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

Quality Manual Edition 7 Supersedes: Edition 6 [8-15-11]

Procedure Listing Subject: Quality Manual Revision Control Sheet Revision: B Date: 9-30-11 Supersedes: Revision A Page 1 of 1 Title Quality Manual Revision Control Sheet Introduction Quality Policy Statement, Malpractice, and Security Company Organization Management Control of Quality Manual Quality Organization Quality Planning and Contract / Purchase Order Review Critical Resource Training and Certification Manufacturing Work Instructions Quality Assurance Records Corrective Action Quality Performance Analysis Quality Audits Engineering Standards New Product Development/Release Engineering Change Control Implementation of Engineering Changes Temporary Authorization - Obsolete Product Identification/ Traceability Control and Calibration of Measuring and Test Equipment Manufacturing Procurement Control Supplier Surveys/Evaluation First Article Inspection of Purchased Material Inspection of Purchased Material Disposition/Corrective Action for Non-Conforming Material In-Process Inspection and Test Final Inspection and Test Customer Product Submittal and Inspection Rights Statistical Sampling Inspection QA Identification Symbols/Stamps Material: Exposure to Mercury, Handling , Movement, Storage and Traceability Shelf Life Handling of ESD Parts, Assemblies, and Equipment Product Packing and Packaging Control of Special Processes Material Verification and Traceability Customer Service Return Authorization Control of Customer Furnished Property Part 21, Reporting of Defects and Noncompliance Commercial Grade Dedication Failure Reporting Process

Procedure NA 1.0 1.1 1.2 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 3.0 3.1 3.2 3.3 3.4 3.5 3.6 4.0 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 4.12 4.13 4.14 4.15 4.16 5.0 5.1 5.2 5.3 5.4 5.5

Rev A NA A A NA B A A A A A B A A NA A A A A A A NA A A A A B A A A A A A A A A A A NA A A A B B

Rev Date 8-15-11 NA 8-15-11 8-15-11 NA 9-30-11 8-15-11 8-15-11 8-15-11 8-15-11 8-15-11 9-30-11 8-15-11 8-15-11 NA 8-15-11 8-15-11 8-15-11 8-15-11 8-15-11 8-15-11 NA 8-15-11 8-15-11 8-15-11 8-15-11 9-30-11 8-15-11 8-15-11 8-15-11 8-15-11 8-15-11 8-15-11 8-15-11 8-15-11 8-15-11 8-15-11 8-15-11 NA 8-15-11 8-15-11 8-15-11 9-30-11 9-30-11

Quality Procedure

Procedure No. 1.1 Subject: Quality Policy Statement Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 1 of 3 QA MANAGER:

ORIGINATOR:

Paul Grabek
PURCHASING:

Paul Grabek
ENGINEERING

Jim Jamieson
MARKETING:

Nick Graziano
MATERIAL CONTROL:

Keith Macdowall
COO:

Jim Jamieson
PRODUCTION:

Luis Lluberes REV DATE
0 1 2 3 4 A 07-17-97 06-01-01 06-23-03 05-30-06 10-01-08 08-15-11

Sam Mandel AUTHOR
Carol Pepin Paul Grabek Paul Raspe Victor Szatkowski Paul Grabek Paul Grabek

DESCRIPTION OF CHANGE
Original Changed President Added cover sheet and formatted policy statement. Changed Inc to LLC in one place. COO was President, added Purchasing Added malpractice and security. No change except Rev. Convert from number Rev to letter Rev.

employees. Luis Lluberes Chief Operating Officer (COO) . We support continuous improvement by maintaining open communications with our customers.1 Subject: Quality Policy Statement. and Security Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 2 of 3 Quality Policy It is a major objective of Prime Technology. 1. Malpractice. to maintain our reputation for leadership in Quality.Quality Procedure Procedure No. It is our continuing goal to provide products and services that meet or exceed our customers’ requirements. LLC. and suppliers.

Malpractice. Security Prime Technology LLC is a Department of Defense supplier and maintains a secure facility. Luis Lluberes Chief Operating Officer (COO) . 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. 1.1 Subject: Quality Policy Statement. and Security Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 3 of 3 Malpractice Prime Technology LLC shall not tolerate malpractice in performance of its obligations to customers.Quality Procedure Procedure No. 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.

Six units was 7. . Organizational chart scanned into document. Updated organization chart Updated department descriptions Convert from number Rev to letter Rev.Quality Procedure Procedure No. Updated organization chart. Implementation: Correct again the typo error that Accounting is responsible for Quality. Exhibit A update. Exhibit A update. Organizational Chart update. Updated Organizational Chart. IV. Manufacturing was production and fabrication. IV. COO was President. Implementation: Correct typo error that Accounting is responsible for Quality. Added cover sheet.2 Subject: Company Organization Revision: A Date: 08-15-11 Supersedes: Revision 9 Page 1 of 3 QA MANAGER: ORIGINATOR: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 1 2 3 4 5 6 7 8 9 A 07-17-97 09-17-97 09-15-00 06-21-02 09-23-02 06-23-03 05-30-06 10-01-08 05-01-10 09-06-10 08-15-11 AUTHOR Carol Pepin Carol Pepin Carol Pepin Paul Grabek Mary Harnois Paul Raspe Victor Szatkowski Paul Grabek Paul Grabek Paul Grabek Paul Grabek Sam Mandel DESCRIPTION OF CHANGE Original Exhibit A. revised organizational chart. Change Inc to LLC in two places. 1. added Purchasing.

Quality Procedure

Procedure No. 1.2 Subject: Company Organization Revision: A Date: 08-15-11 Supersedes: Revision 9 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 unit’s 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.

Quality Procedure

Procedure No. 1.2 Subject: Company Organization Revision: A Date: 08-15-11 Supersedes: Revision 9 Page 3 of 3

EXHIBIT A

Quality Procedure

Procedure No. 2.1 Subject: Control of Quality Manual Revision: B Date: 09-30-11 Supersedes: Revision A Page 1 of 3 QA MANAGER:

ORIGINATOR:

Paul Grabek
PURCHASING:

Paul Grabek
ENGINEERING:

Jim Jamieson
MARKETING:

Nick Graziano
MATERIAL CONTROL:

Keith Macdowall
COO:

Jim Jamieson
PRODUCTION:

Luis Lluberes REV DATE
0 1 01-30-97 06-01-01

Sam Mandel AUTHOR
Carol Pepin Paul Grabek

DESCRIPTION OF CHANGE
Original I. Policy: Deleted: Procedures contained herein satisfy the requirements of ISO 9001 and 10CFR50, 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. None found. Added cover sheet. II. Responsibility: Deleted typo error The Manager. Changed Inc to LLC in one place. COO was President, added Purchasing, revised implementation section, added Exhibit B 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. Page 2, Changed location from: Public, To: Engineering Released Document Folder.

2 3 4 A B

09-20-02 06-23-03 05-30-06 08-15-11 09/30/11

Mary Harnois Paul Raspe Victor Szatkowski Paul Grabek Paul Grabek

Policy It is the policy of Prime Technology. The Engineering Change Notice shall be the approved method for revision to the Quality Manual. Implementation of Engineering Changes . Included within this procedure are the distribution of the manual to the internet / intranet. A written procedure incorporated into the Quality Manual outlining the method or steps to be performed in support of a quality objective.com.Quality Procedure Procedure No. revision processes and procedure format. Revisions to the Quality Manual may be requested through an Engineering Change Request (ECR). For customers the Quality Manual is available on the Prime Technology web site: www.3. Responsibility The Quality Manager has overall responsibility for administration of this procedure and of assuring that written procedures satisfactorily address contractual requirements. 2. LLC to maintain a centrally coordinated manual of procedures related to Quality activities. This is maintained by “read only” access to Prime Technology employees on the company wide intranet. Only the current revision of the manual is available to users. III. The manual is available on the Engineering drive Released document Folder / Quality Manual Folder.primetechnology. This procedure outlines the controls on procedures contained within the Prime Technology Quality Manual. V. Implementation All Procedures included in the Quality Manual are written in the format outlined in Exhibit A. The Quality Manual is included in the Quality Section. Control of the Quality Manual is the responsibility of the Quality Manager. II. Reference Procedure 3. IV. This manual is under the direction and issuance control of the Quality Manager. Definitions Quality Procedure.1 Subject: Control of Quality Manual Revision: B Date: 09-30-11 Supersedes: Revision A Page 2 of 3 I.

This cover sheet will identify the revision status. Revision status is indicated by a letter. A revision control sheet is incorporated into each procedure. Copies of relevant forms are included as attachments. 5. 2. .Quality Procedure Procedure No. 4.1 Subject: Control of Quality Manual Revision: B Date: 09-30-11 Supersedes: Revision A Page 3 of 3 Exhibit A 1. The initial issue of a procedure will be Rev. I II III IV V 2. 3. The structure of Quality Procedures. Policy Responsibility Definitions Implementation Reference Paragraphs are in narrative format. A.

Exhibit B. Policy: Delete phrase: and fulfill quality objectives.Quality Procedure Procedure No. LLC. Changed Inc to LLC in one place. Quality Assurance Organization Chart update. 3 4 5 6 A 09-23-02 06-23-03 05-30-06 10-01-08 08-15-11 Mary Harnois Paul Raspe Victor Szatkowski Paul Grabek Paul Grabek . added Purchasing Updated Exhibit A Convert from number Rev to letter Rev. Exhibit A updated. Exhibit A. Corrected Exhibit A. monthly quality indicator data. Added at Prime Technology. I.2 Subject: Quality Organization Revision: A Date: 08-15-11 Supersedes: Revision 6 Page 1 of 4 QA MANAGER: ORIGINATOR: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 1 2 10-01-96 09-15-00 Sam Mandel AUTHOR DESCRIPTION OF CHANGE Carol Pepin Carol Pepin Original None found. Added VP to C of C signature list. 2. COO was president. IV. Functional Quality Assurance Organization: Add Certificates of Compliance/Conformance/Calibration and * note for authorized sign off. Add cover sheet. Implementation: Delete ways to feedback: CAB.

Quality Procedure

Procedure No. 2.2 Subject: Quality Organization Revision: A Date: 08-15-11 Supersedes: Revision 6 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 MILI-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

Quality Procedure

Procedure No. 2.2 Subject: Quality Organization Revision: A Date: 08-15-11 Supersedes: Revision 6 Page 3 of 4

Exhibit A

Prime Technology, LLC

COO

DR Plant Manager

QA Manager North Branford

DR Manufacturing

Quality Engineer North Branford

DR Quality Assurance Manager

NB Quality Control Inspectors/Testors

DR Quality Assurance Inspectors Quality Assurance Organization Chart

Quality Procedure

Procedure No. 2.2 Subject: Quality Organization Revision: A Date: 08-15-11 Supersedes: Revision 6 Page 4 of 4

Exhibit B
Functional Quality Assurance Organization
Quality Administration * Certificates of Compliance/Conformance/Calibration • Quality Procedures/Manual • Training • Quality Performance/Analysis • Supplier Source/Evaluation • Supplier Support/Interface Review of drawing requirements Procurement requirements Corrective Action • Quality Program Planning • Manufacturing support MRB Root-cause analysis Corrective Actions • Customer Liaison Contract requirements Internal corrective actions Improvement plans/goals • Records Quality Engineering • Calibration Services • Product Reliability Testing • Incoming Inspection Support Inspection instructions Technical support • Manufacturing Support Inspection instructions Methods/Test review Audit Purchased Material Quality

• Quality Auditing • Material Acceptance Lot Inspection • Mfg. Workmanship Performance Lot inspection • Nonconforming Material Documentation • Repair & Returns • First Piece Inspections Receipt • Material Flow Tracking Control/Traceability • Nonconforming Material

* The Quality Manager and the COO are authorized to sign Certificates of Compliance/Conformance and Calibration for goods and services provided by Prime Technology, LLC. When the Quality Manager or COO is not available a company officer of Vice President level may sign as an alternate.

Quality Manager was Quality Assurance. Added LLC in one place. 2 3 4 5 A 09-24-02 06-23-03 05-30-06 10-01-08 08-15-11 Mary Harnois Paul Raspe Victor Szatkowski Paul Grabek Paul Grabek . Quality Plan. Convert from number Rev to letter Rev. COO was President. IV.Quality Procedure Procedure No. Added cover sheet. 2. Implementation: Revised the wording concerning the requirements for a formal Quality Planning document.3 Subject: Quality Planning Revision: A Date: 08-15-11 Supersedes: Revision 5 Page 1 of 2 QA MANAGER: ORIGINATOR: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 1 10-20-97 09-15-00 AUTHOR Carol Pepin Carol Pepin Sam Mandel DESCRIPTION OF CHANGE Original Delete Exhibit A. Formatted document to fit on one page. Contract Quality Planning and Review & B. added Purchasing Updated contract review requirements.

delineating the plan required to assure compliance with the quality requirements of the contract. and instructions are reviewed to insure compatibility and to insure that these documents assure conformance to product specifications. Reference Not applicable. or specification. This may vary from a Quality Assurance Directive. or Purchase order. IV. processes. After the review is completed. Amendments are reviewed for document/specification revisions. Responsibilities The Manager. Non-Standard Products: Those products that are not released to production. The package includes a copy of the proposed contract. Standard Products: Those products that are fully released to production. any product specifications. A determination shall be made during review for the need of Vender Information Requests or waivers if required. The purpose of this procedure is to provide a means for implementing Quality Planning to support Prime Technology. The contract review determines the requirements for a formal Quality Planning document. 2. fixtures.Quality Procedure Procedure No. procedures. specifications. Implementation Quality Planning starts at the bid proposal stage. test equipment. Nuclear/Military contracts are reviewed at the quoting/contract/amendment stages for inclusions or changes to Quality requirements. Requirements shall flow down to suppliers and subcontractors as required by the contract. V. tooling and skills required. Systems requirements are satisfied by the Prime Technology Quality Manual. is responsible for the preparation of Sales Orders and entry of Quality requirements. Sales. Contracts/Purchase Orders shall be the governing document over any other document. Manufacturing documentation including blue prints. . LLC products. where the variances to standard operating procedures are implemented to a full Product Quality Plan (PQP). The planning effort includes a review of contract requirements to identify and make timely provisions for the special controls. drawing. a formal documented Quality Plan is generated. 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. As a part of the planning effort and involvement in product development investigation.3 Subject: Quality Planning Revision: A Date: 08-15-11 Supersedes: Revision 5 Page 2 of 2 I. and any special instructions involving the product requirements when available. 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 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. Any questions relating to customer quality requirements are forwarded to the Quality Manager for resolution. II. The Quality Manager is responsible for the overall implementation of this procedure and the preparation of Quality Plans. When required by contract. all documentation. Definitions Product Quality Plan (PQP): A project-oriented document. process sheets and routings are available to support the product. Policy Quality Planning is accomplished for all contracts to assure product quality. III.

Convert from number Rev to letter Rev. . Implementation: Added yearly eye exam requirement. Changed Inc to LLC in one place.4 Subject: Critical Resource Training and Certification Revision: A Date: 08-15-11 Supersedes: Revision 5 Page 1 of 3 QA MANAGER: ORIGINATOR: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 1 2 3 4 5 A 05-02-97 NA 09-15-00 06-23-03 05-30-06 10-01-08 08-15-11 AUTHOR Carol Pepin Carol Pepin Carol Pepin Paul Raspe Victor Szatkowski Paul Grabek Paul Grabek Sam Mandel DESCRIPTION OF CHANGE Original IV. COO was President. Implementation: Deleted reference to CAB and revised wording of the development of a training plan for identified critical operations. added Purchasing Added customer approval for welding/brazing procedures. Added cover sheet. IV. 2.Quality Procedure Procedure No.

Quality Procedure

Procedure No. 2.4 Subject: Critical Resource Training and Certification Revision: A Date: 08-15-11 Supersedes: Revision 5 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.

Quality Procedure

Procedure No. 2.4 Subject: Critical Resource Training and Certification Revision: A Date: 08-15-11 Supersedes: Revision 5 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 operator’s 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

Quality Procedure

Procedure No. 2.5 Subject: Manufacturing Work Instructions Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 1 of 3 QA MANAGER:

ORIGINATOR:

Paul Grabek
PURCHASING:

Paul Grabek
ENGINEERING:

Jim Jamieson
MARKETING:

Nick Graziano
MATERIAL CONTROL:

Keith Macdowall
COO:

Jim Jamieson
PRODUCTION:

Luis Lluberes REV DATE
0 1 04-04-97 09-15-00

AUTHOR
Carol Pepin Carol Pepin

Sam Mandel DESCRIPTION OF CHANGE
Original IV. Implementation: Delete: from Process Sheets MOP step by step, all of Packaging/Shipping from Material Handling, Storage, and Movement.ESD, all of Special Process. V. Reference: Deleted: 4.13 ESD. 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. Added cover sheet. Corrected typo revision error. Changed Inc to LLC in one place. COO was President, added Purchasing Convert from number Rev to letter Rev. Corrected paragraph IV Testing:, Inspection: and last subparagraph. Reference: added Procedure 3.3.

2 3 4 A

09-24-02 06-23-03 05-30-06 08-15-11

Mary Harnois Paul Raspe Victor Szatkowski Paul Grabek

The purpose of this procedure is to outline the types of work instructions used at Prime Technology. II. concise instructions at the user level and are compatible with acceptance criteria. Responsibility The Quality Manager is responsible for assuring that the provisions of this procedure are implemented. Responsible department: Engineering Manufacturing Process sheets provide critical characteristics necessary to build specific final assemblies. reference to blueprints. Work instructions are written to provide clear. and revision. Responsible department: Quality Testing: Instructions for test are clearly prescribed in production test procedures that are utilized in process and Acceptance Test Procedures (ATP’s). A document that prescribes critical actions to perform a certain task. 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. drawings. These may be in the form of standardized or specific checklists. implementation.Quality Procedure Procedure No. These documents are used to assess compliance with applicable specifications at the finished goods state. or individual instruction sheets. Inspection: Inspection instructions and Quality Assurance Procedures (QAP’s) are generated by Quality. LLC to provide clear and documented instructions for areas affecting quality. Responsible department: Engineering . Definitions Work Instructions.5 Subject: Manufacturing Work Instructions Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 2 of 3 I. Instructions provide the critical characteristics for the process involved and are compatible with acceptance criteria. III. 2. Work instructions are monitored by Quality for completeness. IV. The individual department managers are responsible for assuring that work instructions for which they are responsible meet the requirements of this procedure. Implementation Individual procedures governing activities affecting quality are contained in the Prime Technology Quality Manual. Policy It is the policy of Prime Technology.

11. or general quality problems.3. Reference Prime Technology Quality Procedure Number 2.8 Quality Performance Analysis. Storage.12 Shelf Life. description of use and application. Prime Technology standard practice is to store material or product so as not to degrade quality or to cause damage. Revisions to work instructions may be requested through an Engineering Change Request (ECR). Supplier Surveys/Evaluation Prime Technology Quality Procedure Number 4. Movement and Handling. The Engineering Change Notice shall be the approved method for revision of the work instructions cited to insure conformance to contractual requirements.11. 2.8. Quality Assurance may request that instructions be generated as a result of initial quality planning. and Movement.2 Supplier Surveys/Evaluation. Responsible departments: Quality Assurance and Purchasing The responsible departments listed above will generate work instructions as required. Material Storage. Shelf Life Prime Technology Quality Procedure Number 4. Material Storage.15. For the majority of products manufactured at Prime Technology. and 4. and instructions for field repairs or modifications. Quality Performance Analysis Prime Technology Quality Procedure 3. Responsible department: Engineering Material Handling. These manuals include. Separate procedures in the Quality Manual address specific issues: 4. and 2. Refer to Prime Technology Quality Procedures Numbered 4. Control of Special Processes . Approval of Supplier Prime Technology Quality Procedure Number 4.1 Procurement Control. corrective action request.1. but are not limited to.5 Subject: Manufacturing Work Instructions Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 3 of 3 Installation/Care of Product. 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 to suppliers to meet Prime Technology and contract requirements. Movement. comprehensive manuals are prepared. and Handling Prime Technology Quality Procedure Number 4. Responsible department: Material Control Purchasing. V. 4. Implementation of Engineering Changes Prime Technology Quality Procedure Number 4. installation and maintenance instructions.Quality Procedure Procedure No.14. equipment interface information.12. Product Packing and Packaging Prime Technology Quality Procedure Number 4.2.

Inprocess Performance Report. Daily Inspection Log. 1 Added cover sheet. 2. 2 3 4 5 6 A 09-24-02 06-23-03 05-30-06 10-01-08 05-01-10 08-15-11 Mary Harnois Paul Raspe Victor Szatkowski Paul Grabek John DeCola Paul Grabek . Corrective Action Reports. Records Removed in Rev. Weekly reports changed to Inspection logs. Corrected date typo on Rev. Internal Audits. Training/Certification.6 Subject: Quality Assurance Records Revision: A Date: 08-15-11 Supersedes: Revision 6 Page 1 of 3 QA MANAGER: ORIGINATOR: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 1 04-09-97 09-15-00 Sam Mandel AUTHOR DESCRIPTION OF CHANGE Carol Pepin Carol Pepin Original IV. Add Engineering Drawings as “Permanent Record” Type Document Convert from number Rev to letter Rev. Paragraph IV updated Responsibility titles. 2 that was left as 09-15-00. Purchased Material Performance Report. Page 2: Daily Inspection Report changed to Log. added Purchasing Added OQE correction procedure and software storage. Changed Inc to LLC in one place. Implementation: Records Removed: Customer Return Log. deleted statements on FQA and CAB. COO was President.Quality Procedure Procedure No. Returned all IV.

This procedure outlines those records that are maintained. The customer shall be notified at the end of storage if document possession is desired. Definitions Permanent/Lifetime Records. 2. Quality Manager. Permanent/lifetime records shall be stored for the life of the product or while the product is installed in the plant or in storage. and retention periods for each particular record. III. Records to be considered permanent/lifetime shall meet the following criteria: demonstration of capability of safe operation (safety related products). Engineering Manager. Quality Manager. Records to be Maintained Records Incoming Inspection Folder Shelf Life Log Customer Return Log Material Rejection Report Daily Inspection Report First Piece Inspection Report Certificate of Compliance Certified Test Report Quality Assurance Checklist Final Acceptance Performance Data Internal Audits Corrective Action Reports Work Order Purchased Material Performance Report In-process Performance Report Qualification Test Reports Product Quality Plan Design Eng. Individuals specified in the body of this procedure are responsible for those assigned tasks. Non-Permanent Records. records used for maintaining. repairing. Quality Manager. Quality Manager. 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. reworking. OQE. Quality Manager. Quality Type Non-permanent Non-permanent Non-permanent Non-permanent Non-permanent Non-permanent Non-permanent Permanent Non-permanent Non-permanent Non-permanent Non-permanent Non-permanent Non-permanent Non-permanent Permanent Non-permanent Permanent Non-permanent Non-permanent . Quality Manager.Quality Procedure Procedure No. Quality Manager. Quality Manager. Quality Manager. Quality Manager. Quality Manager. LLC to retain records that demonstrate objective evidence of product quality and compliance to customer requirements. Responsibility The Quality Manager is responsible for assuring implementation of this procedure. responsibility for retention. Implementation The records specified in the body of this procedure are considered minimal requirements. Quality Manager. Quality Manager. Drawing and Change Notices Training / Certification OQE Responsibility Manager. Policy It is the policy of Prime Technology. Objective Quality Evidence IV.6 Subject: Quality Assurance Records Revision: A Date: 08-15-11 Supersedes: Revision 6 Page 2 of 3 I. Quality Manager. Quality Manager. or modifying product. Quality Manager. replacing. Quality Manager. II. Material Control Manager.

