· Web viewREVISIONG _______________________________________ 327 O’Hair Court, Suite D, Santa Rosa, CA 95407. Quality Manual. April 19, 2013. APPROVAL. Datum Technologies developed

_______________________________________ 327 O’Hair Court, Suite D, Santa Rosa, CA 95407

April 19, 2013

REVISION

G

Quality Manual

APPROVAL

Datum Technologies developed and implemented a quality management system to better satisfy the needs of its customers and to improve management of the company. The quality system complies with the international standard ISO 9001 and AS9100. The purpose of this manual is to define and describe the quality system, to define the authorities and responsibilities of the management personnel affected by the system, and to provide general procedures for all activities comprising the quality system, and to present our quality system to our customers to inform them what specific controls are implemented to assure product quality.

Approved:

RICHARD F. HUNT, SR

PRESIDENT/OWNER

ANALISA HUNT CEO/OWNER

Quality Manual/ Revision G Page 2

TABLE OF CONTENTS

APPROVAL…….………………………………………………………………………….. 2

TABLE OF CONTENTS………………………………………………………………... 3

1.0 Introduction and Scope……………………………………………………….. 71.1 Scope…………………………………………………………………………... 7

1.1.1 QMS……………………………………………………………………………….…. 7

1.1.2 QMS Scope…………………………………………………………………….…… 7

1.1.3 QMS Specifications……………………………………………………….…….. 7

1.1.4 QMS Objective…………………………………………………………….……… 7

1.2 Core Business………………………………………………………..……… 81.3 Quality Policy………………………………………………………..……… 81.4 Quality System Documentation……………………………..……….. 81.5 Authority…………………………………………………………..…………. 81.6 Organizational Chart………………………………………..…………… 91.7 Total Manufacturing Solutions……………………….……………… 101.8 Commitment to Excellence………………………….………………… 10

1.8.1 Value Proposition to the Customer…………………………………….11

1.8.2 Mission……………………………………………………………………………11

1.8.3 Vision……………………………………………………………………………..11

1.8.4 Core Values……………………………………………………………….…….11

1.9 Manufacturing Operations and Capabilities…………….……... 121.9.1 Manufacturing Equipment………………………………………..………

121.9.2 Quality Assurance/Metrology Equipment……………………….…. 13

2.0 Quality Manual Structure………………………………………………….… 142.1 Conformance to Standards………………………………………….… 14

3.0 General Quality Terms………………………………………………………... 15


3.1 - 3.43 Terms…………………………………………………….………….15 - 183.44 Abbreviations………………………………………..………….… 18

TABLE OF CONTENTS (continued)

4.0 Quality Management System…………………………………………………. 194.1 General Requirements…………………………………………………… 194.2 Documentation Requirements……………………………………….. 19

4.2.1 General…………………………………………………………………………….19

4.2.2 Quality Manual…………………………………………………………………20

4.2.3 Control of Documents……………………………………………….…..….20

4.2.4 Control of Records…………………………………………………..............21

4.3 Configuration Management…………………………………………… 21

5.0 Management Responsibility…………………………………………………. 225.1 Management Commitment……………………………………........... 225.2 Customer Focus……………………………………………………………. 225.3 Quality Policy……………………………………………………………….. 225.4 Planning………………………………………………………………………. 23

5.4.1 Quality Objectives…………………………………………………..............23

5.4.2 Management System Planning……………………………………………24

5.5 Responsibility, Authority, and Communication……………….. 245.5.1 Responsibility and Authority………………………………………………

245.5.2 Management Representative………………………………………………

24


5.5.3 Internal Communication……………………………………………………24

5.6 Management Review……………………………………………………… 255.6.1 General…………………………………………………………………………….

255.6.2 Review Input…………………………………………………………………….

255.6.3 Review Output………………………………………………………………….

25

6.0 Resource Management…………………………………………………………. 266.1 Provision of Resources……………………………………….............. 266.2 Human Resources…………………………………………………………. 26

6.2.1 General…………………………………………………………………………….26

6.2.2 Competence, Awareness, and Training………………………………..27

6.3 Infrastructure……………………………………………………………….. 276.4 Work Environment………………………………………………………… 27


7.0 Product Realization……………………………………………………........... 287.1 Planning of Product Realization……………………………........... 28

7.1.1 Project Management…………………………………………………………28

7.1.2 Risk Management…………………………………………………………….29

7.1.3 Configuration Management………………………………………………29

7.1.4 Control of Work Transfers…………………………………………………29

7.2 Customer-Related Processes…………………………………………. 307.2.1 Determination of Product Requirements…………....…………….. 30


7.2.2 Review of Product Requirements………………………..…………….30

7.2.3 Customer Communication……….…..………………………………….30

7.3 Design and Development………………………………………………. 31

7.4 Purchasing…..……………………………………………………………… 317.4.1 Purchasing Process………………………………………………...............

317.4.2 Purchasing Information…………………………….……………………..

327.4.3 Verification of Purchased Product……………………………………..

33

7.5 Production and Service Provision………………………………….. 347.5.1 Control of Production………………..……………………………………..

347.5.2 Validation of Processes for Production…………………….…………

367.5.3 Identification and Traceability…………………………………………..

367.5.4 Customer Property…………………………………………………………..

377.5.5 Preservation of Product…………….……………………………………...

37

7.6 Control of Monitoring and Measuring Devices………………... 38



8.0 Measurement, Analysis and Improvement……….…………………… 408.1 General………………………………………………………………………. 408.2 Monitoring and Measurement………………………………………. 40

8.2.1 Customer Satisfaction……………………………………………………...40

8.2.2 Internal Audit…………………………………………………………………41

8.2.3 Monitoring and Measurement of Processes………………………. 428.2.4 Monitoring and Measurement of Product…………………………. 42

8.3 Control of Non-Conforming Product……………………………… 448.4 Analysis of Data…………………………………………………………… 458.5 Improvement………………………………………………………………. 46

8.5.1 Continual Improvement…………………………………………………...46

8.5.2 Corrective Action……………………………………………………………..46

8.5.3 Preventive Action…………………………………………………………….47

Appendix A………………………………………………………………………………. 48

Revision History……………………………………………………………………….. 50


1.0 INTRODUCTION AND SCOPE

1.1 Scope

1.1.1 This quality manual describes the DATUM Technologies Quality Management System (QMS) which meets the requirements of ISO 9001 and AS9100. DATUM Technologies is engaged in the sale, manufacture and distribution of precision machined components for the Test and Measurement, Semiconductor, Medical and Aerospace Industries.

1.1.2 The scope of this QMS includes processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements. Exclusions are listed below:

Section 7.3 Design and Development is not currently applicable to DATUM Technologies operations. DATUM Technologies provides products as specified by its customers.

Section 7.5.1.4 Post Delivery Support - DATUM Technologies does not currently engage in servicing products.

Section 7.5.2 Validation of Processes for Production - DATUM Technologies currently does not have any special processes.

1.1.3 The Quality Management System requirements specified in this standard are complementary (not alternative) to contractual and applicable law and regulatory requirements.

1.1.4 This Quality Manual serves as an employee guide that must be satisfied to meet the objectives of the Quality Policy and Customer expectations. It is also intended to provide a QMS overview to outside organizations


1.2 Core Business

DATUM Technologies is primarily involved in the sale, manufacture and distribution of precision machined components for the Test and Measurement, Semiconductor, Medical and Aerospace Industries. With diverse manufacturing processes, DATUM Technologies is capable of providing “turnkey” products.

