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dominion Taping & Reeling

 QUALITY MANAGEMENT SYSTEM MANUAL

 

 

Based on ISO 9001:2000

International Standard

 

 

Compiled by:

 

Friend L. Wells

Quality Manager

 

QUALITY SYSTEM POLICY MANUAL APPROVAL AUTHORIZATION
FUNCTION
SIGNATURE
DATE
REVISION
PRESIDENT/GENERAL MANAGER

 

 

 

VICE PRESIDENT QUALITY

 

 

 


QUALITY MANUAL INDEX Rev. 0303

 

The first page of this manual (after this table of contents) is an attachment which outlines the changes made between the previous rev level and this one.  This attachment should be reviewed before consulting this document.

CLAUSE                            TITLE

 1                                            Introduction, Purpose, Scope and Exclusions

1.1                Process Interaction

2                      References                                                      

3                      Terms and Definitions                                                  

4                      Quality Management System

    4.1              General Requirements and Interaction of Processes                                 

    4.2              Documentation Requirements                                                    

5                                 Management Responsibility                                                       

5.1                            Management Commitment             

5.4              Planning            

    5.5              Responsibility, Authority and Communication                

    5.6              Management Review                                                       

6                     Resource Management                                     

    6.1              Provision of Resources             

    6.2              Human Resources                                 

    6.3              Infrastructure                

    6.4              Work Environment                   

7                     Product Realization       

    7.1              Planning of Product Realization                                           

    7.2              Customer Related Processes                                         

    7.3              Design and Development                                                         

    7.4              Purchasing                                                        

7.5                            Production and Service Provision  

7.6                            Control of Monitoring and Measuring Devices

8                                      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

 Changes from previous Rev level

This document has undergone major revisions to comply with the ISO 9001:2000 Standard.  For details, please refer to the previous rev. level (October 99) which referenced the ISO 9002 Standard.

 

 

Clause: 1                    

Title: Introduction, Purpose, & Scope

 

 1.01    Executive Introduction

Founded July 1, 1997, Dominion Taping & Reeling, Inc is a full service, surface mount device packaging business located in Richmond, VA.  DTR specializes in 2 areas of the surface mount industry.  (1) Standard packaging on tape & reel of ICs, chips, etc., and (2) custom manufactured carriers.  Our existence in the electronics industry is governed by our Mission Statement, which states:

 

MISSION STATEMENT

 

Dominion Taping & Reeling, through continuous improvement, will achieve the status of being a premier tape & reel provider to the electronics industry by:

 ·        Being committed to our 4 operational priorities: PRICING, QUALITY, TURN-AROUND, & DELIVERY.

·        Having only one customer at a time; i.e. customizing our services to each of our customer needs and expectations.

·        Being committed to training & educating our employees in every aspect of our 4 operational priorities.

·        Paying our suppliers in a timely manner, thereby being considered a preferred customer.

 We at Dominion Taping & Reeling believe that 100% customer satisfaction is the only acceptable outcome.  We also know that 100% customer satisfaction is a continuous journey of flexibility, adaptability, and change.  Dominion Taping & Reeling is committed to this journey.

 

1.02          Purpose

The purpose of this Quality System Manual (QM) is to address and define policies, authorities, and responsibilities that will achieve 3 specific objectives.

            1.)    To serve as a road map that gives direction and meaning  to the operational priority,  “QUALITY” in our Mission Statement.

2.)    To mirror the Statement of Quality Commitment stated here.

3.)    To obtain certification in ISO 9001:2000.

 

 STATEMENT OF QUALITY COMMITMENT

 Dominion Taping & Reeling, Inc. has 4 Operational Priorities; Quality, Pricing, Turn-Around, and Delivery.  Quality is the foundation upon which Dominion Taping & Reeling operates in the electronics industry.  This foundation and bedrock demands that a Quality Management System is integrated into every system and process.

 Meeting or exceeding customer expectations, and meeting or exceeding industry standards are the only acceptable outcomes.  This demands that each and every employee be an integral part of the Quality Management System.  Involvement in, and integration of our Quality Management System will ensure the success and ongoing prosperity of Dominion Taping & Reeling, Inc.

