Manual

INTERACTIVE QUALITY CONTROL MANUALAbraham W. Bolden, Sr.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

ISO 9000 AND QUALITY MANUAL OUTLINE

This out line of The ISO 9000 requirements for quality control is presented to those who are engaged in the production of machined items. The Forms referred to in the text may be acquired by emailing me at [email protected]. Interactive SPC Charts are also available. ISO 9000 interactive form templates are also available for a nominal fee.


mailto:[email protected]


Quality Program Documentation

NAME OF COMPANY, Incorporated Quality Program is governed by comprehensive documentation as referenced herein. Procedures, work instructions, forms, drawings, and similar documentation used by organizations whose direct or supportive participation in processes affecting product Quality, are formally documented and controlled. All such documents are contained in readily identifiable, easily accessible controlled manuals or libraries placed at convenient locations throughout the company.

Manual Issuance

Date Issued:

Issued To:

Department:

Telephone:

Controlled Copy: Uncontrolled Copy:

Control No.

If you need additional copies or additional information, please contact the Quality Control Manager.

By Abraham W. Bolden, Sr.


ISO 9000 QUALITY MANUAL REVISION HISTORY

REVISION APPROVAL

CHANGE DATE

PAGE NO.

CHANGE DESCRIPTION COMMENTS NAME SIGNATURE

APPROVAL


This manual is hereby APPROVED as a complete documentation of those procedures and practices to be used by the NAME OF COMPANY, INCORPORATED for the quality assurance of all manufactured goods and contracted services. This manual should be considered as confidential and the contents of same may not be revised, altered, copied or disseminated without the written permission of the President of NAME OF COMPANY, INCORPORATED or the Quality Control Manager.

Signed By the Below Administrators

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 5

Table of Contents Program Description

1.0 Introduction1.1 Scope1.2 Purpose1.3 Authority1.4 Issue of the Manual1.5 Amendments1.6 Review1.7 ISO Program Representative1.8 Cost of Quality1.9 Definitions

2.0 Company Quality Policy

3.0 Organization Charts

4.0 Quality Policies and Responsibilities4.1 Management Responsibility4.2 Quality System4.3 Contract Review4.4 Design Control4.5 Document & Data Control4.6 Purchasing4.7 Control of Customer - Supplied Product4.8 Product Identification and Tractability4.9 Process Control4.10 Inspection and Testing4.11 Control of Inspection, Measuring and Test Equipment4.12 Inspection and Test Status4.13 Control of Non Conforming Product4.14 Corrective and Preventive Action4.15 Handling, Storage, Packing, Preservation and Delivery4.16 Control of Quality Records4.17 Internal Quality Audits4.18 Training4.19 Servicing4.20 Statistical Techniques


1.0 Introduction

This manual outlines the policy of the company relating to its Quality Management System (QMS).

The Quality Program Manual (QPM), issued and controlled by NAME OF COMPANY, Inc. defines the Quality Management System, which is effective across all disciplines and at all, levels within the company.

1.1 Scope

This Quality Program Manual applies to all activities and personnel within NAME OF COMPANY, Inc.

1.2 Purpose

The primary purpose of this Quality Program Manual is to describe and document the Quality Program currently in practice at NAME OF COMPANY, Inc.

This Manual is the central source of general policies, procedures, and responsibilities that in turn authorize and govern creation of subsidiary quality related documentation and activities.

This Manual provides comprehensive evidence to all customers, supplies, and employees that NAME OF COMPANY, Inc. is committed to establishing and maintaining acceptable levels of measurable Quality in its products and services.

The requirements and procedures addressed in the Quality Manual are intended to meet the requirements of ANSI/ASQC Standard Q9000 - 1994 (ISO 9002) and customer QA

specifications.

1.3 Authority

This manual is issued under the authority of the President of NAME OF COMPANY, Inc.

1.4 Issue of the Manual

Controlled copies of the Manual will be numbered and registered. The Master copies of the manual will be held by the Quality Control Manager and Management Representative. The NAME OF COMPANY, Inc Management Representative is responsible for the issuance of amendments to the Manual, withdrawal of obsolete information and the maintenance of the master copies of the manual.

Uncontrolled copies may be distributed to organizations or persons at the discretion of the Management Representative. These will be current at the date of issue only and will not be subject to amendment action. These copies will be annotated "Uncontrolled Copy."


1.5 Amendments

Controlled Manuals will be updated and revised as required. The issue of amendments requires approval by the Management Representative.

1.6 ReviewThe Manual will be reviewed at a minimum annually and the Quality System audited over this 12-month period to affirm that the current practices conform to the policies set out in the manual.

The Quality Manual is to be treated as confidential and must not be copied, re-printed or the contents divulged to a third party without the permission of the Quality Manager.

1.7 ISO 9000 Management Representative

The NAME OF COMPANY ISO 9000 Management Representative is responsible for all matters concerning the Quality Manual and shall interface directly with the ISO 9000 Program Registrar on all matters in connection with the ISO 9000 program.

Representative: Quality Control Coordinator

1.8 Cost of Quality

The President, vice-President and Administrative Assistant periodically address the Cost of Quality. Actual cost data is considered company confidential. This quality program is designed to produce continuous improvements in all operations. Improvements in quality are measured and evaluated using the cost of quality information.

1.9 Definitions

Acceptance CriteriaDefined limits placed on characteristics, materials, products or services.

AuditA systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives.

CalibrationComparison and adjustment to a standard of known accuracy.

ConformanceCompliance with specified requirements.

ConcessionWritten authority to use or release a quantity of material, components or stores already produced, but which do not conform to the specified requirements.

ControlCreated by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 8

To exercise authority over and regulate.Control Feature

A documented activity to ensure conformance with specific requirements of applicable specifications.

Corrective ActionMeasures taken to rectify conditions adverse to quality and to minimize recurrence.

DefectNot according to contractual specifications or fit for intended usage.

DocumentationRecorded information.

EquipmentAny simple completed unit that can be used for manufacture, processing or assembly.

FailureAny condition which prevents the product or service from performing its specified function.

FindingObjective evidence that a control feature of the approved quality program was not implemented.

GradeAn indicator of category or rank related to features or characteristics that cover different sets of needs for products or services intended for the same functional use.

InspectionActivities such as measuring, examining, testing, gauging one or more characteristics of a product or service and comparing these with specified requirements to determine conformity.

Job Work InstructionsA document that provides detail "how to" instructions to accomplish a task.

Quality System ReviewA formal evaluation by top management of the status and adequacy of the quality system in relation to quality policy and new objectives resulting from changing circumstances.

Non-conformityThe non-fulfillment of specified requirements.

Objective EvidenceFacts that are observed and documented.

Observation


Evidence that a survey able / auditable element exists which is not contrary to documented requirements, but may warrant further qualification or improvement.

PartIndividual pieces used in the assembly of single equipment units.

QualityConformance to specified requirements.

Quality AssuranceAll those planned and systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirements for quality.

Quality ControlThe operational techniques and activities that are used to fulfill requirements for quality.

Quality SystemThe organizational structure, responsibilities, procedures, processes and resources for implementing Total Quality Management.

Servicing Supplier activities at the interface with a customer and the results of all supplier activities to meet the customer needs.

Quality Procedure (QP)A document that specifies or describes how an activity is to be performed. It may include methods to be used, equipment to be used and sequence of operations.

SubcontractorAny individual or organization that furnishes materials, products or services.

SpecificationThe document that prescribes the requirements with which the product or service has to conform.

TractabilityThe ability to trace the history, application or location of an item or activity, or similar items or activities, by means of recorded identification.

VendorAny individual or organization that furnishes materials, products or services.

VerifyTo determine conformance to specified requirements.

WkproWork Procedure and instruction detailing actions to be performed at specific work

station.


2.0 Company Quality Policy

All products and services provided by NAME OF COMPANY, Inc. shall conform to the requirements specified. All employees have the responsibility to carry out their work assignments in accordance with this Quality Policy and other quality system documentation.

We are committed to continually improving all products and services and to establish NAME OF COMPANY, Inc. as a Quality leader in our field.

In order to meet our goals we will pursue the following objectives:

Provide our customers with only the highest quality products and services.

Provide those products on time.

Provide our customers with the best pricing and value for our products.

Provide totally open communications with our customers in order to meet the customer's needs.

Provide a system for Continuous Quality Improvement in conformance with procedures required by the International Standards Organization.

Provide for employee involvement, motivation and training.

Utilize Statistical Process Control where the absence of statistical data would be detrimental to the quality of the product.

The quality program described in this Quality Program Manual has been specifically designed to meet the requirements of International Standard ISO 9002 and to provide the framework to allow accomplishment of the quality objectives and goals of the NAME OF COMPANY, Inc.

The Management Representative has the responsibility for definition, implementation and maintenance of this quality program. The Management Representative shall ensure that this Quality Policy is understood, implemented, and maintained at all levels of the organization.


3.0 Organizational Charts

3.1 Organizational Reporting


4.0 Quality Policies and Responsibilities

4.1 Management Responsibility

4.1.1 Scope

This policy defines the corporate commitment to quality.

4.1.2 Reference

ISO 9002: 1994, Requirement 4.1.

4.1.3 Policy

The corporate quality policy of the NAME OF COMPANY, Inc. is stated in the Company's Quality Policy that has been developed and agreed to by the Senior Management of the Company. The company’s Quality Policy is stated in Section 2.0 of this manual.

The Company is committed to achieve this policy through the implementation and maintenance of an ISO 9000 Quality Management System.

This commitment seeks continual improvement of the system to achieve the company mission. Senior management will review the Quality Management System on an annual basis to ensure its continued effectiveness.

The company is committed to ensuring that all staff is responsible for the quality of their work, and so the personnel who perform the operations carry out verification.

4.1.4 Responsibilities

It is the responsibility of the President of NAME OF COMPANY, Inc. to provide the resources necessary to implement and maintain the Quality Management System.

The Screw Machine Company, Inc. ISO 9000 Management Representative is responsible for all matters concerning the Quality Manual and shall interface directly with the ISO 9000 Registrar on all matters in connection with the ISO 9000 Program. The Management Representative shall ensure that the quality system is established, implemented and maintained in accordance with ISO 9002:94.

The Management Representative is responsible for the coordination of the management review activity.

The Management Representative is responsible for issuing a copy of the Company Quality Policy to new employees, and all Managers are responsible for ensuring that their subordinates are conversant with the company's Quality Policy and its Quality Management System.


4.1.5 Teamwork

Teamwork is the strategy for the company to promote continuous improvement by way of employee involvement. Employee involvement is established and tracked in accordance with the Management Review process.

4.1.6 Management Review

The President and Functional Department Heads shall review the Quality System annually in conjunction with the Management Representative to ensure its continued effectiveness.

The review shall address as a minimum the following:

Confirmation that the Statement of Policy and Authority is still valid and requires no change

A review of the Quality Program Manual and Standard Procedures to confirm that they meet the requirements of ISO 9002

The identification of weaknesses and deficiencies in the Quality System, including those identified as a result of internal and external quality audits and consideration of possible improvements

Wastage, loss and client complaints incurred throughout the year to identify possible savings and reconsideration of existing working practices

Verification that corrective action procedures are effective

The management review shall be conducted in accordance with the Standard Procedure referenced in 4.1.7.

The result of this review shall be documented and agreed non-compliances shall be processed in accordance with the Company's corrective action system (refer to Section 4.14 of this Manual).

4.1.7 Internal Quality Audit

The Management Representative shall be responsible for the planning and implementation of scheduled and unscheduled quality audits to verify compliance with the requirements of the Quality Management System.

Quality audits shall be conducted by suitably qualified personnel, as nominated by the Management Representative in conjunction with the Quality Manager, in accordance with the Standard.


Each element of the Quality Management System shall be audited at least once per annum; however, the frequency of audit of each criterion may be altered on the basis of previous results, at the discretion of the Quality Manager.

The Management Representative shall report to the President and Functional Department Heads the results of the audit and recommend corrective action as appropriate, to ensure adequate implementation.

Agreed corrective action shall be implemented in accordance with the requirements of Section 4.14 of this Manual.

4.1.7 Documents Implementing This Policy

QP 117 Internal Quality Audits


4.2 Quality System

4.2.1 Scope

This policy defines the quality system operated by NAME OF COMPANY, Inc. to ensure that all products and services conform to customer requirements.

4.2.2 Reference

ISO 9002: 1994, Requirement 4.2

4.2.3 Policy

The Company will operate a Quality Management System based on policies and procedures that are documented to meet ISO 9000 standards.

The Quality Management System is structured in three levels. Level One is documented in the form of a Quality Program Manual and contains the corporate policies and responsibilities. Level Two contains the operating standard procedures of the Company that are referenced to the Quality Management System requirements of the Quality Program Manual.

Level Three is the function specific support documentation and forms.


The Quality Manager in conjunction with the Management Representative bears the prime responsibility for establishing and maintaining an effective and economic Quality Management System.

They will resolve any conflicts or difficulties involved in the implementation of the Quality Management System and will ensure that corrective action necessary to prevent recurrences of system shortcomings or non-conformance is implemented.

All Functional Department Heads and employees are responsible for the maintenance of the Company Operating Procedures in their area required for the implementation of the Quality Management System.

It is the responsibility of all members of Management to familiarize themselves with the Quality Management System requirements and to ensure that these are observed accordingly.


QP 107Quality Policy, dated

Organization ChartWkpro-5 -Work Instructions, Quality Control


4.3 Contract Review

4.3.1 Scope

This policy defines the way in which customer requirements will be established and reviewed.

4.3.2 Reference


4.3.3 Policy

The President of NAME OF COMPANY is responsible for ensuring that all quotations and contracts are reviewed prior to acknowledgement to the customer. The President ensures that contracts are adequately defined and documented. This function shall verify that the company has the capability to fulfill the order. It is the policy of the company that all quotations that are special orders or nonstandard product be reviewed according to the Contract Review Procedure prior to release.

The President has the responsibility for organizing contract reviews for customer orders for products and services, and assigning responsibilities for their execution as required.

Customer orders will be reviewed to ensure that the requirements are adequately defined and documented to identify any differences between the order and the original quotation and to determine the company’s capability to meet the specified requirements.

Verbal orders will be documented by the President to ensure that the order requirements are agreed upon before their acceptance.

The company will not accept any order for which it cannot meet the requirements as stated in the contract or purchase order.

4.3.4 Contract Amendments

The Production Control Function is responsible for coordinating amendments to any customer orders. This function shall communicate all changes between the company and customer and notify all affected departments of relevant changes. Contract amendments are coordinated, reviewed, approved, and communicated according to the Contact Review Procedure.

Contract review activities are recorded and related correspondence are documented by the company and maintained in the customer order file by the Administrative Assistant.



The President is responsible for ensuring that all quotations or contracts are reviewed prior to acknowledgement, organizing contract reviews, and documenting all review activity to ensure that customer requirements are adequately defined and can be met.

The Production Control Administrator is responsible for coordinating amendments to any customer orders.


QP 100 Contract ReviewWkpro-1- Work Instructions, Production Control

4.4 Design Control

4.4.1 The NAME OF COMPANY is not engaged in the design activities or development and therefore has no procedure regarding this element.

4.4.2 Documents pertaining to this Policy

QP 101 Design Review


4.5 Document and Data Control

4.5.1 Scope

This policy defines the way in which all documents and data pertaining to the Quality System are controlled.

4.5.2 Reference


4.5.3 Policy

The NAME OF COMPANY, Inc. identifies and controls documents and data that relate to the requirements of this Standard, as well as documents and data supplied by the customer or other sources and used to provide products that meet defined requirements.

....4.5.4 Responsibilities

The Production Control Manager has the authority to review and approve documents pertaining to the manufacture of product and verifies that current versions of documents referenced by customer drawings or specifications, or contract -related work instructions, are readily available to personnel using the source documents.

