prime inc quality_manual

7/29/2019 Prime Inc Quality_Manual

1/178

Twin Lakes Road, P.O. Box 185

North Branford, Connecticut 06471

Phone: (203) 481-5721

Fax: (203) 481-8937

Prime Technology, LLC

Quality Manual

Approved by: Luis Lluberes, Chief Operating Officer

Approved by: Paul Grabek, Quality Manager

Drawing Number QM001

Quality Manual Edition 7 released per ECN-11-180,Dated Sept. 30,2011Quality Manual Edition 6 released per ECN-11-141, Dated Aug. 15, 2011


2/178

Procedure Listing

Quality Manual Subject: Quality Manual Revision Control Sheet

Edition 7 Revision:B

Supersedes: Edition 6 [8-15-11] Date: 9-30-11

Supersedes: Revision A

Page 1 of 1Procedure Rev Rev Date Title

NA A 8-15-11 Quality Manual Revision Control Sheet

1.0 NA NA Introduction

1.1 A 8-15-11 Quality Policy Statement, Malpractice, and Security

1.2 A 8-15-11 Company Organization

2.0 NA NA Management

2.1 B 9-30-11 Control of Quality Manual

2.2 A 8-15-11 Quality Organization

2.3 A 8-15-11 Quality Planning and Contract / Purchase Order Review

2.4 A 8-15-11 Critical Resource Training and Certification

2.5 A 8-15-11 Manufacturing Work Instructions

2.6 A 8-15-11 Quality Assurance Records

2.7 B 9-30-11 Corrective Action

2.8 A 8-15-11 Quality Performance Analysis

2.9 A 8-15-11 Quality Audits

3.0 NA NA Engineering Standards

3.1 A 8-15-11 New Product Development/Release

3.2 A 8-15-11 Engineering Change Control

3.3 A 8-15-11 Implementation of Engineering Changes

3.4 A 8-15-11 Temporary Authorization - Obsolete

3.5 A 8-15-11 Product Identification/ Traceability

3.6 A 8-15-11 Control and Calibration of Measuring and Test Equipment

4.0 NA NA Manufacturing

4.1 A 8-15-11 Procurement Control

4.2 A 8-15-11 Supplier Surveys/Evaluation4.3 A 8-15-11 First Article Inspection of Purchased Material

4.4 A 8-15-11 Inspection of Purchased Material

4.5 B 9-30-11 Disposition/Corrective Action for Non-Conforming Material

4.6 A 8-15-11 In-Process Inspection and Test

4.7 A 8-15-11 Final Inspection and Test

4.8 A 8-15-11 Customer Product Submittal and Inspection Rights

4.9 A 8-15-11 Statistical Sampling Inspection

4.10 A 8-15-11 QA Identification Symbols/Stamps

4.11 A 8-15-11 Material: Exposure to Mercury, Handling , Movement, Storage and Traceability

4.12 A 8-15-11 Shelf Life

4.13 A 8-15-11 Handling of ESD Parts, Assemblies, and Equipment

4.14 A 8-15-11 Product Packing and Packaging

4.15 A 8-15-11 Control of Special Processes

4.16 A 8-15-11 Material Verification and Traceability

5.0 NA NA Customer Service

5.1 A 8-15-11 Return Authorization

5.2 A 8-15-11 Control of Customer Furnished Property

5.3 A 8-15-11 Part 21, Reporting of Defects and Noncompliance

5.4 B 9-30-11 Commercial Grade Dedication

5.5 B 9-30-11 Failure Reporting Process


3/178

Procedure No. 1.1

Quality Procedure Subject: Quality Policy Statement

Revision: A

Date: 08-15-11

Supersedes: Revision 4

Page 1 of 3

ORIGINATOR:

Paul GrabekQA MANAGER:

Paul Grabek

PURCHASING:

Jim JamiesonENGINEERING

Nick Graziano

MARKETING:

Keith MacdowallMATERIAL CONTROL:

Jim Jamieson

COO:

Luis LluberesPRODUCTION:

Sam Mandel

REV DATE AUTHOR DESCRIPTION OF CHANGE

0 07-17-97 Carol Pepin Original

1 06-01-01 Paul Grabek Changed President2 06-23-03 Paul Raspe Added cover sheet and formatted policy statement. Changed Inc to LLC in one

place.

3 05-30-06 Victor

Szatkowski

COO was President, added Purchasing

4 10-01-08 Paul Grabek Added malpractice and security.

A 08-15-11 Paul Grabek No change except Rev. Convert from number Rev to letter Rev.


4/178

Procedure No. 1.1

Quality Procedure Subject: Quality Policy Statement, Malpractice, and Security

Revision: A

Date: 08-15-11


Page 2 of 3

Q u a l i t y P o l i c y

It is a major objective of Prime Technology, LLC. to maintain

our reputation for leadership in Quality. It is our continuinggoal to provide products and services that meet or exceed our

customers requirements. We support continuous improvement

by maintaining open communications with our customers,

employees, and suppliers.

Luis LluberesChief Operating Officer (COO)


5/178

Procedure No. 1.1

Quality Procedure Subject: Quality Policy Statement, Malpractice, and Security

Revision: A

Date: 08-15-11


Page 3 of 3

Malpractice

Prime Technology LLC shall not tolerate malpractice in performance of its

obligations to customers. Malpractice requirements shall flow down to critical

suppliers and subcontractors through Prime Technology LLC purchase

orders.

Prime employees shall receive training on malpractice and shall be required

to sign a copy of the employee manual stating they have been trained and

understand malpractice and its implications.

Security

Prime Technology LLC is a Department of Defense supplier and maintains a

secure facility.

Prime employees shall receive training on security procedures and shall be

required to sign a copy of the employee manual stating they have been trained

and understand security and its implications.

Luis Lluberes

Chief Operating Officer (COO)


6/178

Procedure No. 1.2

Quality Procedure Subject: Company Organization

Revision: A

Date: 08-15-11


Page 1 of 3

ORIGINATOR:


Paul Grabek

PURCHASING:

Jim JamiesonENGINEERING:

Nick Graziano

MARKETING:


Jim Jamieson

COO:


Sam Mandel


0 07-17-97 Carol Pepin Original1 09-17-97 Carol Pepin Exhibit A, Organizational Chart update.

2 09-15-00 Carol Pepin Exhibit A update. IV. Implementation: Correct typo error that Accounting is

responsible for Quality.

3 06-21-02 Paul Grabek Exhibit A update.

4 09-23-02 Mary Harnois IV. Implementation: Correct again the typo error that Accounting is responsible for

Quality. Organizational chart scanned into document.

5 06-23-03 Paul Raspe Added cover sheet. Change Inc to LLC in two places. Updated Organizational

Chart.

6 05-30-06 Victor

Szatkowski

COO was President, added Purchasing, revised organizational chart.

7 10-01-08 Paul Grabek Updated organization chart.

8 05-01-10 Paul Grabek Updated organization chart

9 09-06-10 Paul Grabek Updated department descriptions

A 08-15-11 Paul Grabek Convert from number Rev to letter Rev. Six units was 7. Manufacturing was

production and fabrication.


7/178

Procedure No. 1.2


Revision: A

Date: 08-15-11


Page 2 of 3

I. Policy

It is the policy of Prime Technology, LLC to maintain a management structure that provides the flexibility and

latitude for effectively achieving their goals. The purpose of this procedure is to show the overall organizational

structure, describing each organizational units basic responsibility.

II. Responsibility

The COO is responsible for implementation of this procedure.

III. Definitions

Not applicable.

IV. Implementation

Prime Technology, LLC is divided into six (6) separate organizational units (Exhibit A) reporting to Administration

Human Relations (HR) is grouped with Administration. The departments are Sales, Finance, Quality, Procurement,

Manufacturing, and Engineering.

The Sales Department is responsible for market research, sales, contracts, customer relations, advertising, and

promotion.

The Finance Department is responsible for money management, credit, collections, and accounting.

The Quality Department is responsible for quality management and administration, quality engineering, quality

plans / procedures, inspection, and calibration.

The Procurement Department is responsible for material procurement. Under the auspices of the Procurement

Department the Material Control Department is responsible for material planning, receiving, shipping, stockroom,

and packaging.

