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Extreme Precision Screw Products.

Quality Procedure

QP 4.2-1 Procedure Document Control & Quality Records

Printed copies of this document are for information purposes only and are uncontrolled. Printed copies are REFERENCE DOCUMENTS after the date of printing. This document was printed on 1/7/2014

Rev 4, 2-12-09 of 6

PURPOSE To identify and provide direction for the control, distribution and approval

of Controlled Documents and Data as related and used within the Extreme Precision Screw Products Quality System. This procedure also provides the direction for the appropriate control of Quality Records.

SCOPE All personnel using, reviewing, approving, and issuing controlled

documents and data and Quality Records. RESPONSIBILITY The responsibility for implementation, conformance and maintenance of

this procedure is assigned to the Management Representative. DEFINITIONS: EPSP recognizes four types of controlled documents and data

(Not all-inclusive).

Type #1 Quality System Documentation Quality Manual Quality Procedures Work Instructions Quality System Standard General Customer Requirements Specifications Type #2 Blank Forms used by EPSP

Corrective & Preventive Action Form Part Identification Card Purchase Order Quotation Worksheet Material Analysis Certificate of Compliance Packing Slip Purchase Order Review Check List

Type #3 Customer/Job Specification Documents Customer Purchase Order

Customer Drawings/Prints Job Specific Specifications/Requirements Customer RFQ/Quotation Job Specific Documents Customer Corrective Action Documents Type #4 Quality Record Documents retained as a means to ensure the effective functioning of the Quality

System


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Rev 4, 2-12-09 of 6

PROCEDURES

The following classifications of controlled documents in the EPSP Quality System, the following control methods will apply.

1.0 Type #1 Document Control Procedure.

1.1 This type of document will be listed on a “Quality System Master List” and will

contain the following information (as appropriate):

Document name/number

Current revision level/revision date

Authority for review and approval/ownership This matrix will be kept up to date to ensure obsolete/invalid documents are not used in the system. The matrix for type #1 documents is the responsibility of the Management Representative and will be kept electronically for the organizations use.

2.0 Type #2 Document Control Procedures 2.1 This type of document is a blank form included in a “Master Forms List”. Each

section of the master list will correspond to the EPSP Quality System numbering scheme. The control method for Type #2 documents will consist of a “Master List” of the current released version of the form that is available for use by the personnel in the organization.

2.2 The control and maintenance of the master forms list is the responsibility of the

Management Representative and will be kept electronically for the organizations use.

3 Type #3 Document Control Procedures 3.1 This type of document consists of customer/order specific documentation/files.

The control method will consist of one or more of the following (as appropriate):

Customer name

Customer Purchase Order Number

EPSP assigned job number/Job Card

Current date (At a minimum the customer name and date)

3.2 This document is controlled by the personnel assigned the responsibility for the

document/ of tracking the document or for ensuring the requirements are completed.

3.3 Every characteristic on a customer blueprint is numbered sequentially (ballooning) with visual inspection being the last numbered characteristic. Visual refers to all cosmetic and foreign object debris inspections (FOD). FOD inspection will be performed during final inspection procedure.


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Rev 4, 2-12-09 of 6

4 Type #4 Quality System Documentation 4.1 The format for the Quality System Documentation is to be used for all controlled

copies as released. This is to include the Quality Manual, Procedures, and Work Instructions and any master lists that are included in the system.

4.2 The control feature, in addition to that for Type #1 documents, is to have only the

electronic copy considered as a controlled document. All printed copies are for reference only and will be valid only for the day on which it is printed. The documents are available to all personnel in the organization by electronic media or can be printed and given to personnel on request.

4.3 Quality System documentation is to be backed up electronically to protect the

files from loss in the event of system failure. This is done by the server or on a disc that is saved to reinstall the system if a problem occurs. Back up typically occurs on a weekly basis.

5 Revision to Quality System Documents 5.1 Type #1/Type #2 revisions should be marked on an appropriately identified copy

and reviewed with the Management Representative for the impact of the change and approval by the document owner or the original approval authority.

5.2 Revisions to controlled documents/data will be made by the same

department/functions that were responsible for the original issue.

5.3 Changes of revision levels for all electronically controlled documents of the quality system will be identified in colored text or change of date, depending on the type of document. Work Instructions will use the “marked up copy” to identify the nature of the change and the old revision document will be saved in hard copy for a minimum of one year. This will allow the evolution of the document to be identified through time.

5.4 Obsolete documents kept in hard copy must be appropriately identified to

preclude the use of invalid documents in the Quality System. This requirement includes all obsolete documents retained for historical purposes. Electronic Quality System documents are to be removed from the active file and moved to a history file that is only accessible by the Management Representatives by password protection. The document is to be saved with the last revision level identified for tracking purposes.

5.5 Handwritten changes will be allowed provided they are single lined through and

signed or initialed and dated. This is applicable only to Type #3 documents only.

6 Customer Print & Specifications Control


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6.3 After review of the drawing/specification a folder is assembled to contain the customer’s documents and the revision levels are noted on the lower right corner of the “Office Folder and the Quality Folder”.

6.2 Specifications and special processes included on the drawing are referred to the

Quality Manager to review and ensure the latest level of the document is on file. 6.3 The numbered drawing and any additions to the drawing are initialed by the

originator, dated and if required referenced to the customer. The office folder will contain an unnumbered copy. The Sales Manager or Quality Manager will authorize the drawings to be used for manufacturing purposes.

6.4 The Quality Manager will contact the customer to ensure the specifications and

standards are current and approve the documents for use and issue. 6.5 The specifications/standards are reviewed for content and compatibility with the

E.P.S.P. system and are approved by the Quality Manager by initialing and dating the top of the page to establish the effective date/revision level for the document.

6.6 The original copy of the specification/standard is placed in the appropriate binder

in the library and the document is added to the table of contents in the front of the binder and the master list and distribution determine if needed.

6.7 Control Plans and manufacturing procedures revised require the customer’s

approval prior to implementation. All documents and data will be reviewed as needed by the customer or regulatory agency based on contract or customer requirements.

7. Customer Drawing Revision Control If a revision to a customer print or drawing is needed, the office personnel will initiate the

print change form. The office personnel will review the change and check for any open orders in the system,

change the revision level on the office folder and purge the system for all obsolete superceded documents affected by the revision and forward the drawing to the Quality Department.

7.3 Quality Personnel review the revision change by:

A. Re-numbering the new print B. Changing the revision level on the Inspection Folder C. If open orders exist, the Quality Control Record is located and changed D. Placing a revised blueprint in the job packet

E. Place a current numbered blueprint in the Office Folder F. Destroy packaging tags G. Modify or replace inspection templates H. Checking inventory and re-classify parts, if necessary


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I. Changing the Product Work Instructions

The Production Manager is responsible to check and revise the production computer files

as needed. The same system is followed for any advanced engineer changes except the change is

attached to all prints and it is maintained until an Engineering Change Order or formal revised print is obtained from the customer.

Procedure for Quality Records 8 Identification 8.1 All Quality Records listed on the “Quality Records Matrix” are to have proper

identification in one or more of the following ways (as appropriate)

Customer Name

Form Title

EPSP assigned number The identifier used must be maintained for the life of the record. Supplier records required by E.P.S.P are included in this procedure and process system.

9 Collection, Indexing, Accessing, Filing, Storage, and Maintenance 9.1 Quality Records are to be collected at the appropriate time for storage and use by

the identified personnel on the “Quality Records Matrix”. Quality Records are to be made accessible for customer and other authorities review upon request.

9.2 Quality Records are to be filed and indexed in a matter that permits accessibility

and ease in retrieval for review. All records must remain legible. 9.3 Quality records are to be filed and stored in a manner preserve and protect the

record and prevent deterioration of the record. The records are backed up monthly at a minimum to protect the record and preserve the information.

10 Quality Records Retention Times 10.1 Quality Record retention times are minimums as listed on the Quality Records

Matrix. Disposal after the required retention period will be at the discretion of management. Quality Records used and maintained by EPSP are both electronic and hard copy and are to have the media identified on the Quality Records Matrix. The decisions regarding retention times are dependent on the customer requirements and the needs of the EPSP organization for future informational requirements.

10.2 Quality Records are available to our customers on request, but are kept on site

for storage and availability purposes. Copies may be forwarded if needed for any


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job related information and quality inspection records that the customer may need.