The Production Control Manager assures that invalid or obsolete documents are promptly removed from all points of issue or use.

The Management Representative is responsible for ensuring that all Quality System Documents Quality Manual, Quality System Procedures, and the Quality System-related Work Instructions are available as required by this Standard and is responsible for the

maintenance of the master list of quality oriented documents and data.

The Production Control Manager in conjunction with the Management Representative is responsible for the issuance of revised documents pertaining to customer requirements and specifications. The nature of the revision or change is identified in the document at the time of issue.

4.5.5 Documents Implementing this Policy QP 116 Control of Quality Records QP 102 Document and Data Control Wkpro-1- Work Instructions, Production Control


4.6 Purchasing

4.6.1 Scope

This policy defines the controls on the purchase of materials and services used in the manufacture of the Company's products.

4.6.2 Reference


4.6.3 Policy

The Production Control Manager is responsible for ensuring that all purchased materials and services required for the manufacture of products will be the subject of written purchase orders that will clearly describe the type, class, or other precise identification of the item or service being ordered. The positive identification and applicable specifications, drawings, process requirements, inspection instructions or relevant technical data bearing upon the approval of the purchased item shall be included in or attached to the purchase order upon issuance.

The Production Control Manager is responsible for ensuring that purchasing documents contain data clearly describing the product ordered.

In line with the Company's policy of using only materials that meet the required quality, all materials used in manufacture will be purchased to the Company's written specification.

Wherever possible the Company will procure materials or services from an assessed source acceptable to the company.

Such assessment will be carried out in accordance with the Company's procedure for the selection of suppliers. Preference will be given to ISO 9000 assessed and registered suppliers.

The company will work closely with its suppliers to establish quality procedures that eliminate the need for incoming inspection. Copies of suppliers quality test and/or certifications of results will be used for this purpose. Pending being satisfied that a supplier's quality system is adequate to permit identification testing/ inspection only, instead of full incoming inspection quality test, incoming materials will be subject to inspection on a sample basis.

The results of assessment and the subsequent level of supplier performance will be used to determine the extent of receiving inspection necessary before acceptance of the supplies by the company.

The Company's right to verify materials at source is specified in its conditions of purchase. Source verification requirements will be identified at the contract review stage.



It is the responsibility of the Purchasing Manager to ensure that the procedures established for the control of the purchasing activity are implemented and maintained.

The Quality Function is responsible for establishing and maintaining the approved supplier list.

The Manufacturing Function is responsible for ensuring that material specifications will allow product specifications to be met.

The Quality Function will determine the extent of the receiving inspection activity required and will coordinate the assessment of vendors quality systems.

It is the responsibility of the Quality Function to coordinate any source verification activity required.

4.6.5 Documents Implementing this Policy

QP 100 Contract ReviewQP 104 Supplier SurveyQP 103 Purchasing

Wkpro-1- Work Instructions, Production Control


4.7 Control of Customer-Supplied Product

4.7.1 Scope

This policy defines the way in which Purchaser Supplied Product (or GFP) will be controlled.

4.7.2 Reference


4.7.3 Policy

All Purchaser Supplied Product is examined upon receipt for condition, quantity and conformance with delivery details.

All items are positively identified and stored in a designated area.

Periodic inspection is performed to detect any damage or deterioration of materials.

Material will only be issued against those orders for which it was supplied.

Any customer product that is either lost, damaged, or is otherwise unsuitable for use is recorded, and reported to the customer. Such reports and any investigation predicated upon such reports are documented.


The Production Control Function is responsible for identifying purchaser-supplied product during the contract review activity and for communicating such information to the appropriate company personnel.

The Quality Function is responsible for establishing, implementing and maintaining the procedures required to meet the requirements of this policy.


QP 105 Control of Customer Furnished MaterialWkpro-4- Work Instructions, Shipping, Packaging, ReceivingWkpro-5- Work Instructions, Quality Control


4.8 Product Identification and Tractability

4.8.1 Scope

This policy defines how product identification and trace ability will be established and controlled.

4.8.2 Reference


4.8.3 Policy

The NAME OF COMPANY establishes and maintains a documented procedure for identifying raw materials and supplies, parts and finished products by means of applicable drawings, specifications and other documents from receipt and throughout all stages of production and delivery.

4.8.4 Identification of Incoming Materials

The Material Handler is responsible for ensuring that all materials are clearly identified either individually or as a lot while they are located at Shipping and Receiving or in transit to storage or use in production. The Material Handler maintains records identifying incoming materials by Part Number, and their corresponding purchasing documentation such as specification and other pertinent data.

The Production Control Manager records the receipt of materials and maintains accurate and timely records on inventory location and age, and updates inventory status on a semi-annual basis.

4.8.5 Identification of In-Process Materials

The Production Manager and shop supervisory personnel are responsible for assuring that in-process materials are clearly identified.

Manufactured items are traced by means of job cards and shop routing instructions which identifies the material (part number and description) shows its routing, and denotes its current state of processing. Stock items are identified by part number and customer.

4.8.6 Traceability

The NAME OF COMPANY maintains records for each finished product which include the applicable routing sheets, engineering drawings, and contract specifications used for manufacture. Records pertaining to traceability are maintained for a period of no less than 3 years. Product traceability is controlled through this procedure.


QP 106 Product Identification & Trace abilityCreated by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 23

Wkpro-4- Work Instructions, Shipping, Packing, Receiving 4.9 Process Control

4.9.1 Scope

This policy defines the way in which the manufacturing processes are controlled.

4.9.2 Reference


4.9.3 Policy

Managers of departments involved in production processes which directly effect quality of the end product are responsible for ensuring that these processes are identified, planned and executed under controlled conditions. Controlled conditions are defined to include the following requirements:

Documented procedures and / or work instructions for production items where their absence would adversely affect quality.

Suitable equipment and working environment, to include compliance with government safety, environment, and hazardous material-related regulations.

Compliance with reference standards, codes, and quality plans and / or documented procedures.

Monitoring and control of suitable process and product characteristics, with an emphasis on those characteristics designated as “special” by the customer or NAME OF COMPANY, during production. Special characteristics are designated, documented and controlled as required by the customer.

Approval of processes and equipment, as appropriate.

Criteria for workmanship, which are either written or expressed by means of representative samples.

Suitable maintenance of equipment to ensure continuing capability of the machine or process.

4.9.4 Process Control and Operator Instructions

The Manager of each department with process monitoring and operator instructions is responsible for ensuring that these work instructions are understandable, sufficiently detailed, and accessible at the work station and that they are periodically reviewed as the need arises.

Process Monitoring and operator instructions shall include or reference, as appropriate


Operation Name and/or Number keyed to process flow requirements Part Name and Number Current engineering level / date. Required tools, gages and other equipment. Material identification and disposition instructions. Customer and supplier designated special characteristics. SPC requirements. Relevant engineering and manufacturing standards. Inspection and test instructions where applicable.


The Production Management Function is responsible for establishing Workmanship Standards in the Process Instructions.

It is the responsibility of the Quality Function to ensure that the Quality Control Instructions adequately specify requirements.

The Quality Manager is responsible for ensuring that the Process and Quality Control Instructions are established and maintained.

The Production Planning Team is responsible for the planning and scheduling of work orders.


QP 107 Process Control ProductionQP 121 Machine MaintenanceWkpro-2- Work Instructions, Automatic Screw MachineWkpro-3- Work Instructions, Secondary Setup & OperateWkpro-5- Work Instructions, Quality Control


4.10 Inspection and Testing

4.10.1 Scope

This policy defines the conduct of inspection and testing activities to verify conformance with specified requirements.

4.10.2 Reference


4.10.3 Policy

The NAME OF COMPANY establishes and maintains procedures, work instructions, and quality plans which define the required inspection and testing activities and related records used to verify that all product requirements are met prior to product distribution, processing, or use.

Acceptance criteria, unless otherwise specified by customer contract, in all cases is zero defects. (C=0)

When specified in the contract or as the need arises to ascertain the quality of materials used in the production process, the NAME OF COMPANY shall use accredited laboratory facilities.

4.10.4 Receiving Inspection and Testing

The Production Control Function has the responsibility for ensuring that incoming product is not used or processed until it has been verified as conforming to specified requirements. When product is needed in an urgent production situation, the product or materials are positively identified and recorded in order to permit positive recall in case that the product or material does not meet customer requirements.

The amount and nature of receiving inspection and testing applied to incoming material from suppliers is based upon the following factors:

The supplier’s ability to provide statistical/analytical data to demonstrate product quality.

Results of second or third party assessment of supplier’s location. Documented evidence of product quality obtained through accredited

contractors or test laboratories. The supplier’s ability to provide warrants or certifications, including records of

test results. Records of supplier performance. Customer requirements and/or recommendations.

Verification through inspection and testing is done in accordance with the Receiving Inspection Procedure, which addresses such issues as:


Specification of proper work instructions and/or control plans for receiving inspection.

Reference to the Nonconforming Material Procedure for isolation, identification, and control of nonconforming materials.

Methods for the identification and distribution of acceptable materials. Documentation and storage of inspection records.

4.10.5 In-Process Inspection and Testing

The Production Manager is responsible for ensuring that in-process product is held and not used or processed further until it has been inspected, tested, or otherwise verified as conforming to specified requirements, except when product is released under positive recall.

Inspection of in-process materials is done in accordance with In-Process Inspection Procedures, which addresses such issues as:

Specification of proper work instructions, standards, and/or inspection plans for inspection.

Reference to the Non-conforming Material Procedure for control on nonconforming materials.

First Piece product inspection. Urgent production situations and positive methods for recall. Documentation, use, and storage of records.

4.10.6 Final Inspection and Testing

The Quality Control Manager is responsible for ensuring that no product is dispatched until the following conditions are verified:

All final inspection and testing are complete according to the appropriate documented procedure and/or work instruction or quality plan to show evidence of product conformance to specified requirements.

All data and documentation covering inspections and tests specified in the quality procedures and control plan are available and authorized to show compliance and that the results meet specified requirements.

The requirements of Section I, element 4.10.4 are addressed in detail in the Final Inspection Procedure, which addresses such issues as:

Specification of proper work instructions, standards, and/or inspection plans for final inspection.

Reference to the Nonconforming Material Procedure for control of rejected materials.

Documentation, use, and maintenance of records. Layout inspection of products or other documentation specified by customer.

4.10.8 Inspection and Test Records

Inspection and test records are established and maintained to identify the persons performing inspection activities, and the results of these verification activities. The


responsibility for generating, filing, and maintaining inspection and test records is defined in the quality procedures referenced below.


QP 108 Receiving InspectionQP 109 Inspection & Test StatusQP 110 Final Inspection

QP 111 Quality Assurance Wkpro-5- Work Instructions, Quality Control


4.11 Control of Inspection, Measuring and Test Equipment

4.11.1 Scope

This policy defines the control of inspection, measuring and test equipment used by the company.

4.11.2 Reference


4.11.3 Policy

The Manager of Quality Control is responsible for establishing and maintaining documented procedures and work instructions for insuring that all inspection, measuring, and test equipment used in any stage of production is controlled, calibrated, and properly maintained to demonstrate the conformance of product to the specified requirements.

All equipment used for test and measurements will be subject to annual calibration or calibration prior to use for the qualifying of any production, as detailed in the appropriate calibration procedure. Calibration equipment will be traceable to a national or international standard. Records of calibration will be maintained and a system of call-in for calibration operated. When equipment is found to be out of calibration, the effect of that error on product will be reviewed and appropriate corrective action taken.

The annual due date for the calibration of measuring devices shall include a period from 1 week before to 1 week after the due date as entered in the calibration records.

Measuring equipment belonging to any newly hired employee must be calibrated and assigned an in- house ID number prior to use. The equipment is then documented and re-scheduled for subsequent calibration.

The Screw Machine Engineering uses documented work instructions to perform gage repeatability and reproducibility studies to address measurement uncertainty.

The Manager of Quality Control is also responsible for ensuring that the measurement uncertainty of the inspection equipment is known and that such equipment is used in a manner consistent with the required measurement capability.

The NAME OF COMPANY provides data regarding measurement device calibration to its customers upon request.

4.11.4 Procedure

The NAME OF COMPANY has a formal, documented procedure and work instructions for regularly certifying the accuracy of every inspection instrument that is used in the manufacturing process, including instruments owned by employees. Instruments used to verify dimensions or characteristics, or perform functional testing and thereby accept parts are calibrated periodically.


For each item of equipment, a Calibration Record is maintained which describes the equipment, assigns an ID number, identifies its location as of the date calibrated, lists the date calibrated and the next date re-calibration is due, and the acceptance criteria.

The calibration record also documents the history of all calibration activity including the condition of the instrument at the time of calibration. The calibration record is maintained by Quality Control for a period of 3 years.

Reference and attribute gages issued by quality control are calibrated and/or checked prior to each issue and a gage issue and calibration record is updated at the time of issue. The instrument calibration ID number affixed to each measuring device references a complete history of that device as recorded in the computer based Gagecal file. A condensed copy of the calibration record pertaining to the ID number is issued to each employee at the time of calibration. The employee copy of the calibration record describes the measuring device, shows date calibrated, the date that the next calibration is due, the name of the person who owns the device, and comments as to the condition of the instrument at the time of calibration.

All calibrations and related inspections are performed in environmentally controlled or suitable conditions.

When necessary, outside sources are used to calibrate certain gages and equipment. For each item of equipment, the Calibration Record is completed and a copy of the gage certification is required. All calibration services, whether performed in or outside the plant, are calibrated to standards that are traceable to the National Institute of Standards and Technology (N.I.S.T.)

Inspection and measuring equipment that is not in current calibration is not used. Newly acquired measuring instruments are impounded until calibration has been completed.

Employees that use the measuring equipment are responsible for checking the calibration sticker (or equivalent tag/marker) to ensure that the calibration status is current.

Should calibration activity disclose the potential for discrepant material that has been shipped, the customer shall be notified of all pertinent information. This notification may be followed by a request for deviation or waiver.

Calibration activity that discloses the potential for discrepant material that is within the facilities of the NAME OF COMPANY results in the initiation of a production audit of parts produced and qualified by any measurement device found to be out of calibration. If the production is found to be discrepant, a Non-conforming Material Report is generated.

All inspection, measuring, and test equipment is handled properly and stored in a manner that prevents accidental damage to ensure that the accuracy and fitness for use is maintained.

Test hardware or software used as a suitable means of inspection are subject to the requirements as listed above for inspection, measuring, and test equipment.


4.11.5 Quality Records

The Manager of Quality Control is responsible for the maintenance of calibration records, including communication to customers regarding the potential for nonconforming product due to the out of calibration equipment and for ensuring that the control of measurement equipment meets or exceeds customer requirements.

4.11.6 Measurement System Analysis

The Manager of Quality Control is responsible for the maintenance of gage repeatability and reproducibility and other applicable statistical studies designed to analyze measurement system uncertainty. The NAME OF COMPANY has documented work instructions which include analytical methods and acceptance criteria that meet the specified calibration requirements.


QP 112 Control of Measuring & Test EquipmentQCP 100 Calibration Procedures


4.12 Inspection and Test Status

4.12.1 Scope

This policy defines the way in which inspection and test status will be defined.

4.12.2 Reference


4.12.3 Policy

All materials and products will be suitably identified throughout each stage of manufacture by the use of routing tags, labels, inspection records, physical location designations, or other suitable means, which indicate the conformance or nonconformance of the product with regard to the inspections performed. The identification of inspection and test status is maintained, as defined in the company’s procedures and work instructions and as required by the customer, throughout production to ensure that only product that has passed the required inspections is routed to the next operation or for shipment.

Defective products discovered during the production process will be segregated from all other material pending investigation and final disposition and all such material will be clearly identified.

Inspection and test records will enable the identify of the inspection authority responsible for the release of the finished product to the established.