The Manufacturing Department is responsible for production, assembly, test, repair of products, fabrication of parts

and plant maintenance.

The Engineering Department is responsible for product design, tool / test equipment design, drawing control,

Engineering Standards, and new product design / innovation.

The company organization chart is shown in Exhibit A.

V. Reference

Not applicable.


8/178

Procedure No. 1.2


Revision: A

Date: 08-15-11


Page 3 of 3

EXHIBIT A


9/178

Procedure No. 2.1

Quality Procedure Subject: Control of Quality Manual

Revision: B

Date: 09-30-11


Page 1 of 3

ORIGINATOR:


Paul Grabek

PURCHASING:


Nick Graziano

MARKETING:


Jim Jamieson

COO:


Sam Mandel



1 06-01-01 Paul Grabek I. Policy: Deleted: Procedures contained herein satisfy the requirements of ISO 9001 and10CFR50, Appendix B. IV. Implementation: Revised procedure change review and

comment. Added hardcopy manual distribution replaced by read only intranet. V.

Reference: Corrected 3.3 to 3.4.

2 09-20-02 Mary

Harnois

None found.

3 06-23-03 Paul Raspe Added cover sheet. II. Responsibility: Deleted typo error The Manager. Changed Inc to

LLC in one place.

4 05-30-06 Victor

Szatkowski

COO was President, added Purchasing, revised implementation section, added Exhibit B

A 08-15-11 Paul Grabek Convert from number Rev to letter Rev. Internet / intranet was controlled copies. TA

references deleted. Revised paragraph IV. Revised Exhibit A number 4 and 5.

B 09/30/11 Paul Grabek Page 2, Changed location from: Public, To: Engineering Released Document Folder.


10/178

Procedure No. 2.1


Revision: B

Date: 09-30-11


Page 2 of 3

I. Policy

It is the policy of Prime Technology, LLC to maintain a centrally coordinated manual of procedures related to Quality

activities. This manual is under the direction and issuance control of the Quality Manager. This procedure outlines

the controls on procedures contained within the Prime Technology Quality Manual. Included within this procedure are

the distribution of the manual to the internet / intranet, revision processes and procedure format.

II. Responsibility

The Quality Manager has overall responsibility for administration of this procedure and of assuring that written

procedures satisfactorily address contractual requirements.

III. Definitions

Quality Procedure. A written procedure incorporated into the Quality Manual outlining the method or steps to be

performed in support of a quality objective.

IV. Implementation

All Procedures included in the Quality Manual are written in the format outlined in Exhibit A. Control of the Quality

Manual is the responsibility of the Quality Manager. Only the current revision of the manual is available to users. This

is maintained by read only access to Prime Technology employees on the company wide intranet. The manual is

available on the Engineering drive Released document Folder / Quality Manual Folder. For customers the Quality

Manual is available on the Prime Technology web site: www.primetechnology.com. The Quality Manual is included

in the Quality Section.

Revisions to the Quality Manual may be requested through an Engineering Change Request (ECR). The Engineering

Change Notice shall be the approved method for revision to the Quality Manual.

V. Reference

Procedure 3.3, Implementation of Engineering Changes


11/178

Procedure No. 2.1


Revision: B

Date: 09-30-11


Page 3 of 3

Exhibit A

1. The structure of Quality Procedures.

I Policy

II Responsibility

III Definitions

IV Implementation

V Reference

2. Paragraphs are in narrative format.

3. Copies of relevant forms are included as attachments.

4. A revision control sheet is incorporated into each procedure. This cover sheet will identify the revision status.

5. Revision status is indicated by a letter. The initial issue of a procedure will be Rev. A.


12/178

Procedure No. 2.2

Quality Procedure Subject: Quality Organization

Revision: A

Date: 08-15-11


Page 1 of 4

ORIGINATOR:


Paul GrabekPURCHASING:


Nick GrazianoMARKETING:


Jim JamiesonCOO:


Sam Mandel

REV DATE AUTHOR DESCRIPTION OF CHANGE0 10-01-96 Carol Pepin Original

1 None found.

2 09-15-00 Carol Pepin IV. Implementation: Delete ways to feedback: CAB, monthly quality indicator data.

Exhibit B, Functional Quality Assurance Organization: Add Certificates of

Compliance/Conformance/Calibration and * note for authorized sign off. Exhibit A,

Quality Assurance Organization Chart update.

3 09-23-02 Mary

Harnois

I. Policy: Delete phrase: and fulfill quality objectives.

4 06-23-03 Paul Raspe Add cover sheet. Changed Inc to LLC in one place. Added at Prime Technology, LLC.

Exhibit A updated.

5 05-30-06 Victor

Szatkowski

COO was president, added Purchasing

6 10-01-08 Paul Grabek Updated Exhibit A

A 08-15-11 Paul Grabek Convert from number Rev to letter Rev. Corrected Exhibit A. Added VP to C of Csignature list.


13/178

Procedure No. 2.2


Revision: A

Date: 08-15-11


Page 2 of 4

I. Policy

The primary charter of the Quality Organization at Prime Technology, LLC is improvement. To insure continuous

improvement in the quality of the products and services offered, to insure that all products and services provided to

customers meet or exceed all applicable standards and are defect free. The organization identifies opportunities for

improvement, tracks performance measures, and provides management with performance information. The

organization also coordinates and audits root-cause problem analysis and corrective action efforts.

The Quality Program provides the framework for improvement. It emphasizes continuous improvement throughout

the product life cycle from design conception, through manufacturing, customer delivery, and field support. The

Quality Program is designed to satisfy customer requirements and meet 10CFR50 Appendix B, ISO 9001, and MIL-

I-45208A. The program is flexible such that special customer requirements are supported when required by

purchase order. The purpose of this procedure is to provide an organizational structure for Quality Assurance,

define functional responsibilities, and establish lines of authority.

II. Responsibility

The Manager, Quality Assurance, is responsible for implementation of this procedure.

III. Definitions

Not applicable.

IV. Implementation

The Quality Assurance organization chart is shown in Exhibit A.

Functional responsibilities are delineated in Exhibit B. Detailed procedures and responsibilities that support the

primary functional responsibilities are contained in the individual procedures of the Prime Technology Quality

Manual.

The Manager, Quality Assurance, and all employees of Prime Technology (Exhibit A) have the authority and

organizational freedom to identify and evaluate quality problems and to initiate, recommend, or provide solutions.

Senior management regularly reviews the status and adequacy of the quality program.

It is recognized that other organizations within Prime Technology initiate documentation that can affect the quality

of product (e.g. process sheets, acceptance test procedures). The Quality organization is procedurally required to

review and approve such documentation to insure compliance to requirements.

V. Reference

MIL-I-45208

10CFR50 Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants

ISO9001


14/178

Procedure No. 2.2


Revision: A

Date: 08-15-11


Page 3 of 4

Exhibit A

Prime Technology, LLC

DRPlant Manager

DRManufacturing

QA ManagerNorth Branford

DRQuality Assurance

Manager

Quality EngineerNorth Branford

DRQuality Assurance

Inspectors

COO

NBQuality Control

Inspectors/Testors

Quality Assurance Organization Chart


15/178

Quality Procedure

Exhibit B

Functional Quality Assurance Organization

Quality Administration Quality Engineering Audit

* Certificates of Compliance/Conformance/Calibration

Quality Procedures/Manual Calibration Services Quality Auditing

Training Product Reliability Testing Mfg. Workmanship Performance

Quality Performance/Analysis Incoming Inspection Support Nonconforming Material Supplier Source/Evaluation Inspection instructions Repair & Returns

Supplier Support/Interface Technical support Receipt

Review of drawing requirements Manufacturing Support Tracking

Procurement requirements Inspection instructions

Corrective Action Methods/Test review

Quality Program Planning

Manufacturing support

MRB

Root-cause analysis

Corrective Actions

Customer Liaison

Contract requirements

Internal corrective actionsImprovement plans/goals

Records

* The Quality Manager and the COO are authorized to sign Certificates of Compliance/Conformance and Calibration for goods and se

Technology, LLC. When the Quality Manager or COO is not available a company officer of Vice President level may sign as an alt


16/178

Procedure No. 2.3Quality Procedure Subject: Quality Planning

Revision: A

Date: 08-15-11


Page 1 of 2

ORIGINATOR:


Paul Grabek

PURCHASING:


Nick Graziano

MARKETING:


Jim Jamieson

COO:


Sam Mandel



1 09-15-00 Carol Pepin Delete Exhibit A, Contract Quality Planning and Review & B, Quality Plan. IV.Implementation: Revised the wording concerning the requirements for a formal

Quality Planning document.