Specifically, we are committed to seeing that every job is done right, at or below market price, on time, and delivered according to our customer’s requirements.  We are also committed to the continual improvement of the effectiveness of this quality management system.
 

 

 

 

 1.03 Scope

This manual encompasses Dominion Taping & Reeling, Inc. quality system in accordance with ISO 9001:2000.  The Quality Management System is applicable to the provision of surface mount device packaging services and the production and distribution of custom manufactured carrier tape.

 

1.04   Customer Focus

 The purpose of DTR’s Quality System is to meet and exceed our customer’s requirements.  This includes our four operational priorities of quality, price, turn around time, and delivery.  It also includes our commitment to any requirements not specifically stated by the customer, but necessary for the proper use of the products and services and compliance to accepted industry standards.

 DTR will monitor customer satisfaction per Clause 8.2.1 of this manual.

1.05     Exclusions

ISO 9001:2000 Section 7.3, Design and Development, including all subsections.  Please see justification below in CLAUSE 7.3

 ISO 9001:2000 Section 7.5.2, Validation of process for production and service provision.  Please see justification below in CLAUSE 7.5.2.

 1.10    Process Interaction

The following chart demonstrates the interaction between the various processes of the DTR Quality Management System.  Each process in the flow chart references, in blue, the section in the SOP Manual or Quality Manual where that process is detailed.

 There are other processes in the DTR system which interact with the entire QMS.  These processes are not represented in the flow chart.  These processes include employee training and document control.

 Processes represented in the flow chart include:

 1.      Purchasing – outlined in orange

2.      Production of carrier tape – outlined in brown

3.      Service provision of taping and reeling – outlined in pink

4.      Management – outlined in green

5.      Shipping/ delivery – outlined in blue

 Other items included on the following flow chart are sub-processes of these five main processes.

processflow.JPG

CLAUSE 2

Title: References

  •  This manual refers to the International Standard ISO/FDIS 9001:2000.
  • “EIA Standards” refers to the applicable standards issued by the Electronic Industries Association (ANSI/EIA).
  • This manual references DTR’s Standard Operating Procedures Manual (QMS SOP) where appropriate.  The SOP manual details the processes referred to in the Quality Manual.

CLAUSE 3

Title: Terms and Definitions

 

 3.01   Complaint; any written, electronic, or oral communication that concerns the overall performance, quality, or reliability of a DTR product.

 3.02   Non-Conforming; the failure of a component, manufactured material or finished good to meet specifications either before, during, or after production.

 3.03 Order# Reel Label; the label placed on a reel during pre-production to identify that reel through the production process.

 3.04 Product; any item, or sub-assembly being purchased, or value added service that is controlled by the quality system.

 3.05  Production; all activities related to the receiving of goods through the shipping of the finished product.

 3.06  Tool Request; the written request of a customer to request DTR to have a custom carrier designed for a specific product.

 3.07  Traveler; DTR’s method of tracking a product through production and documenting proper handling and quality through all processes.

CLAUSE 4:

Quality Management System

 

4.1   Title: General Requirements

Dominion Taping & Reeling maintains, and controls Quality System procedures (SOPs) that reflect the standards defined in ISO 9001:2000 International Standard.

 Dominion Taping & Reeling utilizes quality planning that is consistent to the standards defined in this policy and formatted to Dominion Taping & Reeling’s methods of operation.  Our total system will serve as our quality plan unless our customer requires otherwise.

If a customer requests DTR to deviate from our normal SOP’s, the request will be evaluated by the manager on duty.  If manager decides to deviate from the normal SOP, the customer will be required to give written approval for the customized procedure.

  4.2                                 Title: Documentation Requirements

4.2.1 GENERAL (Includes 4.2.2 Quality Manual)

 ·        Dominion Taping & Reeling maintains a documented quality system as a means to ensure that all products and services conform to specified requirements.  The quality system is structured with 4 levels of documentation that are defined in this policy.