ASSOCIATED DOCUMENTS:

Master List Quality System Documentation

Quality Records Matrix

Master List of External Controlled Documents

Print Change Form

Office Folder

Inspection Folder

Configuration Management Document


Quality Procedure QP 5.6-1 Procedure

Management Responsibility, Objectives & Review Process


Rev 2, 10-23-07 Page 1 of 3

PURPOSE The purpose of the management review procedure is to identify and direct the various types of management review. This procedure will also outline the needs and system for setting the objectives and goals of the organization for Extreme Precision Screw Products, Inc.

SCOPE The scope includes the President and other management personnel who

participate in the review of the quality system and in the planning and analysis of the organizations objectives.

RESPONSIBILITY The responsibility for creation, implementation and maintenance of this

procedure rests solely with the Vice Presidents and Management Representative.

DEFINITIONS

None PROCEDURES

1 Total Quality System Review

A review of the total E.P.S.P Quality System will be conducted at a minimum of

once per year. The review is to be scheduled by the Management Representative and the President for the year by issuance of the agenda. The review will typically take place in the 1

st quarter of the New Year.

1.2 The review will include: (not all inclusive)

All elements of the quality system.

Adequacy of the quality policy

1st / 3

rd party audit results

Corrective and Preventive Actions.

Cost and performance objectives and measurables.

Non-conforming material analysis

Customer Satisfaction

Improvements and action items and review item from the MRB Meetings

Follow up needs and action from previous management reviews.

The intended purpose of this review is to understand the performance for the past calendar year and to set the new objectives and plans for the new calendar year to support and promote continuous improvements.

A record of the review is to be documented and maintained by the Management

Representative for future use and review.

Typically the quality system review is to be attended by:

President

Vice President

Management Representative/Quality Manager

Sales Manager

Office Manager

Production Manager





Rev 2, 10-23-07 Page 2 of 3

1.5 The outputs will consist of the new objectives, revisions to the quality system documentation, resource management and other continuous improvements related to the system, process and product. All outputs and actions are recorded and kept as a record for the management review process.

2 Additional Forms of Management Review

E.P.S.P utilizes other forms of management review to monitor the day-to-day

performance of the organization. Typically these reviews will be scheduled; however they can be called at the discretion of management or on an as needed basis. The “Management Review Board” will typically meet quarterly as determined by the Quality Department.

The Management Review Board consists of the following positions in the

organization:

President

Vice President

Quality Manager

Other persons as necessary from the organization

2.3 The Management Review Board is responsible for reviewing the quality system,

customer complaints, preventative actions, cost of quality, corrective actions and their effectiveness, follow-up actions, policy changes, and anything else that can affect the overall effectiveness of E.P.S.P. meeting the requirements of the Quality Manual, quality procedures, quality policy, and its objectives.

2.4 Records of these meetings will be maintained by the Quality Representative and

filed for future use and review.

3. Customer Satisfaction Assessment 3.1 Customer satisfaction is assessed by the organization obtaining, analyzing and

performing trend analysis of on time delivery to the customer, number of customer complaints received and the number of product returns from the customer deemed defective. The customer report cards and evaluation of E.P.S.P performance are also monitored and tracked by management to assess the level of customer satisfaction with the organization.

3.2 The Management Representative is responsible to perform the measurement

and update the data to monitor the level of customer satisfaction.

3.3 The information is presented to management during the quarterly MRB meetings and used as an input into the annual management review for any required actions.





Rev 2, 10-23-07 Page 3 of 3

3.4 The “Management Objectives Document” is the method used to identify the specific measurement methods and to track the management objectives and manage the data and charts for comparative analyses.

RELATED DOCUMENTS

Annual Management Review Agenda Form

Management Review Board Records

Management Objectives Document

Customer Performance Reports



Contract Review & Order Entry Process


Rev 4, 05/25/2012 Page 1 of 5

PURPOSE The purpose of the contract review and order entry process is to establish the activities and reviews required to ensure the customer requirements and product orders are fully defined and recorded. This procedure also defines the requirements for revising and existing customer order and communication of the order revisions internally within the E.P.S.P. organization.

SCOPE Personnel who are responsible for receiving, processing and recording

customer orders for manufacture and entry into the production system. RESPONSIBILITY The Sales Manager or Office Manager has the overall total responsibility

for the contract review and order entry process and is assisted by the Management Team. The Quality Manager is responsible for the customer order documentation and records from contract review.

DEFINITIONS

RFQ = Request for quotation QCR = Quality Control Record I.M. & T.E. = Inspection, Measurement & Test Equipment PROCEDURES

1. Customer Inquiries and RFQ Processing

1.1 The customer inquiries and RFQ’s are received by fax, phone or in hard copy for a project/part by the sales staff or directly at the E.P.S.P. office.

1.2 The Vice President reviews the Request for Quotation to ensure that at a minimum there

is:

An identification of the part

Quantity or Quantities to be quoted

A print of the part to the requested revision level

Any necessary specifications or requirements to the part are specified and understood by E.P.S.P.

If any requirement or specification is not fully understood, the customer is contacted to clarify the question.

1.3 A Quality Team Representative reviews the specifications and standards required to

ensure that E.P.S.P. has the current revision of the required documents and are capable of conforming and complying with the request in full.

1.4 A Production Team Representative reviews the requirements of the request to ensure

that any special tooling, fixturing, and/or equipment that is not presently available to E.P.S.P., and would be needed, is calculated into the piece price or listed separately, depending upon the customers request. Prior to submitting the quotation the Sales Manager reviews the quotation to ensure:





Rev 4, 05/25/2012 Page 2 of 5

A. Customer requirements are adequately defined B. Customer requirements can be met C. Customer requirements are agreeable to EPSP D. Material is available E. Tooling needs are identified F. Pricing is correctly structured

1.5 The Request for Quotation is submitted to the customer as to fulfill all the requirements

requested. Any deviations from, changes of, or exceptions to what is requested by the customer, will be clearly identified on the quotation submitted.

1.6 All quotations submitted to customers have an Office Folder prepared and kept as a

record of the quotation submitted. This Office Folder consists of at a minimum: A print to the latest revision A quotation sheet, with a review, identifying the costs of manufacturing the part Any other supporting documents used in preparing the quotation

1.7 Unless notified by the customer, if no Purchase Order is received after one year, the

Office Folder may be dismantled and papers there in destroyed. 2.0 Receiving & Review of Customer Orders

2.1 Purchase Orders may be received through the mail, other type of delivery service, fax, electronically, or personally delivered. Verbal orders are discouraged and not normally accepted. At a minimum orders received by verbal means are documented by E.P.S.P. until the formal records are received from the customer.

2.2 Office Personnel prepares a “Quality Control Record”. Office Personnel review the

Purchase Order for accuracy and completeness by comparing the quotation and the Quality Control Record against the Purchase Order. The Purchase Order Review Checklist Guideline provides information for performing the Office Review (Located with Form 6) At a minimum Office Personnel will review for:

A. Part number, as compared to quotation B. Blue Print C. Purchase Order Number D. Revision Level E. Inspection Folder F. Quantity G. Customer Requirements H. Material I. Terms and Conditions J. Outsourcing Requirements K. Delivery Date

L. Priority Rating or special handling rating M. Price N. Inspection Folder





Rev 4, 05/25/2012 Page 3 of 5

2.3 If there is any discrepancy between the quotation rendered and the Purchase Order, the

customer is contacted for clarification and additional information prior to acceptance of the order. If the order is correct the “Contract Review Checklist” is initialed and dated by the person performing the review as evidence of the review and acceptance of the order.

2.4 Office Personnel assign each accepted Customer Purchase Order received a job number to follow the order through every operation of production. The assigned job number is logged to track the numbers assigned and monitor the order.

2.5 Office Personnel prepare a “Quality Control Record”, documents the new order on the

Office Folder, obtains a current blueprint, and forwards the package to the Quality Department. If there has been a revision change to the blueprint, the Office Manager is responsible for initiating the blueprint change process.

2.6 A Quality Inspector reviews the Purchase Order and the job packet with the “Inspection

Folder”. At a minimum the review will include:

A. Correctness and completeness of the “Quality Control Record” B. Numbered blueprint with all characteristics sequentially numbered C. Necessary specifications and revisions levels are compared and verified

with customer supplied specifications and revision levels D. Critical Characteristics E. Correct revisions F. Subcontractors G. Terms and Conditions H. Packaging I. First Article J. Special Requirements K. Cautions L. Inspection Folder

M. I.M. & T.E. If acceptable, the reviewer will initial and date the checklist. If there is any discrepancy between the Purchase Order, Quality Control Record, or Inspection Folder, it is brought to the office personnel who prepared the “Quality Control Record” to clarify and correct the problem.





