QMS Manual - Electrical Assembly Company

Electrical Assembly Systems Company Rev. 0

Quality System Manual

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ISO 9001:2008 Quality System Manual

ELECTRICAL ASSEMBLY COMPANY X

Approval Signatures:

Title: President

Title: Quality Manager

CONTROLLED DOCUMENT #

DOCUMENT STATUS

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Attachment “A”

ORGANIZATIONAL CHART

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1.0 GENERAL1.1 CONTROL COPY ISSUED

The Quality Manual is controlled in accordance with QP-4.5.1 Document and Data Control.

Document status shall be indicated on the front cover page, Controlled copies shall have the status of “Controlled” a stamped impression in red. There shall be a select number of Controlled Copies with assigned number and distributed as listed.

When requested by customers, sales representatives or other external concerned parties only “Uncontrolled Copies” will be distributed. These copies will not receive notification changes or additions.

This manual and individual procedures or documents referenced throughout are company confidential and are not to be loaned, duplicated or distributed externally except when duly authorized by the Quality Manager.

Controlled Copies Distribution:

Copy # Position Binder #

1 President 1

2 Quality Manager 23 Shop Supervisor 3

1.2 DOCUMENT REVISION

Rev. Date Responsible Person

Description of Change

0 July 2009 n/a Preliminary Manual

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1.3 TABLE of CONTENTSSUBJECT SECTION PAGE

Electrical Assembly Systems Company –ORGANIZATIONAL CHART Attachment “A”GENERAL 1.0

Control Copy Issued 1.1 Document Revision Page 1.2 Table of Contents 1.3 Definitions 1.4

CORPORATE COMMITMENT 2.0Field of Application 2.1Quality Policy 2.2

HISTORY OF ORGANIZATION 3.0 QUALITY MANAGEMENT SYSTEM 4.0

Introduction and Quality System Exclusions 4.1 Quality System Documentation 4.2

MANAGEMENT RESPONSIBILITY 5.0Management Commitment 5.1 Customer Focus 5.2 Quality Policy 5.3 Planning 5.4 Responsibility, Authority and Communication 5.5 Management Review 5.6

RESOURCE MANAGEMENT 6.0Provision of Resources 6.1 Human Resources 6.2 Infrastructure 6.3 Work Environment 6.4

PRODUCT REALIZATION 7.0Planning of Product Realization 7.1 Customer – Related Processes 7.2 Design and Development 7.3Purchasing 7.4 Production and Service Provision 7.5 Control of Monitoring and Measuring Devices 7.6

MEASUREMENT, ANALYSIS & IMPROVEMENT 8.0General 8.1Monitoring and Measurement 8.2 Internal Audits 8.2.2 Control of Nonconforming Product 8.3 Analysis of Data 8.4 Improvement 8.5

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1.4 DEFINITIONSThe following definitions shall apply to terms used in this QSM and the QMS of Electrical Assembly Company X of which this manual is a part.

Acceptance Criteria- Defined limits placed on characteristics of custom products and services; based on customer requirements and our own quality system.

Audit- A documented investigation to verify that applicable requirements are being implemented.

Calibration- Comparison and adjustment to a standard of known accuracy. Conformance- Compliance with specified requirements. Contract- Agreed requirements between a supplier and customer transmitted by any

means. Control- To exercise authority over and regulate. Delivery- The point in time and physical location at which the agreed transfer of ownership

takes place. Design- A detailed plan for a product. Design Acceptance Criteria- See Acceptance Criteria Design Requirements- Constraints imposed on the design by applicable specifications

and / or customer requirements. Design Review- A formal, documented, comprehensive and systematic examination of a

design (with or without customer inputs) to evaluate the design requirements and the capability of the design to meet those requirements and to identify problems and propose solutions.

Design Validation- The process of proving a design by testing. The required testing is that required by the customer and / or applicable product specification to demonstrate the conformance of the product to design requirements.

Design Verification- The process of examining the result of a given design or development activity to determine conformance with specified requirements.

Dispatch- To send off to a particular destination. Documentation- Recorder information. Establish- Bring into existence. Finding- Survey originated objective evidence that a control feature of the approved

Quality Management System was not implemented with an acceptable level of reliability. Instruction- Information which is given by way of direction or command for a specific

application. Non- Conformance- Any deviation from specified requirements. EASC- Electrical Assembly Company X Objective Evidence- Facts which are observed and documented.

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Observation- Survey originated objective evidence that a control feature of the approved Quality Management System is not being implemented with complete reliability but which does not constitute a finding. An observation may also include a surveyable /auditable element which is not contrary to documented requirements, but warrants further qualification of improvement.

Policy- Instruction and command from corporate management. Practice- A customary performance of certain acts in a professional field. Procedure- Manner or method of proceeding in a process carefully planned in the interest

of controlling conditions. Product- Result of activities or processes. EASC integrates only custom product. Product Realization- All phases of the development of a product. Quality- Conformance to specified requirements. Quality Assurance- Those planned, systematic and preventative actions which are

required to ensure that materials, products or services will meet specified requirements. Quality Control- Inspection, test or examination to ensure that products or services

conform to specified requirements. Quality Management System (QMS) - An established documented system to ensure

quality. Includes the organizational structure, responsibilities, control features, processes and resources needed to manage quality.

Quality System Manual (QSM) - This document. Special Processes- Processes, the results of which cannot be fully verified by subsequent

inspection and /or testing of the product. Specification- Engineering limits describing materials, processes and construction giving

dimension or information not shown on drawings. Specified Requirements- Those requirements necessary to provide product, including

designated QMS elements, design and manufacturing acceptance criteria and customer defined requirements.

Standard- A rule or model established by authority for the measure of quality. Subcontractor- Any individual or organization that provides materials, products or

services to the manufacturer affecting the outcome of final products. Supplier- Any individual or organization who furnishes materials, products or services to

the manufacturer. Survey- A documented investigation, including examination of objective evidence, to verify

that an entity is in conformance. Traceability- The ability to determine the product history through markings and records. Verify- To determine conformance to specified requirements.

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2.0 CORPORATE COMMITMENT

This manual describes Electrical Assembly Systems Company (EASC’s) management system requirements for contracts between its business unit and its customers, and it demonstrates the commitment to provide products that meet and exceed our customer’s requirements.

This manual provides a description of the quality management system in accordance with ISO 9001:2008 and serves as a reference for maintaining and continuously improving our quality management system.