The MRR provides an audit trail for decisions made by the Material Review Board (MRB) on rejected material. Items rejected to Material Rejection Report (MRR) should be annotated with the MRR number. and a brief reason for rejection. Documents utilized during inspection of product indicate the following: a) Nature of observation (i. documentation of the number of lots inspected. records may be boxed in Trans-files and stored in the archives for the balance of the retention period.: 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. Access shall be restricted to Quality and Engineering personnel. The server will be backed up on a weekly basis. 2. The Daily Inspection Log (Purchased Material) provides the number of lots inspected. Digital OQE shall be stored on the main server quality drive. This report is filed by Supplier in Incoming Inspection.e. Corrective Action . V. Reference Prime Technology Quality Procedure Number 2.Quality Procedure Procedure No. Trans-files are suitably identified to permit prompt retrieval. number of lots rejected/accepted. Documents that are OQE shall not have corrections made that use whiteout or correction tape.6 Subject: Quality Assurance Records Revision: A Date: 08-15-11 Supersedes: Revision 6 Page 3 of 3 The Inspection Folder is maintained as a dynamic record by supplier. inspection characteristics. No changes shall be performed on OQE once Prime Technology Quality has accepted product. 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. The review shall determine trends and the possibility for corrective actions. The media shall have restricted access. Corrections shall be a single line drawn through the mistake with a dated signature. After one year. as a minimum. quantities accepted/rejected. This report is retained in the Incoming Inspection Files. and information to audit disposition of rejected material. It contains.7.

MRR form to Rev 2 for next Buy / Printing Added Exhibit “C”. but no less than once per month” & 10 day C/A Response time limit. COO was President. Purchasing was MRB Chairman. Manager.7 Subject: Corrective Action Revision: B Date: 09-30-11 Supersedes: Revision A Page 1 of 6 QA MANAGER: ORIGINATOR: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 1 2 3 4 5 10-01-96 09-23-02 06-23-03 05-30-06 03-31-10 09-22-10 Sam Mandel AUTHOR Carol Pepin Mary Harnois Paul Raspe Victor Szatkowski Paul Grabek Paul Grabek DESCRIPTION OF CHANGE Original None found. Paragraph IV. to “As necessary.Quality Procedure Procedure No. Quality Manager was Manager. CAB Meetings was “Weekly”. 2. Deleted ‘Operation Manager’ from CAB. A 08-15-11 Paul Grabek B 09-30-11 Paul Grabek . Added Audit CAR form and Desc. subparagraph five. Convert from number Rev to letter Rev. Scanned Exhibits A & B. added Purchasing Edit for Part 21 Compliance. Revised Exhibit C for Part 21. Added cover sheet. Added LLC in one place. Quality Assurance.

Quality Assurance. specifying the problem and corrective action required. If a response is not received by the due date. and date completed. Prime Technology. 2. its affectivity. 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. suppliers. Policy It is the policy of Prime Technology. If a third notice is required. the change is made to the log and the file copy of the CAR. review. Conditions adverse to quality shall be promptly identified and corrected. and preventative actions. or practices and/or hardware deficiencies. corrective. Corrective Action Request (CAR): Form used to document corrective action by recording the problem. documented. . Material Rejection Report (MRR) [Exhibit B]: Initiated for deficiencies related to product. for action. which lead to preventive action or a marked improvement toward achieving a quality goal. this form incorporates all steps for the corrective action process. and closure. The CAR Log contains the CAR control number. 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. Responsibility The Manager. follow up. the review by Quality is documented. Quality Assurance. The request is delineated.5 Failure Reporting Process) A process to be used when the cause of a non-compliance must be identified. It is used for supplier-caused defects as well as Prime-caused defects.” The log is updated indicating a second notice was requested. resulting in compliance with a quality requirement. It is initiated for administrative type deficiencies. the proposed corrective action is slated by the responder. and C). and follow-up on the implementation of the action is verified. The resulting report will be used in communications with. departures from established policies. procedures. LLC to maintain a corrective action system that eliminates recurrences of nonconforming material and deviations from established procedures. and corrected where applicable. II. the proposed corrective action. subject. (See 5. Definitions Corrective Action: The measures taken by the supplier or Prime Technology. customers. Car’s are routed through the Manager. 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. is responsible for the overall implementation of this procedure. for logging control number assignment.7 Subject: Corrective Action Revision: B Date: 09-30-11 Supersedes: Revision A Page 2 of 6 I. Completed reports will be kept on file in Prime Technology’s Quality Department. reply within five working days. and help Prime Technology’s internal correspondences regarding root causes.Quality Procedure Procedure No. it is forwarded to the COO. III. addressee. Failure Reporting Process In the Quality Manual. Quality Assurance issues a copy of the CAR to the addressee and his supervisor annotated “Second Notice. If a request for extension is received. and the activity responsible for implementation (See Exhibit A. The request is in narrative form. date of issue. due date.

5. Quality Assurance. individually or collectively. signifies the action taken to verify completion of the corrective action as stated in the reply. Part 21 Reporting of Defects and Non-Compliance. The MRB Chairman assures corrective actions are evaluated. then Audit CAR form (Exhibit “C”) shall be utilized. as measured at Incoming Inspection and on the manufacturing floor. Quality Assurance. signs and dates the CAR. and plans of action are distributed to the members and kept on file in the Quality office.9 Quality Audits) The Corrective Action Board (CAB) consists of the managers of Manufacturing. The Quality Manager provides feedback to the supplier regarding the effectiveness of the corrective action. Disapproval of the answer requires initiation of a new CAR. The CAB members may review this information via the Intranet on the Public Drive in the CAB Meeting Minutes folder. Quality tracks / analyzes / follows-up on non-conformance and corrective action data / trends on a continual basis. are determined and that appropriate corrective action is taken by the responsible suppliers. Materials.3. and feedback is provided to appropriate personnel. Purchasing removes the supplier copy of the MRR and forwards it to the supplier when necessary for root cause analysis and corrective action. assignments. schedules. and Quality or their designees. and implemented. Quality Assurance maintains a file of the completed copy of the MRR. Reference Quality Manual 5. The rejection tag may be used to document remedial action taken in situations where Quality does not feel a CAR is warranted. (Internal or External) and findings are made. The Manager. Quality reviews and analyzes non-conformance data to determine if corrective action is required. The MRB Chairman assures that causes of non-conformances. Failure Reporting Process Forms similar to the attached may be used provided they contain the required information. For supplier caused corrective action the Manager. Engineering. Corrective Action is requested from suppliers or departments within Prime Technology when investigation of customer complaints (data or hardware) warrants such action. CAB Meetings are convened as necessary. 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. Effectiveness of the corrective action is measured by monitoring future lot performance. Quality Manual 5. 2.3 Part 21 “Reporting of Defects and Noncompliance”. When an audit is performed. Supplier corrective action is reviewed by the Quality Manager. "but no less than once per month” to assure all nonconformances and corrective actions are promptly identified. The MRB Chairman who conducts the MRB or preliminary review insures causes of non-conformances are determined. . A review is made to assure implementation of the action and to evaluate its effectiveness.Quality Procedure Procedure No.7 Subject: Corrective Action Revision: B Date: 09-30-11 Supersedes: Revision A Page 3 of 6 The close-out action is by the Manager. Minutes of these reviews detailing commitments. In order to provide timely & effective C/A. V. and corrective actions initiated when required. The MRR form is used to provide corrective action for material. both In-House and Supplier corrective action responses must be submitted to Prime Technology’s Quality Assurance Department within 10 business days from date of issuance. (Reference Procedure 2.

3 Corrective Action Acceptable: Yes ____ No ____ Part 21 Reportable Engineering Yes __________ No_________ If Yes: Process per Procedure 5. 2.7 Subject: Corrective Action Revision: B Date: 09-30-11 Supersedes: Revision A Page 4 of 6 Exhibit A. ___________________________ Discrepancy: Date ________________________ Auditor ______________________ Condition Reported To: _______________________ Action Taken to Resolve Discrepancy: Date ________________________ Signature ___________________________________ Date _________________________ Part 21 Reportable Quality Yes __________ No_________ If Yes: Process per Procedure 5. Corrective Action Request INTERNAL CORRECTIVE ACTION REQUEST EXTERNAL CORRECTIVE ACTION REQUEST Section No.3 Manager.Quality Procedure Procedure No. QA ________________ Auditor ________________ Date __________ .

7 Subject: Corrective Action Revision: B Date: 09-30-11 Supersedes: Revision A Page 5 of 6 Exhibit B.Quality Procedure Procedure No. 2. Material Rejection Report Part 21 Safety Related Yes / No Model 1151 1251 9270 Part 21 Safety Related Yes / No Approved By: Quality __________Engineering __________ .

Addressee. President.: CAR Audit No. QP 2. 2. Other as Required. Area Supervisor.Quality Procedure Exhibit C Procedure No.: Rev.: Rev.9.7 Subject: Corrective Action Revision: B Date: 09-30-11 Supersedes: Revision A Page 6 of 6 AUDIT CORRECTIVE ACTION REQUEST INTERNAL______ Procedure No. Date: Addressee: Auditor: Action Taken to Resolve Discrepancy: Date of Issue: Date Due: Addressee Signature: Corrective Action: Reason for Not Acceptable: Date Completed: Acceptable: ___ Yes ___ No If No.3 Distribution: Quality. QA: Extension Requested: Second Notice: Third Notice: _____ _____ _____ Auditor: Date Closed: New Due Date: Date of 2nd Notice: Date of 3rd Notice: Reply Within 5 Working Days Distribution to President Part 21 Reportable: Quality Yes __________ No_________ If Yes: Process per Procedure 5.: Subject: EXTERNAL______ CAR Control No.3 PART 21 Part 21 Reportable: Engineering Yes __________ No_________ If Yes: Process per Procedure 5. Ref. give reason Manager. .

COO was President.Quality Procedure Procedure No. added Purchasing Convert from number Rev to letter Rev. Deleted paragraph starting with “Data from MPR’s. QA is to be notified of any indicators of quality change that need to be reviewed. Changed Inc to LLC in one place. Implementation: Deleted CAB uses weekly analysis.5. 2 06-23-03 Paul Raspe 3 A 05-30-06 08-15-11 Victor Szatkowski Paul Grabek . IV. Changed wording to per contract or as needed.9. Added cover sheet. II.” V. 2. Added that all data is held on file in the inspection/test areas and that the Manager. Changed list of indicators: delete Process Audit and Overdue Internal Corrective Action Requests and add Purchased Material Quality. inspection. Reference: Delete: 2. 4.8 Subject: Quality Performance Analysis Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 1 of 3 QA MANAGER: ORIGINATOR: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 1 04-09-97 09-15-00 AUTHOR Carol Pepin Carol Pepin Sam Mandel DESCRIPTION OF CHANGE Original IV. and test is input into a PC database.

to trace the effects of previously initiated corrective actions and to plan and obtain quality improvements. rejection reports etc. The document format is specified by the applicable test specification. inspection and test data. test data forms. The SPC data (where applicable). Process quality indicators include. It includes provisions for MRB actions and dispositions. or lots. III. LLC. The purpose of this procedure is to describe the method for reporting. to analyze quality for the purpose of evaluating the overall quality performance within Prime. Implementation The results of inspections / tests performed on Prime Technology fabricated and purchased material are recorded on applicable checklists. Policy It is the policy of Prime Technology. test and inspection data are reviewed by QA. but are not limited to: Purchased Material Quality Final Acceptance In Process Inspection Acceptance . for the purpose of trend analysis to highlight problem areas or negative trends in quality.Quality Procedure Procedure No. when a concern is raised by inspection / test personnel. and acting on quality data. Work Order: A routing sheet that accompanies product through various stages of production. and provision for operation/auditor sign-off when tasks have been completed. Statistical Process Control (SPC): The methodology used to measure the average and variability of any given characteristic. through the use of SPC. These documents are held on file in their respective inspection / test areas. 2. The quality performance information is used by management to identify and evaluate quality problems. Definitions Material Rejection Report (MRR): A form listing the inspection findings for rejected material. parts. IV.8 Subject: Quality Performance Analysis Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 2 of 3 I. Responsibility The Quality Manager or his designee per contract or as needed prepares reports on quality indicators for management review and action as required. summarizing. reference to other documentation. It provides the sequence of operations. as well as monitor the success or failure of initiated solutions to past problems. and documentation. Test Data: The documented results of specific tests performed on an item. abbreviated descriptions of requirements. analyzing. MRR’s. II.

Quality Procedure Procedure No.1.8 Subject: Quality Performance Analysis Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 3 of 3 Field Return data is analyzed and evaluated for cause. 2. Return Authorization . Reference Prime Technology Quality Procedure Number 4. and necessity for corrective action.1.7. Disposition/Corrective Action of Nonconforming Material Prime Technology Quality Procedure Number 2.5. V. recurrences. Return Authorization. Corrective Action Prime Technology Quality Procedure Number 5. Refer to Prime Technology Quality Procedure Number 5.

Policy: Added: It is the policy at Prime Technology. Implementation: Add Quality Assurance Program Audit shall be performed annually. 2 3 4 A 05-30-06 10-01-08 08-30-10 08-15-11 Victor Szatkowski Paul Grabek Paul Grabek Paul Grabek .Quality Procedure Procedure No. Quality Manager was Manager.9 Subject: Quality Audits Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 1 of 6 QA MANAGER: ORIGINATOR: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 1 10-01-96 06-23-03 Sam Mandel AUTHOR DESCRIPTION OF CHANGE Carol Pepin Paul Raspe Original Added cover sheet. 2. added Purchasing. Paragraph 4. III. Quality Assurance. Deleted Exitibit “C”. Quality was Quality Assurance. LLC. IV. Definitions: Add Quality Assurance Program Audit. Add auditor previous training statement. I. Revise Section IV. Convert from number Rev to letter Rev. COO was President. Added malpractice statement.

as appropriate. conducted to verify compliance to the applicable blueprints. II. quantitative measurement or narrative response. Procedure audits are also utilized to verify that contractual requirements are satisfactorily addressed in Prime Technology procedures. The attributes covered in the audit checklist are selected from specific requirements as noted in applicable procedures. An examination of the activities of a department conducted to verify compliance with procedural requirements of the Quality Manual. corrective action requests. or at the request of company management. conformal coating. (If results dictate a need for additional research. 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. the auditor will pursue the investigation to carry out the full intent of the audit). Quality Program Audit. Procedure Audit. Policy It is the policy at Prime Technology. An examination of any number of units. Audits are performed using prepared guidelines or checklists. 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. Guidelines for product and system audits supply criteria for investigation and provide for indication of acceptability or non-acceptability. Such areas could include sales or production control. Definitions Product Audit. at any stage of production.g. painting. Each year the Quality Manager develops an audit schedule. An examination of a manufacturing process (e. drawings or checklists. Checklists of relevant procedures or a compilation of general guidelines can be used in the conduct of systems audits. instructions. Responsibility The Quality Manager is responsible for implementation of this procedure and for the maintenance of a central file for audit reports. process sheet. LLC to perform periodic audits to determine compliance with procedures.9 Subject: Quality Audits Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 2 of 6 I. parts lists. checklists. Prepared checklists for process and procedure audits specify the key attributes for investigation and are written to permit answers regarding compliance. III. Audits are performed to verify adequacy of processes and systems and the acceptability of product. 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. and other known requirements. IV. The schedule is developed with the intent that each procedure in the Quality Manual is audited. 2. The Quality Manager is responsible for developing and scheduling audits and for any subsequent activities necessitated by the audit effort. Process Audit. assembly) conducted to verify compliance to the appropriate manufacturing standard. quality system. The purpose of this procedure is to provide general instructions for conducting and documenting Quality Audits.Quality Procedure Procedure No. and related miscellaneous documentation. specifications. and other applicable documentation necessary to support a cost-effective. Systems Audit. They are performed in accordance with a planned schedule.

Refer to the Prime Technology Quality Procedure Number 2.7. Audits are thorough and concise. It is the responsible supervisor’s prerogative to accompany the auditor on the audit. and other personnel who have a need to know. corrective action responses are evaluated and verified for implementation. Additional distribution includes the Quality file. Documentation for product audits is unspecified due to a large variety of product. Audit reports on product includes. Recommendations may be made as to a means to resolve discrepancies. 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. The responsible authority for the operations or areas being audited is briefed prior to the audit on the purpose and objectives.9 Subject: Quality Audits Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 3 of 6 Audits are scheduled so as to minimize interference with the operations or areas being audited. goals of system Scope Observations Summary comments. 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. COO. . Quality Audit Checklist (Exhibit B) is utilized as guidelines for the audit investigation in process and procedure audits. recommendations Corrective Action Request (Exhibit C) is used to document significant deficiencies. Quality Audit Report (Exhibit A) is utilized to report results from processes and procedure audits. the responsible authority’s supervisor. If the Manager determines a written reply is necessary Quality shall issue a Corrective Action Request (CAR) to be forwarded with the audit report. Reports are forwarded to the responsible authority for the area or item audited. Included in the text is: • • • • • Description of system audited Objectives. Before closing.Quality Procedure Procedure No. Corrective Action. 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. 2.

Quality Procedure Procedure No. 2. Reference Prime Technology Quality Procedure Number 2. including a follow up audit of deficient areas. and shall be maintained on file. . Previous auditor training shall be reviewed by the Quality Manager and if acceptable an inter office communication shall be generated listing acceptable auditors. The auditors shall be appropriately trained personnel not having direct responsibilities in the areas being audited. Evidence of malpractice shall immediately be brought to the attention of the COO and Quality Manager. Auditors shall be aware of malpractice requirements. Follow up action. Corrective Action Forms similar to the attached may be used provided they contain the required information. Audit results shall be documented and reviewed by management having responsibility in the area audited. V. A review of product impact shall be conducted and necessary corrective action completed.7.9 Subject: Quality Audits Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 4 of 6 An overall Quality Assurance Program Audit will be scheduled by the Quality Manager to be performed annually. shall be taken where indicated.

Quality Procedure Procedure No.: _____________________ Rev.: __________ Date: ______________ ________________________________________________________________________________________ _________________________________________________________________________________________ Auditor: ____________________ Approved by: ___________________ Date: ____________ . 2.9 Subject: Quality Audits Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 5 of 6 Exhibit A Quality Audit Report Procedure No.: ________ Title: _____________________________ Audit No.

Quality Procedure Procedure No.9 Subject: Quality Audits Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 6 of 6 Exhibit B QUALITY AUDIT CHECKLIST SCOPE: _________________________________ AUDITOR: _____________________________________ APPLICABLE DOCUMENTS (includes revision level) PERSONNEL CONTACTED: ______________________ DEPARTMENT: __________________________ ITEM CHARACTERISTIC APPLIC. S U N COMMENTS _________________________________________________________________________________________________ _________________________________________________________________________________________________ _________________________________________________________________________________________________ _________________________________________________________________________________________________ _________________________________________________________________________________________________ _________________________________________________________________________________________________ _________________________________________________________________________________________________ _________________________________________________________________________________________________ _________________________________________________________________________________________________ _________________________________________________________________________________________________ _________________________________________________________________________________________________ _________________________________________________________________________________________________ _________________________________________________________________________________________________ _________________________________________________________________________________________________ S = Satisfactory U = Unsatisfactory N = Not Applicable CHECKLIST NO: __________ . 2. PARA.

& C. added Page 6 Convert from number Rev to letter Rev. Implementation: Section greatly expanded and includes reference to Exhibits A. Quality was Quality Assurance 2 3 A 06-23-03 05-30-06 08-15-11 Paul Raspe Victor Szatkowski Paul Grabek . COO was President. IV. 3. Scanned Exhibits A.Quality Procedure Procedure No. Added cover sheet.1 Subject: New Product Development/Release Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 1 of 6 QA MANAGER: ORIGINATOR: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 1 05-02-97 03-02-98 Sam Mandel AUTHOR Carol Pepin Carol Pepin DESCRIPTION OF CHANGE Original Two Versions Found: 4 Page added Exhibit A as New Product Design Flow Chart and original Exhibit A became B and B became C. C. (4 Page). B. Changed Inc to LLC in one place.B. 3 Page deleted new Exhibit A and left other Exhibits as B & C. added Purchasing.

Milestones in product development consist of: defining product requirements. 3. The purpose of this procedure is to define the activities required to support new product development programs. He will direct and verify that testing has been performed according to drawings and specifications. Qualification performance testing is intended to verify the adequacy of the design in the most adverse conditions. Engineering. A project schedule will be initiated (Exhibit B). Each design is reviewed by qualified Engineering personnel who are not directly involved with the design of the product. testing procedures.Quality Procedure Procedure No. This meeting shall be conducted by the responsible design engineer. Product is released through the distribution and signing of the Engineering Drawing Release/Change Notice (Exhibit C) in accordance with Quality Procedure 3. An interdisciplinary design review meeting is held prior to initial release of new products. LLC to develop / release products in a systematic way that meets or exceeds customer expectations. Engineering to review and monitor the design in whatever manner is practicable. is responsible for overall implementation of this procedure. This group is comprised of the disciplines that eventually sign the Engineering Drawing Release package. acceptance criteria. The result of this testing is maintained and stored for future verification. Details will be developed with each new product as required. Parts List. Definitions Not applicable. and Sales. The Manager.2. If it is determined by senior management. Engineering will formulate qualification testing requirements according to specifications and customer drawings. Responsibility The Manager. qualification/verification. Engineering. IV. the typical sequence of product development is outlined in Exhibit A. customer specifications. The design is explained and questions regarding production operations. Engineering. and Quality to proceed. associated drawings. Engineering Change Control . preliminary design review.2. and a technical manual (where applicable). If all or the majority of the Engineering personnel have been involved. customer contracts. They will identify the customer’s requirements and forward this information to Engineering and Quality. test data. V. Sales. Policy It is the policy of Prime Technology. critical design review. Reviews and tests noted in the project schedule will be documented by the cognizant Engineering and Quality personnel. first product run. Reference Prime Technology Quality Procedure Number 3. Manufacturing. Engineering Change Control. III. II. materials.1 Subject: New Product Development/Release Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 2 of 6 I. Quality and Engineering will determine the feasibility of the customer’s requirements. and company specifications. and internal reviews. detailed design. Materials Control. Reviews will consider but not be limited to design calculations. Program review meetings are regularly scheduled. Quality. it is the responsibility of the Manager. A released product consists of a Bill of Materials. are resolved. Implementation Sales will determine the need to pursue a new product.

