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 practicable, the nature of the change shall be identified in the document of the appropriate attachments.

A Master list of document locations and revisions have been created, maintained, and are audited at least once a year for effectiveness; (Forms Q110-07 and –08);

An internal audit of the document control procedures will be made at least once each year or whenever there is any question of the system’s proper operation.

4.5.3.1   Document Change Incorporation

A process has been established to ensure the timely review, distribution, implementation and maintenance of all authorized and released drawings, standards, specifications, planning, and changes.  A record of change effectively is maintained and, when required, these activities  will be coordinated with the customer. (AS 9000)

4.5.4     External documents

4.5.4.1  Sales Department

Documents of External Origin are not controlled.

4.5.4.2  Service Department

Documents of External Origin that apply to calibration, test, modification, upgrade, service and repair of all Measurement and Test Equipment are indexed and placed in the Service Department library.  Changes to these documents supplied by the Original Equipment Manufacturer are incorporated.  Changes made to these documents will be noted on the document in an appropriate location.  The Service Manager has responsibility for control, issue, and approval of external documents in the department.

Documents that do not pertain to the calibration and/or service process (sales literature, technical information of general purpose, sketches and notes made to assist in departmental work, technical magazines, and literature and manuals of uncontrolled equipment such as computers and other ‘tools’ are uncontrolled.

4.5.5  Forms and Records

In this document a record is information contained on a Form.  This document will contain only Forms.  Records will be kept in the master file or distributed as required. 

4.6  Purchasing

4.6.1  General

Established and documented procedures for purchasing are found this section and in

FQD 160.    FLW Product Specialists are responsible for assuring that products

purchased by FLW  comply with stated requirements. Qualified subcontractors are utilized

for the purchase of  replacement parts, distribution products, repair and calibration

services.  Subcontractors are monitored for maintaining required quality standards. 

Subcontractors not meeting  requirements will be “deselected”.

NOTE:  This requirement also applies to product obtained from customer designated sources. (AS9000)

4.6.2  Evaluation of Subcontractors

a).  Subcontractors will be evaluated and selected on their ability to meet contract requirements, including their quality system and any specific quality assurance requirements.  The QA Manager is responsible for the approved Subcontractors list , performing Subcontractor audits, and maintaining audit records.

b).  The Subcontractor approval process is handled with documented procedures (FQD160, FPD322, FPD370-14.0 & 15.0).  This system allows for qualifying Subcontractors to different levels of relationships depending on the type of product, or the impact of subcontracted product on the final product. Where applicable, Subcontractor approval may be based on the quality audit reports and/or quality records  showing the previously demonstrated capability and performance of subcontractor.  Extra surveillance, normal control, or reduced control designations may be noted on the approved Subcontractor list.  Records will be maintained in accordance with section 4.16.

NOTE:  Definition of the extent of control includes a system for disapproval, if necessary (AS9000) (See FQD160 – 4 5.2.2)

c).  A  list of acceptable subcontractors  is located on Form Q160-02.

d).  Supplier and all subcontractors must use customer-approved special process sources when required by contract. (AS 9000)

4.6.3  Purchasing Data  

Purchasing documents shall contain data clearly describing the product or service being ordered, including where applicable:

a).  the type, class, grade or other precise identification;

b).  the title or other positive identification, and applicable issues of specifications, drawings, process requirements, inspection instructions and other relevant technical data, including requirements for approval or qualification of product, procedures, process equipment and personnel

c).  the title, number and issue of the quality system standard to be applied.

Product Specialists will review and approve purchasing documents for adequacy of the specified requirements before release.

4.6.4    Verification of purchased product

NOTE:  Verification methods for purchased product may include receiving / source verification, delegation of verification to the subcontractor, or subcontractor certification.  (AS9000)

4.6.4.1  Supplier verification at subcontractor’s premises

Supplier shall specify verification arrangements and the method of product release in the purchasing documents if he proposes to verify purchased product at the subcontractor/s premises.

4.6.4.2  Customer verification of subcontracted product

Where specified in the contract, the supplier’s customer or the customer’s representative  shall be afforded the right to verify at the subcontractor’s premises and the supplier’s premises that subcontracted product conforms to specified requirements.  Such verification shall not be used by the supplier as evidence of effective control of quality by the subcontractor.  Verification by the customer shall not absolve the supplier of the responsibility to provide acceptable product, nor shall it preclude subsequent rejection by the customer.

