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ISO 9002
1.0 Table of Contents
2.0 Scope of Application & Normative References
3.0 Company Description
4.0 Quality System Requirements
4.1 Management Responsibility
4.2 Quality System
4.3 Contract Review
4.4 Design Control
4.5 Document & Data Control
4.6 Purchasing
4.7 Control of Customer-Supplied Product
4.8 Product Identification & Tracability
4.9 Process Control
4.10 Inspection & Testing
4.11 Control of Inspection, Measuring, & Test Equipment
4.12 Inspection & Test Status
4.13 Control of Non Conforming Products
4.14 Corrective & Preventive Action
4.15 Handling, Storage, Packaging, Preservation & Delivery
4.16 Control of Quality Records
4.17 Internal Quality Audits
4.18 Training
4.19 Services
4.20 Statistical Techniques
2.0 Scope of
Application & Normative References
2.1 Purpose
To outline which standards, beyond ISO9002/1994 itself, apply to Manistar
Electronics' documented system of which this Quality System Manual is a part.
2.2 Scope
This Quality System Manual and its applicable references contain all policies
and procedures constituting the quality management system, including the
companies formal quality policy statement, in place for Manistar Electronics,
Inc. doing business at 26802 Vista Terrace, Lake Forest, CA 92630. In
addition, it summarizes the organizational responsibilities and procedural
controls corresponding to each quality system element related to applicable
standards as noted below.
3.0 Company Description
Manistar Electronics, Inc. stocks and
distributes a broad line of electronic components with global source finding
capabilities. The company provides scheduling and just in time delivery and
cross referencing to customer requirement. In addition, the company offers
market information, competitive pricing and source finding for hard to find
and obsolete parts.
Manistar distributed products are used in a variety of industrial and
commercial applications. Located in Lake Forest , California ,the company
markets its service through its own sales staff and independent sales
representatives directly to industrial Original Equipment Manufacturers (OEM)
and commercial customers as well as to regional distributors on a world-wide
basis.
4.0 QUALITY SYSTEM REQUIREMENTS
4.1 Management Responsibility
4.1.1 Purpose
To establish policy documenting the responsibility, commitment and active
involvement of company management in establishing a quality system
demonstrating conformance to Manistar Electronics' standard requirements.
4.1.2 Quality
Policy The management of Manistar Electronics, Inc. is dedicated and committed
to attaining the quality objectives and goals set forth in this manual.
Management retains the overall responsibility to ensure that its company
quality policy is understood, implemented and maintained at all levels of the
organization. The Company Quality Policy is as follows:
Quality Policy Statement
Manistar Electronics, Inc. strategic quality policy will
continuously seek customer satisfaction to the maximum levels. This is
accomplished through group cooperation, mutual trust and a team atmosphere.
The quality policy is relevant to Manistar Electronics, Inc. organizational
goals and the expectations and needs of their customers.
Manistar Electronics applies ISO 9000 guidelines to ensure that processes are
being driven towards ZERO defects.
Manistar Electronics promotes reliable and innovative quality systems verified
by inspections and tests.
In order to optimize the quality of our services, we support and set up
reliable and innovating systems of quality adapted to our customer's needs.
We are committed to quality improvement by integrating continuous FEEDBACK
from customers and employees.
4.1.3 Organization
The President retains overall responsibility for the effective functioning of
the quality management system. The authority to administer and implement the
quality system is delegated to the Manager of Quality Assurance (acting as
Management's Quality Representative) and others in accordance with Appendix A,
Manistar Electronics Organization Chart, Appendix B, Manistar Electronics
Master Form List and elsewhere as documented in policies and procedures.
4.1.4 Responsibility & Authority
Department supervisors shall have the responsibility and authority to
communicate their resource needs to the President and shall assume
responsibility for quality system conformance requirements when and where
named in documented policies and procedures. Such persons shall also be
responsible for ensuring that personnel under their supervision are familiar
with and comply with the relevant procedures which comprise the quality
management system in accordance with this Quality System Manual, its
referenced Policies and QSP procedures that may apply.
Employee empowerment is essential to quality awareness and
continuous improvement. Therefore, Manistar Electronics employees shall not
only be responsible for procedural compliance, but shall also be empowered to
initiate improvements in the processes and related documentation that they
play a part in maintaining.