It is the responsibility of the Department Manager to ensure that the procedures required to implement this policy are established and maintained.

It is the responsibility of all personnel to observe the requirements of the procedures that implement this policy.

The Quality Manager bears the ultimate authority for the release of the Company's products and is responsible for the delegation of such authority.


QP 109 Inspection & Test StatusWkpro-5 - Work Instructions, Quality Control


4.13 Control of Non Conforming Product

4.13.1 Scope

This policy defines the manner of controlling material that does not conform to specified requirements.

4.13.2 Reference


4.13.3 Policy

The Manager of Quality Control in conjunction with the Management Representative is responsible for maintaining documented procedures and work instructions for ensuring that product not conforming to specified requirements is clearly identified, quarantined and segregated to prevent inadvertent use until the material disposition is determined.

All defective material is, immediately upon detection, identified and held pending investigation and disposition.

Such arrangements apply to material received from suppliers or from internal or external non-conformances.

All defective products are reviewed to determine the need for corrective/preventative action and the subsequent material disposition.

Records of all non-conformance are maintained and are periodically reviewed to establish trends and thereby determine the need for further preventative action.

Material that does not conform to the customer’s specification will be used only after obtaining the customer’s written deviation or consent.

4.13.4 Nonconforming Product Review

The Quality Control Manager has the responsibility for the initial review and control of all suspected nonconforming materials. After initial review, the company President, Quality Control Manager and the person in charge of the department in which the defective materials were produced have the authority to carry out the following emergency actions:

Rework product to meet the specified requirement. Accept product based upon customer grant of material deviation. Use product for alternative applications where product meets required

specifications. Scrap the product.

The occurrence of a nonconforming material condition is documented by use of the Rejection and Sorting Report. This report describes the nonconformity, addresses the disposition, and provides statistical information for possible corrective action and/or


process improvement activities to prevent reoccurrence. The information contained in these reports is tracked and documented in the computer files for the purpose of to continuously reduce the level of nonconforming product.

Product that is reworked or repaired is re-inspected according to appropriate inspection procedures and Quality Plans. Pertinent instructions for rework are either written or delivered orally to appropriate personnel.

The Material Review Board is composed of the company President, Management Representative, Quality Control Manager and the Manager of the department responsible for the nonconforming materials. The MRB shall convene as necessary in order to disposition nonconforming materials received from the customer or discovered during production activity.

4.13.5 Control of Reworked Product

Reworking of product is controlled by the manager of the department responsible for bringing the product within required specification. All reworked product is re-inspected prior to shipment and the product supplied to the customer may not show visible evidence of rework activity unless the customer has granted concession or deviation.

4.13.6 Engineering Deviations and Authorizations

The Management Representative is responsible for managing the customer authorizations of products, including materials provided by suppliers that differ from those currently approved according to the following guidelines that include:

Obtaining written customer approval of Deviation Requests, Engineering Changes and Corrective Action Requests.

Ensuring that the proper documentation is available for materials shipped under customer deviation or waiver.

It is the responsibility of all personnel detecting a non-conformance to ensure that it is properly identified, segregated and reported.

The responsibilities for determining disposition of defective material are defined in the Procedures that implement this policy.


QP 113 Non Conforming Material


4.14 Corrective and Preventive Action

4.14.1 Scope

This policy defines how corrective and preventive actions are identified, implemented and reviewed for effectiveness.

4.14.2 Reference


4.14.3 Policy

The NAME OF COMPANY establishes and maintains documented procedures for implementing both corrective and preventive action. These procedures specify actions for eliminating the cause of actual or potential quality system problems and related nonconformities to a degree commensurate with the magnitude of the problem, its potential outcome, and the level of risk involved. Corrective Action Requests received from the customer are resolved as required by the customer.

The Management Representative and the Quality Control Manager are responsible for ensuring that all company personnel involved in the Corrective Action Process and Preventive Action Program:

Understand their importance in achieving the goals of the Quality Policy.

Are able to provide the personal commitment and resources necessary to execute corrective and preventive actions in an efficient and timely manner.

Are aware of the various problem-solving methods used in determining corrective and preventive action plans.

Understand the importance of corrective and preventive action plans in the Management Review Process.

4.14.4 Implementation of Corrective Action

Corrective Action functions are directed at revising the company’s quality system, policies, processes, procedures, and work instructions in order to eliminate the root cause of the quality problem. Corrective Action Procedures are utilized in the following situations:

To resolve quality system problems related to nonconformities found during internal, external, or third party audits, and issues uncovered during the Management Review process.

To revise the quality system, work processes, quality procedures, and / or work instructions to eliminate the cause of a poor quality product,


customer complaint, or internal quality failure. External failures are handled as required with the customer, and are used as input to the corrective action process.

To resolve quality system problems found through the analysis of customer returns.

Corrective actions are initiated, controlled, and documented through the use of the Corrective Action Request which is specified in the Corrective and Preventive Action Procedure.

The responsibility for undertaking the corrective action lies with the Management Representative in conjunction with the Quality Control Manager. For each corrective action request, the Management Representative with the assistance of Administrative and management personnel shall:

Investigate the extent of the problem.

Determine the root cause(s) of the problem.

Decide on corrective action.

Implement the corrective action.

Initiate permanent changes in any related procedure/instructions (if appropriate).

The Management Representative is responsible for ensuring that the Corrective Action Program is managed effectively. This involves, but is not limited to the following activities:

Issue the Corrective Action Request form to the person responsible.

Follow-up on the progress of Corrective Action activities to help ensure that the corrective action is completed by the promised date.

Verify that the corrective action taken is effective.

Sign off on the Correction Action Report for completed activities, and close out the correction action.

Investigate the cause of failure and take appropriate action when the correction action is not completed according to plan.

Maintain a system of records for managing the corrective action documents, monitoring the status of corrective action activities, and storing closed out Corrective Action Requests for a period of 3 years minimum.


4.14.5 Implementation of Preventive Action

Preventive action is directed at revising the company’s quality process or tooling to eliminate the root cause(s) of potential problems. Preventive and Corrective Action Procedures are used when:

Potential problems are discovered or opportunities for improvement are identified during internal, customer, or third party audits.

Quality records, past production history, customer feedback, process capability studies, and/or management review reports reveal a need for the undertaking of preventive action measures.

Preventive actions are initiated, controlled, and documented through the use of the Corrective Action Request form.

The responsibility for the undertaking of preventive action lies with the Administrative Staff consisting of the company President, Quality Control Manager, Management Representative, and Production Manager who are responsible for the related quality system elements and / or procedures. For each Preventive Action Request, the aforementioned persons shall:

Investigate the nature of the weakness.

Determine the root cause(s) of the weakness.

Decide on preventive action.

Initiate permanent changes in any related procedure or instructions (if appropriate).

The Management Representative is responsible for ensuring that the Preventive Action Program is managed effectively. This function shall document preventive action measures, monitor the status of the activity, and store the closed out preventive action records for a period of 3 years minimum.


QP 114 Corrective and Preventive Action


4.15 Handling, Storage, Packaging, Preservation and Delivery

4.15.1 Scope

This policy defines the controls employed within the Company for the handling, storage, packaging and delivery of materials.

4.15.2 Reference


4.15.3 Policy

Material handling arrangements are made during all stages of manufacture, inspection and test in order to prevent any risk to material quality.

The manner in which material is handled and protected is subject to written instructions where critical handling and transportation considerations are identified. These will refer to any special containers, and handling devices are provided accordingly.

Materials awaiting use or shipment are identified and segregated in secure storage areas. Suitable measures are taken to prevent damage or deterioration including a periodic inspection for materials condition.

The Company's products are packed in accordance with prescribed methods and using materials designed to ensure that the product quality is maintained during transit. Order and product identification are clearly marked and will provide for any contract or carrier requirements.

The product description, destination and transit considerations are specified on the Company's delivery/dispatch documentation.


The Purchasing Materials Function is responsible for ensuring that material is properly received, identified, protected, stored and issued in accordance with the prescribed routines.

They are also responsible for ensuring that products are properly prepared for dispatch and are accordingly identified.

The Purchasing and Materials Functions are responsible for the conduct of regular audits of stock to determine that material is maintained in a satisfactory condition.

The Quality Function is responsible for ensuring that products are properly prepared for dispatch and are accordingly identified. It is the responsibility of all personnel to adopt good material handling practices and for observing the written procedures provided.



QP 115 Handling, Storage, Packaging, Preservation, and DeliveryWkpro-4


4.16 Control of Quality Records

4.16.1 Scope

This policy defines the maintenance of quality records.

4.16.2 Reference


4.16.3 Policy

All essential quality related activities are the subject of records to fully demonstrate the achievement of specified requirements and the effective operation of the company's Quality Management System.

Records are suitably stored and maintained to ensure their safekeeping and subsequent retrieval.

The retention periods and the authority for the disposal of records are defined. Access to quality related records are made available to the purchaser or his representative as required.


The Quality Function is responsible for ensuring that the procedures that implements this policy is maintained and is effective.

The Quality function will coordinate any access to the quality records required by the customer.

It is the responsibility of all personnel to ensure that quality related records are compiled in a complete, legible and accurate manner and are correctly filed and stored in the location provided where applicable.


QP 116 Control of Quality RecordsWkpro-5- work Instructions, Quality Control


4.17 Internal Quality Audits

4.17.1 Scope

This policy defines the conduct of internal Quality Management System audits.

4.17.2 Reference


4.17.3 Policy

NAME OF COMPANY, INC. will ensure that all aspects of its Quality Management System are objectively audited.

Audits are scheduled on the basis of thye status and importance of the activity to be audited.

Results are documented and reviewed by the Management Team to ascertain that the Quality Management System is effective in achieving its objectives and continues to reflect the Company's mission.

Trained personnel independent of the department or process under surveillance will conduct audits.


The Management Representative will coordinate the audit activities and is responsible for ensuring that there are sufficient trained auditors to meet the audit program requirements.

The Head of each department being audited is responsible for investigating, planning and implementing any corrective action agreed upon as a result of the audit.


QP 117 Quality Audits


4.18 Training

4.18.1 Scope

This policy defines the provisions made within the Company to ensure that all personnel are adequately trained for the tasks that they are required to undertake.

4.18.2 Reference


4.18.3 Policy

All tasks within the Company that are adversely affected by the lack of acquired skill will be identified and made the subject of a job description that reflects the extent and evidence of skill required. The Company will use this to appraise the level of competence of personnel both before and during engagement and to identify training needs accordingly.

All staff will receive appropriate training before carrying out manufacturing or testing operations. Training programs are devised to ensure complete familiarity with all requirements of the process. Records will be maintained of training given, and completion of training will be subject to an end of training review. Periodic reviews of training requirements will be made to ensure that training remains effective, and toidentify needs for retraining.


Functional Department Heads are responsible for ensuring that only personnel who are suitably qualified perform tasks requiring acquired skill.

It is the responsibility of the Quality Function to analyze instances of non-conformance for evidence of insufficient skill, job knowledge or training.

The Quality Function is responsible for establishing and maintaining the appropriate training records.


QP 118 Training


4.19 Servicing

The NAME OF COMPANY performs no customer service activities 4.19.1 and therefore has no documented procedure regarding this element.

4.19.2 Document pertaining to this policy

QP 120 Servicing of Customer Returns


4.20 Statistical Techniques

4.20.1 Scope

This policy defines the use of statistical techniques within the Company.

4.20.2 Reference


4.20.3 Policy

Where used within the Company, statistical techniques will be selected to be the most appropriate statistically valid technique for the application.

The techniques used will be defined in procedures, which will prescribe the way the technique is to be applied and the rules governing its use.

Where statistical techniques are used for product verification due regard will be made to the contractual requirements of the customer.


It is the responsibility of all staff specifying the use of statistical techniques to ensure that the requirements of this policy are complied with.

It is the responsibility of all persons using statistical techniques to observe the relevant procedures.


QP 120 Statistical TechniquesSPC Manual, dated 5-1-00



TABLE OF CONTENTS

PROCEDURE NUMBER PAGE

Contract Review QP 100 1

Design Review QP 101 5

Document Control QP 102 6

Purchasing QP 103 9

Supplier Surveys QP 104 13

Customer Supplied Materials QP 105 18

Product Identification and Trace ability QP 106 22

Process Control QP 107 26

Receiving Inspection QP 108 29

Inspection Status QP 109 33

Final Inspection QP 110 35

Quality Assurance QP 111 38

Control of Measuring Equipment QP 112 41

Non Conforming Material QP 113 44

Corrective Action QP 114 49

Shipping And Packaging QP 115 53

Quality Records QP 116 57

Quality Audits QP 117 59

Training QP 118 63

Servicing Customer Returns QP 119 66

Statistical Techniques QP 120 67


CONTRACT REVIEW QP 100

1. PURPOSE

1.1. This procedure provides specific instructions for the review and acceptance of contractual agreements, verifying that elements of the proposal effort have been mutually agreed upon and ensuring implementation of customer contractual requirements.

2. SCOPE

2.1 This procedure applies to product all new or amended orders.

3. DEPARTMENTS RESPONSIBLE FOR IMPLEMENTATION

3.1. Administrative Staff

3.2. Production Control

4. GENERAL

4.1. The purchase order and associated documentation are reviewed by the President, Production Manager, and Production Control to analyze the contractual requirements and note any differences between the purchase order and the terms outlined in the initial Quotation. Any significant differences will be discussed with the customer before proceeding.

4.2. The purchase order contractual requirements are compared to existing company production capabilities and the pre-established proposal summary to determine special requirements. A contract requirements form is initiated to identify the responsible departments, the scheduled completion dates and the documents and tasks that must be completed to meet contractual requirements. Special attention is given to the customer's requirements noted as critical or safety characteristics.

4.3. Production Control and Administrative Staff representatives review the contract requirements and all related documents to determine documentation and other tasks to be completed. The required contractual documents, such as the quality control plan, are forwarded to quality control for completion.

4.4. Production Control coordinates the contract requirements, summarizing and defining all the requirements specified on the purchase order or contract, with appropriate quality assurance personnel.

4.5. The completed and approved contract requirements and such associated documentation as the quality control plan are forwarded to Production Control for submittal to the customer.

4.6. All contractual agreements and documentation associated with the purchase order and Contracts are filed in Central Files and maintained for a minimum period of 3 years.

4.7 Verbal orders for items previously manufactured under formal contract are received by the President or Production Control. Such orders must be confirmed by customer purchase order within seven (7)days. No verbal order will be processed for parts not previously manufactured by this company until all aspects of the purchase order and contract


referenced documents for contractual agreements are complete.

4.8 The President in conjunction with Production Control is responsible for the coordinating amendments to any customer order. Production Control shall communicate, by the issuance of a temporarily revised drawing, all amendments to the purchase order to all departments that might be affected by any amendment to the purchase order.

4.9 Contract amendments are reviewed, coordinated, and approved according to the Contract Review Procedure.

5. PROCEDURE

Responsibility .

5.1. President

Action

5.1.1. Reviews all aspects of the purchase order and contract and referenced documents for contractual requirements and completes the contract requirements form. Advises the customer of any significant differences from and exceptions to the pre-established proposal summary.

5.1.2. Reviews contract schedule commitments for their impact on other contractual requirements.

5.1.3. Assures that contractual requirements are adequately defined and documented. Where no written statement of requirement is available for an order received by verbal means, the president assures that the order requirements are agreed upon before acceptance.

5.1.4. Verifies that NAME OF COMPANY has the capacity to meet the contract or accepted order requirements.

5.1.4. Approves or rejects the contract or Purchase Order.

Responsibility

5.2. Production Control Action

5.2.1. Receives proposed amendments to the purchase order, contract or referenced documents for contractual requirements and notes differences from the pre-established proposal summary

5.2.2. Forwards proposed amendments to president for approval or rejection.

5.2.3. Communicates all changes to acceptable contracts to relevant departments and subcontractor, where applicable.Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 2

5.2.4. Completes the Quote and forwards a formal serialized quotation to the customer with a copy of Screw Machine Industry Conditions of Sale requirements.