2 09-24-02 Mary Harnois Formatted document to fit on one page.

3 06-23-03 Paul Raspe Added cover sheet. Added LLC in one place.

4 05-30-06 Victor

Szatkowski


5 10-01-08 Paul Grabek Updated contract review requirements.

A 08-15-11 Paul Grabek Convert from number Rev to letter Rev. Quality Manager was Quality Assurance.


17/178

Procedure No. 2.3

Quality Procedure Subject: Quality Planning

Revision: A

Date: 08-15-11


Page 2 of 2

I. Policy

Quality Planning is accomplished for all contracts to assure product quality. The planning effort includes a review

of contract requirements to identify and make timely provisions for the special controls, processes, test equipment,

fixtures, tooling and skills required. When required by contract, a formal documented Quality Plan is generated.

Contracts/Purchase Orders shall be the governing document over any other document, drawing, or specification.

Requirements shall flow down to suppliers and subcontractors as required by the contract, or Purchase order. The

purpose of this procedure is to provide a means for implementing Quality Planning to support Prime Technology,

LLC products.

II. Responsibilities

The Manager, Sales, is responsible for the preparation of Sales Orders and entry of Quality requirements.

The Quality Manager is responsible for the overall implementation of this procedure and the preparation of Quality

Plans.

III. Definitions

Product Quality Plan (PQP): A project-oriented document, delineating the plan required to assure compliance with

the quality requirements of the contract.

Standard Products: Those products that are fully released to production. Manufacturing documentation including

blue prints, process sheets and routings are available to support the product.

Non-Standard Products: Those products that are not released to production.

IV. Implementation

Quality Planning starts at the bid proposal stage. Once the decision has been made to bid and the need for Quality

support is determined a copy of the bid package is provided to the Quality Manager or his designee by Sales. The

package includes a copy of the proposed contract, any product specifications, and any special instructions involving

the product requirements when available. The contract review determines the requirements for a formal Quality

Planning document. This may vary from a Quality Assurance Directive, where the variances to standard operating

procedures are implemented to a full Product Quality Plan (PQP). As a part of the planning effort and involvement

in product development investigation, all documentation, specifications, procedures, and instructions are reviewed to

insure compatibility and to insure that these documents assure conformance to product specifications.

Contracts for standard products need not be reviewed as Quality Planning has been completed and incorporated in

the manufacturing documentation traceable by a fifteen digit part number. Systems requirements are satisfied by the

Prime Technology Quality Manual. Nuclear/Military contracts are reviewed at the quoting/contract/amendmentstages for inclusions or changes to Quality requirements. Amendments are reviewed for document/specification

revisions. A determination shall be made during review for the need of Vender Information Requests or waivers if

required. Any questions relating to customer quality requirements are forwarded to the Quality Manager for

resolution.

After the review is completed, the Sales clerk includes the specific quality requirements during sales order entry so

they will be printed as instructions on the face of the Sales Acknowledgement and Pick List.

V. Reference

Not applicable.


18/178

Procedure No. 2.4

Quality Procedure Subject: Critical Resource Training and Certification

Revision: A

Date: 08-15-11


Page 1 of 3

ORIGINATOR:


Paul Grabek

PURCHASING:


Nick Graziano

MARKETING:


Jim Jamieson

COO:


Sam Mandel


0 05-02-97 Carol Pepin Original1 NA Carol Pepin IV. Implementation: Added yearly eye exam requirement.

2 09-15-00 Carol Pepin IV. Implementation: Deleted reference to CAB and revised wording of the

development of a training plan for identified critical operations.

3 06-23-03 Paul Raspe Added cover sheet. Changed Inc to LLC in one place.

4 05-30-06 Victor

Szatkowski


5 10-01-08 Paul Grabek Added customer approval for welding/brazing procedures.

A 08-15-11 Paul Grabek Convert from number Rev to letter Rev.


19/178

Procedure No. 2.4


Revision: A

Date: 08-15-11


Page 2 of 3

I. Policy

It is the policy of Prime Technology, LLC to identify and provide support to Critical Operations within

manufacturing activities. This procedure provides the guidelines by which Critical Resource Training is governed.

II. Responsibility

Manufacturing supervision is responsible for ensuring that certified and trained personnel perform operations that

require training or certification.

Quality Assurance is responsible for administering training and certification activities.

III. Definitions

Critical Operation. An operation that cannot be directly inspected or validated for compliance to requirements;

and/or an operation involving a knack or skill that must be learned through specific training/experience.

Critical Resource. People that perform a Critical Operation.

IV. Implementation

Seminars, workshops, and training classes are conducted to ensure that all operation groups are instructed in and

develop means for compliance with Prime Technology Quality Procedures. Topics include statistical quality

control, explanation of new procedures, sampling plans, test methods, soldering, and other educational programs to

enhance professional development.

Critical Operations require specialized training. Training/Certification Plans shall be documented. Training involves

classroom and hands on activities. Certification requires demonstration of the acquired skill/expertise. Only

certified operators are authorized to perform Critical Operations.

Critical Resource Training/Certification is comprised of the following major activities (listed in sequence):

1. Identification and Review of Critical Operations

2. Development of Training/Certification Plans

3. Implementation of Training/Certification

4. Maintenance of Trained Critical Resources

Once Critical Operations are identified, a Training Plan is developed. The plans are structured with a training

outline (safety outline if applicable), certification requirements, and follow up. Plans are revision/date controlled

and signed by the Manager, Quality Assurance. Any of the functions represented on the Material Review Board

may be assigned the responsibility to develop specific training/certification plans.


20/178

Procedure No. 2.4


Revision: A

Date: 08-15-11


Page 3 of 3

Prior to initial Critical Resource training within any specific manufacturing process, all of the affected (direct and

support) employees are briefed. This briefing details the training/certification objectives, the Critical Operations to

be addressed, and provides a general product orientation. The individual who developed the training/certification

plan performs the initial training. This same individual administers the certification tests for the initial training. The

completed training/certification plan, the certification test results, and any certification test samples are retained by

Quality Assurance.

An operators certification may be withdrawn for any of the following reasons:

--Significant reject trends that additional training does not correct

--Intentional violations of procedures and/or requirements

Operators whose performance is reviewed for potential decertification are evaluated on an individual, case-by-case

basis. Any decertification actions require the concurrence of Manufacturing and QA Management.

Inspectors and personnel responsible for final acceptance of product are required to have a yearly eye exam.

Operators trained and certified for operations such as welding or brazing shall utilize procedures approved by the

customer when required by contract or purchase order.

V. Reference

Prime Technology Quality Procedure Number 4.15, Control of Special Processes


21/178

Procedure No. 2.5

Quality Procedure Subject: Manufacturing Work Instructions

Revision: A

Date: 08-15-11


Page 1 of 3

ORIGINATOR:


Paul Grabek

PURCHASING:


Nick Graziano

MARKETING:


Jim Jamieson

COO:


Sam Mandel



1 09-15-00 Carol Pepin IV. Implementation: Delete: from Process Sheets MOP step by step, all ofPackaging/Shipping from Material Handling, Storage, and Movement.ESD, all of

Special Process. V. Reference: Deleted: 4.13 ESD.

2 09-24-02 Mary

Harnois

Formalized revised Rev 1, 09-15-00. Hard Copy of Rev 1, 09-15-00 with no changes

from Rev 0, 04-04-97 exists.

3 06-23-03 Paul Raspe Added cover sheet. Corrected typo revision error. Changed Inc to LLC in one place.

4 05-30-06 Victor

Szatkowski


A 08-15-11 Paul Grabek Convert from number Rev to letter Rev. Corrected paragraph IV Testing:, Inspection:

and last subparagraph. Reference: added Procedure 3.3.