4.6.4.3     Right of Entry

The supplier shall include provisions in subcontracts to allow the supplier, customer, and regulatory agencies right of entry to any place necessary to determine and verify the quality of contracted work, records and material. (AS9000)

4.6.4.4     Delegation of Supplier Verification to Subcontractors.

Where the supplier proposes to delegate product verification to a subcontractor, the supplier shall define the requirements for the delegation and maintain a list of the delegations. (AS 9000)

4.6.5     Requirements Flowdown

The supplier shall flow down quality system requirements to subcontractors to the extent necessary to ensure that characteristics not verifiable upon receipt are adequately controlled by the subcontractor.  Key characteristics requirements shall be flowed down if the supplier subcontracts the key characteristics process. (AS 9000)

4.6.6  Material that is ordered by a customer directly from a manufacturer (or ordered through FLW) where the material  is not received, handled, stored, modified or shipped by  FLW is considered to be outside the FLW Quality System.

References:

FQD 160 - Purchasing; FPD 370 Calibration System

4.7  Control of Customer-Supplied Product

Supplier has established and maintains documented procedures for the control of verification, storage and maintenance of customer-supplied product provided for incorporation into the supplies or for related activities.  Any such product that is lost, damaged or is otherwise unsuitable for use shall be recorded and reported to the customer.

Verification by the supplier does not absolve the customer of the responsibility to provide acceptable product.

Reference:  FQD 150 – Product Control; FQD 140 – Product  Identification and Traceability.

4.8  Product Identification and Traceability

Supplier has established and maintains  documented procedures for identifying the product by suitable means from receipt and during all stages of production, delivery and installation.

Where and to the extent that traceability is a specified requirement, the supplier has established and maintains documented procedures for unique identification of individual product or batches. This identification shall be recorded.

Product Specialists are responsible for product identification and traceability of product at all stages of production and delivery.  All distribution material and customer owned material is recorded at receipt on electronic data bases.  All material is then stored in unique locations for protection, identification and traceability.

Distribution material is recorded only by part number and quantity.  Customer owned Measurement and Test Equipment is recorded by manufacturer, by manufacturer’s serial number, by a unique FLW tracking number, customers’ name and, if possible, by customer’s purchase order or other customer tracking number.

References:

FQD 140 - Product Identification and Traceability; FQD 150 - Product Control;

FQD 160 – Purchasing

4.9  Process Control

Supplier will identify and plan  controls for all processes that directly affect quality.  Such  controls shall include written work instructions with examples of workmanship standards, where possible, conformance to standards and codes that apply to  industry,  continuous monitoring of the process, and approval of all processes and new machinery.  Special processes will be continuously monitored to assure conformance to requirements. 

Processes should be carried out under controlled conditions.  Controlled conditions include the following:

1)  documented procedures defining the manner of production, installation and servicing,  where the absence of such procedures could adversely affect quality;

2)  use of suitable production, installation and servicing equipment, and a suitable working environment;

3)  compliance with reference standards/codes, quality plans, and/or documented procedures;

4).  monitoring and control of suitable process parameters and product characteristics;

(1) monitoring and control of key characteristics when required by purchase order/contract   (AS 9000);

5)  the approval of processes and equipment, as appropriate;

6)  criteria for workmanship stipulated in the clearest practical manner;

7).  suitable maintenance of equipment to ensure continuing process capability.

8).  Accountability for all product during manufacture(e.g.,part quantities, split orders, nonconformities);  (AS 9000)

9).  Evidence that all manufacturing and inspection operations have been completed as planned, or as otherwise documented and authorized;  (AS 9000)

10). Provisions for the prevention, detection , and removal of foreign objects; (ARD 9000)

Where the results of processes cannot be fully verified by subsequent inspection and testing of the product and where, for example, processing deficiencies may become apparent only after the product is in use, the processes shall be carried out by qualified operators and/or shall require continuous monitoring and control of process parameters to ensure that the specified requirements are met.

The requirements for any qualification of process operations, including associated equipment and personnel  (see FQD 105 4.18), shall be specified.  Records shall be maintained for qualified processes, equipment and personnel, as appropriate (see FQD 112 4.16 ).

Note:  Such processes requiring pre-qualification of their process capability are frequently referred to as special processes.