1.3 Quality Policy

”DATUM Technologies is committed to meeting the Customers’ stated and implied requirements. Our key objectives are to: provide quality products, reliability, deliver on-time, increase Customer satisfaction, and continually improve and comply with the Quality Management System. We utilize production facilities that are designed to achieve world class rating in the development and application of innovative solutions and progressive technology”.

1.4 Quality System Documentation

DATUM Technologies has three primary levels of Quality System documentation.

Level 1 – The Quality Manual (QM) describes the DATUM Technologies Quality System in accordance with the stated Quality Policy and Objectives, and the ISO 9001/AS9100 standards.

Level 2 – Documented procedures as required by ISO 9001 and/or AS9100.

Level 3 - Other documentation such as reference documents, training documents, forms, records and work instructions are created as needed to support overall quality objectives.

All products provided by DATUM Technologies are manufactured and verified in accordance with the Quality Management System described in this Quality Manual.

1.5 Authority

The DATUM Technologies Quality Management System is authorized by the President of DATUM Technologies and administered by the Quality Assurance Manager who serves as the Management Representative.

Quality Manual/Revision F Page 9

ANALISA HUNTCEO/OWNERADMINISTRATIONACCOUNTING/FINANCESTRATEGICPLANNINGDOCUMENTCONTROLORGANIZATIONAL CHART

1.6 Organizational Structure

Figure 1.0 illustrates the organizational structure of various functions within DATUM Technologies.

Figure 1.0


1.7 Total Manufacturing Solutions

DATUM Technologies is a woman owned precision machining/manufacturing, swiss turning company that manufactures custom parts to the customer’s specifications using a variety of materials and processes. DATUM Technologies provides close tolerance, highly technical, precision machining/manufacturing services (large and small precision CNC turning, and vertical CNC milling) to primarily original equipment manufacturers in the Analytical Test Instrumentation, Medical Instrumentation, Optical Equipment, Semiconductor Equipment, and Aerospace industries. DATUM Technologies provides NPI/Prototype and tooling capabilities with In-Plant Engineering and Design for Manufacturing (DFM) services.

1.8 Commitment to ExcellenceDATUM Technologies has a demonstrated commitment to excellence. DATUM Technologies provides the customer with a “Turnkey” solution (One Stop Shopping) to totally manage their entire precision machining and manufacturing requirements.

DATUM Technologies’ highly experienced staff covers the full spectrum of manufacturing processes: R&D Prototyping, Precision Machining, Tooling, Fixturing, Precision Microcircuit Deburring, support processes, outside processes, (plating, heat treating), and assembly.

As a vertically integrated company, DATUM Technologies manages the complete process from initial request for quote (RFQ) to 100% Quality, On-Time products delivered to the customer at a competitive price with guaranteed Customer Satisfaction.DATUM Technologies offers electronic data exchange for most design software file formats, i.e., IGES and DXF. We have extensive experience in machining Kovar, Carpenter 49 Nickel, Hy-Mu 80, Stainless Steel, Titanium, Be Cu, Tungsten, Copper, Brass, Aluminum, Graphite, and Plastics.

With regard to technology and quality, DATUM Technologies utilizes its expertise in manufacturing methodologies and processes to manage and produce all precision machining requirements ensuring the highest level of quality to the customer.


DATUM Technologies assures responsiveness and customer satisfaction. President/Owner, Richard Hunt, is the main contact dealing with all customer related issues: quoting, lead-time, purchase orders, scheduling, prioritization, and delivery. With over forty years in Manufacturing and Materials Management and as a business owner, he ensures you are aware of any potential issues that could affect product supply.

DATUM Technologies provides its customers with an industry competitive lead time and 100% on-time delivery. That’s our guarantee!

DATUM Technologies has a very solid understanding of all cost components and provides the customer with very competitive pricing through Continuous Process Improvement (CPI) methodology.

1.8.1 Value Proposition to the Customer DATUM Technologies totally manages the entire process and

thereby minimizes customer resource requirements. DATUM Technologies provides a unique blend of technical

expertise, Materials, Manufacturing Management, and Business Savvy.

DATUM Technologies’ relationship based philosophy focuses on providing the highest level of Customer Satisfaction possible.

DATUM Technologies’ low overhead structure makes the company extremely flexible and responsive to the needs of the customer.

We would like to invite you to visit our facility. We are confident you will be favorably impressed!

These commitments are further described in this quality manual and are supported using on-going measurement and analysis techniques to ensure each objective is achieved.

1.8.2 MissionProfitably produce components for our customers with 100% quality,

on-time!1.8.3 Vision

DATUM Technologies is a recognized leader of precision machining and value-added manufacturing services; attracting and employing a team of the most technically skilled individuals in the industry, who are committed to the mission, values, and strategy of the company.


1.8.4 Core Values: We produce quality every time. We demonstrate pride of ownership in everything we do. We strive to be on the forefront of technology. We are committed to on-time delivery. We value each other and recognize individual contributions. We are committed to excellence in everything we do. We are committed to training and development. We respect our environment.

1.9 Manufacturing Operations and Capabilities

DATUM Technologies possesses the capability to fabricate a wide variety of products. We utilize a variety of quality equipment for speed, accuracy, dependability, and advanced technology.

1.9.1 Manufacturing EquipmentSome of the equipment that we use includes: Two Nakamura-Tome SC-300 M-NCBFT CNC Turning Centers

with 21-TB Fanuc Control, Main Spindle with C-Axis, Indexable Sub-Spindle, Live Milling, LNS Quickload Barfeeder with 2 5/8” capacity

Citizen CINCOM L25 7-Axis CNC Swiss Screw Turning Center Mori Seiki SLO Turning Center with Fanuc Control, 8 tool stations Two HAAS VF-2SS CNC Vertical Machining Centers with

30”x16”x20” (XYZ) 30-HP, 12000 RPM In-Line Direct Drive Spindle, 1400 IPM Rapids, 24 Tool high speed tool changer, High Speed Machining and Touchprobe

HAAS SL-20 CNC Turning Center, 20 HP Vector Dual Drive, 10.3” X 20”; 4000RPM Spindle. Chip Conveyor, Tool Presetter, Intuitive Programming System (IPS)

HAAS ST-20 CNC Turning Center, 20 HP Vector Dual Drive, 15” X 20.5”, 4000 RPM High Torque Spindle, Fully Programmable Hydraulic Tailstock, Automatic Tool Presetter System and Chip Conveyor

Bridgeport Milling Machine – 1 HP w/2 axis DRO, 9”x48” power table feed, 2720 max RPM


Hardinge HLV-H Precision Tool Room Lathe Gardner-Denver 15HP Model # INT-15EFB, integrated rotary

screw air compressor Mastercam X, 3D programming software (mill/lathe) Clausing/Kalamazoo KC12AX Automatic Horizontal Bandsaw Additional tooling and equipment to support all in-house CNC

machinery HAAS UMC 750 Vertical Machine Center - 30” x 22” x 20” with

630 x 500mm Integrated 2-Axis Trunnion Rotary Table, 40 Taper, 30 HP12,000 RPM Spindle, Thru-Spindle Coolant

1.9 (continued)1.9.2 Quality Assurance/Metrology Equipment:

Mitutoyo Crystal M574 Coordinate Measuring Machine (CMM) with Renishaw MH20 Indexable head probe system and MCOSMOS-M1 IBM Think Center PC System

Mitutoyo PH-A14 - 14” Optical Comparator AMSCOPE Stereo Microscope w/9 Megapixel Camera Mitutoyo 18” Digital Height Indicator 6 Fowler Mark IV Digital Drop Indicators 24”x36” Standridge Granite Table Laser Micrometer Model # 183 Micrometers, Gages and Tooling to support all QA Functions


2.0 QUALITY MANUAL STRUCTUREDATUM Technologies’ Quality Manual is written for maximum clarity, and ease of interpretation. It is structured around the key elements of ISO 9001 and AS9100.