22/178

Procedure No. 2.5


Revision: A

Date: 08-15-11


Page 2 of 3

I. Policy

It is the policy of Prime Technology, LLC to provide clear and documented instructions for areas affecting quality.

Instructions provide the critical characteristics for the process involved and are compatible with acceptance criteria.

Work instructions are monitored by Quality for completeness, implementation, and revision. The purpose of this

procedure is to outline the types of work instructions used at Prime Technology.

II. Responsibility

The Quality Manager is responsible for assuring that the provisions of this procedure are implemented.

The individual department managers are responsible for assuring that work instructions for which they are

responsible meet the requirements of this procedure.

III. Definitions

Work Instructions. A document that prescribes critical actions to perform a certain task.

IV. Implementation

Individual procedures governing activities affecting quality are contained in the Prime Technology Quality Manual.

Other areas or instructions that may affect the quality of product are contained in Acceptance and Production Test

Procedures and individual Process and Routing sheets. Work instructions are written to provide clear, concise

instructions at the user level and are compatible with acceptance criteria.

Inspection: Inspection instructions and Quality Assurance Procedures (QAPs) are generated by Quality. Thesemay be in the form of standardized or specific checklists, reference to blueprints, drawings, or individual instruction

sheets.

Responsible department: Quality

Testing: Instructions for test are clearly prescribed in production test procedures that are utilized in process and

Acceptance Test Procedures (ATPs). These documents are used to assess compliance with applicable specifications

at the finished goods state.

Responsible department: Engineering

Manufacturing

Process sheets provide critical characteristics necessary to build specific final assemblies.



23/178

Procedure No. 2.5


Revision: A

Date: 08-15-11


Page 3 of 3

Installation/Care of Product. For the majority of products manufactured at Prime Technology, comprehensive

manuals are prepared. These manuals include, but are not limited to, description of use and application, equipment

interface information, installation and maintenance instructions, and instructions for field repairs or modifications.


Material Handling, Storage, and Movement. Prime Technology standard practice is to store material or product so

as not to degrade quality or to cause damage. Separate procedures in the Quality Manual address specific issues:

4.12 Shelf Life, and 4.11, Material Storage, Movement and Handling.

Responsible department: Material Control

Purchasing. Procedures are contained in the Prime Technology Quality Manual to assure the quality of purchased

material and to provide guidelines relative to the selection of suppliers and transmitting quality requirements tosuppliers to meet Prime Technology and contract requirements. Refer to Prime Technology Quality Procedures

Numbered 4.1 Procurement Control, 4.2 Supplier Surveys/Evaluation, and 2.8 Quality Performance Analysis.

Responsible departments: Quality Assurance and Purchasing

The responsible departments listed above will generate work instructions as required. Quality Assurance may

request that instructions be generated as a result of initial quality planning, corrective action request, or general

quality problems.

Revisions to work instructions may be requested through an Engineering Change Request (ECR). The Engineering

Change Notice shall be the approved method for revision of the work instructions cited to insure conformance to

contractual requirements.

V. Reference

Prime Technology Quality Procedure Number 2.8, Quality Performance Analysis

Prime Technology Quality Procedure 3.3, Implementation of Engineering ChangesPrime Technology Quality Procedure Number 4.1, Approval of Supplier

Prime Technology Quality Procedure Number 4.2, Supplier Surveys/Evaluation

Prime Technology Quality Procedure Number 4.11, Material Storage, Movement, and Handling

Prime Technology Quality Procedure Number 4.12, Shelf Life

Prime Technology Quality Procedure Number 4.14, Product Packing and Packaging

Prime Technology Quality Procedure Number 4.15, Control of Special Processes


24/178

Procedure No. 2.6

Quality Procedure Subject: Quality Assurance Records

Revision: A

Date: 08-15-11


Page 1 of 3

ORIGINATOR:Paul Grabek QA MANAGER:Paul Grabek

PURCHASING:


Nick Graziano

MARKETING:


Jim Jamieson

COO:


Sam Mandel



1 09-15-00 Carol Pepin IV. Implementation: Records Removed: Customer Return Log, Daily Inspection Log,

Internal Audits, Corrective Action Reports, Purchased Material Performance Report, In-process Performance Report, Training/Certification. Page 2: Daily Inspection Report

changed to Log, deleted statements on FQA and CAB.

2 09-24-02 Mary

Harnois

Returned all IV. Records Removed in Rev. 1

3 06-23-03 Paul Raspe Added cover sheet. Corrected date typo on Rev. 2 that was left as 09-15-00. Changed Inc

to LLC in one place.

4 05-30-06 Victor

Szatkowski


5 10-01-08 Paul Grabek Added OQE correction procedure and software storage.

6 05-01-10 John DeCola Add Engineering Drawings as Permanent Record Type Document

A 08-15-11 Paul Grabek Convert from number Rev to letter Rev. Paragraph IV updated Responsibility titles.Weekly reports changed to Inspection logs.


25/178

Procedure No. 2.6


Revision: A

Date: 08-15-11


Page 2 of 3

I. Policy

It is the policy of Prime Technology, LLC to retain records that demonstrate objective evidence of product quality

and compliance to customer requirements. This procedure outlines those records that are maintained, responsibility

for retention, and retention periods for each particular record.

II. Responsibility

The Quality Manager is responsible for assuring implementation of this procedure. Individuals specified in the body

of this procedure are responsible for those assigned tasks.

III. Definitions

Permanent/Lifetime Records. Records to be considered permanent/lifetime shall meet the following criteria:demonstration of capability of safe operation (safety related products), records used for maintaining, reworking,

repairing, replacing, or modifying product. Permanent/lifetime records shall be stored for the life of the product or

while the product is installed in the plant or in storage.

Non-Permanent Records. Records to be considered non-permanent are those records that show evidence of

inspection or that work was performed in accordance with applicable requirements or procedures. Non-permanent

records shall be stored and maintained for seven (7) years or for the duration prescribed in a purchase order or

contract requirements. The customer shall be notified at the end of storage if document possession is desired.

OQE. Objective Quality Evidence

IV. Implementation

The records specified in the body of this procedure are considered minimal requirements.

Records to be Maintained

Records Responsibility Type

Incoming Inspection Folder Manager, Quality Non-permanent

Shelf Life Log Manager, Quality Non-permanent

Customer Return Log Manager, Quality Non-permanent

Material Rejection Report Manager, Quality Non-permanent

Daily Inspection Report Manager, Quality Non-permanent

First Piece Inspection Report Manager, Quality Non-permanent

Certificate of Compliance Manager, Quality Non-permanent

Certified Test Report Manager, Quality Permanent

Quality Assurance Checklist Manager, Quality Non-permanent

Final Acceptance Performance Data Manager, Quality Non-permanent

Internal Audits Manager, Quality Non-permanent

Corrective Action Reports Manager, Quality Non-permanent

Work Order Manager, Material Control Non-permanent

Purchased Material Performance Report Manager, Quality Non-permanent

In-process Performance Report Manager, Quality Non-permanent

Qualification Test Reports Manager, Quality Permanent

Product Quality Plan Manager, Quality Non-permanent

Design Eng. Drawing and Change Notices Manager, Engineering Permanent

Training / Certification Manager, Quality Non-permanent

OQE Manager, Quality Non-permanent


26/178

Procedure No. 2.6


Revision: A

Date: 08-15-11


Page 3 of 3

The Inspection Folder is maintained as a dynamic record by supplier. It contains, as a minimum, documentation of

the number of lots inspected, quantities accepted/rejected, inspection characteristics, and information to audit

disposition of rejected material.

The Daily Inspection Log (Purchased Material) provides the number of lots inspected, number of lots

rejected/accepted, and a brief reason for rejection. Items rejected to Material Rejection Report (MRR) should be

annotated with the MRR number. This report is retained in the Incoming Inspection Files.

The MRR provides an audit trail for decisions made by the Material Review Board (MRB) on rejected material.

This report is filed by Supplier in Incoming Inspection.

Work Orders provide the sequential operations undertaken to manufacture the item.

Records in this procedure are maintained for a minimum of one year in the Central Files. After one year, records

may be boxed in Trans-files and stored in the archives for the balance of the retention period. Trans-files are

suitably identified to permit prompt retrieval.