4.1.5 Resources
The President shall be responsible for providing adequate resources in the
form of trained personnel, machines, equipment, and technologies sufficient to
achieve the quality objectives set forth in this manual . The adequacy of
resources shall be assessed in accordance with QSP 1.1, Organizing
&Implementing the Quality System & the Quality Policy.
4.1.6 Management Representative
The Manager of Quality Assurance shall act as the President's Management
Representative who, irrespective of other responsibilities, shall have defined
authority and responsibility for ensuring that the requirements of ISO9002 and
any other standard or regulatory requirements are implemented and maintained.
This person shall have defined authority and responsibility for:
· Ensuring that a quality system is established,
implemented and maintained in accordance with ISO9002.
· Reporting on the performance of the quality system to
the President as a basis for continuous monitoring and improvement of the
quality system.
4.1.7 Management
Review The quality system shall be reviewed by the President and the Manager
of Quality Assurance (acting as the Management Representative) at least twice
per year to initiate corrective actions and otherwise ensure the system's
continuing suitability and effectiveness. Available for these reviews shall be
the results of continuous internal and external quality audits (product and
system); corrective and preventive actions attendant to such audits or
notifications; adequacy of resources; quality trend and performance data;
supplier performance data and customer complaints, if any. Such reviews shall,
where appropriate, involve coordination with process owners in order to
achieve continuous quality system improvement.
4.1.8 Records
Quality records of all Management Review meetings shall be documented and
maintained by Quality Assurance in accordance with QSP 1.2, Reviewing Quality
System Performance.
4.2 Quality System
4.2.1 Purpose
To establish policy implementing a documented system structure in order to
demonstrate conformance to quality requirements.
4.2.2 General
The documented quality management system shall be organized and structured to
ensure that Manistar Electronics products meet specification and that quality
systems designed and implemented to meet such goals conform to applicable
national commercial or regulatory standards by means of adherence to quality
processes documented in writing. Such standards shall include ISO9002/1994
also known as ANSI/ASQC Q9002/1994 in the U.S.
There shall exist a Manistar Electronics Quality System Manual outlining
quality policies and system structure meeting requirements. The system shall
consist of specific quality policies which are in turn referenced to
procedures, work instructions forms, tags, labels and specific quality records
(whether generated by the company, its suppliers or customers) contained in
department sub-manuals and files.
The Manager of Quality Assurance shall be responsible for the design and
maintenance of the documented quality management system.
4.2.3 Quality System Structure
The Manistar Electronics documented quality management system shall consist of
four procedural levels structurally organized and controlled along
departmental lines as detailed in Appendix C, Manistar Electronics, Inc.
Quality System Sub-Manual Structure. Adherence to documented requirements
contained in procedures shall be mandatory for those employees concerned and
changes to such documents shall be subject to approval and distribution
control in accordance with applicable procedures for referenced documents and
data so controlled.
4.2.4 Quality System Procedures
Policies & procedures contained in the Quality System Manual shall be
called QSM's and those contained in department level sub-manuals shall be
called QSP's each of which shall be driven by a corresponding policies
contained in the QSM. QSP's shall be created when additional information at
the department level is needed to implement QSM policy.
Subordinate to QSP's shall exist Quality System Instructions (QSI's).
Written QSI's shall be published when the risks of quality non-conformance are
high and where there has been no provision for employee job training and/or
qualification testing as a substitute for such instructions. QSP's and QSI's
shall be located together in department level sub-manuals and shall not exist
unless referenced to each other and to one or more QSM's.
4.2.5 Other Quality Documents
QSM's, QSP's and QSI's shall reference all hard copy forms, tags, labels and
software programs, reports or instructions of which they are a part. Each
referenced item, whether published internally or externally to the company,
shall be uniquely identified, referenced and controlled and a master copy
maintained in the Manistar Electronics Master List of Forms maintained by
Document Control.
In addition, Appendix B shall contain a Manistar Electronics Master List of
Forms containing a list of all hard copy forms, tags, labels and software
programs, reports or instructions associated with the documented system.
4.2.6 Quality Records
QSM's, QSP's and QSI's shall also reference relevant quality records of which
they are a part. Each record shall be uniquely identified, referenced and
controlled in the same manner as the document to which they are referenced.
