CARLIN SYSTEMS, INC.
QUALITY SYSTEM
MANUAL
ISO 9001:2008
AS 9120A
REVISION H
DATED 05/15/14
31 Floyds Run
Bohemia, New York 11716
631-471-2000
www.carlinsystems.com
THIS DOCUMENT IS CONTROLLED ONLY IF COPY
IS STAMPED ‘CONTROLLED’ IN RED INK
INDEX
PAGE
PAGE
PAGE
PAGE
PAGE
2
3
4
5
6
PAGE 7
PAGE 8
PAGE 9
INDEX
COMPANY HISTORY
QUALITY POLICY/QUALITY OBJECTIVES
ORGANIZATIONAL CHART
EIGHT QUALTY MANAGEMENT PRINCIPLES AS A BASIS OF
Q9001:2000
PROCESS APROACH TO QUALITY MANAGEMENT
PROCESS MAP OF ORDER FULLFILLMENT
SUMMARY OF CHANGES
ISO
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 18
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
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COMPANY HISTORY
CARLIN SYSTEMS, INC.
Carlin Systems, Inc. (CSI) Originated in 1991 by John and Chris Giovan. Their goal was to
provide superior service throughout the distribution cycle. As present, CSI occupies 8000
square feet of office and warehouse space in Bohemia, NY, and has 16 employees.
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
President
Christopher Giovan
Vice President
Nicholas Giovan
ISO Management Representative
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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:
 Maintain product conformity
 Maintain customer satisfaction
 Maintain on time delivery
John Giovan
President
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ORGANIZATIONAL CHART
PRESIDENT
John Giovan
ISO MANAGEMENT
REPRESENTATIVE
Nick Giovan
VICE PRESIDENT
Q.A. MANAGER
Chris Giovan
Nick Giovan
HUMAN
RESOURCES
Grace Gallo
SALES
PURCHASING
RECEIVING
WAREHOUSE/SHIPPING
pping
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EIGHT QUALITY MANAGEMENT PRINCIPLES
AS A BASIS OF ISO9001
CUSTOMER FOCUS: AN ORGANIZATION DEPENDS ON THEIR CUSTOMERS AND
SHOULD THEREFORE 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
MANAGING 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 BENEFICIAL SUPPLIER RELATIONSHIPS: AN ORGANIZATION AND ITS
SUPPLIERS ARE INDEPENDENT AND A MUTUALLY BENEFICIAL RELATIONSHIP
ENHANCES THE ABILITY OF BOTH TO CREATE VALUE.
THESE EIGHT QUALITY M MANAGEMENT PRINCIPALS FORM THE BASIS FOR THE
QUALITY MANAGEMENT SYSTEM STANDARDS WITHIN THE ISO 9000 FAMILY.
SOURCE ANSI/ISO/ASQ Q9000-2000
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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
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).
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interactions
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CARLIN SYSTEMS, INC.
MAP OF ORDER FULLFILLMENT PROCESS
CUSTOMER
SALES
VENDOR
RECIEVING
QUALITY
INSPECTION
Evaluates and
approves
ORDER ENTRY
STOCK
PURCHASING
SHIPPING
..
1) Customer places order via phone, fax and/or email 2) Order is handwritten or typed 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/lot 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.
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SUMMARY OF CHANGES
Revision
ORG
A
B
C
Change(s)
Effective Date
Original
August 1, 2003
Added 7.5.1(f) and 7.5.4 to
Quality Manual Scope
(Section 4.2.2) as per audit
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
Removed form 80203Rev.
October 28, 2003
Approved by
November 5, 2003
November 13, 2003
ORG on page 4
D
Removed “at least” under
November 4, 2004
8.2.2 ;Added “Review of
Manual” on page 9;Changed
text under 7.2.3
E
Added more objectives to be
October 28, 2005
consistent with our quality
policy on page 4
F
Reviewed and adjusted the
May 18, 2010
entire manual to comply with
the latest ISO 9001-2008
standard.
