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Q. Assurance.

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TABLE OF CONTENTS:

1.0 Forewords

2.0 Introduction

3.0 Policy and Objectives

4.0 Quality Systems

5.0 Organizations

6.0 Authority and Responsibilities

7.0 Compliance With ISO9001

8.0 Documentations and Change Control

9.0 Records

10.0 Training

11.0 Servicing

12.0 Design Control

13.0 Underlying Quality Principles

14.0 Conclusion
1.0 FOREWORDS

In order to statisfy design of a product that completed, and been detailed, the
quality mangement process are used to distinguish good companies from bad,
succesful business from failure. These basic defenitions go to make up the subject of
Quality Engineering apart of branch which deals with principles and practice of
product and service quality, assurance and control.

The generally accepted definitions of quality assurance (QA) and related terms are
based on those promulgated by the International standards Organization, who Issued
ISO 8402 in 1986:

i. Quality.
ii. Quality Assurance
iii. Quality Control
iv. Inspection
v. Quality Surveillance

Control of QA must be well planned and organised, just like other business
parameter. There is no single factor in the avoidance of failures in manufacturing,
servicing even welded construction if the right Quality Assurance is applied.

2.0 INTRODUCTION

On October 1, 2006, the Secretary of Energy created the Office of Health,


Safety and Security (HSS) to integrate Department of Energy (DOE) Headquarters-
level functions for health, safety, environment, and security into one unified office.
To accomplish this important responsibility, HSS is focused on providing the
Department with effective and consistent policy development, technical assistance,
education and training, complex-wide independent oversight, and enforcement.
Additionally, HSS addresses Department-wide cross-cutting issues and enhances
collaboration and sharing of technical expertise.
3.0 POLICY AND OBJECTIVES

Quality Policy

It is the policy of the Department of Energy to establish quality requirements


to ensure that risks and environmental impacts are minimized and that safety,
reliability, and performance are maximized through the application of effective
management systems commensurate with the risks posed by the facility or activity
and its work. The Department implements this policy through the QA Order and the
QA rule directives to ensure quality assurance requirements are clearly specified for
the broad spectrum of work performed by DOE and its contractors.

Objective

The objective of the QA requirements are to establish an effective management


system (i.e., quality assurance programs) using the performance requirements
coupled technical standards where appropriate that ensure:

i. Senior Management provides planning, organization, direction, control, and


support to achieve DOE's objectives;
ii. Line organizations achieve quality;
iii. Line organizations minimize environment, safety, and health risks and
impacts while maximizing reliability and performance;
iv. Line organizations have a basic management system in place that is
consistent with the principles and functions of the Integrated Safety
Management System Policy (DOE P 450.4); and,
v. Each DOE element reviews, evaluates, and improves their overall
performance and that of their contractors using a rigorous assessment process
based upon an approved Quality Assurance Program (ref. 48 CFR 970.1100).

4.0 QUALITY SYSTEM


Fundamentals of the DOE Quality System

The quality assurance program is a management system involving all


organizational components and should not be regarded as the sole domain of any
single group. The Order and Rule reflects the concept that all work is a process that
can be planned, performed, assessed, and improved. The basic requirements are
broken into three categories:

MANAGEMENT

PERFORMANCE

ASSESSMENT

This format permits managers, those performing the work, and those
assessing the planning implementation, and results of the work to focus on their
unique responsibilities in carrying out the provisions of the quality assurance
program. The three categories capture the range of activities common to all work,
from organizing and staffing to assessing results and providing feedback for process
improvement.

Application of the QA basic requirements extends from the planning and


conduct of basic and applied research, scientific investigation, and engineering
design to operations, maintenance and repair of facilities, and eventual
environmental restoration. These basic requirements reflect a comprehensive way of
doing business throughout the life cycle of DOE programs and projects.

DOE's goal is to achieve continuous improvement. This requires a culture that


encourages setting and maintaining high standards, identifying and resolving
problems, accepting recommendations for improvement, and fostering mutual
respect and effective communication between DOE and its contractors. DOE and
contractor management are responsible for continuously pursuing enhancements to
safety and reliability--not just complying with a minimal set of requirements.
Many DOE Orders assist contractors and DOE Field Offices to achieve their
objectives, but prior to 1991 there was no single DOE Order that defines how to
integrate these requirements and other policies into a management system. The basic
requirements of the QA Order represent functional categories that interrelate these
other DOE Orders and policies; in effect, pulling together all work performed by an
organization.