Rev 4, 05/25/2012 Page 4 of 5

2.7 A Quality Inspector assembles the job packet in a protective cover, consisting at a

minimum the following:

A. Quality Control Record B. Current blueprint C. Current Product Work Instruction (If needed) (may be deferred to Quality Personnel to provide at a later time)

A Quality Clerk ensures that the “Product Work Instructions”, if needed, are placed with all new job packets and the Quality Manager forwards the job packet to the Purchasing Manager.

2.8 The Production Manager, is responsible for reviewing the job packet. At a minimum

Production Manager will review for:

A. Processes B. Equipment capabilities compatibility C. Tooling requirements can be satisfied D. Terms and Conditions E. Any priority ratings F. Critical or key characteristics identified G. Coatings that may affect dimensions are reviewed H. Delivery date I. I.M &T.E.

J. Critical Stages (Any in process points where any dimensions or characteristics cannot be verified after a subsequent operation)

K. Establishment of an appropriate process with controls if the customer has identified any critical or key characteristics

L. Product Work Instructions

If acceptable, the checklist is initialed and dated by the reviewer. If there is any discrepancy, conflict, or problem in fulfilling the Purchase Order Production Manager will

contact the Quality Manager and the President. By verification of all areas of the “Contract Review Checklist”, risk analysis for the customer purchase order has been satisfied. Any exceptions or issues are to be mitigated and resolved prior to full acceptance of the order. Risk analysis discrepancies and their supporting documents will be entered on the back of the Contract Review Checklist or attached.

2.9 Office Personnel will send an acknowledgement for the accepted Purchase Order to the customer if it is required or requested.

3 Contract and Purchase Order Amendments

3.1 The Sales Manager is responsible for reviewing the amendment for correctness and

completeness.





Rev 4, 05/25/2012 Page 5 of 5

3.2 The Sales Manager is responsible for forwarding the amendment to the Production

Manager; to ensure the amendment requirements can be met. If the amended requirements can be met, the “Quality Control Record” is changed to reflect the amendment and the amendment is marked to indicate so. If the amended requirements cannot be met, the amendment is forwarded to the Sales Manager, who will contact the customer to discuss the issue and come to an agreement.

3.3 The amendment is forwarded to the Office Personnel to change the manufacturing

schedule, and attach the amendment to the original Purchase Order.

RELATED DOCUMENTS

Customer RFQ

E.P.S.P. Quote Log

Customer Quotations

Quality Record

Contract Review Checklist



Supplier Selection, Evaluation & Purchasing Process


Rev 5, 12-12-13 Page 1 of 5

PURPOSE This documented procedure has been established to provide guidance and direction for the Purchasing activity in the selection and evaluation process of suppliers and for the purchase of required product from approved suppliers. The verification of purchased product is addressed in the procedures for inspection.

SCOPE Personnel actively selecting and monitoring suppliers and purchasing

product for incorporation into the products and services of EPSP are included in this procedure.

RESPONSIBILITY The Purchasing Manager/Vice President’s has the overall total

reasonability for the Purchasing process and supplier selection for raw materials. The Quality Manager has the overall total responsibility for the Purchasing Process for Outsourced services and products.

DEFINITIONS APSL Approved Supplier List

PROCEDURES

1. Supplier Selection 1.1 Supplier selection begins with the need for a product or service and

determination of the need for additional or new suppliers based on the need. The existing suppliers on the “Approved Supplier List” are approved as of 1-15-04. Additional suppliers added after this date will be formally reviewed for their ability to service and supply the needs of EPSP.

1.2 The Purchasing Manager/Quality Manager will initiate the process and issue the

first order to the prospective new supplier once the information on their abilities is obtained and reviewed. New suppliers will be given initial orders and will be subject to receiving verification and inspection to validate their success as an approved supplier to EPSP.

1.3 Any nonconformance identified in the first few orders will be evaluated and

reviewed by the Quality Manager and the Purchasing Manager to determine if the supplier will be formally approved. All actions and correspondence to the supplier during this period will be recorded.

1.4 Customer designated suppliers (subcontractors) will be used when designated by

the customer’s Purchase Order or requirements. If EPSP quality department deems that any subcontractors on the customer’s ASL are not qualified, the Quality Manager will contact the customer for direction.

2. Supplier Evaluation and Perpetual Monitoring 2.1 EPSP Management, based upon the supplier’s response and performance in the

initial order will approve suppliers. Suppliers will be evaluated based upon:

Delivery





Rev 5, 12-12-13 Page 2 of 5

Quality Following acceptance through the initial approval process, the supplier is entered into the Approved Supplier List” and the performance for the supplier is tracked and recorded electronically. Each supplier, if used, is given a color code (Red, Yellow, or Green) on the APSL. These colors identify the level of acceptance to the purchasing department and management. “Red” specifies that the company can only be used by the purchasing department with the authorization of the Management Representative or Vice President on a case by case basis. “Yellow” identifies that the company is under surveillance because of a quality (CAR, Non-Conforming Products) or late delivery problem and should be used with caution. The color “Green” identifies the company as an excellent supplier to the Purchasing Department and Management and therefore can be used without question. Pricing criteria is at the Purchasing Managers discretion. A “Supplier Monitor Record” is established for each supplier to maintain the records for review and evaluation of product quality.

2.2 Suppliers will be subject to a perpetual review of any Non-Conformance in the

categories of delivery and quality. If a Non-Conformance is received, any documentation and records will be included in the individual supplier’s performance records file. Documentation can and will include the following: (as applicable)

Corrective and Preventive Actions

Supplier Non-Conformance Reports

Notes, faxes, correspondences

Shippers & receiving documents with appropriate notation

Inspection reports 2.3 If a trend of Non-Conformance issues is identified, the Quality Manager or

Purchasing Manager can take action as deemed appropriate:

If, during the quarterly review, a supplier has a PPM of 1000 or higher or 3 or more late deliveries, management will evaluate them for action to be taken; (change of color status, CAR, Non-Conformance Report, removal from list or no action taken).

Issuance of an “EPSP Corrective Action Report” to the supplier as formal notification of a complaint.

Issuance of “EPSP Product Non-Conformance Report” detailing a problem.

A visit to the supplier by EPSP staff or to require the supplier to meet at the EPSP facility for resolution.

A total Re-evaluation of the supplier’s status and standing as a supplier to EPSP.

2.4 Records of approved suppliers, supplier evaluations will be kept both

electronically or in hard copy where needed by the Purchasing Manager or Quality Manager, and will be available for review. These records are identified on the “Quality Records Matrix” in section 7 available from the “Quality System Master List”.





Rev 5, 12-12-13 Page 3 of 5

3 Elimination of Suppliers 3.1 If through the evaluation process a supplier continually is unable to meet the

EPSP supplier evaluation criteria they can be removed from the approved list of suppliers.

3.2 Formal documentation and records will be maintained and the eliminated supplier

can only be re-approved by documented proof that the cause of the nonconformance has had valid corrective action applied.

4 Supplier Development Package 4.1 All suppliers will receive a copy of the “Supplier Development Document”. This

document outlines the needs and requirements of EPSP concerning Quality, Environmental and contractual obligations and conditions for premium freight as well as the requirements concerning customer designated sources.

4.2 This document forms the basis for development of our suppliers and details

performance expectations to the EPSP organization. 4.3 A signed confirmation of acceptance and agreement to the conditions as outlined

in the document is made part of the suppliers file. 5 Verbal Purchasing Documents 5.1 Outside purchased product such as shop supplies and non-critical products or

materials may be ordered verbally and are verified by the purchaser to ensure the order was filled accurately.

5.2 The purchaser will provide the supplier with the pertinent information required to

deliver the needed supplies and is verbally given to the supplier and then verified on receipt against the requirements given to the supplier.

6 Non Verbal Purchasing Documents / Data 6.1 Critical products such as raw materials, outsourced product processing and gage

calibration will have a formal purchase order completed to outline the requirements for the products.

6.2 The following individuals are authorized to purchase:

President

Vice President

Quality Manager

Production Manager





Rev 5, 12-12-13 Page 4 of 5

6.3 When it is necessary to purchase raw material to be used for the manufacturing of parts, the Production Manager will review the Quality Control Record, Inventory, and Customer requirements to determine the lot size of parts to be manufactured. A Request for Quote [RFQ ] will be prepared and sent out to qualified mills and service centers. Qualified mills and service centers are determined from the company Approved Supplier List and Customer requirements. At their discretion, management may eliminate the RFQ process. The Production Manager is responsible for issuing the Purchase Order to the mill or service center, ensuring that all customer requirements will be met. Once the material is received, it will be processed per QP 8.2-2, Para. 2.