  ·        Level 1:  Quality Management System Manual

The manual describes Dominion Taping & Reeling’s quality policy and the general company-wide structure and methods for maintaining the quality management system.

 Level 2:  Standard Operating Procedures (SOP)

Procedures are used to specify WHO does WHAT, WHEN, HOW it is done, WHAT DOCUMENTATION is used to verify that the quality activity was executed as required and WHERE the next step is performed as required by the ISO Standard.

Level 3: Operating instructions

Refers to operating instructions and manuals provided for and located with individual pieces of equipment.

Level 4:  Records and Form

Forms, designated (FORM) refers to tags, labels, stickers, preprinted sheets, stamps, and other means used to identify the status of materials, products, equipment, gauges, and other devices used in the company to achieve the specified requirements.  These will be referred to in the appropriate level procedure.

Records are maintained by Dominion Taping & Reeling in conjunction with SOP’s to provide assurance/evidence that the required product or service quality was achieved, and to ensure that the company’s quality system has been implemented correctly.

4.2.3    Control of Documents

 GENERAL

·        Dominion Taping & Reeling Inc., per QMS-4.5-SOP, maintains procedures to control all documents and data that relate to the requirements of this standard and are necessary to ensure adequate control.  Documents and data may be in the form of any printed or electronic media.

DOCUMENT AND DATA APPROVAL AND ISSUE

 ·        The Quality Manager and the Management Representative are responsible for ensuring that all Quality System Documents have the following controls in place: 

A.)        Documents, prior to distribution and use, are reviewed and have provisions for review/approval signatures and a means for indicating the document revision level.

B.)         Documents are numbered and assigned to an individual or area of use.  A master list is kept to indicate the document/rev. level/copy number, and the names and location of all controlled documents.

C.)        Obsolete documents are removed from all points of issue and use.

D.)        Any obsolete documents retained for legal or historical information purposes

         are appropriately identified.

 

DOCUMENT AND DATA CHANGES

Document changes and modifications are reviewed and approved by the same personnel or departments that performed the original review and approval unless specifically designated otherwise.  In those situations, all pertinent background information is provided or is available to the qualified designees in order to allow for an accurate and consistent review and approval.  A written record indicating the nature of document changes shall be maintained and stored with management review meeting minutes.

4.2.4    CONtrol of Quality Records

 GENERAL

 ·        Dominion Taping & Reeling maintains documented procedures for the identification, collection, filing, storage, and disposition of all quality records.  Quality records are maintained for the following reasons;

      1.      Demonstrate conformance to specified requirements.

       2.      Historical value to monitor effectiveness of quality system.

 ·        Procedures are detailed in QMS-4.16-SOP.

 CONTROL OF QUALITY RECORDS

 ·        All quality records are stored either as hard copy and/or electronic media.

·        All Department Managers have the authority and responsibility to store the quality records in such a way that they are readily retrievable, and in an environment to prevent damage, loss, or deterioration. 

·        Appropriate retention times for a specified quality record are defined in QMS-4.16-SOP.

 

·        Quality Management System (QMS) Records include:

 

1.      Management Review

2.      Approved Supplier List (ASL)

3.      Instrument Calibration Logs

4.      Internal and External Audit Records

5.      Corrective and Preventative Action Records

6.      Training Records

CLAUSE 5: Management Responsibility

 

5.1    Title: Management Commitment

 

We are committed to excellence which will result in outstanding pricing, quality, turn around and delivery that exceeds our customers’ expectations.

 

·        Dominion Taping & Reeling’s policy, (as embodied in our mission statement and our statement of quality), is to effectively communicate and educate our employees and customers regarding our commitment to quality.  The policy is also presented to all new employees in our quality awareness orientation training, and is continuously reinforced by management to insure understanding and commitment at all levels in the company

·        Our quality policy is used to maintain Dominion Taping & Reeling’s reputation for quality.  It also serves to maintain a rewarding, productive, and disciplined working environment.

