Prepared by: __________________________________________________ Date: ____________
Lyell Kinney, Sales Manager
Approved: __________________________________________________ Date: ____________
Steve Saffell, Service Manager
Approved: __________________________________________________ Date: ____________
Lyell Kinney, Sales Manager
Approved: __________________________________________________ Date: ____________
Paul Peek, QA Manager, acting
Revision | Section | DCF ID Number | Description of Change |
| 5.0 | ALL | N/A | Manual rewritten to meet the requirements in ISO 9002 |
| 5.1 | Various | 00001 | Renumbered level two documents, changed references |
| 6.0 | Various | 00011 | Upgrade to ISO 9002 1994 revisions |
| 7.0 | Various | 00028 | Changes made to correct or clarify in compliance with NQA audit number 96/92626/M01 - 1)added 'suitability & effectiveness to 2nd para. In 4.1.1; 2)added management rep. To fig 1; 3) added supplier quality statement to 4.2.2; 4) revised 4.2.3 to reinforce planning; 5) added 4.5.2-external documents; 6) removed para. Citing 'customer data' from 4.1.b; 7) added policy statement on accuracy to 4.11.2; 8) removed reference to customer-owned material from 4.13; 9) removed 'if at all possible' from 4.17;10) changed 4.0 to reflect quality reviewing for 'suitability and effectiveness; 11) rewrote 4.19 to reflect intent of standard. |
| 1.0 | Scope................................................................................................................... | |
| 2.0 | References............................................................................................................ | |
| 3.0 | Definitions........................................................................................................... | |
| 4.0 | Quality-System Requirements............................................................................... | |
| 4.1 | Management Responsibility................................................................................... | |
| 4.2 | Quality System..................................................................................................... | |
| 4.3 | Contract Review................................................................................................... | |
| 4.4 | Design Control...................................................................................................... | |
| 4.5 | Document and Data Control................................................................................. | |
| 4.6 | Purchasing........................................................................................................... | |
| 4.7 | Control of Customer-Supplied Product................................................................. | |
| 4.8 | Product Identification and Traceability................................................................. | |
| 4.9 | Process Control.................................................................................................... | |
| 4.10 | Inspection and Testing.......................................................................................... | |
| 4.11 | Control of Inspection, Measuring and Test Equipment........................................... | |
| 4.12 | Inspection and Test Status.................................................................................... | |
| 4.13 | Control of Nonconforming Product....................................................................... | |
| 4.14 | Corrective and Preventive Action.......................................................................... | |
| 4.15 | Handling, Storage, Packaging, Preservation and Delivery...................................... | |
| 4.16 | Control of Quality Records................................................................................... | |
| 4.17 | Internal Quality Audits......................................................................................... | |
| 4.18 | Training................................................................................................................ | |
| 4.19 | Servicing............................................................................................................... | |
| 4.20 | Statistical Techniques............................................................................................ |
Appendix A - Cross Reference
to Standards and FLW Quality & Process Documents...........
29
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) 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.
3.0 DEFINITIONS
3.1 This section is for definitions not referenced
in ISO 8402.
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 service material supplied to FLW to be utilized in modification
or repair of customer-owned property.
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.
3.1.6 Special Process Procedures - Procedures
written by the customer for calibration of their instrumentation
that FLW is asked to calibrate.
4.0 QUALITY-SYSTEM REQUIREMENTS
4.1 Management Responsibility
4.1.1 Quality Policy
FLW's Quality Policy is for management to provide
the training and leadership to all employees in the art of continuous
improvement and to constantly seek improved quality at reduced
costs that still exceed the expectations of our customers and/or
industry standards.
This policy will be evaluated at least once a year
by management to confirm the suitability and effectiveness of
this policy is being met. It is management's responsibility to
ensure this policy is understood, implemented and maintained by
all personnel of the organization.
4.1.2 Organization
4.1.2.1 Responsibility and authority
Personnel listed below have the responsibility and
authority to manage and verify the work affecting quality. They
have the freedom and authority to initiate action to prevent the
occurrence of any nonconformity relating to the product, process
and quality system; they have the responsibility to identify and
record any problems relating to the quality process, initiate
solutions and verify the implementation of these solutions. Further,
they can control further processing or delivery of nonconforming
product until any deficiency has been corrected.
