such as personal notes written on a scratch pad, post-it note or form identified with a watermark or the term “Note Pad”.

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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 reference to the applicable Engineering Order number (EO) exhibited on each document. 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 not available for general access. 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 then confirm that their stamped and released document is the latest revision prior to each use. If the document is not marked "Released" it is marked with the date printed and expires thirty (30) days after printing. 4.4. Change Control

5.0 QUALITY MANAGEMENT SYSTEM PROCEDURES 5.1. Creating New QMS Procedures

5.2. Review and Approval

5.3. Distribution

.

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In some cases,

5.4. Change Control

.

6.0 GENERAL WORK INSTRUCTIONS 6.1. Creating New Work Instructions

. 6.2. Review and Approval

6.3. Distribution

. 6.4. Change Control

7.0 INSPECTION INSTRUCTIONS 7.1. Creating New Inspection Instructions

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New inspection instructions are

. 7.2. Review and Approval

7.3. Distribution

7.4. Change Control

8.0 FORMS 8.1. Creating New Forms

8.2. Review and Approval

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8.3. Distribution

8.4. Change Control

9.0 EXTERNAL DOCUMENTS 9.1.

. 9.2.

10.0 PERIODIC RE-EVALUATION OF DOCUMENTS


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INTERNAL AUDITING


Identifier: Internal Auditing




Abstract: This document describes the procedure used to audit the quality management system. Copyright © JnF Specialties, LLC. All rights reserved worldwide. Co

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

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

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

Copyright © JnF Specialties, LLC. All rights reserved worldwide. www.quality-control-plan.com/copyright.htm

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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 3.1 Internal quality audits are conducted by an audit team of two auditors to promote objectivity and to ensure ongoing compliance with requirements of the Company’s policies and procedures. This is accomplished by auditing all identified processes against requirements at least once annually. 3.2 Audit requirements include

. 3.3 Auditors may not be

3.4 Minimum auditor training requirements are as follows: •

.

3.5 The Quality Manager

3.6 The Quality Manager 3.7 Using the Internal Audit Report, the Lead Auditor will

3.8

3.9

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3.10

3.11

3.12

3.13 The results of internal audits are also

3.14 In all cases, auditees are expected to cooperate fully with the audit team. Copyright © JnF Specialties, LLC. All rights reserved worldwide.

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4.0 PROCESS MAP


OK?

Internal Auditing Process Owner:

.

INPUT from other processes: o

Auditors conduct audit in following stages: o

Findings / Observations?

YES NO

YES

MANAGEMENT

Quality Manager

OUTPUT o

NO

Finalize audit report

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Your Logo INTERNAL AUDIT REPORT

Page 1 of 8

PLAN - STEP ONE: Audit Preparation & Planning

Process to Audit (Audit Scope):

Audit Date(s): Lead Auditor:

Audit #: Other Auditor(s) on Team:

Applicable Clauses of Quality Plan:

List Inputs to the process:

:

List any other applicable documents, if any:

Document Title Revision


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DO - STEP TWO: Compare Documentation vs. Requirements

Question Y/N Evidence or Notes Sheet Ref. #

Indicate any suggestions for improvement related to the documentation:


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CHECK - STEP THREE: Compare Actual Practice vs. Requirements Compare the requirements of Quality Plan and other documentation against what employees are actually doing in everyday practice.

Requirement Reference Question Y/N

Evidence or Notes Sheet Ref. #

Requirement Reference Question Y/N

Evidence or Notes Sheet Ref. #

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ACT - STEP FOUR: Verify the Effectiveness of the Process

?

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STEP FIVE: Summarize Your Findings for RFS System

NONCONFORMITIES RFS # Describe finding as it should appear in the RFS system


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Page 6 of 8

STEP FIVE: Summarize Your Findings for RFS System

OPPORTUNITIES FOR IMPROVEMENT

STEP SIX: Review Audit Report and Submit

Signature of Lead Auditor Audit report reviewed and ready for submission:

Date


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STEP SEVEN: Submit Audit Report to Appropriate Managers


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Page 8 of 8

NOTES PAGE

Note # Notes, evidence, findings, comments, etc.

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MANAGEMENT PROCESS


Identifier: Management Process




Abstract: This document describes the management review process. Copyright © JnF Specialties, LLC. All rights reserved worldwide. Co

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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.................................... 5

6.0 PROCEDURE: INTERNAL COMMUNICATION................................................................................... 5

7.0 PROCEDURE: RESOURCE MANAGEMENT........................................................................................ 6

Appendix A: Process Map ...................................................................................................................................... 7


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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 its processes. Those processes are identified in the Quality Manual; however, management itself must also be treated as a process. This means that the management activities must have inputs, outputs, controls and reaction plans (when things do not work out as expected.) 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.