4.2.7 Quality Plans
This Quality System Manual constitutes the essential quality plan for all
Manistar Electronics, Inc. functional activities related to quality. In
addition, however, individual, written, limited-life quality requirements
expressed as written quality plans may be prepared and issued in accordance
with customer contracts or pre-contractual technical proposals/bids. Such
requirements shall be reviewed, approved and released as controlled documents
to those parties concerned in order to meet quality requirements but none
shall waive or preempt standard requirements expressed as policy in this
quality system manual without the written consent of both the President and
the Manager of Quality Assurance.
Once customer contracts have been fulfilled, Quality Plans related to them
shall be retired.
4.3 Contract Review
4.3.1 Purpose
To establish policy implementing a documented system for contract review and
acknowledgment of all incoming orders, as well as for the handling of changes
or product returns associated with same.
4.3.2 General
Applicable procedures shall exist for contract review and acknowledgment of
all customer orders, as well as for the handling of changes or product returns
associated with same.
The President or others as may be assigned shall be responsible for
functioning and maintenance of contract review processes.
4.3.3 Contract Review
All incoming commercial and military orders, whether for domestic or export
customers as well as quotations or bids shall be reviewed and approved by
those assigned. Such orders may include but are not limited to:
Contract review procedures governing the order acceptance process shall
ensure that:
o Customer quality plans, if any have been documented,
reviewed and incorporated.
o Commercial, military or regulatory standards, if any,
have been referenced, reviewed and incorporated.
o Customer requirements have been adequately defined &
documented including those related to quality, quantity and delivery.
o That Manistar Electronics has the capability to meet such
customer requirements.
4.3.4 Contract Acknowledgment
· Each customer order, once reviewed and accepted, shall
be acknowledged in writing.
· Customer verbal orders shall be followed by hard copies
confirmation.
4.3.5 Domestic Product
All domestic orders shall be processed in accordance with documented
procedures.
4.3.6 Export Product
All orders for export shall be processed in accordance with documented
procedures.
4.3.7 Contract
Amendments Any contractual changes, waivers or deviations shall be identified,
communicated and documented in writing and agreed to by the customer and
Manistar Electronics prior to their acceptance and incorporation.
4.3.8 Product Returns
Whether under warranty or not, all customer returns shall be processed in
accordance with documented procedures.
4.3.9 Contract
Records Records of all contracts, contract reviews, approvals, changes,
deviations, waivers, acknowledgments, invoices, shippers and other customer
correspondence shall be maintained by the Accounting in accordance with
documented procedures.
4.4 Design Control
Manistar Electronics does not design the products it sells. ISO9002 does not
require the coverage of the Design.
4.5 Document & Data Control
4.5.1 Purpose
To establish policy implementing a system to maintain and control documents
and data, whether provided by Manistar Electronics or its customers,
pertaining to the quality management system.
4.5.2 General
There shall exist documented procedures to ensure that all documents and data
comprising the quality management system, whether provided by Manistar
Electronics or its customers, are approved before issue, controlled during use
and removed or obsoleted when no longer valid for their intended purpose.
President shall be responsible for the control of documents and data in any
media including hard copy or electronic form and ensure that:
o A master list called the Manistar Electronics Master
List of Controlled Documents & Data naming such items be maintained.
o A master list of document holders called the Manistar
Electronics Document Holder's List naming such items be maintained.
4.5.3 Document & Data
Approval & Issue Review, approval and issue of controlled documents and
data shall be recorded and otherwise accomplished in accordance with
established procedures. Such procedures shall ensure that prior to issue, each
controlled document:
o Is reviewed and approved for adequacy by authorized
personnel with access to pertinent background information upon which to base
such an approval.
o Carries a unique identification number and control block
clearly identifying the document by name, date of issue and applicable
revision level.
o Is available to those parties concerned at appropriate
locations.
o Issuance be recorded on a master list, database or
equivalent system to clearly identify those parties holding current copies of
the document.
A quality record shall be documented and maintained by the Document Control
Department which provides a list of those parties holding current copies of
controlled documents and data and be identified as the Manistar Electronics
Master Document Holders List.