G
Revised page numbering
June 8, 2010
H
Updated to AS9120A
May 15, 2014
REVIEW OF MANUAL
NAME
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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 ISO 9001:2008 and AS9120A, and any customer and
applicable statutory and regulatory requirements (OHSA, ITAR, EPA,etc).
Carlin Systems
a) determines 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) monitors, measures (where applicable) 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.
Carlin Systems does not outsource any of its processes or activities. Should any outsourcing
of processes or activities be necessary in the future, standard vendor evaluation controls
would be utilized.
NOTE: Processes needed for the quality management system referred to above include
processes for management activities, provision of resources, product realization,
measurement, analysis and improvement.
4.2 Document requirements
4.2.1 General: Carlin Systems’ Quality Management System documentation shall include
a)
b)
c)
d)
documented statements of a quality policy and quality objectives,
a Quality Manual,
documented procedures and records required by this International Standard,
documents, including records, determined by the organization to be necessary to
ensure the effective planning, operation, and control of its processes.
Management will ensure personnel have access to and are made aware of relevant Quality
Management System documentation and changes.
NOTE: Where the term ‘documented procedure’ appears within this international standard,
this means that the procedure is established, documented, implemented and maintained. A
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single document may address the requirements for one or more procedures. A requirement
for a documented procedure may be covered by more than one document.
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 9001:2008 and AS9120A.
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:
 Clause 7.3, Product R&D, as Carlin Systems does not currently design product
 Clause 7.5, The Service portion of Production and Service Provision, as Carlin
Systems does not provide after-market servicing of any kind
 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
 Clause 7.5.2, “Special Processes”, as Carlin Systems has, to date, performed no such
processes
 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 4.2.3)
a)
b)
c)
d)
e)
f)
to approve documents prior to issue,
to review and update as necessary and re-approve documents,
to ensure changes and the current revisions status of documents are identified,
to ensure relevant versions of applicable documents are available at the points of use,
to ensure that documents remain legible and are readily identifiable,
to ensure that documents of external origin determined by the organization to be
necessary for the planning and operation of the quality management system 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.
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4.2.4 Control of records: Records established to provide evidence of conformity to requirements
and of the effective operation of the Quality Management System are controlled.
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).
Records will be maintained so as to remain legible, readily identifiable, and retrievable.
Records will include, when applicable, manufacturer and distributor test and inspection reports,
original certificates of conformity, nonconformance and corrective action records, lot traceability
records, and environmental and shelf life condition records.
Where records are stored in an electronic form, back-up procedures have been developed. These
electronic are secured to prevent unauthorized alteration or change, and cannot be corrupted due to
software or system changes.
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.
Executive Management will ensure that product conformity and on-time delivery performance is
measured, and that appropriate action is taken if planned results are not, or will not be, achieved
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.
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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 Company’s 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
d) the organizational freedom and unrestricted access to top management to resolve
quality management issues
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.
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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 affect 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 conformity to product
requirements are competent on the basis of appropriate education, training, skills and
experience.
NOTE: Conformity to product requirements can be affected directly or indirectly by personnel
performing any task within the quality management system.
6.2.2 Competence, Training and Awareness: Carlin Systems shall
a) determine the necessary competence for personnel performing work affecting
conformity to product requirements.
b) where applicable, provide training or take other actions to achieve the necessary
competence.
c) evaluate the effectiveness of the actions taken.
d) 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.
e) maintain appropriate records of education, training, skills and experience. Carlin
Systems has an SOP (See SOP 6.2.2) to address training requirements.
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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, communication, or information systems)
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.
NOTE: The term ‘work environment’ relates to those conditions under which work is
performed including physical, environmental, and other factors (such as noise, temperature,
humidity ,lighting, or weather).