2.1 FIELD OF APPLICATION

This manual is applicable:

In contractual situations when the contract and product requirements are stated in performance terms, or need to be established.

When product conformance is attained by demonstration of production, installation, and service capabilities.

2.2 QUALITY POLICY

Electrical Assembly Systems Company QUALITY POLICY

To meet or exceed the expectations of our customers through our commitment to continuously provide excellent customer service while constantly improving the effectiveness of our Quality

Management System.

In addition, we are committed to empowering our employees to get the job done correctly and efficiently.

The Quality Policy acknowledges Electrical Assembly Company X and its business unit’s commitment to Quality and its intent to maintain ongoing compliance with the ISO 9001:2008 standard.

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The Quality Policy is relevant to Electrical Assembly Company X and its business unit‘s organizational goals and meets the needs of the customer.

The policy is communicated throughout the organization by means of a Statement of Quality being posted throughout the facility and endorsed by the signature of the President. The policy is reviewed and revised, as required, to reflect Electrical Assembly Company X and its business unit’s ongoing commitment to Quality and Customer Requirements.

All employees know and understand the quality program as demonstrated by following policies and procedures.

Implementation of the quality policy throughout the organization is indicated by meeting or exceeding customer’s requirements.

3.0 HISTORY OF THE ORGANIZATION

Since 1985, Electrical Assembly Company X (EASC) has provided complete and customized turnkey control solutions for a wide variety of applications. Projects range from large multi-phase pipeline controls systems to single installation relay panels.

Electrical design expertise, in-house CAD, custom manufacturing, strict quality control and project-focused customer service make EASC the professionals’ choice.

EASC has over 24 years of combined experience with customizing press fit connectors, custom backplane assemblies, stamping and molding, PLC panels, DCS control buildings, etc.

EASC specializes in working with our customer’s engineering staff through all phases of design, procurement, fabrication, delivery, installation and on-site testing.

Our history of success and experience enhances our ability to support our customer’s needs. Our custom product is tested and inspected at all process levels; consequently, we are able to meet or exceed our customer’s expectations, every time.

In the last several years, we have added resources which enable us to produce the most reliable and cost competitive product in the industry.

Electrical Assembly Company X provides custom:

DESIGN ENGINEERING FABRICATION INTEGRATION

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4.0 QUALITY MANAGEMENT SYSTEM

Scope of Certification:

Design and integration of custom automated control systems

and custom control buildings.

4.1 INTRODUCTION AND QUALITY SYSTEMS EXCLUSIONS

This Quality System Manual provides information to our company personnel and customers, regarding policies and procedures for assuring and controlling product and service quality.

With it we succeed in the continual improvement of the quality management system and compliance to requirements defined within ISO Standard 9001:2008.

This Quality Manual establishes Electrical Assembly Company X management policy and refers to Quality Procedures. These procedures have been developed to provide product that meets or exceeds customer and applicable regulatory requirements.

When one of the business units chooses to outsource any process that affects product quality the unit shall ensure control over such processes. Control of outsource processes shall be identified within the quality management system.

Unless otherwise defined, the definition of specific term used within this document shall be outlined within ISO 9001:2008.

When used, the Acronym (EASC) refers to Electrical Assembly Company X

Electrical Assembly Company X’s quality management system is documented, implemented and maintained. We are continually improving its effectiveness in accordance with requirements as defined within ISO 9001:2008 and our own stated policies to ensure that products and services provided meet or exceed customer requirements.

The criteria and methods needed to ensure that both the operation and control of these processes are effective. Refer to section 7.1 of this manual.

All the processes that make up Electrical Assembly Company X quality management system shall be managed in accordance with the requirements of the ISO 9001:2008 Standard.

EXCLUSIONS

Based on the following justification defined within the ISO 9001:2008 standard do not apply to our type of operation and have been excluded from our quality management system.

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7.5.2 Validation of processes for production and service provisionThe organization shall validate any processes for production and service provision where the resulting outputcannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies becomeapparent only after the product is in use or the service has been delivered.Validation shall demonstrate the ability of these processes to achieve planned results.The organization shall establish arrangements for these processes including, as applicable,defined criteria for review and approval of the processes,approval of equipment and qualification of personnel,use of specific methods and procedures,ISO/FDIS 9001:2008(E)© ISO 2008 – All rights reserved 11requirements for records (see 4.2.4), andrevalidation.

REFERENCES

Quality Management Procedures (QP)ISO Standard 9001:2008 Quality Management Systems – RequirementsISO Standard 9000-2008 Quality Management Systems – Fundamentals and Vocabulary.

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4.2 QUALITY SYSTEM DOCUMENTATION

This section describes the quality management system (QMS) documentation used to ensure product and service compliance to quality and contractual requirements and includes the control, review, approval and storage of these documents and quality records.

The documentation structure consists of four levels as follows:

Level 1 Quality System Manual (QSM): Defines quality policy, objectives and commitment to customer satisfaction and continual improvement. Addresses each of the quality management system processes required by ISO 9001:2008.

Level 2 Quality Procedures (QP): Consist of documents to ensure the effective planning, operation and control of processes. Defines who is responsible for what, when it would apply and why it is being done.

Level 3 Work instructions (WI): Consist of documents which specify detailed instructions and, as needed, how to perform specific tasks.

Level 4 Quality Forms (Form): documents for inspection and testing, calibration, production and service processes, records, audit checklist, workmanship standards and quality plans.

This Quality System Manual has been established and shall continue to be maintained in order to provide the following:

The scope of the quality management system, including details of, and justification for, any exclusion. Refer to section 4.1

A reference to all documented Quality Management System procedures (as noted in Reference section)

A description of the interaction between the processes of the quality management system.

CONTROL OF DOCUMENTS

Documents required for the quality management system such as the Quality System Manual, Quality Procedures, Work Instructions and, Forms shall be reviewed, approved and controlled in accordance with procedure QP-4.5.1 and / or QP-4.16.1 including documents of external origin such as standards, specifications and customer drawings.

Document Control shall maintain a master list of documents generated. The master list shall identify the current revision status of each document and its date of effectiveness.

Changes or additions to approved company documents and data shall be identified within the document or appropriate attachments.

All documents shall be legible, readily identified and retrievable.

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Invalid and /or obsolete documents shall be identified as such.

CONTROL OF RECORDS

Quality records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system.

Records shall remain legible, readily identifiable and retrievable.

A periodic assessment of stored documentation shall be conducted in accordance with procedure QP-4.17.1 to ensure that environment, access and other requirements are met.