Responsibility

5.3. The Production Control Administrative Staff

Action

5.3.1. Combines information received from quality and technical engineering.

5.3.2. Prepares an estimate cost summary.

5.3.3. Forwards the cost summary to the President for review.

5.3.4. Distributes approved copies of the cost summary to:

President Production Manager

5.3.5. Files all documentation associated with the purchase order and contract in central files.

6. ACCEPTANCE

6.1. Acceptable documents are approved and signed by the President where such approval and signature is required for completion of the transaction. 7. REJECTION

7.1. Unacceptable documents are returned to the customer for clarification and/or revision

8. RECORDS

Contract review activities are recorded and related correspondence are documented by the company President and Production Manager and maintained in the customer order file for a period of 3 years minimum.

9. FORMS

9.1. FO1-01 Quotation Cost Summary Worksheet.

9.2. FO1-02 Parts Processing Worksheet.

9.3 Serialized Quotation.

9.4. Purchase Order.

9.5. Condition of Sale and Manufacturing Practices.


9.6. Job Process Shop Paper.

10. DEFINITIONS

Not applicable

11. REFERENCE DOCUMENTS

11.1 ISO 9002, paragraph 4.3.


DESIGN CONTROL QP 101

1. The NAME OF COMPANY is not engaged in the design activities or development and therefore has no procedure regarding this element.


DOCUMENT AND DATA CONTROL QP 102

1. PURPOSE

1.1. This procedure provides specific instructions for the release of drawings and documents, including subordinate documents and subsequent changes to drawings.

2. SCOPE

2.1. This procedure applies to the control of drawings and documents, including subordinate documents that explain the engineering requirements, manufacturing processes, assembly methods, test procedures and inspection instructions related to manufacturing activity.


3.1. Quality Assurance


3.3. Manufacturing

4. GENERAL

4.1. Production Control has the primary responsibility for the preparation, release, initial distribution and control of drawings, specifications and other design documentation.

4.2. Production Control has the primary responsibility for the preparation, release, initial distribution and control of subordinate documents that provide fabrication, assembly and process methods and instructions, such as shop orders, assembly instructions, process specifications and process procedures or instructions.

4.3. Production Control administers all customer change notifications and subsequent revisions to the subordinate documents.

4.4. Quality Control has the primary responsibility for the preparation of inspection methods and instructions and work standards (i.e., accept or reject criteria).

4.5. Quality Control administers all change requests and subsequent revisions to inspection instructions and work standards.

4.6. The users of the documentation are responsible for the removal of obsolete documentation from work areas.

4.8. Quality Control audits compliance to this quality procedure.


5. PROCEDURE

Responsibility


Action

Upon the receipt of any customer document, drawing or written specification, the Production Control Manager shall:

5.1.1. Date Stamp the document or otherwise indicate in the document the day upon which the document was received.

5.1.2. Review the document for adequacy and completeness.

5.1.3. Approve the document when such approval is necessary.

5.1.4. Assign document, file, or drawing number .

5.1.5. Release the document to Administrative and/or manufacturing personnel

5.1.6. Receive, process, administer and control customer-engineering revisions in a timely manner.

5.1.7. Determine the number (stock items or work in process) of disposition parts in manufacturing effected by the revision.

5.1.8. Remove obsolete documents from Master files.

5.1.9. Revise all subordinate documents as applicable.

Responsibility

5.2. Management Representative

Action

5.2.1. Maintains a Master list of quality system documents identifying the current revision status.

5.2.2 Initiates Engineering change requests.

5.2.3. Reviews and re-issues revised documents in conjunction with Production Control.


Responsibility

5.3 Quality Control

Action

5.3.1. Audits and ensures compliance

6. RECORDS

6.1. Customer change orders are maintained by purchasing. Change implementation is incorporated into inspection and test records.

6.2. Information relating to customer issued blueprints or other drawings are entered and stored in the Job Boss computer files. These files show Customer Code Identification, Part number, Job Number, Job Code Number, and current drawing revision. No additional or separate Master list is maintained.

6.3. One copy of an obsolete drawing is voided and filed in the VOID drawing cabinet in Administrative files. The voided copy is stored until such time that the customer issues a new revision.

7. FORMS

7.1 Form Listing and Revision Status

8. DEFINITIONS

8.1. Drawings - Engineering prints, schematics and artwork

8.2. Documents - Engineering specifications

8.3 Subordinate documents - Manufacturing, test, and inspection procedures or instructions


9.1. ISO 9002, paragraph 4.5.


PURCHASING QP 103

1. PURPOSE

1.1. This procedure provides specific instructions to ensure that purchased product conforms to specified requirements

2. SCOPE

2.1. This procedure applies to all suppliers providing materials, parts, or other products purchased by the NAME OF COMPANY.


3.1. Quality Control

3.2 Administrative Function

3.3 Production Control

4. GENERAL

4.1. The approved suppliers list is initiated, documented, updated, maintained and distributed by purchasing in conjunction with the Quality Control Function..

4.2. Quality uses the supplier quality performance rating report, surveys, audits and questionnaires to ensure that the selected suppliers can provide the specified product.

4.3. The approved suppliers list contains the following information:

Supplier number Commodity or Service. Method of supplier approval (e.g., supplier surveys). Method of supplier approval (e.g., supplier surveys).

4.4. The commodity service that identifies the supplier's capabilities is determined by purchasing from information supplied by the supplier.

4.5. The method of supplier approval is classified (for purchasing department use) as follows:

Previous Record - The supplier has a previous record of supplying high-quality articles of the type being procured. These records are supported by documentation that includes the supplier history and the supplier quality performance rating.

Survey - A survey of the supplier's facilities and quality program has been performed and accepted. Results of the survey are documented.


Mail - A questionnaire completed by the supplier denoting supplier's capabilities and quality program has been reviewed and accepted. The results are documented and on file.

Temporary - The supplier has only limited qualifications. The limitations are included in the approved suppliers list.

Distributor - The supplier is an authorized factory distributor, contracted to supply commercial or military hardware.

Note: Suppliers not satisfying at least one of the above conditions are referred to the quality manager for consideration and special provisions.

4.6. Suppliers are removed from the approved suppliers list by the purchasing manager, at the direction of the quality manager, for the following quality considerations:

An unacceptable quality performance rating that cannot be resolved.

An unsatisfactory survey, audit, unanswered corrective action request, or specific quality problems that cannot be resolved.

4.7. Suppliers are removed from the list at the discretion of the purchasing manager for reasons other than quality considerations.

4.8. The approved suppliers list is updated or revised every six months by purchasing. Additions, disapprovals, and corrections are made as the need arises by means of an addendum issued by purchasing and quality.

4.9. The Administrative Function reviews purchase orders to ensure that Purchasing documents contain data clearly describing the product ordered as to type, class, grade or other precise identification. All purchase orders must include the title or other positive identification, specifications or drawings, process requirements, inspection requirements (where applicable) and other relevant technical data including approval requirements or qualification of the product, or procedures.

4.10. The approved supplier list is checked to verify that the supplier specified on the purchase order is an approved source for the products or services listed. New suppliers must be approved.

4.11. Contracts requiring government inspection of sub-tier orders are presented to the local government representatives for review and delegation.

4.12. Copies of acceptable purchase orders are reviewed for accuracy and completeness by the Administrative Function and a copy of the accepted purchase order is filed in the supplier's P.O. file.

4.13. Receiving/Inspection follows the P.O. requirements for the necessary inspection requirements. If on-site inspection of supplier product a requirement of the purchase order,


the Management Representative will contact the supplier and arrange for the inspection to be carried out. Such verification at supplier premises does not absolve the supplier of supplier responsibility to provide an acceptable product and cannot be use by supplier as evidence of effective control of supplier quality.

4.14 The Management Representative provides the pertinent inspection and audit forms to be used for supplier quality confirmation purposes.

5. PROCEDURE

Responsibility


Action

5.1.1. Accumulates suppliers' names and addresses from a current listing of active suppliers.

5.1.2. Determines commodity and service for each supplier.

5.1.3. Coordinates with the Quality Function to determine the methods of supplier approval and the quality-level approval.

5.1.4. Reviews Purchasing Documents for adequacy and accuracy of specified requirements.

5.1.5. Ensures that the current revision drawings, specifications and special requirements are referenced and are applicable to the part number and distribution.

5.1.6. Verifies that the correct quality requirement codes are listed on the purchase order.

5.1.7. Verifies that the supplier specified is on the approved supplier list.

5.1.8. Reviews revised purchased orders.

Responsibility

5.2 Management Representative

Action

5.2.1. Performs surveys and audits of suppliers and views records of past performance to choose methods of supplier approval and quality-level approval.

5.2.2. Forwards copies of survey results and audits to purchasing with the methods of supplier approval, the quality-level and memos, if appropriate.

5.2.3. Completes the supplier performance rating report and forwards a copy to purchasing with recommendations, if any, of suppliers to be disapproved and removed from the list.

5.2.4. Documents the Approved Suppliers List in Audit XLS. Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 11

Responsibility

5.3 Purchasing

Action

5.3.1. Initiates the approved supplier list.

5.3.2. Informs the Management Representative when approved list is revised.

5.3.3. Reviews and revises approved suppliers list when necessary to:

5.3.3.1. Add new suppliers5.3.3.2. Delete disapproved suppliers5.3.3.3. Make other corrections

Responsibility

5.4. The Management Representative and Administrative Function

Action

5.4.1. Evaluates suppliers yearly for active production controls.

5.4.2. Amends supplier lists accordingly.

6. RECORDS

6.1. Master copies of the approved suppliers list are maintained by purchasing. The quality department maintains master copies of supplier quality performance rating reports, surveys, and audits. Documents pertaining to the Approved Supplier List are maintained for the active life of the supplier.

7. FORMS

7.1 PFO1-16 SQAAL-Approved Supplier & Audit List

8. DEFINITIONS

8.1. Not applicable


9.1. ISO 9002, 4.6.



SUPPLIER SURVEY QP 104

1. PURPOSE

1.1. This procedure provides specific instructions for performing surveys and evaluations of proposed suppliers to ensure the consistency of quality procedures and controls employed by suppliers.

2. SCOPE

2.1. This procedure applies to all suppliers who provide materials, parts, subassemblies, assemblies or services.


3.1. Quality

3.2. Purchasing

4. GENERAL

4.1. Each supplier is evaluated before placement of any order. This evaluation is accomplished by supplier quality and inspection evaluations. The objectives of this evaluation are:

To establish uniform standards for evaluating the degree and effectiveness of quality practices and control.

To identify quality problems for evaluation and correction To evaluate various methods of controlling a specific area.

4.2. Suppliers are surveyed and evaluated for the following reasons:

To qualify a new supplier for future work. To evaluate a supplier for specific work before awarding a purchaser

order. To evaluate a supplier's capabilities for proposed supplies and services. To ensure that a supplier has adequate quality control systems. To re-qualify a supplier after one-year lapse in supplier contact. To re-qualify a supplier after poor quality performance.

4.3. The purchasing department asks the quality department to perform on-site surveys and evaluations of suppliers who perform calibration, assembly or test operations to company drawings or specifications and special processes. The quality department schedules the survey in coordination with purchasing and the supplier.

4.4. Quality, purchasing and any necessary technically qualified individuals perform the on-site evaluation of the supplier's facilities and determine the supplier's capabilities. They then issue a supplier quality and inspection system evaluation report.


4.5. When orders are considered for placement with an unapproved supplier, a supplier quality and the supplier completes inspection system evaluation report. The form is forwarded to the supplier by purchasing and reviewed and approved by the purchasing manager and quality manager before orders are placed with that supplier. Disapproved suppliers may request an on-site evaluation.

4.6. Noted deficiencies must be corrected by the supplier before the award of a purchase order.

4.7. Re-evaluation of previously qualified suppliers occurs when necessitated by a change in supplier performance, supplier facility relocation, a change in ownership or changes in specification or contractual requirements.

4.8. Quality and purchasing review the evaluation report and:

Approve or disapprove the supplier.

Publish and update the approved suppliers list, including the approved Supplier’s name, address, type of service and quality capabilities.

4.9. Each supplier shall be given periodic notice of quality and delivery performance based upon

the supplier’s past performance.

5. PROCEDURE

Responsibility

5.1. Purchasing

Action

5.1.1. Determines the need for a new supplier.

5.1.2. Forwards a questionnaire to the supplier.

5.1.3. Reviews completed questionnaire, approves or disapproves it and forwards it to quality.

Responsibility

5.2. Quality Department

Action

5.2.1. Enters the questionnaire results in the log, reviews the data and approves or disapproves it.


5.2.2. Issues an approved suppliers list addendum to list holders.

5.2.3. Forwards the questionnaire results to the purchasing manger for forwarding to the supplier

5.2.4. Files the questionnaire and any associated documentation by supplier (alphabetically) in quality records.

Responsibility

5.3. Purchasing

Action

5.3.1. Updates the approved suppliers list if required.

5.3.2. Notifies the supplier of the questionnaire results and any corrective action that is required before awarding a purchase order.

On-site Evaluations

Responsibility

5.4. Purchasing

Action

5.4.1. Determines the need for a new supplier or the re-evaluation of an old supplier.

5.4.2. Requests an on-site evaluation from quality control.

5.4.3. Coordinates with quality department for additional technical staff.

5.4.4. Coordinates the evaluation with the supplier and quality department.

Responsibility


Action

5.5.1. Enters the survey request in the log.

5.5.2. Schedules the evaluation visit and assigns personnel to perform the evaluation.

5.5.3. Issues periodic supplier ratings based upon records of supplier’s past performance.

.

Responsibility


5.6. Purchasing

Action

5.6.1. Accompanies quality personnel performing the survey.

Responsibility

5.7. Quality Department

Action

5.7.1. Performs the evaluation.

5.7.2. Completes the evaluation report and enters the results in the log.

5.7.3. Forwards a copy of the evaluation report with a cover letter listing the evaluation results as follows:

5.7.3.1. Approves or disapproves the supplier. 5.7.3.2. Issues conditional approval as applicable (i.e., notes that corrective

action is required before approval can be granted).

5.7.4. Reschedules the evaluation, if required.

5.7.5. Issues an addendum to holders of the approved supplier's list.

5.7.6. Files the completed evaluation and any associated documentation by supplier name (alphabetically) in quality records.

Responsibility

5.8. Purchasing

Action

5.8.1. Updates the approved supplier's list as required. 5.8.2. Forwards a copy of the evaluation results to the supplier along with notice of any

corrective action that must be taken before a purchase order can be awarded.

6. RECORDS

6.1. Supplier quality and inspection system evaluation reports and associated documentation are filed in the quality department.

6.2. Quality maintains a log of requests for supplier evaluations and evaluation reports.


7. FORMS

7.1. PFO1-13 SQCS - Supplier Quality Control Survey7.2. PFO1-16 SQAAL – Approved Supplier & Audit List 7.3. PFO1-18 SQAR – Supplier Action Plan Response7.4. PF01-17 SQES – Supplier on-site Evaluation 7.5. PFO1-21 SQR – Supplier Quality Rating

8. DEFINITIONS

8.1. Special Process

An operation that alters the properties of parts or material. The results of these alterations (e.g. plating, welding, soldering, and etching) cannot be readily determined by end item inspection.

8.2. Supplier Level Rating

Supplier level ratings are categorized as follows:

- E (excellent) - Capabilities exceed requirements in all phases of operation. - G (good) - Capabilities meet requirements. - F (fair) - Good rating on work capability; minor deviation from quality requirements, but capable of maintaining acceptable quality. - C (conditional) Minor deviations must be corrected before approval, or past performance requires re-evaluation before awarding future orders. - U (unacceptable) Major deviations make the supplier unacceptable.