6.4 When it is necessary to have outside processing performed on parts being manufactured, the Quality Manager is responsible for the processing of all outsourcing of parts. Once the parts have been received into the inspection room for outsourcing, the inspector will review the Product Work Instruction, the Quality Control Record, the Blueprint and the Inspection Folder to ensure that the parts are going to be process for the correct procedure in the correct sequence. All critical and process affected dimensions will be inspected on the DIP to ensure that they are correct for the process to be performed. At management’s option, RFQs may be sent out to qualified subcontractors. Qualified contractors are determined from the company Approved Supplier List and Customer requirements. A Purchase Order will be prepared listing all the processes to be performed, with revision levels when applicable. The Purchase Order will be reviewed and initialed by a second inspector or management for accuracy. The parts will be properly packaged to ensure they are not damaged during shipping. Once the parts have been received back from the subcontractor, they will be received per QP 8.2-2, Para 3.

6.5 When necessary to have gages sent outside for calibration, the Quality Manager

is responsible for the processing of all orders. The procedure for the processing of orders is per QP 7.6-1

6.6 The purchasing information will contain such items as:(as appropriate to the

purchased product)

Quantity for the product

Delivery date

Part number

Priority Rating

Any quality system requirements

Right of Entry clause

Right to Evaluate clause

Right to Inspect clause

Critical or key characteristics

Specifications with their types, classes, and revision level

Customer restricted processes and/or procedures

Request for material certification to the level required by the customer 7. Product Verification





Rev 5, 12-12-13 Page 5 of 5

7.1 Product verification is outlined in the procedures for Inspection and Nonconforming Product procedure.

Associate Documents

Approved Supplier List

Purchase Orders

Supplier Development Document

Shippers

Nonconforming Material Report

Corrective and Preventive Action Form



Process Control & Maintenance System


Rev 6, 05-31-13 Page 1 of 5

PURPOSE The Process Control & Maintenance System procedure has been defined to

provide direction in the manufacturing and production of customer products. This procedure defines how orders are processed and the production controlled to ensure all customer requirements are satisfied. This procedure also outlines the maintenance system utilized by Extreme Precision Screw Products. Products processed are run using normal processes/procedures. These products are supervised and jobs are monitored/tracked by the responsible company.

SCOPE All EPSP Personnel who are responsible for manufacturing, production,

and the maintenance of the key equipment used in production areas. RESPONSIBILITY The Production Manager is fully responsible for all manufacturing and

production processes and is also fully responsible for the maintenance activity in the company.

DEFINITIONS

None PROCEDURES

1.0 Order Entry

1.1 The production process begins after successful contract review of the customer’s requirements. A job number is assigned and recorded on the customer purchase order. The order and job number are logged in the front office.

1.2 A Purchase Order Review Checklist is attached and completed to the purchase

order to ensure that the information being assemble in the job packet is correct and to the current customer revision level. Purchase Order Checklists are attached to the initial purchase order. All subsequent orders are considered releases and do not require the checklist. The checklist is initialed and dated as evidence of the review and approval for production.

1.3 A “Quality Control Record” is initiated for the job and the required information is

completed on the card. The “Quality Control Record” is utilized for each run of the job after the initial production run. Each time the job is run the same card is used to record the information from the job and control the process. A full record is maintained and a second record is attached and continued to monitor each run of the job.

1.4 The job packet goes to the material and stock personnel to verify if EPSP has the

correct blank or any completed parts currently in stock. The results of the review for stock and inventory are recorded on the “Quality Control Record’. If completed parts are in inventory the parts and the job packet go directly to the Final Inspection Department for inspection and shipping. If there are no parts in





Rev 6, 05-31-13 Page 2 of 5

inventory a “Product Work Instruction” is printed for the job and included with “Quality Control Record”.

1.5 The Product Work Instruction is the process that is to be followed for the specific part and outlines or details the correct process for the production of the part. The “Quality Control Record” and the “Product Work Instruction” (orange sheet) are then forwarded to the Production Manager.

2.0 Process Control 2.1 The Production Manager reviews the job for material condition and status. If

material is needed the Production Manager will initiate the purchasing process for obtaining the needed material.

2.2 The sequential order of operations and processes as listed on the Product Work

Instructions are to be followed in the manufacturing and production process. The operator completes the work and inspects the job to ensure the work is correct to the customer drawing and specifications. New processes or first run jobs may be developed during manufacturing and recorded on the work instruction as the job progresses. The Production Manager is responsible to ensure the work instruction is complete and accurate.

2.3 The operator sets up the job at the particular work center and a first piece

inspection for all operations is performed by the Production Manager/Vice President’s and recorded on the “Quality Control Record”. Once released for production, the two cup method is used to verify that the product meets the customer’s requirements; refer to QP 8.2-2.4.

2.4 Each operator initials the Product Work Instruction at the completion of the job to

verify the operation is complete and conforms to specification. If an operator receives a Product Work Instruction from the previous operation that is not signed off and completed the operator will notify the Production Manager or Quality Control Manager for correction.

2.5 The Production Manager, Quality Manager, or the Vice President’s must approve

any deviation from the established Product Work Instructions. If it is deemed necessary to change the sequence in the work instructions process of any given part, the Yellow Card (QP 7.5-1 para 3.5) will be documented to explain the change and signed off by the Production, Vice-President, or President. The Yellow Card will then be affixed to the front of the Quality Control Record. The Yellow Card will be removed from the QCR only after the change in sequence has been properly completed and approved by one of the individuals listed above.

2.6 Unless otherwise indicated by the customer, when serialization of a part is

required by the blueprint or the Purchase Order, the parts are serialized as follows:

Serial number consists of the identification code assigned by the customer (if applicable) followed by a dash (-), then consecutive numbers starting with the number (0001). A log of serialized parts is kept in the Inspection Folder. The log contains the following:





Rev 6, 05-31-13 Page 3 of 5

A. Customer name B. Purchase Order number C. Beginning serial number D. Ending serial number E. Date shipped

The method of marking is in accordance with the blueprint, purchase order, or customer requirement.

3.0 Product Identification & Traceability 3.1 Raw material is color coded in accordance with the Raw Material Color Control

Chart prior to storage or use. A Raw Material Control Card is prepared on all raw material received. Raw material received with an acceptable certification is placed in the certified material storage racks.

3.2 Raw Material received without an acceptable certification is segregated from the

certified material. The material will remain segregated until acceptable certification is received. The material is moved to the certified material storage racks when an acceptable certification is received.

3.3 Additional product identification and traceability is provided by the following:

A. Job Packet: A protective covering, containing at a minimum:

The Quality Control Record

Product Work Instructions

Blueprint.

B. Quality Control Record: The official record of a specific Purchase Order received for a particular part to be manufactured. It contains at a minimum:

Part number

Customer name

Purchase Order Number

Latest blueprint revision

Packaging requirements

Job number

Order quantity

Shipping dates and quantities

Cautions

Material needed

Inventory on hand

Required outsourcing

C. Product Work Instructions: A sequence listing of procedures to be taken in the manufacturing of a product that may include computer program numbers, special tooling, special fixtures, cautions, and any other information useful in producing the product.

D. Blueprint: Customer supplied drawing of the part to be manufactured.





Rev 6, 05-31-13 Page 4 of 5

E. Container: A vessel used to hold parts to maintain separated lots. F. Shipping Label: A sequence listing of information that is affixed to the outside of

the shipping container that identifies the contents and lists all customer required information.

G. Individual Part Package Label: A sequence listing of information that is affixed to or enclosed in the packaging container containing one piece that identifies the contents and lists all customer’s required information. Prior to the printing of these labels, the information on them will be checked by at least two different people. When the customer requires serialization or lot identification the following requirements will also be met:

Enough labels will be printed to cover the entire lot plus any/all supporting documents after the lot is inspected and prior to the first shipment from the lot.

One of the labels will be affixed to the Inspection Folder and/or the DIP, as a sample representative of the lot’s tag.

A notation will be made on the Inventory Shipping Log {blue sheet} indicating from which lot the parts from inventory are being shipped.

3.4 Material Certifications that provide traceability to the raw materials are

maintained. EPSP is able to trace the material for any job in production to verification and purchasing records. The traceability information is recorded on the “Quality Control Record” for each run of the specific customer part.

3.5 Throughout the production process the job packet accompanies the product. A

Production/Identification Card is used to provide information on the status of each lot of product. Dissimilar lots are segregated. The reason for segregation is stated on the Identification Card.

Red card = Scrap product (May be kept for setup purposes)

Yellow card = More work is to be done on the lot or lots are segregated. The reason for segregation is stated on the Identification Card. Cards will remain with the lot until the lot is completed and passed final inspection.

