FLW QUALITY MANUAL

APPROVAL SIGNATURES

Prepared by: ___________________________       Date: ____________

                        Lyell Kinney, Assistant to the Quality Manager

Approved:     ____________________________       Date: ____________

 Paul Peek,  President and Quality Manager

Approved:     ___________________________       Date: ____________

Dale Henderson, Service Manager  & ISO Management Representative

Document Change Record

1.0  SCOPE

This Quality Manual outlines the policies, procedures and requirements of the FLW Quality System.  FLW’s Quality System is structured to comply with the conditions set forth in the International Standard ISO 9002:1994 (ISO 9002), MIL-STD-45662A, AS -9000 and ANSI/NCSL Z540-1-1994 (Z540-1).

2.0  REFERENCES

2.1   International Standard ISO 8402:1994, Quality Management and Quality Assurance - Vocabulary.

2.2   International Standard ISO 9002:1994, Quality Systems - Model for Quality Assurance in Production, Installation and Servicing.

2.3   ISO 10012-1:1993-03-15, Quality Assurance Requirements for Measuring Equipment - Part 1.

2.4   ANSI/NCSL Z540-1-1994, Calibration Laboratories and Measuring and Test Equipment - General Requirements.

2.5   MIL-STD-45662A, Calibration Systems Requirements.

Note:  Items marked ( AS 9000) in this manual have been inserted to bring this quality system into compliance with AS9000 – Aerospace Basic Quality System Standard.

3.0  DEFINITIONS

3.1  For the purposes of this document, the definitions given in International Standard IS0 8402, Quality Management and Quality Assurance – Vocabulary, and the following definitions apply:

3.1.1  Customer-owned property - Any type of instrumentation, accessories, manuals, or shipping containers that belong to a customer.

3.1.2  Customer-supplied product - Any type of material provided to FLW to be incorporated  in the supplies for related activities.

3.1.3  Distribution Material - Distribution material is product which is FLW (company) owned and is used for resale.

3.1.4  Local Service Procedures - These are procedures written by FLW for calibration and repair on instrumentation which do not have written manufacture procedures or for clarification on existing written procedures.

3.1.5 Service Material - Service material is product (parts, components, assemblies, etc.) that is used to repair or modify distribution material or customer-owned property.

3.1.6 Material supplied by companies for whom FLW acts as Representative -  Material that is delivered directly to the customer from the original manufacturer and is not stocked, handled, stored, or processed by FLW and which is considered to be outside the FLW Quality System.

3.1.7  Special Process Procedures - Procedures written by the customer for calibration

modification or repair of their instrumentation that FLW is asked to service.

3.1.8  Key Characteristics – The features of a material or part whose variation has a significant influence on product fit, performance, service life, or manufacturability.

3.1.9  Regrade – A disposition of a nonconformity that (1) determines that the product is not acceptable for it’s original intended design, and (2) directs the product to be redesignated or modified for an alternate use.

3.1.10 – Customer – recipient of a product provided by the supplier.

3.1.11 – Supplier – organization that provides a product to the customer.  For the purposes of this Quality Manual, the supplier is F.L.W., Inc.

3.1.12 – Subcontractor – the organization that provides a product to the supplier.

3.1.13 – Product – a product may include service, hardware, processed materials, software, or a combination thereof.  A product may be tangible ( hardware) or intangible ( knowledge or concepts).

4.0  QUALITY-SYSTEM REQUIREMENTS

4.1  Management Responsibility

4.1.1  Quality Policy

FLW’s Quality Policy is “TO CREATE AND MAINTAIN A QUALITY SYSTEM OF CONTINUOUS IMPROVEMENT OF WORK PROCESSES FOCUSED ON CUSTOMER EXPECTATIONS.”

                                                         _____________________________

                                                                                          Paul Peek, President

This policy is relevant to FLW’s organizational goals and the expectations and needs of it’s customers.    It has been defined and documented by FLW management with executive responsibility.  This policy will be evaluated at least once a year by management to confirm that it’s suitability and effectiveness is being met.  It is management’s responsibility to ensure this policy is understood, implemented, distributed to and maintained at all levels of the organization.

4.1.2  Organization

4.1.2.1  Responsibility and authority

Personnel listed below and in related documents have the responsibility and authority to manage and verify the work affecting quality.  a) They have the freedom and authority to initiate action to prevent the occurrence of any nonconformity relating to the product, process or quality system; b) they have the responsibility to identify and record any problems relating to the quality process; c)  initiate, recommend or provide solutions; and d) verify the implementation of these solutions.  Further, they can;  e) control further processing or delivery of nonconforming product until any deficiency has been corrected.

The organization of FLW upper management with executive responsibility for quality is illustrated in Appendix D.