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, and documents, and to provide resources specific to
the product;
c) required verification, validation, monitoring, measurement, 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;
e) configuration management appropriate to the product
The output of this planning shall be in a form suitable for our method of operations,
7.1.1 Configuration Management
Executive Management has established, implemented, and maintains a configuration
management process that includes, as appropriate to the product
a) configuration management planning
b) configuration identification
c) change control
d) configuration status
e) configuration audit
7.1.2 Control of Work Transfers
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Executive Management has established a process for planning and controlling temporary or
permanent transfer of work and to verify the conformity of the work to requirements.
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 applicable to the product, and
d) any additional requirements considered necessary by the organization.
NOTE: Post-delivery activities include, for example, actions under warranty provisions,
contractual obligations such as maintenance services, and supplementary services such as
recycling or final disposal.
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,
c) that the company has the ability to meet the defined requirements,
d) risks (e.g., new technology, short delivery time scale) have been identified
 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.
7.4 Purchasing
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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.
Executive Management takes responsibility for the conformity of all products purchased from
suppliers, including product from sources defined by the customer.
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 (see 4.2.4).
Carlin Systems:
a) maintains a register of suppliers that includes the approval status and the scope of the
approval,
b) periodically reviews supplier performance; results of these reviews will be used as a
basis for establishing the level of controls to be implemented,
c) defines the necessary actions to take when dealing with suppliers that do not meet
requirements,
d) ensures where required that both the Company and all suppliers use Customerapproved special process sources,
e) defines the process, responsibilities, and authority for approval status decision,
changes of the approval status, and conditions for a controlled use of suppliers
depending on the supplier’s approval status,
f) determine and manage risk when selecting and using suppliers, and
g) implemented controls to prevent the purchase of counterfeit/suspect unapproved
products.
7.4.2 Supplier control process: Purchasing information shall describe the product to be
purchased, including where appropriate
a)
b)
c)
d)
requirements for approval , procedures, and equipment,
requirements for the qualification of personnel,
Quality Management System requirements,
the identification and revision status of specifications, drawing, process requirements,
inspection/verification instructions and other relevant technical data,
e) requirements for design, test, inspection, verification, use of statistical techniques for
product acceptance, and related instructions for acceptance by the Company, and as
applicable critical items including key characteristics
f) requirements regarding the need for the supplier to
- notify the Company of nonconforming product,
- obtaining Company approval for nonconforming product disposition,
- notifying the Company of changes in product and/or process, changes of suppliers,
changes of manufacturing facility location, and where required, obtain Company
approval,
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- flow down to the supply chain the applicable requirements including customer
requirements,
g) records retention requirements, and
h) right of access by the Company, our Customers, and regulatory authorities to the
applicable areas of all facilities, at any level of the supply chain, involved in the order and
to all applicable records
i) requirements for a certificate of conformity, test reports, and/or airworthiness certificate
The Purchasing Manager or his/her designee will approve all purchase orders for accuracy.
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.
Carlin Systems has receiving work instructions for the receipt of purchased materials and
services. (See SOP 7.4)
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)
b)
c)
d)
e)
f)
g)
the availability of information that describes the characteristics of the product,
the availability of instructions as necessary,
the use of suitable equipment,
the availability and use of monitoring and measuring equipment,
the implementation of monitoring and measurement,
the implementation of product release, delivery, post-delivery activities,
accountability for all product during production (e.g., parts quantities, split orders,
nonconforming product),
h) evidence that all production and inspection/verification operations have been
completed as planned, or as otherwise documented and authorized,
i) provision for the prevention, detection, and removal of foreign objects,
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j) monitoring and control of utilities and supplies (e.g., water, compressed air, electricity,
chemical products) to the extent they affect product quality, and
k) criteria for workmanship, specified in the clearest practical way (e.g., written
standards, representative samples or illustrations).
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
product realization. Where traceability is required by contract, Carlin Systems shall control
the unique identification of the product and maintain records.
Identification of the configuration of the product will be maintained in order to identify any
differences between the actual configuration and the agreed configuration.
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.
Acceptance authority media are used (e.g., stamps, electronic signatures, passwords) under
appropriate controls for the media.