3.1 Subject: New Product Development/Release Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 3 of 6 EXHIBIT A.Quality Procedure Procedure No. NEW PRODUCT DESIGN FLOWCHART .

Project Schedule .1 Subject: New Product Development/Release Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 4 of 6 Exhibit B.Quality Procedure Procedure No. 3.

1 Subject: New Product Development/Release Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 5 of 6 Exhibit C. 3.Quality Procedure Procedure No. Engineering Change Control .

3.1 Subject: New Product Development/Release Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 6 of 6 Exhibit C.Quality Procedure Procedure No. Engineering Change Control .

0 Policy. and Closure Statement Convert from number Rev to letter Rev.Quality Procedure Procedure No. Corrected routed to departments. revise explanation list of ECN terms. . added Purchasing. Add Approval Block Instructions.2 Subject: Engineering Change Control Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 1 of 7 QA MANAGER: ORIGINATOR: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 1 2 3 4 A 10-01-96 06-23-03 05-30-06 10-01-08 9-20-10 08-15-11 Sam Mandel AUTHOR Carol Pepin Paul Raspe Victor Szatkowski Paul Grabek John DeCola Paul Grabek DESCRIPTION OF CHANGE Original Added cover sheet. Changed Inc to LLC in one place. added Page 7 Added: reviewed for accuracy to 1. COO was President. 3. Scanned Exhibit B.

or combinations of both. 3. A parts list is a tabulation of all parts and bulk materials used in the item to which the list applies. or disapproval of changes in the configuration of an item (part. ECN’s shall be processed in a reasonable time frame and reviewed for closure by Eng manager or his designee. Changes are identified by a control number. Material Control is responsible for the implementation of the stock disposition. It is the responsibility of Quality Assurance to assess the impact of the proposed change. parts. reviewed for accuracy. Purchasing is responsible for implementation of engineering changes with suppliers and for assessment of material on order. Definitions Engineering Drawing.Quality Procedure Procedure No. that it does not invalidate the qualified configuration. assembly. . or product) after establishment of its configuration identification. Engineering Change. and modifying engineering documentation. which completely describes and authorizes release of or change to released engineering documentation. Drafting Request. approval. Drawings which have been released for production will not have their technical contents changed without an Engineering Change Notice (ECN) having been processed. An engineering change is a revision to a parts list. The Engineering manager or his designee shall mark approval blocks “N/A” (with initials. the physical and functional end-product requirements of an item. and raw materials that go into a parent assembly showing the quantity of each required to make an assembly. III. The Sales Department is responsible for customer notification. III. It is the responsibility of Manufacturing to review changes for impact in production regarding tools and the manufacturing process. coordination. Parts List (P/L). A bill of material is a listing of all subassemblies. A request of engineering assistance in the technical investigation and /or documentation of an engineering change. Responsibilities The Engineering Manager is responsible for the overall implementation of this procedure. maintaining. or drawings authorized by the Engineering Department. Engineering Drawing Release/Change Notice. II.2 Subject: Engineering Change Control Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 2 of 7 I. and date) where the department is not effected by the ECN change. Policy There is one practice employed within Prime Technology. and to determine technical correctness and verify the material disposition code. Bill of Material (BOM). An engineering drawing is an engineering document that discloses (directly or by reference) by means of pictorial or textual presentations. bill of materials. and approved by all cognizant personnel. LLC for the evaluation. An engineering release/change notice is a document. The Engineering Department is responsible for generating. The change control system provides for systematic review and approval of engineering changes. and to investigate specific notifications and/or approvals to ensure proper implementation.

being put together to make assemblies. Class II Engineering Change. Effective Date. The effective date for an approved mandatory change shall be immediate. Class II changes result in a revision change to the part number. The request is completed and returned to engineering. or document. End-Item. An item number is the Prime Technology part number for a part. Product Structure. A typical product structure would show. The bill of material system provides for the effective start and stop date. correct deficiencies. This document is completed in such a manner that the proposed change is described without interpretation or further explanation. 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. The effective date is the date on which a component of an operation is introduced or deleted from a bill of material. Implementation Change to released engineering documentation is started by a Engineering Change Request (Exhibit A). inadequacies. 3.2 Subject: Engineering Change Control Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 3 of 7 Engineering Drawing Release. Each engineering change must have a cover sheet as outlined below: . This form can be initiated by anyone. Mandatory Change. the Engineering Manager reviews the request and forwards it to the cognizant engineer. or ambiguities found in the documentation or to provide parts standardization. Class I Engineering Change. for non-mandatory it is at the discretion of Material Control. A non-mandatory change is one intended to improve system performance. etc. An engineering change shall be classified Class II when it does not fall within the definition of a Class I engineering change. an engineer is assigned to initiate the proper changes. either an individual part or assembly.Quality Procedure Procedure No. A Class I engineering change results in a part number change. or function of the item. Item Number. The cognizant engineer completes the form. An engineering change to an item shall be classified Class I when it affects the contractually specific form. IV. IV. The method of formally placing engineering documentation under formal change control. The effective dates are used in the explosion process to create demands for the correct material or assembly labor. Engineering changes are generated by the Engineering Drawing Release/Change Notice (Exhibit B). A mandatory change is one intended to eliminate a deficiency which will adversely effect performance. Product structure is the way components go into a product during its manufacture. fit. An end-item is an item. subassemblies going into assemblies. in final or completed state. for example. assembly. It is assigned a number by the Engineering Manager and recorded in the Engineering Change Log. fit. provide a cost savings. raw material being converted into fabricated components. If the reason is determined valid. Non-Mandatory Change.

Sales. Quality. B. I. Reference Not applicable. and updated revisions of the engineering documentation as required per the change notice will be to Quality. Drafting will incorporate the approved changes. Distribution of the Engineering Drawing Release / Change documentation. G. 3. If the affected document is a Parts List. Revision: New revision. F. E. D. After completion of the Engineering Drawing Release / Change Notice the package consisting of the revised parts list. C. Manufacturing and Initiator for review and approval. Size: Indicate the size of the document affected by the proposed change. J. General Description: Comments which may enhance the understanding of the proposed engineering change. V. drawings. Manufacturing. Only those changes that are specified and authorized on the Engineering Drawing Release / Change Notice will be incorporated. Purchasing. H. and any other departments as deemed necessary. Notes: Specifics regarding changes to the drawing number.Quality Procedure Procedure No. Drawing Number: Drawing number affected by the change Stock Disposition: Indicates the material disposition code. . Comments are reconciled by the cognizant engineer. Forms similar to the attached may be used provided they contain the required information. When applicable the Customer and Offshore Plant Manager shall be included in the review and approval process.2 Subject: Engineering Change Control Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 4 of 7 A. Impact of Change: Fill in the appropriate boxes Initiated by: Sign and indicate the date. Purchasing. and associated documentation is routed to Engineering. Models Affected: Indicate the product family or end-item model number in which the affected assembly or component is used. Reason for Change: Indicate the reason for change. “PL” should be indicated.

2 Subject: Engineering Change Control Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 5 of 7 Exhibit A.Quality Procedure Procedure No. 3. Engineering Drawing Request .

Engineering Drawing Release/Change Notice . 3.Quality Procedure Procedure No.2 Subject: Engineering Change Control Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 6 of 7 Exhibit B.

Engineering Drawing Release/Change Notice Procedure No.Quality Procedure Exhibit B.2 Subject: Engineering Change Control Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 7 of 7 . 3.

3. Added cover sheet. added Purchasing.3 Subject: Implementation of Engineering Changes Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 1 of 4 ORIGINATOR: QA MANAGER: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV 0 1 2 3 A Sam Mandel AUTHOR Carol Pepin Mary Harnois Paul Raspe Victor Szatkowski Paul Grabek Original None found. added Page 4 Convert from number Rev to letter Rev. Rework was salvaged. Scanned Exhibit A.Quality Procedure Procedure No. COO was President. DATE 05-02-97 09-23-02 06-23-03 05-30-06 08-15-11 DESCRIPTION OF CHANGE . Changed Inc to LLC in one place.

. LLC. to review engineering changes for proper material disposition and identify affected areas. Update pick lists (change pick lists. Coordinate with Purchasing the return for credit of unique material. The Material Control Department’s objective is to effect the change with the least impact on schedule and cost. II.3 Subject: Implementation of Engineering Changes Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 2 of 4 I. The Material Control Department is responsible for notifying sales representatives of changes in the delivery schedule. III. Purge and place on the rejection shelf in Incoming Inspection material to be reworked or scrapped. 3. 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. Implementation Upon receipt of an approved Engineering Change Notice it is the Material Control Department’s responsibility to implement the disposition of material identified on the Engineering Drawing / Release Change Notice (Exhibit A).Quality Procedure Procedure No. Reference Not applicable. IV. Definitions Not applicable. Typical areas that are also addressed in the implementation of engineering changes are: • • • • • • When to effect change Update of revision levels on work orders. V. Review shop status of any work orders that may be affected Disposition of excess or obsolete material. Responsibility The Material Control Department is responsible for assuring that the provisions of this procedure are met. Forms similar to the attached may be used provided they contain the required information. Policy It is the policy of Prime Technology. Material that has other “where used” listing is returned to stock.

3.3 Subject: Implementation of Engineering Changes Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 3 of 4 . Engineering Drawing / Release Change Notice Procedure No.Quality Procedure Exhibit A.

3 Subject: Implementation of Engineering Changes Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 4 of 4 . Engineering Drawing / Release Change Notice Procedure No. 3.Quality Procedure Exhibit A.

Added cover sheet. TA procedure – obsolete. 3. . Scanned Exhibit A. added Purchasing Added TA form locations. COO was President. Changed Inc to LLC in one place.Quality Procedure Procedure No. Convert from number Rev to letter Rev.4 Subject: Temporary Authorization Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 1 of 2 QA MANAGER: ORIGINATOR: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 1 2 3 4 A 04-14-97 09-23-02 06-23-03 05-30-06 10-01-08 08-15-11 Sam Mandel AUTHOR Carol Pepin Mary Harnois Paul Raspe Victor Szatkowski Paul Grabek Paul Grabek DESCRIPTION OF CHANGE Original None found.

Quality Procedure Procedure No. Reference Prime Technology Quality Procedure Number 3. Disposition/Corrective Action of Nonconforming Material .2.4 Subject: Temporary Authorization Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 2 of 2 I. 3.5. II. Policy The Temporary Authorization process is obsolete concurrent with this revision. The MRR /MRB and ECN procedures shall be utilized in lieu of the TA procedure. Engineering Change Control Prime Technology Quality Procedure Number 4. Responsibility N/A III. Implementation N/A V. Definitions N/A IV.

IV. Added third paragraph to Purchased Material and Exhibit L. Quality Assurance. . Changed Inc to LLC in one place. COO was president.5 Subject: Product Identification/Traceability Revision: A Date: 08-15-11 Supersedes: Revision 5 Page 1 of 14 QA MANAGER: ORIGINATOR: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 1 2 3 4 5 A 05-14-97 09-23-02 06-23-03 05-30-06 10-01-08 09-20-10 08-15-11 Sam Mandel AUTHOR Carol Pepin Mary Harnois Paul Raspe Victor Szatkowski Paul Grabek Paul Grabek Paul Grabek DESCRIPTION OF CHANGE Original None found. updated Exhibits. 3. Scanned Exhibits A-K. added Purchasing. Added cover sheet. Changed from Production Control to Final Inspection for assigning serial numbers.Quality Procedure Procedure No. Exhibit K was Material Control Purge Form Contractual marking requirements defined. Align Department Names with new Organization Chart Convert from number Rev to letter Rev. Quality Manager was Manager.

When parts are received at Prime Technology. part number. III. blueprint. delivery.6. IV. Material Control is responsible for generation of work orders. factory order number and customer unique requirements identified by Quality. A collection of components and parts needed to build a specific assembly. a Receiver (Exhibit D) is generated indicating date received. Disposition / Corrective Action for Nonconforming Material. 3. and overall implementation of this procedure. The purpose of this procedure is to outline these controls. is responsible for providing and maintaining product bills of materials. is moved to Incoming Inspection. is responsible for sales order release (picker) and assignment of a factory order. Documentation package comprised of a parts list. Implementation Components and parts are assigned a part number and revision level. purchase order number. Drawings are released via the Engineering Drawing Release / Change Notice. The Receiver. The Manager. This information is entered into the mainframe indicating receipt. Definitions Sales Order Release (Picker). The Quality Manager is responsible for inspection. and process sheets. and installation as required. along with the material. the purchase order and quantity are verified in Receiving. The requisition is given to the Purchasing Department for purchase order placement (Exhibit C).4. providing documentation with the work order kit. part lists. quantity. Supervisors in all areas are responsible for the completion of documentation as required by work order in their areas. part number. and overall implementation of this procedure. 4. If found unacceptable. the Receiver is initialed or stamped and dated by Quality. LLC to identify and control the status of material during all stages of procurement. Policy It is the policy of Prime Technology. Inspection of Purchased Material). The material is inspected in accordance with the purchase order and specifications (refer to Prime Technology Quality Procedure No. II. If correct. Sales. . audit. it is documented on a Material Rejection Report and rejected in accordance with Prime Technology Quality Procedure 4. Kit. or applicable Process Sheet issued with each kit.5 Subject: Product Identification/Traceability Revision: A Date: 08-15-11 Supersedes: Revision 5 Page 2 of 14 I. Responsibility The Manager. Work Order Package. The picker contains a minimum of customer purchase order number. production. Purchased Material Material is purchased by generating a purchase requisition (Exhibit B). If material is accepted.Quality Procedure Procedure No. Engineering. [Exhibit A] Document generated as a result of order entered by Sales. and quantity.

The material shall be processed as described in the previous paragraphs. V. receiver number. purchase order number. Inventory bin cards are adjusted for quantity. Inspection of Purchased Material Prime Technology Quality Procedure Number 4. The material with certification and support documentation as required shall be submitted to Incoming Inspection. A new receiver with the assigned part number shall be generated. Disposition/Corrective Action of Nonconforming Material Forms similar to the attached may be used provided they contain the required information. A Sales Order Release or Picker (Exhibit A) is generated. In-process or subassembly material transfer is done by Quality after inspection using a move ticket (Exhibit G). This is accomplished using the Engineering Change Notice form (Exhibit K). Items requiring serialization shall be assigned by Final Inspection. The serial number log book contains serial number. revision. QC Form 118 is used to transfer the material and remains with the bin box in the stockroom. Product Manufacturing When a customer order is accepted by Prime Technology the Sales Order is entered into the mainframe. Factory Order assigned by Prime Technology. and date accepted. Material shall be received by the Receiving Clerk and a ‘Engineering Use Only’ label placed on the material / packaging for identification (Exhibit L). . Packing List. 3. along with the parts are delivered to the Stock Room. a Process Sheet (Exhibit I). a move ticket is used for material transfer.5 Subject: Product Identification/Traceability Revision: A Date: 08-15-11 Supersedes: Revision 5 Page 3 of 14 QC Form 118 (Exhibit E) is completed indicating part number. and customer unique requirements identified by Quality Assurance. The mainframe transaction is made to the appropriate assembly department when the kit is released. A Work Order (Exhibit F) is assigned a nine digit (subassembly) and fifteen digit (final assembly) part number.5. Stock Purge Material that has been determined unacceptable will be removed from the Stockroom and normal processing channels.4. Material procured for Engineering development shall be procured with certification and support documentation as required. Kits for these are picked from the stockroom per the Work Order. and a Sales Order Release (Picker). quantity. The Receiver. References Prime Technology Quality Procedure Number 4. Information entered includes customer’s purchase order number. Final Assembly kits include an Order Acknowledgement (Exhibit H). factory order. The receiver is released from the incoming QC location in the Visual system. Return to Stock Over issued or excess material is re-inspected by Quality before restocking. Product shall be inspected against required documentation for proper marking. model. Product is inspected per the Process Sheet and associated work instructions.Quality Procedure Procedure No. This includes nameplates and traceability marking as required. material is transferred via a move ticket and mainframe transaction indicating closure of the work order. After acceptance of product. and purchase order number is entered into the mainframe when material is accepted into inventory. quantity. When accepted. the part number. and QC Form 118. date. If material is approved for use a part number shall be assigned and released on a ECN. and part number (Exhibit J). Part number. customer name. and work order accordingly.

3.Quality Procedure Procedure No.5 Subject: Product Identification/Traceability Revision: A Date: 08-15-11 Supersedes: Revision 5 Page 4 of 14 .

3.Quality Procedure Procedure No. Purchase Requisition .5 Subject: Product Identification/Traceability Revision: A Date: 08-15-11 Supersedes: Revision 5 Page 5 of 14 Exhibit B.

Quality Procedure Procedure No.5 Subject: Product Identification/Traceability Revision: A Date: 08-15-11 Supersedes: Revision 5 Page 6 of 14 . 3.

3.Quality Procedure Procedure No.5 Subject: Product Identification/Traceability Revision: A Date: 08-15-11 Supersedes: Revision 5 Page 7 of 14 Exhibit D. Receiver .

Engineering Use Only WARNING Engineering Use Only This material is for engineering development. Do not use unless material has been processed through the provisions of Quality Manual Procedure no.5. . 3. 3.5 Subject: Product Identification/Traceability Revision: A Date: 08-15-11 Supersedes: Revision 5 Page 8 of 14 Exhibit L.Quality Procedure Procedure No.

5 Subject: Product Identification/Traceability Revision: A Date: 08-15-11 Supersedes: Revision 5 Page 9 of 14 Exhibit F. Work Order . 3.Quality Procedure Procedure No.

3.5 Subject: Product Identification/Traceability Revision: A Date: 08-15-11 Supersedes: Revision 5 Page 10 of 14 Exhibit G.Quality Procedure Procedure No. Move Ticket .

5 Subject: Product Identification/Traceability Revision: A Date: 08-15-11 Supersedes: Revision 5 Page 11 of 14 Exhibit H.Quality Procedure Procedure No. 3. Order Acknowledgement .

3.Quality Procedure Procedure No.5 Subject: Product Identification/Traceability Revision: A Date: 08-15-11 Supersedes: Revision 5 Page 12 of 14 Exhibit I. Process Sheet .

Quality Procedure Procedure No. Serial Number Log .5 Subject: Product Identification/Traceability Revision: A Date: 08-15-11 Supersedes: Revision 5 Page 13 of 14 Exhibit J. 3.

5 Subject: Product Identification/Traceability Revision: A Date: 08-15-11 Supersedes: Revision 5 Page 14 of 14 Exhibit K. ECN Form .Quality Procedure Procedure No. 3.

Delete Corrective Action and Follow Up paragraph. (Page 1 of 10 Rev 4 dated 04-19-01 found that the text was the same as 08-03-00 and 09-23-02.I. Scanned a set of Exhibits. Corrected Exhibit B from PM Check List to Calibration Record. Added that the location of equipment is in the respective files. Implementation: Delete PM equipment. COO was President.S. Revised Calibration Status section.Quality Procedure Procedure No. III. Changed Inc to LLC in one place. 08-03-00 Carol Pepin 4 5 09-23-02 06-23-03 Mary Harnois Paul Raspe 6 7 A 05-30-06 10-01-08 08-15-11 Victor Szatkowski Paul Grabek Paul Grabek . (Rev 1 to 3) III.6 Subject: Control and Calibration of Measuring and Test Equipment Revision: A Date: 08-15-11 Supersedes: Revision 7 Page 1 of 9 ORIGINATOR: QA MANAGER: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 1 2 3 04-14-97 09-17-97 Sam Mandel AUTHOR Carol Pepin Carol Pepin DESCRIPTION OF CHANGE Original Added Exhibit E. Changed QA maintains a master equipment list with Master Schedule. Definitions: Delete Preventative Maintenance (PM). V. Change No Calibration Required to Reference Only. References: Update MIL-STD-45662 to MIL-STD-45662A.T from NBS in several locations. updated exhibits Deleted exhibit ‘D’. added Purchasing. Paragraph IV added: stored pending calibration statement. Corrected Page 3 now 4 – Calibration Record Sheet (Exhibit A to B) and Calibration Instruction Sheet (Exhibit B to A). 3. Record Card for Mechanical Instruments and description of use of it. Definitions: Added Out-Of-Tolerance Condition. Convert from number Rev to letter Rev. None found. Corrected Exhibit D form to one for mechanical measuring instruments (form was one for electronic measuring instruments per Exhibit B). Change No Calibration Required to Reference Only. Not found. Revised red sticker section. mechanical record card.) Added cover sheet. Updated N. There were 2 different sets of 4 Exhibits found. IV. Changed Test Equipment File is filed by asset number to calibration due date. IV.

N. Standards of the highest accuracy order in a calibration system that establish the basic accuracy values for that system. . Out-Of-Tolerance Condition. Issuance and follow-up of any Corrective Action Requests issued as a result of evaluations. Quality Procedure Procedure No.I. Policy It is the policy of Prime Technology. When scheduled calibration is performed on an instrument and it is found to not meet the manufacturer published tolerance specifications. II. and: Evaluation of impact of out-of-tolerance items. correlate.S. and the U. for contracting outside services. any variation in the accuracy of the item being compared. Department managers are responsible for insuring that equipment in their department is maintained to the calibration schedule.. Definitions Calibration. test. 3.T. Measurement Standard (transfer). Designated measurement equipment used in a calibration system as a medium for transferring the basic value of reference standards to lower equipment used in transfer standards of measuring and test equipment. or report.S.S. Measurement Standard (reference). Responsibility The Manager. N. Comparison of a measurement standard or instrument of known accuracy with another standard or instrument to detect.I. LLC to maintain a system for the calibration of all measuring and test equipment used in development. Measuring and test equipment (all devices) which are used to measure. • Fundamental or natural physical constants with Values assigned or accepted by the U. manufacture.I. The ability to relate individual measurement results through an unbroken chain of calibrations to one or more of the following: • U.T. Customer notification should an out of tolerance condition exist that adversely impacts acceptable Performance / compliance on hardware that has shipped. The purpose of this procedure is for the effective control and calibration of test and measuring equipment that also satisfies the requirements of MIL-STD45662A. Transfer standard is hereafter referred to as department standard. National Institute of Standards and Technology Traceability.S. Naval Observatory. or otherwise examine items to determine compliance to specifications are calibrated per this procedure. test.S. or acceptance of Prime products. inspect.6 Subject: Control and Calibration of Measuring and Test Equipment Revision: A Date: 08-15-11 Supersedes: Revision 7 Page 2 of 9 I. National Standards maintained by N. III. Insuring that suppliers maintain an adequate calibration system.T. gage. is responsible for assuring the implementation of this procedure.S. Quality Assurance.