Documents utilized during inspection of product indicate the following:

a) Nature of observation (i.e.: characteristic inspected)

b) Number of observations made

c) Number and type of deficiencies found

d) Disposition of material

The Supplier / In-process Logs in Receiving Inspection shall be reviewed quarterly by the Quality Manager or his

designee. The review shall determine trends and the possibility for corrective actions.

Documents that are OQE shall not have corrections made that use whiteout or correction tape. Corrections shall be

a single line drawn through the mistake with a dated signature.

Digital OQE shall be stored on the main server quality drive. The server will be backed up on a weekly basis. The

media shall have restricted access. Access shall be restricted to Quality and Engineering personnel. No changes

shall be performed on OQE once Prime Technology Quality has accepted product.

V. Reference

Prime Technology Quality Procedure Number 2.7, Corrective Action


27/178

Procedure No. 2.7

Quality Procedure Subject: Corrective Action

Revision: B

Date: 09-30-11

Supersedes: Revision APage 1 of 6

ORIGINATOR:


Paul Grabek

PURCHASING:


Nick Graziano

MARKETING:


Jim Jamieson

COO:


Sam Mandel

REV DATE AUTHOR DESCRIPTION OF CHANGE0 10-01-96 Carol Pepin Original

1 09-23-02 Mary Harnois None found. Scanned Exhibits A & B.

2 06-23-03 Paul Raspe Added cover sheet. Added LLC in one place.

3 05-30-06 Victor Szatkowski COO was President, added Purchasing

4 03-31-10 Paul Grabek Edit for Part 21 Compliance. MRR form to Rev 2 for next Buy / Printing

5 09-22-10 Paul Grabek Added Exhibit C. Added Audit CAR form and Desc. CAB Meetings

was Weekly, to As necessary, but no less than once per month & 10

day C/A Response time limit.

A 08-15-11 Paul Grabek Convert from number Rev to letter Rev. Quality Manager was Manager,

Quality Assurance. Deleted Operation Manager from CAB. Paragraph

IV, subparagraph five, Manager, Purchasing was MRB Chairman.

B 09-30-11 Paul Grabek Revised Exhibit C for Part 21.


28/178

Procedure No. 2.7


Revision: B

Date: 09-30-11

Supersedes: Revision APage 2 of 6

I. Policy

It is the policy of Prime Technology, LLC to maintain a corrective action system that eliminates recurrences of non-

conforming material and deviations from established procedures. The purpose of this procedure is to describe the

steps for initiating and completing corrective action when evidence shows that product quality or operational

performance has degraded. Conditions adverse to quality shall be promptly identified and corrected.

II. Responsibility

The Manager, Quality Assurance, is responsible for the overall implementation of this procedure.

III. Definitions

Corrective Action: The measures taken by the supplier or Prime Technology, which lead to preventive action or a

marked improvement toward achieving a quality goal, resulting in compliance with a quality requirement.

Corrective Action Request (CAR): Form used to document corrective action by recording the problem, the proposed

corrective action, its affectivity, and the activity responsible for implementation (See Exhibit A, and C). It is initiated

for administrative type deficiencies, departures from established policies, procedures, or practices and/or hardware

deficiencies.

Material Rejection Report (MRR) [Exhibit B]: Initiated for deficiencies related to product; this form incorporates all

steps for the corrective action process. The request is delineated, the proposed corrective action is slated by the

responder, the review by Quality is documented, and follow-up on the implementation of the action is verified. It isused for supplier-caused defects as well as Prime-caused defects.

Corrective Action Board (CAB): A board consisting of Prime Technology management representatives with the level

of responsibility and authority necessary to assure that causes of non-conformance are identified and that corrective

actions are implemented throughout Prime Technology.

Failure Reporting Process In the Quality Manual, (See 5.5 Failure Reporting Process) A process to be used when the

cause of a non-compliance must be identified, documented, and corrected where applicable. The resulting report will

be used in communications with, customers, suppliers, and help Prime Technologys internal correspondences

regarding root causes, corrective, and preventative actions. Completed reports will be kept on file in Prime

Technologys Quality Department.

IV. Implementation

Corrective Action pertaining to procedural or administrative deficiencies are initiated by a Corrective Action Request

(CAR) and addressed to the operational activity involved. The request is in narrative form, specifying the problem and

corrective action required. Cars are routed through the Manager, Quality Assurance, for logging control number

assignment, review, follow up, and closure. The CAR Log contains the CAR control number, subject, addressee, date

of issue, due date, and date completed.

If a response is not received by the due date, Quality Assurance issues a copy of the CAR to the addressee and his

supervisor annotated Second Notice, reply within five working days. The log is updated indicating a second notice

was requested. If a request for extension is received, the change is made to the log and the file copy of the CAR. If a

third notice is required, it is forwarded to the COO, Prime Technology, for action.


29/178

Procedure No. 2.7


Revision: B

Date: 09-30-11


Page 3 of 6

The close-out action is by the Manager, Quality Assurance. A review is made to assure implementation of the action

and to evaluate its effectiveness. The Manager, Quality Assurance, signifies the action taken to verify completion of

the corrective action as stated in the reply, signs and dates the CAR. Disapproval of the answer requires initiation of a

new CAR.

The MRR form is used to provide corrective action for material. Quality reviews and analyzes non-conformance data

to determine if corrective action is required. The MRB Chairman who conducts the MRB or preliminary review

insures causes of non-conformances are determined, and corrective actions initiated when required. The MRB

Chairman assures corrective actions are evaluated, and feedback is provided to appropriate personnel. Quality

Assurance maintains a file of the completed copy of the MRR. The rejection tag may be used to document remedial

action taken in situations where Quality does not feel a CAR is warranted.

For supplier caused corrective action the Manager, Purchasing removes the supplier copy of the MRR and forwards it

to the supplier when necessary for root cause analysis and corrective action. The MRB Chairman assures that causes

of non-conformances, individually or collectively, are determined and that appropriate corrective action is taken by the

responsible suppliers. Supplier corrective action is reviewed by the Quality Manager. Effectiveness of the corrective

action is measured by monitoring future lot performance, as measured at Incoming Inspection and on the

manufacturing floor. The Quality Manager provides feedback to the supplier regarding the effectiveness of the

corrective action.

When an audit is performed, (Internal or External) and findings are made, then Audit CAR form (Exhibit C) shall be

utilized. (Reference Procedure 2.9 Quality Audits)

The Corrective Action Board (CAB) consists of the managers of Manufacturing, Engineering, Materials, and Quality

or their designees. CAB Meetings are convened as necessary, "but no less than once per month to assure all non-

conformances and corrective actions are promptly identified, and implemented. Quality tracks / analyzes / follows-up

on non-conformance and corrective action data / trends on a continual basis. The CAB members may review this

information via the Intranet on the Public Drive in the CAB Meeting Minutes folder. Minutes of these reviews

detailing commitments, assignments, schedules, and plans of action are distributed to the members and kept on file in

the Quality office. Corrective Action is requested from suppliers or departments within Prime Technology when

investigation of customer complaints (data or hardware) warrants such action.

In order to provide timely & effective C/A, both In-House and Supplier corrective action responses must be submitted

to Prime Technologys Quality Assurance Department within 10 business days from date of issuance.

Part 21 Applicability: Safety related equipment or materials that require corrective action shall follow this procedure

and reportable findings shall be processed via Quality Manual Procedure 5.3 Part 21 Reporting of Defects and

Noncompliance.

V. Reference

Quality Manual 5.3, Part 21 Reporting of Defects and Non-Compliance.

Quality Manual 5.5, Failure Reporting Process

Forms similar to the attached may be used provided they contain the required information.