4.5.4 Issuance of Uncontrolled
Documents or Data Unapproved or uncontrolled documents shall not be used for
quality acceptance purposes . All documents used for quality acceptance shall
be clearly identified with the words "Controlled Document".
4.5.5 Document & Data Changes
Document and data changes shall be reviewed by those parties concerned and,
when possible, approved by the original issuing authority. Relevant background
information shall be furnished to reviewing and approving authorities prior to
the implementation of changes in accordance with documented procedures. Such
procedures shall ensure that:
o Changes be reviewed and approved by those parties most
closely associated with release of the original document.
o A change history be maintained and, where practical,
approved changes flagged on controlled documents.
o Issuance be recorded on a master list, database or
equivalent system to clearly identify those parties holding current issues of
the document.
o Be promptly re-issued when applicable changes have been
made.
o Be promptly recalled from all points of use as soon as
invalidated or obsoleted.
o As required, be stored in accordance with applicable
procedures as inactive documents or data.
All controlled documents shall be maintained in legible, traceable
condition and be revised and re-issued as often as necessary to maintain
system effectiveness.
4.6 Purchasing
4.6.1 Purpose
To establish policy implementing a documented system to ensure that purchased
products and services conform to requirements and that supplier quality and
delivery performance meets Manistar Electronics requirements.
4.6.2 General
There shall exist documented procedures to ensure that purchase specifications
are accurately communicated.
The company shall purchase materials and services from approved suppliers.
The Purchasing Manager shall be responsible for functioning of the
purchasing system.
4.6.3 Purchase Specifications
Originators shall provide clear descriptions of required products or services,
including revisions and applicable specifications. Typically, such data shall
include:
o The type, class, grade or other precise identification
(e.g., Manistar Electronics or supplier part number).
o The title or other positive identification and applicable
issues of specifications.
o Manufacturer and catalog/commercial grade descriptions
and Date Codes.
o Quantity, delivery and terms of business.
o The specification of quality system and quality assurance
requirements.
All purchase requisitions shall be approved by the governing department
manager from which the request originated and Purchase Orders by the
Purchasing Manager and President.
Approved purchase data shall originate with customer requirements and flow
through to Purchasing via the approving authority and Quality Assurance in
accordance with documented procedures.
Buyers shall review and approve each Purchase Order for adequacy to
specified requirements but shall not change technical or quality requirements
without approval prior to release from the originator in accordance with
documented procedures.
4.6.4 Subcontractor Evaluation & Control
Subcontractors, if any, shall be selected on the basis of their ability to
meet quality requirements. Selection shall be the result of a coordinated
effort by Purchasing, Quality Assurance and office of President in accordance
with documented procedures.
Subsequent to establishment, a supplier shall be added to the Manistar
Electronics Approved Vendor List as controlled and issued by Quality Assurance
in accordance with documented procedures.
As necessary, the Quality Assurance shall impose specific inspection and/or
audit assessments on selected suppliers to ensure that Manistar Electronics
quality system configuration requirements are being met and/or to resolve
quality problems at the supplier's site. Such assessments may take the form
of:
o Evaluation of product samples
o Evaluation of past performance to specification,
including delivery history.
o Registration of the suppliers quality system by a
recognized authority
4.6.5 Verification of Purchased Product
Receiving inspection activities to verify purchased product shall be conducted
by Quality Assurance in accordance with documented procedures.
Where verification of purchased product at the supplier's premises becomes
Manistar Electronics requirement (Manistar Electronics source inspection), the
Manager of Quality Assurance shall ensure verification arrangements and the
method of product release is specified by Purchasing in the supplier's
purchase order.
When a Manistar Electronics customer stipulates a right to verify purchased
product at Manistar Electronics supplier site (customer source inspection),
the Manager of Quality Assurance shall ensure that such a requirement is
specified by Purchasing in Manistar Electronics supplier purchase order.
4.6.6 Purchasing Records
A master list of approved vendors meeting Manistar Electronics quality
requirements shall be documented and maintained by Quality Assurance,
communicated to Purchasing and identified as the Manistar Electronics Approved
Vendors List.
Records of subcontractor performance, if any, shall be documented and
maintained by Quality Assurance, communicated to Purchasing and be identified
in the Manistar Electronics Approved Vendors List
4.7 Control of Customer
Supplied Product
4.7.1General
Manistar Electronics does not normally accept customer-supplied products.