The approach to be used for the identification, storage, protection, retrieval, retention time and disposition of quality records shall be identified in procedure QP-4.16.1.

REFERENCES

QP- 4.5.1 Document ControlQP- 4.16.1 Quality RecordsQP- 4.17.1 Internal Quality AuditsISO Standard 9001:2008 Quality Management Systems – Requirements

5.0 MANAGEMENT RESPONSIBILITY5.1 MANAGEMENT COMMITMENT

This section describes the management commitment to the development, implementation and continuing improvement of the quality management system and identifies the evidence of this commitment.

NS Controls, Inc is committed to the policies and procedures referenced within this manual, to continually improve performance while addressing the needs of all interested parties and to the following quality management principles.

Customer Focus: As a customer focused organization, we must understand current and future customer needs, should meet customer requirements and strive to exceed our customer expectations.

Leadership: We must establish unity of purpose and direction and create and maintain the internal environment in which our employees can become fully involved in achieving our company’s objectives.

Involvement of People: We must ensure that our employees are fully involved and informed in order to enable them to use their abilities for the benefit of the company.

Process Approach: We must ensure that when activities and related resources are managed as a process a desired result is achieved more efficiently.

System Approach to Management: We must identify, understand and manage interrelated processes of our quality management system to achieve objectives while contributing to the effectiveness and efficiency of our company.

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Continual Improvement: We must ensure that continual improvement and overall performance should be a permanent objective of our company.

Factual Approach to Decision Making: We must ensure that decisions are effective and are based on the analysis of data and information.

Mutually Beneficial Supplier Relationships: We must enhance our ability to create a mutually beneficial relationship with our suppliers.

Electrical Assembly Company X’s management reinforces its commitment to the development and implementation of the quality management system and continually improves its effectiveness by:

Communicating the importance of meeting customer as well as statutory and regulatory requirements throughout the organization by any or all of the following ways:

o Internal and quality indoctrination training sessions.o Postings and bulletin boards.o E-mail notification.o Establishing a Quality Policy that is relevant.o Ensuring that quality objectives are established, relevant and remain measurable

while consistent with quality policy.o Quality management reviews shall be conducted, to ensure the continuing

suitability, effectiveness and efficiency of the quality management system.o Ensuring availability of resources to implement and improve the processes for the

quality management system and customer satisfaction.

REFERENCES:

none

5.2 CUSTOMER FOCUS

Electrical Assembly Company X shall ensure that customer needs requirements are determined and are met with the aim of enhancing customer satisfaction. Refer to section 7.2 of this manual.

Electrical Assembly Company X shall monitor and measure customer perception as to whether the organization has met customer requirements. Refer to section 8.2 of this manual.

REFERENCES

None

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5.3 QUALITY POLICY

This section covers the overall objective of quality policy as expressed by management.

Electrical Assembly Systems Company QUALITY POLICY

To meet or exceed the expectations of our customers through our commitment to continuously provide excellent customer service while constantly improving the effectiveness

of our Quality Management System.

In addition, we are committed to empowering our employees to get the job done correctly and efficiently.

Electrical Assembly Company X management shall ensure that the Quality Policy is appropriate to the organization, along with a commitment to meet or exceed customer requirements and continually improve the effectiveness of the quality management system.

EASC management shall provide a framework for establishing and reviewing quality objectives. Refer to section 5.4

The quality policy is communicated and understood within the organization by providing training and conducting internal quality audits. Refer to procedures QP-4.17.1 and QP-4.18.1.

The quality policy shall be reviewed for continuing suitability on an ongoing basis. Refer to procedure QP-4.1.3.

REFERENCES

QP-4.1.3 Management Review

QP-4.17.1 Internal Quality Audits

QP-4.18.1 Training

5.4 PLANNING

This section describes how quality objectives and planning are established to ensure product and service compliance to quality and customer requirements.

QUALITY OBJECTIVES

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Electrical Assembly Company X’s management shall ensure that quality requirements:

Include the identification of suitable verification at appropriate stages in the realization of the product.

Are established at relevant functions and levels Are measurable Are consistent with the quality policy defined within section 5.3.

Electrical Assembly Company X quality objectives fall into four main areas:

Management Policy Objectives are established to identify the intentions and direction of the company. Input for establishing management policy objectives shall include:

Customer satisfaction surveys Customer complaints Productivity and inventory reports Sales and marketing research Quality management reviews Customer Communication

Process Objectives (Processes are activities which use resources to transform inputs into outputs); Inputs for instituting process quality objectives include:

Process capability studies Inspection, testing and examination of process results Internal nonconformances New technology and equipment Quality management reviews

Product Objectives; Inputs for establishing product quality objectives shall include:

Inspection and test reports Customer Satisfaction surveys Customer Complaints Customer Communication Product nonconformances and returns

Quality System Objectives; To achieve customer satisfaction by meeting specified product requirement and by continually improving performance. Inputs for implementing quality system objectives shall include:

Internal and external audit results Revisions to quality standards Changes to management policy Customer satisfaction surveys Corrective and preventive action Customer Communication

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Quality Management reviews

The methods to be used and the personnel responsible for establishing and implementing Electrical Assembly Company X quality objectives shall be as defined within procedure QP-4.1.4.

QUALITY MANAGEMENT SYSTEM PLANNING

Electrical Assembly Company X management shall ensure that the planning of the quality management system is carried out as explained below in order to achieve the activities noted in section 4.1 of this manual and the quality objectives identified in this section.

Quality planning shall include:

The processes of the quality management system; The resources needed to achieve quality objectives; The continual improvement of the quality management system.

Inputs to quality planning shall include:

The needs and expectations of customers and other parties; Product and system process performance; Lessons learned from previous experiences: Opportunities for improvements.

The outputs of quality planning shall include:

The responsibility and authority to carry out improvement plans; The identification of skills and knowledge needed; Improvement approaches, methods and tools; Resources required; Indicators for performance achievement, and The need for documentation and records.

The methods to be used and the personnel responsible for quality planning shall be as defined within procedure QP-4.1.4.

REFERENCES

QP-4.1.4 Quality Planning

5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATIONS

This section covers the managerial responsibilities, authority and interrelationships within Electrical Assembly Company X and its business units as well as internal communication.

RESPONSIBILITY AND AUTHORITY

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NS Controls, Inc has established functions in: Quality, Production, Design, Purchasing, Sales and Marketing, Finance and Personnel.

