ANSI/ISO/ASQ Q9001:2000 DOCUMENT
CARLIN SYSTEMS, INC.
QUALITY MANUAL
THIS DOCUMENT IS CONTROLLED ONLY
IF COPY
IS STAMPED ‘CONTROLLED’ IN RED INK
INDEX
PAGE 2 INDEX
PAGE 3 COMPANY HISTORY
PAGE 4 QUALITY POLICY/QUALITY OBJECTIVES
PAGE 5 ORGANIZATIONAL CHART
PAGE 6 EIGHT QUALTY MANAGEMENT PRINCIPLES AS
A BASIS OF ISO
Q9001:2000
PAGE 7 PROCESS APROACH TO QUALITY MANAGEMENT
PAGE 8 PROCESS MAP OF ORDER FULLFILLMENT
PAGE 9 SUMMARY OF CHANGES
QUALITY MANUAL
PAGE 10 4.0 QUALITY SYSTEM
4.1 GENERAL REQUIREMENTS
4.2.1 DOCUMENT REQUIRMENTS
4.2.2 QUALITY MANUAL
4.2.3 CONTROL OF DOCUMENTS
4.2.4 CONTROL OF RECORDS
PAGE 12 5.0 MANAGEMENT RESPONSIBILITY
5.1 COMMITMENT
5.2 CUSTOMER FOCUS
5.3 QUALITY POLICY
5.4 PLANNING
5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION
5.6 MANAGEMENT REVIEW
PAGE 14 6.0 RESOURCE MANAGEMENT
6.1 PROVISION OF RESOURCES
6.2 COMPETENCE, AWARENESS AND TRAINING 6.3 INFRASTRUCTURE
6.4 WORK ENVIRONMENT
PAGE 15 7.0 PRODUCT REALIZATION 7.1 PLANNING
7.2 CUSTOMER RELATED PROCESSES 7.3 DESIGN AND DEVELOPMENT
7.4 PURCHASING
7.5 PRODUCTION
7.6 CONTROL OF MONITORING AND MEASURING
DEVICES
PAGE 19 8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT 8.1 GENERAL
8.2 MONITORING AND MEASUREMENT 8.3 CONTROL OF NONCONFORMING PRODUCT
8.4 ANALYSIS OF DATA
8.5 IMPROVEMENT
COMPANY
HISTORY
CARLIN SYSTEMS, INC.
Carlin Systems, Inc.
(CSI) Originated in 1991 by John and
Carlin Systems
services a wide variety of customers, both domestically and internationally,
with electronic components as well as computer products. Some of our customers
take advantage of our dock to stock program where our quality and reliability
allow them to bypass their receiving inspection and enter the components
directly into their inventory.
Carlin Systems is
continually evaluating opportunities to obtain additional franchises as long as
it enhances our service to present and future customers.
Carlin Systems is
dedicated to providing our customers with superior service and quality products
which are competitively priced and delivered on schedule.
John Giovan Christopher Giovan
President Vice President
Nicholas Giovan
ISO Management Representative
CARLIN
SYSTEMS, INC.
QUALITY POLICY
Carlin Systems is a customer
oriented company that continually strives to meet or exceed our customer’s
expectations in quality, price, delivery and service innovation. In addition to
these goals, Carlin Systems is committed to continually improving the
effectiveness of our Quality Management System.
We provide our customers with
quality products that are competitively priced and delivered on time.
QUALITY OBJECTIVES
Carlin
Systems Quality Objectives for the coming year are to reduce the number of RMAs
attributable to Carlin’s own activities and to maintain pricing, on time
delivery schedules, and service innovation at consistently high levels to our
customers.
John Giovan
President
ORGANIZATIONAL CHART
EIGHT QUALITY MANAGEMENT PRINCIPLES
AS A BASIS OF ISO9001
CUSTOMER FOCUS:
AN ORGANIZATION DEPENDS ON THEIR CUSTOMERS AND SHOULD THERFORE UNDERSTAND
CURRENT AND FUTURE NEEDS. AN ORGANIZATION SHOULD ALSO MEET CUSTOMER
REQUIREMENTS AND
STRIVE TO EXCEED CUSTOMER EXPECTATIONS.
