CLAUSE 7: Product Realization
7.1
Title: Planning of Product Realization
·
Managers of departments involved in production processes which directly affect the quality of intermediate and
end products are responsible for ensuring that these processes are identified, planned, and executed under controlled conditions. Controlled conditions are defined to include one or more of the following requirements:
a)
Documented procedures for production and installation where their absence would adversely affect quality.
b)
Compliance with reference standards, codes, and quality plans
c)
Monitoring and control of suitable process parameters and product characteristics
d)
Approval of processes and equipment as appropriate
e)
Criteria for workmanship are either written procedures or expressed by means of representative samples.
f)
Suitable maintenance of equipment to ensure continuous process capability
Process records are defined in QMS SOP 4.9 and maintained according to QMS SOP 4.16.
Dominion Taping & Reeling maintains documented procedures for inspection
and testing in order to verify that the specified requirements for product are met.
These procedures are detailed in QMS-4.10-SOP.
7.2 Title:
Customer Related Processes
7.2.1 DETERMINATION OF REQUIREMENTS RELATED TO THE PRODUCT
·
Before the acceptance of an order or contract, the responsible person will determine
a) Requirements specified by
the customer, including requirements for delivery
b) Requirements not stated by
the customer but necessary for intended use
c) Any applicable industry standards related to the service or product.
d) Any other requirements determined by DTR
7.2.2 REVIEW OF
REQUIREMENTS RELATED TO THE PRODUCT
·
Before the acceptance of an order or contract, the responsible person will review the documents to ensure that:
a) The requirements are adequately
defined and documented
b) Any requirements differing
from those in the tender are resolved, agreed upon, and documented
c) Dominion Taping & Reeling
has the capability to meet the contractual requirements
d) All requirements comply with
applicable industry standards
·
Dominion Taping & Reeling will not accept any order or enter into any contract for which it cannot satisfy
the above criteria.
· The
General Manager has the primary responsibility for coordinating contract reviews of a customer order for products and/or services. He or she is also responsible for assigning the duty for their execution.
· Contract Reviews
are conducted, documented, and coordinated with the customer according to Contract
Review Procedure, QMS-4.3-SOP
·
The General Manager has the primary responsibility to document changes to contracts or orders and communicate
them to the respective functional areas.
· Contract reviews and related data are documented
by Dominion Taping & Reeling using an order number, and customer name. This
documentation is maintained in the customer file for minimally, the length of the contract.
7.2.3 CUSTOMER COMMUNICATION
·
DTR has determined and implemented effective arrangements for communicating with customers in relation to
a)
Product and service information
b)
Inquiries, contracts or order handling, including amendments
c)
Customer feedback, including customer evaluations and complaints
- The General Manager has
the primary responsibility for coordinating contract reviews of a customer order for products and/or services. He or she is also responsible for assigning the duty for their execution.
·
Contract Reviews are conducted, documented, and coordinated with the customer according to Contract Review Procedure, QMS-4.3-SOP
·
The General Manager has the primary responsibility to document changes to contracts or orders and communicate
them to the respective functional areas.
·
Contract reviews and related data are documented by Dominion Taping & Reeling using an order number, and
customer name. This documentation is maintained in the customer file for minimally,
the length of the contract.
·
These requirements are addressed in detail in QMS 4.3 SOP.
7.3 Title:
Design and Development
Justification for Exemption: Dominion Taping and Reeling
does not engage in design and development as defined in the Standard. All principle
product characteristics are specified by the customers. Our activities are limited
to developing methods and means of production.
7.4 Title:
Purchasing
7.4.1 PURCHASING PROCESS
· The Manager of Purchasing is responsible for ensuring
that all purchased products and subcontracted services that have an impact on the quality of Dominion Taping & Reeling
products or services conform to specified requirements per QMS-4.6-SOP.
· The Manager of Purchasing is responsible for the
following activities:
a)
Establish an Approved Supplier List (ASL) on the basis of defined criteria related to supplier’s ability to meet
Dominion Taping & Reeling requirements for quality, cost, and delivery.
b)
Maintain the ASL based upon supplier performance and review of the supplier’s capability versus Dominion Taping
& Reeling requirements.
c)
Define the extent of control Dominion Taping & Reeling has over subcontractors.
Control
is defined by, but not limited to, EIA Standards and customer/product specific
standards.