Green card = Part that has passed Final Inspection and is ready to be shipped to the customer.

3.6 When required by the customer, product will be marked with the vendor requested identification, marking or logo.

4.0 CNC Programs 4.1 CNC programs are developed and controlled by the Set-Up Person for each

CNC piece of equipment. CNC programs are stored in an external computer system to the CNC equipment. The control factor is the part number and the drawing revision level as supplied by the customer. Each Set-Up Person is





Rev 6, 05-31-13 Page 5 of 5

assigned a password to access the computer that stores their programs. Each Set-Up Person is assigned a two digit personal identifier that is placed in front of the four digit part number identifier to identify the author of the program and part number of the program. The Production Manager maintains a back up disc. The Set-Up Person verifies the drawing level and part number of the program prior to use. A dry run of the program must be performed before production begins.

4.2 At times there are multiple machines available to run a specific part. Each author

of a program stores their program on their computer system. CNC programs will not be permanently stored in the CNC equipment control. The program as developed is stored on the machine by part number/program number and the current customer drawing revision level. The operator is to verify the program and its correctness prior to use. No other controls are required for CNC programs.

5.0 Maintenance System 5.1 Maintenance criteria are listed on a maintenance form that includes the codes

and required frequency. It is performed by the operator and recorded by code on the maintenance record. Additional checks of machine and tooling are performed each and every time the machine is started, (beginning of shift, breaks, bar changes and tooling changes).

5.2 The maintenance records are kept at each machine and available for review as

needed. The records are typically reviewed at the end of the calendar year and if no unusual conditions exist, the records are replaced and the old records from the previous year are discarded.

5.3 If conditions are identified, the Production Manager will record the issue and

determine the applicable action needed. RELATED DOCUMENTS

Customer RFQ

E.P.S.P. Quote Log

Customer Quotations

Quality Record

Contract Review Checklist


Quality Procedure QP 7.6-1 Gage Calibration Process


Rev 1, 6/06/05 Page 1 of 3

PURPOSE The purpose of the procedure to outline the process and system to calibrate gages used for inspection purposes in the process at Extreme Precision Screw Products. This procedure will provide direction; define the responsibility and reference the calibration work instructions for the calibrations performed in house at EPSP. Employee owned gages are included in this process.

SCOPE All gages that are customer, employee or company owned used for

inspection purposes are outlined in this procedure. RESPONSIBILITY The Quality Manager has the overall total responsibility for gage

calibration. The Quality Manager coordinates the gage calibration system with personnel assigned to perform the individual in house calibrations and the outside laboratories used to certify and calibrate Extreme Precision Screw Products equipment and measuring tools.

DEFINITIONS

Gage Calibration: Adjustments and repairs needed to bring a gage or measuring device back to the manufacturer’s specifications.

Gage Verification Checks and inspections performed to compare

gage accuracy against a standard traceable to national standards and masters.

Gage Certification Certification of a gage or measuring device to

affirm its accuracy to national standards. An outside-accredited laboratory registered by a third party accreditation body performs certification.

PROCEDURES

1 Gage Calibration Program 1.1 Extreme Precision Screw Products utilizes an Electronic Gage Master List and an

Electronic Gage Calibration Program to coordinate the calibration activity. The following items are required and included in the Gage Calibration Program:

All gages are to have a unique identifier applied to enable accurate identification and traceability of the gage. Serial number or the employee’s initials or numbers can accomplish this.

All gages will be entered into the Electronic Gage Program. (Non inspection and Reference Only” gages are not included in this requirement.)

All gage entries into the Electronic Gage Program will have an identified frequency; calibration work instructions assigned, and are monitored accordingly.

Records of calibration will be stored in the Gage Program electronically.

Outsourced calibrations will be so noted and must be performed by an outside-accredited laboratory.




Rev 1, 6/06/05 Page 2 of 3

1.2 Outsourced calibrations are to be defined to the supplier performing the service using the Extreme Precision Screw Products purchasing system to correctly communicate the required calibrations to the supplier. All outsourced calibrations are to be performed by an accredited gage calibration laboratory to the ISO/IEC 17025 guidelines. A copy of the laboratory certificate and scope is to be on file at EPSP.

1.3 Gage calibrations are to be performed according to the requirements as listed by work

instruction in the “Gage Calibration Program” process. Gage Calibration records are to be updated accordingly and may be kept in either an electronic or hard copy format.

1.4 The Calibration Clerk is responsible to receive all outsourced calibration

records/certifications and intern calibration/verification records and update the gage program. Update accreditation information is to be included in the “Approved Supplier List”

1.5 Gage Calibrations will be performed under the same conditions (environment) as

those of which it is used. No environmental controls are needed or utilized at Extreme Precision.

1.6 Gages & Measuring devices found to be out of calibration are to have the previous

calibrations verified and previous results reviewed. If a gage is found to be out of specification the Quality Manager or management are to be notified and an investigation of products performed to determine if product quality is affected and to determine the appropriate follow actions. All actions, decisions and communication with the customer are to be recorded.

1.7 Gages are to be handled and stored in such a manner to protect the condition and

maintain the gages accuracy. 1.8 Any gage having adjustments that if tampered with could render the calibration void,

will have safeguard (Tamper Proof Label) applied. Employees are not to make any adjustments to any gage after calibration, unless the Quality Manager is notified.

2 Calibration Prior To Use In addition to the calibrations performed per the specified frequency on the individual

gage master lists, all gages are calibrated prior to use and assignment to the shop personnel.

Upon request for a gage, the Inspection Personnel responsible for the calibration

system will verify the gage accuracy and note the actual results obtained on the individual gage record for each gage. The record is kept electronically and controls the gage location, fitness for use and the date the gage was returned to the inspection department. (EXCEPT FOR GAGES ASSIGNED TO A SPECIFIC MACHINE)

The Inspection Personnel will obtain the gage, verify its accuracy, date the record for

the issue of the gage and provides the gage to the operator. The gage is then returned after use to the inspection room.




Rev 1, 6/06/05 Page 3 of 3

The Inspection Personnel will verify the accuracy of the gage and by entry of the check in date on the record for the return of the gage will provide evidence of the condition of the gage on return to inspection.

3 Gage Calibration Work Instructions A gage calibration work instruction is to be used during the specified calibration

process to provide direction and instruction on a step-by-step basis in the correct methods to complete calibration requirements for a specific type of gage. This applies only to the calibrations listed on the individual master gage list.

The “Gage Calibration” work instruction is applicable to all gages that are being

calibrated in house by Extreme Precision Screw Products personnel. Personnel performing gage calibration are to perform the calibration according to this procedure and the applicable work instructions

Frequencies may be extended depending on the findings from calibration to

calibration if product quality is not diminished. Cost for calibration and the use of the gage are to be heavy determining factors in the decisions for calibration. Outside suppliers used to calibrate and certify the gages are to be supplied with a date for calibration by Extreme Precision Screw Products personnel in the purchasing information given to the supplier.

Associated Documents:

Master Gage List

Individual Gage Record

Gage Calibration Work Instructions.



Internal Quality Audit Process


Rev 3, 7-30-13 Page 1 of 3

PURPOSE The purpose of this procedure is to define the Internal Audit process for the EPSP Quality System and our organization. This procedure also includes the requirements for dock audits of finished product.

SCOPE Personnel actively participating in the EPSP Quality System assigned as

auditors, audit coordinator and the management responsible for the audit results review and subsequent corrective action.

RESPONSIBILITY The Management Representative has the overall total responsibility for

the internal audit program. The Vice President is responsible to ensure the audit findings are reviewed and the corrective actions are completed and implemented with the individual department managers.

DEFINITIONS CAR= Corrective Action Report

PROCEDURES

1.0 Planning The Internal Audit.

1.1 The Quality Manager is responsible for the planning and completion of the audit

schedule. Each process of the EPSP Quality System is required to have an audit performed at least once per calendar year. All shifts running at the time of the audit are to be audited and records maintained.

1.2 Additional audits may be scheduled/requested based on the following:

Past audit results from our third party registrar.

Non-conformance levels/trend analysis.

Customer complaints and reports of defective engines.

Performance measurables.

Past internal audit findings 1.3 The audit checklist/guideline to be used will be assigned by the Quality Manager

prior to the audit and may consist of (as appropriate):

Prepared guideline/checklist.

Procedures/work instructions from the EPSP Quality System. It is preferred that the normal Quality System records and documentation be

used to conduct the audit to establish conformance to our procedures and processes. This will provide for an in-depth review of the system. This type of audit will support the process audit concept and will support continuous improvement of the system and its implementation into all areas and levels of the organization.