The organization of FLW Sales and Service Corporation
is illustrated in Figure 1.
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 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 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 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 required materials,
and shipping, and receiving in the Laboratory and Service areas.
The Service Manager is responsible for maintaining the Laboratory's
compliance with ANSI/ANCL Z 540-1 and ISO 9002:1994(E). The Service
Manager reports directly to the president.
The personnel listed above shall identify resource
requirements and provide adequate resources, including the assignment
of trained personnel for the management, performance of work and
verification activities including internal quality audits.
4.1.2.3 Management Representative
The QA Manager is designated as Management Representative with defined authority for:
a) ensuring that a quality system is established, implemented and maintained in
accordance with ISO 9002 and ANSI/NCSL Z540-1 and
b) reporting on the performance of the quality system to FLW management for
review and as a basis for improvement of the quality
system.
c) The QA Manager is appointed FLW's ISO representative.
4.1.3 Management Review
Management 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 and Z540-1.
These reviews will be held on a quarterly basis or at closer intervals
when necessitated.
References:
FQD 100 - Management Review
4.2 Quality System
4.2.1 General
FLW shall establish, document and maintain a Quality
System to ensure a quality program that supports its effort to
provide customers with quality products and services. 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 the industry standards.
4.2.2 Quality System Procedures
Quality System Procedures are documented to establish and maintain continuity of each activity or function affecting quality. Quality procedures will be readily available to personal for reference and implementation. The quality document structure is illustrated in Figure 2.
Figure 2
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. Changes to the
quality system will be made as conditions or services change or
mature. 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:
References:
FQD 180 - Servicing; FPD 370 - Calibration
4.3 Contract Review
4.3.1 General
Procedures shall be established and maintained for
contract review. The Sales Department 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 any differences with the
original quote, if any, are resolved, and that all requirements
can be met. They will also maintain written procedures controlling
their review processes. While responsibility rests with the departmental
managers, trained Product Specialists implement the customer/company
interface.
4.3.2 Reviewing
4.3.2.1 Sales
Customer contracts and purchase orders are reviewed
to ensure that all stated requirements are understood and can
be adhered to. Options, such as product modification and compliance
to Industrial or Government Standards, will be reviewed for compliance
to the customer requirements. Any discrepancy or deviation in
previously agreed terms for payment, delivery and/or technical
requirements must be remedied prior to acceptance.
4.3.2.2 Service
Customer contracts, part orders and job orders are
reviewed to ensure that all the stated requirements are understood
and can be adhered to. Customer's requests for service which are
not listed in the Manufacture's or FLW's Price Lists, will be
brought to the Service Manager for review and approval. Any deviation
in terms for payment, delivery and/or technical specifications
must be remedied prior to acceptance.
4.3.3 Amendments
Amendments to any order or contract 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. All changes
must be reviewed and approved by designated personal prior to
implementation. Ultimate responsibility in each department is
the department manager.
4.3.4 Records
Customer contracts, purchase orders, parts orders, and job orders will be maintained while active and archived as stated in section 4.16.
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
FLW will establish and maintain documented procedures
to control all documents and data that relate to the requirements
of ISO 9002 and Z540-1. Internal documents are controlled with
current revisions identified in the Master Document Index. This
index is maintained by the QA Manager.
All new or revised internal documents shall be approved by a central authority. This central authority will then track the status, revision number, and location of all documentation under their control The central authority will ensure that pertinent issues of appropriate documents are available at all locations where operations essential to the effective functioning of the quality system are performed; that invalid and/or obsolete documents are promptly removed from all points of issue or use and obsolete documents, if retained for legal and/or knowledge-preservation purposes, are suitable identified.
The central (control ) authority for each type of document is as follows:
*QA Manual and documents related to testing and inspection
- QA Manager
*Engineering drawings, customer specification, and
similar documents - Service Manager.
*Purchase orders, customer contact forms, and similar
documents - Product Specialists
*Sales related documents - Sales Manager
*Other documents - Office Manager
Each authority will assure that:
documents under their responsibility are up to date, available where needed, signed and dated with revision numbers, and reissued when appropriate and that obsolete documents are replaced;
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;
a master list of document locations and revisions has been created, maintained, and audited at least once a year for effectiveness and that a copy of this master list is in their possession;
an internal audit of the document control procedures for documents under their control is made at least once each year or whenever there is any question of the system's proper operation;
This policy meets the requirements of Section 4.5 of IS0 9002 and Section 5.0 of
ANSI/NCSL Z540-1-1994.