30/178

Procedure No. 2.7


Revision: B

Date: 09-30-11


Page 4 of 6

Exhibit A, Corrective Action Request

INTERNAL CORRECTIVE ACTION REQUEST

EXTERNAL CORRECTIVE ACTION REQUEST

Section No. ___________________________ Date ________________________

Discrepancy:

Auditor ______________________

Condition Reported To: _______________________ Date ________________________

Action Taken to Resolve Discrepancy:

Signature ___________________________________ Date _________________________

Part 21 Reportable Quality Part 21 Reportable Engineering

Yes __________ No_________ Yes __________ No_________If Yes: Process per Procedure 5.3 If Yes: Process per Procedure 5.3

Corrective Action

Acceptable: Yes ____ No ____

Manager, QA ________________ Auditor ________________ Date __________


31/178

Procedure No. 2.7


Revision: B

Date: 09-30-11


Page 5 of 6

Exhibit B, Material Rejection Report

Part 21 Safety Related Yes / No Approved By: Quality __________Engineering __________

Part 21 Safety Related Yes / No

Model 1151 1251 9270


32/178

Procedure No. 2.7


Revision: B

Exhibit C Date: 09-30-11


Page 6 of 6

AUDIT CORRECTIVE ACTION REQUEST

INTERNAL______ EXTERNAL______ CAR Control No.: CAR

Procedure No.: Audit No.:

Subject: Rev.: Rev. Date:

Addressee: Date of Issue:

Auditor: Date Due:

Action Taken to Resolve Discrepancy:

Addressee Signature: Date Completed:Corrective Action: Acceptable: ___ Yes ___ No If No, give reason

Reason for Not Acceptable:

Manager, QA: Auditor: Date Closed:

Extension Requested: _____ New Due Date:

Second Notice: _____ Reply Within 5 Working Days Date of 2n

Notice:Third Notice: _____ Distribution to President Date of 3

rNotice:

Part 21 Reportable: Quality PART 21 Part 21 Reportable: EngineeringYes __________ No_________ Yes __________ No_________If Yes: Process per Procedure 5.3 If Yes: Process per Procedure 5.3

Distribution: Quality, Area Supervisor, Addressee, President, Other as Required. Ref. QP 2.9.


33/178


34/178

Procedure No. 2.8

Quality Procedure Subject: Quality Performance Analysis

Revision: A

Date: 08-15-11


Page 2 of 3

I. Policy

It is the policy of Prime Technology, LLC. through the use of SPC, inspection and test data, rejection reports etc. to

analyze quality for the purpose of evaluating the overall quality performance within Prime. The quality performance

information is used by management to identify and evaluate quality problems, to trace the effects of previously

initiated corrective actions and to plan and obtain quality improvements. The purpose of this procedure is to describe

the method for reporting, summarizing, analyzing, and acting on quality data.

II. Responsibility

The Quality Manager or his designee per contract or as needed prepares reports on quality indicators for

management review and action as required.

III. Definitions

Material Rejection Report (MRR): A form listing the inspection findings for rejected material, parts, or lots. It

includes provisions for MRB actions and dispositions.

Statistical Process Control (SPC): The methodology used to measure the average and variability of any given

characteristic.

Test Data: The documented results of specific tests performed on an item. The document format is specified by the

applicable test specification.

Work Order: A routing sheet that accompanies product through various stages of production. It provides the

sequence of operations, abbreviated descriptions of requirements, reference to other documentation, and provision

for operation/auditor sign-off when tasks have been completed.

IV. Implementation

The results of inspections / tests performed on Prime Technology fabricated and purchased material are recorded on

applicable checklists, test data forms, and documentation. These documents are held on file in their respective

inspection / test areas. The SPC data (where applicable), MRRs, test and inspection data are reviewed by QA,

when a concern is raised by inspection / test personnel, for the purpose of trend analysis to highlight problem areas

or negative trends in quality, as well as monitor the success or failure of initiated solutions to past problems.

Process quality indicators include, but are not limited to:

Purchased Material Quality

Final Acceptance

In Process Inspection Acceptance


35/178

Procedure No. 2.8

Quality Procedure Subject: Quality Performance Analysis

Revision: A

Date: 08-15-11


Page 3 of 3

Field Return data is analyzed and evaluated for cause, recurrences, and necessity for corrective action. Refer to

Prime Technology Quality Procedure Number 5.1, Return Authorization.

V. Reference

Prime Technology Quality Procedure Number 4.5, Disposition/Corrective Action of Nonconforming Material


Prime Technology Quality Procedure Number 5.1, Return Authorization


36/178

Procedure No. 2.9

Quality Procedure Subject: Quality Audits

Revision: A

Date: 08-15-11


Page 1 of 6

ORIGINATOR:


Paul Grabek

PURCHASING:


Nick Graziano

MARKETING:


Jim Jamieson

COO:


Sam Mandel



1 06-23-03 Paul Raspe Added cover sheet. I. Policy: Added: It is the policy at Prime Technology, LLC. III.Definitions: Add Quality Assurance Program Audit. IV. Implementation: Add Quality

Assurance Program Audit shall be performed annually. Add auditor previous training

statement.

2 05-30-06 Victor

Szatkowski

COO was President, added Purchasing.

3 10-01-08 Paul Grabek Added malpractice statement.

4 08-30-10 Paul Grabek Deleted Exitibit C, Revise Section IV, Paragraph 4.

A 08-15-11 Paul Grabek Convert from number Rev to letter Rev. Quality Manager was Manager, Quality

Assurance. Quality was Quality Assurance.


37/178

Procedure No. 2.9


Revision: A

Date: 08-15-11


Page 2 of 6

I. Policy

It is the policy at Prime Technology, LLC to perform periodic audits to determine compliance with procedures,

instructions, and other applicable documentation necessary to support a cost-effective, quality system.

Audits are performed to verify adequacy of processes and systems and the acceptability of product. Audits are

performed using prepared guidelines or checklists. They are performed in accordance with a planned schedule, or at

the request of company management. The purpose of this procedure is to provide general instructions for

conducting and documenting Quality Audits.

II. Responsibility

The Quality Manager is responsible for implementation of this procedure and for the maintenance of a central file

for audit reports, checklists, corrective action requests, and related miscellaneous documentation.

III. Definitions

Product Audit. An examination of any number of units, at any stage of production, conducted to verify compliance

to the applicable blueprints, parts lists, drawings or checklists.

Process Audit. An examination of a manufacturing process (e.g. conformal coating, painting, assembly) conducted

to verify compliance to the appropriate manufacturing standard, process sheet.

Procedure Audit. An examination of the activities of a department conducted to verify compliance with procedural

requirements of the Quality Manual. Procedure audits are also utilized to verify that contractual requirements are

satisfactorily addressed in Prime Technology procedures.

Systems Audit. An examination of significant scope designed to highlight certain systems outside the normal realm

of quality and to evaluate their adequacy in enabling the company to meet its objectives and goals. Such areas could

include sales or production control. Checklists of relevant procedures or a compilation of general guidelines can be

used in the conduct of systems audits.

Quality Program Audit. A global examination of the quality system within Prime Technology. The audit will

address the status and adequacy of the quality assurance program relative to customer requirements.

IV. Implementation

Audits may be geared to cover a particular area and involve general procedures or may cover a specific process or

procedure employed in one or more areas. The Quality Manager is responsible for developing and scheduling auditsand for any subsequent activities necessitated by the audit effort. Prepared checklists for process and procedure

audits specify the key attributes for investigation and are written to permit answers regarding compliance. (If results

dictate a need for additional research, the auditor will pursue the investigation to carry out the full intent of the

audit). The attributes covered in the audit checklist are selected from specific requirements as noted in applicable

procedures, specifications, and other known requirements. Guidelines for product and system audits supply criteria

for investigation and provide for indication of acceptability or non-acceptability, quantitative measurement or

narrative response, as appropriate. Each year the Quality Manager develops an audit schedule. The schedule is

developed with the intent that each procedure in the Quality Manual is audited.


38/178

Procedure No. 2.9


Revision: A

Date: 08-15-11


Page 3 of 6

Audits are scheduled so as to minimize interference with the operations or areas being audited. The responsible

authority for the operations or areas being audited is briefed prior to the audit on the purpose and objectives. It is the

responsible supervisors prerogative to accompany the auditor on the audit. Audits are thorough and concise.

Unsatisfactory conditions are brought to the attention of the responsible supervisor so that corrective actions can be

implemented as soon as practical

The audit report is prepared by the auditor upon completion of the audit and lists items to be resolved together with

any immediate action taken. Recommendations may be made as to a means to resolve discrepancies. Reports are

forwarded to the responsible authority for the area or item audited. If the Manager determines a written reply is

necessary Quality shall issue a Corrective Action Request (CAR) to be forwarded with the audit report. Refer to the

Prime Technology Quality Procedure Number 2.7, Corrective Action. Additional distribution includes the Quality

file, the responsible authoritys supervisor, COO, and other personnel who have a need to know.