Rev 3, 7-30-13 Page 2 of 3

2.0 Audit Schedule/Auditor Assignment 2.1 The Quality Manager will assign the auditors and identify the scheduled month

for the audit using the “EPSP Audit Schedule/Auditor Assignment Form”. An outside auditor can also perform this responsibility if the audit is subcontracted or an independent auditor is not available internally. If an outside auditor is used the requirements of this procedure will still be applicable and must be satisfied including the requirement for training.

2.2 Personnel assigned, as auditors must be independent of the area being audited. 2.3 Auditors must complete “Internal Auditor Training” either in-house or by an

outside source and have training records on file if internal auditors from our personnel are used.

2.4 Upper management will perform a monthly layered audit at a minimum, dimensionally inspecting parts before shipment has been conducted. This layered audit will verify proper inspection techniques are being utilized and procedures are being followed. Upper management will document the results and attach a copy to the DIP and enter the results on the Audit Log.

3.0 Conducting the Audit 3.1 While conducting the audit, the auditor seeks objective evidence demonstrating if

the activity or process meets the requirements of the EPSP Quality System as documented/implemented.

3.2 Positive audit results/objective evidence are documented on the checklist,

guideline, or attached audit notes and also be recorded directly on the “Audit Procedure”.

3.3 Significant non-conformance is to be documented using the EPSP Corrective

Action Report (C.A.R.) Insignificant nonconformance can be recorded and corrected at the time of audit but must be fully reviewed by management and closed in the records. The identified nonconformance is to be reviewed with the related personnel to show the specifics of the identified deficiency and the related Quality System or Documentation that provides the instruction and requirements of the activity or process. Not all nonconformance identified is worthy of a formal corrective action form and process.

3.4 Audit results are brought to the attention of the Vice President, or the assigned

area management. This will be evidenced by signature/initials on the audit results or C.A.R. and can also be recorded by meeting minutes of the presentation to management during a closing meeting or recap summary of the audit. The review and discussion of the “Internal Audit Results” during a management review will also indicate the management has been made aware of the findings and improvement needs.





Rev 3, 7-30-13 Page 3 of 3

4.0 Corrective Action and Follow Up 4.1 Corrective action and follow-up on audit results is to be coordinated by the

Quality Manager working with the assigned auditors and will follow the Corrective and Preventative Procedure for any formal corrective actions written.

4.2 Audit findings and corrective actions are to be formally addressed in 30 days.

Final closure is desired in the 30-day period unless the corrective action requires more time for implementation. If the 30-day period is extended, it will be noted on an “Action Item List” attached to the corrective action to record and verify the actions taken to date and to ensure the actions are being addressed.

4.2 All audit results, C.A.R.’s; follow-up actions are to be made available for the

Management Review process as a means to promote continuous improvements of the EPSP organization


Audit results and records

Audit Checklist/Procedures

EPSP Annual Audit Schedule



Inspection and Testing & Nonconforming Product Process


Rev 9: 12-12-13 Page 1 of 8

PURPOSE The purpose of this procedure is to define the product inspection process

for the Extreme Precision Screw Products manufacturing and purchasing system. This procedure will also outline the requirements and the process for identifying, segregating, dispositioning and recording nonconforming product.

SCOPE Personnel actively participating in the E.P.S.P. Quality System assigned

inspection personnel or quality personnel. RESPONSIBILITY The Quality Manager has the overall total responsibility for the

Receiving, In-Process and Final Inspection Systems. The Quality Manager and President are responsible for the dispositioning and conformance for the nonconforming product process.

DEFINITIONS NCMR = Nonconforming Material Report CAR = Corrective Action Report MRB = Management Review Board

PROCEDURES

1.0 Receiving Verification and Inspection.

1.1 All products, services and material are subject to verification at the receiving

activity of EPSP. The verification of material may require a formal inspection to specification or customer requirements.

1.2 Inbound product is verified for the following items (as appropriate):

Correct paperwork

Material certifications

Correct quantity received

Correct part numbers received

Obvious shipping damage 1.3 The packing slip is to be reviewed against the product and if the verification is

correct the personnel performing the receiving will sign and date the packing slip/certification as evidence the review and verification was performed and was successful. The packing slip is forwarded to the Office Manager for correct processing of the purchase closure.

1.4 The Quality Department determines, from our Purchase Order to the supplier, or

the product received from our customer, if the receiving inspection is recorded on the Quality Control Record, the Outsourcing Card, or the Final Inspection Card.

1.5 Certified product is inspected and if the product is acceptable, the Certification of

Compliance is initialed and dated by the person performing the receiving inspection.





Rev 9: 12-12-13 Page 2 of 8

1.6 Any identified nonconformance’s are to be recorded on the packing slip or if

needed a “Nonconforming Material Report” is to be completed according to the nonconforming product portion of this procedure.

1.7 Communication of the nonconformance is made to the Quality Manager for

inclusion into the “Supplier Performance Evaluation System” and to update the supplier’s records accordingly.

2.0 Receiving Raw Material 2.1 If the customer requires material certification, raw material received for the purpose of

fabrication into parts is obtained with chemical and physical test analysis reports or a “Certification of Compliance” assuring that the material meets customer requirements. The Production Manager is responsible for the inspection of all raw material received to the extent necessary for verification to the Purchase Order and customer requirements.

2.2 The condition of the material is checked to ensure that the order is properly filled, it is

serviceable, and has not been damaged during shipping. Discrepancies/damage found with the material is reported to the supplier and is recorded on the “Nonconforming Material Report”. Rejected material will be marked and separated from the rest of the material.

2.3 All certifications and pertinent data is initialed and dated after all required material

attributes have been verified against the specification. Certifications will be maintained on file. Raw material is color coded in accordance with the Raw Material Color Control Chart prior to storage or use.

2.4 A Raw Material Control Card is prepared on all raw material received. Raw material

received with an acceptable certification is placed in the “Certified Material” storage racks. Raw Material received without an acceptable certification is segregated from the certified material. The material will remain segregated until acceptable certification is received. The material is moved to the “Certified Material” storage racks when an acceptable certification is received.

2.5 At least once a quarter, a sample of raw material is tested for chemical and physical

properties to confirm the supplier’s certification. A log is maintained to ensure that all types of materials, and sources of materials normally used are checked over a period of time. Test results are kept on file.

3.0 Receiving Inspection of Outsourced Product 3.1 Incoming product is not to be used or processed (except for pre-releases) until it has

been inspected by the Quality Department for acceptance. All Certifications of Compliance, when ordered, are identifiable to the part number and traceable to the Purchase Order.

3.2 In the event the service cannot be inspected, the Certification of Compliance is

acceptable.





Rev 9: 12-12-13 Page 3 of 8

3.3 The Quality Department determines, from our Purchase Order to the subcontractor, if the

receiving inspection is recorded on the Quality Control Record, the Outsourcing Card or the Final Inspection Card.

3.4 If the service is acceptable, the Certification of Compliance is initialed and dated by the

person performing the receiving inspection. Service deemed unacceptable is tagged and the disposition of it is the responsibility of the Quality Manager and is recorded on the Nonconforming Material Report and the incident entered into the suppliers history file.

3.5 Products processed are run using normal processes/procedures. These products are

supervised and jobs are monitored/tracked by the responsible company.

4.0 In Process Inspection System 4.1 The set-up person is responsible for qualifying the set up of the machine and

inspecting the first piece, using the Quality Control Record to keep a record of which dimensions on the print were machined. The findings dimensionally and the list of the inspection measuring test equipment or gauging is to be recorded on the “Quality Control Record”.

4.2 Upon his acceptance, the operator submits the first piece to the Production

Manager or his designee. The Production Manager, or designee, inspects the dimensions machined, the gauging being used, and compares his findings with that of the operators, and assigns the frequency of inspection. The Production Manager must ensure that the gauging that the operator is using has sufficient and proper tolerance range for the characteristic being measured.

4.3 If the part is acceptable, the Production Manager or designee, initials and dates

the “Quality Control Record” and the operator can proceed to In-Process Inspection. The frequency at which the operator inspects characteristics is assigned by using the sampling plan from the customer’s requirements.

4.4 If the part is not acceptable, the set-up person makes all necessary adjustments

to correct the deficiencies and re-inspects his part prior to re-submitting the part to the Production Manager or designee. Full production and machining in the operation is not to begin without first obtaining conformance to product requirements status from the first piece inspection.

4.5 Machined parts are segregated from the lot using the two containers or symmetrical

arrangement until the dimensions being machined are verified to be acceptable, using the frequency assigned by the Production Manager or designee.