2.1 Conformance to Standards

DATUM Technologies’ Quality Manual is designed as a model for compliance to:

ISO 9001 Quality Management Systems - Requirements AS9100 Quality Management Systems - Requirements

DATUM Technologies Quality Management System implementation is consistent with the listed standards except for exclusions noted in Section 1.1.2.


3.0 GENERAL QUALITY TERMS The following are used throughout the DATUM Technologies Quality Manual and Operations Procedures. They are provided here to assist the reader of the DATUM Technologies Quality Manual and Operations Procedures Manual. Additional terms are defined in ISO 9000 (Quality Management Systems – Fundamentals and Vocabulary)

TERMS

3.1 Conformance - Meets the customer-specified and implied requirements.

3.2 Contract - (accepted order) - Agreed requirements between a supplier and customer

3.3 Contract Review - Systematic activities carried out by the supplier before signing the contract to ensure that the requirements for quality are adequately defined, free from ambiguity, documented, and can be realized


by the supplier. A contract review may be repeated at different phases of the contract as needed.

3.4 Configuration Management Process - Configuration Management requires that a management discipline be applied over the life cycle of a product to provide visibility and control of its functional and physical characteristics. The configuration management process must begin at the product's design-and-development phase and continue along the entire value stream, providing visibility and control of the product’s functional and physical characteristics. “Configuration management documents the product’s configuration. It provides identification and traceability, the status of achievement of its physical and functional requirements, and access to accurate information in all phases of the life cycle”.

3.5 Controlled Document - Any document that is reviewed and approved before release for use or for reference.

3.6 Continual Improvement - Recurring activity to increase the ability to fulfill requirements.

3.7 Corrective Action - Action to eliminate the cause of a detected non-conformity or other undesirable condition.

3.8 Customer - The recipient of a product provided by DATUM Technologies.

3.9 Customer Owned Property - Any type of instrumentation, accessories, manuals, software, drawings or documentation that belongs to a customer.

3.10Customer Satisfaction - Customer’s perception of the degree to which the customer’s requirements have been satisfied.

3.11Customer Supplied Product - Any type of service or material supplied to be utilized in the manufacture, modification, or repair of customer-owned property.

3.12Delegated Quality Verification – Within the DATUM Technologies QM, this term shall refer to the act of DATUM Technologies allowing a designated supplier to perform quality acceptance verification on DATUM Technologies behalf. The requirements must be expressed clearly in a P/O or other suitable means including any flow-down of customer requirements, and the supplier must be qualified and competent to perform the verification. Additionally, a Register of Delegations must be maintained. (See DATUM Technologies -QM-7.4.3, Verification of Purchased Product, for full requirements).


3.13 Entity - Item that can be individually described and considered. An Entity may be an activity, process, product, organization, system, person or any combination of these.

3.14 Inspection - Conformity evaluation by observation and judgment with use as appropriate of measurement, testing or gauging.

3.15Key/Critical Characteristics - The features of a material, process, or part whose variation has a significant influence on product fit, performance, service life, or manufacturability.

3.16Management Review - Formal evaluation by top management of the status and adequacy of the quality system in relation to quality policy and objectives.

3.17Multi-disciplinary Approach - Typically includes management, production, engineering, quality and other appropriate personnel.

3.18Non-Conformance - Does not meet the Customer-specified and implied requirements.

3.19Organization/Company - DATUM Technologies

3.20Preventive Action - Action to eliminate the cause of a potential non-conformity or other undesirable condition.

3.21Procedure - Specified way to perform an activity or a process.

3.22Process - Set of interrelated resources and activities which transform Process Inputs into outputs. Resources may include personnel, finance, facilities, equipment, techniques, and methods.

3.23Product - Results of activities or processes.

3.24Proposal - Offer made by an organization in response to an invitation to satisfy a contract award to provide product.

3.25Positive Recall System - The ability to recall (for any reason – including the need to release for production prior to inspection) material or product when it has been released to production under the condition that the material or product may need to be captured and isolated at a later time.

3.26Quality - The degree to which requirements are met.


3.27Quality Audits - A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives.

3.28 Quality Assurance - Part of quality management focused on providing confidence that requirements will be fulfilled.

3.29Quality Control - Part of quality management focused on fulfilling quality requirements.

3.30Quality Management - Coordinated activities to direct and control an organization with regard to Quality.

3.31Quality Plan - Document specifying which procedures and associated resources shall be applied by whom and when to a specific project, product, process or contract.

3.32Quality Planning - Part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfill the quality objectives.

3.33Quality Policy - Overall intentions and direction of an organization related to Quality as formally expressed by top Management.

3.34Quality Records - Documentation of those activities wherein records of those activities must be maintained as specified in procedures or work instructions.

3.35Quality System - Organizational structure, procedures, processes, and resources needed to implement quality management.

3.36Quote - See “tender.”

3.37 Rework - Action on a non-conforming product to make it conform to the requirements, or as otherwise, instructed by the Customer.

3.38Specification - Document stating requirements. A specification includes drawings or other related documents and indicates the means and the criteria where conformity can be checked.

3.39Subcontractor - Organization that provides a product to the supplier (e.g., shot peening).

3.40Supplier - An organization that provides materials or information to DATUM Technologies.

3.41Tender (Quote) – Offer made by a supplier in response to an invitation to satisfy a contract award to provide product.


3.42Traceability - Ability to trace the history, application or location of that which is under consideration.

3.43Verification – Conformation, through the provision of objective evidence, that specified requirements have been fulfilled.Notes:1. A product may include processed material, assemblies or combination

thereof.

2. A product can be tangible (e.g., assemblies or processed material) or intangible (e.g., knowledge or concepts), or a combination thereof

As related to DATUM Technologies, the sale, manufacture and distribution of precision machined components for the Test and Measurement, Semiconductor, Medical and Aerospace Industries “product”.

3.44Abbreviations ANSI American National Standards Institute AS Aerospace Standard ASQ American Society for Quality BOP Blanket Order Protocol CAD Computer Aided Design CAM Computer Aided Manufacturing CAR Corrective Action Request CNC Computer Numerical Control ISO International Organization for Standardization MRB Material Review Board MRP Material Resource Planning NCR Non-Conformance Report NPI New Product Introduction OP Machine Operation OSP Outside Processing OTS Operator Time Sheet PDCA Plan, Do, Check, Act QA Quality Assurance RMA Return Material Authorized SPC Statistical Process Control S/T Shop Traveler WC Work Center(s)


4.0 QUALITY MANAGEMENT SYSTEM

4.1 General Requirements

DATUM Technologies has established, documented, implemented and maintains a Quality Management System in accordance with the requirements of ISO 9001 and AS9100 as a means of ensuring that product conforms to specified customer requirements. The Quality Management System is monitored for effectiveness and continual improvement opportunities. DATUM Technologies continuously seeks to improve the effectiveness of its quality system in order to address both customer and company needs.

DATUM TECHNOLOGIES:

Has identified the processes needed for the Quality Management System and its application throughout the organization.