4.9.1      Process Specification Requirements:

When special processes requiring customer approval are required by drawing, specification, or purchase order, the supplier shall obtain qualification prior to processing or subcontract the processes to a customer approved source (AS RD 9000).

4.9.2      Tooling

The supplier’s system shall maintain and control production tooling to ensure that the product meets design requirements. (AS RD 9000)

Reference:  FQD170 – Process Control .  Also see documents in this volume under the heading “Quality Process Documents”.

 4.10  Inspection and Testing

4.10.1  General

Documented procedures are established and maintained for inspection and testing activities in order to verify that the specified requirements for the product are met.  Required records and procedures for inspection and testing will be detailed in the quality plan or in documented procedures.

4.10.1.1    Subcontracting Inspection Activities

When the supplier proposes to subcontract inspection activities, the supplier shall control the subcontracted activity consistent with the requirements of Section 4.6. (ASRD 9000).

4.10.2  Receiving Inspection and Testing

 4.10.2.1

Incoming product will not be used or processed ( except in the circumstances described in 4.10.2.3) until it has been inspected or otherwise verified as conforming to specified requirements.  Verification of conformance to the specified requirements shall be in accordance with the quality plan and/or documented procedures.  FLW Product  Specialists are responsible for receiving inspection and verification as required for all products under their control. (see FQD 160)

Incoming service material will be inspected for the correct part number and quantity received.  Service materials used in repairs and calibrations are tested when they are installed in the instrument, the instrument is then tested to insure it meets specifications.

Customer-owned property is inspected to insure all items received match those listed on the customer’s paperwork and that there is no evidence of shipping damage. The Service Manager has overall responsibility for all test and inspection in the Laboratory and holding areas.

4.10.2.2      FLW will determine the amount and nature of receiving inspection, with

consideration to the amount of control exercised at the subcontractors premises and the recorded evidence of conformance provided.

4.10.2.3     Where incoming product is released for urgent production purposes prior to verification it shall be positively identified and recorded in order to permit immediate recall and replacement in the event of nonconformity to specified requirements.

4.10.2.4       When certification test reports are used as a means of product acceptance, procedures shall document the types and frequencies of analyses to validate certifications. (AS 9000)

Reference:  FQD 141 – Inspection and Test

4.10.3  In-process Inspection

a).  the product will be inspected and tested as required by the quality plan and/or documented procedures;

b).   the product will be held until the required inspection and tests have been completed or necessary reports have been received and verified, except when product is released under positive-recall procedures ( see 4.10.2.3). 

4.10.4  Final Inspection and Testing

All final inspection and testing shall be made in accordance with the quality plan and/or documented procedures to complete the evidence of conformance of the finished product to the specified requirements.

The quality plan and/or documented procedures for final inspection and testing shall require that all specified inspection and tests, including those specified either on receipt of product of in-process, have been carried out and the results meet specified requirements.

No product shall be dispatched until all the activities specified in the quality plan and/or documented procedures have been satisfactorily completed and the associated data and documentation are available and authorized.

4.10.5  Inspection and Test Records

Records have been established and are maintained which provide evidence that the product has been inspected and/or tested. These records show clearly whether the product has passed orf failed the inspections and/or tests according to defined acceptance criteria.  Where the product fails to pass any inspection and/or test, the procedures for control of nonconforming product shall apply ( see 4.13).

Records identify the inspection authority responsible for the release of product(see FQD 141).

4.10.5.1    First Production Article

When specified under contract, a process as appropriate will be implemented for the inspection, verification, and documentation of the first production article. (AS y" RD 9000).

References:

FQD 141 - Inspection & Test;  FPD 370 - Calibration System

4.11  Control of Inspection, Measuring and Test Equipment

4.11.1  General

Documented procedures are established and maintained for the control, calibration and maintenance of inspection & measuring and test equipment (including test software)  is used to demonstrate the conformance of product to the specified requirements.  Inspection, measuring and test equipment shall be used in a manner which ensures that the measurement uncertainty is known and is consistent with the required measurement capability ( see FPD 370).  Records of these inspections will be maintained for audit purposes.  This process is the responsibility of the Service Manager.