 ·        The organizational structure shown in figure 1.1 illustrates the cross functional relationships and authority of personnel who manage, execute, and verify work affecting the quality of products and services provided by Dominion Taping & Reeling.

 

orgchart.jpg

5.4                                           Title: Planning

 5.4.1    Objectives for Total Quality

 ·        Provide quality products and services by striving to exceed the needs and expectations of our customers.

·        Develop a quality system based on ISO 9001:2000 Standard to foster continuous process improvement and problem prevention.

·        Define and implement our quality system based upon employee involvement and commitment to excellence.

·        Give all employees the training and support needed to provide quality products and services to all customers.

·        Communicate our mission and quality objectives to all employees, and assign individual responsibilities and accountability.

·        Establish and maintain a working environment that supports the production and delivery of high quality products and services.

·        Form relationships with both customers and vendors that will improve quality in all aspects of product usage and purchased parts.

·        Develop and maintain a team approach that emphasizes enhancing the competitiveness of the company through increased quality and productivity.

·        Provide an atmosphere that encourages every employee to achieve his or her full potential and pride in workmanship.

 

5.5     Title: Responsibility, authority and communication

 5.5.1    RESPONSIBILITY AND AUTHORITY

 ·        The responsibility and authority for the execution of the quality system and procedures are delegated to the departmental managers as integral parts of their assigned responsibilities.  Departmental managers may delegate the authority for implementation of the quality functions within their functional area, but still retain the responsibility for their execution

·        The verification of quality is a responsibility shared by Quality Assurance and individual department managers.

·        Persons to whom department managers delegate authority have the authority and organizational freedom to:

·        Identify & document quality problems for corrective actions that prevent the occurrence of nonconforming product.

·        Recommend, initiate, implement, and verify solutions for continuous quality and process improvement with appropriate approval.

·        Department managers have the authority to terminate the processing, delivery, and/or use of nonconforming items, until proper disposition of material or rectification of deficient conditions has occurred.

 ·        The responsibilities for the execution of the Quality System are as follows: (See figure 1.1)

·        Chief Executive Officer- Oversees and gives direction to all company operations.

·        President/General Manager- Oversees all functional areas.  His primary responsibilities are budgeting and contract review.

·        Vice President/Quality- Has responsibility and authority to oversee the Quality Management System.

·        Management Representative- Oversees the Quality Management System including serving as a liaison between management and auditing personnel.

·        Production Manager- Oversees the day to day scheduling, production and shipping of goods and services.

·        Human Resource Manager- Responsible for training, hiring and firing employees.

·        Office Manager- Responsible for office administration matters, invoicing, credit control and budgeting.

·        Purchasing Manager- Responsible for maintaining inventory and purchasing supplies and services for upcoming, approved work orders and other company operations.

 

5.5.2 MANAGEMENT REPRESENTATIVE

 ·        The management representative shall have the authority to establish implement, maintain and report on a quality system that complies with the ISO 9001:2000 Standard.

·        Management Rep will serve as a liaison between management and External Auditors as needed.

·        Management Rep will coordinate management reviews on a regular basis per QMS 5.6.

5.6      Title: Management Review

5.6.1 GENERAL

 ·        The quality management system at Dominion Taping & Reeling is reviewed by management personnel having direct responsibility for the system at a minimum interval of 12 months.

·        The quality system management review is coordinated by the Management Representative.  The review addresses the agenda items listed under 5.6.2 and 5.6.3.

·        A written report addressing these agenda items and the conclusions reached is submitted to the Quality Manager, the General Manager, and the company CEO by the internal auditor.

·        Records of the management reviews are filed and maintained for a period of five (5) years per SOP 4.16.  The records shall show evidence of how the review was conducted, who was involved, what factors were considered, what conclusions were reached, and what actions were taken.