Documents of External Origin are not controlled.
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.
References:
FQD 110 - Document Control
FQD 111 - Data Control
FPD 121 - Internal Audits
4.6 Purchasing
4.6.1 General
FLW Product Specialists are responsible for assuring
that products purchased by FLW
comply with stated requirements. Qualified suppliers are utilized for the purchase of
replacement parts, distribution products, repair and calibration services. Suppliers
must be monitored for maintaining required quality
standards. Suppliers not meeting
requirements will be "deselected".
4.6.2 Evaluation of Subcontractors
Subcontractors will be evaluated and selected on
their ability to meet contract requirements, including the quality
system and any specific quality assurance requirements. The QA
Manager is responsible for the approved suppliers list, performing
supplier audits, and maintaining audit records.
The supplier/subcontractor approval process is handled
with documented procedures. This system allows for qualifying
suppliers to different levels of relationships. Extra surveillance,
normal control, and reduced control designations may be noted
on the approved suppliers list. Records will be maintained in
accordance with section 4.16.
4.6.3 Purchasing Data
Purchasing documents shall contain data clearly describing
the product or service being ordered. Product Specialists will
review and approve purchasing documents for adequacy of the specified
requirements prior to release.
4.6.4 Verification of purchased product
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
Supplier 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.
4.6.5 Material that is ordered by a customer directly
from a manufacturer (or via 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
The Product Specialists are responsible for the control
of customer supplied products while they are at FLW.
When customer-supplied product is received it is inspected for correct quantity, proper identification and possible shipping damage. Accompanying paper work is checked for clearness of instructions. The material is then placed in unique areas for identification and storage. Care is taken to preclude physical damage while at FLW by these unique storage areas. Material to be calibrated/verified or repaired is noted on an electronic log for traceability. Procedures for control of customer supplied material are referenced below.
(Reference: FQD 150 - Warehousing; FQD 140 - Material
Identification and Traceability; FPD 370 - Calibration System
)
4.8 Product Identification and Traceability
The 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 both 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 - Material Identification and Traceability; FQD 150 - Warehouse Control;
FQD 160 - Purchasing; FPD 370 - Calibration System
4.9 Process Control
FLW will identify and plan process controls for all
processes which directly affect quality. Such process controls
shall include written work instructions with examples of workmanship
standards, where possible, conformance to standards and codes
that apply to our industry, the 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 processes where
the absence of such procedures could adversely affect quality;
2) use of suitable equipment, and a suitable working
environment;
3) compliance with reference standards/codes, quality
plans, and/or documented procedures;
4) monitoring and control of process parameters and
product characteristics, when required;
5) the approval of processes and equipment;
6) criteria for workmanship;
7) maintenance of equipment to ensure continuing
process capability.
Instructions, requirements and acceptance criteria
for each process affecting quality are documented in Quality Documents,
Process Documents, Special Process Procedures, Manufacturers Specifications,
Industry Standards, or Local Service Instructions.
Department Managers are required to train personnel on each process and equipment category they are assigned to. Training requirements are defined in section 4.18.
( Reference FPD 370 - Calibration System ; FQD 105
- Training Requirements )
4.9.1 Sales
Sales has controlled processes that insure timeliness of delivery. These controls apply to purchasing, invoicing, modifications, storage, shipping, and receiving.
( Reference FQD 106 - Customer Complaints; FQD 140
- Material Identification and Traceability; FQD 150 - Warehouse
Control; FQD 160 - Purchasing )
4.9.2 Service
Service has controlled processes that insure the accuracy of repair and calibration. These controls apply to purchasing, equipment repair & calibration, workmanship, calibration standards, storage, invoicing, shipping and receiving. Maintenance of inspection, measuring and test equipment is critical to the Service Department and is addressed in section 4.11 and FPD 370 - Calibration System.
( See references in 4.9.1 above and FPD 370 Calibration
System )
4.10 Inspection and Testing
4.10.1 General
Documented procedures will be established and maintained
for the inspection and testing of distribution materials, customer-owned
property and service materials. Records for inspection and testing
will be detailed in documented procedures.