9.1. ISO 9002, 4.6.


CONTROL OF CUSTOMER FURNISHED MATERIAL QP 105

1. PURPOSE

1.1. This procedure provides specific instructions for the control of customer furnished material or equipment.

2. SCOPE

2.1. This procedure applies to all customer furnished material and equipment used in the development, manufacture, inspection and test of company products.


3.1. Quality/Assurance


3.3. Shipping and Receiving

3.4 Production Manager

4. GENERAL

4.1. Customer furnished material and equipment is examined by the Receiving Clerk on receipt to detect damage in transit.

4.2. Customer furnished property is inspected by the Receiving Clerk for completeness, type and adequacy of documentation.

4.3. Functional testing is conducted by Quality Control before or after installation, or both, as required by contract or by quality to determine whether operation is satisfactory.

4.4. Precautions are taken by the Receiving Department to ensure adequate storage conditions and to guard against damage from handling and deterioration during storage. Periodic inspections are performed.

4.5. Production Control reports to the customer any properly found damaged, malfunction, or otherwise unsuitable for use, whether upon receipt or in subsequent use. In the event of damage or malfunction during or after receipt, the company determines and records the probable cause.

4.6. The Quality Control and Receiving Department provides such identification as property control or calibration labels, as appropriate.

4.7. The Receiving Department maintains records of all material receipts of customer supplied product.

4.8. The Quality Control Manager maintains customer record of calibration of customer gages and is responsible for the return of customer measuring devices when gages are no longer needed for production purposes.


5. PROCEDURE

Responsibility


Action

5.1.1. Coordinates communication with the customer regarding customer furnished property requirements.

5.1.2 Provides quality control and the end user with customer furnished property specifications and requirements.

5.1.3. Administers property records forms when they are required by contract (with support from the customer.)

5.1.4. Notifies customer when damaged property is received or when property is lost or otherwise discovered to be unsuitable for the purpose intended. Such notification is initiated immediately by telephone or fax and documented according to customer instructions or confirming memoranda.

Responsibility

5.2 Quality Control

Action

5.2.1. Reviews customer-furnished property specifications and requirements to determine any required action.

5.2.2. Coordinates with the department end-user and prepares, as required, receiving inspection instructions and test or calibration plans.

Responsibility

5.3. Receiving

Action

5.3.1. Receives customer property and records the date of receipt on documents accompanying the product.

5.3.2. Notifies Production Control of the receipt of customer property.

5.3.3. Attaches an identification tag showing Customer Name, Part Number and date received.

5.3.4. Prepares receiving records.


5.3.5. Forwards the property to receiving inspection when operational or dimensional verification is required.

Responsibility


Action

5.4.1. Notifies the customer that property has been received when required by prior agreement.

5.4.2. Observes the condition of the property as received and unpacked.

Responsibility

5.5. Shipping Manager

Action

5.5.1. Advises Production Control when customer product has been received.

5.5.2. Inspects the property for completeness, type, and damage during transit as well as completeness of documentation and any other requirements outlined in the shipping documents.

5.5.3. Fills out property tags and attaches them to customer property that is acceptable.

5.5.4. Forwards the property to the department that will be the custodian of the property (e.g., quality assurance, engineering or operations).

5.5.5. Notifies Quality Control when any property is found to be damaged or does not meet required specifications.

5.5.6. Isolates damaged or otherwise questionable product pending customer notification and/or final disposition

5.5.7. Delivers the Quality Control Rejection Report and any associated documentation to Production Control for disposition.

Responsibility


Action

5.6.1. Maintains records pertaining to customer supplied product.Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 21

5.6.2. Assigns a property identification, if appropriate, to the customer furnished equipment.

5.6.3. Interfaces with the customer or government property administration representative by telephone or in person.

Responsibility

5.7 Quality Control

Action

5.7.1. Documents and stores customer gages or other measuring equipment

5.7.2. Prepares Inspection Plan where customer product dimensional verification is appropriate.

Responsibility

5.8 Production Manager.

Action

5.8.1. Ensures that the customer or government equipment identification is preserved.

5.8.2. Ensures that the customer or government equipment is used only as specified in its contract.

5.8.3. Notifies Production Control if the customer or government property is found damaged, malfunctioning or otherwise unsuitable for use.

6. RECORDS

6.1. Such records as receiving, inspection, calibrations and maintenance are maintained in accordance with the customer contract or other customer recommendatrions.

7. FORMS

7.1. Property tag

8. DEFINITIONS

8.1. Customer-furnished property includes consumable material (e.g., raw stock, parts, subassemblies and assemblies) used in the manufacture of products. It also includes equipment used for the development, manufacture, inspection or test of products.

9. REFERENCE DOCUMENTSCreated by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 22

9.1. ISO 9002, 4.7.

PRODUCT IDENTIFICATION AND TRACEABILITY QP 106

1. PURPOSE

1.1. This procedure provides specific instructions pertaining to the identification and traceability of deliverable products.

2. SCOPE

2.1. This procedure applies to all records that establish trace ability of the various components of all deliverable products (e.g., raw material, parts, processes, components, subassemblies and assemblies).


3.1. Material Handler


3.3. Production Manager

4. GENERAL

4.1. Production Control is responsible for the generation of the necessary documents used to trace the various components manufactured items. Production Control is also responsible for preparing special instructions required to implement a specific contract.

4.2. All incoming raw material, purchased parts, and parts subjected to outside special processes are assigned lot control numbers by Production Control. The numbers are recorded on acceptance tags that are attached to and remain with the material through the various stages of storage and fabrication.

4.3. The Material Handler is responsible for the identification, receipt, and storage of raw materials or finished product used in manufacturing processes.

4.4. The Production Manager is responsible for the proper execution of all traceability documents during the active production phase.

5. PROCEDURE

General


Responsibility


Action

5.1.1. Reviews the contract quality requirements to determine special trace ability requirements.

5.1.2. Prepares additional procedures, if necessary.

5.1.3. Specifies trace ability requirements on the purchase orders pass-down, if required.

5.1.4. Issues raw material purchase order to material receiving.

5.1.5. Originates Job Boss computer generated Shop Paper showing part number, number of parts to be produced, routing of operations, materials required , and additional information pertaining to the manufacture of the product.

Responsibility

5.2. The Receiving Function

Action

5.2.1. Receives raw materials and checks materials against purchasing specifications.

5.2.2. Stores the material and attaches the identification tag to raw material bin.

5.2.3. Inspects material for size, cracks or other obvious defects.

5.2.4. Delivers material certifications to Production Control when received.

5.2.5. Stores raw material by Bin and Part numbers

5.2.6. Records date and number of bars or bar pounds received on the material purchase order.

5.2.7. Delivers material purchase order to Production Control after completion.

Responsibility


Action

5.3.1. Enters received raw materials in the material receipt log.

Responsibility


5.4. Material Handler

Action

5.4.1. Receives material requirement from Production Supervisor.

5.4.2. Releases material to the machine shop.

5.4.3. Records amount of material issued on the reverse side of the job shop paper located at the active production site.

Responsibility

5.5. Manufacturing

Action

5.5.1. Fabricates parts according to the drawing.

5.5.2. Completes Job Card showing number of parts required, part number, machine and operator.

5.5.3. Delivers shop paper showing materials issued to Production Supervisor.

5.5.4. Completes Routing tag to next operation

5.5.5. Signs off on shop paper as evidence of completion of required operation.

5.5.6. Perform assigned duties of Material Handler under the direct supervision of the Production Supervisor

Responsibility

5.6. Washing

Action

5.6.1. Receives parts from manufacturing 5.6.2. Washes parts in degreaser or Turbocharge washer as required by Wash instruction procedure guideline book or verbal instructions from Production Supervisor.

5.6.3. Completes routing tag to next operation.

5.6.4. Moves cleaned items to shipping for counting, packaging and /or further processing

Responsibility

5.7 Shipping and Receiving


Action

5.7.1. Receives finished items from final operation.

5.7.2. Checks items against requirements of shop paper and routing tag.

5.7.3. Counts and prepares items for shipment.

5.7.4. Draws sample of product and delivers to Quality Control Final Inspection.

5.7.5. Prepares shipping ticket and documents ticket number and number of parts shipped on the reverse of the shop paper.

6. RECORDS

6.1. Job cards with completed operations are filed in accordance withQP 116 Control of Quality Records.

7. FORMS

7.1. FO1-11 C8516 – Production Job Card7.2. FO4-03 BINTAG – Material Identification Bin Tag7.3. FO4-02 MATRL – Material Inventory Log7.4. FO2-02 MOVE – Production Move Ticket

8. DEFINITIONS

8.1. Not applicable


9.1. ISO 9002, 4.8.


PROCESS CONTROL QP 107

1. PURPOSE

1.1. This procedure provides specific instructions for the control of manufacturing process .

2. SCOPE

2.1. This procedure applies to all processes employed by manufacturing, such as turning, threading, drilling, milling, marking, fabricating, grinding, and polishing. This procedure applies to all products produced by NAME OF COMPANY..



3.2. Production Planning

3.3. Quality

4. GENERAL

4.1 The President and Production Control review Engineering drawings and specifications in order to determine new process requirements or required revisions to existing processes. For new orders the Production Planning Team conducts a documented review of the processes

and makes recommendations as necessary.

4.2. Production Control prepares or revises process procedures for each process in sufficient step-by-step detail to control and define the material, equipment and process. Attention to detail includes cleaning requirements before and after and the requirements for tolerances (minimum, maximum, and margin of error for dimensions, time and special requirements).

4.3. The process procedures are included in the operation sheets or computer generated shop paper or are published separately.


4.4. Quality, in conjunction with Production Control, identifies quality provisions associated with specific processes. The quality provisions are incorporated in the operation sheets, assembly instructions or process special work instructions.

4.5. Manufacturing, in conjunction with quality, identifies certain processes as candidates for process control charting, where applicable.

4.6. Quality audits manufacturing processes on a random basis to ensure material, equipment and process compliances.

4.7. Plating, honing and finish grinding, if specified by the drawing, are identical as special processes, requiring subcontractor participation.

4.8. The Administrative function maintains the records for approved subcontractors and the records of subcontractor audits are maintained by the Management Representative.

5. PROCEDURE

Responsibility


Action

5.1.1. Reviews engineering drawings and specifications and prepares copies for distribution to manufacturing operations, as applicable.

5.1.2. Initiates manufacturing process requirements and operation sheet.

5.1.3. Forwards process specifications and shop paper (operation and routing sheet) to all departments for incorporation of applicable quality and material routing provisions.

5.1.4. Identifies process control charting requirements or other special quality considerations when specified in customer purchase order.

Responsibility


Action

5.2.1. Views manufacturing process requirements, operation sheets and drawing specifications and incorporates applicable quality provisions.

5.2.2. Identifies and implements process control charts, Fmea Risk evaluation, and Control Plan construction where required.

5.2.3. Constructs Quality Assurance Inspection Plans for distribution to manufacturing.


5.2.4. Verifies certification requirements for all special process subcontractors.

Responsibility

5.3 Production Manager

Action

5.3.1. Assigns qualified personnel to carry out the production tasks required and monitor the process.

5.3.2. Issues tooling, gages, setup, sample part (where available) and work instructions to operator.

5.3.3. Approves processes and equipment to be used in the process.

5.3.4. Issues Job Card, Shop Routing Paper and Routing tags.

5.3.5. Assigns suitable equipment and working environment and confirms compliance with government safety, environment, and hazardous material requirements.

5.3.6. Returns completed process control documents to Production or Quality Control for processing.

6. RECORDS

6.1. Documents requiring completion by production personnel such as process route sheets, Job Cards, are delivered to Production Control by the Production Manager for record keeping and disposition.

6.2 Documents pertaining to quality control applications are forwarded to the Quality Control Department for storage and disposition.

7. FORMS

7.1. FO1-03 Fmea.7.2. FO1-04 Control Plan.7.3. FO1-05 Fmea Risk.7.4. Internal Shop Paper.7.5. PFO1-18 PPLRPT – Production Planning Report7.6. Material Inventory Report

8. DEFINITIONS

8.1. Qualified Personnel = An operator with proven knowledge and/or experience (as evidenced by past performance, training or previous record of employment) needed to perform the tasks required.


9.1. ISO 9002, 4.9.Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 29

9.2. AIAG (FMEA) 2nd Ed., 1995

9.3. AIAG (PPAP) 3rd Ed., 1999

9.4. AIAG (APQP) 2nd Ed, 1995

RECEIVING INSPECTION QP 108

1. PURPOSE

1.1. This procedure provides specific instructions for performing receiving inspection of purchased material or parts, including outside processes.

2. SCOPE

2.1. This procedure applies to all purchased materials, parts and processes that are used (or could be used) in the fabrication and ultimate delivery of a product.


3.1. Quality



3.2. Receiving

4. GENERAL

4.1. The Quality Control Manager determines the acceptance criteria for all products received and determines the inspection methods to be used. The quality function initiates or revises receiving inspection instruction as necessary listing all characteristics to be checked, the equipment to be used and the records to be completed.

4.2. Items are sampled inspected in accordance with the applicable quality inspection plan.

4.3. Purchased items are not released into stock until adequate inspection or test operations that verify product conformance have been performed.


4.4. When product is needed in an urgent production situation, the product or materials are positively identified and recorded to permit positive recall if necessary.

4.5. A material discrepancy report is initiated for all defective material.

4.6. Records of inspection or test are filed and are maintained according to the Control of Quality Records Procedure (QP 116).

5. PROCEDURE

Responsibility


Action

5.1.1. Forwards a copy of the blueprint and shop paper to quality.

5.1.2. Maintains record of materials received by Customer, Part Number, Job Number, Amount, and date received.

5.1.3. Notifies Quality Control Manager if unverified product is needed in an urgent production situation.

5.1.4. Notifies Production Manager if unverified product is needed in an urgent production situation.

5.1.5. Documents use of unverified product on the face of the shop paper pertaining to the manufacture or other use of the items unverified.

Responsibility

5.2. Quality Control Manager

Action

5.2.1. Prepares or revises the receiving inspection instructions, determining the characteristics to be checked, the equipment to be used and the sampling plan.

5.2.2. Provides technical assistance and direction to receiving personnel, as required.

5.2.3. Documents the use of unverified materials on the face of the Quality Control copy of the shop paper

Responsibility

5.3. Receiving Clerk

Action


5.3.1. Checks the receiving ticket against incoming material or parts to ensure the accuracy and completeness of the count and to find any apparent damage to parts.

5.3.2. Records incoming material or parts on the receiving report.

5.2.3. Delivers samples of the parts received to inspection using Mil. Spec. 105D (modified) as guide to sample size.

5.2.4. Isolates and holds any incoming product until inspection is concluded.

Responsibility

5.4. The Receiving Inspector

Action

5.4.1. Retrieves route ticket and parts from the applicable shelf.

5.4.2. Obtains the material or parts history folder and ensures that the drawings or specifications Quality Control Inspection Plan is available.

5.4.3. Ensures that certifications or test reports are included with the paperwork, if required.

5.4.4. Performs inspection or tests in accordance with the receiving inspection instructions, pulling the sample size indicated.

5.4.5. When material or parts are accepted:

5.4.5.1. - Completes the Final Inspection Log, affixing initials and date.5.4.5.2. - Completes the inspection report.5.4.5.3. - Moves material or parts to the applicable outgoing shelf with acceptance tag.5.4.5.4. - Returns the inspection data to the file.

5.4.6. When all material or parts are non-conforming:

5.4.6.1. - Completes a Rejection and Sorting Report and attaches a copy to the rejected Materials.

5.4.6.2. - Oversee the isolation of rejected materials in the Inspection Hold Area.5.4.6.3. - Initiates a copy of the DMR to be forwarded to the supplier.