4.6 Only after acceptance, are the machined parts in the first container added to the second

container. 4.7 The operator keeps count of the number of parts inspected until the job is completed.

When the job is completed the number is entered on the Quality Control Record. The operator initials, dates, and records the number of parts accepted during the operation, the number of parts scrapped, and the number of parts stocked in stores.





Rev 9: 12-12-13 Page 4 of 8

4.8 Any deviation from the print is reason to stop the operation until the cause is found and

corrected. All affected parts are 100% inspected for dimensions affected prior to being added to the lot.

4.9 When an operation is stopped for any correction, the Production Manager or designee

must perform a first piece inspection, before the operation can be continued. Any parts found not conforming to print requirements are tagged using a Part Identification Card. A rework sheet is prepared describing the discrepancy found. Any processes requiring the joining of two or more parts, the joining characteristics are 100% inspected prior to joining.

5.0 Final Inspection Requirements

5.1 All parts manufactured, processed, or modified must pass a final inspection using the

Final Inspection Report and any customer specific requirements (see Quality Data Files). This includes all dimensions, characteristics, and notes listed on the blueprint and any attachments. During Final Inspection the outsourced certifications when applicable must be verified, following the same procedure as paragraph 3.4. and must be signed and dated from someone other than the original inspector. This secondary step must be completed before shipment has been made. Visual inspections will be performed, at a minimum, under illuminated 10x magnification. The final inspector will ensure that they use a different gauge for Final Inspection than the gauge used during production [Production gauge identification can be found on the Quality Control Record].

5.2 The classification of characteristics on a drawing during final inspection of all parts is

performed in accordance with the customer’s requirements and with zero defects being accepted (C=0). If a characteristic is found to be out of the allowable tolerance, the characteristic will be 100% inspected for the entire lot and the frequency of inspection will be increased to the next level for the next two lots.

5.3 Accepted parts are forwarded to shipping by the approving inspector. Parts to be

shipped will be packaged per customer requirements whether packaged in house or subcontracted to an off-site packaging service. When parts are pulled from complete parts inventory, the inspector pulling parts must have the blueprint in hand to verify the correct part is being pulled by comparing the part number and a visual against the blueprint. All parts with the same last three digits of the part number or visually similar must perform the additional task of having a second inspector verifying the correct parts have been pulled. Parts will be shipped by a customer requested/approved shipping method. All parts left over after shipping will be stored in such a manner that no deterioration of the product will occur. In the electronically stored inventory system, a part with the same last three digits as any other part number for that customer will be color shaded in YELLOW to identify that caution must be taken to ensure the correct part number is pulled when needed.

5.4 It is not our practice to Drop Ship parts directly from our Sub-Tier contractors to our

customers. If our customer requires this action to take place, we will require the customer to dictate all the procedures to be taken to us.





Rev 9: 12-12-13 Page 5 of 8

5.5 Discrepant parts are tagged or recorded on a “Nonconforming Material Report” as

such listing all the discrepancies in detail, and forwarded to the Quality Manager or his designee

5.6 All certification and inspection reports are kept on file.

6.0 Customer Source and Self Release Inspections

6.1 A copy of the customers Purchase Order is furnished to the Government representative

who has cognizance over this company. If a G.S.I. office cannot be located, the Sales Manager notifies the customer issuing the Purchase Order. When the product is ready for inspection, the Sales Manager notifies the G.S.I. office,

6.2 If a Customer source Inspection is required, the Quality Manager will contact the

customers Quality Manager and comply with the customer’s requirements.

6.3 If a Customer Self Release Inspection is required, the person qualified to perform the inspection will comply with the customer’s requirements. In addition to, upper management will verify parts being shipped to customer by visual inspection of packaged final product against blue print and PO. Once completed and accepted upper management will sign off on shipping log.

7.0 First Article Inspections 7.1 First Article Inspection Reports are the responsibility of the Quality Manager. If required

by the customer, First Article Inspection Reports are prepared on all new parts, after any engineering change, after a lapse of two years or more since the last shipment, or per the customer’s requirements.

7.2 The First Article Inspection Report is either recorded on the EPSP 1

st Article Inspection

Form or the specific customer supplied/dictated form. 7.3 The original copy is forwarded to the customer in accordance with their shipping

instructions. A copy is maintained on file.

7.4 All necessary characteristics and notes on the drawing are sequentially numbered. The classification of characteristics on a blueprint and the First Article Inspection is performed in accordance with the customer’s requirement with zero defects being accepted.

7.5 Any discrepancies found are reported to the Quality Manager for disposition.

7.6 When required, a First Article Inspection Report is prepared to the customers drawing on

one piece from the first lot of each part number. The piece is representative of the lot. The First Article Inspection Report includes at a minimum:

Part Number

Latest engineering change letter or number

Part Name





Rev 9: 12-12-13 Page 6 of 8

Purchase Order number

Date,

Manufacturing process instructions,

Inspector’s name,

Customer supplied stamps

Applicable identifying codes and/or references.

7.7 All dimensions and characteristics on the customer drawings completed to the customer’s required drawing level. All general notes are listed and the method of verification is indicated and recorded.

7.8 When variable gauging is used (micrometers), the actual value is recorded and the type

of gauging used is noted. When non-variable gauging is used (plug gages) the largest accepted gage is recorded.

7.9 When customer owned tooling or gauging is used, the identifying number is listed.

If customer approval of the First Article Inspection Report is required prior to shipping the parts, the Quality Manager contacts the customer or their representative.

7.10 All First Article Inspection Reports are signed by the Quality Manager or his designee, and submitted to the customer for review with the first shipment. A corresponding numbered blueprint accompanies the First Article Inspection Report. A copy of all certifications of materials, special processes, and controlled processes accompany the First Article Inspection Report. A copy of any customer approved deviation request accompanies the First Article Inspection Report. When a First Article Inspection Report is required on an assembly a First Article Inspection Report will be prepared on each individual part.

8.0 Nonconforming Product Inspection

8.1 The Quality Manager is notified if a part is out of drawing or customer specification. The

Quality Manager is responsible to determine if the discrepancy was caused by “in house” source or if the nonconforming product is due to outsourced services including raw material suppliers.

8.2 Parts in question are segregated, tagged, and stored in a separate area controlled by the Quality Department. The nature of the nonconformance is recorded on the “Nonconforming Material Report’ The Quality Manager determines the disposition of the nonconforming product and provides any instruction needed for the disposition.

8.3 Disposition may include (as appropriate)

Parts to be reworked are returned to the Production Manager with a Non Conforming Sheet. After reworking, parts are resubmitted for final inspection and or testing.

Parts that need to be repaired must have Customer approval prior to any repair work being done. Exact process for obtaining Customer approval will be dictated by the Customer.

Parts to be scrapped are disposed of immediately by depositing them in the red scrap barrels.





Rev 9: 12-12-13 Page 7 of 8

Parts to be submitted for material review on a case record will have all applicable forms prepared and are moved to an inspection holding area. Parts are not moved and all data on the parts is retained until the customer’s material review decision is made.

8.4 Parts held for customer approval are kept segregated pending the customer’s approval, and then the parts are re-inspected for compliance to the deviation granted and forwarded to shipping. All customer information and decisions are recorded on the “Nonconforming Material Report Form”.

8.5 Discrepant parts that may be reworked or repaired are forwarded to the Production

Manager for rework; after rework, parts are resubmitted for inspection and or testing. All rework and/or repairs are noted on the Rework Sheet and attached to the Quality Control Record.

8.6 Discrepant parts that were processed “out-of-house” are returned to that supplier for

rework. Discrepant parts that cannot be reworked are forwarded to the Quality Manager for disposition. All supplier issues are handled by the Quality Manager and are subject to corrective action from the supplier.

8.7 Parts deemed as possibly usable are tagged and submitted to the customer for material

review action. If accepted by the customer the decision and actions are to be recorded and the lot traceability for the production lot in question recorded and tracked. .

8.8 To ensure product conformity, for any internal or external rejection we will 100% inspect

the specific dimension in question for the entire remainder of the lot. This inspection will continue for at least the next three lots manufactured or as directed by the customer. All inspections will be documented on a DIP and kept as a record.

8.9 Shipping records are checked to ensure non-conforming parts have not been shipped to

the customer. If non-conforming parts have been shipped, the Quality Manager contacts the customer, within 24 hours. The Quality Manager will provide the customer the following information:

Part number, nomenclature of part

Date shipped, packing slip number

Quantity

Nature of the defect

Any other information necessary to assist the customer in locating the non-conforming parts.

Customer assigned vendor code as applicable

8.10 A search of inventory is done to identify any parts needing corrective action. If any product is found it is to be segregated and entered into the nonconforming product system.