LEADERSHIP:
LEADERSHIP ESTABLISHES UNITY OF PURPOSE AND DIRECTION. STRONG LEADERSHIP
CREATES AND MAINTAINS AN OPERATING ENVIRONMENT IN WHICH PEOPLE CAN BECOME FULLY
INVOLVED IN ACHIEVING ORGANIZATIONAL OBJECTIVES.
INVOLVEMENT:
PEOPLE AT ALL LEVELS ARE THE ESSENCE OF AN ORGANIZATION. FULL INVOLVEMENT
ENABLES THEIR ABILITIES TO BE USED FOR THE ORGANIZATION’S BENEFIT.
PROCESS APPROACH:
A DESIRED RESULT IS ACHIEVED MORE EFFICIENTLY WHEN ACTIVITIES AND RELATED
RESOURCES ARE A MANAGED PROCESS.
SYSTEM APPROACH TO MANAGEMENT: identifying, understanding and
manageing interrelated processes as a system contributes to the organization’s
effectiveness and efficiency in achieving it’s objectives.
continual improvement: continual improvement of the
organization’s overall performance should be a permanent objective of the
organization.
factual approach to
decision-making: effective decisions are based on the analysis of the data and
information.
mUTUALLY BENEFCIAL SUPPLIER
RELATIONSHIPS: AN ORGANIZATION AND ITS
SUPPLIERS ARE INDEPENDENT AND A MUTUALLY BENIFICIAL RELATIONSHIP ENHANCES THE
ABILITY OF BOTH TO CREATE VALUE.
tHESE
EIGHT QUALITY M ANAGEMENT PRINCIPALS FORM THE BASIS FOR THE QUALITY MANAGEMENT
SYSTEM STANDARDS WITHIN THE ISO 9000 FAMILY.
SOURCE
ansi/iso/asq q9000-2000
PROCESS APPROACH
The basic requirement
of a quality management system is that the organization must identify and
manage the family of processes needed to ensure conformity. The quality
management system ensures compliance of the quality policy and quality
objectives are met. Organizations should not lose sight of these basic
concepts. It is too easy to get so absorbed in documenting a system that the
basic concept is lost. While documentation is important, the organization’s
primary emphasis should be on developing and implementing effective quality management
system processes.
Clause 4.1 requires
that processes be developed and implemented to make up the overall system. It
also requires that the processes be managed and continually improved. These
improvement activities must include the monitoring, measurement and analysis of
these processes.
The activities that
Carlin Systems, Inc. needs to consider the following:
1. The identification of processes and
their interrelationships, sequences and interactions
2. The establishment of criteria and means
to effectively operate, monitor, measure, analyze
and control the process
3. The improvement of the Quality
Management System’s effectiveness (including improvements
to the process).
CARLIN SYSTEMS, INC.
MAP OF ORDER
FULLFILLMENT PROCESS
..
1) Customer places order via phone
and/or fax 2) Order is handwritten on order form by Sales 3) Purchasing writes
up PO and places order with Vendor 4) Order and PO are submitted to Order Entry
to be checked and entered into system (and print-out of order generated) 5)
Order and PO are filed by receiving and await receipt of goods 6) Product
arrives and order and PO are pulled (by Receiving) according to PO # on Vendor
packing slip and Customer Order # 7) Product is inspected by Receiving
Inspector for damage, correct part #, date code, country of origin, etc. 8) If
product passes inspection and is due to ship, the order is filled-out and the
product is sent to Shipping for packing/shipping 9) If product is not due to
ship, a copy of the order is made and placed with the product awaiting
delivery. Copy of order is placed with appropriate Salesperson. 10) Product
purchased for stock is inspected by Receiving, an inventory card is filled-out
and it is placed into stock awaiting future sale 11) Once orders are due to ship they are
carefully packed by Shipping and shipped according to pre-arranged instructions
to the Customer.