 

5.6.2    Review Input

             Input for Management Review Meetings shall include:

                  A.     Results of audits

B.     Customer feedback

C.     Process performance and product conformity (our four operational priorities)

                                 1.      Done right – measured by QA stats, customer feedback and CA’s

2.      At or below market price- measured by market research

3.      On time- measured by stats from travelers, customer feedback

4.      Delivered according to customer requirements- measured from travelers, customer feedback, CA’s.

                  D.     Status of preventative and corrective actions

E.      Follow-up actions from previous meetings

F.      Planned changes that could affect the QMS

G.     Recommendations for improvement

5.6.3        Review Output

                  Output from management Review Meetings shall include:

                  A.     Improvement of QMS

B.     Improvement of product related to customer requirements

C.     Resource needs

D.     Statistics sheet to production and other areas reporting four operational priorities.

CLAUSE 6: Resource Management

 6.1                               Title: Provision of Resources

 Dominion Taping & Reeling identifies and provides adequate resources for the ongoing adherence to, and maintenance of its Quality Management System through the use of regular internal audits, training of personnel and other verification activities.

 These resources include but are not limited to

·        Competency and awareness training procedures for personnel

·        Verification activities to monitor all processes

·        Internal quality audits

·        Infrastructure that supports productivity and customer satisfaction

·        Work environment that is conducive to error free service

 6.2                                           Title: Human Resources

 6.2.1 GENERAL:

·        Dominion Taping & Reeling maintains documented procedures for identifying training needs and the implementation of training all personnel.  These procedures are detailed in QMS-4.18-SOP.

 6.2.2 COMPETENCE, AWARENESS AND TRAINING:

 ·        The General Manager, and Department Heads have the responsibility and authority for the education, and training of all personnel employed by the company.  This responsibility includes:

a)      Determining the necessary competence for personnel       performing work affecting product quality.

b)      Providing training or other actions to meet these needs

c)      Evaluating the effectiveness of this training or action

d)      Ensuring that all personnel understand the relevance and importance of their activities and how they contribute to the quality objectives of DTR

e)      Maintaining appropriate records of education, training and experience

 ·        Training records are documented and stored per QMS-4.16-SOP. 

6.3                                           Title: Infrastructure

 ·        DTR shall determine, provide and maintain the infrastructure needed to achieve our quality objectives.  This includes:

                  a)      Buildings, workspace and related facilities

b)      Process equipment, both hardware and software

c)      Supporting services such as communication

 

6.4                                           Title: Work Environment

 ·        DTR shall determine and manage the work environment needed to achieve our quality standards and ensure employee satisfaction and productivity.

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. 

CLAUSE 8: Measurement, Analysis and Improvement

8.1      General 

Dominion Taping and Reeling plans and implements the monitoring, measurement, analysis and improvement processes needed

a)      to demonstrate conformity of the product

b)      to ensure conformity of the quality management system

c)      to continually improve the effectiveness of the quality management system

 

8.2      Title: Monitoring and Measurement 

8.2.1 CUSTOMER SATISFACTION 

Dominion Taping and Reeling will conduct an annual customer satisfaction survey to determine customer perception as to whether DTR has fulfilled customer requirements.  This survey may be conducted by mail, fax, e-mail, telephone or other appropriate means.  As stated in 5.6.2 above, the results of this survey will be considered as part of the input to management review meetings and the output of that meeting will reflect the results of the survey.  Where practicable every active customer will be given the opportunity to participate in this survey. 

8.2.2 INTERNAL AUDIT 

·         The Quality Manager is responsible for scheduling quality audits.  Audits will be performed at scheduled intervals (per QMS SOP 4.17) to determine whether the quality management system

a)      Conforms to the planned arrangements discussed in 7.1 above, to the requirements of the Standard and the QMS requirements established by DTR.

b)      Is effectively implemented and maintained.

·        All areas of the Quality Management System are audited minimally once per year.

·        Audits are performed by one or more of the following individuals:

1.      A qualified in-house “Internal Auditor.”

2.      An outside consultant trained and certified as an ISO Trainer & Auditor.

3.      The Quality Manager, and General Manager.

·        Where practicable, auditors shall not audit their own work.

·        The Quality Manager compiles and records the results of Internal Audits per QMS-4-16-SOP.  The records will be given to department heads having responsibility in the areas audited.  Corrective Action Records will be given to department heads with a scheduled follow-up audit date set to verify, and record the implementation and effectiveness of the action taken.