However, should this situation develop, Manistar Electronics will establish
and maintain documented procedures for control of verification, storage, and
maintenance of customer-supplied product provided for incorporation into
supplies or for related activities. Any such product that is lost, damaged, or
is otherwise unsuitable for use will be recorded and reported to customer.
Verification by Manistar Electronics does not absolve the customer of the
responsibility to provide acceptable product.
4.8 Product
Identification & Traceability
4.8.1 Purpose
To establish policy implementing a documented system to ensure product is
identified by suitable means throughout all stages of receiving, delivery,
packaging and shipment.
4.8.2 General
There shall exist documented procedure to ensure that product, is identified
by suitable means throughout all stages of receiving, shipping, delivery and
packaging.
Product shall be identified upon receipt by affixing a label or mark on the
product and/or its container such that positive identification is assured
throughout all stages of product realization to the point of delivery to
customer or supplier.
Product Identification and Control shall be the responsibility of the
President for configuration control and the Manager of Quality Assurance for
recall of traceable product, or others as may be assigned.
4.8.3 Product Traceability
If a contractual or regulatory requirement, product traceability shall be
ensured by unique identification of individual product or batches the results
of which shall be filed and otherwise provided to those parties concerned.
In such a case, quality records of all traceable product shall be
maintained by Quality Assurance and identified as Manistar Electronics Product
Traceability Records.
4.9 Process Control
4.9.1 Purpose
To establish policy implementing a documented system to ensure shipment
processes directly affecting product quality are planned then carried out
under controlled conditions.
4.9.2 General
There shall exist documented procedures which ensure shipment processes
directly affecting product quality are planned then carried out under
controlled conditions.
Process control and Planning & Logistics shall be the responsibility of
the President or others as may be assigned.
4.9.3 Process Planning & Control
There shall exist documented procedures for control of inventories such that
shipment can be effectively planned and scheduled.
There shall exist documented procedures to ensure that shipment is planned
and scheduled in accordance with quality requirements.
There shall exist documented procedures to ensure shipment processes are
controlled by means of:
o Identification and use of appropriate carriers
o Approval of carriers prior to use
o Maintenance of a suitable working environment
o Maintenance of documented procedures defining the manner
of shipment where their absence could adversely affect quality
o Monitoring and control of appropriate process parameters
o Communication of workmanship standards to those concerned
4.10 Inspection & Testing
4.10.1 Purpose
To establish policy implementing a documented system to ensure that inspection
is carried out in accordance with documented plans and procedures to ensure
that the shipping products meet quality specifications.
4.10.2 General
All purchased product shall be inspected and in accordance with such plans and
procedures necessary to verify such products meet quality specifications.
Inspection shall be the responsibility of the Manager of Quality Assurance
or others as may be assigned.
4.10.3 Receiving Inspection & Testing
There shall exist documented procedures for inspection of all as-received
material in accordance with a written plan. Such plans and procedures shall be
based on documented incoming quality requirements and specifications.
Decisions as to acceptance of such material shall be based on documented
quality criteria and documented supplier performance established through
product and source surveillance records the results of which shall be recorded
.
Only incoming product that bears evidence of inspection acceptance by a
delegated verification authority shall be released to inventory for subsequent
shipment.
4.10.4 Final Inspection and Testing
Documented procedures shall exist for inspection and testing of all materials
in accordance with a written plan. Such a plan and procedures shall exist on
the basis of Manistar Electronics documented quality requirements. Decisions
as to acceptance of such materials shall be based on Manistar Electronics
documented criteria based on inspection attributes and where, appropriate by
using Statistical Quality Control methods outlined in section 4.20 of this QSM.
4.10.5 Inspection & Test
Records In the case of unverified dispatch of received material, quality
records of such dispatched items subject to possible recall shall be
maintained by Quality Assurance and identified as Non-verified Incoming
Quality Records.
Receiving inspection test records shall be maintained by Quality Assurance
and identified as Manistar Electronics Receiving Inspection Records.
Final inspection or test records shall be maintained by Quality Assurance
and identified as Manistar Electronics final inspection / test record.