. A schedule is maintained to ensure that all equipment is calibrated.Quality Procedure Procedure No. Calibration instructions for Prime fabricated test fixtures are developed by Engineering. It is the responsibility of those using measurement and test equipment to be sure that the equipment is within the calibration schedule. Calibration instructions include as a minimum: • Title—Calibration being performed. preventive maintenance) is not required. • Comparison to consensus standards Reference Only.g. Implementation Fixtures and test equipment used by all departments in the development. This equipment is used in conjunction with calibrated equipment such that its proper operation is continuously validated. Employee-owned measuring equipment is not allowed for inspection and acceptance of product. • Procedure—Steps required to perform calibration.I.S. and accuracy of the measurement standard and the acceptable tolerance of each instrument characteristic being calibrated. • Ratio type of calibrations. Equipment for which no known standard is available and for which periodic functional checks (e. are checked periodically. Calibration is performed in house or by approved outside laboratories depending upon resources and available standards.T. The instructions for commercially sold test equipment may be a compilation of published standard practices or manufacturer’s written instructions. • Standard—Standard used for calibration. Written instructions are utilized for calibration of all measuring and test equipment. fabrication. • Accuracy—The required parameter. All calibrated test equipment is moved. Repaired or redesigned test equipment is removed from service and recalibrated to regain active status. This equipment will be audited periodically to assure proper use with calibrated equipment and to review its observable condition.6 Subject: Control and Calibration of Measuring and Test Equipment Revision: A Date: 08-15-11 Supersedes: Revision 7 Page 3 of 9 • National standards of other countries that are correlated with N. test. and stored to prevent degradation of accuracy or damage to equipment. range. 3. • Tolerance range limits. . or acceptance of Prime Technology products. Refer to Exhibit A. handled. IV.

Intervals may be shortened or lengthened when the results of previous calibrations indicate that such action is appropriate to maintain acceptable reliability.I. Measurement standards and measuring and test equipment are calibrated as often as necessary to maintain prescribed accuracy. the collective uncertainty of measurement standards shall not exceed 25 percent of the acceptable tolerance for each characteristic being calibrated. Subsequent calibrations shall be performed by designated personnel. Standards used in the calibration system are supported by certificates. range. and year. Standards are calibrated at least once a year by an approved outside service using standards traceable to the N. A folder shall be maintained in the Quality Department for each piece of measuring or test equipment in the calibration system.. stability. 3. N. Initial calibration of purchased test equipment is performed by the supplier and supported by a Certificate of Calibration. usage. It is filed by calibration due date and referred to as the Equipment File. Calibration of Prime fabricated test equipment is done by Engineering. the equipment’s proper operation is continuously validated. Overdue equipment is removed from the floor. Quality maintains a Master Schedule that includes measuring and test equipment with a scheduled calibration due date. When equipment with a storage label is pending calibration by authorized personnel the equipment folder shall be kept with the equipment until calibration is completed. . and provided with a calibration Record sheet as objective evidence that calibration was performed. This is determined by the Quality Manager.I. “Reference only” equipment is used in conjunction with calibrated equipment. Mechanical measuring equipment utilized by inspection for verification that is labeled with a limited calibration label shall be verified prior to each use with a calibrated instrument. or data sheets and the NBS test number as appropriate. All changes to these intervals must be authorized by the Quality Manager. In this way.S.T. the Out-of-Tolerance Report. the Calibration Instruction Sheet (Exhibit A). Intervals are stated in terms of time or usage. The intervals are measured by month. Requirements of this nature are written onto the Purchase Order. and resolution required for the intended use. or other agencies. records.T. where practical. stability.6 Subject: Control and Calibration of Measuring and Test Equipment Revision: A Date: 08-15-11 Supersedes: Revision 7 Page 4 of 9 Measurement standards established by Prime for calibrating the measurement and test equipment used in controlling product quality are traceable and have the accuracy.S. Initial intervals are assigned by the Quality Manager.Quality Procedure Procedure No. day. previous history of the equipment. recommendation of the manufacturer. Unless otherwise specified in the contract requirements. degree of accuracy required. A calibration interval is developed on evaluation of the type. where applicable (Exhibit C) and unit location. Calibrated equipment is physically recalled for calibration and functional checks. The Equipment File contains the Calibration Record Sheet (Exhibit B). and a red do not use ‘Storage’ label shall be applied. Department supervisors are responsible to schedule equipment for calibration with Quality.

When examined by the Quality Department. If the equipment cannot be restored. would cause an item to fail one or more required test parameters. When equipment is in continuous use at the time of its due date. the equipment will be sealed appropriately (i. Refer to Exhibit C. LIMITED CALIBRATION—This label is used in special application or when full parameters are not required. month. A calibration label will be affixed to the equipment reflecting an extension. The Quality Department insures that equipment is restored to within the tolerance limits prior to returning it to service. glyptol.e. .This label is used when calibration has expired. Label includes: • Date Calibrated (day. The adverse impact of an out of tolerance condition is one in which when the equipment. In cases where it is not possible to place the label in this area. will affect calibration. month. The seal (s) shall be affixed to operator accessible controls or adjustments that.Quality Procedure Procedure No. Completed “Out-of-Tolerance Reports” are maintained in each piece of equipment’s unique folder. if moved. Customers will be notified should an out of tolerance condition exist that adversely impacts acceptable performance/compliance. Limitations shall be noted on the sticker. a written extension may be requested from the Quality Manager. it will be taken out of service. This report is forwarded to the cognizant Project Engineer for an evaluation of impact on product quality and appropriate product corrective actions. year) • Date Due • Individual/laboratory performing Calibration • Identification Number (serial number) • Limitations Seals are affixed to provide a tamper-resistant seal. when readjusted to its specification limits. An “Out-of-Tolerance Report” is forwarded to the Quality Manager whenever an item calibrated is not within the specified tolerance. 3. year) • Date Due • Individual/Laboratory Performing Calibration • Identification Number (serial number) REFERENCE ONLY STORAGE DO NOT USE .6 Subject: Control and Calibration of Measuring and Test Equipment Revision: A Date: 08-15-11 Supersedes: Revision 7 Page 5 of 9 CALIBRATION STATUS Prime Technology owned equipment in the calibration program shall have a calibration label as follows: CALIBRATION . wax) by the Quality Department.This label includes the following: • Date Calibration (day. corrective action will be taken. if these seals are disturbed.

Forms similar to the attached may be used provided they contain the required information. Corrective Action. Calibration Systems Requirements.6 Subject: Control and Calibration of Measuring and Test Equipment Revision: A Date: 08-15-11 Supersedes: Revision 7 Page 6 of 9 A list of Prime Technology personnel authorized to perform calibration and preventive maintenance is maintained by the Quality Manager. Quality Systems—Model for Quality Assurance in design.Quality Procedure Procedure No. Prime Technology Quality Procedure Number 2. . ISO-9001. installation. development. References MIL-STD-45662A. production. Calibration Instructions are approved by the Quality Manager. and servicing. 3. V.7.

Calibration Instruction Sheet . 3.Quality Procedure Procedure No.6 Subject: Control and Calibration of Measuring and Test Equipment Revision: A Date: 08-15-11 Supersedes: Revision 7 Page 7 of 9 Exhibit A.

6 Subject: Control and Calibration of Measuring and Test Equipment Revision: A Date: 08-15-11 Supersedes: Revision 7 Page 8 of 9 Exhibit B. Calibration Record . 3.Quality Procedure Procedure No.

3.6 Subject: Control and Calibration of Measuring and Test Equipment Revision: A Date: 08-15-11 Supersedes: Revision 7 Page 9 of 9 Exhibit C.Quality Procedure Procedure No. Out of Tolerance Report .

Quality Procedure Procedure No. Revised IV paragraph four. Returned to the 2 Exhibits as in Rev 0. to paragraph. Implementation: Corrected Exhibit A. Second Rev 2 found. Quality Manager was Manager Quality Assurance. Material Mill Certs. Add Parallel supplier evaluation w/first buy. Purchasing was Quality for requisition review. Deleted formal distribution of PR. updated exhibits Added flow down requirement and malpractice. 2 3 08-03-00 06-23-03 Carol Pepin Paul Raspe 4 5 6 A 05-30-06 10-01-08 05-01-10 08-15-11 Victor Szatkowski Paul Grabek John DeCola Paul Grabek .1 Subject: Procurement Control Revision: A Date: 08-15-11 Supersedes: Revision 6 Page 1 of 4 QA MANAGER: ORIGINATOR: Paul Grabek PURCHASING Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 1 2 05-14-97 01-20-00 Sam Mandel AUTHOR Carol Pepin Carol Pepin DESCRIPTION OF CHANGE Original Not found. Added cover sheet. added purchasing. IV. Scanned Exhibits. Changed enterprise with visual system. Add statement that QA reviews contracts and notifies sales and planning of special requirements. Supplier Listing and changed Exhibit B. PR to B and add Exhibit A. IV. Supplier Listing. Implementation: Deleted reference to CAB and need for Manager (QA and Operations) to initial and date review of PR. and DFAR compliance. 4. IV. Convert from number Rev to letter Rev. Deleted Exhibit A. Changed Inc to LLC in one place. Purchase Order Requisition to A. Removed delivery performance from rating a supplier. COO was president.

LLC to utilize only those suppliers who consistently meet the quality and requirements specified by management. Forms similar to the attached may be used provided they contain the required information. Once it is determined to use a supplier. price. are responsible for the quality of material purchased from suppliers. Purchasing. III. A prospective supplier is evaluated in three categories: 1) overall requirements for materials/services supplied. and Manager. brazing. a purchase order is placed and the supplier is added to the Supplier Listing. Implementation The Purchasing Department maintains a supplier base capable of supporting all objectives regarding quality. V References Prime Technology Quality Procedure Number 1. Along with the purchase order for Prime designed items the supplier receives the latest revision of the engineering drawing for the part number ordered. II.1 Subject: Procurement Control Revision: A Date: 08-15-11 Supersedes: Revision 6 Page 2 of 4 I. and Security. The Purchase Order shall require that the original Mill Testing Lab Certification (or a copy) be provided with all raw metal materials shipped to Prime Technology. If a supplier is determined unacceptable.Quality Procedure Procedure No. and flag the Inspection Report document as being a first receipt from new supplier. flow down.1. It is also our practice to provide a comprehensive review of procurement documents for purchased parts and services to insure that all procedural and contractual requirements are met. testing. they are removed from the list. and 3) capability to meet Prime Technology Quality Assurance requirements. or his designee checks the supplier evaluation status. Receiving inspection will hold the parts. Quality Policy Statement. and malpractice requirements shall be included on purchase requisitions. Supplier shall provide a statement certifying metal used is in compliance with DFAR requirements when specialty metals such as stainless steel are procured. IV. The purpose of this procedure is to outline the methods for determination and review to ensure that purchases conform with specified requirements. Parts will remain on hold until the Quality Manager. Definitions Not applicable. . The objective in maintaining the Supplier Listing (Exhibit A) is to control the number of suppliers utilized by Prime Technology and insure greater control over supplier performance. Policy It is the policy of Prime Technology. etc. Responsibility The Quality Manager. and evaluate a supplier may be necessary to meet contractual requirements. Malpractice. 4. Release of material shall be upon approval of said supplier. Purchasing insures that the purchase requisition contains a complete description of the supplies ordered including applicable requirements for manufacturing. Material may be received and inspected. Under certain conditions a parallel effort to purchase from. Prime and International Instruments division drawings that specify special process purchase requirements such as welding. Once supplier is approved conforming parts are sent to stock. Performance is measured by the material acceptance rate in Incoming Inspection. 2) financial and manufacturing integrity. Purchasing places the order with an assigned purchase order number and enters the information in the visual system. Suppliers are added or removed from the Supplier Listing only following a comprehensive review of their performance and capabilities. and delivery of production materials. Procurement is accomplished by initiating a purchase requisition (Exhibit B).

4.Quality Procedure Procedure No. Supplier Listing .1 Subject: Procurement Control Revision: A Date: 08-15-11 Supersedes: Revision 6 Page 3 of 4 Exhibit A.

1 Subject: Procurement Control Revision: A Date: 08-15-11 Supersedes: Revision 6 Page 4 of 4 Exhibit B. 4. Purchase Requisition .Quality Procedure Procedure No.

Supplier Quality System Form deleted. 4. Implementation: Deleted section on SQSS.Quality Procedure Procedure No. updated exhibits. LLC. added Purchasing. IV. Definitions: Added SQSS and ISO-9000. COO was President. IV. Policy: Add: by Prime Technology. Exhibit A. I. added pages 4-8 Added VPAR requirement. Definitions: Deleted SQSS. 4 5 A 05-30-06 10-01-08 08-15-11 Victor Szatkowski Paul Grabek Paul Grabek . Convert from number Rev to letter Rev. III. III. Added cover sheet.2 Subject: Supplier Surveys/Evaluations Revision: A Date: 08-15-11 Supersedes: Revision 5 Page 1 of 8 QA MANAGER: ORIGINATOR: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 1 2 3 10-19-96 08-03-00 06-23-03 Sam Mandel AUTHOR Carol Pepin Carol Pepin Paul Raspe DESCRIPTION OF CHANGE Original Not found. Implementation: Added use of SQSS and ISO-9000 certification.

Implementation When a potential new supplier is identified. new suppliers of Class I or special processes are evaluated for their ability to provide an acceptable product or service prior to the issue of a purchase order. and technical support are taken into consideration. II. SQSS. . manufacturing capabilities. Represents an international consensus of what makes a good quality management system.2 Subject: Supplier Surveys/Evaluations Revision: A Date: 08-15-11 Supersedes: Revision 5 Page 2 of 8 I. the supplier’s quality system. If an on-site survey is required. Resurveys will be conducted if the individual circumstances resulting from product rejection indicate that changes in survey elements may occur. has overall responsibility of this procedure. in addition to corrective action requests and other pertinent correspondence. Exhibit A. Supplier survey and evaluation reports. process controls. 4. Based on the volume of supplier deliveries Class I and special process suppliers will be re-evaluated every two years. the Purchasing Department notifies Quality prior to the issuance of a purchase order so appropriate controls can be planned. IV. ISO-9000. are filed in the QA Supplier Files. Forms similar to the attached may be used. When unusual conditions indicate a need to use a supplier whose survey was rated unacceptable. VPAR. organization. Vendors that provide special process capability such as welding or brazing shall require VPAR approval when required by contract or purchase order. Policy As part of the supplier approval process by Prime Technology. III. LLC. Supplier Quality System Survey Form. The purpose of this procedure is to provide a means of conducting evaluations of suppliers.Quality Procedure Procedure No. Vendor Procedure Approval Request. IV Reference Not applicable. provided they contain the required information. Purchasing notifies Quality. Evaluation is conducted using an objective evaluation of the supplier’s ability to provide Prime Technology with a product or service that meets Prime’s requirements. Responsibility The Manager. These maybe verified by a SQSS filled out by the supplier or an on-site-survey and /or current facility ISO-9000 certification. As a means of evaluating this ability. and effected departments can be advised of cost and effect of such controls. Quality Assurance. This group includes purchases for products or services that are either complex or have critical application for which conformance to requirements cannot or should not for economical reasons be fully determined upon receipt. visits are coordinated through the Purchasing Department. ISO 9000 Certification means a facility has verified documented procedures in place and is following them. Definitions Class I Purchase.

4. Supplier Quality System Survey Form .2 Subject: Supplier Surveys/Evaluations Revision: A Date: 08-15-11 Supersedes: Revision 5 Page 3 of 8 Exhibit A.Quality Procedure Procedure No.

Supplier Quality System Survey Form .2 Subject: Supplier Surveys/Evaluations Revision: A Date: 08-15-11 Supersedes: Revision 5 Page 4 of 8 Exhibit A.Quality Procedure Procedure No. 4.

Quality Procedure Procedure No. 4.2 Subject: Supplier Surveys/Evaluations Revision: A Date: 08-15-11 Supersedes: Revision 5 Page 5 of 8 Exhibit A. Supplier Quality System Survey Form .

4.Quality Procedure Procedure No.2 Subject: Supplier Surveys/Evaluations Revision: A Date: 08-15-11 Supersedes: Revision 5 Page 6 of 8 Exhibit A. Supplier Quality System Survey Form .

2 Subject: Supplier Surveys/Evaluations Revision: A Date: 08-15-11 Supersedes: Revision 5 Page 7 of 8 Exhibit A.Quality Procedure Procedure No. 4. Supplier Quality System Survey Form .

2 Subject: Supplier Surveys/Evaluations Revision: A Date: 08-15-11 Supersedes: Revision 5 Page 8 of 8 Exhibit A. Supplier Quality System Survey Form . 4.Quality Procedure Procedure No.

added Purchasing Remake FAI form with no procedural changes Convert from number Rev to letter Rev. 4. Changed Inc to LLC in one place.Quality Procedure Procedure No.3 Subject: First Article Inspection of Purchased Material Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 1 of 4 ORIGINATOR: QA MANAGER: John DeCola PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV 0 1 2 3 A Sam Mandel AUTHOR Carol Pepin Paul Raspe Victor Szatkowski John DeCola Paul Grabek Original Added cover sheet. DATE 04-21-97 06-23-03 05-30-06 09-30-10 08-15-11 DESCRIPTION OF CHANGE . COO was President. Scanned Exhibit A.

parts. • Initial order/receipt following a hardware design change—no prior receipts of the new revision level.7. Corrective Action. Inspection is performed of each characteristic on the drawing unless otherwise noted. this is in accordance with Quality Procedure Number 2. The inspector/auditor completes the heading on the FAI Report as applicable.3 Subject: First Article Inspection of Purchased Material Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 2 of 4 I. If corrective action is required. IV. functional tests. Following receipt of an item requiring first article inspection. etc. Inspect and record results under Column 1. Prime Technology-designed items are materials. Responsibility Quality and Purchasing are responsible for the implementation of this procedure. Code each dimension or characteristic on the drawing numerically and record under “D/P Dim” column. and coordinated through Purchasing. and Purchasing to forward to the supplier. Completed FAI Reports are distributed to Incoming Inspection for record retention. Specified Characteristics. III. Implementation First Article Inspection (FAI) is required under any of the following conditions: • Initial order/receipt—no prior receipts of the part. Actual dimensions or characteristics are recorded and not “rounded off”. and assemblies manufactured by suppliers in accordance with Prime Technology Engineering design and documentation. Results are documented as follows: A. the FAI Report is reviewed by Quality and Engineering for disposition. Engineering. B. Out-of-tolerance readings are circled. If the FAI is approved. LLC. altered item drawings and specification drawings. and dated. are non-destructive. Specified characteristics are all requirements of the Prime Technology controlling documents. Definitions Prime Technology-Designed Items. II. the inspector/auditor initiates a “First Article/Sample Report” (FAI Report) [Exhibit A]. the supplier must make the proper changes to bring the item into conformance. Destructive tests are those stress tests that shorten the life of. The purpose of this procedure is to outline the requirements for inspection of purchased material. such as assembly drawings and associated parts lists. Burn in. . Destructive Testing. • Initial receipt from a supplier—no prior receipts of the part from a specific supplier. such as environmental and life tests. Policy It is the policy of Prime Technology. to evaluate supplier conformance of product and production process capability via a first article inspection to all specified characteristics except those normally verified by destructive testing. initialed. When inspection is completed. If it is rejected.Quality Procedure Procedure No. 4. degrade or destroy the item. it is checked.

4.Quality Procedure Procedure No.4. .3 Subject: First Article Inspection of Purchased Material Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 3 of 4 V. Corrective Action Prime Technology Quality Procedure Number 4. Reference Prime Technology Quality Procedure Number 2. Inspection of Purchased Material Forms similar to the attached may be used provided they contain the required information.7.

First Article/Sample Report (FAI Report) . 4.3 Subject: First Article Inspection of Purchased Material Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 4 of 4 Exhibit A.Quality Procedure Procedure No.

4 Subject: Inspection of Purchased Material Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 1 of 6 QA MANAGER: ORIGINATOR: John DeCola PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 1 2 3 4 A 01-30-97 01-30-98 06-23-03 05-30-06 9-22-10 08-15-11 Sam Mandel AUTHOR Carol Pepin Carol Pepin Paul Raspe Victor Szatkowski John DeCola Paul Grabek DESCRIPTION OF CHANGE Original IV. Changed Inc to LLC in one place. . COO was President. Added Purchasing.B. Convert from number Rev to letter Rev. Add Mill Cert Requirement for metallic stock. 4. Added cover sheet.Quality Procedure Procedure No.C. Scanned Exhibits A. Implementation: Added Class 1E paragraph. updated exhibits. Corrected revisions on Exhibits. and DFAR Compliance. Quality Manager was Manager Quality Assurance.

This document is also used as a vehicle to move purchased parts into stock. Production material is designated by a part number on the purchase order. Disposition / Corrective Action for Nonconforming Material. • Initial order/receipt following a hardware design change—no prior receipts of the new revision level. Characteristics not meeting the specification are detailed on a Material Rejection Report per Prime Technology Quality Procedure Number 4. Current drawings are maintained by part number. • Initial receipt from a supplier—no prior receipts of the part from a specific supplier. The purpose of this procedure is to provide a method for the inspection of purchased material. objective evidence of inspection performed. history of part quality. purchase order. The Incoming Inspection Folder is returned and filed by supplier in the Incoming Inspection File. The Purchase Order shall require that the original Mill Testing Lab Certification (or a copy) be provided with all metallic Raw Materials shipped to Prime Technology. First piece inspection is required for Prime Technology designed parts under any of the following conditions: • Initial order/receipt—no prior receipts of the part. with the Receiver. 4. The Receiver accompanies the material until stocked. and his/her initials or stamp on the Receiver. . The Receiving Department generates a Receiver for each lot receipt. IV. Responsibility The Quality Manager is responsible for assuring that all provisions of this procedure are carried out. The inspector records the quantity accepted. and AQL. and correspond to C of C / Mill Certification when required by contract. The material. clear. Definitions Incoming Inspection Files. Material is controlled and a disposition made according to that procedure. II. Receiver. Inspection assures all traceability marking are present.4 Subject: Inspection of Purchased Material Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 2 of 6 I. The inspector inspects the lot of material according to the Supplier Inspection Record. referenced prints. Material that does not meet requirements for the characteristics inspected is rejected. The Receiving Department distributes a document providing the purchase order and quantity received.5. Refer to Exhibit B. Material is accepted when it meets the specifications outlined in the Inspection Record. A unique folder for each supplier is maintained. This folder contains at a minimum: characteristics to be inspected. and specifications. legible. III. date. Record system maintained in the Incoming Inspection area. LLC to maintain a comprehensive inspection system for the acceptance of purchased material which satisfies requirements and specifications. Refer to Exhibit A.Quality Procedure Procedure No. The inspector completes data entry in the Inspection Folder. The inspector records accept/reject quantities on the Supplier Inspection Record (Exhibit A) for characteristics inspected. Policy It is the policy of Prime Technology. is transferred to the stockroom with QC Form 118 (Exhibit C). Supplier shall provide a statement certifying metal used is in compliance with DFAR requirements when specialty metals are procured. to retain historical information pertinent to purchased material. Supplier Inspection Record. Implementation Incoming purchased material is placed with the Receiver on the Incoming Inspection shelves by the Receiving Department.