·        Internal Quality Audit Records are maintained by the Quality Manager for 5 years. 

8.2.3 MONITORING AND MEASUREMENT OF PROCESSES 

·        Management Review meetings are used to reevaluate the need for statistical techniques.

·        DTR uses statistical techniques to establish, control and verify process capability and quality.  Procedures for these techniques may be found in QMS 4.20 SOP. 

8.2.4 MONITORING AND MEASUREMENT OF PRODUCT 

·        Management Review meetings are used to reevaluate the need for statistical techniques.

·        QMS-4.10-SOP specifies that all required inspections and tests shall be carried out and the results meet specified requirements.  DTR uses statistical techniques to establish, control and verify product conformance and quality.  Procedures for these techniques may be found in QMS 4.10 SOP AND 4.20 SOP.

·        The responsibilities for generating, filing, and maintaining inspection and test records are defined in the QMS-4.10-SOP.  Records containing evidence of conformity will be maintained per QMS 4.16 SOP.

·        Quality Assurance is responsible for ensuring that no product is dispatched until all final inspection and testing are completed to show evidence of product conformance to specified requirements.  All data and documentation covering all inspections and tests (incoming, in-process, and final) specified in QMS-4.10-SOP are available and authorized.

·        Dominion Taping & Reeling identifies the inspection and test status of all products by using records and 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.  See Policy 4.10

·        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.

 

8.3    Title: Control of Nonconforming Product 

·        Dominion Taping & Reeling maintains documented procedures with provisions to address proper handling of nonconforming product.  This control provides for identification, segregation, and disposition of the nonconforming product. It also provides for notification to be communicated to the functional areas affected, as well as notifying the affected customer.  These procedures and controls are detailed in QMS-4.13-SOP.

·        The Quality Manager, in accordance with QMS-4.13-SOP, reviews nonconforming product and has the responsibility for determining the disposition of said product.  Determinations may be:

1.      Reworked to meet specified requirements.

2.      Accepted with or without repair by concession from the customer.

3.      Rejected/Returned to customer or supplier.

4.      Rejected/Discarded.

5.      Rejected/Regraded for alternative uses, such as training.

·        All reworked products are re-inspected in accordance with quality procedures. 

8.4      Title: Analysis of Data

Dominion Taping and Reeling 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 system can be made.  In addition to the monitoring and measurement data discussed in 8.2 above, DTR also uses corrective and preventative action as a means of collecting data (8.5 below).  The analysis of this data provides information relating to:

a)      Customer satisfaction (8.2.1)

b)      Conformance to product requirements (7.2.1)

c)      Characteristics and trends of processes and products including opportunities for preventative action and improvement

d)      Suppliers

 

8.5      Title: Improvement 

8.5.1 Continual improvement 

Dominion Taping and Reeling seeks to continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventative actions and management review. 

8.5.2 Corrective Action 

·        Corrective action at Dominion Taping & Reeling is directed at revising the company’s quality systems, procedures and policies in order to eliminate the root cause(s) of problems.  The Corrective Action Procedure is utilized per QMS SOP 4.14 as follows:

a)      To review non-conformities found during either internal, external (customer) or third party audits

b)      To determine the causes of nonconformities

c)      To revise the quality systems, work processes, and quality procedures to eliminate the cause of a poor quality product or service, customer complaint or internal quality feature.

d)      To resolve quality system problems found during the “Management Review” process.

e)      To record the results of action taken

f)        To review the effectiveness of the corrective action taken

8.5.3 Preventative Action 

·     Preventive action at Dominion Taping & Reeling is directed at revising the company’s quality systems, procedures and policies in a PROACTIVE manner to eliminate problems and non-conformities before they exist. 

·     Any preventive actions are initiated with controls to ensure their effectiveness per QMS SOP 4.14.

·  Relevant data is submitted for management review to confirm the preventive actions effectiveness per 5.6 above.

 

END OF DOCUMENT

 
 
 
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