Corrective action responses are adequate only when they define specific actions to be taken on deficiencies noted

with effective date or when they give reasons acceptable to the Quality Manager as to why specific actions cannot be

taken. Before closing, corrective action responses are evaluated and verified for implementation.

Quality Audit Report (Exhibit A) is utilized to report results from processes and procedure audits.

Quality Audit Checklist (Exhibit B) is utilized as guidelines for the audit investigation in process and procedure

audits.

Documentation for product audits is unspecified due to a large variety of product. Audit reports on product

includes, at a minimum:

Prime Technology part number

Characteristics

Number inspected

Number accepted

Number rejected

Total number of defects

Disposition

Auditor

Date

Location

Documentation for system audits is generally in memorandum form. Included in the text is:

Description of system audited

Objectives, goals of system Scope

Observations

Summary comments, recommendations

Corrective Action Request (Exhibit C) is used to document significant deficiencies.


39/178

Procedure No. 2.9


Revision: A

Date: 08-15-11


Page 4 of 6

An overall Quality Assurance Program Audit will be scheduled by the Quality Manager to be performed annually.

The auditors shall be appropriately trained personnel not having direct responsibilities in the areas being audited.

Previous auditor training shall be reviewed by the Quality Manager and if acceptable an inter office communication

shall be generated listing acceptable auditors, and shall be maintained on file.

Auditors shall be aware of malpractice requirements. Evidence of malpractice shall immediately be brought to the

attention of the COO and Quality Manager. A review of product impact shall be conducted and necessary corrective

action completed.

Audit results shall be documented and reviewed by management having responsibility in the area audited. Follow

up action, including a follow up audit of deficient areas, shall be taken where indicated.

V. Reference




40/178

Procedure No. 2.9


Revision: A

Date: 08-15-11


Page 5 of 6

Exhibit A

Quality Audit Report

Procedure No.: _____________________ Rev.: ________ Audit No.: __________

Title: _____________________________ Date: ______________

________________________________________________________________________________________

_________________________________________________________________________________________

Auditor: ____________________ Approved by: ___________________ Date: ____________


41/178

Procedure No. 2.9


Revision: A

Date: 08-15-11


Page 6 of 6

Exhibit B

QUALITY AUDIT CHECKLIST AUDITOR: _____________________________________

SCOPE: _________________________________ APPLICABLE DOCUMENTS (includes revision level)

PERSONNEL CONTACTED: ______________________

DEPARTMENT: __________________________

APPLIC.

ITEM CHARACTERISTIC PARA. S U N COMMENTS

_________________________________________________________________________________________________

_________________________________________________________________________________________________

_________________________________________________________________________________________________

_________________________________________________________________________________________________

_________________________________________________________________________________________________

_________________________________________________________________________________________________

_________________________________________________________________________________________________

_________________________________________________________________________________________________

_________________________________________________________________________________________________

_________________________________________________________________________________________________

_________________________________________________________________________________________________

_________________________________________________________________________________________________

_________________________________________________________________________________________________

_________________________________________________________________________________________________

S = Satisfactory U = Unsatisfactory N = Not Applicable CHECKLIST NO: __________


42/178

Procedure No. 3.1

Quality Procedure Subject: New Product Development/Release

Revision: A

Date: 08-15-11


Page 1 of 6

ORIGINATOR:


Paul Grabek

PURCHASING:


Nick Graziano

MARKETING:


Jim Jamieson

COO:


Sam Mandel



1 03-02-98 Carol Pepin Two Versions Found: 4 Page added Exhibit A as New Product Design Flow Chart andoriginal Exhibit A became B and B became C. 3 Page deleted new Exhibit A and left

other Exhibits as B & C. IV. Implementation: Section greatly expanded and includes

reference to Exhibits A,B, & C. (4 Page).

2 06-23-03 Paul Raspe Added cover sheet. Scanned Exhibits A, B, C. Changed Inc to LLC in one place.

3 05-30-06 Victor

Szatkowski

COO was President, added Purchasing, added Page 6

A 08-15-11 Paul Grabek Convert from number Rev to letter Rev. Quality was Quality Assurance


43/178

Procedure No. 3.1


Revision: A

Date: 08-15-11


Page 2 of 6

I. Policy

It is the policy of Prime Technology, LLC to develop / release products in a systematic way that meets or exceeds

customer expectations. The purpose of this procedure is to define the activities required to support new product

development programs.

II. Responsibility

The Manager, Engineering, is responsible for overall implementation of this procedure.

III. Definitions

Not applicable.

IV. Implementation

Sales will determine the need to pursue a new product. They will identify the customers requirements and forward

this information to Engineering and Quality. Quality and Engineering will determine the feasibility of the customers

requirements. If it is determined by senior management, Sales, Engineering, and Quality to proceed, the typical

sequence of product development is outlined in Exhibit A. A project schedule will be initiated (Exhibit B).

Milestones in product development consist of: defining product requirements, preliminary design review, detailed

design, critical design review, qualification/verification, first product run, and internal reviews. Details will be

developed with each new product as required. Program review meetings are regularly scheduled. Reviews and tests

noted in the project schedule will be documented by the cognizant Engineering and Quality personnel. Each design is

reviewed by qualified Engineering personnel who are not directly involved with the design of the product. If all or themajority of the Engineering personnel have been involved, it is the responsibility of the Manager, Engineering to

review and monitor the design in whatever manner is practicable. Reviews will consider but not be limited to design

calculations, materials, test data, customer contracts, customer specifications, and company specifications.

Qualification performance testing is intended to verify the adequacy of the design in the most adverse conditions. The

Manager, Engineering will formulate qualification testing requirements according to specifications and customer

drawings. He will direct and verify that testing has been performed according to drawings and specifications. The

result of this testing is maintained and stored for future verification.

An interdisciplinary design review meeting is held prior to initial release of new products. This meeting shall be

conducted by the responsible design engineer. This group is comprised of the disciplines that eventually sign the

Engineering Drawing Release package; Engineering, Quality, Manufacturing, Materials Control, and Sales. The design

is explained and questions regarding production operations, testing procedures, acceptance criteria, are resolved.

Product is released through the distribution and signing of the Engineering Drawing Release/Change Notice (Exhibit

C) in accordance with Quality Procedure 3.2, Engineering Change Control. A released product consists of a Bill of

Materials, Parts List, associated drawings, and a technical manual (where applicable).

V. Reference

Prime Technology Quality Procedure Number 3.2, Engineering Change Control


44/178

Procedure No. 3.1


Revision: A

Date: 08-15-11


Page 3 of 6

EXHIBIT A, NEW PRODUCT DESIGN FLOWCHART


45/178

Procedure No. 3.1


Revision: A

Date: 08-15-11


Page 4 of 6

Exhibit B, Project Schedule


46/178

Procedure No. 3.1


Revision: A

Date: 08-15-11


Page 5 of 6

Exhibit C, Engineering Change Control


47/178

Procedure No. 3.1


Revision: A

Date: 08-15-11


Page 6 of 6

Exhibit C, Engineering Change Control


48/178

Procedure No. 3.2

Quality Procedure Subject: Engineering Change Control

Revision: A

Date: 08-15-11


Page 1 of 7

ORIGINATOR:


Paul Grabek

PURCHASING:


Nick Graziano

MARKETING:


Jim Jamieson

COO:


Sam Mandel


0 10-01-96 Carol Pepin Original1 06-23-03 Paul Raspe Added cover sheet. Scanned Exhibit B. Changed Inc to LLC in one place.

2 05-30-06 Victor

Szatkowski

COO was President, added Purchasing, revise explanation list of ECN terms,

added Page 7

3 10-01-08 Paul Grabek Added: reviewed for accuracy to 1.0 Policy.

4 9-20-10 John DeCola Add Approval Block Instructions, and Closure Statement

A 08-15-11 Paul Grabek Convert from number Rev to letter Rev. Corrected routed to departments.