Acceptance is denoted by initialing and dating by the Quality Manager. Reference Prime Technology Quality Procedure Number 4. Disposition/Corrective Action for Nonconforming Material Forms similar to the attached may be used provided they contain the required information.4 Subject: Inspection of Purchased Material Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 3 of 6 Upon receipt of Class 1E Safety Related services the Quality Manager reviews Certificates of Conformance and other relevant documentation for completeness. 4.5. V. Review is performed in accordance to purchase order requirements. .Quality Procedure Procedure No.

Quality Procedure Procedure No.4 Subject: Inspection of Purchased Material Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 4 of 6 Exhibit A. 4. Supplier Inspection Record .

Quality Procedure Procedure No.4 Subject: Inspection of Purchased Material Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 5 of 6 Exhibit B. Receiver . 4.

Quality Procedure Procedure No. 4. QC Form 118 .4 Subject: Inspection of Purchased Material Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 6 of 6 Exhibit C.

3 4 5 A 05-30-06 03-31-10 09-30-10 08-15-11 Victor Szatkowski Paul Grabek Paul Grabek Paul Grabek B 09-30-11 Paul Grabek . IV. Quality Assurance. COO was President. updated exhibits Edited for Part 21 Compliance Description for MRB revised Convert from number Rev to letter Rev. Quality Manager was Manager. Implementation: Deleted MRR distribution statement at the end of this section. 4. Change from traveler to be on file to other supporting documentation. Paragraph IV. Added Exhibit C.Quality Procedure Procedure No. added Purchasing. Exhibit A Part 21 block expanded and detailed in paragraph IV. Scanned Exhibits. Corrected spelling of Supersedes in two places. Changed Inc to LLC in three places. Rejection Tag title. RTV: debit memo responsibility redefined.5 Subject: Disposition/Corrective Action for Non-Conforming Material Revision: B Date: 09-30-11 Supersedes: Revision A Page 1 of 7 ORIGINATOR: QA MANAGER: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 1 2 04-17-97 09-23-02 06-23-03 Sam Mandel AUTHOR Carol Pepin Mary Harnois Paul Raspe DESCRIPTION OF CHANGE Original IV. Added cover sheet. Implementation: Remove the traveler as a document to replace the MRR Form and Rejection Tag. Added Vendor fault requirements to IV.

III. and implementation of a corrective action system. Nonconformance. Subjecting nonconforming material to an approved process designed to reduce but not completely eliminate the nonconformance. interchangeability. performance. Use As Is. 4. The purpose of this statement is to establish a procedure for the review of nonconforming material. A departure from the requirements specified in the specification. or other approved product description. Material Review Board (MRB). or weight or appearance when a factor. Minor Nonconformance. drawing. A deviation that affects safety in a Nuclear Power Plant. Representatives of the departments necessary to determine the proper or recommended disposition of nonconforming material deferred to them. The purpose of repair is to bring nonconforming material into an acceptable condition. The current approved list is maintained and controlled by the Quality Manager.Quality Procedure Procedure No. Definitions Nonconforming Material. A nonconformance other than minor. A nonconformance which does not adversely effect any of the following: health or safety. . Material Rejection Report Form (MRR). Any item. Procedure 5. or other approved product description. Repair. MRB Chairman. Scrap. Rework. A document used to evaluate and disposition non-conformances (Exhibit A). Responsibility The Quality Manager is responsible for the overall implementation of this procedure. Nonconforming material that is not usable for its intended purpose or cannot be economically reworked or repaired. Return to Vendor (RTV). Disposition of material with minor non-conformances that is determined to be satisfactory for its intended purpose. The Chairman is the Quality Manager. reliability.5 Subject: Disposition/Corrective Action for Non-Conforming Material Revision: B Date: 09-30-11 Supersedes: Revision A Page 2 of 7 I. drawing. II. Policy It is the policy of Prime Technology. Part 21. Disposition returning material to the source from which it was procured. Reprocessing nonconforming material to make it completely conform to the drawings or specifications.3. LLC to process nonconforming material in a systematic manner and to establish prompt corrective action to eliminate future occurrences. Major Nonconformance. part. or product with one or more characteristics which depart from the requirements in the specification. Part 21. See Quality Manual. Reporting of Defects and Noncompliance. Repair is distinguished from rework in that the item after repair still does not completely conform to the applicable drawings or specifications. identify deviations. or maintainability.

and help Prime Technology’s internal correspondences regarding root causes. and corrected where applicable. and preventative actions. or repaired economically are scrapped. Materials which are not usable and cannot be RTV’d. IV. specifying the nonconformance. to rework/repair in-house. purchasing or production foreman for preliminary review. The MRB determines appropriate dispositions and assures that appropriate corrective actions are defined and taken. Provides routing. (See § 5. design change or changes to technical documentation). and it is in the best interest of Prime Technology. suppliers. . rework or repair instructions. Appropriate dispositions are as follows: • Use As Is. Purchasing. The material is re-inspected following the rework..Quality Procedure Procedure No. If the rework does not correct the nonconformance. and transfer documentation to Incoming Inspection.5 Subject: Disposition/Corrective Action for Non-Conforming Material Revision: B Date: 09-30-11 Supersedes: Revision A Page 3 of 7 III. LLC. Nonconforming material from manufacturing operations is moved with the MRR. provides the MRB with purchasing and material planning considerations / requirements during Incoming Inspection MRB actions. • Supplier Caused Rework/Repair/Special Handling. Scrap materials are identified or mutilated in such a manner to preclude its use and is retained in the impound area until disposed of. reworked. RTV. repair instructions are subject to customer approval. Definitions Continued Failure Reporting Process In the Quality Manual. an MRR is used. Scrap action caused by a supplier requires the processing of a debit memo by the Purchasing Department. The originating department supervisor reviews and concurs with all noted discrepancies prior to signing the MRR form. When material is found to be nonconforming. The cognizant Foreman assures that the Work Order (Exhibit B) and Rejection Tag is filled out correctly. This disposition can be selected only by MRB and includes a determination of the appropriateness of a documentation change and the method for accomplishing any recommended change (i. MRB meetings are called by any member on an as needed basis. the Rejection Tag (Exhibit C) may be used in place of an MRR. customers. For assembly errors or workmanship discrepancies that necessitate rework requiring replacement parts or necessitate scrap actions. coordinates material availability and schedule issues. A materials department representative.e. and corrective actions. • Rework or Repair. the QA representative evaluates the material for disposition at the location of the initial detection. Preliminary review is to determine which one of the following is appropriate: rework. 4. The Materials Department is responsible for reissue/repurchase of scrap material. A material department representative. documented.5 Failure Reporting Process) A process to be used when the cause of a non-compliance must be identified. a non-voting member. For assembly errors or workmanship discrepancies that require rework within the department of rejection. If required by contract. The resulting report will be used in communications with. corrective. the Foreman initiates an MRR and refers it to the QA Department. customer approval is necessary. If required by contract. the Manager. The MRB is chaired by the Quality Manager and at a minimum includes a product design engineer. scrap. or refer to MRB. • Scrap. Completed reports will be kept on file in Prime Technology’s Quality Department. Implementation Nonconforming material is rejected and written on an MRR form with all discrepancies clearly defined. Nonconforming purchased materials at Incoming Inspection are moved with the MRR and receiving documentation to the controlled material disposition area. When the discrepancy is supplier caused. the required rework . must contact the supplier.

forwards the supplier copy of the MRR to the supplier when necessary for root cause analysis and corrective action. and follow up. and any other supporting documents are kept on file by Quality for future references. All MRR’s. Reporting of Defects and Noncompliance Forms similar to the attached may be used provided they contain the required information.5 Subject: Disposition/Corrective Action for Non-Conforming Material Revision: B Date: 09-30-11 Supersedes: Revision A Page 4 of 7 • RTV. Corrective Action Prime Technology Quality Procedure Number 5. the following information is added to the MRR: • • • • • V. date. as measured at Incoming Inspection. This applies to deviations that may represent possible defects and possible non-compliances for safety related components.D. LLC is not justified. Vendor at fault MRR’s shall be recorded in the Receiving Inspection Log fault column by the Receiving Inspector.5 Failure Reporting Process . The Quality Representative who conducts the MRB or Preliminary Review assures that causes of non-conformances are determined and corrective actions taken when required. Reference Procedure No. Effectiveness of the corrective action is measured by monitoring future lot performance. Purchasing. e. and description if warranted Identification of disposition authorities Applicable Part 21 Defect / Noncompliance Reference Prime Technology Quality Procedure Number 2. Supplier corrective action is reviewed by the Quality Manager and the Manager. P/N Number of occurrences Location where nonconformance was detected Description of nonconformance Disposition Identification of personnel responsible for the disposition Applicable Part 21 Defect / Noncompliance Vendor / Other Corrective Action Block The Quality Representative insures that all required information is included on the documentation. Prime Technology Quality Procedure Number.7. analysis. If referred to MRB for disposition. The Manager. Corrective action required is determined prior to disposition. Part 21.3. Material. Action taken when processing the material at Prime Technology. MRR and debit memo are sent to the Shipping Department for return of the material to the supplier. 4. Documentation of non-conformances on MRR’s include the following information: • • • • • • • • • • • Initiator of document Date of initiation Form I.5. for traceability Material I. Purchasing. Reporting a Part 21Defect or Noncompliance The MRR form has a block that pertains to Part 21 failure reporting. Engineering analysis if performed Final disposition Corrective actions planned—responsibilities. Rejection Tags.g.Quality Procedure Procedure No. Quality will provide feedback to the supplier regarding the effectiveness of the corrective action. The material and MRR copy are moved to a designated hold area until a debit memo is prepared by the Purchasing Department. Reporting of Defects and Noncompliance to make a determination of applicability.3 Part 21.D.. 5.

Material Rejection Report (MRR) 10 CFR Part 21 Reportability Determination:Yes ____No____ If yes.5 Subject: Disposition/Corrective Action for Non-Conforming Material Revision: B Date: 09-30-11 Supersedes: Revision A Page 5 of 7 Exhibit A.3 for Part 21 instructions 1151 1251 9270 . 4. see Quality Manual Procedure 5.Quality Procedure Procedure No.

4.Quality Procedure Procedure No.5 Subject: Disposition/Corrective Action for Non-Conforming Material Revision: B Date: 09-30-11 Supersedes: Revision A Page 6 of 7 Exhibit B. Work Order .

Quality Procedure

Procedure No. 4.5 Subject: Disposition/Corrective Action for Non-Conforming Material Revision: B Date: 09-30-11 Supersedes: Revision A Page 7 of 7

Exhibit C, Rejection Tag

Quality Procedure

Procedure No. 4.6 Subject: In-Process Inspection and Test Revision: A Date: 08-15-11 Supersedes: Revision 2 Page 1 of 5 QA MANAGER:

ORIGINATOR:

Paul Grabek
PURCHASING:

Paul Grabek
ENGINEERING:

Jim Jamieson
MARKETING:

Nick Graziano
MATERIAL CONTROL:

Keith Macdowall
COO:

Jim Jamieson
PRODUCTION:

Luis Lluberes REV DATE
0 1 2 A 04-18-97 06-23-03 05-30-06 08-15-11

Sam Mandel AUTHOR
Carol Pepin Paul Raspe Victor Szatkowski Paul Grabek

DESCRIPTION OF CHANGE
Original Added cover sheet. Scanned Exhibits A & B. Changed Inc to LLC in one place. IV. Change directly to directed by Quality Assurance. COO was President, added Purchasing, updated exhibits Convert from number Rev to letter Rev. Quality Manager was Manager, Quality Assurance.

Quality Procedure

Procedure No. 4.6 Subject: In-Process Inspection and Test Revision: A Date: 08-15-11 Supersedes: Revision 2 Page 2 of 5

I.

Policy It is the policy of Prime Technology, LLC. as part of its Quality program to conduct specific inspections/tests and document them at designated times during the in-process phase of product manufacture. This procedure provides for such inspections / tests and prevails unless otherwise specified by contractual requirements. The purpose of this procedure is to provide for and direct inspections and tests during the product manufacturing (in process) phase. It also describes the types of inspections/tests performed.

II.

Responsibility The Quality Manager is responsible for assuring that the provisions of this procedure are carried out. Quality Assurance is responsible for performing periodic audits and maintenance of stamp issuance records. The Department Supervisor is responsible for the implementation of this procedure within the Manufacturing area.

III.

Definitions

In-Process Inspection. An inspection of material, subassembly, or assembly during the manufacturing phase. In-Process Test. A test of a component, subassembly, or assembly during the manufacturing phase. Inspection Status. A method utilized to identify inspected/tested and non-inspected/tested material. IV. Implementation Material is inspected/tested per the Work Order (Exhibit A) or engineering drawing during the manufacturing process. These inspections/tests are scheduled prior to any operation that would make such inspection/test difficult or prohibitive. The degree of inspection/test performed at any given point is determined through the joint efforts of Manufacturing and Quality. Inspections / tests may also be performed after the completion of a specific operation to verify the operation was performed to workmanship standards, inspection and test procedures. The results of all inprocess tests and inspections are documented on the Work Order or the Inspection Record (Exhibit B) and are retained per Prime Technology Quality Procedure 2.6, Quality Assurance Records. Where inspection of processed material is impossible or disadvantageous, indirect control by monitoring processing methods, equipment, and personnel may be performed, as directed by Quality. Inspection checklists, test procedures, engineering drawings, and customer specifications used for inspection / test will provide criteria for acceptance. Rejected material is identified in accordance with Prime Technology Quality Procedure Number 4.5, Disposition/Corrective Action for Nonconforming Material. All documentation or products requiring the identification of personnel performing inspection and testing operations is accomplished by the use of identification stamps or initials. The presence or absence of a stamp / initials indicates whether or not an operation, test, or inspection was performed. A suitable system is maintained by Quality that provides accountability of identification stamps per Prime Technology Quality Procedure Number 4.10, Quality Identification Symbols / Stamps.

4.5. QA Records Prime Technology Quality Procedure Number 4.5. Disposition/Corrective Action for Nonconforming Material Prime Technology Quality Procedure Number 4.10. . Manufacturing Work Instructions Forms similar to the attached may be used provided they contain the required information. Reference Prime Technology Quality Procedure Number 2.6.6 Subject: In-Process Inspection and Test Revision: A Date: 08-15-11 Supersedes: Revision 2 Page 3 of 5 V. Quality Identification / Stamps Prime Technology Quality Procedure Number 2.Quality Procedure Procedure No.

6 Subject: In-Process Inspection and Test Revision: A2 Date: 08-15-11 Supersedes: Revision 2 Page 4 of 5 Exhibit A. 4. Work Order .Quality Procedure Procedure No.

Quality Procedure Procedure No. Inspection Record . 4.6 Subject: In-Process Inspection and Test Revision: A Date: 08-15-11 Supersedes: Revision 2 Page 5 of 5 Exhibit B.

Quality Manager was Manager. IV.Quality Procedure Procedure No. V. COO was President. Implementation: Change Daily Inspection Report to Inspection Checklist per Sales Order. Added cover sheet. 3 4 A 05-30-06 10-01-08 08-15-11 Victor Szatkowski Paul Grabek Paul Grabek . Definitions: Added FIS 1000 to QAP. Corrected the spelling of Supersedes on 2 pages.1 and 4. Changed Inc to LLC in one place. added Purchasing Added OQE and Malpractice. Change reports are forwarded to QA Manager for analysis to reports are put on file in Quality with a copy of the Sales Order. Quality Assurance. Convert from number Rev to letter Rev. Reference: Added 4.4. IV. 4. Implementation: Added Dedication of Commercial Grade Items (CGI) paragraph.7 Subject: Final Inspection and Test Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 1 of 3 QA MANAGER: ORIGINATOR: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 1 2 04-17-97 07-18-00 06-23-03 Sam Mandel AUTHOR Carol Pepin Carol Pepin Paul Raspe DESCRIPTION OF CHANGE Original III.

and the Sales Order. test. The purpose of this procedure is to outline requirements for test and inspection of completed items. Responsibility The Quality Manager is responsible for assuring that the provisions of this procedure are complied with review of PTP’s. reworked.7 Subject: Final Inspection and Test Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 2 of 3 I. Prime Technology Workmanship Standards. IV. drawings) prepared by Quality that provides instructions for inspection personnel. III. LLC to perform those tests and inspections that will demonstrate conformance of product to specification and customer requirements. Implementation All product is routed through the various manufacturing. quantity rejected. quantity accepted. blueprints. lot disposition. this is specified as are other unique equipment. Disposition / Corrective Action of Nonconforming Material. Quality Acceptance Procedure (QAP).5. Material is forwarded through production operations with work orders and process sheets when applicable that specify the critical characteristics of the item. disposition of defectives (e. written instructions from Quality. drawings. 4. Policy It is the policy of Prime Technology.g. and inspection sequences. Testing is performed in strict accordance with prescribed test procedures at a 100% inspection level. MRR). sample size. Same as an ATP also includes FIS 1000. ATP’s. who will investigate and take action as required. . An instruction defining steps to be taken during the manufacturing process. If product is repaired.. These are generated by Engineering and reviewed by Quality. The reports are put on file in Quality with a copy of the Sales Order. and QAP’s to insure product specification and for the preparation of inspection instructions. Inspection Instruction (II). Production. Results are recorded on an Inspection Checklist per Sales Order and includes: lot size. Production Test Procedure (PTP). Product rejected is processed in accordance with Prime Technology Quality Procedure Number 4. or compilation of documents (checklists. Inspection Instructions. The Product Engineer is responsible for the preparation of test procedures. part lists. Acceptance Test Procedure (ATP). Quality is responsible for final inspection and test audit on completed product. and number and type of deficiencies.Quality Procedure Procedure No. Definitions Final Quality Assurance (FQA). Test equipment and fixtures are maintained under the Prime calibration system. or modified. A document. An instruction defining the steps necessary for acceptance of final product. it will be re-inspected to the original requirements. II. If tooling on a fixture is required. Problems encountered during inspection are reported to the Manager. For final acceptance product is inspected utilizing requirements obtained from standardized checklists.

and Security Prime Technology Quality Procedure Number 3. Malpractice. Inspection of Purchased Material.5. or questionable situations are brought to the attention of the responsible individuals. Dedication of Commercial Grade Items (CGI) All parts.1. Inspection or test is in accordance to Quality Procedure 4.4.6. No other method is acceptable. Product related problems are reported to the design activity via the rejection process per Prime Technology Quality Procedure 4. Procurement Control Prime Technology Quality Procedure Number 4. to the degree necessary.7 Subject: Final Inspection and Test Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 3 of 3 All test and inspection criteria are developed to provide assurance of overall product quality and to simulate. or products that are required to produce a finished product are dedicated on the basis of demonstration based on test reports from qualified testing facilities (i. and to select the characteristics to be tested or inspected so that CGI is acceptable for use. At any stage of manufacture / test / inspection. Disposition/Corrective Action of Nonconforming Material Prime Technology Quality Procedure Number 4. Objective Quality Evidence (OQE) Documentation that forms the OQE package for product shall not be modified or corrected with whiteout or correction tape. Procurement Control. Control/Calibration of Measuring and Test Equipment Prime Technology Quality Procedure Number 4. The mistake shall be drawn through with a single line. deficiencies. Inspection problems are reported and resolved by the Quality Manager.Quality Procedure Procedure No.1 on malpractice V.4. Quality Policy Statement. and dated. 4. components procured by Prime Technology are commercial grade items.e.5. unusual problems. Test and inspection procedures / instructions are reviewed by Quality to insure that the above requirements are met. Inspection of Purchased Material . or this procedure. Identification and control of CGI is performed in accordance with Quality Procedure 4. critical characteristics. See Procedure Number 1. seismic and environmental test reports). product end use and functionality. Safety Related Material. It is the responsibility of the Engineering Department to determine the suitability. The Design Activity is a mandatory member of MRB. Reference Prime Technology Quality Procedure Number 1.1.1. initialed.

4. IV. Quality Assurance. added Purchasing Added inspection rights statement Convert from number Rev to letter Rev. 2 3 A 05-30-06 10-01-08 08-15-11 Victor Szatkowski Paul Grabek Paul Grabek . Policy: Added: at Prime Technology. COO was President. Implementation: Change the results of customer test and inspection will be recorded on appropriate data sheets by the FQA inspector to Contractual data items are complied by the FQA inspector for and signed off by the customer representative(s).Quality Procedure Procedure No. LLC. Quality Manager was Manager.8 Subject: Product Submittal to Customer Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 1 of 2 QA MANAGER: ORIGINATOR: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 1 04-28-97 06-23-03 Sam Mandel AUTHOR Carol Pepin Paul Raspe DESCRIPTION OF CHANGE Original Added cover sheet. Change copies are forwarded to the Quality Assurance Manager to copies of these papers are kept on file in Quality with other related documents. I.

II. either in whole or in part unless such presentation is accomplished through the Quality. Policy Quality at Prime Technology.8 Subject: Product Submittal to Customer Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 2 of 2 I.Quality Procedure Procedure No. Final Quality Assurance (FQA). Under no circumstances will product be presented to the customer for acceptance. rework and retest will be accomplished and recorded as applicable. FQA will schedule customer test and inspection and will present the equipment to the customer. The results of Final Inspection and test will be recorded. All test and inspection equipment required to allow customer verification of product shall be provided to the customer. Contractual data items are compiled by the FQA inspector for and signed off by the customer representative(s). and any special documentation required by the Sales Order Release (SOR). Definitions Final Inspections and Test. The purpose of this procedure is to provide for presentation of product to a customer. Reference Prime Technology Quality Procedure Number 4. V. FQA will present product to the customer along with required test data. Final Inspection and Test Prime Technology Quality Procedure Number 2. Responsibility The Quality Manager is responsible for the implementation of the procedure. The customer or his authorized representative shall have access to the facility. 4. Those functions that ensure completion of required operations and the acceptable condition of the product for presentation to the customer.7. Prime Technology personnel are made available to assist customer representatives when required. III. QA Records . completed submission from drawings. Copies of these papers are kept on file in Quality with other related documents. LLC shall submit product to the customer for purposes of preliminary or final acceptance.6. IV. Implementation FQA will review all status documentation to determine completeness of prior operations and will perform a Final Inspection in accordance with applicable controlled drawings and Prime Technology workmanship standards. Upon completion of the foregoing. Those functions that ensure conformance with all quality requirements and equipment / software correlation in accordance with contractual requirements as identified on a Sales Order Release (Picker). Any failures during equipment testing in the presence of the customer necessitates immediate notification of the Quality Manager.