4.10.2 Receiving Inspection and Testing
4.10.2.1 Sales
Distribution material is inspected for the correct
part number and quantity received using FLW Purchase Orders and
the packing slips received with the incoming shipment. Product
Specialists are responsible for receiving inspection and testing
for all products under their control.
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.
4.10.2.2 Service
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. Product Specialists
are responsible for all material under their control. The Service
Manager has overall responsibility for all test and inspection
in the Laboratory and holding areas.
4.10.3 In-process Inspection
In-process inspection is normally a process of the
FLW Laboratory. Customer Measurement and Test Equipment returned
for verification or calibration is inspected for physical damage
or obvious defects prior to test. Part of the calibration process
is often an in-process verification to measure changes from previous
calibrations. These verifications may cause a change in the instruments'
calibration cycle. These in-process inspections/verifications
are the responsibility of the calibration technician. Results
of the verifications are usually documented and reported only
if the change is greater than allowed by the specification to
which the instrument is being tested. Changes of a significant
nature may be reported to the customer if it is deemed that the
change may affect his quality system.
4.10.4 Final Inspection and Testing
4.10.4.1 Service Department
Customer-owned property is calibrated and/or performance
tested to ensure it meets specification. A final inspection of
paperwork, equipment labels and cleanliness, and matching of accessories
is completed prior to shipping/delivery. This inspection is usually
a part of the calibration process and may be recorded by the calibration
technician's signature, or stamp, on the Calibration Report.
4.10.4.2 Sales Department
Any modified or reworked distribution material will
be calibrated and/or performance tested to ensure it meets specification.
Distribution materials are inspected to verify the
customer name, ship-to address, part number and quantity are correct
prior to shipment.
4.10.5 Inspection and Test Records
Records will be established and maintained which
provide evidence customer-owned property has been inspected and/or
tested. Any failure will be handled as nonconforming product in
accordance with section 4.13.
References:
FQD 141 - Inspection & Test; FPD 370 - Calibration
System
4.11 Control of Inspection, Measuring and Test Equipment
4.11.1 General
Documented procedures will be established and maintained
for the control, calibration and maintenance of inspection &
measuring and test equipment (including test software) which is
used to demonstrate the conformance of distribution material and
customer-owned property to the specified requirements. Records
of these inspections will be maintained for audit purposes. This
process is the responsibility of the Service Manager.
4.11.2 Control Procedure
Documented procedures shall:
1) 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.
2) provide traceability to the National Institute
of Standards and Technology (NIST) and/or to other nationally
or international recognized standards. Procedures will include
standards that are on loan, leased or rented to FLW;
3) identify all inspection, measuring and test equipment
that affect quality and define calibration and adjustment intervals;
4) 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;
5) identify inspection, measuring and test equipment
with a suitable indicator or approved identification record to
show the calibration status;
6) maintain calibration records for inspection, measuring
and test equipment;
7) assess and document the validity of previous inspection
and test results when, inspection, measuring and test equipment
is found to be out of calibration;
8) ensure that the environmental conditions are suitable
for the calibrations, inspections, measurements and tests being
carried out;
9) 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 (sec. 4.15);
10) protect inspection, measuring test hardware and
test software from adjustments which would invalidate the calibration
setting.
References:
FPD 370 - Calibration System
4.12 Inspection and Test Status
FLW will identify the inspection and test status
of distribution material and customer-owned property by indicating
conformance or nonconformance by using stamps, labels, and/or
physical locations. The identification of inspection and test
status will be maintained to give evidence that only conforming
product is released to the customer. Responsibility for Inspection
and Test is that of the Product Specialists, the Sales Manager
and the Service Manager.
Reference:
FQD 142 - Test Status
4.13 Control of Non-Conforming Material
4.13.1 General
Documented procedures will be established and maintained
to ensure that distribution material and service material which
do not conform to specified requirements is prevented from being
used, shipped or installed. Control of Non-Conforming Material
is the responsibility of the Product Specialists and the Service
Manager.
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
Product Specialists are responsible for determining
the disposition of non-conforming material. Non-conforming material
will be reviewed in accordance with documented procedures. Non-conforming
material may be handled by the following methods:
References:
FQD 103 - Control of Non-Conforming Material
4.14 Corrective and Preventive Action
4.14.1 General
Documented procedures shall be established and maintained
for implementing corrective and preventive action. Corrective
or preventive actions taken to eliminate causes of actual or potential
nonconformity's shall be to a degree appropriate to the magnitude
of the problem and comparable to the risks encountered. Product
Specialists, the Service Manager and the Sales Manager are responsible
for the control of non-conforming material.