49/178

Procedure No. 3.2


Revision: A

Date: 08-15-11


Page 2 of 7

I. Policy

There is one practice employed within Prime Technology, LLC for the evaluation, coordination, approval, or disapproval

of changes in the configuration of an item (part, assembly, or product) after establishment of its configuration

identification. The change control system provides for systematic review and approval of engineering changes.

Drawings which have been released for production will not have their technical contents changed without an Engineering

Change Notice (ECN) having been processed, reviewed for accuracy, and approved by all cognizant personnel.

II. Responsibilities

The Engineering Manager is responsible for the overall implementation of this procedure. The Engineering Department

is responsible for generating, maintaining, and modifying engineering documentation, and to determine technical

correctness and verify the material disposition code. The Engineering manager or his designee shall mark approval

blocks N/A (with initials, and date) where the department is not effected by the ECN change. ECNs shall be

processed in a reasonable time frame and reviewed for closure by Eng manager or his designee.

It is the responsibility of Quality Assurance to assess the impact of the proposed change, that it does not invalidate the

qualified configuration, and to investigate specific notifications and/or approvals to ensure proper implementation.

It is the responsibility of Manufacturing to review changes for impact in production regarding tools and the

manufacturing process.

Purchasing is responsible for implementation of engineering changes with suppliers and for assessment of material on

order.

Material Control is responsible for the implementation of the stock disposition.

The Sales Department is responsible for customer notification.

III. III. Definitions

Engineering Drawing. An engineering drawing is an engineering document that discloses (directly or by reference) by

means of pictorial or textual presentations, or combinations of both, the physical and functional end-product

requirements of an item.

Bill of Material (BOM). A bill of material is a listing of all subassemblies, parts, and raw materials that go into a parent

assembly showing the quantity of each required to make an assembly.

Engineering Change. An engineering change is a revision to a parts list, bill of materials, or drawings authorized by theEngineering Department. Changes are identified by a control number.

Engineering Drawing Release/Change Notice. An engineering release/change notice is a document, which completely

describes and authorizes release of or change to released engineering documentation.

Drafting Request. A request of engineering assistance in the technical investigation and /or documentation of an

engineering change.

Parts List (P/L). A parts list is a tabulation of all parts and bulk materials used in the item to which the list applies.


50/178

Procedure No. 3.2


Revision: A

Date: 08-15-11


Page 3 of 7

Engineering Drawing Release. The method of formally placing engineering documentation under formal change control.

Item Number. An item number is the Prime Technology part number for a part, assembly, or document.

Effective Date. The effective date is the date on which a component of an operation is introduced or deleted from a bill

of material. The effective dates are used in the explosion process to create demands for the correct material or assembly

labor. The bill of material system provides for the effective start and stop date. The effective date for an approved

mandatory change shall be immediate; for non-mandatory it is at the discretion of Material Control.

End-Item. An end-item is an item, either an individual part or assembly, in final or completed state.

Product Structure. Product structure is the way components go into a product during its manufacture. A typical product

structure would show, for example, raw material being converted into fabricated components, being put together to makeassemblies, subassemblies going into assemblies, etc.

Mandatory Change. A mandatory change is one intended to eliminate a deficiency which will adversely effect

performance, fit, or computability of items or to correct a deficiency found during manufacturing or system/item

functional checkout and is necessary to make the system/item fit or work.

Non-Mandatory Change. A non-mandatory change is one intended to improve system performance, provide a cost

savings, correct deficiencies, inadequacies, or ambiguities found in the documentation or to provide parts

standardization.

Class I Engineering Change. An engineering change to an item shall be classified Class I when it affects the

contractually specific form, fit, or function of the item. A Class I engineering change results in a part number change.

Class II Engineering Change. An engineering change shall be classified Class II when it does not fall within the

definition of a Class I engineering change. Class II changes result in a revision change to the part number.

IV. IV. Implementation

Change to released engineering documentation is started by a Engineering Change Request (Exhibit A). This form can

be initiated by anyone. The request is completed and returned to engineering, the Engineering Manager reviews the

request and forwards it to the cognizant engineer. If the reason is determined valid, an engineer is assigned to initiate the

proper changes.

Engineering changes are generated by the Engineering Drawing Release/Change Notice (Exhibit B). It is assigned a

number by the Engineering Manager and recorded in the Engineering Change Log. The cognizant engineer completes

the form. This document is completed in such a manner that the proposed change is described without interpretation or

further explanation. Each engineering change must have a cover sheet as outlined below:


51/178

Procedure No. 3.2


Revision: A

Date: 08-15-11


Page 4 of 7

A. Models Affected: Indicate the product family or end-item model number in which the affected assembly or

component is used.

B. Impact of Change: Fill in the appropriate boxes

C. Initiated by: Sign and indicate the date.

D. General Description: Comments which may enhance the understanding of the proposed

engineering change.

E. Reason for Change: Indicate the reason for change.

F. Size: Indicate the size of the document affected by the proposed change. If the affected document is aParts List, PL should be indicated.

G. Revision: New revision.

H. Notes: Specifics regarding changes to the drawing number.

I. Drawing Number: Drawing number affected by the change

J. Stock Disposition: Indicates the material disposition code.

After completion of the Engineering Drawing Release / Change Notice the package consisting of the revised parts list,

drawings, and associated documentation is routed to Engineering, Quality, Sales, Purchasing, Manufacturing and

Initiator for review and approval. When applicable the Customer and Offshore Plant Manager shall be included in thereview and approval process. Comments are reconciled by the cognizant engineer. Drafting will incorporate the

approved changes. Only those changes that are specified and authorized on the Engineering Drawing Release / Change

Notice will be incorporated.

Distribution of the Engineering Drawing Release / Change documentation, and updated revisions of the engineering

documentation as required per the change notice will be to Quality, Manufacturing, Purchasing, and any other

departments as deemed necessary.

V. Reference

Not applicable.



52/178

Procedure No. 3.2


Revision: A

Date: 08-15-11


Page 5 of 7

Exhibit A, Engineering Drawing Request


53/178

Procedure No. 3.2


Revision: A

Date: 08-15-11


Page 6 of 7

Exhibit B, Engineering Drawing Release/Change Notice


54/178

Procedure No. 3.2


Revision: A

Date: 08-15-11


Exhibit B, Engineering Drawing Release/Change Notice Page 7 of 7


55/178

Procedure No. 3.3

Quality Procedure Subject: Implementation of Engineering Changes

Revision: A

Date: 08-15-11


Page 1 of 4

ORIGINATOR:


Paul Grabek

PURCHASING:


Nick Graziano

MARKETING:


Jim Jamieson

COO:


Sam Mandel



1 09-23-02 Mary Harnois None found. Scanned Exhibit A.

2 06-23-03 Paul Raspe Added cover sheet. Changed Inc to LLC in one place.

3 05-30-06 Victor

Szatkowski

COO was President, added Purchasing, added Page 4

A 08-15-11 Paul Grabek Convert from number Rev to letter Rev. Rework was salvaged.


56/178

Procedure No. 3.3

Quality Procedure Subject: Implementation of Engineering Changes

Revision: A

Date: 08-15-11


Page 2 of 4

I. Policy

It is the policy of Prime Technology, LLC. to review engineering changes for proper material disposition and identify

affected areas.

II. Responsibility

The Material Control Department is responsible for assuring that the provisions of this procedure are met.

III. Definitions

Not applicable.

IV. Implementation

Upon receipt of an approved Engineering Change Notice it is the Material Control Departments responsibility to

implement the disposition of material identified on the Engineering Drawing / Release Change Notice (Exhibit A). The

Material Control Departments objective is to effect the change with the least impact on schedule and cost. Typical areas

that are also addressed in the implementation of engineering changes are:

When to effect change

Update of revision levels on work orders. Update pick lists (change pick lists, stock requisitions and revision levels)

Requisition additional material that may be required. Verify the new requirements are covered by either a purchase

requisition or work order.

Review shop status of any work orders that may be affected

Disposition of excess or obsolete material. Material that has other where used listing is returned to stock.

Coordinate with Purchasing the return for credit of unique material. Purge and place on the rejection shelf in

Incoming Inspection material to be reworked or scrapped.

The Material Control Department is responsible for notifying sales representatives of changes in the delivery schedule.