SUMMARY OF
CHANGES
|
Revision |
Change(s) |
Effective Date |
Approved by |
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ORG |
Original |
August 1, 2003 |
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A |
Added
7.5.1(f) and 7.5.4 to Quality Manual Scope (Section 4.2.2) as per audit |
October 28, 2003 |
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B |
Changed
Quality Objective text to read “RMAs” not “customer returns” on page 4 of
this manual; changed text of 8.2.4 and removed reference to “retired”
SOP, as per audit |
November 5, 2003 |
|
|
C |
Removed form 80203Rev. ORG on
page 4 |
November 13, 2003 |
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D |
Removed “at least” under 8.2.2
;Added “Review of Manual” on page 9;Changed text under 7.2.3 |
November 4, 2004 |
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E |
Added more objectives to be
consistent with our quality policy on page 4 |
October 28, 2005 |
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REVIEW OF MANUAL
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POSITION |
SIGNATURE
& DATE |
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4.0 Quality Management System
4.1 General requirements:
Carlin Systems has established, documented, implemented and maintains a Quality
Management System and continually improves its effectiveness in accordance with
the requirements of ANSI/ISO/ASQ Q9001:2000.
Carlin Systems
a)
identifies the
process as needed for the Quality Management System,
b)
determines the
sequence and interaction of these processes,
c)
determines the
criteria and methods required ensuring the effective operation and control of
these processes,
d)
ensures the
availability of information and resources necessary to support the operation and
monitoring of these processes,
e)
measures, monitors and analyzes these processes, and implements
action necessary to achieve planned results and continual improvement of these
processes.
These processes shall
be managed by the organization in accordance with the requirements of these
international standards.
4.2 Document requirements
4.2.1 General:
Carlin Systems’ Quality Management System documentation shall include
a)
documented
statements of a quality policy and quality objectives,
b)
a Quality
Manual,
c)
documented
procedures required by this International Standard,
d)
documents
needed by the organization to ensure the effective planning, operation, and
control of its processes, and
e)
records required by this International Standard.
4.2.2 Quality Manual:
This manual is issued to describe the Quality Management System and related
processes employed in all operations by Carlin Systems, Inc. This manual and
the systems and processes it describes serve to:
·
ensure
conformance to customer requirements
·
implement
Carlin Systems’ Quality Policy and Quality Objectives
·
address
the intent and requirements of ISO 9001:2000
Carlin Systems is a
value added reseller of electronic components and computer products. Carlin
Systems’ customer base includes OEMs, contract manufacturers, exporters and
distributors. The sequence of operation
starts with marketing/sales determining customer requirements. The next step is
purchasing or product, inspection, packaging/shipping and delivery. Support operations
include development and administration of the quality system, planning,
training, management review, resource management, monitoring and measuring,
internal auditing, control of nonconforming product and continual improvement.
This manual also contains a process map which graphically represents the
interaction of various processes at CSI (See page 8).
Excluded from the scope of this
manual:
v Clause 7.3,
Product R&D, as Carlin Systems does not currently design product
v Clause 7.5,
The Service portion of Production and Service Provision, as Carlin Systems does
not provide after-market servicing of any kind
v
Clause 7.5.1(f), Post-Delivery is
excluded from line f, as Carlin Systems does not currently provide
post-delivery activities of any kind
v Clause 7.5.2,
“Special Processes”, as Carlin Systems has, to date, performed no such
processes
v
Clause 7.5.4, Customer Property,
as Carlin does not use or otherwise incorporate customer property into products
4.2.3 Control of documents: Carlin Systems has a documented procedure for the control
needed (see SOP 4.2.4)
a)
to approve
documents prior to issue,
b)
to review and
update as necessary and re-approve documents,
c)
to ensure
changes and the current revisions status of documents are identified,
d)
to ensure
relevant versions of applicable documents are available at the points of use,
e)
to ensure that
documents remain legible and are readily identifiable,
f)
to ensure that
documents of external origin are identified and their distribution controlled
and,
g)
to prevent the unintended use of obsolete documents and to apply
suitable identification to them if they are retained for any purpose.