Has determined the sequence and interaction of these processes. Has determined the criteria and methods needed to ensure that both the

operation and control of these processes are effective. Is ensuring the availability of resources and information necessary to support

the operation and monitoring of these processes. Is monitoring, measuring, and analyzing these processes. Is implementing actions as necessary to achieve planned results and continual

process improvement.

DATUM Technologies occasionally outsources a number of processes. Outsource quality is monitored and controlled through the Supplier Management Process and by incoming material inspections.

Note: QMS Processes include Management Activities (1), Review and Planning (2), Purchasing (3), Product Realization and Measurement (4), as described on the Flow Chart in Appendix A.

See appendix A for a description of the processes and their interaction and interfaces.

4.2 Documentation Requirements4.2.1 General

DATUM Technologies includes the following documents in its Quality Management System:


a. Statements of the Quality Policy (see Section 1.4) and Quality Objectives (see Section 5.4.1). Key objectives are stated in the Quality Policy.

b. This Quality Manualc. Procedures (established, documented, implemented and

maintained) as required by ISO 9001 and AS9100d. Documents, including records, needed by DATUM Technologies to

ensure the effective planning, operation and control of its processes records required by the ISO 9001 and AS9100 standards

e. Quality system requirements imposed by the applicable regulatory authorities

DATUM Technologies employees have access to Quality Management System (QMS) Documentation and are made aware or relevant procedures through regular training. Customer and/or regulatory authorities may have access to DATUM Technologies QMS documentation when requested.

4.2.2 Quality ManualDATUM Technologies has prepared and maintains a Quality Management System (QMS) in accordance with the ISO 9001 and AS9100 Standards except for exclusions noted in Section 1.1.2.

This manual contains:

a. The scope of DATUM Technologies QMS, including details for exclusions (see Section 1.1.2)

b. References to the quality management system procedures.c. A description of the interaction of processes within the quality

management system.

4.2.3 Control of DocumentsDocuments specified within DATUM Technologies’ Quality System are controlled (examples: drawings, specifications, work instructions, job records, Quality Manual, purchase orders, contracts, etc.). (See Section 4.2.4 for record control). DATUM Technologies Quality System documentation provides for:


a. Determination of document adequacy prior to useb. Review, update, and re-approval of documents as required c. Document change management (revision status of documents are

identified)d. Availability of correct document versions and revisions at points of

usee. Maintenance of legible and identifiable documentsf. External origin documents are identified, and their distribution is

controlledg. Prevention of obsolete documents from being used – including

identification of these documents, if retained

DATUM Technologies coordinates document changes with customers and/or regulatory authorities in accordance with contract or regulatory requirements as appropriate.

4.2.4 Control of RecordsDATUM Technologies maintains records to provide evidence of conformity to requirements including the effective operation of the Quality Management System. Typically, quality records are maintained for at least two years unless otherwise specified by the customer or DATUM Technologies. Records are maintained in a manner to prevent damage and allow for easy access in the Document Control Department. Quality records are available for customer and regulatory review when requested.

DATUM Technologies documented procedures define the method for controlling records that are created by and/or retained by suppliers.

Operation Procedure Manual References:

Control of Documents Procedure Control of Records Procedure

4.3 Configuration Management

DATUM Technologies is not currently engaged in the design or development of products, but rather manufactures component parts from furnished customer designs and established configurations as controlled by its customers. DATUM Technologies product


configuration shall be in accordance to customer contractual requirements. Processes described within the DATUM Technologies Quality Manual and Procedures provide additional configuration support (contract review, document control, process control, change control, change control processes, traceability, product marking, and maintenance of supporting records, quality control process, and other).

5.0 MANAGEMENT RESPONSIBILITY 5.1 Management Commitment

DATUM Technologies management team is committed to the development and implementation of the Quality Management System and to its continual improvement. This commitment is demonstrated by:a. Communicating the importance of meeting customer expectations (and

legal and regulatory requirements) through regular employee meetings and training.

b. Establishment and communication of a Quality Policy (see Sections 1.4 & 5.3).

c. Establishing and communicating Quality Objectives (see Section 5.4.1).d. Conducting regular (documented) management reviews of the quality

system (see Section 5.6).e. Ensuring that adequate resources are made available (see Sections

5.6.3 & 6.0).

5.2 Customer Focus

Customer focus is a critical management responsibility. DATUM Technologies management team ensures that customer requirements are determined, communicated, and met so that customer satisfaction may be enhanced, (See Sections 7.2.1 & 8.2.1). The intent of all the policies,


objectives and processes described in this Quality Manual and its associated documents, is to provide a mechanism (Quality Management System) for consistently fulfilling customer requirements and expectations, and thereby fostering increased Customer Satisfaction.

Top Management has taken steps to assure the measurement of product conformance and on-time delivery and to take appropriate action when planned results are not, or will not be achieved.

5.3 Quality Policy

Top Management ensures that the Quality Policy:a. Is appropriate to the purpose and objectives of DATUM Technologiesb. Indicates a commitment to comply with customer requirements and

implies a commitment to continual improvement (customer “implied requirements”)

c. Provides a framework for establishing and reviewing Quality Objectivesd. Is communicated and understoode. Is reviewed for continuing suitability

The management team is responsible for communicating the Quality Policy to all employees. The Quality Policy is reviewed at least annually for continuing suitability. DATUM Technologies’ Quality Policy is stated in Section 1.3 of this Quality Manual.

DATUM Technologies’ management is committed to continual improvement of its Quality Management System. As a minimum, the following elements are used to identify opportunities for improvement (see Section 8.5.1):

Relevant Quality Policy which focuses on customer needs Identification, documentation, and performance measuring of Quality

Objectives Use of internal and external quality audits Analysis of appropriate quality related data Corrective and preventive action initiatives Regular management review of the quality system Customer feedback


Employees at all levels of the organization are expected to fulfill the requirements of this policy in all work-related decisions and efforts.

5.4 Planning

5.4.1 Quality ObjectivesTop management establishes measurable Quality Objectives at relevant levels that are consistent with the Company’s Quality Policy and/or customer expectations and Product Realization (see Section 7.1). These objectives are communicated to relevant functions and levels within the organization and through regular company meetings. The key Quality Objectives are embedded in the Quality Policy. Appropriate measures provide feedback on quality performance and point to areas that present opportunities for improvement.

Our Quality Objectives are: Increase and maintain customer satisfaction Meet sales and operating goals Maintain on-time delivery Provide innovative products and technology Provide quality and reliable products

5.4.2 Quality Management System Planning

Top management ensures that:a. Appropriate planning is carried out so that both the General

Requirements, as indicated in Section 4.1 and DATUM Technologies’ Quality Objectives (see Section 5.4.1), are met

b. The integrity of the QMS is maintained when changes to the Quality Management System are planned and implemented

5.5 Responsibility, Authority and Communication


5.5.1 Responsibility and Authority

Top management ensures that responsibilities and authorities are defined and communicated within the organization. This is accomplished through the use of organizational charts, job descriptions, work instructions, job reviews and other means as appropriate. Appropriate distribution of related documents and associated training assures clear communication of this information.

5.5.2 Management Representative

The Quality Assurance Manager (designated Management Representative) has the responsibility and authority to:a. Establish, implement and maintain Quality Management System

processes as appropriateb. Report to top management on Quality Management System

performance and improvement needsc. Ensure that customer needs are well known within DATUM

Technologiesd. Organizational freedom and unrestricted access to Top

Management to freely resolve matters pertaining to quality

The management representative interfaces with outside parties (customers, vendors, etc.) on quality and QMS issues as appropriate.