4.11
Control of Inspection, Measuring, & Test Equipment
4.11.1 Purpose
To establish policy implementing a documented system to ensure the calibration
tools are sufficiently controlled, calibrated and maintained.
4.11.2 General
All calibration tools shall be calibrated to working measurement standards or
transfer measurement standards which in turn shall be calibrated to reference
measurement standards.
All purchased calibration services shall be from vendors appearing on the
Approved Vendors List in accordance with provisions contained in QSM 4.6 for
Purchasing and otherwise be selected and monitored in compliance with ANSI/NCSL
Z540-1 General Requirements for Calibration Laboratories & Measuring and
Test Equipment.
The control of calibration tools shall be the responsibility of the Manager
of Quality Assurance or others as may be assigned.
4.11.3 Contract Calibration Services
Calibration services shall be purchased in accordance with quality
requirements set forth in Section 4.6 of this QSM for purchased goods and
services and be conducted in accordance with this procedure and its applicable
references.
4.11.4 Standards Traceability
Only those calibration standards with a valid, traceable relationship to the
National Institute of Standards & Technology (NIST) shall be used for such
purposes.
4.11.5 Equipment Identification & Record Keeping
All tools subject to calibration and placed in service shall be identified
with a unique identification number and its calibration history recorded such
that its in-service performance and recommended calibration schedule can be
found.
4.11.6 Calibration Scheduling
Tools' calibration shall be performed at prescribed intervals (or prior to
each use) in accordance with a published schedule found in the calibration
history record determined on the basis of stability, purpose and usage or
sooner if there is reason to believe that the device needs recalibration.
4.11.7 Calibration & Inspection/Testing
Conditions & Methods Calibration work shall be performed in accordance
with documented procedures by trained personnel under environmental conditions
suitable for the work being performed.
4.11.8 Proof of Acceptability
Calibrated Tools shall be checked in accordance with documented procedures
following each calibration cycle to prove its capability to verify the
acceptability of its measurement.
4.12 Inspection & Test
Status test
4.12.1 Purpose
To establish policy implementing a documented system to ensure the inspection
of conforming and non-conforming product or material is identified.
4.12.2 General
There shall exist documented procedures which ensure the inspection status of
conforming and non-conforming product or material is identified with respect
to occurrences and outcomes of inspections.
4.12.3 Methodology
Where necessary, product or material shall be assigned unique part numbers to
identify and trace inspection status .
The inspection status of product or material shall be identified throughout
the shipment, receiving and delivery cycle by means of documented procedures
incorporating travelers, tags, labels, stamps and/or records, including
inspection records.
4.13 Control of
Non-Conforming Product
4.13.1 Purpose
To establish policy implementing a documented system for identification,
documentation, evaluation, segregation and disposition of product that does
not conform to specified quality requirements.
4.13.2 General
There shall exist documented procedures for to ensure that material and
product that does not conform to specified requirements is clearly identified
and controlled to prevent unintended shipment. Methods of controls shall
include, but are not limited to, segregation, tagging, marking or any other
means determined to be necessary.
The Manager of Quality Assurance, and others as may be assigned, shall be
responsible for the functioning of systems designed and implemented to handle
non-conforming material or product.
4.13.3 Identification
Upon its discovery, all non-conforming product shall be identified and
physically segregated for subsequent disposition in accordance with applicable
procedures.
4.13.4 Categorization & Disposition of Non-Conforming product
All non-conforming purchased product shall be categorized, evaluated and
dispositioned by a Material Review Board (MRB) comprised of (at a minimum)
representatives from President, Sales and Quality Assurance in accordance with
applicable procedures.
MRB shall disposition non-conformant material as follows:
o Scrap - the disposal of an item that could not
repaired to an acceptable level and is unfit for further use.
o Return-to-Vendor-or-Customer - the return of an
acceptable or unacceptable item to supplier from which it was obtained,
including a vendor subcontractor.
o Use-As-Is - the determination that considers the material
to be satisfactory for "use as-is" without waiver of the
specification and without adverse affect on form, fit or function including
safety, performance, interchange ability or reliability.
4.13.5 Reworked or Repaired
Product MRB shall classify and control all reworked or repaired product to
ensure it is processed and re-inspected in accordance with documented
procedures the details of which shall be recorded prior to release.
When contractually required, customers shall be notified when deliverable
product has been repaired.