The following paragraphs define the responsibilities and authorities for each of the above functions with lines of communications and the interrelationship of positions as shown within the organizational chart on Attachment “A”

President: The President has the responsibility and authority to develop and implement strategic planning and budgeting and to ensure staff are assigned to adequately manage daily operations, including the policies and procedures within this quality manual.

Quality: The Quality Manager reports directly to the President and is responsible for the implementation and compliance of the company quality policy, quality objectives and procedures defined or referenced within this manual. The scope of the Quality Manager’s responsibility and authority is to:

Maintain a quality management system in accordance with ISO Standard 9001:2008 Control and revise as required, this manual and all procedures referenced within; Represent Electrical Assembly Company X in resolving matters pertaining to quality

with suppliers, customers and representatives from external regulatory bodies. Ensure that quality related deficiencies are adequately documented, investigated

and corrected; Ensure that manufactured items are adequately documented and traceable as

required;

Shop: The Shop Supervisor reports to the president and has the responsibility and authority to coordinate production personnel and equipment so as to result in on-time product completion and quality.

Design: The Project Manager reports directly to the president and has the responsibility and authority to maintain drawings for custom products, develop parts list and design any required item for manufacturing and product assembly. Has the responsibility and authority to purchase all raw materials, subcontracted services and goods required for production.

Sales: Sales report directly to the president and have the responsibility and authority to represent Electrical Assembly Company X in the bidding and closing of contracts, prepare annual sales forecasts and develop open business relationships with customer representatives, for the mutual benefit of both companies.

Accounting: Accounting reports directly to the President and has responsibility and authority for the financial reporting and analysis, money management, credit and collections accounting systems.

MANAGEMENT REPRESENTATIVE

Electrical Assembly Company X management has appointed the Quality Manager to monitor, coordinate, manage and evaluate the quality management system processes including responsibility and authority to:

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Ensure the establishment, implementation and maintenance of the processes needed for the quality management system;

Report to top management on the performance of the quality management system including needs for improvement;

Ensure the awareness of customer requirements throughout the organization. INTERNAL COMMUNICATION

o The quality policy, quality management system requirements and objectives are understood , implemented and maintained at all levels in the organization:

o A copy of the quality manual and procedures shall be issued to each department.

o The quality policy is communicated to employees being posted throughout the facility and is endorsed by management.

The Quality Manager shall ensure the effectiveness of the quality management system is properly communicated to various levels and functions within the organization through:

Departmental meetings Posting on bulletin boards Quality training sessions and presentations

REFERENCES

ISO Standard 9001:2008 Quality Management Systems – Requirements

Electrical Assembly Company X – Organization Chart, Attachment “A”

5.6 MANAGEMENT REVIEW

This section covers the review and continuous improvement of the quality management system through the management review process.

GENERAL:

At least once year, the management review team shall review the quality system to ensure its suitability, adequacy and effectiveness. These reviews shall include evaluating opportunities for improvement.

The process used to review the quality system and the personnel who make up the Review Team shall be described within procedure QP-4.1.3.

REVIEW INPUT:

Quality management reviews shall include the following sources of information regarding the performance of the quality system and opportunities for improvement (as applicable):

Audit reports (internal, customer and third-party) Customer feedback Process and product performance

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Supplier performance Status of preventive and corrective actions Action items from previous quality management reviews Changes that could affect the quality management system Employee suggestions for improvement

REVIEW OUTPUT:

Outputs from quality system reviews shall be documented review minutes and shall include decisions made and actions related to (as applicable):

The improvement of the effectiveness of the quality system and its processes The improvement of product as related to customer requirements Resources needs

Management review minutes shall be maintained in accordance with Quality Records procedure QP-4.16.1.

REFERENCES


QP-4.16.1 Quality Records

6.0 RESOURCE MANAGEMENT6.1 PROVISION OF RESOURCES

This section applies to the provision of all resources needed for the quality management system within Electrical Assembly Company X, including people, suppliers, information and work environment.

Management shall determine and provide, in a timely manner, the resources needed to:

Implement, maintain and continually improve the quality management system To enhance customer satisfaction by meeting customer requirements

When determining these resources, consideration shall be given to: Current business opportunities and constraints Mechanisms that will encourage continual improvement Future resource requirements

REFERENCES

none

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6.2 HUMAN RESOURCES

This section applies to all personnel with assigned responsibilities in the quality management system and includes their training to ensure competency when performing activities affecting quality during purchasing, manufacturing and servicing.

GENERAL

Personnel who perform work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.

COMPETENCY, AWARENESS AND TRAINING

Each manager shall identify the competency needs for personnel performing activities that affect product quality within their department.

Managers shall then evaluate employees under their direction to determine any competency gaps.

Based on these gaps, required training or other actions to satisfy these needs shall be identified and provided to the employees through on-the-job instruction, internal training sessions and external sources.

To ensure that employees are aware of the importance of their activities and how they contribute to the achievement of quality objectives, the quality department shall develop and present quality indoctrination courses (as needed).

These internal courses shall provide employees with a variety of quality related information for performing verifications, validations and preparing reports and may result in additional training being provided to selected employees as required.

Refresher courses to reinforce quality awareness and knowledge of quality policy and objectives shall be given as determined by the Management Review Team.

The procedure to be used and the personnel responsible for identifying competency gaps and coordination training provided to personnel shall be defined within procedure QP-4.18.1

Training Records

Records related to employee education, training, skills qualifications, experience and training assessments shall be retained on file for a period of not less than (5) years unless otherwise specified by contract.

REFERENCES

QP-4.18.1 Training

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6.3 INFRASTRUCTURE

This section covers the provision and maintenance of all facilities.

To ensure product and service conformity to requirements, Electrical Assembly Company X shall determine, provide and maintain all infrastructures required, including, as applicable:

o Buildings, Workspace and associated utilities and equipment: To ensure continuous quality output, process equipment as well as office and shop buildings and utilities shall be routinely maintained in accordance with procedure QP-4.9.4

o Hardware and software: To ensure that only acceptable monitoring and measuring hardware and software are used to verify and validate products and processes, all such devices shall be controlled and subject to calibration as defined within procedure QP-4.11.1

o Supporting services: All required support services and processes to ensure the product or service conformity, and customer satisfaction shall be provided as identified within this quality manual.

Infrastructure shall be reviewed for continual compliance to operational needs on an ongoing basis with required corrective and preventive action taken as defined under QP 4.14.1.

REFERENCESQP-4.9.4 Preventive MaintenanceQP 4.14.1&2 Corrective and Preventative ActionsQP-4.11.1 Control of Monitoring and Measurement Devices

6.4 WORK ENVIRONMENT

This section covers work environment including both the human and physical factors which influence it.