5.5.3 Internal Communication

Top management ensures that appropriate communication processes exist so that the effectiveness of the Quality Management System is communicated. These processes include the posting of quality performance data, quality meetings, monthly communication meetings, and other means as appropriate.

5.6 Management Review

5.6.1 GeneralThe DATUM Technologies’ Management Staff reviews the Quality Management System annually to ensure its continued suitability and effectiveness in satisfying the requirements of ISO 9001 /AS9100 and DATUM Technologies stated Quality Policy and Quality Objectives. The review includes assessment of opportunities for improvement


and changes needed. Records of the Management Reviews are maintained by the Document Control Department (see Section 4.2.4).

5.6.2 Review InputInput to the Management Review Process shall consist of, but not

limited to:a. Results from internal and external auditsb. Customer feedbackc. Process performance information & product conformityd. The status of corrective and preventive actionse. Follow-up actions from previous Management Reviewsf. Any changes that could impact the Quality Management Systemg. Recommendations for improvementh. Resource requirements

5.6.3 Review OutputOutput from the Management Review Process shall include, but not be limited to, decisions and actions concerned with:a. Improvement of the effectiveness of the Quality Management

System and related processesb. Product improvement based on customer needsc. Resources needed for continual improvement initiatives

6.0 RESOURCE MANAGEMENT

6.1 Provision of ResourcesQuality Manual/ Revision G Page 28

DATUM Technologies’ top management determines and provides the resources

needed to:a. Implement, maintain and continually improve the effectiveness of the

Quality Management System (QMS)b. Enhance customer satisfaction by meeting or exceeding the customer’s

stated or implied requirements

The Company officers assess the need for resources to support the goals and objectives of the company. Resource needs are conveyed to the President of DATUM Technologies during the budgeting process and as needs for additional resources becomes apparent. Resources are allocated based on customer needs and company objectives. Resource needs are also discussed in the Management Review (see Section 5.6.3)

6.2 Human Resources

6.2.1 GeneralDATUM Technologies employees are certified as competent based on:

Education Training Demonstration of skills Experience

The record of certification is contained in the individual employee file folder.

Requirements for education, experience and training are documented in DATUM Technologies’ Job Descriptions. Those employees who have not achieved certification are classified as trainees or apprentices, and will be closely supervised by a certified employee.


6.2.2 Competence, Awareness and Training

DATUM Technologies utilizes the following process to ensure competence:

a. Determines required competency needs for employees who affect product quality through evaluation of customer requirements, company objectives, and through creation of work procedures and job descriptions.

b. Provides training or takes actions as necessary to satisfy competency needs.

c. Evaluates the effectiveness of actions taken.d. Ensures that employees are aware of how their activities impact

company Quality Objectives.e. Maintains appropriate education, training, skills, experience, and

certification records.

6.3 Infrastructure

DATUM Technologies’ top management identifies, provides, and maintains the infrastructure needed to achieve conformance to product specifications. Infrastructure includes items such as:

a. Buildings, workspace, required utilitiesb. Process equipment (hardware & software)c. Supporting services such as transport, communication, or information

systems

Infrastructure needs are formally identified during the budgeting process, Management Review or as needs arise.

6.4 Work environment

DATUM Technologies considers and addresses the major aspects of the work environment that impact product quality such as: health and safety, work methods, temperature/air conditioning/humidity/ventilation, lighting, facility maintenance, cleanliness/housekeeping, and employee relations.


7.0 PRODUCT REALIZATION

7.1 Planning of Product Realization

DATUM Technologies plans and develops processes needed for Product Realization that are consistent with other Quality Management System processes (see Section 4.1). As part of this planning process, the following are determined as appropriate:

a. Quality Objectives and Product Requirements (see Section 5.4.1)Note: Quality Objectives and requirement for the product include, as appropriate Product and personal safety Reliability, maintainability and availability Productibility and inspectability Suitability of parts and materials used in products Selection and development of embedded software Recycling or final disposal of the product at the end of life

b. Need for product-specific processes, documents and resourcesc. Need for product-specific requirements for verification, validation,

monitoring, inspection and test activities, and product acceptance criteria

d. Records, as appropriate, that provide evidence that the realization processes and resulting product meet requirements (see Section 4.2.4)

e. Configuration management appropriate to the productf. Resources to support the use and maintenance of the product

Quality planning is documented in the DATUM Technologies QMS, production routers, and as otherwise required based on Customer/product needs.

7.1.1 Project ManagementAs appropriate to DATUM Technologies and our products, we plan and manage product realization in a structured manner to meet requirements at acceptable risk within resource and schedule constraints.


7.1.2 Risk ManagementDATUM Technologies has established and maintains a process for minimizing risk to the achievement of applicable requirements that includes as appropriate to DATUM Technologies and the product:

a. Assignment of responsibilities for risk managementb. Definition of risk criteria (e.g., likelihood, consequences, risk

acceptance)c. Identification, assessment and communication of risks

throughout Product Realizationd. Identification, implementation, and management of actions to

mitigate risks that exceed the defined risk acceptance criteria e. Acceptance of risks remaining after implementation of

mitigating actions

7.1.3 Configuration ManagementDATUM Technologies has established, implemented and maintains a configuration process that includes, as appropriate to the product:

a. Configuration management planningb. Configuration identificationc. Change controld. Configuration status accountinge. Configuration audit

7.1.4 Control of Work TransfersDATUM Technologies has established, implemented, and maintains a process to plan and control the temporary or permanent transfer of work (e.g., from us to another organization, from us to a supplier, or from one supplier to another) and to verify the conformity of work to requirements.


7.2 Customer-related Processes

7.2.1 Determination of Product RequirementsDATUM Technologies determines the following requirements:a. Customer requirements including delivery and post-delivery

requirementsb. Unstated but necessary requirements for specified or intended

customer use, where knownc. Statutory and regulatory obligations related to the productd. Any other relevant requirements

Note: Requirements related to product can include special requirements.

7.2.2 Review of Product RequirementsDATUM Technologies reviews requirements related to customer products prior to commitment to supply the product to ensure that:a. Product requirements are definedb. Any changes from initial quotation are resolvedc. Requirements can be metd. Special requirements related to product are determinede. Risks (e.g., new technology, short delivery time scale) have

been evaluated

Records of review results and follow-up actions are maintained (seeSection 4.2.4).Verbal agreements are to be confirmed before acceptance. In the event requirements change, DATUM Technologies: Updates necessary documentation Notifies all affected personnel


7.2.3 Customer CommunicationDATUM Technologies has established and continually improves, as appropriate, its arrangements for communicating with customers in regards to: Product information Enquiries, contracts, order handling and contract amendments Customer feedback, including customer complaints

There are several communication channels between DATUM Technologies and its customers. The Sales Department is responsible for: literature, the DATUM Technologies internet site, routine customer visits, and contract issues. The Quality Department coordinates responses to customer complaints through the use of Corrective and Preventive Actions.

7.3 Design and DevelopmentDATUM Technologies is engaged in contract manufacturing of customer designed products. ISO 9001/AS9100 Sections 7.3.1 through 7.3.7 are therefore, excluded. (Section 1.1.2)

7.4 Purchasing7.4.1 Purchasing Process

DATUM Technologies has developed procedures to ensure materials, products and/or services purchased for deliverable products conform to the specified requirements of DATUM Technologies and/or its Customers.

DATUM Technologies assumes responsibility for the quality of all products purchased from suppliers, including Customer-designated sources unless contract stipulates otherwise.