5.4.7. When part of the material or parts are defective and the rest is accepted:

5.4.7.1. - Completes a Rejection and Sorting Report.5.4.7.2. - Completes a supplier history report, noting the amounts accepted and non-

conforming and initials the dates.5.4.7.3. - Moves the acceptable material or parts to the applicable outgoing shelf.

5.4.7.4. - Affixes white copy Rejection and Sorting Report or red rejection ticket to each container of a multiple-container lot of defective material.

5.4.7.5 Documents rejection of materials in Rejection Summary (REJSUM XLS) Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 32

report.

Responsibility


Action

5.5.1. Ensures that in-process product is held and not used or processed further until it has been inspected, tested, or otherwise verified as conforming to specified requirements.

5.5.2. Affixes “Do Not Mix” tag when information confirms that product has not been inspected or otherwise verified as conforming to specified requirements.

6. RECORDS

6.1. Inspection and test status on each lot of purchased material is recorded on the inspection report and supplier history record.

6.2. Inspection criteria for each part number are maintained on Quality Control Inspection Plan (QAIP)

6.3. Non-conforming material is entered on the material discrepancy report.

7. FORMS

7.1. FO5-10 QCFINAL – Final Inspection Log7.2. FO4-01 SHLOG - Vendor / Supplier Shipping Log7.3. FO5-16 REJ – In House Sorting and Rejection Report7.4. FO5-21 REJSUM- Rejection Summary

8. DEFINITIONS

8.1. Lot - The shipment received, partial or whole, which is presented for inspection.


9.1. ISO 9002, 4.10.


INSPECTION AND TEST STATUS QP 109

1. PURPOSE

1.1. This procedure is for the purpose of describing the company's system for indicating the inspection status of materials and parts produced at the NAME OF COMPANY.

2. SCOPE

2.1. This procedure applies to all deliverable materials whether in process or storage.


3.1. Quality

3.2. Production

4. GENERAL

4.1. All departments who either inspect or sign off on manufactured products or inspect in-process products will maintain associated records of the inspection activity and results of the inspection or other operation monitoring activity.

5. PROCEDURE

Responsibility


Action

5.1.1. The status of materials, and production parts are recorded on color-coded routing tags.

5.1.2. Production routing tags (white) are issued by the Production Manager and are completed by the operator after manufactured items have been cleared for further processing.

5.1.3. The Rejection (red) and the three (3) copy Sorting and Rejection Reports, are to be used for identifying and routing rejected parts for disposition.

5.1.4. The Accepted Tag (green) is to be used for identifying goods that have been inspected and found to be fit for the purpose intended..

5.1.5. Items inspected at their source are to be identified with accepted tag, or accompanying paperwork prior to release for further processing or shipment.

5.1.6. Rejection and Sorting Reports will be filled out in triplicate with the original white copy attached to the container, the golden copy retained in Quality Control and the pink copy forwarded to data entry.


5.1.7. Stamps, when required for product identification or routing purposes, are issued by the Quality Control Manager with a record of issuance documented on the appropriate log.

5.1.8. Inspection of in-process items must be conducted after each operation and the shop paper pertaining to the produced items must be signed or initialed by the person responsible for the inspection of the production.

5.1.9. Production not conforming to specification must be tagged and isolated in the Inspection Hold Area until disposition is final.

6. RECORDS

6.1. All inspection records are to be retained and maintained, QP 116 Control of Quality Records.

6.2. Previous Move tags may be removed from the active production container at the startup or completion of the current operation.

7. FORMS

7.1. FO2-02 - Production Move Ticket (White)

7.2 FO5-13 - Rejection Tag (Red)

7.3 FO5-16 - Sorting & Rejection Report (3) copy

7.4 FO5-14 - Special purpose Move Ticket (Green)

7.5 FO5-15 - Final Inspection Move Ticket (Brown)

7.6 FO5-07- STAMP

8. DEFINITIONS

8.1. Not applicable


9.1. ISO 9002, 4.12.


FINAL INSPECTION QP 110

1. PURPOSE

1.1. This procedure provides specific instructions for the final inspection of completed end items to verify conformance to specified requirements.

2. SCOPE

2.1. This procedure applies to the final inspection of all finished salable end items.


3.1. Quality

3.2. Shipping

4. GENERAL

4.1. Final inspection is conducted for all items being released for shipment to the customer or to a subcontractor for intermediate processing.

4.2. Quality, in coordination with manufacturing, determines the content and points of final inspection. The final inspection is conducted for all manufactured items being shipped for outside subcontracted services or to the customer as completed items. The inspection methods are determined by the assigned quality personnel and included as part of the inspection instructions.

4.3. Inspection personnel ensure that only currently calibrated tools, gauges and test equipment are used.

4.4. Inspection and shipping personnel ensure that all previous operations, inspections and tests have been completed as indicated on the route card or shop paper .

4.5. Items to be inspected are referenced by Job Number to engineering drawings, route cards and other documentation deemed necessary.

4.6. Final inspection is performed on a 100% basis to the inspection instructions or acceptance test procedures and recorded on final inspection log.

For accepted items an acceptance/ inspection tag is initiated and placed in the product container. The end items are acceptance stamped when this is directed by the instructions.

Rework of any rejected parts is determined by the Material Review Committee

unless defect is of obvious nature and can be sorted or otherwise corrected immediately.


5. PROCEDURE

Responsibility

5.1. Shipping

Action

5.1.1. Receives product from final manufacturing process.

5.1.2. Retrieves shop paper and drawing pertaining to items.

5.1.3. Pulls representative sample of lot based upon Mil 105D, Level II, S1.

5.1.4. Delivers samples and copy of shop paper to Quality Control for Final Inspection.

5.1.5. Prepares accepted items for shipment.

5.1.6. Contains rejected items for disposition by Quality Control.

Responsibility


Action

5.2.1. Determines inspection points, method and acceptance criteria.

5.2.2. Reviews job shop paper for completeness of operations.

Responsibility

5.3. Final Inspector

Action

5.3.1. Inspects items in accordance with the drawing, manufacturing instructions, job shop paper, and applicable inspection instructions.

5.3.2. Records the results of all inspections on the Quality Control Final Inspection Log, noting defects discovered (if any).

5.3.3. When items are accepted:

5.3.3.1. Applies acceptance move ticket to items, if applicable.5.3.3.2. Applies signature/date to route card or shipping log directly adjacent to the operation performed.5.3.3.3. Forwards items to the finished goods out shelf.5.3.3.4. Forwards the route card or shipping log to shipping.


5.3.4 . When items are defective:

5.3.4.1. Forwards items and rework tags to production if the items can be reworked or repaired.

5.3.4.2 Inspects reworked items to the original specification and documents results. Forwards acceptable items to the finished goods out shelf.

5.3.4.3. Forwards route cards (and rework tags) to Quality Control Manager.

6. RECORDS

6.1. Completed job cards data are filed by Production Control.

7. FORMS

7.1. FO5-10 QCFINAL

7.2 FO5-05 QAIP

7.3 FO5-11 GHFSTPCE

7.4 FO5-15 MOVE

7.5 FO5-16 Rejection And Sorting Report

8. DEFINITIONS

8.1. Reworkable – Non-conforming materials or items that can be reprocessed to conform completely to drawings, specifications or contract requirements.

8.2. Repair - The reprocessing of a defective item so that it is unusable but still does not completely conform to the applicable drawing, specifications or contract requirements.

8.3. Non reworkable - Items or materials that either do not meet the definition of reworkable as stated in paragraph 4.6.B or require rework of such significance that written and planned rework instructions are required.


9.1. ISO 9002, 4.10.


QUALITY ASSURANCE QP 111

1. PURPOSE

1.1. This procedure provides specific duties and responsibilities of Quality Assurance personnel for the control of inspection operations, quality and/or tractability of manufactured items .

2. SCOPE

2.1. This procedure applies to fabrication, test, and inspection operations used to verify the quality of parts being fabricated, tested or inspected.



3.2. Operations

4. GENERAL

4.1. The Quality Control Manager or his or her designee controls the assignment of duties to all subordinate inspectors.

4.3. The quality control of all goods received or manufactured is the responsibility of the Quality Control Manager who may at his discretion delegate responsibilities to supporting inspectors either orally or by written job instructions with the consent of the President of NAME OF COMPANY, Inc..

4.4. The Layout Inspector is responsible for the dimensional verification of all first piece samples submitted for review by manufacturing or outside source suppliers.

4.5. The Line or Floor Inspector will make periodic inspection of all parts being produced and communicate with production personnel for the purpose of maintaining acceptable quality during active production.

5. PROCEDURE

Responsibility

5.1. The Quality Assurance Director (or Designee)

Action

5.1.1. Assigns duties and responsibilities to subordinate inspectors.

5.1.2. Receives Shop papers, print and other necessary materials from Production Control.

5.1.3. Maintains quality control files.

5.1.4. Prepares First Article Inspection Report documents and Quality Inspection Plans.Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 39

5.1.5. Prepares PPAP, FMEA, Control Plan and FMEA Risk evaluations for completion and distribution when required.

5.1.6. Conducts process and capability studies as required by customer or Screw Machine Engineering co., Inc.

5.1.7. Prepares Statistical Process Control charts for distribution.

5.1.8. Evaluates customer rejections and correspondence pertaining to corrective action requests.

5.1.9. Calibrates (or causes to be calibrated or certified as necessary) gauges used in the manufacture of production parts..

5.1.10. Maintains all records relating to inspection processes.

Responsibility

5.2. Layout Inspection

Action

5.2.1. Assists the Quality Control Manager in the discharge of quality functions.

5.2.2. Inspects first piece samples presented by manufacturing and records results on data reports.

5.2.3. Maintains first piece submission log.

5.2.4. Performs final inspection of completed items in conjunction with the Quality Control Manager.

5.2.5. Records and files First Piece and Setup reports.

5.2.6. Assists production operators in dimensional verification when necessary.

Responsibility

5.3. Line Inspection

Action

5.3.1. Inspects production items during active machining in Screw Machine and Secondary Departments.

5.3.2. Notifies appropriate personnel if non-conformances are discovered during inspection procedures.

5.3.3. Maintains a Floor Inspection Log showing Machine Inspected, Date, Part Number, Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 40

Accept or Reject and the cause of any rejection issued.

5.3.5. Oversees parts being transported to the Inspection Hold Area during the active production phase of the manufacturing process.

5.3.6. Assists Quality Control Manager in the maintenance, assignment, calibration, and inventory of inspection materials.

5.3.7. Assists in the overseeing and monitoring of SPC charts or other quality control forms issued to manufacturing personnel.

5.3.8. Accepts or rejects manufactured items and oversees sorting activity in conjunction with the Production Manager.

6. RECORDS

6.1. Records are maintained by the Quality Assurance Department.

7. FORMS

7.1. FO5-01 FAQR – First Piece Article Report7.2. FO5-02 FSTPCE1- First Piece and Final Report7.3. FO5-03 QAIP1 - Quality Assurance Inspection Plan7.4. FO5-04 1ST PCE - Computerized First Piece Inspection 7.5. FO5-06 PROSPO - Computerized Process Potential Study 7.6. FO5-06A CHART - Computerized X bar & R chart7.7. FO5-06B PRECONTRL - Computerized Pre-Control chart7.8. FO5-08 GAGEISS - Gage Issue and Calibration Record7.9. FO5-09 DATARPT - Measurement Data report7.10. FO5-09A RANGECHT - X and Range chart7.11. FO5-10 QCFINAL - Final Inspection Log7.12. FO5-12 FLINSP - Floor Inspection Audit Report7.13. FO5-16 REJ - In - House Sorting and Rejection Report

8. DEFINITIONS

8.1. Not applicable


9.1. ISO 9002, 4.10.


CONTROL OF MEASURING AND TEST EQUIPMENT QP 112

1. PURPOSE

1.1. This procedure provides specific instructions for the verification, calibration and maintenance of measuring and testing equipment to ensure proper functioning and continued accuracy, thus ensuring that parts, products and measurements adhere to prescribed design requirements.

2. SCOPE

2.1. This procedure applies to all measuring equipment used by company personnel for verification of part and product acceptability.


3.1. Quality

3.2 Calibration Technician


4. GENERAL

4.1. All adjustable inspection gauges and tools and adjustable production hand tools are annually calibrated in a manner that complies with MIL-STD-45662A (or other N.I.S.T Standard according to the type of measuring equipment being calibrated). The system provides for the prevention of inaccuracy by ready detection of deficiencies and timely corrective action.

4.2. Plain Plug and other nonadjustable gages are checked for accuracy and condition at the time of issue and periodically checked by the operator during the active production phase using

standards issued by Quality Control.

4.3. Adjustable Functional Gages are set by Quality Control at the time of issue and settings are maintained with master blocks or setting masters placed at the gage location during production.

4.4. A commercial standards laboratory is used for all necessary calibration and repair of comparators, gage blocks, or other measuring instruments requiring calibration to standards not measurable in-house. The facility must comply with MIL-STD-45662A(or other N.I.S.T

Standard). Calibration certificates are required whenever outside calibration services are utilized.

4.5. Gages are calibrated in a humidity controlled 68 º temperature whenever possible. Any gage that fails to meet calibration standards during the calibration process is either adjusted or removed from service and any current production manufactured using the failed gage reviewed for conformance to specification.

4.6. Records and documentation of calibration activity are maintained in the computer Gagecal XLS. File.


4.7. Each employees is issued a condensed record of calibration pertaining to the calibration status of personally owned equipment

4.8. The employee is responsible for the maintenance of all gages and measuring devices being used during the production cycle and any gage suspected of requiring calibration due to regular calibration schedule, accidental circumstances, or normal wear must be brought to the attention of the Quality Control Manager.

5. PROCEDURE

Responsibility

5.1. Quality Control Function

Action

5.1.1. Establishes an overall gauge log and assigns serial numbers to each adjustable gauge subject to calibration

5.1.2. Directs or initiates a purchase requisition for outside calibration and maintenance.

5.1.3. Sets all adjustable gauges used in the production process.

5.1.4. Finds out-of-tolerance conditions and notifies calibration designee

5.1.5. Conducts gage repeatability and reproducibility studies when required using computer program GageCpk XLS.

5.1.6. Checks plain plug, thread plug, thread ring, and all references gages before each issue.

5.1.7. Maintains records of production gages issued to and returned by manufacturing personnel.

5.1.8. Determines validity of prior inspections if out of tolerance conditions are found

Responsibility

5.2. Calibration Technician

Action

5.2.1. Consults Gagecal XLS. Computer files on a weekly basis to determine the calibration status of measuring equipment.

5.2.2. Notifies personnel when calibration activity is to begin.

5.2.3. Calibrates equipment per QCP 100.Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 43

5.2.4. Notifies Quality Control Manager when significantly out of calibration conditions are discovered.

5.2.5. Enters calibration results in the Gagecal XLS record.

Responsibility


Action

5.3.1. Ensures that production-measuring equipment is properly maintained after issue.

5.3.2. Ensures that equipment used by new employees is presented for calibration.

5.3.3. Responsible for identification, isolation, and transportation of parts produced where measuring equipment is found to be significantly out of calibration.

6. RECORDS

6.1. Gauge or tool calibration records are maintained for a period of 3 years

7. FORMS

7.1. FO5-18 GAGECAL7.2. FO5-17 GAGECPK7.3. FO5-17A GAGECPK

8. DEFINITIONS

8.1. Significantly out of tolerance - An error in the calibration measurement process exceeding 20% of the allowed parameter tolerance. For example:

A. Caliper tolerance .00120% x .001 - .00020Total .00120 (significant)


9.1. ISO 9002, 4.11.


NONCONFORMING MATERIAL QP 113

1. PURPOSE

1.1. This procedure provides specific instructions for identifying, reporting, segregating, controlling and processing defective materials found during production, inspection or test in order to prevent unauthorized use.