Changes to documented procedures resulting from corrective
and preventive action will be implemented and recorded.
4.14.2 Corrective Action
Documented procedures for corrective action will
include:
1) effective handling of customer complaints and
reports of nonconformities;
2) investigation of the cause of nonconformities
relating to product, process and quality system, and recording
the results of the investigation;
3) determination of the corrective action needed to eliminate the cause of nonconformities;
4) application of controls to ensure that corrective
action is taken and that it is effective.
4.14.3 Preventive Action
Documented procedures for preventive action will
include:
1) 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;
2) determination of the steps needed to deal with
any problems requiring preventive action;
3) initiation of preventive action and application
of controls to ensure that it is effective;
4) ensuring that relevant information on actions
taken is submitted to management for review.
References: FQD 104 - QA Corrective Action Procedure,
FQD 106 Customer Complaints
4.15 Handling, Storage, Packaging, Preservation and
Delivery
4.15.1 General
Documented procedures will be established and maintained for the handling, storage, packaging, preservation and delivery of distribution material, customer-owned property and service materials. While all personnel are responsible for the correct handling, storage, packaging, preservation and delivery of products the end responsibility lies with the Produce Specialists, the Sales Manager and the Service Manager.
( Reference: FQD 150- Warehouse Control )
4.15.2 Handling
Distribution material, customer-owned property and service material is handled carefully to minimize the chance of damage or alteration of performance. Electrostatic Discharge (ESD) sensitive components or assemblies are to only be handled at static-safe work stations. Personnel will be trained in the ESD handling procedures (see section 4.18).
( Reference: FQD 102 - Procedure for Handling ESD
Devices )
4.15.3 Storage
Storage areas will be designated for the storage
of distribution material, customer-owned property, service material,
and FLW assets. Designated areas will be assigned so damage and
deterioration will be prevented. ESD sensitive devices will be
stored in static safe containers or bags.
4.15.4 Packaging
Customer-owned property and distribution material
will be shipped in cardboard boxes with protective packing material.
The type and amount of protective packing material is determined
by the size and weight of the shipment. ESD sensitive devices
will be packaged in static safe containers or bags and marked
with a static sensitive device warning label.
Any special packaging requirements specified on the
customer's purchasing documents will be followed.
4.15.5 Preservation
FLW will establish and maintain a first-in, first-out
system on all distribution material. Customer-owned property does
not normally require special measures for insuring preservation.
Any preservation requirements specified on the customer's purchasing
documents will be followed.
4.15.6 Delivery
Delivery will be arranged to insure the protection
of distribution material and customer-owned property. Deliveries
are accomplished by one of the following methods:
References:
FQD 102 - Procedure for Handling ESD Devices
FQD 150 - Warehouse Control
4.16 Control of Quality Records
FLW shall establish and maintain documented procedures
for identification, collection, indexing, access, filing, storage,
maintenance, and disposition of quality records. Responsibility
rests with the Sales and Service Managers and with the QA Manager.
Quality records will be maintained to show conformance
and effective operation of the quality system. Quality records
from subcontractors will be maintained.
All quality records will be legible. Records will
be stored and retained so they are readily available. They will
be stored to prevent damage, deterioration and/or loss. Records
may be in the form of any type of media, such as hard copy or
electronic media.
Quality record retention times will be established
and recorded.
References:
FQD 112 - Record Control
4.17 Internal Quality Audits
Documented procedures will be established and 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.
Quality audits will be scheduled on the basis of
the importance of the activity to be 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 performed by personnel
independent of those having direct responsibility for the activity
being audited and 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. Deficiencies found during
the audit will require a corrective action report as per section
4.14.
Follow-up audits 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
4.18 Training
FLW will establish and maintain 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
Many products depend on regular maintenance, and
servicing is specified in the contract. In addition, after market
modifications and updates may be required. These activities are
normally contractual and the following should be considered:
References:
FQD 180 - Servicing; FPD 370 - Calibration System
4.20 Statistical Techniques
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 good enough 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 inspection and testing.
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.
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