DATUM Technologies suppliers are evaluated, selected, and re-evaluated based on their ability to supply products in accordance to specified requirements. DATUM Technologies uses incoming inspection to verify that purchased product conforms to specified purchase requirements. Supplier quality records including evaluations and any resulting actions are maintained.

Note: The selection of suppliers can include factors, as appropriate, such as the Online Aerospace Suppliers


Information System Database, NADCAP and Government Sources. These sources are to be used as one (1) factor in supplier selection.

DATUM Technologies:a. Maintains a register of approved suppliers that includes the

scope of the approvalb. Periodically reviews supplier performance – records of these

reviews shall be used as a basis for establishing the level of controls to be implemented

c. Defines the necessary actions to take when dealing with suppliers that do not meet requirements

d. Ensures, where required, that both DATUM Technologies and all suppliers use customer-approved special process sources when indicated

e. Ensures that the function having responsibility for approving supplier quality systems has the authority to disapprove the use of sources

f. Determine and manage risk when selecting and using suppliers

7.4.2 Purchasing InformationPurchasing documents shall contain data clearly describing the product ordered, including where applicable:

a. Requirements for approval of product, procedures, processes and equipment

b. Requirements for qualification of personnelc. Quality Management System requirementsd. The name, or other positive identification, and applicable

issues of specifications, drawings, process requirements, inspection instructions and other relevant technical data

d. Requirements for design, test, examination, inspection and related instructions for acceptance by DATUM Technologies

e. Requirements for test specimens (e.g., production method, number, storage conditions) for design approval, inspection, investigation or auditing

f. Requirements relative to: Supplier notification to DATUM Technologies of non-

conforming product


Arrangements for DATUM Technologies approval of supplier non-conforming material

g. Requirements for the supplier to notify DATUM Technologies of changes in product and/or process definition and, where required, obtain DATUM Technologies approval

h. Right of access by DATUM Technologies, our customer, and regulatory authorities to all facilities involved in the order and to all applicable records

i. Requirements for the supplier to flow down to sub-tier suppliers the applicable requirements in the purchasing documents, including key characteristics where required

DATUM Technologies reviews and approves purchasing documents for adequacy prior to release. Technical and quality support is provided, as necessary.

7.4.3 Verification of Purchased ProductDATUM Technologies maintains quality processes as necessary to ensure that purchased product meets specified purchase requirements.

Verification activities may include:

Obtaining objective evidence of the quality of the product from suppliers (e.g., accompanying documentation, certificate of conformity, test reports, statistical records, process control)

Inspection and audit at supplier’s premises Review of the required documentation Inspection of products upon receipt Delegation of verification to the supplier, or supplier

certification


DATUM Technologies does allow the release of purchased product prior to the completion of verification activities.

Purchased material shall be conformance verified prior to processing or using.

When test reports are used to verify purchased product, the report data shall be acceptable per the applicable specifications. DATUM Technologies will periodically validate test reports for raw material (as appropriate based on product and customer requirements).

If verification is delegated to the supplier, the requirements for delegation shall be defined and a register of delegations maintained. (See QM 3.1.12 for additional information).

Where DATUM Technologies or its customer proposes to verify purchased product at the supplier’s premises, DATUM Technologies shall specify verification arrangements and the method of product release in the purchasing documents.

Where specified in the contract, DATUM Technologies customer or customer representative shall be afforded the right to verify at the supplier’s premises and/or DATUM Technologies’ premises that the subcontracted product conforms to specified requirements.

Verification by the customer shall not be used by DATUM Technologies as evidence of effective control of quality by the supplier and shall not absolve DATUM Technologies of the responsibility to provide acceptable product, nor shall it preclude subsequent rejection by the customer.

Verification activities can include: Obtaining evidence of conformity of the product from the

supplier Inspection and audit at the supplier’s premises Review of required documentation Inspection of products upon receipt Delegation of verification to the supplier or supplier

certification

7.5 Production and Service ProvisionQuality Manual/ Revision G Page 37

DATUM Technologies does not presently engage in servicing (see Section 1.1.2). Should servicing become a specified requirement, DATUM Technologies will establish and maintain documented procedures for performing, verifying, and reporting that the servicing meets the specified requirements.

7.5.1 Control of ProductionProduction planning considers as applicable: The establishment of process controls and development of

control plans for critical items where key characteristics have been identified (see Section 3.1.13)

The identification of in-process verification points when adequate verification of conformance cannot be performed at a later stage of realization

The design, manufacture, and use of tooling so that variable measurements can be taken, particularly for key characteristics

Special processes (see Section 7.5.2)

DATUM Technologies identifies and plans the production processes which directly affect quality and ensures that these processes are carried out under controlled conditions. These controlled conditions shall include, as applicable:a. Availability of product characteristics information, such as,

drawings and specificationsb. Availability of documented work instructions, such as, shop

travelersc. Use of suitable equipmentd. Availability and use of suitable monitoring and measuring devicese. The implementation of monitoring and measurement processes as

necessaryf. The implementation of release, delivery and post-delivery activities

such as inspection processes, shipping instructions, and warranty policies


g. Accountability for all product during manufacture (e.g., parts quantities, split orders, non-conforming product)

h. Evidence that all manufacturing and inspection operations have been completed as planned, or as otherwise documented and authorized

i. Provision for the prevention, detection, and removal of foreign objects

j. Monitoring and control of utilities and supplies such as water, compressed air, electricity to the extent they affect DATUM Technologies product quality

k. Criteria for workmanship, which shall be stipulated in the clearest practical manner (e.g., written standards, representative samples or illustrations)

7.5.1.1 Production Process Verification

DATUM Technologies production operations are carried out in accordance with approved data. This data shall contain as necessary:a. Drawings, parts lists, process flow charts including

inspection operations, production documents (e.g., manufacturing plans, traveler, router, work order, process cards); and inspection documents (see Section 8.2.4.1),

b. A list of specific or non-specific tools and numerical control (NC) machine programs required and any specific instructions associated with their use

c. The first production part is used to verify that the production process, production documentation, and tooling are capable of producing parts and assemblies that meet requirements. When changes are encountered the first production part is re-inspected. When that inspection is accepted the production may continue whether it is the first piece produced or after a change.

7.5.1.2 Control of Production Process Changes Persons authorized to approve changes to production processes have been identified.

DATUM Technologies shall identify and obtain acceptance of changes that require customer and/or regulatory authority approval in accordance with contract of regulatory requirements.


DATUM Technologies documents changes affecting processes, production equipment, tools and software programs. Procedures are available to control their implementation.

DATUM Technologies assesses the results of production process changes to confirm that the desired affect has been achieved without adverse effects to product quality.

7.5.1.3 Control of Production Equipment, Tools and Numerical Control (NC) Machine Programs

DATUM Technologies production equipment, tools and programs shall be validated prior to use and maintained and inspected periodically according to documented procedures. Validation prior to production use shall include verification of the first article produced to the design data/specification.

Storage requirements, including periodic preservation/condition checks, shall be established for production equipment or tooling in storage.

7.5.1.4 Post Delivery Support - Excluded (Section 1.1.2)

7.5.1.5 Control of Work Transferred, on a Temporary Basis, Outside DATUM Technologies Facilities:DATUM Technologies defines the process to control and validate the work quality in the event of a temporary transfer work to a location outside its facility.

7.5.2 Validation of Processes for Production - Excluded (Section 1.1.2)

7.5.3 Identification and TraceabilityDATUM Technologies has developed procedures for identifying the product by suitable means from material receipt and during all stages of production, delivery, and installation. Materials and drawing revision levels are traceable for deliverable product.