2. SCOPE

2.1. This procedure applies to all material, parts, and end items that do not conform to drawings, specifications, procedures, standards or contract requirements.


3.1. Production Operators



3.4. Management Review

3.5. Department Managers

4. GENERAL 4.1. Defective material is identified and segregated from the normal material

flow and placed in the Inspection Hold Area.

4.2. A rejection ticket is issued and processed for material inspected and found to be non-conforming except in cases where rework can be completed during the current production cycle or where a small quantity is found during the inspection or manufacturing process that is obviously scrap by visual examination and can be sorted without delay.

4.3. When initiating the rejection tag, the following requirements are adhered to:

Only one part number is used on each rejection and sorting report.

Nonconforming product must be immediately separated from other product in

process.

4.4. Defective material reported on a material discrepancy report is analyzed, reviewed and disposition is made by the material review board representatives (President, Quality Control Manager, Management Representative and Department Manager).


4.5. Defective material that can be reworked or repaired without an adverse effect on safety, performance, interchange ability or reliability is isolated until appropriate rework is complete. Material that has been satisfactorily reworked or repaired is returned to the normal flow of material only after having been reviewed by quality control.

4.6. Purchased items used in the production process found to be defective are rejected by Quality Control and moved to the Inspection Hold Area. Such items are immediately returned to the supplier unless, due to an emergency situation, the President, Quality Control Manager and the Department Manager agree to use the materials and that the use of the materials would not compromise the quality of the final product.

4.7. Defective material determined to be scrap is identified and segregated from all other material pending final disposition.

4.8. No defective materials are knowingly shipped to any customer except under grant of customer deviation request or wavier of specified requirements.

4.9. Corrective action is initialed, as required, by quality to prevent recurrence of nonconformities reported on the material discrepancy report.

4.10. Records relating to the documentation of nonconforming materials are maintained for a minimum period of 2 years.

4.11. In cases where defective material is discovered during processing procedures and records indicate that there is a likelihood that defective products have been shipped to the customer, the customer will be immediately notified by telephone or fax and will be given sufficient information for the positive identification and subsequent isolation of the suspect shipment.

5. PROCEDURE

Responsibility

5.1. Quality Control Function

Action

5.1.1. The Quality Control Manager is responsible for the routing, safekeeping and final disposition of all nonconforming materials.

5.1.2. The Management Representative is responsible for the construction of all documentation required for the disposition of all nonconforming materials.

5.1.3 The Management Representative shall notify the customer of nonconforming materials inadvertently shipped and shall be responsible for documentation required by the

customer confirming such notification.

Responsibility

5.2. Production PersonnelCreated by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 46

Action

5.2.1. Personnel engaged in the active production of any product shall follow the following procedures if the production contains or is suspected of containing nonconforming items:

5.2.1.1. Cease production of the suspected parts until cause of nonconformance can be determined.

5.2.1.2. Contain all parts suspected of not conforming to specifications or other requirements.

5.2.1.3. Identify the product with Routing Tag showing Date, Part Number, Machine Number, and Operator.

5.2.1.4. Notify the Department Manager immediately.5.2.1.5. Notify the Quality Control Manager.5.2.1.6. Escort the items to Shipping & Receiving for wash and or count.

(Do not remove any Hold or Reject Ticket from the container).5.2.1.7. Move all rejected parts to the Inspection Hold Area.

5.2.2. Sorting and rework of nonconforming product is governed by the following guidelines:

5.2.2.1 Parts may not be detailed in the immediate vicinity of the work station or machine that produced the nonconforming materials except by permission of the Quality Control Manager.

5.2.2.2. Gages to be used for sorting or re-work activity must be approved by Quality Control.

5.2.2.3. Rejection tags, reports or other documentary evidence of nonconformance must remain with the parts throughout all sorting and/or rework activity.

5.2.2.4. Sorted or reworked product must conform to specification and product may not show evidence of rework (visually or dimensionally) unless the customer has granted concession, deviation, or waiver.

5.2.2.5. Sorted and/or reworked parts must be returned to Quality Control for inspection and disposition. No sorted or reworked parts shall be mixed with or included as a part and partial of past or current production items without the permission of the Quality Control Manager.

Responsibility


Action

5.3.1. The Quality Control Manager, or designate, shall take the following actions for the documenting, containment, and final disposition of nonconforming products manufactured at the NAME OF COMPANY:

5.3.1.1. Identify nonconforming product with rejection tag or Sorting and Rejection Report.


5.3.1.2. Verify that all suspected defective items are properly transported to the Inspection Hold Area for further processing or review.

5.3.1.3 Deliver the pink copy of the Rejection and Sorting Report to the Management Representative or other data entry source for recording in the Reject Summary (REJSUM XLS.) record.

5.3.1.4. Deliver the yellow copy of the Rejection and Sorting Report to Production Control for review.

5.3.1.5. Close out the white copy of the Rejection Report after sorting and / or re-work is concluded.

5.3.1.6. Issue any special gages or measuring equipment required for sorting or re-work activities.

5.3.1.7. Re-inspect re-worked or sorted product for conformance to specifications.

Responsibility


Actions

5.4.1. The Management Representative is responsible for the following activities for the documentation, containment and release of nonconforming product:.

5.4.1.1. The providing of forms or other documents required for the control of nonconforming product.

5.4.1.2. Customer communication pertaining to Requests for Deviation, Engineering Change Requests, Supplier and Customer Corrective Action Requests, and clarification of drawing specification where appropriate.

5.4.1.3. The maintenance and distribution of in-house and customer records relating to nonconforming materials.

5.4.1.4. The scheduling of Material Review Board activities and agenda.5.4.1.5. The issuance of supplier and in-house Corrective Action Requests.

Responsibility

5.5 Material Review Board

Actions

5.5.1. The Management Representative shall prepare the agenda, notify the respective members, and document the meeting of the MRB.

5.5.2. The Material Review Board shall be composed of the President, Management Representative, Quality Control Manager, and the Manager of the Department in which the nonconforming materials were produced.

5.5.3. The Material Review Board shall meet as often as necessary to ensure that nonconforming material is properly evaluated.


5.5.4. The Material Review Board shall investigate the nonconformity, address the disposition, and determine corrective or preventative action measures required to improve the process where appropriate.

5.5.5 The Material Review Board shall not release product that does not conform to customer requirements except by customer grant of deviation or waiver.

6. RECORDS

6.1. Completed material discrepancy reports (masters) are forwarded to the quality department to be audited and filed.

6.2. The report log is maintained by the Management Representative.

7. FORMS

7.1. FO1-06 Internal Corrective Action Report

7.2. PFO1-07 Supplier Corrective Action Request.

7.3. FO1-10 Nonconforming Material Report

7.4. PFO1-08 Deviation Request

7.5. PFO1-15 Corrective Action Req. Log

8. DEFINITIONS

8.1. Use as is - The determination for defective material that considers the material to be satisfactory for use as it is without adverse effects to safety, performance, interchange ability or reliability.

8.2. Rework - The process required to make a defective item conform in its entirety to the original drawing or specification requirements.

8.3. Repair - The process required to make an item fit for the functional purpose intended.

8.4. Return to vendor - The return of unacceptable items to the supplier from which they were purchased. (Normally, the supplier will have caused the unacceptable condition).

8.5. Scrap - Material that cannot economically be made acceptable and is unfit for use.


9.1. ISO 9002 4.13.


CORRECTIVE ACTION AND PREVENTIVE ACTION QP 114

1. PURPOSE

1.1. This procedure provides specific instructions for identifying and determining the cause of discrepancies or procedure violations and the methods used to obtain the required corrective actions.

2. SCOPE

2.1. This procedure applies to corrective and preventive action activities relating to the resolution of complaints arising from internal or external sources.






4. GENERAL

4.1. The quality department regularly reviews and analyzes inspection and test records from incoming as well as in-process inspections for adverse quality trends. Corrective action requests are initiated when needed.

4.2. The quality function reviews complaints and in response to material discrepancy reports, customer return reports, or deficiency reports, issues corrective action requests when appropriate.

4.3. Quality reviews each report and documents corrective action requests of internal or external origin.

4.4. Corrective Action Requests are generated for the following reasons:

Critical dimensions or performance characteristics are out of tolerance.

Repetitive discrepancies occur in fabrication, assembly, inspection or test.

Non conformance to system procedures, system and instructions occur.

Defective material is received from suppliers.

A Corrective Action Request is received from the customer.


Corrective Action is required by virtue of an audit process.

4.5. Quality Control initiates the Internal Corrective Action Request and follows up all correctiveand preventive action activity.

4.6. The Management Representative is responsible for ensuring that the Corrective and Preventive Action Programs are managed effectively. The Management Representative maintains a system of records that document the requirements of this element.

5. PROCEDURE

Responsibility

5.1. Administrative Personnel

Action

5.1.1. It is the responsibility of the Management Representative to resolve inquiries related to Corrective and Preventive Action Requests received as a result of internal, external

(Customer), or third party audits. Upon receipt of a written Request for Corrective or Preventive Action, Administrative Personnel shall:

5.1.1.1. Stamp the document with the date received.5.1.1.2. Deliver the original copy of the Request to the Management Representative.5.1.1.3. Deliver the original copy of any letter or other attachment received with the

request to the Management Representative.5.1.1.4 In the absence of the Management Representative, the Quality Control Manager

shall receive all documents necessary for the resolution of all issues relating to internal or external corrective action matters.

5.1.1.5 The Management Representative or Quality Control Manager shall approve and close out corrective or preventive action proposals submitted by suppliers and shall follow-up such actions or proposals to ensure implementation.

Responsibility


Action

5.2.1. Upon receipt of an external Corrective or Preventive Action Request, the Management Representative shall:

5.2.1.1. Make one copy of documents pertaining to the Request and deliver to the Quality Control Manager.

5.2.1.2. Obtain a copy of any drawing, specification, shop paper or other documents needed to investigate the Request.

5.2.1.3. Notify Production and Shipping Managers of the Request (if appropriate).5.2.1.4. Investigate the extent of the problem.


5.2.1.5. Determine the root cause(s) of the problem.5.2.1.6. Decide on corrective action.5.2.1.7. Oversee the implementation of the corrective action.5.2.1.8. Initiate permanent changes in any related procedure/instructions (if appropriate).5.2.1.9. Respond to the Request within the time period required and sign off on the

request.5.2.1.10. Deliver a copy of the completed Request to the Quality Control Manager.5.2.1.11. File one copy of completed Request in Customer Corrective Action Folder.5.2.1.12. Periodically review Request for effectiveness of Actions undertaken.

Responsibility

5.3. The Quality Manager

Action

5.3.1. Upon receipt of an external Corrective or Preventive Action Request, the Quality Control Manager shall:

5.3.1.1. File one copy of the Request in the proper parts file or other folder pertaining to the Request.

5.3.1.2. Halt the shipment or active production of any product that might contain similar defects or nonconformities.

5.3.1.3. Oversee the movement of the same or similar product to the Inspection Hold Area

5.3.1.4. Examine identical or similar product for the defect identified in the Request.5.3.1.5 Examine prior Corrective or Preventive Action Requests pertaining to

identical or similar product.5.3.1.6. Determine the root cause(s) of the problem.5.3.1.7. Follow up on the progress of Corrective Action activity to ensure that the

Action is completed by the promised date and the problem has been eliminated.

Responsibility


Action

5.4.1. Internal Corrective Action Requests (when necessary) are initiated by the Management Representative for investigative documentation of the causes of an internal or external quality problem. When the issuance an Internal Corrective Action Request is appropriate, the Management Representative shall take the following actions:

5.4.1.1. Complete the Internal Corrective Action Request Form.5.4.1.2. Investigate the problem by interview of the personnel associated with the

problem.5.4.1.3. Determine the root cause of the problem.


5.4.1.4. Decide on corrective action and the personnel responsible for completion of the action.

5.4.1.5. Verify that the production personnel responsible for the nonconforming product, the manager of the department producing the defective product, and the Quality Control Manager signoff on the report.

5.4.1.6. File the Request and maintain for a period of 3 years.

Responsibility

5.5 Administrative Staff

Actions

5.5.1. The responsibility for the undertaking of preventive action lies with the Administrative Staff consisting of the company President, Quality Control Manager, Management Representative, and the Production Manager. The Administrative Staff is responsible for the related quality system elements and procedures. For preventive action requests,

it is the responsibility of each member of the staff to:

5.5.1.1. Investigate the nature of the weakness.5.5.1.2. Determine the root cause(s) of the weakness.5.5.1.3. Decide on preventive action.5.5.1.4. Implement the preventive action.5.5.1.5. Recommend permanent changes in any related procedure/instruction (if

appropriate.

5.5.2. The Management Representative is responsible for ensuring that the Preventive Action Program is managed effectively and a system of records for managing the preventive action documents exists, monitoring the status of preventive action activities, and storing closed out Preventive Action Requests for a period of 3 years minimum.

6. RECORDS

6.1. Copies of Corrective Action Requests are maintained by Quality Control for a period of 3 years minimum.

7. FORMS

7.1. PFO1-10 Supplier corrective action request

7.2. PFO1-09 Corrective action request

7.3. Customer corrective action request

7.4. FO1-06 Internal Corrective Action Request

7.5. PFO1-07 Corrective Action RequestCreated by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 53

8. DEFINITIONS

8.1. Not applicable.


9.1. ISO 9002, 4.14.

Handling, Storage, Packaging, Preservation, and Delivery QP 115

1. PURPOSE

1.1. This procedure provides specific instructions for the performing of handling, storage, packaging, preservation, and delivery requirements for product manufactured by the NAME OF COMPANY.

2. SCOPE

2.1. This procedures applies to all manufactured items processed by the shipping and packaging department.




3.3. Shipping Clerk


3.5. Parts Washer

4. GENERAL

4.1. Handling, transportation and storage methods and procedures are determined by the Shipping Manager

4.2. Methods and procedures to prevent handling damage are implemented during all phases of fabrication, processing, inspection, and transportation. The use of clean bags, racks, containers, trays and tote boxes is required, and special attention is given to delicate items, such as plated items, pre-finished materials, and precision machined parts. Special attention is also given to the need for desiccants, covers, wrapping, cushioning, dividers or supplementary containers (e.g., tubs and vials). Specific customer requirements are implemented as applicable.

4.3. Methods and procedures are implemented to define specific storage requirements and ensure the necessary protection of materials in storage from damage, dust, moisture and deterioration. Identification of material; preservation of the finished product; obsolete


material; first-in, first-out methods and procedures, and storage of flammable material will be given special attention. Material may be stored in the same containers used for handling.

4.4. Items will not accepted into the stockrooms or finished goods stores without evidence of inspection acceptance (i.e., an acceptance tag). Items not processed through inspection for acceptance will be returned to inspection.

4.5. An internal auditor will perform periodic audits of the handling and storage methods to ensure compliance to specific procedures and customer requirements. Finished products may be re inspected or tested on a random basis to verify identification and detect any damage or changes. The results are documented on an audit report.

4.6. The Production Control function is responsible for the implementation of the process for developing, evaluating, and tracking adherence to lead time requirements in order to optimize delivery performance.

5. PROCEDURE

Responsibility


Action

5.1.1. Issues shop paper, including special instructions regarding shipping due date requirements and special packaging or packaging instructions.

5.1.2. Stamps the back of the shop paper with format for shipping and packaging entry showing date shipped, shipping ticket number and number of items shipped.