To achieve product and service conformity, Electrical Assembly Company X shall manage both the human and physical factors which affect the work environment as defined below:

Human Factors Creative Work Ideas: Electrical Assembly Company X promotes and encourages employee

participation, creativity and new ideas from everyone within the company. Safety Rules and Guidance: Safety rules and guidance are provided in the Safety Manual;

including the use of protective equipment and special facilities which have been allocated for personnel.

Physical Factors: The heat, lighting, humidity, noise level, cleanliness and proper air flow within our office and shop facilities shall be controlled and continually monitored by all department managers and supervisors to ensure the positive enhancement of our personnel’s performance.

REFERENCES

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Safety Manual

7.0 PRODUCT REALIZATION7.1 PLANNING OF PRODUCT REALIZATION

This section covers how Electrical Assembly Company X plans the realization processes to produce a product or provide a service.

Electrical Assembly Company X shall plan and develop the processes and sub-processes to ensure product conformance throughout the manufacturing, installation and servicing.

These processes shall be identified and documented and, as applicable, shall identify:

the quality objectives and requirements to be achieved for the product project or contract involved

where additional processes or documentation need to be established the resources and facilities needed to produce the product or service involved each verification, validation, monitoring, inspection and test actives specific to the product

and criteria for product acceptance mandatory hold points established by the customer which requires their verification of

selected characteristics of an item or process and beyond which work shall not progress until verification has been completed

Records needed to provide evidence of process and product conformity to requirements.

Quality Plans shall reference procedures and instructions to be followed while performing each activity, as applicable.

Upon completion, Quality Plans shall be subject to review and approval by the Quality and Production Managers to ensure that all resources and facilities will be provided.

Revisions to Quality Plans shall be reviewed and approved in the same manner as originals.

When contractually required, Quality Plans and their revisions shall be submitted for customer acceptance.

If specified, work shall not proceed beyond a verification, hold or witness point established by the customer as a contractual requirement without the activity being performed and accepted by the customer. An exception to this, would be a signed release or waiver issued or granted by the customer.

The procedure to be used and the personnel responsible for the planning of product realization shall be as defined within procedure QP-4.9.1

REFERENCES

QP-4.9.1 Planning of Product Realization

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7.2 CUSTOMER – RELATED PROCESSES

This section covers how the needs and exceptions of customers are defined, implemented and maintained including the review and evaluation of all requests for quotation prior to bidding and contracts prior to acceptance.

DETERMINATION OF REQUIREMENTS RELATED TO THE PRODUCT

Upon receipt of a customer’s request for quotation or inquiry, Electrical Assembly Company X shall determine the customer’s requirements:

Specified product requirements Requirements for delivery and post – delivery activities Product requirements not specified by the customer but, considered essential for intended

or specified use, where known Statutory and regulatory requirements, related to the product

REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT

All requested for quotation, customer requirements shall be reviewed prior to bid to determine:

What is being requested by the customer What product requirements apply Which statutory or regulatory entity would apply and what their requirements would be What personnel would be required to perform the work What materials are required What facilities would be required to achieve the work What lead time is necessary to ensure on – time delivery What costs would be incurred, to accomplish the work Does Electrical Assembly Company X have the ability to meet all of the requirements

specified by the customer

Upon receipt of a contact or order, and prior to acceptance sales and / or the project manager shall review and evaluate the contract or order to determine:

If differences exist between the original quote and the contract received The title and relevant issue of all codes, standards and specifications applicable The quality objectives to be attained The formal lines of communication

Should any differences be detected between the original quote submitted and the customer order received, Electrical Assembly Company X shall notify the customers of these discrepancies in writing.

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No contract or order shall be accepted until such time as all differences noted have been resolved with the customer.

In the event the customer does not provide any documented requirements, Electrical Assembly Company X shall confirm requirements with customer before acceptance.

Accepted contracts or orders and any amendments shall be documented and information distributed to the relevant personnel as required.

Contract or Order Amendments

Any customer changes to an existing contract or order shall be subject to the same review and approval as an original contract or order. Based on the requested change, Electrical Assembly Company X shall advise the customer of any cost or schedule impact and shall require approval of these changes from the customer prior to acceptance.

Changes to contracts or orders initiated by Electrical Assembly Company X shall be submitted to and approved by the customer prior to being implemented, including any cost or schedule impacts.

Records

Unless otherwise defined by contract, records of contract and order reviews performed shall be contract and order reviews shall be maintained on file for a period of not less than (5) years.

CUSTOMER COMMUNICATION

Electrical Assembly Company X shall implement effective arrangements for communication with customers relating to:

product information; Inquiries, contracts or order handling, including amendments; Customer feedback, including customer complaints and surveys.

The procedure used and the personnel responsible for conducting and documenting the request for quotation and review of contracts or orders, their amendments and customer communications shall be defined in procedure, QP-4-3.1

REFERENCES

QP-4.3.1 Customer Requirements and Communication

7.3 DESIGN AND DEVELOPMENT

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REFERENCES

xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx

7.4 PURCHASING

This section applies to the procurement of materials, equipment, parts, assemblies, subcontracts and services that shall be used in or form part of product to customers.

PURCHASING PROCESS

To ensure that purchased products conform to all quality and contractual requirements, purchasing processes shall be in accordance with procedure QP-4.6.1.

The type and extent of control exercised over suppliers and purchased products shall be dependent upon the effect of the purchased product on following processes, or on the final product delivered to the customer.

Material and products procured shall be subject to verification and testing, as defined within procedure QP-4.12.1.

Evaluation and Selection of Suppliers

The process to be used and the personnel responsible for evaluating and selecting suppliers shall be as defined within procedures QP-4.6.2 and QP-4.6.3.

The criteria for supplier selection, evaluation and re-evaluation shall be based on the criticality and classification of the products or services to be purchased as defined within procedure QP-4.6.2.

Quality records of supplier evaluations and follow up with necessary actions shall be maintained in accordance with procedure, QP-4.16.1.

PURCHASING INFORMATION

Electrical Assembly Company X procurement documents shall contain a clear description of the item(s) or service(s) required and shall include or reference any or all of the following as applicable:

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Requirements for approval or qualification of:o producto procedureso processeso equipmento personnel

Quality management system requirements.

To ensure that contractual requirements have been adequately specified, procurement documents for raw material, equipment, parts, assemblies or services shall be reviewed prior to release.