Where traceability is a requirement, the unique identification of the product will be controlled and
records maintained (ref. sect. 4.2.4 Control of Quality Records).
Product identification and traceability will be maintained from receipt, during splitting, storage,
packaging, and preservation operations, and until delivery (including subcontracted handling or
packing operations).
7.5.5 Preservation of product: Carlin Systems preserves the product during internal
processing and delivery to the intended destination in order to maintain conformity to
requirements. As applicable, preservation shall include identification, handling, packaging,
storage, and protection. Preservation also 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.
Preservation of product will also include, where applicable in accordance with product specifications
and applicable statutory and regulatory requirements, provisions for:
a) cleaning,
b) prevention, detection and removal of foreign objects,
c) special handling for sensitive products,
d) marking and labeling including safety warnings,
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e) shelf life control and stock rotation,
f) special handling for hazardous materials,
7.6 Control of monitoring and measuring equipment: Carlin Systems determines the
monitoring and measurements to be taken and the monitoring and measuring equipment
needed to provide evidence of conformity of product to determine requirements.
A register of the monitoring and measuring equipment is maintained, and define the process
employed for their calibration/verification including details of equipment type, unique
identification, location, frequency of checks, check method and acceptance criteria.
Executive Management has established processes to ensure that monitoring and measurement
can be carried out and are carried out in a manner that is consistent with the monitoring and
measurement requirements.
Calibrations are performed under environmental conditions that are suitable for the calibrations,
inspections, measurements and tests being carried out.
Currently, Carlin Systems’ only calibrated equipment is a counting scale that is maintained
and calibrated by an outside vendor (annually). This equipment is:
a) calibrated or verified, or both, at specific intervals according to calibration/maintenance
contract.
b) In the event the equipment is suspected to be out of calibration or to have become
damaged the equipment will be adjusted or readjusted as necessary.
c) identified in order to determine the calibration status.
d) safeguarded from adjustments that would invalidate the measurement results.
e) protected from damage and deterioration during handling, maintenance and storage,
as applicable.
A process has been established, implemented and maintained for the recall of monitoring and
measurement equipment requiring calibration or verification.
Carlin Systems assesses and records the validity of the previous measuring results when the
equipment is found not to conform to requirements.
Records of the results of calibration and verification shall be maintained (see 4.2.4).
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:
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a) to demonstrate conformity to product requirements,
b) to ensure conformity of the Quality Management System, and
c) 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.
8.2 Monitoring and measurement
8.2.1 Customer satisfaction: As one of the measurements of the performance of the
Quality Management System, Carlin Systems monitors information relating to customer
perception as to whether the organization has met customer requirements.
Information to be monitored and used for evaluation of customer satisfaction includes product
conformity, on-time delivery performance, customer complaints, and corrective action requests.
Plans will be developed and implemented for customer satisfaction improvement that address
deficiencies identified by these evaluations, and assess the effectiveness of results.
NOTE: 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
a) conforms to planned arrangements, the requirements of this standard, and to the
Quality Management System requirements established by Carlin Systems,
b) 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 status and
importance of the processes and areas to be audited, as well as the results of the previous
audits. The audit criteria, scope, frequency and the method are defined in the required
documented procedure. The selection of auditors and conduct of audits shall ensure
objectivity and impartiality of the audit process.
Carlin’s SOP (SOP 8.2.2) defines the responsibility and requirements for planning and
conducting the audit, reporting results and maintaining records.
Records of the audits and their results shall be maintained (see 4.2.4).
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 any necessary corrections and
corrective 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.
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8.2.3 Measurement and monitoring of Processes: Carlin Systems applies applicable
methods for monitoring and where applicable, measurement of the quality management
system processes. These measurements shall demonstrate the ability of the process to
achieve planned results. When a planned result is not achieved, correction and corrective
action shall be taken, as appropriate.