7.4.2 PURCHASING INFORMATION
· The Manager of Purchasing will initial all purchasing
documents to ensure that they clearly describe the product ordered, including where applicable:
a)
The type, class, style, grade, or other precise identification.
b)
The title or other positive identification, and applicable issue of specifications, drawings, process requirements,
inspection instructions, and other relevant technical data including requirements for approval or qualification of product,
procedures, process equipment and personnel.
7.4.3 VERIFICATION OF PURCHASED PRODUCT
· The Manager of Purchasing is responsible for verifying
that purchased product conforms to specified requirements.
· Dominion Taping & Reeling performs no supplier
verification at any subcontractor premises.
· When contractually specified or mutually agreed
upon, Dominion Taping & Reeling’s customer or customer representative shall be afforded the right to verify at the
subcontractor’s premises that the product conforms to specified requirements.
· This verification shall not be used by Dominion
Taping & Reeling as evidence of effective quality control.
· This verification shall not absolve Dominion Taping
& Reeling of the responsibility of providing acceptable product, nor does it waive the right of the customer to reject
product.
· Dominion Taping & Reeling does not use incoming
product until it has been verified as conforming material.
· Verification through inspection and testing is
done in accordance with Dominion Taping & Reeling QMS-4.10-SOP which addresses
such issues as:
a)
Use of proper methods for inspection and testing.
b)
Isolation, identification, and control of nonconforming materials.
c)
Identification and distribution of acceptable materials.
d)
Documentation and storage of inspection records and certificates of compliance.
·
Dominion Taping & Reeling relies predominantly on subcontractor Certificates of Compliance (COCs), as recorded
evidence of product conformity that cannot be verified by inspection.
7.5 Title: Production and Service Provision
7.5.1 CONTROL OF PRODUCTION AND
SERVICE PROVISION
· The Production Manager is responsible for
ensuring that in-process product is held and not used or processed further until it has been inspected, tested, or otherwise
verified and conforming to specified requirements.
· Process monitoring and control of materials
is done in accordance with Dominion Taping & Reeling’s QMS-SOP which
address such issues as:
a) The
availability of product information (4.7 SOP)
b) The
availability of work instructions (4.5 SOP)
c) The
use of suitable equipment (4.9 SOP)
d) The
availability and use of monitoring and measuring devices (4.11 SOP)
e) The
implementation of monitoring and measurement (4.7 SOP)
f)
The implementation of release, delivery and post-delivery activities (4.15 SOP)
g)
Control of nonconforming materials (4.13 SOP)
h) First piece/product inspection (4.7 & 4.9 SOP)
i)
Rework policy and process. (4.13 SOP)
j)
Documentation and use of records (4.16 SOP)
·
Dominion Taping & Reeling ensures that the quality of product, and the conformance to specified requirements
is extended to include delivery to destination.
·
Only insured and reputable shippers with electronic tracking capabilities are used.
· Dominion Taping
& Reeling maintains an adequate amount of insurance coverage to replace product that is damaged or destroyed.
7.5.2 VALIDATION OF PROCESSES
FOR PRODUCTION AND SERVICE PROVISION
Justification for Exemption: DTR is able to verify the output of all processes for production and services before
products or services have been delivered.
7.5.3 IDENTIFICATION AND TRACEABILITY
· Dominion Taping & Reeling, Inc. establishes
and maintains methods for identifying supplies, component parts, subassemblies, and finished goods throughout all stages of
production, installation, and delivery. Product identification is maintained
and controlled through Dominion Taping & Reeling QMS-4.8 SOP.
· Dominion Taping & Reeling uses computer-based
software to record the receipt of materials, and maintain accurate records on inventory status and levels on a real time basis.
· The Purchasing Manager is responsible for ensuring
that all incoming materials are clearly identified either individually (where appropriate) or as a lot while they are located
at incoming inspection or in transit to storage or use in production.
· The Purchasing Manager maintains records identifying
incoming materials by part number, and their corresponding purchasing documentation such as specifications, inspection requirements,
acceptance criteria, and other pertinent data.
· The Production Manager is responsible for ensuring
that in-process materials are clearly identified.
· Customer supplied product is “labeled” by means
of a 2 part identification and tracking system which identifies the material (part # and description), shows its routing,
and identifies its current state of processing.