5.1.3. Issues standard packaging slip for items to be shipped.

5.1.4. Issues bar coded shipping label (when appropriate) showing:

5.1.4.1. Customer5.1.4.2. Purchase Order No.5.1.4.3. Part No.5.1.4.4. Quantity Shipped5.1.4.5. Release No.5.1.4.6. Description of Product5.1.4.7. No. of Packages Shipped5.1.4.8. Total Weight of Each Parcel

Responsibility

5.2. Parts Washer

Action


5.2.1. Receives finished product from manufacturing.

5.2.2. Washes parts in degreaser or Turbocharge washer as required.

5.2.3. Applies Rust inhibitor to parts as required.

5.2.3. Transports product to Shipping for processing.

Responsibility


Action

5.3.1. Count the items to be shipped.

5.3.2. Draw required number of samples of product and delivery to Final Inspection (see MIL 105D, S1 sampling plan).

5.3.3. Store materials accepted by Final Inspection in metal or plastic containers if product is destined for outside operations.

5.3.4. Identify contents of each container with:

5.3.4.1. Job Number.5.3.4.2. Number of parts in the container.5.3.4.3 Customer Name

5.3.5 Review Finished Order File for due date of finished product.

5.3.6 Pack items accepted by Final Inspection in cardboard boxes( 72 lbs. Maximum weight per box) if product is destined for delivery to the customer.

5.3.6.1. Parts being shipped to customers are packed in cardboard boxes with dividers and/or additional reinforcement support as required in order to prevent damage while in transit.

5.3.7. Document shipping record on the back of the shop paper showing:

5.3.7.1. Number of items shipped.5.3.7.2. Date shipped.5.3.7.3. Shipping Ticket Number

5.3.8. Deliver shop paper to Production Control when customer order is complete.

5.3.9. Store stock material in clean, dry area


Responsibility

5.4. Quality

Action

5.4.1. Inspects the shipment in accordance with appropriate instructions and returns items to shipping and packaging or rejects the items and places the shipment on hold.

6. RECORDS

6.1. Not applicable

7. FORMS

7.1. PFO1-10 Nonconformance Material Report7.2. FO5-14 Move Ticket7.3. FO4-01 SHLOG7.4. FO5-10 QCFINAL

8. DEFINITIONS

8.1. Not applicable


9.1. ISO 9002, 4.15.


CONTROL OF QUALITY RECORDS QP 116

1. PURPOSE

1.1. This procedure provides specific instructions for the control and retention of quality records.

2. SCOPE

2.1. This procedure applies to quality records generated during receiving inspection, fabrication, assembly, testing and inspection and to other records required to implement the quality program .


3.1. Quality Manager3.2. Administrative Assistant

4. GENERAL

4.1. Quality identifies requirements for the control and maintenance of quality records generated during receiving inspection, fabrication, assembly, and test and inspection operations.

4.2. Active records are filed and maintained in a manner that provides for safe storage and ready access.

4.3. Records containing company confidential or classified information are identified; they are maintained in secured files accessible only to those persons with a need to know as defined by company policy or procedure.

4.4. Quality records are reviewed yearly. Records that no longer need to be retained are destroyed or discarded.

4.5. The Administrative Assistant identifies requirements for the control and maintenance of office records relating to quotations, purchase orders from customers and to suppliers, lost or damaged customer supplied product, personnel records, and other documents relating to financial matters.

5. PROCEDURE

Responsibility

5.1. The Quality Control Manager

Action

5.1.1. Reviews records and data for completeness, accuracy and legibility.


5.1.2. Retains all quality records pending destruction.

Responsibility

5.2. Administration

Action

5.2.1. Files and stores records relating to, contracts, quotations, purchase orders, production Histories, financial transactions, and other miscellaneous records pertaining to general business procedures.

5.2.2. Reviews filed records yearly and discard any that have passed their retention date.

6. RECORDS

6.1. Quality Records are stored and maintained by the Quality Control Manager and will be made . available for review upon authorized customer request

6.2. The retention period for records shall be as required by customer contract and/or purchase order or by company requirement.

6.3. Where no customer requirement exists the retention period of inspection records are:

6.3.1. Heat treat, grinding, and material certifications- 1 year minimum6.3.2. Metallurgical inspection reports-1 year minimum6.3.3. In process, receiving, final, first piece reports-1 year minimum6.3.4. Process capability, FMEA, Control plan, SPC reports-1 year minimum6.3.5. Internal Audit Reports-3 year minimum 6.3.6. Supplier Audit Reports-During active period of supplier plus 2 years6.3.7. Gage Calibration Records-3 years6.3.8. Customer generated reports and/or documents-3 years minimum6.3.9. Deviation , Correction Action, Preventative Action Requests are maintained for the life of the part plus 2 years6.3.10. Records pertaining to Management Review Activity – 3 years minimum6.3.11. Training Records – Active status of employee plus 1 year

6.4 Where no customer requirement exists, the retention periods of administrative records are:

6.4.1. Quotations and allied documentation - 3 years minimum 6.4.2. Purchase Orders from customers – 3 years minimum 6.4.3. Purchase Orders to Suppliers – 3 years minimum

6.4.4. General Business Records – 7 years

7. FORMS

Not applicable

8. DEFINITIONS



9.1. ISO 9002, paragraph 4.5. INTERNAL QUALITY AUDITS QP 117

1. PURPOSE

1.1. This procedure provides specific instructions for auditing quality procedures, company processes or products, the supplier base and associated documentation.

2. SCOPE

2.1. This procedure applies to engineering operations, quality assurance and supplier functions that relate to the quality of company products.





4. GENERAL

4.1. The Management Representative plans, prepares and maintains records and schedules pertaining to audit requirements. In general, audits are scheduled or planned because of:

A change in quality assurance provisions of contracts.

Deteriorating quality or reliability of the product.

Failure on the part of any department to take corrective action.

A request from an internal department.

A request from customer quality representatives.

A change in company quality procedures.

An annual complete audit of company procedures.

4.2. The audit is performed by company trained or certified auditors. If possible, the audit is performed by an individual who has no direct responsibility in the area selected for audit; if necessary, a technically qualified individual evaluates any production activity being audited.

4.3. The auditors randomly perform a detailed, step-by-step evaluation of the process, specification, procedure or product that has been selected for audit.


4.4. During an audit, the auditors evaluate conformity with (and effectiveness of) company procedures and their continued conformance to ISO 9000 requirements.

4.5. A quality audit report is generated for each audit performed, documenting the requirements and results.

4.6. Nonconformity found by the auditors is reported in writing to the responsible area supervisor on a corrective action report.

4.7. Quality enters the audit report in the quality audit report log and maintains a complete history of all audits, including the status of those requiring corrective action.

4.8. Audits of supplier products or processes are conducted as necessary. Results of these audits are documented on the supplier audit report. Supplier corrective action requests are initiated if nonconformity is found.

5. PROCEDURE

Responsibility


Action

5.1.1. Determines the documents, processes or products to be audited and prepares the schedule.

5.1.2. Assigns a quality representative to perform or direct the audit.

5.1.3. Assists purchasing in the initiation of supplier audits and/or reviews.

5.1.4. Obtains and reviews all associated documentation applicable to the product, operation and area to be audited. Fills in the requirements section of the quality audit report or supplier quality report before the actual audit

5.1.5. Selects an auditor, if necessary, who does not have direct responsibility in the selected audit area. Chooses any other technical personnel deemed necessary to make adequate evaluations.

5.1.6. Advises the applicable department supervisor, in advance, to coordinate time and support personnel, if appropriate.

5.1.7. Reviews all results and determines whether corrective action is needed.

5.1.8. Initiates a corrective action request if significant nonconformity is found at a supplier.

5.1.9. Initiates a supplier corrective action request if significant nonconformity is found at a supplier.

5.1.10. Enters the audit results in the quality audit report log.

5.1.11. Reviews the audit results with applicable area supervisors.Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 61

Responsibility

5.2 Auditor

5.2.1. Audits the selected process, specification, procedure or product. Examines each one step by step, including equipment, personnel and all related documentation. Carefully observes materials, results, tools, facilities and documents used by the operators, technicians or inspectors involved.

5.2.2. Verifies on-station availability, use and revision level of required documents.

5.2.3. Verifies use of qualified personnel and equipment, as required.

5.2.4. Examines a product for conformity to specified requirements (e.g., engineering documentation, test procedures, assembly instructions, route cards, inspection instructions and work quality standards).

5.2.5. Records the results of the audit on the quality audit report or the supplier quality report.

Responsibility


Action

5.3.1. Approves the audit report and applicable corrective actions by signing the quality audit report.

5.3.2. Sends the supplier corrective action request to purchasing for forwarding to the supplier. Reviews and approves the request upon return.

5.3.3. Maintains a current status file of audits and corrective action requests to ensure that required follow-up action is taken.

5.3.4. Distributes copies of the audit reports to applicable department supervisors and managers.

5.3.5. Reviews the quality audit report log weekly to update and close out audits by returning corrective action requests.

6. ACCEPTANCE

6.1. Acceptable audit results are indicated by a check in the appropriate area of the Internal or Supplier Audit Report.

An approval signature on the corrective action request or supplier corrective action request indicates acceptable corrective actions.

7. REJECTIONCreated by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 62

7.1. Unacceptable audit results (nonconformity) are indicated by a notation in the "FAILED" or Unacceptable area on the quality audit or supplier audit report. Audits that reflect significant nonconformity require corrective actions.

8. RECORDS

8.1. All audit reports are maintained in a sequential file in quality. The quality audit reports log reflects the status of pending and completed audits and corrective action.

9. FORMS

9.1. PFO1-14 SQAR

9.2. PFO1-13 SQCS

9.3. PFO1-16 SQAAL

9.4. PFO1-17 SQES

9.5. PFO1-15 SCALOG

10. DEFINITIONS

10.1. Audit -- A pre-planned thorough examination and evaluation of a defined product or activity or portion thereof.

10.2. Product -- A part or combination of parts produced to meet requirements specified on drawings, specifications or other controlled documents.


11.1 ISO 9002, 7.15.


TRAINING QP 118

1. PURPOSE

1.1. This procedure provides general instructions for establishing and maintaining an education and training program for management, quality and other personnel who are participants in or are directly responsible for the determination of product quality.

2. SCOPE

2.1. This procedure applies to those functions within the company that have the responsibility to plan, implement or evaluate product or data quality.



3.2. Production

3.3. Quality

4. GENERAL

4.1. It is the policy of the NAME OF COMPANY to identify, and document the training needs and provide for the training of all personnel performing activities affecting quality.

4.1. For this procedure, education and training is divided into two categories:

General awareness and education

Planning awareness and education

4.2. General awareness and education is typically informal and, as a result, does not necessarily include a record of an event or who attended.

4.3. Planning awareness and education is more formal and typically includes all or most of the following processes:

Policy statement and objectives for quality. Concepts and documentation structure of ISO 9000. Quality organization, responsibility, authority, and structure. The employee’s job specific training.

5. PROCEDURE


Responsibility

5.1. The General Management Staff

Action

5.1.1. Identifies and assesses employee education and training needs

5.1.2. Evaluates the qualification of employees performing tasks affecting quality.

5.1.3. Maintains appropriate training records where appropriate.

5.1.4. Arranges for the mechanisms for delivery of training.

5.1.5. Evaluates the effectiveness of training activities.

Responsibility


Action

5.2.1. Announces kick-off meeting (what, who, where and when).

5.2.2. Conducts meeting, provides documents and agenda where appropriate.

5.2.3. Issues minutes and records action items and due dates.

5.2.4. Implements follow-up and closes specific requirements (product or data items).

5.2.5. Documents training activities and results in Training XLS. Files.

Responsibility

5.3. Management Review Committee

Action

5.3.1. Annually reviews and re-evaluates training needs of employees.

6. RECORDS

6.1. General awareness and education requires no records.

6.2. Training records are documented in the computer Training XLS file and are maintained for the length of active employment of the employee plus 1 year minimum.


7. FORMS

7.1. Certificates where appropriate.

8. DEFINITIONS

8.1. General awareness and education - Includes awareness of general quality and reliability information disseminated by the company, customer or industry through lecture, seminar or film presentation conducted by senior management or its representatives.

8.2. Planning awareness and education - Includes awareness of specific company, industry, or customer purchase order and subcontract requirements about material, design, process, inspection, test, data items, packaging or shipping by those functions responsible for their implementation.

8.3. Specific implementation and training and certification - Includes special process personnel certification and employee accredited job specific training courses sponsored by state of private educational sources.


9.1. ISO 9002, paragraph 4.18.


SERVICING OF CUSTOMER RETURNS QP 119

1. The NAME OF COMPANY performs no customer service activities and therefore has no documented procedure regarding this element.

STATISTICAL TECHNIQUES QP 120

1. PURPOSE

1.1. This procedure defines the method in which statistical techniques are used for control of processes.

2. SCOPE

2.1. This procedure applies to all manufacturing processes that qualify for statistical sampling, as determined by quality control.



3.2. Production

3.3. Administrative

4. GENERAL

4.1. Quality Control determines the sample size to be used in determining the capability of the process based upon the end-item use, inspection history, manufacturing methods, classification and contractual requirements.

4.2. Statistical Process Control is used : To quantify and display current levels of quality.

To verify and control process capability and product characteristics .

To identify where to focus quality improvement resources and effort .

To show the effectiveness of improvement efforts.

4.3. The responsibility for identifying the need for statistical techniques and establish methods and instructions for the beneficial application is assumed by the Quality Function. The selection of the appropriate statistical tools for individual processes is established through quality planning and is documented in the Control Plan.

4.4. Xbar and R , Pre-Control Charts, and Parts Verification Forms are used for the control and monitoring of ongoing processes.


4.5. The selection of the statistical method to be applied for individual processes is established by Quality Planning or the Quality Control Manager and is documented in the Quality Control Inspection Plan where appropriate.

5. PROCEDURE

Responsibility

5.1. Quality Function

Action

5.1.1. Reviews the shop paper, and applicable documents for quality requirements on the initial purchase of a new item.

5.1.2. Initiates Production planning meeting to discuss quality procedures.

5.1.3. Reviews drawing for customer critical dimensions and special dimensional requirements.

5.1.4. Initiates FMEA, Control Plan, and Risk evaluation documents whenever the absence of such planning would jeopardize the quality of the product.

Responsibility

5.2. The Quality Control Manager

Action

5.2.1. Provides control charts, inspection plans and dimensional logs to operators for completion.

5.2.2. Oversees and reviews charting activities, collects charts, and changes charts when necessary.

Responsibility

5.3. The Receiving Function

Action

5.3.1. Forwards any customer required statistical file and related documents to customer, with shipment, if required.

Responsibility

5.4. The In-Process or Final Inspector (Machine Shop)


Action

5.4.1. Reviews the operation sheet, the inspection instruction and applicable specifications to determine dimensions to be charted.

5.4.2. Reviews the special work instruction (QAIP) to determine the sample size to be pulled, if applicable.

5.4.3. Pulls a random sample.

5.4.4. Records the results of the inspection on the chart and initials the form.

RESPONSIBILITY

5.5 Production Operator

ACTION

5.5.1. Sets the machine according to furnished tooling and drawing received from Production Manager

5.5.2. Presents five parts to Quality Control for first piece evaluation.

5.5.3. Runs a minimum of thirty consecutive parts for capability study and delivers parts to Quality Control.

5.5.4. Receives SPC chart from Quality Control with instructions as to charting procedures and requirements written on the face of the chart.

5.5.5. Charts the process as instructed noting problems encountered during charting activities on the face or reverse of the chart.

5.5.6. Turns in completed charts at the end of the production run.

6. RECORDS

6.1. Previous process studies if available. Records pertaining to statistical process controls are maintained for a period of 1 year.

7. FORMS

7.1. FO1-03 FMEA7.2. FO1-04 CONTROL7.3. FO1-05 RISK7.4. FO5-02 FSTPCE17.5. FO5-06 PROSPO7.6. FO5-06A CHART

8. DEFINITIONS


Not Applicable


9.1. ISO 9002, 4.20.9.2. SPCMAN –Statistical Process Control Manual


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