4.2.4 Control of records:
Carlin Systems has a documented procedure for the control required for the
identification, storage, protection, retrieval, and retention time of quality records
(See SOP 4.2.4).
5.0 Management responsibility
5.1 Management commitment: The management at Carlin Systems has a
commitment to the development and implementation of the Quality Management
System, as well as a commitment to continually improve its effectiveness by
a) communicating to the organization the importance of meeting customer as well as statuary and regulatory requirements,
b)
having clearly
defined quality objectives,
c)
adhering to
quality policy,
d)
conducting
management reviews on, at least, an annual basis, and
e)
providing all the required resources necessary to maintain the
Quality Management System.
5.2 Customer focus:
Carlin Systems ensures that the customer requirements are determined and met
with the aim of enhancing customer satisfaction.
5.3 Quality policy:
Executive management at Carlin Systems shall ensure that its quality policy
a)
is appropriate
to the purpose of the organization,
b)
includes a
commitment to comply with requirements and continually improve the
effectiveness of the Quality Management System,
c)
provides a
framework for establishing and reviewing quality objectives,
d)
is
communicated and understood within the organization, and
e)
is reviewed for continuing suitability.
5.4 Quality objectives:
Executive management must ensure that quality objectives, including those
needed to meet requirements for product, are established at relevant functions
and levels within the organization. The quality objectives shall be measurable
and consistent with the quality policy.
5.4.2 Quality planning: Executive
management shall ensure that
a) the planning of the Quality Management System is carried out in order to meet the requirements given in 4.1 as well as quality objectives, and
b)
the integrity of the Quality Management System is maintained
when changes to it are planned and implemented.
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority: Management shall ensure that responsibilities and authority
are defined and communicated to all employees with an organizational chart and
clearly defined job descriptions.
5.5.2 Management representative: The Quality Assurance Manager has been appointed as ISO
Management Representative, and, irrespective of his other duties, will have the
responsibility for
a) ensuring that the process as needed for the Quality Management System are established, implemented, and maintained,
b)
reporting to
top management on the performance of the Quality Management System and any
needed improvement and
c)
ensuring the promotion of awareness of customer requirements
throughout the organization.
5.5.3 Internal communication: Management shall ensure that appropriate communication
processes are established within the organization and communication takes place
regarding the effectiveness of the Quality Management System.
5.6 Management Review:
5.6.1 General:
Top management shall review the organizations Quality Management System at
least semi-annually to ensure the system's continuing suitability, adequacy and
effectiveness. This review shall include assessing opportunities for
improvements and the need for change to the Quality Management System,
including the quality policy and quality objectives. Carlin Systems maintains minutes of the
reviews.
5.6.2 Review Input:
The input to management review shall include information on:
a)
results of
audits,
b)
customer
feedback,
c)
process
performance and product conformity,
d)
status of
preventive and corrective actions,
e)
follow-up
actions from previous management reviews,
f)
changes that
could effect the Quality Management System, and
g)
recommendations for improvement.
5.6.3 Review output:
The output from the management review shall include any decisions and actions
related to
a) improvements of the effectiveness of the Quality Management System and its processes,
b)
improvements
of product related to customer requirements, and
c)
resource needs
6.0 Resource management
6.1 Provision of resources: Carlin Systems determines and provides resources needed
a) to implement and maintain the Quality Management System and continually improve its effectiveness, and
b)
to enhance customer satisfaction by meeting customer
requirements.
6.2 Human resources
6.2.1 General: All Carlin Systems employees performing work affecting quality are competent on the basis of appropriate education, training, skills and experience.
6.2.2 Competence, awareness and training: Carlin Systems shall determine the necessary competence for
personnel performing work affecting product quality, provide training or take
other necessary actions to satisfy these needs, evaluate the effectiveness of
the actions taken, ensure that its personnel are aware of the relevance and
importance of their activities and how they contribute to the achievement of
the quality objectives, and maintain appropriate records of education,
training, skills and experience. Carlin Systems has an SOP (See SOP 6.2.2) to
address training requirements.