8.11 The Product Work Instructions are reviewed by the Production Manager to ensure any

and all necessary changes to the parts manufacturing process are made. The inspection folder is marked identifying any corrective action report number/case record number and the reason for the action





Rev 9: 12-12-13 Page 8 of 8


Inspection Records

Nonconforming Material Record Form

1st Article Inspection Form

Material Certifications

Quality Control Record



Corrective and Preventative Actions


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PURPOSE The purpose of this procedure is to outline the process for initiating and completing the continuous improvement process for the Extreme Precision Screw Products organization including the processing of customer complaints. The corrective and preventive action disciplines and records are a part of this procedure and are considered an integral part of the continuous improvement process.

SCOPE Personnel of EPSP actively participating in the Quality System or

processing customer complaints and corrective actions are included in the requirements of this procedure.

RESPONSIBILITY The President has the overall total responsibility for the Continuous

Improvement Process. The Quality Manager/Vice President is responsible to monitor the corrective and preventive action process including the timely completion of CAR’s.

DEFINITIONS

CAR= Corrective Action Report PROCEDURES

1.0 Customer Complaints

1.1 Customer calls and complaints are to be routed to the Quality

Manager/Management Representative for proper handling. The complaint or concern is to be recorded on an EPSP Corrective and Preventive Action Report, Red Non-Conforming Material Report, or a note pad to ensure all the pertinent information is obtained for review. All valid customer complaints will be recorded by EPSP Personnel and communication maintained with the customer.

1.2 The investigation of the complaint is handled by the Management Rep. or Quality

Manager who investigates/troubleshoots the complaint to verify it is a valid complaint. The customer specifications, contracts, order and any other information that is received is used to establish validity.

1.3 Customer correspondences such as “Performance Reports or a Customer

Corrective Action Report/Request” are to be completed and returned to the customer by the Quality Manager. The President will review all correspondence with the customer prior to communication of the information back to the customer.

1.4 Management Personnel will ensure that follow up communication is made with

the customer regardless of whether or not the complaint is handled using the formal corrective and preventive action system or addressed in verbal communication.





Rev 4, 12-11-13 Page 2 of 5

1.5 Customer performance ratings that are received indicating a less than

satisfactory performance documented and handled as a customer complaint and logged for review and tracking purposes.

1.6 Customer products that are returned as defective to EPSP are to be brought to

the attention of the Quality Manager. The Quality Manager collects as much information about the defective product and/or finding as possible. This information should be attached to the Corrective & Preventative Action Report.

1.7 The Quality Manager determines the source of the defective product. The

Quality Manager contacts the Production Manager for all in-house discrepancies to ensure the problem is isolated and not systemic at any other point in the company. Quality Manager contacts the subcontractor or customer for all out-of-house discrepancies and requests for return material. This supports good containment action.

1.8 The information obtained is used to support root cause analysis. The supplier is

contacted for corrective action if it is determined that the cause comes from their location external to EPSP. Personnel associated with the problem or having the expertise to correct the issues addresses the internal non-conformance in product and process.

1.9 All customer complaints are fully recorded and addressed by personnel of EPSP

and reviewed during the management review.

2 Corrective Action 2.1 By utilizing a multi-disciplined, analytical problem solving system, the following

actions can be realized and documented (as applicable):

Investigation as to the cause of the non-conformance

Results recorded for investigation and historical information.

Determination of appropriate corrective action

Effective implementation of the corrective action

Verification that the corrective action is effective

Determination of root cause for internal deficiencies and nonconforming product if needed based on the performance measurables.

2.2 The EPSP Corrective Action & Preventative Report will provide a basis for the

correct process in effective corrective action and in maintaining a disciplined system for a step-by-step analytical problem solving process. All actions taken during the implementation and follow up for the corrective action are to have the effectiveness determined to ensure the action will fully eliminate the affects and the occurrence of the issue from recurring.

2.2 The Management Team of Quality, Supervision and Purchasing is utilized as the

“Multi Disciplined Problem Solving Team”. Several employees in various areas of





Rev 4, 12-11-13 Page 3 of 5

the organization, who have been trained in analytical problem solving, participate in customer complaints and product nonconformance support this team. This will ensure the effectiveness of the process and will communicate the continuous improvements to the key areas of the organization.

3 Preventative Actions 3.1 Preventative action will be implemented to eliminate the problem/non-

conformance from occurring again. A systematic review for other potential applications of corrective and preventative action to other customers, and processes will be performed.

3.2 The review can utilize any of the following information services (as applicable):

Other Screw Machine Product Applications

Non-conformance reports received from the customer and also the ones that are part of our performance measurables.

Audit results both internal and external

Quality records within EPSP

Performance Measureables 3.3 Preventative actions are to be documented and applied to other potential

applications as identified during the review of the action. 3.4 Some other measures of preventive action entail the use of brainstorming items

that were not part of the root cause but still have the threat or potential for occurrence in the system. These are given attention and if preventive action can be implemented it is done.

Note: Preventative action can be documented on the EPSP C.A.R. form without

the initiation of corrective action. It is encouraged that the organization be proactive to preventing the initial occurrence of a problem than reacting to it after the fact.

4.0 Employee Preventive Actions 4.1 The Quality Department is responsible for keeping records of work operations and

processes that affect quality, concessions audits results, quality records, and customer complaints. Any employee is authorized to identify and record any problems relating to product, process, or the quality system, and forward them to the Quality Manager as a concern or an area that might be open to preventive action.

4.2 Any employee is authorized to submit to management any suggestions that modify the

part being manufactured or procedures taken during the manufacturing that may provide a cost savings to the company or an improved product to our customer. Suggestions submitted that require customer approval are submitted through the customers proper channels. Management will investigate and answer all suggestions in a timely manner and record the decisions.

4.3 Any employee is authorized to make changes to the Product Work Instructions for any

operation that they are familiar with and performing. All changes are initialed so that the





Rev 4, 12-11-13 Page 4 of 5

Quality Manager is able to contact the author if a question arises during the review and implementation of the change. Any change to the Product Work Instruction is reviewed prior to implementation and approved by the Quality Manager/Management Rep.

4.4 Any employee is authorized to stop the production or the handling of any product if he

believes that the action to be taken can result in the damage or destruction of the product, equipment or injury to themselves or their fellow workers. This stopping of production is reported to the Production Manager or designee.

4.5 Preventative actions submitted, accepted and enacted are evaluated during production

for there effectiveness and the Product Work Instruction is amended to reflect the change taken are implemented by the Quality Manager.

4.6 Any employee is authorized to contact the Quality Manager if any changes or proposed

changes may affect the quality of the product. The Quality Manager will evaluate the change and determine if the customer is to be notified. If it is determined that the quality of the product may be affected the Quality Manager will notify the customer. This includes, but is not limited to changes of personnel, procedure, manufacturing, major equipment, subcontractor, internal changes at a subcontractor’s facility, or facility relocations.

5 Verification of Corrective Action 5.1 After the implementation date, the corrective action will be verified either through

an audit of records or an analysis of data, or by personal observation (See QP 8.2-1 Para. 8.1 for post verification inspection requirements). Once the implementation of a Corrective Action is verified, the corrective action request can be closed. Preventive actions are verified to ensure the action was taken and was effective.

5.2 The Quality Manager/Management Rep. is responsible for ensuring that the

corrective action process is monitored. Monitoring will include review of the status of open C.A.R. (s) and overall evaluation of the effectiveness of the Corrective Action program.

5.3 The status of open C.A.R. (s) and the effectiveness of the Corrective Action

program will be reviewed by the Quality Manager and the President during the informal management reviews and meetings in the organization.

6.0 Management Review 6.1 The Management Representative will review the “Corrective and Preventative

Action Log” Quarterly (at a minimum) and will notify the President if any delinquent or outstanding actions are overdue.

6.2 The review will provide the following (not all inclusive):

Identification of non-conformance trends

Negative trends in the EPSP performance measurables





Rev 4, 12-11-13 Page 5 of 5

Notification to management of Customer Complaints as recorded in the Customer Concern Log.

Internal/external audit non-conformances

Timely response and follow up to Corrective and Preventative Actions as needed

Verification of complete closure

6.3 All Corrective and Preventative action forms must be reviewed and approved by the Quality Manager for final closure.

7.0 Continuous Improvements 7.1 Continuous improvements will be documented in one or more of the following

ways:

Management objectives and goal revisions

Revision to the Quality System Documentation

Financial results and key performance graphs and charts ASSOCIATED DOCUMENTS:

Corrective Action Log (Electronic)

Corrective and Preventative Action Report (Electronic)