Detailed Sales and Service and Quality department organizational charts as well as

 responsibilities, authority and the interrelation of personnel are contained in documents FQD

101, FPD 205 and FPD 370

The President is responsible for the organizational structure, allocation of resources and the development of policies to ensure the implementation of FLW’s quality system and its conformance to ISO 9002:1994, MIL-STD 45662A and ANSI/NCSL  Z540-1-1994 requirements.

The Quality Assurance Manager is responsible for developing, directing and monitoring the quality system’s goals, procedures and policies.  The QA Manager is responsible for the coordination of all quality activities of the FLW organization.  The QA Manager reports directly to the president.

The Sales Department Office Manager is responsible for directing and monitoring the quality system goals, procedures and policies for Distribution and Representative sales and their associated purchasing, shipping, and receiving functions.  The Sales Department Office Manager reports directly to the president.

The Service Manager is responsible for directing and monitoring the quality system goals, procedures and policies for calibration/verification and repair, purchasing of required materials, and shipping , and receiving in the Laboratory and Service areas.  The Service Manager is responsible for maintaining the Laboratory’s compliance with MIL-STD-45662A, ANSI/ANCL Z 540-1 and ISO 9002:1994(E).

4.1.2.2   Resources

The personnel listed in Appendix D above shall identify resource requirements and provide adequate resources, including the assignment of trained personnel for management, performance of work and verification activities including internal quality audits.

4.1.2.3  ISO  Management Representative

FLW management with executive responsibility has designated the Service Manager as ISO  Management Representative with defined authority for:

a) Ensuring that an effective quality system is established, implemented and maintained in accordance with ISO 9002, MIL-STD-45662A and ANSI/NCSL Z540-1

b) Reporting on the performance of the quality system to FLW management for review and as a basis for improvement of the quality system. 

NOTE:  The responsibility of the ISO Management Representative also includes liaison with external parties on matters relating to the supplier’s quality system.

c) Ensuring that the requirements of the ISO standard are implemented, maintained and are effective.

d)  The ISO  Management Representative reports directly to the President.

4.1.2.4  Suppliers Responsibilities ( AS 9000)

When required by contract, suppliers having a quality assurance activity performed by an individual process owner (e.g., operator, buyer, planner) shall have procedures that define the specific tasks and responsibilities that are authorized and the corresponding requirements and training necessary to perform those tasks.

4.1.3 Management Review

Management with executive responsibility will make periodic reviews at all operational levels to assess the quality system’s continuing suitability and effectiveness in meeting the requirements of ISO 9002, MIL-STD-45662A, Z540-1and FLW’s stated Quality Policy.  These reviews will be held on a periodic basis.  Records of reviews will be maintained.

References:

FQD 100 - Management Review

4.2  Quality System

4.2.1  General

FLW has established, documented and maintains a Quality System to ensure a quality program that supports its effort to provide customers with quality products and services that conform to specified requirements.  This Quality Manual, QA-100, includes and makes reference to the quality system procedures and outlines the structure of the documentation used in the FLW Quality system. FLW’s quality system consist of two main areas:

4.2.1.1  Sales

To provide efficient sales service to meet the needs of the customer’s requirements, stated or implied. 

4.2.1.2  Service

To provide expedient repair and calibration services, which meet customer’s requirements and/or  industry standards. 

4.2.2    Quality System Procedures:  FLW has:

prepared documented procedures consistent with the requirements of ISO9002 and FLW’s stated Quality Policy;

b.  effectively implemented the quality system and its documented procedures;

c.  ensured that quality system procedures are readily available to personnel who are responsible for compliance to requirements, and to customers and/or regulatory agency representatives. (AS 9000)

NOTE:  Documented procedures may refer to work instructions that define how an activity is performed.  For the purposes of this document, the range and detail of the procedures that form part of the quality system shall be dependent upon the complexity of the work, the methods used, and the skills and training needed by personnel involved in carrying out the activity.  

Quality System Procedures are documented to establish and maintain continuity of each activity or function affecting quality.  Quality procedures are readily available to personal for reference and implementation.  The quality document structure is illustrated in Figure 1 .