6.3 Infrastructure:
Carlin Systems determines, provides, and maintains the infrastructure needed to
achieve conformity to product requirements. This infrastructure includes, as
needed:
a)
buildings,
workspace and associated utilities,
b)
process
equipment (both hardware and software), and
c)
supporting services (such as transport or communication).
These above mentioned
elements of infrastructure will be considered during management review
meetings, and where changes are deemed necessary they will be discussed and
plans generated. The manager of the department where changes to infrastructure
are to be implemented will evaluate the impact of these changes on product
integrity to ensure that acceptable product can still be produced, before they
are placed into production.
6.4 Work environment:
Carlin Systems determines and manages the work environment needed to achieve
conformity to product requirements. The conditions under which work is
performed (including physical, social and psychological factors) will be
reviewed and evaluated during management review meetings.
7.0 Product realization
7.1 Planning of product realization: Carlin Systems plans and develop the processes needed for
product realization. Planning of product realization shall be consistent with
the requirements of the other processes of the Quality Management System. While
planning product realization Carlin Systems determines the following as
appropriate:
a)
quality
objectives and requirement for the product;
b)
the need to
establish processes, documents, and provide resources specific to the product;
c)
required
verification, validation, monitoring, inspection and test activities specific
to the product and the criteria for product acceptance;
d)
records needed to provide evidence that the realization processes
and resulting product meet requirements.
The output of this
planning shall be in a form suitable for our method of operations,
7.2 Customer-related processes
7.2.1 Determination of requirements related to the product: Carlin Systems determines
a) requirements specified by the customer, including the requirement for delivery and post delivery activities,
b)
requirements
not stated by the customer but necessary for specified or intended use, where
known,
c)
statutory or
regulatory requirements related to the product, and
d)
any additional requirements determined by the organization.
7.2.2 Review of requirements related to the product: Carlin Systems reviews the requirements related to the
product prior to accepting the customer’s order. Carlin has an SOP (see SOP
7.2.2) to describe requirements of such “Contract Reviews”) and ensure that
a)
product
requirements are defined,
b)
contract or
order requirements differing from those previously expressed are resolved prior
to accepting the contract, and
c)
that the company has the ability to meet the defined
requirements.
¨ Records of the review will be maintained
¨ Carlin Systems does not accept verbal orders.
¨ Where an amendment to an order is requested, the sales
department will make such an amendment, if possible.
7.2.3 Customer communication: Carlin Systems determines and implements effective
arrangements for communicating with customers in relation to
a)
product
information,
b)
inquiries,
contract or order handling, including amendments, and
c)
customer feedback, including customer complaints.
The sales department
maintains all communication with buyers and customers and communicates any
relevant complaints to a concern/complaint form. These complaints are then discussed within
the management review meetings.
7.4 Purchasing
7.4.1. Purchasing process:
The type and extent of control applied to the supplier and the purchased
product is dependent upon the effect the purchased product has on subsequent
product realization or the final product.
Carlin Systems evaluates and selects suppliers on their ability to supply product in accordance with their requirements (see SOP 7.4). Criteria for selection, evaluation and reevaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained.
7.4.2 Supplier control process: Purchasing information shall describe the product to be
purchased, including where appropriate
a)
requirements for
approval , procedures, and equipment,
b)
requirements
for the qualification of personnel,
c)
Quality
Management System requirements.
The Purchasing
Manager or his/her designee will approve all purchase orders for accuracy.
Carlin Systems has
receiving work instructions for the receipt of purchased materials and
services.
7.4.3 Verification of Purchased
Product: Carlin Systems shall
establish and implement the inspection or other necessary activities necessary
for ensuring that purchased product meets specified purchase requirements.
Carlin Systems
assures that no product is used or processed prior to receiving inspection to
ensure that all incoming products conform to all specific requirements.
Carlin Systems does
not release product without receiving inspection. The amount of receiving inspection
required by Carlin Systems depends upon
the control exercised by the vendor and the past history of the
vendor
When a customer or
Carlin Systems intends to perform verification at the suppliers premise the verification
arrangements and the method of product release will be stated in the purchase
order.