Any amendments to a procurement document shall be processed and reviewed the same as the original document.

Within amendments, the original procurement document number shall be referenced.

VERIFICATION OF PURCHASED PRODUCT

Procured products or services shall be evaluated to determine the amount of inspection and auditing required for verification of purchase.

Implementation of required verification activities shall be as defined within procedure QP-4.12.1.

Any nonconforming product detected while verifying purchased product shall be processed in accordance with procedure QP-4.13.1

Verification at Suppliers Premises

EASC, in order to continually improve quality, may elect to perform an on-site or survey evaluation of suppliers, as needed.

Customer Verification at Supplier’s Premises

When required by contract, Electrical Assembly Company X arranges visits of subcontractors by customers.

Customers of Electrical Assembly Company X are provided the right to verify the product produced by the company and the conditions under which such product is manufactured.

This verification does not absolve Electrical Assembly Company X of the responsibility to provide acceptable products.

REFERENCES

QP-4.6.1 PurchasingQP-4.6.2 Survey VendorQP-4.6.3 Vendor RatingQP-4.12.1 Inspection and Test Status

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QP-4.13.1 Material ReviewQP-4.16.1 Quality RecordsQP-4.17.1 Quality AuditsDoc. 0001 Material / Service Classification List

7.5 PRODUCTION AND SERVICE PROVISION

This section covers the activities to control, identify, trace and preserve product, including those provided by our customers and how processes are validated.

CONTROL OF PRODUCTION AND SERVICE PROVISION

Electrical Assembly Company X shall plan and carry out production and service operations under controlled conditions.

Information pertaining to product characteristics, including the criteria for acceptance shall be identified or referenced within the Job Binder issued for each job.

Where their absence could adversely affect quality, work instructions shall be developed, referenced within the Job Binder and made available.

To ensure continuous quality output, Process equipment shall be routinely maintained as defined within procedure QP-4.9.4.

Only valid, calibrated monitoring and measuring devices shall be used to verify production processes and products as defined within procedure QP-4.11.1

Work in progress shall be monitored to ensure good workmanship standards and specifications are being maintained.

Products shall be subject to inspection and / or testing as defined in procedure QP-4.12.1 including completed products prior to release.

Product delivery and post-delivery activities shall be performed and monitored in accordance with procedure QP-4.15.1

VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION

Electrical Assembly Company X shall validate production and service processes where resulting output cannot be verified by monitoring or measurement including:

Where validation of product is not possible.

Where product deficiencies will only be apparent after the product is in use or the service has been delivered.

Validation shall demonstrate the ability of these processes to achieve planned results.

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Arrangements for these processes shall be established including as applicable:

Criteria for review and approval of process Approval of equipment and qualification of personnel Use of specific methods and procedures Requirements for records Re-validation

The procedure to be used and the personnel involved in qualifying processes, equipment and personnel along with records to be maintained shall be accordance with procedure QP-4.9.2.

Process Changes

Process changes which affect the characteristics of a product shall be identified, recorded, evaluated, reviewed, authorized and controlled to ensure that changes made benefit the needs and expectations of the customer.

Re-validation:

After changes have been made to a process and to verify that change(s) made had the desired effect, both the process and any resulting product shall be re-validated.

IDENTIFICATION AND TRACEABILITY

Electrical Assembly Company X maintains a tagging system throughout the realization process as defined within procedure QP-4.12.1 that identifies the inspection and/or test status of items.

This system of tagging allows personnel to distinguish items that have been inspected and/or tested and also indicates status of items (accepted or rejected).

Items found to be nonconforming shall be identified by generating a nonconformance report as described in procedure QP-4.13.1

Unless otherwise defined by contract, product identification and traceability shall be performed, controlled and documented as defined in procedure QP-4.8.1.

Where traceability required by a customer exceeds existing procedures, the extent of control for recording unique product identification shall be established with the customer during the review of customer requirements refer to procedure QP-4.3.1.

CUSTOMER PROPERTY

Upon receipt of customer property, Electrical Assembly Company X shall examine items for completeness, proper identification and possible transit damage. Refer to procedure QP-4.7.1

Items found to be nonconforming shall be tagged and recorded as defined in procedure QP-4.13.1 and brought to the immediate attention of the Quality Manager, Project Manager and customer.

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Electrical Assembly Company X, shall exercise care to ensure the protection of customer property against loss or damage until it is used into the product or returned to the customer.

The Identification, segregation, handling and protection of customer property from time of receipt, storage and during the production cycle shall be performed as referenced in procedure QP-4.7.1

In the event that customer property is lost, damaged or otherwise identified as unusable while under EASC control, this shall be recorded and reported to the customer.

PRESERVATION OF PRODUCT

Electrical Assembly Company X, shall preserve product during internal processing and delivery to the intended destination; including identification, handling, packaging, storage and protection. Reference procedure QP-4.15.1

REFERENCESQP-4.7.1 Customer Supplied MaterialQP-4.8.1 Identification and TraceabilityQP-4.9.4 Preventive MaintenanceQP-4.11.1 Control of Monitoring and Measuring DevicesQP-4.12.1 Inspection and Test StatusQP-4.13.1 Material ReviewQP-4.15.1 Handling, Storage, PackagingQP-4.3.1 Customer Requirements and CommunicationQP-4.9.2 Validation of ProcessesQP-4.9.8 Monitoring and Measurement of Product

7.6 CONTROL OF MONITORING AND MEASURING DEVICES

This section covers all monitoring and measuring devices used by personnel, including test software, which assist in determining product and process conformance.

General:

All monitoring and measurements made to show evidence of product conformity shall be identified either on drawings, inspections and test forms, or control plans and shall include the monitoring and measuring devices to be used.

The procedure and processes to ensure that monitoring and measurement is consistent with the requirements are as described within procedure QP-4.9.1.

Controls for Monitoring and Measuring Devices:

The methods used and the personnel responsible for conducting, documenting and controlling calibration of monitoring and measuring devices used shall be described in procedure QP-4.11.1.

Each monitoring and measuring device used for the purpose of verifying product quality or monitoring processes shall have a unique identification control number.

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At defined intervals, based on stability and degree of usage, measuring and monitoring devices shall be subject to calibration. The specific measurements to be made, the accuracy required and the standards to be used shall be identified within calibration instructions.

Calibration (when required) shall be performed using reference standards and or equipment whose calibration is traceable to National Institute of Standards & Technology (NIST). Where no recognized standard exists, Electrical Assembly Company X shall record the basis used for calibration.