In the event of process nonconformity, the following will occur:
a) appropriate action is taken to correct the nonconforming process,
b) evaluation is made to determine whether the process nonconformity has resulted in
product nonconformity,
c) determine if the process nonconformity is limited to a specific case or whether it could
have affected other processes or products, and
d) identification and control the nonconforming product (see 8.3).
NOTE: When determining suitable methods, it is advisable that the organization consider the
type and extent of monitoring or measurement appropriate to each of its processes in relation
to their impact on the conformity to product requirements and on the effectiveness of the
quality management system.
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 (see 7.1). Evidence of
conformity with the acceptance criteria shall be maintained.
Measurement requirements for product acceptance are documented and include
a)
b)
c)
d)
criteria for acceptance and/or rejection
where in the sequence measurement and testing operations are performed,
required records of the measurement results, and
any specific measurement instruments required and any specific instructions associated
with their use
When sampling inspection is used as a means of product acceptance, the sampling plan will
be justified on the basis of recognized statistical principles and appropriate for use.
Inspection is performed by an authorized inspector and records are maintained which
indicate which inspector performed inspection/verification of product integrity/conformity and
release of product for delivery to the customer (see 4.2.4).
Where required to demonstrate product qualification, records will provide evidence that the product
meets the defined requirements.
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The release of product and delivery of service to the customer does not proceed until all the planned
arrangements have been satisfactorily completed, unless otherwise approved by Executive
Management, and where applicable, by the Customer.
All documents required to accompany the product will be present at delivery.
8.2.5 Evidence of Conformance – Certificate of Conformity: When required, the Customer
will be provided evidence of the product’s conformity.
When splitting product, copies of original documents will be annotated with the following
information: amount delivered relative to amount received, purchase order number,
customer's name, and supplier's name.
Where there is a formal agreement with the Customer, a Certificate of Conformity that
references the original manufacturer's conformance documents that are retained and
traceable, will be provided, and if applicable, defines requirements have been met throughout
the company’s processes.
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. SOP 8.3 defines the controls and related responsibility and authorities for dealing
with nonconformities.
A documented procedure defines the responsibility and authority for review and disposition of
nonconforming product and the process for approving personnel making these decisions.
Where applicable, Carlin Systems shall deal 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
d) by taking action appropriate to the effects, or potential effects, of the nonconformity
when nonconforming product is detected after delivery or use has started
- The nonconforming product control process provides for timely reporting of delivered
nonconforming product.
e) By taking actions necessary to contain the effect of the nonconformity on other
processes or products.
Product dispositioned for scrap will be conspicuously and permanently marked, or positively
controlled, until physically rendered unusable.
When nonconforming product is corrected it shall be subject to re-verification to demonstrate
conformity to the requirements.
Records of the nature of the nonconformities and any subsequent action taken, including
concessions obtained, are maintained (see 4.2.4).
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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 (see 8.2.1),
b) conformity to product requirements (see 8.2.4),
c) characteristics and trends of processes and products including opportunities for
preventive action (see 8.2.3 and 8.2.4), and
d) suppliers (see 7.4)
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.
Executive Management will monitor the implementation of improvement activities and evaluate
the effectiveness of the results.
8.5.2 Corrective action: Carlin Systems takes action to eliminate the causes 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)
b)
c)
d)
e)
f)
g)
reviewing nonconformities (including customer complaints),
determining the cause of the nonconformities,
evaluating the need for action to ensure that nonconformities do not recur,
determining and implementing action needed,
records of the results of actions taken,
reviewing the effectiveness of the corrective action taken
flow down of the corrective action requirements to a supplier when it is determined that
the supplier is responsible for the nonconformity
h) specific actions where timely and/or effective corrective actions are not achieved, and
i) determining if additional nonconforming product exists based on the causes of the
nonconformities and taking further action when required.
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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)
b)
c)
d)
e)
determining potential nonconformities and their causes,
evaluating the need for action to prevent occurrence of nonconformities,
determining and implementing action needed,
records of results of action taken (see 4.2.4), and
reviewing the effectiveness of the preventive action taken
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