7.5 Production provision
7.5.1 Control of production: Carlin Systems carries out production under controlled
conditions. Carlin Systems has an SOP (SOP 7.5) to address the requirements of
“Process Control” that includes, as applicable
a)
the
availability of information that describes the characteristics of the product,
b)
the
availability of instructions as necessary,
c)
the use of
suitable equipment,
d)
the
availability and use of monitoring devices,
e)
the
implementation of monitoring and measurement, and
f)
the implementation of release and delivery activities.
7.5.3 Identification and traceability: Where appropriate, Carlin Systems identifies the product as
to the monitoring and measuring requirements of the product throughout the
production process. Where traceability is required by contract, Carlin Systems
controls and records the unique identification of the product.
All incoming
materials is identified by the customer’s part number or the manufactures part
number. The Receiver or the Receiving Inspector will assure that all product
received is identified with the correct part number as required by the Purchase
Order. If differences are noted they are resolved prior to the acceptance of
the order.
It is the Warehouse Managers responsibility to assure proper
identification
during the storage operation.
Prior to delivery, the packer will ensure that the product
is properly identified.
v
Traceability
is not a requirement at this time at Carlin Systems. If it ever
becomes a requirement, documented procedures will be
initiated.
7.5.5 Preservation of product: Carlin Systems preserves the conformity of the product
during internal processing and delivery to the intended destination. This
preservation contains identification, handling, packaging, storage, and
protection (Where preservation applies to the constituent parts of a product).
Carlin Systems has an SOP (SOP 7.5.5) to control the handling, storage,
packaging and delivery of a product.
7.6 Control of monitoring and measuring devices: Carlin Systems determines the monitoring and measurements to
be taken and the monitoring and measuring devices needed to provide evidence of
conformity of product to determine requirements.
Currently, Carlin
Systems’ only calibrated equipment is a counting scale that is maintained and
calibrated by an outside vendor. This equipment is calibrated at specific
intervals according to calibration/maintenance contract. In the event the
equipment is suspected to be out of calibration or to have become damaged the
equipment will adjusted or readjusted as necessary. The scale is identified to
enable the calibration status be determined and it is safeguarded from
adjustments that would invalidate the measurement results as well as protected
from damage and deterioration during handling, maintenance and storage, as
applicable.
Carlin Systems
assesses and records the validity of the previous measuring results when the
equipment is found not to conform to requirements.
Carlin Systems does
not use computer hardware or software for inspection and will develop
procedures for controlling such activities should such equipment be used.
8.0 Measure, analysis and improvement
8.1 General:
Carlin plans and implements the monitoring, measurement, analysis and
improvement process needed to demonstrate conformity of the product, to ensure
conformity of the Quality Management System, and continually improve the
effectiveness of the Quality Management System. This includes the determination
of applicable methods, including statistical techniques and the extent of their
use.
The Quality Assurance
Manager will evaluate all processes and products to determine if there is a
need for statistical techniques to establish, control and verifying process
capability or processes characteristics. All new or modified product or
operations will be evaluated during the quality planning stages and the results
recorded in the quality planning report. If the decision to use statistical
techniques is determined, the Quality Assurance Manager is responsible for
generating a documented procedure to implement and control the application of
the statistical technique identified, as well as for the training of all
employees using the technique in the data collection.
8.2 Monitoring and measurement
8.2.1 Measurement and monitoring of customer satisfaction: Carlin Systems monitors information relating to customer
perception as to whether the organization has met customer requirements. This is
performed by logging in complaints and returns for evaluation as well as by a
Customer satisfaction Survey that is sent out randomly and evaluated for
results. The results of customer perception-related data collected is one of
many inputs evaluated during the annual management review meeting.
8.2.2 Internal audits:
Carlin Systems conducts internal audits twice per year to determine if the
Quality Management System conforms to planned arrangements, the requirements of
this standard, and to the Quality Management System requirements established by
Carlin Systems, as well as to determine how effectively the system is
implemented and maintained.
Carlin’s SOP (SOP
8.2.2) describes how this program takes into consideration the importance of
the processes and areas to be audited, as well as the results of the previous
audits. The scope, frequency and the method are defined in the required
documented procedure, along with the responsibility and requirements for
planning and conducting the audit, reporting results and maintaining records.