Any devices such as jigs, fixtures or templates used by production shall be subject to accuracy verification prior to usage.

The use of personally owned tools and gages used for the purpose of product evaluation by production personnel shall be permitted, provided these tools are understood for use as reference only.

The calibration status of each monitoring or measuring device shall be indicated by a calibration sticker or tag affixed to the item calibrated. Identified on the sticker or tag shall be the date that the calibration was performed and the next date on which calibration is due.

Monitoring and measuring devices, including test hardware and software, shall be safeguarded from adjustments that would invalidate the measurement results.

All monitoring and measuring devices shall be removed from use by the date that calibration is due and shall be protected against damage and deterioration during handling, maintenance and storage.

When monitoring or measuring devices are found to be out of calibration, previous documented verification or test results for which the device was used shall be re-evaluated to assess the validity of results obtained.

Calibration records shall be maintained and updated throughout the life of each monitoring or measuring device.

Computer software used for monitoring and measuring of specified requirements shall be validated prior to initial use and reconfirmed as necessary.

Calibration certificates received from outside laboratories and in house generated calibration records shall be retained on file in accordance with procedure QP-4.16.1. These records shall be made available to the customer upon request.

REFERENCES

QP-4.16.1 Quality RecordsQP-4.9.1 Planning of Product RealizationQP-4.11.1 Calibration Control and Recall

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8.0 MEASUREMENT, ANALYSIS & IMPROVEMENT8.1 GENERAL

This section applies to the planning and implementation of monitoring, measurement, analysis and improvement actives to assure product and system conformity and continually improve the quality management system effectiveness.

Planned and implemented activities to assure product and system conformity and to continually improve the effectiveness of the quality management system are defined within sections 8.2, 8.3, 8.4 and 8.5 of this manual and as outlined below, including the methods and statistical techniques to be employed.

To demonstrate product conformity during the realization cycle, Electrical Assembly Company X shall plan and implement the monitoring and measurement activities defined within procedure QP-4.9.8.

To ensure process conformity, the monitoring and measurement methods defined within procedure QP-4.9.7 shall be used with validation of processes completed in accordance with procedure QP-4.9.2.

To ensure conformity of the quality management system, internal quality audits shall be planned and conducted as defined within procedure QP-4.17.1.

To continually improve the quality management system, monitoring and measurement data shall be collected and analyzed in accordance with procedure QP-4.11.2 in order to support the planning for continual improvement as defined within procedure QP-4.1.3.

Methods and statistical techniques used, including the extent of their use, shall be routinely evaluated during Quality Management Reviews as described within procedure QP-4.1.3 to ensure that information collected remains useful, relevant and supportive of continual improvement.

REFERENCES

QP-4.1.3 Management ReviewQP-4.9.2 Validation of ProcessesQP-4.17.1 Quality AuditsQP-4.9.7 Monitoring and Measurement of ProcessesQP-4.9.8 Monitoring and Measurement of ProductQP-4.11.2 Analysis of Data

8.2 MONITORING AND MEASUREMENT

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This section covers the activities used to monitor and measure the overall effectiveness and efficiency of the quality management system, as well as product attributes, process adequacy and customer satisfaction.

CUSTOMER SATISFACTION:

As one of the measurements to evaluate the performance of the quality management system, Electrical Assembly Company X shall monitor the following factors that affect customer perception as to whether requirements have been met:

Issues causing customer dissatisfaction such as:o defective products or serviceo late deliveryo poor response time to inquires or complaints

Issues causing customer satisfaction, such as:o expected product qualityo on time deliveryo attention to inquires or complaints

This data may be collected using two survey methods as defined in procedure QP-4.9.6

Data collected shall be compiled by the Quality department and presented containing:

the results of interviews and questionnaires a conclusion as to what factors have contributed to the current level of customer

satisfaction a comparison to previous results and trends.

Customer satisfaction reports shall be distributed, reviewed and analyzed during quality management reviews as described in procedure QP-4.1.3.

Analysis shall determine opportunities for improvement, such as:

correction or prevention of nonconformities continuous improvement.

Opportunities for improvement shall be documented, approved and planned and processed in accordance with procedure QP-4.1.3.

Results of improvement implementations shall be reviewed by the Management Review Team to ensure the effectiveness of the actions taken.

MONITORING AND MEASUREMENT OF PROCESSES:

Processes utilized to perform contracted work which directly affect quality shall be accomplished under controlled conditions as defined in procedure QP-4.9.1.

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To ensure continuous quality output, processes equipment shall be routinely maintained as specified in procedure QP-4.9.4.

The methods used and the personnel responsible for the monitoring and measurement of processes shall be specified in procedure QP-4.9.7.

Where applicable, process measurements shall be performed to confirm the consistent output of a process or processes to achieve planned results; if planned results are not achieved, corrective action shall be taken to ensure product conformity as defined in procedure QP-4.14.1.

MONITORING AND MEASUREMENT OF PRODUCT:

General

Electrical Assembly Company X shall plan for monitoring, measurements, test and product / service verification activities required by contract and established to ensure product conformance as specified in procedure QP-4.9.8.

These activities shall be identified and documented within quality Plans and include the following stages of product realization:

Receiving

All incoming items received for usage within deliverable products shall be forwarded to production, inventory or storage until the required inspections and test have been completed or the required test reports or certifications have been received and verified as acceptable.

Submitted objective evidence of the supplier’s verification of product quality may also be reviewed and evaluated to determine if quality and contract requirements have been met.

Any product observed as nonconforming shall be identified and processed as specified in procedure QP4.13.1

In-Process

Parts, components, sub-assemblies and assemblies produced or procured shall be verified and tested as required during manufacturing.

In-process inspections shall be accomplished as identified within Quality Plans and in accordance with documented procedures and relevant instructions.

Work in-process shall be monitored with walk-through surveillance to ensure good workmanship and specification compliance are being maintained.

Products shall not be allowed to progress to the next operation until the required verifications and test have been completed.

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Any nonconforming items shall be identified and processed as specified in procedure QP4.13.1.

Final

All completed products shall be subject to final inspection and or testing as identified in the Quality Plan prior to shipping or, when applicable, submission to the customer for evaluation and acceptance.

All contracted work operations and nonconformance corrections shall be verified for completeness and acceptability.

Unless otherwise approved by the customer, only items which meet contract requirements shall be shipped to the customer for evaluation and acceptance.

Records

Records shall be maintained for a minimum of 5 years or as required by individual customers.