COO was President. 4. C. Policy: Added: at Prime Technology. Convert from number Rev to letter Rev.9 Subject: Statistical Sampling Inspection Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 1 of 7 QA MANAGER: ORIGINATOR: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 1 2 3 A 04-18-97 06-23-03 05-30-06 10-01-08 08-15-11 Sam Mandel AUTHOR Carol Pepin Paul Raspe Victor Szatkowski Paul Grabek Paul Grabek DESCRIPTION OF CHANGE Original Added cover sheet.Quality Procedure Procedure No. . Quality Manager was Manager. deleted MIL-HDBK-53 (Cancelled no S/S document). ASQC-Z1.9 WAS MIL-STD-414. deleted Appendix B and C. B. I. LLC. Quality Assurance. Scanned Appendixes A. added Purchasing MIL-STD-105E was MIL-STD-105D.

Policy In addition to any statistical methods by the contract or customer. such that they are clearly visible to the user and likely to be objectionable. Minor (MI) • Will not cause an operating failure or degrade operation of end item during its intended use. • Appearance defects that are extreme in intensity. Types of sampling inspection include inspection by attributes. The purpose of this procedure is to establish an approved method for sampling inspection of purchased or in-house fabricated or assembled material at Prime Technology. Classification of Defects and Defectives. and functional requirements.g. . Sampling inspection is not used where prohibited by the contract or customer (e. A designated value of percent defective (or defects per hundred units) that will be accepted most of the time by the acceptance sampling procedure to be used.. Lot Tolerance Percent Defective (LTPD). quality. 4. statistical sampling is used to provide assurance of compliance with reliability. II. Responsibility The Quality Manager has overall responsibility for the implementation of this procedure. 100% final test). or control chart techniques. • Will likely cause personal injury or property loss during intended use of the item or final product. LLC. • Appearance defects that are not clearly visible to the user and are not likely to be objectionable. III. including the evaluation of alternate sampling plans to insure compliance to contractual requirements. The Supervisor of Production is responsible for insuring that the requirements of this procedure are complied with all production operations.Quality Procedure Procedure No. Critical (C) • Will cause an operating failure of the end item or final product during its intended use.9 Subject: Statistical Sampling Inspection Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 2 of 7 I. Major (MA) • Will likely cause operating failure of the end item or final product during its intended use. • Will cause degraded operation of the end item or final product during its intended use. Definitions Acceptable Quality Level (AQL). inspection by variables. A designated value of percent defective (or defects per hundred units) that is the worst product quality that the consumer is willing to accept at a specified level of probability.

without regard to degree of conformance or nonconformance. and a measurement is recorded. Inspection Lot./sec. • Types of Sampling Plans (Lot Acceptance) ♦ Single Sampling. One or more units of product drawn at random from an inspection lot. or to inspect another unit. ♦ ♦ ♦ ♦ ♦ Inspection by Variable. etc.9). with respect to given requirements. Inspection whereby a specified quality characteristic on a unit of product is measured on a continuous scale. defined by an AQL.Quality Procedure Procedure No. A sampling plan whereby the inspection of the first sample leads to a decision to accept. Inspection whereby the unit of the product is classified as defective or non-defective. A sample plan. level and type. such as pounds. After each unit is inspected. The product entity inspected. tightened) within an AQL which is determined by supplier or in-house production performance for a product category. Sampling Level. or take a second sample. . and wherein these measurements are statistically evaluated in order to arrive at an accept/reject decision (refer to ASQC-Z1. The sampling table (normal. Acceptance Number.9 Subject: Statistical Sampling Inspection Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 3 of 7 Inspection by Attributes. Inspection by Variable. for lot acceptance. Sampling plans wherein certain quality characteristics are quantitatively measured. These constituents of the plan will provide the sample size and accept/reject numbers. reject. Sequential Sampling. Inspection of the remaining units of product in an inspection lot for those characteristics found defective in the sample. depending on the quality of the product presented (refer to MIL-STD-1235). the decision is made to accept. Sample. Double Sampling.. Sampling Plan. One-Hundred Percent Inspection. A sampling plan whereby a lot is accepted or rejected based on the inspection of one sample. when required. A sampling plan similar to double sampling except that more than two samples may be required for a lot accept/reject decision. 4. A unit-by-unit sampling plan in which the sample units are selected one at a time. A sampling plan that permits a systematic increase or decrease in the fraction of units to be inspected. The maximum allowable number of defective pieces in a sample of a particular size. to reject. Continuous Sampling. reduced. inches. ft. It may or may not be the same as the unit of purchase. Multiple Sampling. A collection of units of product of the same status which are processed together and from which a sample is to be drawn and inspected for conformance or nonconformance to given requirements. Unit of Product. then leads to a decision to accept or reject the lot. Screening. Inspection of each unit of product in an inspection lot for detection and removal of defective units. The inspection of the second sample..

0% AQL Prime Technology produced and purchased material shall utilize normal inspection. 4. Sampling Inspection Level II is used unless specifically stated. All sampling will begin as normal inspection. Implementation The sampling plan from Appendix A of this document is used for those products requiring inspection to MIL-STD105E. Classification by Defect Critical Major Minor Inspection Rate 100% Inspection 0. The switch to tightened will commence immediately following the second lot rejection. and the AQL for each product category. Tightened or reduced inspection will continue for each class of defects or defectives on successive lots or batches except where the switching procedures given below require a change. Lot. single sampling (AQL 2. class. Units of product of a single type. or continuous are listed in MIL-STD-105E and may be obtained from the Manager.40-1. grade. the respective measurements procedures to be used. Level II. Defective Unit. A nonconformance to a specified requirement. multiple. A unit of product containing one or more defects.50-4.5). The AQL for a given product is established by Quality. and composition manufactured under essentially the same conditions. such as double. size.Quality Procedure Procedure No. The AQL is noted in the individual inspection folder. Quality Assurance. . Other sampling plans.9 Subject: Statistical Sampling Inspection Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 4 of 7 Defect. • Normal. ♦ Production is at a steady rate. ♦ The total number of defects/defectives in the samples from the ten lots is less than or equal to the applicable limit number per Appendix B. • Tightened sampling is employed when two out of five consecutive lots have been rejected on normal original inspection. Inspection Instruction. and at essentially the same time. AQL’s established by Quality are based on parameters listed below. and no lot has been rejected on original inspection. • Reduced inspection is employed when the following conditions are satisfied: ♦ The preceding ten lots have been on normal inspection. IV. An inspection document stating the characteristics to be inspected.0% AQL 1.

♦ A lot is accepted.4. If the number of defective pieces in the sample are equal to or greater than the reject number. If the number of defective pieces in the sample is less than equal to the acceptance number.9 Subject: Statistical Sampling Inspection Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 5 of 7 Return to Normal Sampling when: • Tightened to Normal sampling is authorized when five consecutive lots on tightened original inspection have been accepted. however. Reference Prime Technology Quality Procedure Number 4. the number of defects or defectives is greater than the acceptance number but is not equal to or greater than the reject number. every piece in an inspection lot has an equal chance of being selected. the switch from normal to tightened is required. 4. To correctly follow the switching rules within the guidelines of MIL-STD-105E. The sample size and acceptance number is determined from the applicable plan and the sample units of product are selected in a random manner: i. the entire lot shall receive a disposition in accordance with Prime Technology Quality procedure Number 4. V. the inspection lot is accepted after removing and holding for disposition any pieces found defective in the sample.5.Quality Procedure Procedure No.6. Disposition / Corrective Action of Nonconforming Material.. • Reduced to Normal sampling is required when either/or: ♦ Lot is rejected. The switch from normal to reduced is an option. Inspection of Purchased Material Prime Technology Quality Procedure Number 4. Disposition/Corrective Action of Nonconforming Material .e.

Quality Procedure Procedure No.9 Subject: Statistical Sampling Inspection Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 6 of 7 APPENDIX A . 4.

9 Subject: Statistical Sampling Inspection Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 7 of 7 APPENDIX A .Quality Procedure Procedure No. 4.

added Purchasing Change Stamp Verification Cycle. Yearly was Six Months. Quality was Quality Assurance.10 Subject: QA Identification Symbols/Stamps Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 1 of 4 QA MANAGER: ORIGINATOR: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 1 2 3 A 04-17-97 06-23-03 05-30-06 05-01-10 08-15-11 Sam Mandel AUTHOR Carol Pepin Paul Raspe Victor Szatkowski John DeCola Paul Grabek DESCRIPTION OF CHANGE Original Added cover sheet. Changed Inc to LLC in one place. Convert from number Rev to letter Rev. Scanned Stamps.Quality Procedure Procedure No. Revised paragraph IV third paragraph. COO was President. 4. . Update Names.

Responsibility The Quality Manager is responsible for ensuring implementation of this procedure by auditing. Manufacturing department supervisors are responsible for the implementation of this procedure in their respective departments and insuring that work orders/product are properly stamped or signed by appropriate personnel. If a stamp is reported lost. If a stamp is lost or damaged.Quality Procedure Procedure No. Implementation Quality issues stamps. and type of stamp. maintaining a stamp issue log and periodically verifying legibility of issued stamps. Stamps are issued for such activities as in-process audits and test. which outlines production sequence by department and work center. . Supervisors must insure that stamps are returned to Quality if an employee is transferred from the position that necessitates stamp issue or if an individual leaves Prime Technology. Damaged stamps are destroyed and the stamp issue log so noted. The inspector as evidence that the unit has passed test will stamp International Instruments division products for final acceptance testing. All stamps are of a design distinctively different from customer / government stamps / symbols. which indicates that an operation has been completed and that material conforms to applicable quality/workmanship requirements. The Work Order provides brief work instructions. and test data. LLC employment. Product is stamped as noted on the work order when the inspector performing the operation is satisfied that the operation is complete and the product conforms to quality requirements. IV. II. The purpose of this procedure is to outline requirements for the use by Quality Assurance and Manufacturing to indicate completed. it will be permanently deactivated and so noted with affectivity date. 4. The stamp will be located so as not to obscure other markings. acceptable work. A report generated from this audit is kept on file in Quality. Stamps are audited yearly to verify ownership and legibility. daily reports. inspection checklists / folders. the owner must report this to Quality as soon as practicable. on the stamp issue log. Policy It is the policy of Prime Technology. Stamps may be used instead of signature on a number of documents including: work orders. Returned stamps may be reissued after six months. III. LLC to assure that product is routed through all required operations and that unique symbols/stamps and/or appropriate sign-offs are employed to indicate acceptability of product.10 Subject: QA Identification Symbols/Stamps Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 2 of 4 I. A list is maintained listing the individual to whom the stamp was issued. reference to applicable standards or procedures and provides a space for operation sign-off. A document prepared by Material Control. the stamp number. issuing controlled stamps as required. Definitions Work Order.

In-Process Inspection and Test Prime Technology Quality Procedure Number 4. Final Inspection/Test .7.6.Quality Procedure Procedure No.10 Subject: QA Identification Symbols/Stamps Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 3 of 4 V. 4. Reference Prime technology Quality Procedure Number 4.

4.10 Subject: QA Identification Symbols/Stamps Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 4 of 4 .Quality Procedure Procedure No.

2 06-23-03 Paul Raspe 3 4 5 A 05-30-06 10-01-08 05-30-10 08-15-11 Victor Szatkowski Paul Grabek John DeCola Paul Grabek . Add detailed steps for returning excess components back to inventory. V.11 Subject: Material: Exposure to Mercury. Added cover sheet. 4. I. Movement. Handling .Quality Procedure Procedure No.13. added Purchasing Added mercury exposure.13 reference. COO was President. Implementation: Change the word antistatic to antacid. Policy: Added: LLC. Returned ESDS protection statement and Quality Procedure 4. 4. Implementation: Deleted statements about printer circuit boards requiring ESDS protection and reference to Quality Procedure No. IV. References: Deleted 4. Quality was Quality Assurance. Convert from number Rev to letter Rev. Storage and Traceability Revision: A Date: 08-15-11 Supersedes: Revision 5 Page 1 of 3 QA MANAGER: ORIGINATOR: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 1 01-30-97 08-08-00 Sam Mandel AUTHOR Carol Pepin Carol Pepin DESCRIPTION OF CHANGE Original IV.13.

All material handling and movement follows sound practices.13. .13. Small parts are packaged in bulk providing the finish is not critical. walkways or heavily trafficked areas. 4. III. plated. and movement that protect the quality of products and prevent loss. Movement. Definitions FIFO--First In. Efforts should be made to containerize these assemblies as quickly as possible. The purpose of this procedure is to describe the manner in which material is protected during handling. Handling . Implementation Although the majority of Prime Technology purchased material is adequately protected by good commercial practice. coated. painted.11 Subject: Material: Exposure to Mercury. and damage will not occur. Protection of ESDS Parts/Assemblies. Examples are: • Precious metals or materials plated with precious metals are handled with gloves or other antacid devices and enclosed in bags or heavy neutral paper. provisions are made to accommodate special situations. degradation or inadvertent substitution of product. and storage. storage.Quality Procedure Procedure No. Storage and Traceability Revision: 5 Date: 05-01-10 Supersedes: Revision 4 Page 2 of 3 I. Responsibility All managers and supervisors of departments that handle or move material are responsible for insuring that the provisions of this procedure are complied with. Parts of identically formed shapes without sharp projections can be nested provided they are wrapped with heavy neutral paper or other protective material to prevent scratches. See Section V for details. movement. damage. This is done via statements included on the Purchase Order. or polished material is securely wrapped in a heavy neutral paper or placed in individual plastic bags to prevent damage and scratches. II. Assemblies not requiring ESDS protection are generally transported in containers that prevent board to board contact. LLC to employ practices in the areas of handling. deterioration. • Stacking of materials or containers is allowed to a height that tipping will not occur. for damage and proper packaging to prevent damage and scratches during storage. Protection of ESDS Parts/Assemblies. Any ESD sensitive device is stored and handled according to Prime Technology Quality Procedure Number 4. First Out ESDS--Electrostatic Discharge Sensitive IV. • Material being returned to stock is inspected to assure correct P/N. Lead terminated components are packed to prevent any strain to lead/body interface during storage and handling. Printed circuit boards are subject to more stringent requirements. • Material is not allowed to block aisles. Printed circuit assemblies with ESDS components are handled in accordance with Prime Technology Quality Procedure Number 4. Policy It is the policy of Prime Technology. Dissimilar materials are stored separately unless part of an assembly.

13. 7. Excess W/O Material Return to Stock Circumstance: Excess parts remain after W/O has been completed. Handling . 4.Quality Procedure Procedure No.7. Material and product at any stage shall not be exposed to mercury. If product is still non-conforming.7. 8. containers are properly identified and assure parts are OK for return to stock. Corrective Action Prime Technology Quality Procedure Number 4. Special requirements for handling. or otherwise identified clearly. and identified clearly P/Ns being accepted. Storage and Traceability Revision: A Date: 08-15-11 Supersedes: Revision 5 Page 3 of 3 Material shall not be exposed to mercury. or his designee will place excess parts. boxes or other approved container. and marked W/O copy onto the In-process Inspection shelf. or storage may be included in process sheets or operations work orders for specific products where warranted. Once P/Ns. Corrective Action. Parts. Parts must not be mixed together. Procurement Control Prime Technology Quality Procedure Number 4. References Prime Technology Quality Procedure Number 2. but in individual bags.11 Subject: Material: Exposure to Mercury. movement. 4. Inspector will stamp acceptance on W/O. These requirements will be stipulated on the Sales order Release and/or Quality Plan. Inspection will verify correct P/N. Not modified by production in any way as to preclude they from being reissued in the future. 9. and enter the required transaction into the system. 2. The Production supervisor.1. Specific customer requirements that exceed the requirements of this procedure are transmitted to the appropriate departments by Quality. for each P/N. Protection of ESDS Parts/Assemblies Prime Technology Quality Procedure Number 4. and W/O then delivered to the stock room. Quality will initiate Corrective Action Requests if serious or repeated violations of this procedure are encountered. an MRR will be used to disposition. Purchased material shall be free of mercury and mercury free certification shall be required when specified.5. 3. 1. Copy of original W/O material page/s with P/N. Parts must be the same basic configuration as they were issued. and resubmitted to Inspection. Stock room will return parts into inventory. Disposition/Corrective Action of Nonconforming Material . Special requirements shall flow down to suppliers and subcontractors as required by the contract or purchase order. Movement. and returned quantity highlighted. Non-conforming product will be returned to production for rework. & W/O are verified. 5. V. 6. Refer to Prime Technology Quality Procedure Number 2. and must be returned to stock.

Deleted Exhibit B. COO was President. Convert from number Rev to letter Rev. IV.Quality Procedure Procedure No. Revised procedure to provide a practical process to control shelf life for material utilized by Prime Technology LLC. IV. Shelf Life Log. Added Exhibit B. Add evaluation form & Align Dept Heads on Org chart. updated exhibits Modify Shelf Life Process. which indicates each month what items will expire. Changed Inc to LLC in two places.12 Subject: Shelf Life Revision: A Date: 08-15-11 Supersedes: Revision 5 Page 1 of 6 QA MANAGER: Paul Grabek ENGINEERING: Nick Graziano MATERIAL CONTROL: Jim Jamieson PRODUCTION: Sam Mandel AUTHOR Carol Pepin Carol Pepin DESCRIPTION OF CHANGE Original IV. added Purchasing. Quality was Quality Assurance. Shelf Life Log. Implementation: Added references to Exhibit B. Remove the statement that a procurement code is used to state that a C of C w/shelf life is required. Shelf Life Log. Shelf Life Log and the stockroom maintains a file for shelf life material. Implementation: Deleted reference to Exhibit B. Scanned Exhibit A & B. Added cover sheet. 4. ORIGINATOR: Paul Grabek PURCHASING: Jim Jamieson MARKETING: Keith Macdowall COO: Luis Lluberes REV 0 1 DATE 04-17-97 08-17-00 2 3 09-23-02 06-23-03 Mary Harnois Paul Raspe 4 5 A 05-30-06 05-10-10 06-22-11 Victor Szatkowski John DeCola Paul Grabek .

Providing the material meets inspection criteria. expiration date. store. Upon completion of inspection of shelf life material the inspector shall make an entry in the Shelf Life Log (Exhibit B). and Prime Technology Quality Procedure Number 4. Disposition/Corrective Action for NonConforming Material. Material whose shelf life has reached the expiration date is purged and brought to Incoming Inspection for disposition in accordance with Paragraph V of this document. The completed form shall be filed in the Shelf Life Certification Binder Book with the original product data located in Receiving Inspection. Definitions Shelf Life Item. II. Anyone may initiate a Shelf Life Extension form for material that is required for production. Quality Assurance: Evaluate material performance & disposition (Approve/Reject) Engineering: Evaluate material performance & disposition (Approve/Reject) Production: Process shelf life material and enter information on the extension form. An item that will begin to degrade after a specified date. The purpose of this procedure is to outline Quality requirements pertaining to material with a limited shelf life. Inspection of Purchased Material. . This indicates each month what items will expire.5. Items which are part of the product and items which are used as required supplies.Quality Procedure Procedure No.12 Subject: Shelf Life Revision: A Date: 08-15-11 Supersedes: Revision 5 Page 2 of 6 I. Material is received and inspected in accordance with Prime Technology Quality Procedure Number 4. received date. III. If shelf life material is received and an expiration date cannot be found. It is the responsibility of all department heads to discard any material stored in their departments that has exceeded its expiration date. the inspector will identify the shelf life items by affixing a Limited Life Control Sticker (Exhibit A) to the material. IV. Non-critical material and as required material that is not part of the product may be used beyond the original shelf life. Implementation Shelf life material is identified on the purchase order via a request for a certificate of conformance specifying shelf life. and inspection date. and efficiently utilize material which has a stipulated shelf life in order to minimize scrap. Quality Inspector: Process incoming shelf life material.5. it is referred to the Quality Manager for resolution. & manage extensions. The sticker will be completed with Control Number. The stockroom maintains a file for shelf life material. Responsibility All departments shall observe and adhere to shelf life expiration.4. Refer to paragraph V of this procedure and Prime Technology Quality Procedure Number 4. Disposition/Corrective Action for Non-Conforming Material. 4. A new expiration date shall also be recorded on the form. Items which are part of the product and critical to its operation shall not be authorized for use beyond its shelf life unless proper performance of properties can be verified. Shelf life items are categorized in two general types. LLC. The results shall be recorded on the Shelf Life Extension Evaluation form (page 6). to identify. Policy It is the policy of Prime Technology.

Extension of solder paste is predicated on satisfactory performance of the binders used only for proper flow. During application.e. the paste shall cover satisfactorily through the screen.3. The evaluation may be on the first piece of any production lot requiring the part number of solder paste in question. The length of extension shall be based on the individual material and usage history.5.1. etc.12 Subject: Shelf Life Revision: A Date: 08-15-11 Supersedes: Revision: 5 Page 3 of 6 Shelf Life Extension Evaluation V. Metallic paste filler itself is not subject to deterioration over time. V. routing. Inspection of Purchased Material Prime Technology Quality Procedure Number 4.7 RTV. The batch will be processed and the properties evaluated as necessary. pot life.). V. This specification shall not apply to rubber compounds covered by Military or similar consensus specifications. Age extension records shall make reference to this Specification.4.Quality Procedure Procedure No. Disposition/Corrective Action of Nonconforming Material .4. The Shelf Life Extension Evaluation form shall be stored with the original product certification in Receiving Inspection.5 All containers shall be prominently marked with the new shelf life and the number of extension(s). V. The finished joints shall be examined in accordance with and meet the acceptance criteria of that Part Number’s Inspection Plan. The paste shall be prepared and soldered according to normal procedures for the particular part involved.2. Acceptable evaluation to this section recorded on the Evaluation form is required to extend a shelf-life date. SCOPE This section describes the procedure for evaluating shelf-life limited materials reaching the normal end of the original shelf life.8 Solder Paste Unless otherwise specified solder pastes may be age extended from the original expiration date in increments equal to the original shelf life period.O GENERAL REQUIREMENTS V. V. the following is required for specific types materials: V. VI. some discretion may be allowed for non-essential properties (i. V. Deviations normally result in rejection.6. V. 4. Unless otherwise specified by this procedure material may be age-extended based on historical usage. Material Specific Methods and Requirements In addition to the general requirements defined above. however.). material directions etc. Epoxy and Similar Material A batch of the material shall be prepared using the normal instructions provided to manufacturing personnel (drawing. Reference Prime Technology Quality Procedure Number 4. V. For inventory control purposes the Stockroom Supervisor or his designee shall be notified of each extension as it occurs.