                                                 Figure 1

4.2.3  Quality Planning

The requirements for quality will be met by documenting specific quality practices and activities for all processes including meeting contractual requirements, understanding and meeting customer needs and with emphasis on problem prevention.  Considerations will be given for updating the quality system in relation to changes brought about by new technologies, quality concepts, market strategies and social or environmental conditions (ISO9004 -1, 5.5(c)).  Written quality and audit plans will be prepared for these changes which will be consistent with all other requirements of the company’s quality management system.  Quality and audit plans should include:

a)     the preparation of the quality and audit plan.  (This plan may be in the form of a reference to the appropriate documented procedures that form an integral part of this quality system.)

b)     acquiring appropriate Measurement and Test Equipment, processes, fixtures, resources and skills that may be needed to achieve the required quality results;

(1) the design, manufacture, and use of tooling so that variable measurements can be taken, particularly for key characteristics ( AS9000); 

c)     making sure that the process, servicing, installation, inspection and test procedures and documentation are appropriate and compatible;

d)     Updating quality control and inspection and test procedures as required, including the development of new instrumentation &/or procedures;

e)     identification of necessary measurement requirements involving capability that exceed known state of the art, in sufficient time for the needed capability to be developed;

f)      identification of in-process and final inspections &/or verification at appropriate stages in the realization of product;

(1)  the identification of in-process verification points when adequate verification of conformance cannot be performed at a later stage of realization (AS 9000);

g)     the clarification of standards of acceptability for all features and requirements, including those which contain a subjective element;

h)     the identification and preparation of quality records and test procedures.

i)       the identification and selection of subcontractors capable of meeting quality requirements and the appropriate flowdown of requirements – (see QA100, 4.6.5) -  (AS 9000);

j)       the establishment of appropriate process controls and development of control plans if key characteristics have been identified by the customer. (AS 9000)

References:

FQD 180 - Servicing; FPD 370 – Calibration; FQD 101 – Quality System.

4.3  Contract Review

4.3.1  General

Procedures have been established and are maintained for contract review.  The Sales Department Office Manager and the Service Department Manager are responsible for coordinating and supervising contract review to make sure that the needs of the customer are well understood and documented.  That differences with the original contract, if any, are resolved, and that all requirements can be met.  While responsibility rests with the departmental managers, trained Product Specialists implement the customer/company interface. ( see FQD 160 5.0)

4.3.2                Review

Before submission of a tender, or the acceptance of a contract or order ( statement of requirement), the tender, contract or order shall be reviewed by the supplier to ensure that:

a.  the requirements are adequately defined and documented; where no written statement of requirement is available for an order received by verbal means, the supplier shall ensure that the order requirements are agreed before their acceptance;

b.  any differences between the contract or order requirements and those in the tender are resolved;

c.  the supplier has the capability to meet the contract or order requirements.

4.3.3         Amendments to a Contract

Amendments to any order or contract by the customer may be submitted in writing or negotiated by telephone, FAX or E-mail.  If negotiated by telephone, a written record will be made and placed with the original purchase order or contract.  These records may be eliminated after the order is placed on the electronic file.  It is the Product Specialists responsibility to adjust all records to reflect contract amendments and correct any work in progress changes.  All changes must be reviewed and approved by appropriate personal before implementation.  Ultimate responsibility in each department is the department manager.

4.3.4   Records

Customer contracts, contract review,  purchase orders, parts orders, and job orders will be maintained while active and archived as stated in section 4.16.  Appropriate and effective contract review is assumed when the order or contract is entered into the FLW electronic data file.

References:  FQD 130 - Contract Review

4.4  Design Control

The scope of this International Standard does not include quality-system requirements for design control.  This subclause is included to align the clause numbering with ISO 9000.

4.5  Document and Data Controls

4.5.1 General

FLW has established and maintains documented procedures to control all documents and data that relate to the requirements of ISO 9002, MIL-STD45662A and Z540-1 and, to the extent applicable, documents of external origin such as standards and customer drawings.  Documents and data can be in the form of any type of media, such as hard copy or electronic media.

4.5.2 Document and Data Approval and Issue

All new or revised internal documents shall be reviewed and approved for adequacy by authorized personnel prior to issue.  Internal documents are controlled with current revisions identified in the Master Document Index (Form Q110-06) which is the first section of this e FLW Quality Manual.  The QA Manager maintains this index. Authorized personnel will track the status, revision number, and location of all documentation under their control.

 They will ensure that:

a.) the pertinent issues of appropriate documents are available at all locations where operations essential to the effective functioning of the quality system are performed;

b).  that invalid and/or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use;

c).  any obsolete documents retained for legal and/or knowledge-preservation purposes are suitable identified.

Note: The authorized authority for each type of document is as follows:

*Quality manual and quality procedures - QA Manager;

*Engineering drawings,  documents related to testing and inspection, work instructions, inspection instructions, laws, regulations, standards documents, customer specifications, and similar documents - Service Manager;

*Purchase orders, customer contact forms, and similar documents - Product Specialists;

*Sales related documents - Sales Office Manager;

*Other documents - Sales Office Manager

4.5.3     Document and data changes

Changes to documents and data shall be reviewed and approved by the same functions/organizations that performed the original review and approval, unless specifically designated otherwise.  The designated functions/organizations shall have access to pertinent background information upon which to base their review and approval.  Where p