Quality records are to identify the personnel authorizing product release and shall be filed and maintained as specified in procedure QP-4.16.1

8.2.1 INTERNAL AUDIT

Internal quality auditing of each system process shall be planned and conducted at least once a year to determine:

the effectiveness and continued suitability of the quality management system the extent to which the quality management system conforms to the requirements of the

ISO 9001:2008 standard the extent to which the quality management system conforms to internal system

requirements.

Audit program planning shall take into consideration the status and importance of the activities and areas to be audited as well as the results obtained from previous audits.

The procedure used and the personnel responsible for planning, conducting, reporting and following up on internal quality audits shall be defined in procedure QP-4.17.1.

To ensure objectivity and impartiality of the audit process, internal quality audits shall be performed by personnel who are independent of the activity being evaluated.

Audit findings shall be documented and brought to the attention of the responsible manager for the area or activity.

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Management shall take timely corrective action to resolve deficiencies found during an audit, including their causes.

Follow-up of corrective action taken shall be performed to verify effectiveness and shall be documented. Unless otherwise defined by contract, these records shall be retained for a period of not less than five years.

A summary of audit findings shall be forwarded to the members of the Management Review Team for evaluation to determine possible system improvement opportunities.

REFERENCES

QP-4.16.1 Quality Records


QP-4.9.1 Planning of product realization

QP-4.9.4 Preventive Maintenance

QP-4.9.2 Validation of Processes

QP-4.11.1 Control of Monitoring and Measuring Devices

QP-4.9.6 Measuring Customer Satisfaction

QP-4.17.1 Internal Audits

QP-4.9.7 Monitoring and Measurement of Processes

QP-4.9.8 Monitoring and Measurement of Product

QP-4.13.1 Material Review Process

QP-4.14.1 Corrective and Preventive Action

ISO Standard 9001:2008 Quality Management Systems – Requirements

8.3 CONTROL OF NONCONFORMING PRODUCT

This section covers the control, documentation and processing of materials or products that have been identified as nonconforming.

General

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Materials or products that do not conform to requirements shall be identified as a nonconformance and shall be controlled to prevent unintended use or delivery.

These controls and the responsibility and authority for handling nonconforming product shall be defined in procedure QP-4.13.1.

Nonconformances shall include conditions adverse to quality such as:

Failures, deficiencies or changes in production and installation processes, tooling or facilities

Inadequate or non compliant procedures and documentation Inadequate control of work

All Electrical Assembly Company X personnel have the authority and responsibility to report a nonconformance during any stage of the realization process.

Nonconforming product shall be tagged or segregated from conforming items and documented using a NonConforming Material Report (NCR).

The Quality department shall maintain control of NCRs. No nonconforming material, or product, shall be released for use or allowed to be further processed until a “dispositioned” NCR has been received or an approval for release is issued by the Quality Manager.

Review and Disposition of Nonconforming Product

Nonconforming product may be “dispositioned” as:

Rework scrap repair use as is return to vendor or request for deviation or waiver

Repair, Request for Deviation or Waiver and use-as-is dispositions require the authorization by the Quality manager and acceptance by the customer.

Nonconformances requiring rework or repair shall be subject to re-verification and re-testing.

Authority to use materials, components or information not within contract specification and requirements that could affect quality must be obtained from the customer prior to implementation.

Reports and Follow-up Actions

NCRs shall identify and include:

The type and extent of the nonconformance detected The disposition of the nonconformance

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That rework and repairs were successfully carried out, re-verified and re-tested and found to be acceptable.

Nonconformances that are detected after delivery or use

Electrical Assembly Company X shall notify the customer of the problem as soon as possible and work out an agreement for the replacement or correction of the item(s) involved.

REFERENCES

QP-4.13.1 Control of Non-Conforming Product

Form NCR and NCRlog

8.4 ANALYSIS OF DATA

This section covers how data shall be collected, analyzed and used to improve the quality management system.

Electrical Assembly Company X shall collect and analyze appropriate data to determine the effectiveness of the quality management system and to evaluate where improvements can be made.

Data collected for analysis may include, but is not limited to:

Results from customer surveys. Customer, supplier and employee feedback. Results from internal audits. Results from process monitoring and measurements. Results from product monitoring and measurements. Discrepant material reports. Returned products.

The purpose of analyzing this data shall be:

To assess organizational performance against established quality plans and stated quality objectives

To identify areas for improvement. To help determine the cause of problems. To provide guidance for the most appropriate and effective corrective or preventive action

to take.

Upon completion, analyzed data shall provide information on:

Customer satisfaction and dissatisfaction. Conformance to product requirements.

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Characteristics and trends of processes and product, including opportunities for preventive action.

Suppliers and their contribution. Organizational effectiveness and efficiency.

The results of data analysis shall be shown whenever possible and shall be distributed to members of the Management Review Team.

The methods used and the personnel responsible for collecting, analyzing, reporting and distributing quality management system data shall be as specified in procedure QP-4.11.2.

REFERENCES

QP-4.11.2 Analysis of Data

8.5 IMPROVEMENT

This section covers actions taken to resolve or prevent nonconformances which have been detected or are perceived as potential problems by customers or suppliers.

CONTINUAL IMPROVEMENT

Electrical Assembly Company X shall continually improve the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and quality management reviews.

The methods used and the personnel responsible for planning, implementing and reviewing the results of continual improvement activities shall be as defined in procedure QP-4.1.3.

CORRECTIVE AND PREVENTIVE ACTION

Electrical Assembly Company X shall promptly correct nonconformances and conditions adverse to quality when discovered.

To prevent re-occurrence, these nonconformances shall be investigated in order to:

Determine the causes of the nonconformity Evaluate the need for actions to prevent recurrence Determine and implement required corrective action Record results of action taken Review the implementation of the corrective action taken to ensure its effective to resolve

the problem

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Potential nonconformities shall also be investigated in order to:

Determine their causes Evaluate the need for action to prevent the occurrence of nonconformities Determine and ensure the implementation of preventive action needed Record the results of action taken Review the results of preventive action taken to ensure its adequacy to prevent the

problem(s) identified

Corrective and preventive action shall be to the degree appropriate based on the magnitude of the problem(s) and risk(s) involved.

The methods to be used and the personnel responsible for determining corrective and preventive action, for initiating these actions and for establishing controls to ensure their effective implementation shall be as specified in procedure QP-4.14.1&2

REFERENCES


QP-4.14.1&2 Corrective and Preventive Action

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