SOP 8.2.2 clearly
outlines how auditors cannot audit their own work. It also describes how the
management of the area being audited shall ensure that actions are taken
without undue delay to eliminate detected nonconformities and causes. The
nonconformities will be followed up by the auditor to ensure that they have
been implemented and are effective.
8.2.3 Measurement and monitoring: Carlin Systems applies applicable methods for monitoring
and where applicable, measurement of the management system processes. These
measurements shall demonstrate the ability of the process to achieve planned
results. When a planned result is not achieved, appropriate corrective action
is taken.
8.2.4 Measurement and monitoring of a product: Carlin Systems monitors and measures the characteristics of
the product to whatever degree deemed
necessary or otherwise appropriate by Carlin Systems to ensure the product’s
integrity. This is carried out during receiving inspection in accordance with
planned arrangements. Inspection is performed by an authorized inspector and
records are maintained which indicate which inspector performed
inspection/verification of product integrity/conformity.
Carlin requires that
all operations required be completed and found to be acceptable prior to
delivery.
8.3 Control of nonconforming product: Carlin Systems ensures that product that does not conform
to product requirements is identified and controlled to prevent unintended use
or delivery. The controls and related responsibility and authorities for
dealing with nonconformities are defined in a documented procedure (See SOP
8.3).
Carlin Systems deals
with nonconforming product by one or more of the following ways:
a)
by taking
action to eliminate the detected nonconformity;
b)
by authorizing
its use, release or acceptance under concession by a relevant authority, and
where applicable by the customer;
c)
by taking action to preclude its original intended use or
application.
Records of the nature
of the nonconformities and any subsequent action taken, including concessions
obtained, are maintained.
When nonconforming
product is corrected it shall be verified to the requirement.
When nonconforming
product is detected after delivery or use has started, Carlin Systems will take
action appropriate to the effect or potential effect of the nonconformity.
Where it is determined that the nonconformity is so significant as to warrant
it, Carlin Systems will contact the recipients of such product via phone, fax
or email and alert them of the issue or recall and replace the product. A CAR
will be issued to record the nonconformity and will be saved as per 4.2.4.
8.4 Analysis of data:
Carlin Systems determines, collects and analyzes appropriate data to
demonstrate the suitability and effectiveness of the Quality Management System,
and to evaluate where continual improvement of the effectiveness of the Quality
Management System can be made. This uses data generated as a result of
monitoring and measurement and from any other relevant resources.
The analysis of data
shall provide information relating to
a)
customer
satisfaction,
b)
conformity to
product requirements,
c)
characteristics
and trends of processes and products including opportunities for preventive
action, and
d)
suppliers.
8.5 Improvement
8.5.1 Continual improvement: Carlin Systems continually improves the effectiveness of
the Quality Management System through the use of the quality policy, quality
objectives, audit results, analysis of data, corrective and preventive actions
and management review.
8.5.2 Corrective action:
Carlin Systems takes action to eliminate the cause of nonconformities in order
to prevent recurrence. Corrective actions shall be appropriate to the effects
of the nonconformities encountered.
A documented procedure
has been generated (see SOP 8.5.2) to define the requirements for
a)
reviewing
nonconformities (including customer complaints),
b)
determining
the cause of the nonconformities,
c)
evaluating the
need for action to ensure that nonconformities do not recur,
d)
determining
and implementing action needed,
e)
records of the
results of actions taken, and
f)
reviewing corrective action taken.
8.5.3 Preventive action:
Carlin Systems determines actions to eliminate the causes of potential
nonconformities in order to prevent their occurrence Preventive action shall be
appropriate to the effect of the potential problem.
A documented
procedure has been generated for preventive action (see SOP 8.5.3) to define
the requirements for
a)
determining
potential nonconformities and their causes,
b)
evaluating the
need for action to prevent occurrence of nonconformities,
c)
determining
and implementing action needed,
d)
records of
results of action taken (see 4.2.4), and
e)
reviewing preventive action taken.