Product configuration identification, as supplied by the Customer or DATUM Technologies standards, may be used to trace any differences that might exist between the actual configuration and the agreed configuration. These differences will normally be documented in Customer engineering or Purchase Order change notices, NCRs, router notes and other documents as applicable.

Where and to the extent that traceability is a specified requirement, DATUM Technologies has developed procedures for unique identification of individual product or batches. This identification is recorded in accordance with the applicable DATUM Technologies Operations Procedures.

When acceptance authority media are used for acceptance of product (e.g., stamps, electronic signatures, and passwords), DATUM Technologies has established and documented controls for the media used.

According to the level of traceability required by contract, regulatory, or other established requirement, DATUM Technologies system provides for: Identification to be maintained throughout the product life

(marking is specified by DATUM Technologies Customers as appropriate for their applications)

All products manufactured from the same batch of raw material or from the same manufacturing batch to be traced, as well as the destination (delivery, scrap) of all products of the same batch

For an assembly, the identity of its components and those of the next higher assembly are traced

For a given product, a sequential record of its production (manufacture, assembly, inspection) to be retrieved

7.5.4 Customer Property

DATUM Technologies had developed procedures for the identification, verification, storage, and maintenance of customer-supplied product that is provided for the manufacturing of their goods (including intellectual property and confidential information). Any such product that is lost, damaged, or otherwise unsuitable for use will be recorded and reported to the customer. Customer property can include


intellectual property, including customer furnished data used for production and/or inspection.

7.5.5 Preservation of Product

DATUM Technologies has developed procedures for the identification, handling, storage, packaging, preservation, and delivery of products including their constituent parts.

Handling - DATUM Technologies provides methods of handling product that prevent damage or deterioration.

Storage - DATUM Technologies has designated storage areas and stock rooms to prevent damage or deterioration of product, pending use or delivery. Appropriate methods of authorizing receipt to and dispatch from such areas is stipulated. In order to detect deterioration, the conditions of product in stock are assessed at appropriate intervals.

Packing - DATUM Technologies controls packing, packaging, and marking processes (including materials used) to the extent necessary to ensure conformance to specified requirements.

Preservation - DATUM Technologies applies appropriate methods for preservation and segregation of product when the product is under DATUM Technologies control.

Delivery - DATUM Technologies arranges for the protection of the quality of product after final inspection and test. Where contractually specified, this protection will be extended to include delivery to destination.

Preservation of product includes, as applicable in accordance with product specifications and/or applicable regulations, provisions for:

a. Cleaningb. Prevention, detection and removal of foreign objectsc. Special handling for sensitive productsd. Marking and labeling including safety warningse. Shelf life control and stock rotationf. Special handling for hazardous materials


DATUM Technologies ensures that documents required by the contract to accompany the product are present at delivery and are protected against loss and deterioration.

7.6 Control of Monitoring and Measuring Devices

DATUM Technologies determines the monitoring and measurement activities and devices required as necessary to provide evidence of product conformity to requirements.

DATUM Technologies maintains a register of these monitoring and measuring devices, and defines the process employed for their calibration including details of equipment type, unique identification, location, frequency of checks, check method and acceptance criteria. DATUM Technologies maintains calibration records of inspection, measuring and test equipment.

Monitoring and measuring devices may include (but not limited to): test hardware, test software, automated test equipment (ATE) and plotters used to produce inspection data. It also includes personally owned and customer supplied equipment used to provide evidence of product conformity.

DATUM Technologies determines the measurements to be made and the accuracy required, and selects the appropriate inspection, measuring, and test equipment that is capable of the necessary accuracy and precision.

DATUM Technologies ensures that the environmental conditions are suitable for the calibrations, inspections, measurements, and test being carried out.

To ensure valid results, DATUM Technologies:a. Identifies all inspection, measuring, and testing equipment that can

affect product quality, and calibrates and adjusts them at prescribed intervals, or prior to use, against certified equipment having a known valid relationship to internationally or nationally recognized standards. Where no such standards exist, the basis used for calibration is documented;

b. Defines the process employed for the calibration of inspection,measuring, and test equipment, including details of equipment type, unique identification, location, frequency of checks, check method,


acceptance criteria, and the action to be taken when results are unsatisfactory;

c. Identifies inspection, measuring, and test equipment with a suitable indicator or approved identification record to show the calibration status;

d. Safeguards inspection, measuring, and test facilities, including both test hardware and test software, from adjustment which would invalidate the calibration setting;

e. Ensures that the handling, preservation, and storage of inspection, measuring, and test equipment are such that the accuracy and fitness for use are maintained.

DATUM Technologies assesses and documents the validity of previous inspection and test results when inspection, measuring, and test equipment are found to be out of calibration (appropriate action will be taken on equipment and any product affected by out-of-calibration devices).

When applicable, DATUM Technologies ensures that, prior to use, monitoring and measurement software is validated.

8.0 MEASUREMENT, ANALSYSIS AND IMPROVEMENT

8.1 General

DATUM Technologies plans and implements the monitoring, measurement, analysis and improvement processes as needed to:a. Ensure that products meet requirementsb. Ensure conformity of the Quality Management System requirementsc. Continually improve the effectiveness of the Quality Management

System

As part of the quality planning process, DATUM Technologies determines the applicable methods, including statistical techniques, to support product conformance and the continual improvement effort.

Depending on the product nature and specified requirements, statistical techniques may be used to support:


Design verification (e.g., reliability, maintainability, safety) – unless specifically called out in the contract, this is a Customer function.

Process control Selection and inspection of key characteristics Process capability measurements Statistical process control Design of experiment

Inspections – matching sampling rate to the criticality of the product and to the process capability

Failure mode and effect analysis

8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction

Information regarding customer satisfaction and perceptions of DATUM Technologies performance is vitally important to the continual improvement and resource provision processes. Methods for determining whether or not the customer’s requirements have been met have been determined.

The information to be monitored to evaluate customer satisfaction includes, but is not limited to, product conformity, on-time delivery performance, customer complaints and corrective action requests. DATUM Technologies has developed a process for the development and implementation of plans to improve customer satisfaction when deficiencies are identified by these evaluations and the effectiveness of the results.

Key DATUM Technologies personnel are also available to its customers via direct telephone, FAX, or E-mail contact.

8.2.2 Internal Audit


DATUM Technologies conducts regularly scheduled internal audits of its Quality Management System to ensure that:

a. The Quality Management System conforms to its written documentation and the ISO and AS9100 Standards.

b. The Quality Management System is effectively implemented and is being maintained.

c. The audit process is based on the status and significance of the audit area and previous audit results. Audit criteria, scope, frequency and methods are defined, and the appointment of internal auditors is such that objectivity and impartiality is ensured.

d. Datum Technologies may choose to outsource Internal Audits.

The audit schedule also includes customer contractual arrangements.

DATUM Technologies has well-defined procedures regarding the selection, training, and expectations of internal auditors. Procedures include: planning audits, reporting results, and record maintenance. At a minimum, all quality system elements are audited once per year. The audit schedule will be adjusted as necessary by the Management Representative based on audit results and other corrective action activities. When appropriate, internal audits may be outsourced to qualified consultants.

When deficiencies are found, the management responsible for the affected area ensures that action is taken in an appropriate timeframe. Follow-up activities are conducted to verify actions taken, and the verification results are documented.