4.13.6 Scrap
MRB shall classify non-conformant material or product and control its
disposition as scrap.
The disposition of scrap shall be recorded.
4.13.7 Return-to-Vendor-or-Customer
MRB shall classify non-conformant product for the purpose of returning it to
vendor subcontractors or customers in which case such material shall be bonded
and the customer notified for disposition in accordance with applicable
procedures the details of which shall be recorded.
4.13.8 "Use-As-Is"
MRB shall classify non-conforming product as "Use As-Is" and
authorize its continuing use in accordance with applicable procedures the
details of which shall be recorded.
4.13.9 Authorization to Classify and Disposition Goods
Manistar Electronicss shall maintain the right to classify and disposition
non-conforming material or product unless otherwise specified by contract.
When required by contract, the use or proposed use or repair of such product
shall be submitted for concession to the customer or customer's representative
at which time the non-conformity and the actual condition shall be recorded
and reported.
4.13.10 Records
Records of all non-conforming events shall be maintained by Quality Assurance
in accordance with documented procedures to ensure investigation of causes as
well as corrective and preventive actions are completed preventing future
recurrence of detrimental quality events.
4.14 Corrective &
Preventive Action
4.14.1 Purpose
To establish policy implementing a documented system for implementing
corrective and preventive action to improve quality.
4.14.2 General
There shall exist documented procedures for implementing corrective and
preventive actions that improve quality. Such corrective and preventive
measures shall be undertaken as appropriate to the magnitude of quality
problems or risks encountered.
The Manager of Quality Assurance, or others as may be assigned, shall be
responsible for the functioning of systems designed correct and prevent
quality problems.
4.14.3 Identification
All requests for corrective or preventive action, including those communicated
by customers as complaints, shall be identified in writing.
4.14.4 Categorization & Disposition of Corrective or Preventive Action
Requests
All requests for corrective or preventive action shall be categorized,
evaluated and dispositioned by a Material Review Board (MRB) in accordance
with documented procedures.
Corrective and preventive action requests shall be categorized on the basis
of problems they are issued to correct such as:
o Complaint - A verbal or written complaint received from a
customer.
o Process - a problem related to an internal process.
o Product - a problem related to a product returned from
customers
o Vendor - a problem related to material or services
supplied by others.
o Audit - a problem related to a first, second or third
party adequacy or compliance audit.
4.14.5 Corrective Action
MRB shall evaluate the need for corrective action and then assign such actions
to those parties concerned and record the results.
4.14.6 Preventive Action
MRB personnel shall evaluate the need for preventive action and then assign
such preventive actions to Quality Assurance and record the results.
4.14.7 Records
Records of all corrective or preventive actions, including customer
complaints, shall be maintained by Quality Assurance in accordance with
documented procedures to ensure detrimental quality events do not re-occur.
The corrective actions and data to be reviewed and scheduled in Management
Review meetings.
4.15
Handling, Storage, Packaging, Preservation & Delivery
4.15.1 Purpose
To establish policy implementing a documented system for handling, storage,
packaging, preservation and delivery of product.
4.15.2 General
To prevent damage or deterioration, there shall exist documented procedures
for handling, storage, packaging, preservation and delivery of product
delivered to the customer.
The Manager of Quality shall be responsible for the design of packaging
systems that ensure safe storage, process and delivery of product and the
Shipping/Receiving, shall be responsible for compliance to such requirements.
4.15.3 Handling & Storing
Product To prevent damage or deterioration, there shall exist documented
methods for handling and storing product during all stages of receipt,
storage, shipping and delivery.
To prevent damage or deterioration while stored. There shall exist documented
methods for assessment of condition of material or product including aged
product at scheduled interval.
4.15.4 Packaging of Material
To prevent damage or deterioration, there shall exist documented methods for
packaging of product during all stages of storage, shipment and delivery.
4.15.5 Preservation of Material
To prevent damage or deterioration, product shall be organized, segregated and
preserved under conditions that ensure its integrity for use.
4.15.6 Delivery of Material
To prevent damage or deterioration, product shall be prepared for shipment in
a manner that preserves its as-inspected condition.
When specified in the customer's contract, the condition of as-inspected
product shall be further preserved during delivery such that quality
characteristics and integrity for use are assured.