Where test software or comparative references such as test hardware are used as suitable forms of inspection, they shall be checked to prove that they are capable of verifying the acceptability of product, prior to release for use during production, installation or servicing, and shall be rechecked at prescribed intervals.  FLW has established the extent and frequency of such checks and shall maintain records as evidence of control (see FPD 370 9.0)

Where the availability of technical data pertaining to the inspection, measuring and test equipment is a specified requirement, such data shall be made available, when required by the customer or customer’s representative, for verification that the inspection, measuring and test equipment is functionally adequate.

NOTE:  For the purposes of this document, the term “measuring equipment” includes measurement devices.

4.11.1.1  Definition:  Inspection, measuring and test equipment includes all types of devices used by any supplier or subcontractor personnel to verify materials, products, processes, or other inspection, measuring and test equipment.  This includes tooling used as media of inspection, test hardware, test software, automated test equipment (ATE) , and plotters used to produce inspection media.  Also included is personally owned equipment used for product or process acceptance. (AS 9000).

4.11.2  Control Procedure

Documented procedures shall:

a)  determine the measurements to be made and the accuracy required, and select the appropriate inspection, measuring and test equipment that is capable of the necessary accuracy and precision.

b)  identify all inspection, measuring and test equipment that affect product quality and calibrate and adjust 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 shall be documented;

c)  define the process used 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 the results are unsatisfactory;

(1) the process shall consider the recall of inspection equipment, as appropriate (AS 3:28 RD 9000).

d)  identify inspection, measuring and test equipment with a suitable indicator or approved identification record to show the calibration status;

e)  maintain calibration records for inspection, measuring and test equipment;

f)  assess and document the validity of previous inspection and test results when, inspection, measuring and test equipment is found to be out of calibration;

g)  ensure that the environmental conditions are suitable for the calibrations, inspections, measurements and tests being carried out;

h)  ensure that the handling, preservation and storage of inspection, measuring and test equipment is such that the accuracy and fitness for the use are maintained ;

i)    safeguard inspection, measuring and test facilities, including both hardware and test software, from adjustments which would invalidate the calibration setting.

Note:  The metrological confirmation system for measuring equipment given in

ISO 10012 may be used for guidance.

References:  FPD 370 - Calibration System

 4.12  Inspection and Test Status

The inspection and test status of product shall be identified by suitable means, which indicate the conformance or nonconformance of product with regard to inspection and tests performed.  The identification of inspection and test status shall be maintained, as defined in the quality plan and/or documented procedures, throughout production, installation and servicing of the product to ensure that only product that has passed the required inspections and tests (or released under an authorized concession (see 4.13.20) is dispatched, used or installed.

4.12.1    Acceptance Authority Media

When acceptance authority media are used (e.g., stamps, electronic passwords), the supplier’s system shall establish and document controls for the media. (AS 9000)

Reference:

FQD 142 - Test Status; FQD 140 – Product Inspection and Traceability; FQD150 – Product Control; FQD-370, 8.0, 9.0 – Calibration System

4.13  Control of Non-Conforming Material

4.13.1  General

Documented procedures have been established and maintained to ensure that product which does not conform to specified requirements is prevented from unintended use or installation.  This control  provides for identification, documentation, evaluation, segregation ( when practical), disposition of nonconforming product, and for notification to the functions concerned.

Notes:

1.  Parties requiring notification of nonconforming product may include internal organization, customers, distributors and government agencies. (ASRD 9000)

2.  The term “nonconforming product” includes nonconforming product returned from a customer. (AS 9000)

FLW measurement standards, inspection, measuring and test equipment found to be in non-conformance relative to their intended use, are labeled and removed from the work areas to prevent usage.

4.13.2  Review and Disposition of Non-Conforming Product

The responsibility for review and authority for the disposition of nonconforming product is defined in FQD103 3.0.

Non conforming product shall be reviewed in accordance with documented procedures.  It may be:

a)      reworked to meet the specified requirements,

b)      accepted with or without repair by concession,

c)      regraded for alternative applications, or

d)      rejected or scrapped.

Where required by the contract, the proposed use of repair of product (see 4.13.2b) which does not conform to specified requirements shall be reported for concession to the customer or customer’s representative.  The description of the nonconformity that has been accepted, and of repairs, shall be recorded to denote the actual condition.

Repaired and/or reworked product shall be re-inspected in accordance with the quality plan and/or documented procedures.