Limited Shelf Life Sticker . 4.Quality Procedure Procedure No.12 Subject: Shelf Life Revision: A Date: 08-15-11 Supersedes: Revision: 5 Page 4 of 6 Exhibit A.

Shelf Life Log .Quality Procedure Procedure No. 4.12 Subject: Shelf Life Revision: A Date: 08-15-11 Supersedes: Revision: 5 Page 5 of 6 Exhibit B.

4.12 Subject: Shelf Life Revision: A Date: 08-15-11 Supersedes: Revision: 5 Page 6 of 6 Shelf Life Extension Evaluation\Work Sheet _____________________________ Part Number to be Evaluated _____________________________ Original Expiration Date Record Basic Process Used: ______________________________ Originator Date ______________________________ Initial Shelf Life Period (Full Length) Evaluation Results (Accept / Reject) _______________________________________ Processed by: _______________________________ Quality Assurance Approval & Date _________________________________ New Expire Date To be marked Clearly on every Sticker ______________________________ Engineering Approval & Date MRR # when applicable Accept __________________________________ Reject Stamp .Quality Procedure Procedure No.

Cycle. & Up-Date Names. Annually. was Twice a Year. 4.Quality Procedure Procedure No.13 Subject: Handling of ESD Parts. Align department Heads with new organization chart Convert from number Rev to letter Rev. Quality Manager was Quality Assurance Manager. added Purchasing Change ESD Cal. and Equipment Revision: A Date: 08-15-11 Supersedes: Revision: 2 Page 1 of 5 QA MANAGER: ORIGINATOR: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 1 2 A 06-23-03 05-30-06 05-01-10 08-15-11 Sam Mandel AUTHOR Paul Raspe Victor Szatkowski John DeCola Paul Grabek DESCRIPTION OF CHANGE Original COO was President. . Assemblies.

The training course outline will include but not be limited to the following elements: A. Electrostatic Discharge Sensitive (ESDS) . Protective areas and grounded work stations F.13 Subject: Handling of ESD Parts.Quality Procedure Procedure No. 4. II. The Engineering Department shall identify and classify ESD sensitive devices. IV. III. Electrical and electronic ESD sensitive items D.A controlled area where ESDS items may be safely handled. Responsibility The Quality Manager has overall responsibility for implementation of this procedure within the company and their inspection and test areas. shipping and receiving. Assemblies.An electronic component or assembly that can be electrically degraded or destroyed by the discharge of static electricity through internal paths of the unit. Handling precautions and procedures G.20-1999 Protection of Electrical and Electronic Parts. The Engineering Manager shall be responsible for implementation of this procedure in their engineering areas. Principles of static electricity C. Implementation Personnel Training and Certification Training in ESD awareness shall be provided for all personnel who specify. . ESD protective materials and equipment E. and Equipment Revision: A Date: 08-15-11 Supersedes: Revision 2 Page 2 of 5 I.An environmental condition that electrically degrades or destroys ESDS units. handle or test ESDS items or assemblies. design. stockroom. Packaging and shipping ESDS items Certification of satisfactory completion of this training will be documented for all personnel who attended and demonstrated a comprehension of the elements of this training course. ESD Controlled Work Station . Policy It is the policy of Prime Technology. Definitions Electrostatic Discharge (ESD) . The Quality Manager shall appoint an ESD Coordinator to train. evaluate and internally audit the administration of this procedure. The Department Heads shall be responsible for implementation of this procedure in their respective manufacturing areas. assemble. purchase. Assemblies and Equipment (Excluding Electrically Initiated Explosive Devices) that replaces MIL-STD-1686. This ESD control program plan is in accordance with ANSI/ESD S20. LLC to identify and protect electrostatic discharge sensitive devices from damage and degradation due to improper handling. ESD control program B. The Manufacturing Manager shall be responsible for implementation of this procedure in scheduling.

E. Receiving Inspection: Remove the unit package from the shipping container but do not open the unit package. CAUTION: ESD protective packaging shall only be opened on the ESD protected table and the operator will have the wrist strap on and connected to the table prior to opening any packages. The incorporation of grounding system for processing machinery and the use of ionizers where grounding cannot be implemented. 4. Examine each unit package for proper labeling and ESD protective packaging. F. If the protective packaging is opaque.O. Place unit packages on the ESD protected table and insure that the wrist strap is connected. Assemblies. packaging material. and annually thereafter. B. When the count has been verified. Perform quantity counts on ESDS items to verify P. clothing and work stools The incorporation of personnel grounding system such as personnel ground straps or alternative grounding system consisting of protective flooring.Quality Procedure Procedure No.13 Subject: Handling of ESD Parts. parts trays. Absence of prime generators in the ESD protected areas or near ESD protected work benches at least 1 meter away from ESDS items. Each ESD protected work area shall be posted with “attention static safe guarded work area” and shall be identified with date of last certification and next certification and due date. transfer the packages to the grounded ESD protected work station in the Receiving Inspection department. quantities. The ability of grounding to reduce residual electrostatic voltages below the sensitivity level of ESDS items being handled. and conductive shoes. carts. solder pots and test equipment used at ESD grounded work stations. Each ionizing air blower shall be examined and cleaned and will be identified (by date) when cleaned. tote boxes. The grounding of power tools such as soldering irons. or if counts can not be verified without opening the ESD protective packaging. each ESD protected area and work station shall be certified to the following elements of protection: A. Receiving: Review the purchase order and / or shipping documents for notification of ESD sensitive items. Resistance measurements of all grounds with ohmmeters or megohmmeters to assure that resistances are low enough to limit residual ESD voltages and high enough to protect personnel from nearby voltage sources. G. carriers. The use of ESD protective materials wherever ESDS items normally come in close proximity or have direct contact such as table tops. bins. H. or when humidity is below 30%. C. . the items will be returned to the original ESD protective package. grounded work stools. and humidity control where used. Do not open packages containing ESDS items. D. built-in detectors and alarms. Effectiveness of ESD protective equipment such as ionizers. and Equipment Revision: A Date: 08-15-11 Supersedes: Revision 2 Page 3 of 5 Certification of Protected Work Areas and Grounded Work Benches Upon initial installation.

Item inspection: Open the unit packages on the protected work table. insuring proper marking. F. Identify ESDS items on all kitting documentation. Stockroom and Kitting: A. Do not open unit packages of ESDS items for count issuances or kitting until required. Upon completion of testing. When required. C. Be aware of which items in the kit are designated as ESDS Do not use any ESDS items that were issued without being inside the ESD protective package. Repack all ESDS items in ESD protective packages and mark all packages with the sensitive electronic device symbol and caution. final inspection and testing shall be performed in ESD protected work areas and when possible.Quality Procedure Procedure No. D. Upon completion of inspection.). In-process. D. Static causing materials or tools must be at least 1 meter away from the work area. or around. on properly grounded bench tops. C. D. and Equipment Revision: A Date: 08-15-11 Supersedes: Revision 2 Page 4 of 5 The inspection is to be performed as follows: A. Insure all packages and kits issued from the stockroom containing ESDS items are marked with the ESD symbol and precaution. plastic tool handles. package the items in ESD protective bags and insure proper symbols and cautions are placed on the containers prior to transporting to stock. repackage the tested items in the protective packages. B. . discharges from personnel or objects. No ESD marking and no ESD protective package: These items shall be rejected. If packaging is not marked. the work station (common plastics. Insure that ESDS items are delivered to the inspection and/or test areas in ESD protected containers. electrostatic field and Electromagnetic Pulse (EMP) from ESD high voltage spark discharge.13 Subject: Handling of ESD Parts. etc. opening of unit packages of ESDS items shall be performed on the grounded work table which has been provided for in the kitting area. B. The date code(s) shall be recorded on the inspection record sheet and these items shall not be accepted if resubmitted by the vendor. Transport all ESDS items to and from inspection and test in ESD protective bags. apply the proper marking and contact the vendor to remind him to supply proper marking on future shipments. C. Plug a Wrist Strap and place it on your wrist. Insure that no static generating material is on. Inspect to verify conformance to the precautionary labeling and protective packaging as required by the purchase order and/or drawings. Transport ESDS items to and from the stockroom area in ESD protective packages which will protect the ESDS items from tribo-electric charges. but in protective packaging. Assembly: A. C. Non-ESDS marked packages: It is the supplier’s responsibility to properly mark packages containing ESDS items. (A certified ESD protected work area). Inspection and Test: A. Insure that the work area and bench top is properly grounded. B. Perform inspection and/or tests as shown on the inspection record sheet for that item part number. Assemblies. 4. B. E.

Assemblies.Quality Procedure Procedure No.13 Subject: Handling of ESD Parts. Disposition/Corrective Action for Non-Conforming Material Prime Technology Quality Procedure Number 4. Material Storage. for any reason.5. and Handling . Insure that shipping documents indicate ESDS items.. an ESDS items must be removed from the ESD protected container. and Equipment Revision: A Date: 08-15-11 Supersedes: Revision 2 Page 5 of 5 Shipping: A. If. C. i. V.11. insure that it is only done on a properly grounded work station. B. Insure that ESDS items submitted for shipment are received in ESD protected shipping containers and so marked. 4. “Caution this shipment contains ESDS items. Movement. observe precautions for handling electrostatic sensitive devices”.e. Reference Prime Technology Quality Procedure Number 4.

4. Add that Military and Nuclear Safety contracts are processed though to shipping by QA. III.Quality Procedure Procedure No. added Purchasing. Scanned Exhibit A. Change Exhibit A to be Customer Order Acknowledgement. Quality Manager was Manager. update exhibit Align Department Heads with Organization Chart Convert from number Rev to letter Rev. Quality Assurance. V. COO was President. IV. 3 4 A 05-30-06 9-20-10 08-15-11 Victor Szatkowski Paul Grabek Paul Grabek .5. Changed Inc to LLC in one place. Implementation: Delete the paragraph concerning QA audits weekly. References: Delete QP 4. Definitions: Change Acknowledgement to Pick List.14 Subject: Product Packing and Packaging Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 1 of 3 QA MANAGER: ORIGINATOR: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 1 2 04-17-97 08-03-00 06-23-03 Sam Mandel AUTHOR Carol Pepin Carol Pepin Paul Raspe DESCRIPTION OF CHANGE Original III. Corrected error in page numbering. Added cover sheet. Definitions: Change Sales Order Release to Customer Order Acknowledgement. Change Exhibit A title to Pick List.

LLC. marking. packing.14 Subject: Product Packing and Packaging Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 2 of 3 I. Where sales order documents specify packing. and marking. Material Control insures that all material has been packaged and packed in accordance with customer requirements. The purpose of this procedure is to outline how customer packaging. packaging. good commercial practice is used.3. V. packing. Sales Order document which reflects part number. quantity. Prime Technology transmits them to the user level and verifies compliance to these requirements. Reference Prime Technology Quality Procedure Number 2. and other customer requirements unique to the order.3. III. Responsibility The Quality Manager is responsible for insuring that the provisions of this procedure are implemented. Implementation Contracts for military and nuclear safety related products are reviewed by Quality in accordance with Quality Procedure Number 2. Policy It is the policy of Prime Technology. and shipping requirements are routinely transmitted to the Shipping Department. The Sales Department communicates packaging requirements via the Sales Order. Packaging instructions are either included in the sales order release or refer to a specific methods sheet. to provide adequate protection to material shipped to prevent damage in transit or site storage. . PPP&M. special packaging. Definitions Customer Order Pick List (Exhibit A). II. IV. shipping/billing instructions and PPP&M requirements. packaging. Quality Planning. purchase order number. Quality Planning Forms similar to the attached may be used provided they contain the required information. or shipping requirements. The Sales Department reviews commercial products for documentation. A sales order is generated to transmit this information.Quality Procedure Procedure No. Quality tracks Military and Nuclear Safety contracts at Prime Technology through shipping. For orders where the customer has not specified requirements. marking. Preservation. 4. marking.

Quality Procedure Procedure No.14 Subject: Product Packing and Packaging Revision: A Date: 08-15-11 Supersedes: Revision 4 Page 3 of 3 Exhibit A. Customer Order Pick List . 4.

. Changed Inc to LLC in one place. Quality Assurance. Convert from number Rev to letter Rev.15 Subject: Control of Special Processes Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 1 of 2 QA MANAGER: ORIGINATOR: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 1 2 3 A 04-21-97 06-23-03 05-30-06 10-01-08 08-15-11 Sam Mandel AUTHOR Carol Pepin Paul Raspe Victor Szatkowski Paul Grabek Paul Grabek DESCRIPTION OF CHANGE Original Added cover sheet. Quality Manager was Manager.Quality Procedure Procedure No. COO was President. added Purchasing Added VPAR requirement. 4.

Controlled Conditions. Corrective Action. and subcontractor survey reports on file in the Quality office. Purchase orders will specify this requirement for certification. LLC. and heat treating. adequate production equipment and/or any special working environment. inspection instructions.7. A method of testing. Manufacturing Work Instructions .7. Examples of special processing include brazing. Policy It is the policy of Prime Technology. IV. to assure that all basic production operations of any type. II. 4. Responsibility The Quality Manager is responsible for implementation of this procedure and for maintaining a list of suppliers approved for special processes. Processes performed by a supplier or subcontractor shall be approved by Prime Technology. Specific certification / test data will accompany all material processed outside Prime to assist in verifying that the material conforms to the applicable specifications. and material associated with such processes whether they are performed by Prime Technology or its supplier/subcontractor. Controlled conditions include documented work instructions. When customer concurrence is required the appropriate documentation shall be submitted via a VPAR (Vendor Procedure Approval Request) or similar as required by the contract. industry.Quality Procedure Procedure No. III. Quality maintains records of special process certification. Corrective action is taken when non-compliances occur in accordance with Quality Procedure 2. manufacturing or inspecting material that is highly complex and/or requires specialized operator skills. The Quality requirements for each process are also contained in the Engineering procedure. Reference Prime Technology Quality Procedure Number 2. Definitions Special Process. are accomplished under controlled conditions.5. The purpose of this procedure is to establish a control of special processes and all equipment. V. welding. Engineering is responsible for preparation of an Engineering procedure for special processes. Quality will audit special processes to insure that applicable customer. or purchase order. and / or Prime Technology specifications and standards are met.15 Subject: Control of Special Processes Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 2 of 2 I. Corrective Action Prime Technology Quality Procedure Number 2. together with all processing and fabricating of any type. inspection. test reports. Implementation Engineering defines the procedures required to assure a quality product when special processes are involved.

added Purchasing Added traceability requirements. Changed Inc to LLC in one place. 4. COO was President. Quality was Quality Assurance.16 Subject: Material Verification and Traceability Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 1 of 3 QA MANAGER: ORIGINATOR: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 1 2 3 A 04-22-97 06-23-03 05-30-06 10-01-08 08-15-11 Sam Mandel AUTHOR Carol Pepin Paul Raspe Victor Szatkowski Paul Grabek Paul Grabek DESCRIPTION OF CHANGE Original Added cover sheet.Quality Procedure Procedure No. Convert from number Rev to letter Rev. .

Certifications are kept on file in the QA office. etc. Testing consists of one or more of the following tests as required by the applicable specification: • Chemical Composition • Yield Strength • Tensile Strength • Elongation • Hardness • Other tests as required by specification Specific testing requirements are determined by Quality and are included on the purchase order. Policy It is the policy of Prime Technology.5.Quality Procedure Procedure No. 4. Metallic material shall be marked with a permanent marker in multiple locations (each piece or roll.16 Subject: Material Verification and Traceability Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 2 of 3 I. When a specific process changes the original material properties such as with heat treating the material must be reidentified and certified. Testing of material is specified by applicable standards. . IV. The purpose of this procedure is to define the Quality activities required to support material verification. Compliance is noted by initial and date on the test certification. The metallic material shall be 100% inspected for legible traceability marking and appropriate certification / data. This procedure also defines raw material traceability requirements II. Base material used in the manufacture of production hardware. Traceability Metallic materials shall be purchased with an original mill test lab certification. Verification Two raw material samples are selected annually for testing and shall be sent to an accredited independent test lab. Definitions Raw Material.) with the original purchase order number. Disposition/Corrective Action for Non-Conforming Material. III. the test piece and associated lot of material are rejected per Prime Technology Quality Procedure 4. LLC to periodically perform verification testing on raw materials to insure compliance with specification. Should test material be found out of specification limits. The original manufacturer data shall have certification signed by an authorized representative. The certification results are analyzed by Quality to insure compliance with requirements. Responsibility Quality is responsible for the implementation of this procedure. Chemical and mechanical test data shall be traceable to its heat identification.

Quality Procedure Procedure No.7.5. Disposition/Corrective Action for Non-Conforming Material . V. Reference Prime Technology Quality Procedure 2. Corrective Action Prime Technology Quality Procedure 4.5. apply for a waiver. A determination shall be made to scrap. or re-identify via an approved test procedure. The procedure shall have customer approval when required by purchase order or contract.16 Subject: Material Verification and Traceability Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 3 of 3 Material that has lost its traceability shall be rejected and placed on an MRR via Quality Procedure 4. 4.

COO was President. Quality Manager was Manager.1 Subject: Return Authorization Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 1 of 7 QA MANAGER: ORIGINATOR: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 1 05-01-97 06-23-03 Sam Mandel AUTHOR Carol Pepin Paul Raspe DESCRIPTION OF CHANGE Original Added cover sheet. added Purchasing. Quality was Quality Assurance.Quality Procedure Procedure No. IV. 2 3 A 05-30-06 03-31-10 08-15-11 Victor Szatkowski Paul Grabek Paul Grabek . Quality Assurance. Implementation: Change that QA gets initial RMA on a case-by-case basis. updated exhibits. Add that Production input is required on the Traveler as needed. Changed Inc to LLC in one place. Scanned Exhibits A. 5. Convert from number Rev to letter Rev. added page 7 Edited for Part 21 Compliance. B. & C.

and serial number (if applicable) • RMA Number • Part 21 Safety Related Item. Quality receives all Part 21. Implementation The Return Authorization process is initialized in Sales. modification. When the returned product is received from the customer.Quality Procedure Procedure No. The approximate time required and parts needed for any repair are estimated at this time. Definitions RMA . serial number (if applicable). to provide efficient processing of product returned for repair. and phone number • Customer contact • Reason for return • Part number. description. or upgrade. When customer contact is made. customer name. Responsibility The Quality Manager and the Manager. the evaluation is marked Beyond Economical Repair (BER). Upon completion. Copies of this form are distributed to Receiving. III. the technician provides the information in the “Evaluation” section of the Traveler. Safety related repairs require evaluation per Procedure 5. description. and log in by. quantity. address. A Test Technician evaluates the product and attempts to verify the customer’s complaint. date code. it is processed through the Receiving Department. replacement. If the equipment is deemed not repairable. and selected RMAs as determined by the Sales Administrator. quantity. As required.1 Subject: Return Authorization Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 2 of 7 I. if available. 5.Return Material Authorization IV. Policy It is the policy of Prime Technology. LLC. Production input is added to the Traveler. II. Sales. At this point the Traveler is forwarded to the Sales Administrator for resolution under the following conditions: • Product was damaged by the customer • No trouble was found . The product and Report are delivered to the Test Department for evaluation. Receiving initiates a Receiving Report (Exhibit B) completing the RMA number.3 for reportability. have overall responsibility for the implementation of this procedure. The purpose of this procedure is to identify the coordination required to service the customer in a minimum amount of time. date received. the Return Material Authorization (Exhibit A) is filled out by Sales with the following information: • Initials of person issuing Return Material Authorization • Date • Customer name.

. Disposition/Corrective Action for Non-Conforming Material Procedure 5.1 Subject: Return Authorization Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 3 of 7 • Customer approval required for repair to proceed • Repair not cost effective (BER). 5. A Work Order is created. Procedure 4. When required by the customer or a safety related item.Quality Procedure Procedure No. The product then goes to Final Quality for inspection.5. Failure Reporting Process Forms similar to the attached may be used provided they contain the required information. V. exceeds value of product • Product not repairable • Hold for Part 21 Evaluation and Processing to Procedure 5. Reporting of Defects and Noncompliance Procedure 5.5. the product and Traveler are forwarded to a technician for repair. Part 21. parts are issued. the Quality Manager completes the Test Failure Report or Corrective Action Request. Reference Exhibit C.3. Once resolved.3. or if customer prior approval was received. The Traveler is forwarded to the Sales Administrator who will generate a Sales Order Picker and coordinate billing with the Accounting Department. and labor is logged against the W/O.

1 03-31-2010 . Return Material Authorization Part 21 Safety Related Yes / No.Quality Procedure Procedure No. 5. 1151 1251 9270 .1 Subject: Return Authorization Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 4 of 7 Exhibit A. Approved / Reviewed By: Quality _______________ Engineering _______________ RMA Form Rev.

Receiving Report Traveler Part 21 Safety Related Yes / No 1151 1251 9270 Quality Assurance Engineering Form Rev 2 03-31-2010 . 5.1 Subject: Return Authorization Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 5 of 7 Exhibit B.Quality Procedure Procedure No.

1 Subject: Return Authorization Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 6 of 7 .Quality Procedure Exhibit C. 5. Return Authorization & Repair Schematic Procedure No.

5. Receiving Report Traveler .Quality Procedure Procedure No.1 Subject: Return Authorization Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 7 of 7 Exhibit D.

COO was President. Quality Assurance. added Purchasing Convert from number Rev to letter Rev.Quality Procedure Procedure No. Changed Inc to LLC in one place.2 Subject: Control of Customer Furnished Property Revision: A Date: 08-15-11 Supersedes: Revision 2 Page 1 of 2 QA MANAGER: ORIGINATOR: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 1 2 A 05-01-97 06-23-03 05-30-06 08-15-11 Sam Mandel AUTHOR Carol Pepin Paul Raspe Victor Szatkowski Paul Grabek DESCRIPTION OF CHANGE Original Added cover sheet. Quality Manager was Manager. Quality was Quality Assurance. 5. .