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

4.2 This review shall

4.3 Minutes of the meetings are

. 4.4 The Management Review meeting should include analysis of the following inputs: •

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•

4.5 Management shall

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

5.2 Each process objective must

5.3 Top management will . 5.4 Throughout the year, assigned managers and staff will 5.5 During Management Review the data will be

5.6 When a process does not meet a goal,

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

5.8 Over time, management shall

6.0 PROCEDURE: INTERNAL COMMUNICATION 6.1 Internal communication is

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6.2 The following methods are used: 6.2.1

6.2.2

6.2.3 .

6.2.4 .

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 include: •

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

7.4 During Management Review, managers shall

.

7.5 From that data, top management can


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Appendix A: Process Map

Objective:

INPUT from other processes

INPUT from other processes

NO

NO

YES


?

Objective met?

MANAGEMENT

Owner:


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from previous page…


NO

YES

.

OUT

ALL other processes

Planning, resources or controls needed?

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Your Logo 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



Abstract: This document provides the management review report. Copyright © JnF Specialties, LLC. All rights reserved worldwide.

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Your Company Name Rev: Orig

Page 2 of 6 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.

CREATION LOG Issue Date Comment Author 0-0

REVISION RECORD Issue Item Reason for Change


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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.

:

ITEM 2: Internal audit results.

ITEM 3:

ITEM 4:

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ITEM 7: Review of quality objectives, data and goals. .

Process Quality Objective Data Metric Current Standing

Goal

Management

ITEM 8: .

ITEM 9:


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ITEM 10:

ITEM 11.

ITEM 12.

ITEM 13. :

1

2

3

4

5

6 ITEM 14.

ITEM 15. :

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PRODUCTION PROCEDURE


Identifier: Production




Abstract: This document describes the production process. Copyright © JnF Specialties, LLC. All rights reserved worldwide. Co

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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 AND GOVERNMENT 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 ................. 8

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


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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: • Ensuring Operators have a good work environment and training • Ensuring Operators have good equipment and tools • Properly handling and preserving product and raw materials • Supplying adequate work instructions, drawings, etc., where needed

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 established process controls and could affect or actually affects the quality of a production process or business operation. It is understood that the appropriate responsible authority will occasionally not be available for support; in that event, safely stop the process and contact each of the following personnel in the order listed until an appropriate authority can make a decision to resolve the problem. No disciplinary action may be attached to an employee’s attempt to resolve a problem (Corrective and Preventive Action Procedure, 3.3). • Affected Area Line Leader • Affected Area Line Supervisor • Affected Area Supervisor • Affected Area Manager • Affected Area QC Inspector • QC Manager (Quality Manual, 5.5.2) • Plant Manager

4.0 PROCEDURE: PRODUCTION DOCUMENTATION 4.1 All revision controlled production documents are available at the point of use and display the part number and revision of the item being produced. 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 referenced on a traveler or other instruction by management or supervisory staff. 4.3 Such documentation includes the drawing part number and revision, and when applicable, the PCD (Production Control Document) for the production operation or product line or any other WI’s (Work Instructions) developed by the Company.

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4.4

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

5.2

5.3

5.4

. 5.5

6.0 PROCEDURE: PRODUCT HANDLING 6.1

7.0 PROCEDURE: PRESERVATION 7.1 Operators will

.

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7.2

7.3 . 7.4

7.5

. 7.6 7.7

8.0 PROCEDURE: CUSTOMER AND GOVERNMENT PROPERTY CONTROL 8.1 Customer and Government Property (C&G Property) means all hardware property owned by or leased to the Customer and Government or acquired by the Customer and Government under the terms of a contract. This includes: 8.1.1

8.2 All Customer and Government furnished property shall be

8.3 C&G Property shall be

8.4 Sensitive material,

8.5 C&G Property will

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8.6 C&G provided equipment shall be

8.7 Quality shall

8.8 Requirements for the control of C&G property shall

.

9.0 PROCEDURE: VALIDATION OF PROCESSES 9.1

. 9.2 Provisions for validation and verification includes: •

10.0 PROCEDURE: INSPECTION AND TEST OF PRODUCT 10.1 Receiving inspection is performed according to the Receiving Procedure. 10.2 First Article Inspection

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10.2.7 Any item failing first article inspection

10.3 In Process Inspections

10.4 Final Inspection

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


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11.1.1


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12.0 PROCESS MAP

Production Process Owner:

Quality objective: .

NO YES

Create Requisition

.

.

PURCHASING

Next Page


INPUT


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PROPRIETARY