· Finished products manufactured either by or for
Dominion Taping & Reeling are identified by means of a job order number, part number, and other pertinent data as required
by the contract.
· Dominion Taping & Reeling identifies the
inspection and test status of all products by using RECORDS & FORMS, per
4.2.3, which indicate the conformance or nonconformance of the product with regard to the inspection and tests performed. The identification of inspection and test status is maintained, as necessary, throughout
production and installation of the product to ensure that only product that has passed the required inspections and tests
is dispatched, used, or installed.
· Company personnel responsible for the release
of conforming product, based upon inspection and test activities, are responsible for “signing off” on the appropriate
inspection and/or test “reports” which serve as records.
· Company personnel who detect non-conforming product
are responsible for following the policies and procedures addressed in this manual and the SOP manual.
· Dominion Taping & Reeling maintains records
for each job order that include specification sheets, bill of materials, engineering drawings, and contract specifications
used for manufacture where applicable.
· The responsibilities
for generating, filing, and maintaining records are defined in the QMS-4.10-SOP.
7.5.4 CUSTOMER PROPERTY
· The Quality Manager is responsible
for, and maintains procedures for ensuring that all component parts, subassemblies, and test materials supplied by our customers
are verified against specified requirements, identified, and maintained in adequate storage until required for use or incorporated
into our products. The assignment of responsibilities for control of customer
supplied product, and guidelines for the reporting and documentation of lost, damaged, or unsuitable product, are addressed
in the previous section and in Dominion Taping & Reeling’s QMS-4.7 &
4.10-SOP.
7.5.5 PRESERVATION OF PRODUCT
· Dominion
Taping & Reeling maintains documented procedures for the handling, storage, packaging, preservation, and delivery of product. These procedures are detailed in QMS-4.15-SOP.
·
Dominion Taping & Reeling maintains Standard Operating Procedures (SOP), that are designed to reflect the
requirements of this clause. These procedures include:
1. Proper
handling of inventory used to create a finished good.
2. Proper
handling of customer supplied product.
3. Extensive,
and detailed instructions concerning Electro-Static Discharge, (ESD).
·
Dominion Taping & Reeling uses designated storage areas, and stock rooms to prevent damage or deterioration
of product pending use or delivery.
·
Dominion Taping & Reeling utilizes First-In, First-Out (FIFO) to ensure proper inventory rotation, and usage. Inventories are performed at designated intervals to detect deficiencies in rotation
or product deterioration. Proper methods of receipt and dispatch of product are
utilized and documented.
·
All active components are stored in Black Conductive storage bins once received, and scheduled for production.
·
Dominion Taping & Reeling uses written procedures to ensure the proper handling, packaging, and shipping
of all products dispatched from our premises.
·
Dominion Taping & Reeling utilizes the following two (2) methods to ensure the proper segregation and preservation
of all products when under Dominion Taping & Reeling control.
1. Standard
Operating Procedures (SOP), specifying proper methods to reflect this clause.
2. Proper
identifying Forms and Records specifying job order when applicable, location in storage, or location in process.
7.6 Title: Control of Monitoring and Measuring Devices
· Dominion Taping & Reeling
maintains documented procedures to control, calibrate, and maintain inspection, measuring, and test equipment. These procedures are designed to demonstrate conformance of product to specified requirements.
· The Quality Manager is responsible for ensuring
that all inspection, measuring, or test equipment used in any stage of production or installation is controlled, calibrated,
and maintained to accurately and consistently demonstrate the conformance of product to specified requirements. These procedures are detailed in QMS-4.11-SOP.
· The Control Procedure, QMS-4.11-SOP, includes provisions for:
1.
Determinations of measurements to be made and the accuracy required.
2.
Identifying all inspection, measuring, and test equipment that effects product quality, and calibrate at prescribed
intervals.
3.
Calibration processes specifically defined using certified equipment, and nationally recognized standards. These processes include frequency of checks, acceptance criteria, check methods, and action to be taken
when results are unsatisfactory.
4.
Identifying all inspection, measuring, and test equipment with an approved identification form.
5.
Maintenance of calibration records.
6.
Documenting the validity of previous results when inspection, measuring, and test equipment is found to be out of calibration.
7.
Maintenance, care, and storage of calibrating equipment and standards.