The purpose of this procedure is to outline requirements for receiving. Implementation All CFP received is visually inspected by the Receiving Department for external damage prior to signing the carrier’s freight bill. Receiving personnel complete the required documentation to acknowledge receipt. periodic calibration. II. This encompasses hardware. After inspection.2 Subject: Control of Customer Furnished Property Revision: A Date: 08-15-11 Supersedes: Revision 2 Page 2 of 2 I. Any problems are referred to the Quality Manager for resolution. receipt inspection and quantity verification. the equipment is entered into the calibration system. Upon completion of inspection. Responsibility The Quality Manager is responsible for assuring that the provisions of this procedure are complied with. and date inspected. rejected). LLC to control customer furnished property at each stage of utilization that will insure that the property is suitable for its intended use at all times. or used to test Prime Technology Products. software. equipment. IV. and controlling customer furnished property. handling.Quality Procedure Procedure No. processing. if required. the file folder is annotated with the intended department for use. III. Any incidence of damage observed is noted on the freight bill. For the purpose of this procedure. and adequate storage. The CFP is then moved to Final Quality for inspection. CFP is defined as customer furnished property that is intended to be shipped with. Definitions Customer Furnished Property (CFP). 5. and manuals. V. and transferred to the appropriate department. Reference Not applicable. . An inventory is taken annually by the Quality Manager and forwarded to the customer as required. incorporated into. condition of goods (accepted. but are not limited to. It excludes product returned in or out of warranty. A file folder is established for all CFP. functional testing as applicable. Such controls include. Policy It is the policy of Prime Technology. reason for rejection.

IV. . Implementation: Added minor changes to match current 10 CFR 21. Deleted Operation Manager from: Evaluation of Defects and Nonconformance and Exhibit B.Quality Procedure Procedure No. (Per NRC’s Mark-Up) Add 5. Changed Inc to LLC in one place.1 RMA & 5. COO was president. 5. added Purchasing NRC edits pages 5-7.5 Failure Reporting Convert from number Rev to letter Rev. Reporting of Defects and Noncompliance Revision: A Date: 08-15-11 Supersede: Revision 3 Page 1 of 7 QUALITY MANAGER: ORIGINATOR: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 1 2 3 A 07-17-97 06-23-03 05-30-06 03-31-10 08-15-11 Sam Mandel AUTHOR Carol Pepin Paul Raspe Victor Szatkowski Paul Grabek Paul Grabek DESCRIPTION OF CHANGE Original Added cover sheet.21.3 Subject: Part 21.

in order to identify a reportable defect or failure to comply that could create a substantial safety hazard. Reporting of Defects and Noncompliance Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 2 of 7 I. Failure Reporting Process In the Quality Manual. III. Deviation Deviation is defined as a departure from the technical requirements included in a procurement document of a Basic Component.g. inspection.3 Subject: Part 21. documented.5 Failure Reporting Process) A process to be used when the cause of a non-compliance must be identified. Substantial Safety Hazard Substantial Safety Hazard is defined as a loss of safety function to the extent that there is a major reduction in the degree of protection provided to public health and safety at a nuclear power plant. were it to remain uncorrected. or whether a failure to comply is associated with a Substantial Safety Hazard. Implementation (a) Each individual. 5. system. Reporting of Defects and Noncompliance. (See § 5. in all cases within 60 days of discovery. Responsibility Under the provision of Paragraph 21.e. and corrected where applicable. Evaluation Evaluation is defined as the process of determining whether a particular deviation could create a substantial Safety Hazard. or other entity subject to the regulations in this part shall adopt appropriate procedures to -(1) Evaluate deviations and failures to comply to identify defects and failures to comply associated with substantial safety hazards as soon as practicable. a defect is a deviation in a delivered (i. except as provided in paragraph (a)(2) of this section. LLC to fulfill the requirements of Title 10 Code of Federal Regulations Part 21. accepted for use at a nuclear power plant) Basic Component that would create a Substantial Safety Hazard. and. partnership. and help Prime Technology’s internal correspondences regarding root causes. suppliers. In all cases Basic Component includes safety related design. Policy It is the policy of Prime Technology. Definitions Basic Component Basic Component is defined as a plant structure. corrective . A deviation includes hardware and services provided (e. corporation. testing services).Quality Procedure Procedure No. Completed reports will be kept on file in Prime Technology’s Quality Department. Defect As used in this procedure. II. fabrication. and preventative actions. and . component. dedicating entity. The resulting report will be used in communications with. customers. The purpose of this procedure is to provide an outline for reporting such cases.21 of 10CFR21. or part thereof necessary to assure the safety of a nuclear power plant. replacement parts. analysis. Abbreviations: FTC = Failure to Conform / Comply RMA = Return Material Authorization NRC = Nuclear Regulatory Commission COO = Chief Operations Officer IV. the COO is responsible for implementation of this procedure and notification. testing.

or (ii) A basic component that is within his or her organization’s responsibility and is supplied for a facility or an activity within the United States that is subject to the licensing requirements under parts 30. order. then the supplier must inform the purchasers or affected licensees within five working days of this determination so that the purchasers or affected licensees may evaluate the deviation or failure to comply. and (2) Maintaining auditable records for the dedication process.21(c)(5). 50. . 61. pursuant to §21. 5. 70. or 72 of this chapter and that is within his or her organization’s responsibility.3 Subject: Part 21. or any applicable rule. (d)(1) A director or responsible officer subject to the regulations of this part or a person designated under §21.Quality Procedure Procedure No. within the 5 working days after completion of the evaluation described in §21. an interim report is prepared and submitted to the Commission through a director or responsible officer or designated person as discussed in §21.21(c)(5) must notify the Commission when he or she obtains information reasonably indicating a failure to comply or a defect affecting – (i) The construction or operation of a facility or an activity within the United States that is subject to the licensing requirements under parts 30. or 72 of this chapter. 40. and the supplier determines that it does not have the capability to perform the evaluation to determine if a defect exists.21(a). are not required if the director or responsible officer has actual knowledge that the Commission has been notified in writing of the defect or the failure to comply. 60. as amended. The interim report should describe the deviation or failure to comply that is being evaluated and should also state when the evaluation will be completed. and.21(a)(1) or §21. or a basic component supplied for such facility or activity – (i) Fails to comply with the Atomic Energy Act of 1954. (2) The notification to NRC of a failure to comply or of a defect under paragraph (c)(1) of this section and the evaluation of a failure to comply or a defect under paragraphs (a)(1) and (a)(2) of this section. regulation. or services associated with basic components. 71. (3) Ensure that a director or responsible officer subject to the regulations of this part is informed as soon as practicable.21(a)(2) if the construction or operation of a facility or activity. or (ii) Contains a defect. 50. or license of the Commission relating to a substantial safety hazard. 40. Reporting of Defects and Noncompliance Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 3 of 7 (2) Ensure that if an evaluation of an identified deviation or failure to comply potentially associated with a substantial safety hazard cannot be completed within 60 days from discovery of the deviation or failure to comply. 61. 60. in all cases. This interim report must be submitted in writing within 60 days of discovery of the deviation or failure to comply. 71. (b) If the deviation or failure to comply is discovered by a supplier of basic components. 70. (c) A dedicating entity is responsible for – (1) Identifying and evaluating deviations and reporting defects and failures to comply associated with substantial safety hazards for dedicated items.

(viii) Any advice related to the defect or failure to comply about the facility. and the length of time that has been or will be taken to complete the action. the name of the individual or organization responsible for the action. (ii) Written notification to the NRC at the address specified in §21. supplied for. this shall not relieve the director or responsible officer of his or her responsibility under this paragraph. (iv) Nature of the defect or failure to comply and the safety hazard which is created or could be created by such defect or failure to comply. the activity. (vii) The corrective action which has been. 5.21(a)(2). This paragraph does not apply to interim reports described in §21. to the extent known: (i) Name and address of the individual or individuals informing the Commission. or basic component that has been. is being. or being supplied for one or more facilities or activities subject to the regulations in this part.3 Subject: Part 21. activity. Reporting of Defects and Noncompliance Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 4 of 7 (3) Notification required by paragraph (d)(1) of this section must be made as follows – (i) Initial notification by facsimile. the following information. or the basic component supplied for such facility or such activity within the United States which fails to comply or contains a defect. on the identification of a defect or a failure to comply. which is the preferred method of notification. (e) Individuals subject to this part may be required by the Commission to supply additional information related to a defect or failure to comply. is being. or will be taken. (iii) Identification of the firm constructing the facility or supplying the basic component which fails to comply or contains a defect. (v) The date on which the information of such defect or failure to comply was obtained. on the identification of a defect or a failure to comply. to the NRC Operations Center at (301) 816-5151 or by telephone at (301) 816-5100 within two days following receipt of information by the director or responsible corporate officer under paragraph (a)(1) of this section. Commission action to obtain additional information may be based on reports of defects from other reporting entities. Verification that the facsimile has been received should be made by calling the NRC Operations Center. . (vi) In the case of a basic component which contains a defect or fails to comply. (4) The written report required by this paragraph shall include. or will be given to purchasers or licensees.Quality Procedure Procedure No. the number and location of all such components in use at.5 within 30 days following receipt of information by the director or responsible corporate officer under paragraph (a)(3) of this section. (ii) Identification of the facility. but need not be limited to. provided that. (5) The director or responsible officer may authorize an individual to provide the notification required by this paragraph.

Quality Procedure Procedure No. an employee should consider the following: (a) Is a design in the revision stage after design reviews are made or new information is received from vendors? There is no need to report such revisions. then the Quality Manager shall document this on Form 150 and return a copy to the employee and the employee’s supervisor. Before reporting a deviation or possible noncompliance in accordance with this procedure.7. (b) Is the basic component within Prime Technology LLC’s responsibility? (c) Has the design (drawing. Quality Procedure 2. Corrective Action Quality Procedure 4.e. Return Authorization Quality Procedure 5.3 Subject: Part 21. Evaluation of Defects and Nonconformance Upon receipt of Form 150.5. If the criteria of the checklist are not met. Title 10. Disposition/Corrective Action for Nonconforming Material Quality Procedure 5. software) been offered for acceptance by a customer? The Quality Manager or his designee shall identify the deviation or possible nonconformance using Form 150 (see Exhibit A). and the NRC. Disposition/Corrective Action for Nonconforming Material and 5. Failure Reporting Process Forms similar to the attached may be used provided they contain the required information. however. Reporting of Defects and Noncompliance Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 5 of 7 Reporting a Defect or Noncompliance This procedure applies to deviations that may represent possible defects and possible non-compliances recognized by an employee or formally reported in writing to an employee from an external source (i. 4. 5.1.7. Reference USNRC Rules and Regulations.5. If the reported deviation or possible nonconformance meets the criteria of the checklist. then the information shall be reported to the Vice President of Sales.5. Corrective Action and Control of Nonconforming parts or components shall be handled in accordance with Quality Procedure 2. . Part 21-Reporting Defects and Noncompliance. Corrective Action. the Quality Manager in conjunction with the Manager of Engineering shall evaluate the reported deviation or possible nonconformance using the checklist form P21RDN (see Exhibit B) to determine if a Part 21 exists. Chapter 1.1. supplier). COO. Return Authorization. V. Code of Federal Regulations—Energy.

Quality Procedure Procedure No.3 Subject: Part 21. Dated 8-15-11) . NRC. 5. Forward to employee with copy to employee’s supervisor. ____ No Form 150 (Rev. A.) _________________________________________________________________________________________ _________________________________________________________________________________________ _________________________________________________________________________________________ _________________________________________________________________________________________ _________________________________________________________________________________________ Signature: ____________________________ Date: ___________________________ ***************************************************************************************** Received by Quality Manager or his designee Date: ____________ Time: ____________ Does this possible defect or FTC meet the criteria of the checklist on form P21RDN (see Exhibit B)? ____ Yes Forward copy to COO with copies to the Vice President of Sales. and the employee’s supervisor. Reporting of Defects and Noncompliance Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 6 of 7 Exhibit A POTENTIAL PART 21 REPORT Name: _________________________________ Page #: ________________________ Dept/Div: ______________________________ Position: _______________________ Project Name: ___________________________ Project #: _______________________ ___________________________ TO: Quality Manager or his designee Description of Possible Defect or FTC: (Identify all affected documents. Attach additional sheets if required.

A. The integrity of the reactor coolant pressure boundary. The answer to II. The capability to prevent or mitigate the consequences of accidents? OR II.3 are yes OR 2. A.Quality Procedure Procedure No. If a deviation exists.B is yes ___ ___________________ Quality Manager ___________ Date _________________________________ Engineering Manager ____________ Date Form P21RDN (Rev. 5.B. does this condition or circumstance fail to comply with the Atomic Energy Act of 1984 as amended or any applicable NRC rule or regulation? ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ NO ___ A potential Defect or FTC exists and is potentially reportable if: Does Not Exist ___ Exist 1. The capability to shut down the reactor and maintain it in a safe shutdown condition? OR 3. Is there a departure from the technical requirements of a Basic Component procurement document? B.2 . A. Is the Basic Component necessary to assure: 1.A is yes OR 3. The answer to II. The answer to I. I. and at least one of I. If a deviation exists. Reporting of Defects and Noncompliance Revision: A Date: 08-15-11 Supersedes: Revision 3 Page 7 of 7 Exhibit B 10CFR21 Potential Reportable Determination Checklist YES I.3 Subject: Part 21. is this a condition or circumstance involving a Basic Component that could contribute to the exceeding of a safety limit as defined in the technical specifications? OR B.B.1. OR 2. A.B. or 1. Dated 8-15-11) .

Define 24 hour burn-in and department responsibilities.4 Subject: Commercial Grade Dedication Revision: B Date: 09-30-11 Supersedes: Revision A Page 1of 3 QUALITY MANAGER: ORIGINATOR: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV DATE 0 A B 05-01-10 08-15-11 09-30-11 Sam Mandel AUTHOR Paul Grabek Paul Grabek Paul Grabek DESCRIPTION OF CHANGE Original Convert from number Rev to letter Rev. . Added second dedication package review. Added base component definition.Quality Procedure Procedure No. 5.

and any other characteristic that may impact safety function. suppliers. Completed reports will be kept on file in Prime Technology’s Quality Department.3. Failure Reporting Process is to be used when the cause of a non-compliance must be identified. IV. This includes items that have been manufactured by a different supplier that were not part of the original qualified component. These meter models were seismic qualified to industry requirements for safety related applications. Critical characteristics include seismic qualification. The resulting report will be used in communications with. chemical composition of solder. documented. Implementation by Department for a Base Component Engineering: Engineering shall determine the safety function of a components end use and the critical characteristics.Quality Procedure Procedure No. and help Prime Technology’s internal correspondences regarding root causes. appendix B or commercial grade items which have successfully completed the dedication process. and other documentation as required for the dedication of a safety related components function. and corrected where applicable. Quality: Quality shall review purchase orders or contracts per Procedure 2. III. Sales: Purchase Orders or Contracts that specify a safety related meter or sub-component shall be forwarded by Sales for review by Quality. 1251. Policy It is the policy of Prime Technology. corrective. Definitions Base Component Items designed and manufactured under a quality assurance program complying with 10 CFR 50. and preventative actions. Quality Planning and Contract / Purchase Order Review. Commercial Grade Item A Commercial Grade Item (CGI) is a component that affects safety that was not designed and manufactured in accordance with the requirements of Standard NQA-1. accuracy. procedures. 5. II.5.4 Subject: Commercial Grade Dedication Revision: B Date: 09-30-11 Supersedes: Revision A Page 2 of 3 I. Responsibility The Quality Manager and the COO have overall responsibility for the implementation of this procedure. The purpose of this procedure is to provide a process for insuring CDG is performed to contract requirements and will perform its Safety Function(s) in relation to Prime Technology LLC supplied products. Engineering shall develop drawings. . Failure Reporting Process Quality Manual Procedure 5. customers. LLC to fulfill the requirements of Standard NQA-1 for Commercial Grade Dedication (CGD). Commercial Grade Dedication An acceptance process undertaken to provide reasonable assurance that a CGI to be used in a safety system / facility meets specified requirements. 9270 and any sub-component thereof may be classified as safety related. Safety Related Prime Products Meters part number 1151.

4 Subject: Commercial Grade Dedication Revision: B Date: 09-30-11 Supersedes: Revision A Page 3 of 3 Procurement: Material shall be procured from approved venders. Inspections and testing shall follow the prescribed process delineated by the work order. and packaging requirements. Inspection: A final inspection shall be completed. Disposition/Corrective Action for Nonconforming Material.3.4. test data. Inspection of Purchased Material Quality Procedure 4. Quality Planning and Contract / Purchase Order Review Quality Procedure 2. Quality Procedure 4. The review shall verify order requirements. Certificate of compliance and test data when required shall be verified for content and accuracy. and Quality Procedure 5.7. Corrective Action Quality Procedure 4. The item shall be safety related certified to the requirements as specified by the purchase order/contract as stated on the order acknowledgement.3. Meter models 1151/1251 shall be processed utilizing engineering approved drawings and or procedures. Disposition/Corrective Action for Nonconforming Material Quality Procedure 5.5. Burn-in is not required for these model meters.7. Production: Production shall assemble utilizing drawings and procedures as developed by engineering. When a previous approved item is no longer available from a supplier Procurement shall notify Engineering so a replacement supplier may be qualified.5. A 24 hour burn-in @ ambient temperature for electronics (9270 related) shall be completed and documented. This includes but not limited to the revision and date of the Prime Technology LLC 10 CFR50 Appendix ‘B’ approved Quality Manual. Receiving Inspection: Receiving Inspection shall verify critical characteristics of items via engineering approved drawings and or procedures. V. Test data shall be completed per the applicable Final Inspection Procedure (FIS). certificate of compliance. Items found to be acceptable shall be marked/tagged as required. applicable IEEE Standards. Reporting of Defects and Noncompliance Quality Procedure 5.Quality Procedure Procedure No. Part 21. The Quality Manager or his designee and a second designee shall sign and date the order acknowledgement as evidence of the review. a Qualification Report. Test: Test shall perform an Acceptance Test Procedure (ATP) on the component. 5. Failure Reporting Process .3. Manufacturing Work Instructions Quality Procedure 2. Items that fail to meet the necessary requirements shall be processed via the following quality procedures: Quality Procedure 2. Reference NQA-1 Quality Assurance Requirements for Nuclear Facilities Applications Quality Procedure 2. Quality: Upon completion of work and prior to release for shipment the Quality Manager and another designee shall review order documentation (Dedication Package) for accuracy. Test data /certificate of compliance shall be reviewed for accuracy and completeness.5. Material control: A work order shall be released to manufacturing. Part 21. and other order specific requirements. Reporting of Defects and Noncompliance. Corrective Action.5.

DATE 03-25-10 08-15-11 09-30-11 DESCRIPTION OF CHANGE . Quality Assurance. Added: Reporting a Part 21 to paragraph. Quality was Quality Assurance. Quality Manager was Manager.Quality Procedure Procedure No. 5.5 Subject: Failure Report Process Revision: B Date: 09-30-11 Supersedes: Revision A Page 1of 4 ORIGINATOR: QUALITY MANAGER: Paul Grabek PURCHASING: Paul Grabek ENGINEERING: Jim Jamieson MARKETING: Nick Graziano MATERIAL CONTROL: Keith Macdowall COO: Jim Jamieson PRODUCTION: Luis Lluberes REV 0 A B Sam Mandel AUTHOR John DeCola Paul Grabek Paul Grabek Initial Release Convert from number Rev to letter Rev. IV. Format changed to agree with manual.

. Responsibility The Quality Manager is responsible for the overall implementation of this procedure. fully assembled units. The purpose of this procedure is to assure that conditions that are adverse to quality. Corrective Action Request (CAR): Form used to document corrective action by recording the problem. Failure Reporting Process: A process to be used when the cause of a non-compliance must be identified. The review by Quality is documented and follow-up on the implementation of the action is verified. This form is used for supplier caused defects as well as Prime caused defects. Definitions / Tools 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. suppliers and help Prime Technology’s internal correspondences regarding root causes. II. Material Rejection Report (MRR) Initiated for deficiencies related to product. Proposed corrective action is supplied by the responsible activity. This form incorporates all steps for the corrective action process.Quality Procedure Procedure No. or practices and / or hardware deficiencies. It is initiated for administrative type deficiencies. The corrective action request is delineated. defective material. or perform acceptance tests. and non-conformances are promptly identified and corrected. procedures. or the equipment used to fabricate. Policy It is the policy of Prime Technology. proposed corrective action. deficiencies. deviations. III. equipment. malfunctions. departures from established policies. LLC to provide efficient feed back to Manufacturing. and preventative actions. 5. its affectivity and the activity responsible for implementation. corrective. Public Drive: Quality/Historic Data Base/ Failure_Report_Log. However the Failure Reporting process can be initiated by anyone who has observed conditions that are adverse to quality that needs Quality and / or Engineering intervention to help reduce rework or scrap. Failure Reports for Part 21 Safety Related products will be scanned and kept on file on the company Intranet. and corrected where applicable. such as failures. Non-Conforming products could include individual components. Completed reports will be kept on file in Prime Technology’s Quality Department.5 Subject: Failure Report Process Revision: B Date: 09-30-11 Supersedes: Revision A Page 2 of 4 I. Engineering and when required to Customers regarding Non-Conforming products. sub-assemblies. The resulting report will be used in communications with customers. documented.

Use N/A where necessary but do not leave any lines blank. Quality Manual 2. Corrective Action Forms similar to the attached may be used provided they contain the required information.009 to .170 – 2.3.250 ohms over maximum) Verify all Controlling Engineering Prints. Using the attached Failure Report form fill in as much information as available. Record findings on Prime Technology’s RMA Report. and completeness of assembly. .161 to 2. This report circulation will be triggered by the Quality Master Schedule.007 under minimum) Electrical ATP Example: Acceptance Test Requirement: 1. and concise. Dimensional Example: Required Print Dimension: 2.5.Quality Procedure Procedure No.500 ohms (. Distribution Failure reports will be distributed to management quarterly when activity dictates. Part 21 Reporting of Defects and Non-Compliance. Vl. V.750 to 2. Verify correct unit information is recorded on RMA Reports. This applies to deviations that may represent possible defects and possible non-compliances for safety related components.7. Reporting of Defects and Noncompliance to make a determination of applicability.5 Subject: Failure Report Process Revision: B Date: 09-30-11 Supersedes: Revision A Page 3 of 4 IV. Management determination shall be made regarding the expenditure of resources to perform cost effective Failure Reporting. Procedure Non-conformances that are detected are candidates for failure reporting.180 inches Actual Measured: 2. Detail a brief general description about failure category and then record the specifics of the nonconformance in detail using a format that is clear.163 (.250 ohms Circuit A-B Actual Measured Values: 2. Acceptance Test Procedures. 5. Visually examine unit for obvious damage. Reporting a Part 21Defect or Noncompliance Block 12 of the failure form pertains to Part 21 failure reporting. Reference Quality Manual 5. Reference Procedure No.3 Part 21. and other related specifications are of the correct / current revision. More frequent notifications will be used where volume warrants.

5.5 Subject: Failure Report Process Revision: B Date: 09-30-11 Supersedes: Revision A Page 4 of 4 .Quality Procedure Procedure No.

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