4.13.2.1   Material Review Authority

Notwithstanding the requirements of 4.13.2, the supplier shall not use dispositions of use-as-is or repair, unless specifically authorized by the customer, if (1) the product is produced to customer design, or (2) the nonconformity results in a departure from the contract requirements. (AS RD 9000)

4.13.2.2     Regrading Material

Product dispositioned for regrade requires a change in product identification to preclude the product’s original use.  Adequate test reports and certifications shall reflect the regrading. (AS RD 9000)

4.13.2.3   Scrap Material

Product dispositioned for scrap shall be conspicuously and permanently marked until physically rendered unsuitable for use in completed products. (AS 9000)

4.13.2.4   Notification

The supplier’s system shall provide for timely reporting of nonconformances that may affect product already delivered. (AS 9000)

References:

FQD 103 - Control of Non-Conforming Material

4.14  Corrective and Preventive Action

4.14.1  General

Documented procedures are established and maintained for implementing corrective and preventive action.  Corrective or preventive actions taken to eliminate causes of actual or potential nonconformities shall be to a degree appropriate to the magnitude of the problems and commensurate with the risks encountered

Changes to documented procedures resulting from corrective and preventive action will be implemented and recorded.

4.14.2  Corrective Action

Procedures for corrective action will include:

a)  effective handling of customer complaints and reports of product nonconformities;

b)  investigation of the cause of nonconformities relating to product, process and quality system, and recording the results of the investigation;

c)  determination of the corrective action needed to eliminate the cause of nonconformities;

d)  application of controls to ensure that corrective action is taken and that it is effective.

4.14.3  Preventive Action

Procedures for preventive action will include:

a)  the use of appropriate sources of information such as, processes and work operations which affect product quality, concessions, audit results, quality records, service reports and customer complaints to detect, analyze and eliminate potential causes of nonconformities;

b)  determination of the steps needed to deal with any problems requiring preventive action;

c)  initiation of preventive action and application of controls to ensure that it is effective;

d)  ensuring that relevant information on actions taken is submitted to management for review.

References:  FQD 104 - QA Corrective Action Procedure, FQD 106 Customer Complaints; FQD115 – Customer Reply Card Program.

 4.15  Handling, Storage, Packaging, Preservation and Delivery

4.15.1  General

Procedures are established and maintained for the handling, storage, packaging, preservation and delivery of product

4.15.2  Handling

Methods of handling product have been established that prevent damage or deterioration. ( see FQD 150)    

4.15.3  Storage

Areas have been designated for the storage of product to prevent damage or deterioration pending  use of delivery.  Methods for authorizing receipt to and dispatch from such areas have been stipulated.  To prevent deterioration, the condition of product in stock is regularly assessed (see FQD102 and FQD150).

4.15.4  Packaging

Appropriate methods for packing, packaging and marking processes (including materials used) to the extent necessary to ensure conformance to specified requirements are in place and monitored for effectively (see FQD102 and FQD150)

4.15.5  Preservation

Appropriate methods for preservation and segregation of product when the product is under supplier’s control have been implemented (see FQD102 and FQD150).

4.15.6  Delivery

Arrangements have been made for the protection of the quality of product after final inspection and test.  Where contractually specified,  protection shall be extended to include delivery to destination  (see FQD1500).

 Deliveries are accomplished by one of the following methods:

·         an approved common carrier

·         method stipulated by the customer

·         FLW van

·         customer pick up

4.16  Control of Quality Records

FLW has established and maintains documented procedures for identification, collection, indexing, access, filing, storage, maintenance, and disposition of quality records.  The Quality Manager has the responsibility for maintaining these records.

Quality records are maintained to show conformance to specified requirements and the effective operation of the quality system.  Pertinent quality records from subcontractors are maintained as an element of these data.

All quality records must be legible.  Records will be stored and retained so they are readily available.  They will be stored to prevent damage, deterioration and/or loss.  Retention times of quality records have been established and recorded (see FQD 112).  Where agreed to contractually, quality records are made available for evaluation by the customer or the customer’s representative for an agreed period.

 Records may be in the form of any type of media, such as hard copy or electronic media.