DATUM Technologies has developed tools and techniques such as check sheets, process flowcharts, or similar methods, as appropriate to support audits of the Quality Management System requirements. Where audits are contracted to others, similar tools are used. Acceptability of these tools and techniques will be measured against the effectiveness of the internal audit process and overall organization performance.

Operations Manual Reference: Internal Auditing Procedure


8.2.3 Monitoring and Measurement of Processes

DATUM Technologies has established methods including the monitoring and measurement, as appropriate, of key Quality Management System processes that impact customer expectations such as product conformance. When planned results are not achieved, appropriate corrective action is taken to ensure product conformity

In the event of process non-conformity, the organization shall:

a. Take appropriate action to correct the non-conforming process

b. Evaluate whether the process non-conformity has resulted in product non-conformity

c. Determine whether the process non-conformity is limited to a specific case or whether it could have affected other processes or products

d. Identify and control the non-conforming product in accordance with clause 8.3

8.2.4 Monitoring and Measurement of Product

DATUM Technologies has documented procedures regarding the measurement of product characteristics at various stages of production to ensure that customer requirements are achieved. When key characteristics have been identified, they are monitored and controlled with established processes, as appropriate.Measurement requirements have been documented and

include:a. Criteria for acceptance and/or rejectionb. Where in the sequence inspection and testing are performedc. Required records of measurement resultsd. Any specific measurement instruments required and any

specific instructions associated with their use

When DATUM Technologies uses sampling inspection as a means of product acceptance, the plan shall be statistically valid and appropriate for use. Lots whose samples have known non-conformities will not be accepted. When required, sampling plans shall be submitted for customer approval.


Product shall not be used until it has been inspected or otherwise verified as conforming to specified requirements, unless the product is released under a positive-recall procedure pending completion of all required measurements and monitoring activities.

Evidence of conformity with requirements, including those authorizing shipment, is documented in the Quality Records.

All required documents required to be delivered with the product shall be included in the shipment to the customer.

Unless customer-approved, products are not released until required activities have been satisfactorily completed.

e. Inspection Documentation:Measurement requirements for product acceptance shall be documented (may be part of the production documentation) and shall include: Criteria for acceptance and/or rejection Where in the sequence measurement and testing

operations are performed A record of the measurement results Type of measurement instruments required and any

specific instructions associated with their use. (Specific instruments and instructions, when applicable, will be specified in the production router, otherwise, instruments are appropriately selected by qualified employees according to the feature properties. Other arrangements will be according to customer requirements).

Test records shall show actual test results data when required by specification or acceptance test plan. Where required to demonstrate product qualification, DATUM Technologies will ensure that records provide evidence that the product meets the defined requirements.

8.3 Control of Non-Conforming ProductQuality Manual/ Revision G Page 48

DATUM Technologies has documented procedures that provide for the identification, controlling, and processing of non-conforming materials/products (including customer returns) to avoid unintended use or delivery.

DATUM Technologies’ documented procedure defines the responsibility for review and authority for the disposition of non-conforming product and the process for approving personnel making these decisions.

In the event non-conformity is found, DATUM Technologies will either:

a. Eliminate the non-conformity so that customer requirements are achieved.

b. Obtain authorization for acceptance by the appropriate authority, including the customer.

c. Scrap, return to customer as appropriate, or otherwise salvage – (to preclude original intended use).

d. Take action appropriate to the effect, or potential effects, of the non-conformity when non-conforming product is detected after delivery or use has started.

e. DATUM Technologies will take action to contain the effect of the non-conformity on other processes or products.

DATUM Technologies does not use dispositions of use-as-is or repair, unless specifically authorized by the Customer, if:

The product is produced to customer design, or The non-conformity results in a departure from the contract

requirements Only a person from the customer responsible for the design may

authorize a use-as-is or repair disposition

Product dispositioned for scrap is conspicuously and permanently marked, or positively controlled, until physically rendered unusable.

Records of non-conformities, concessions and any actions taken are maintained.

Reworked products are re-verified to demonstrate conformance.

DATUM Technologies will take appropriate action related to any non-conformance detected after delivery.


In addition to any contract or regulatory authority reporting requirements, DATUM Technologies system provides for timely reporting of delivered non-conforming product that may affect reliability or safety. Notification shall include a clear description of the non-conformity, which includes as necessary parts affected, customer and/or organization part numbers, quantity, and date(s) delivered. (Parties requiring notification of non-conforming product may include suppliers, internal organizations, customer, distributors, and regulatory authorities).

Operations Manual Reference: Control of Non-Conforming Product Procedure

8.4 Analysis of Data

DATUM Technologies identifies, collects and analyzes process data (measures), as appropriate, to:

Demonstrate the suitability and effectiveness of the Quality Management System

Identify opportunities for continual improvement in the effectiveness of the Quality Management System

Additionally, DATUM Technologies analyzes monitoring and measurement data from other sources such as customer quality reports.

Process data is analyzed to determine:a. Customer satisfaction (Section 8.2.1)b. The degree customer requirements are met (Section 7.2.1)c. Characteristics and trends 0f processes and products that point to the

need for corrective or preventive actiond. Supplier performance

Based on analysis of all data, appropriate improvement initiatives are established.


8.5 Improvement

8.5.1 Continual ImprovementDATUM Technologies uses the following to continually improve the effectiveness of its Quality Management Process:

Quality Policy Quality Objectives Audit Results Data Analysis Corrective and Preventive Actions Management Review Process Lessons Learned, problem resolution, and benchmarking best

practices

DATUM Technologies monitors the implementation of improvement activities in order to evaluate the effectiveness of the results.

8.5.2 Corrective ActionDATUM Technologies takes appropriate action(s) to eliminate causes of non-conformities to prevent recurrence. Corrective actions are established to be appropriate to the effects of the non-conformities encountered.

`Documented procedures have been established that provide for: a. Identification and review of non-conformities (Customer NCRs may

be used to document non-conformities and general complaints. Complaints may also be communicated via FAX, E-mail, telephone, DATUM Technologies -generated customer surveys, or directly to the assigned account representative)

b. Determination of root causesc. Evaluation of actions to prevent recurrenced. Identification and implementation of effective corrective actionse. Recording results of actions taken (see Section 4.2.1)f. Review of corrective action taken for effectiveness


g. Flow down of the corrective action requirement to a supplier, when it is determined that the supplier is responsible for the root cause non-conformity

h. Specific action when timely and/or effective corrective actions are not achieved

i. Determining if additional non-conforming product exists based upon the causes of non-conformities and taking further action, when required

Operations Manual Reference: Corrective and Preventive Action Procedure

8.5.3 Preventive ActionDATUM Technologies determines needed actions to eliminate the causes of potential non-conformities in order to prevent their occurrence. Preventive actions are appropriate to the effects of the potential problems identified.

These procedures provide for:a. Determining potential non-conformities and their causes.b. Evaluation of the need for action to prevent occurrence of non-

conformities.c. Determination and implementation of actions needed.d. Recording of results for action taken (see Section 4.2.4).e. Review of preventive actions taken for effectiveness.

Sources of preventive action may come from risk management, error proofing, FMEA, and information based on product problems from external sources.

Operations Manual Reference: Corrective and Preventive Action Procedure


Appendix A


Appendix A


Revision History:


6/29/2012Initial Release as draft 1 8/16/2012Incorporate original red line mark-ups 3/14/2013Rev. E, Initial Release incorporating AS9100 Requirements 4/02/2013Rev. F, Corrections and additions to Initial Release of Rev. E 4/19/2013Rev. G, Corrections made after Stage 1 of AS9100 Audit