4.16 Control Of Quality Records
4.16.1 Purpose
To establish policy implementing a documented system for the identification,
collection, indexing, accessing, filing, storage, maintenance and disposition
of quality records.
4.16.2 General
All quality records which furnish evidence of conformance to quality
requirements shall be named, referenced and otherwise identified, collected,
indexed, filed, accessed, stored, maintained and dispositioned in accordance
with written procedures comprising the documented quality system.
Where identified in the written contract and upon advance notice and approval
of the President, quality records shall be made available to customers or
other regulatory agencies for on-site or off-site review.
4.16.3 Legibility
All quality records shall be legible and readily retrievable from a storage
environment that will not deteriorate the records themselves.
4.16.4 Referencing
The name, location and storage custodian for all quality records which are a
part of the documented quality system shall be referenced in procedures of
which they are a part.
Unreferenced quality records shall not be considered part of the documented
quality system.
4.16.5 Storage & Backup
Unless a longer period is specified by customers or regulatory authorities,
quality records shall be maintained for a minimum period of three years from
the recordation date.
In the event quality records are stored on computer file form, such
computer systems shall be supported with a disaster recovery plan which
includes appropriate file back-up and recovery procedures.
4.17 Internal Quality Audits
4.17.1 Purpose
To establish policy implementing a documented system to ensure that all
aspects of the quality management system are assessed for procedural adequacy
and verified for compliance at regular intervals in accordance with
requirements. In addition, to identify any non-conformance's and report them
to the President for appropriate follow-up and subsequent corrective action.
4.17.2 General
There shall exist documented procedures ensuring internal audits of all
aspects of the quality management system are assessed for procedural adequacy
and verified for compliance at regular intervals in accordance with
requirements. In addition, those who audit shall identify any
non-conformance's and report them to the President for subsequent corrective
action and appropriate follow-up.
The Manager of Quality Assurance shall be responsible for functioning of
the internal quality audit system.
4.17.3 Scheduling
The quality management system, including the internal quality audit function,
shall be audited at least twice per year in accordance with a written schedule
published by the Manager of Quality Assurance.
Those conducting audits shall not be a part of the system or work being
audited.
The frequency of such audits shall be based on the results of previous
audits, audit status, and the importance of the activity to be audited.
4.17.4 Corrective Action Reporting & Follow-Up
Internal quality audit results shall be documented as Corrective Actions and
provided to those persons responsible for the area audited in order to
initiate and complete necessary corrective and preventative actions.
4.17.5 Records
Records of all internal audit schedules, checklists, findings, corrective or
preventive actions shall be maintained by Quality Assurance and identified as
Manistar Electronics Internal Audit and/or Corrective Action Records.
4.18 Training
4.18.1 Purpose
To establish policy implementing a documented system to identify quality
training needs and provide for the training and skills qualification of all
personnel, whether new or existing employees, performing activities affecting
quality.
4.18.2 General
There shall exist documented procedure which ensure the training needs of
those whose activities affect quality, whether new or existing employees, are
identified and that each is provided necessary training and/or skills
qualification adequate to meet quality requirements.
The Manager of Quality Assurance shall be responsible for functioning of
the quality training system.
4.18.3 Records
There shall exist a list of those parties who have been trained and qualified
in those tasks related to quality and such individual employee records shall
be identified as Manistar Electronics Employee Training and Qualification
Records.
4.19 Servicing
Manistar Electronics does not service the products it sells under separate
contract, therefore, ISO9002 provisions for Servicing do not apply.
4.20 Statistical Techniques
4.20.1 Purpose
To establish policy implementing a documented system to ensure methods for
controlling and verifying process capability or product characteristics using
statistical methods are proceduralized and recorded.
4.20.2 General
There shall exist documented procedures to ensure methods for controlling and
verifying process capability or product characteristics using statistical
methods are proceduralized and recorded.
The Manager of Quality Assurance shall be responsible for deployment and
use of statistical quality control tools and methods.
4.20.3 Identification of Need
Statistical methods shall be validated before use and deployed with quality
plans and procedures which dictate their use.
4.20.4 Records
The results of statistical methods in verifying product or process shall be
recorded.
Applicable Procedural References
Internal Ref. Quality Process Sub-Manual
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