4.16.1  Record Availability

Records shall be readily available for review by the customer or regulatory agencies (AS 9000)

References:   FQD 112 - Record Control

4.17  Internal Quality Audits

Documented procedures have been established and are maintained for planning and implementing internal quality audits.  Quality audits will be used to verify whether quality activities and related results comply with planned expectations to determine the effectiveness of the quality system.  The QA Manager has the responsibility for implementing internal quality audits. Reports of all internal quality audits will be recorded and copies routed to the Sales Manager, the Service Manager and the President.  Records will preserved in accordance with FQD 112 - Record Control. 

Internal quality audits will be scheduled on the basis of the status and importance of the activity to be audited and shall be carried out by personnel independent of those having direct responsibility for the activity being audited.   Special attention will be given to the Service Department (Laboratory), the Quality System, the Audit System and the Document System. Audits will be made in accordance with the requirements found in ISO 9002:1994(E) and ANSI/NCSL Z540-1-1994. Audits will be in accordance with guidelines set forth in ISO 10011-1:1990.  Audit results will be brought to the attention of the person responsible for the area.  The management personnel responsible for the area shall take timely corrective action on deficiencies found during the audit.  Deficiencies found during the audit will require a corrective action report as per section 4.14.

Follow-up audit actives will be used to verify and record the implementation and effectiveness of the corrective action taken. Audit results and any resulting corrective action required will be reviewed in the regular Management Review meeting.

References:  FQD 120 - Quality Audits;  FPD121- Internal Audits; FQD100 – Management Review.

4.18  Training

FLW has established and maintains  documented procedures for identifying training needs and provide for the training of all personnel performing activities affecting quality.  Personnel performing specific assigned tasks will be qualified on the basis of appropriate education, training and/or experience, as required.  The importance of training at FLW is reflected in paragraph 4.1.1 of this document - Quality Policy.  The QA Manager is responsible for training and related documentation. Training records will be controlled and maintained as quality records in accordance with section 4.5.

References:

FQD 105 - Training Requirements

4.19 Servicing

Where servicing is a specified requirement, the supplier shall establish and maintain documented procedures for performing, verifying and reporting that the servicing meets the specified requirements.

Servicing activities are normally contractual and the following should be considered:

.       service responsibilities among supplier, distributor and user should be clarified;

·         service activities should be planned;

·         special tools, jigs, parts and measurement and test equipment should be acquired as appropriate;

·         Quality and Audit plans should be made;

·         provisions should be made for whatever special labor, equipment, parts, documentation, quality procedures, etc., may be required,

·         provision should be made for adequate back-up, to include technical advice and support, customer personnel training and Laboratory personnel training;

·         plans should be made for corrective and preventative action as required.

4.19.1  When appropriate, the supplier shall maintain a system for receiving and acting on service information consistent with contractual and/or regulatory requirement. (AS 9000)

References:  FQD 180 - Servicing; FPD 370 - Calibration System

4.20  Statistical Techniques

4.20.1  Identification of Need

The supplier shall identify the need for statistical techniques required for establishing, controlling and verifying process capability and product characteristics.

NOTE:  FLW does not have requirements for statistical techniques at this time as existing standards, such as MIL-STD 45662A and IEEE-498(1985) encourage the use of arbitrary test uncertainty ratios (TURS ) as a means for controlling the penalties associated with inaccurate measurements.  In these standards, a TUR of 4:1 is declared to be satisfactory for the purposes of those invoking the standard.

(A TUR of 4:1 means that the specification limits of the parameter tested must be a least four times greater than the uncertainty of the instrument or system used to measure it.)

As standards change; or if a requirement arises, FLW will establish a system for statistical techniques, especially in the area of statistical methods for instrument calibration.  It will be the responsibility of both the QA Manager and the Service Manager to implement and document this process.

FLW realizes that the documentation resulting from the application of statistical methods can be an effective means of demonstrating conformance to requirements for quality, and can be used as a form of quality records.

4.20.2  Procedures

The supplier shall establish and maintain documented procedures to implement and control the application of the statistical techniques and/or uncertainties  Various methods and processes are available in the Guide to Uncertainty Measurements (GUM), ANSI-NCSL Z40-2, NCSL RP-12, NIST Technical Note 1297, NAMAS NIS 3003, ISO 10012 and ISO 5725-1.  The use of the Uncertainty Calculator form the Compaq company is authorized.

4.20.3  Sampling Inspection

When the supplier uses sampling inspection as a means of product acceptance, the plan shall be statistically valid and appropriate for use.  The plan shall preclude the acceptance of know defectives in the lot. (AS 9000)