Management should review existing requirements, policies, and operating


procedures in light of this Order; care should be taken not to create redundancies.
The Safety Management System Policy, P 450.4 further strengthens integrating
safety with the work process. The QA basic requirements are to be applied to the
implementation of SMS Policy. These two management systems are also to be
integrated to ensure Quality Assurance and Safety Management policies effectively
work together to achieve quality and safety in the Department's work.

Guidance developed specifically for the Order and Rule, and used in
combination with it, assists management in developing quality assurance programs
that satisfy the basic requirements. The guidance interprets the Order's basic
requirements as they apply to different types of work performed by DOE, such as
reactor operations, basic and applied research, and environmental restoration. Other
guidance such as international and U.S. consensus standards, should be used
provided it results in acceptable performance.

Organizations should use standards and guides as sources of information that


provide ways to meet the basic requirements. The format, such as the number of
criteria of an organization's quality assurance program, should be based on the
organization's individual needs; and is only important if it affects the organization's
performance. DOE and contractor management must assume a different leadership
role than in the past when DOE defined quality solely in terms of conformance to
standards. Today quality is defined in terms of satisfying the customer in the most
resource-efficient manner. The scope of employee's work must be expanded to
include value-added activities, such as finding new and innovative ways to improve
the quality of their work. The following policy, principles and value-added attributes
are articulated in the Order and Rule.
5.0 ORGANIZATION

6.0 AUTHORITY & RESPONSIBILITIES

Value-Added Attributes of the QA Requirements

i. Senior Management Ownership

Senior management must take full ownership of the quality assurance


program. These managers should establish policies and objectives focused on
achieving the organization's mission while improving the quality of the
organization's products and services. They must create an environment that
promotes quality and the improvement of quality throughout the entire
organization.
ii. Line Organization Responsibility

People who perform the work have the greatest affect on item and process
quality. They should be empowered. They determine the extent to which
management's objectives are met. Individual employees should seek ways to
improve the quality of their work by suggesting product and process
improvements.

iii. Effective Assessment

The self-assessment process consists of three types of assessments: worker,


management, and independent. Worker assessment deals with the individual
taking responsibility for their work as part of their work ethic. As work is
performed, workers should critically assess their efforts and determine if they
have accomplished what they set out to do, that is, meet management's
objectives.

Management assessment identifies, corrects and prevents management


problems that hinder the achievement of the management's objectives. The
assessments focus on broad categories of management issues to determine the
effectiveness of the integrated management system.

Independent assessment expands traditional audit techniques to include a


myriad of tools that allow independent assessment personnel to better focus
on real issues that affect the organization's performance. In their role of
assessing item quality and process effectiveness, independent assessment
personnel act on behalf of and as an advisor to, senior management.
Personnel performing assessments should be technically qualified and
performance-oriented.

iv. Quality Results

A measure or the success of an organization is the quality of the services and


products it provides. Product and service quality, rather than rigorous
programs, procedures, and documentation, is the organization's primary
measure of success.

v. Cost and Schedule

To achieve quality products and services, managers must take into account
resource considerations, such as cost and schedule. These considerations must
be an integral part of management's decision-making process.

vi. Training and Qualification

Every individual must be capable of doing his/her job. The Order requires
that all personnel, including managers, receive the appropriate training to
ensure they are capable of performing their assignments.

vii. Quality Improvement

Problem prevention is more desirable than problem correction. The Order


emphasizes that DOE and DOE contractor management is responsible for
continuously pursuing enhancements to their products and services--not just
complying with the minimum set of requirements. Everyone must strive to
find new and innovative ways to ensure that the quality of products and
services are continually improved. Process and product problems must be
identified, documented, and corrected with the goal of promoting higher
levels of quality.

viii. Graded Approach

Not all items, processes and services have the same effect on safety and
reliability. The rigor with which the QAP should be applied must be
determined using a graded approach. Specific information should be
considered, such as the relative importance of safety, safeguards, and
security; the management of any hazard; life cycle stage; programmatic
mission; characteristics of the facility; consequences of failure; complexity or
uniqueness of design or fabrication; special controls; ability to demonstrate
functional compliance; quality history; degree of standardization; impact on
the environment; and impact on cost or schedule or both.

7.0 COMPLIANCE WITH ISO9001

Statutes, Regulations, and Directives Providing Basis for the Classification and
Controlled Information Programs Classification:
Atomic Energy Act of 1954 - Establishes Government-wide policies for
classifying, safeguarding, and declassifying Restricted Data information.
10 CFR Part 1045, Nuclear Classification and Declassification - Establishes
the Government-wide policies and procedures for implementing sections
141 and 142 of the Atomic Energy Act of 1954 for classifying and
declassifying RD and FRD and implements those requirements of Executive
Order 12958 concerning NSI that affect the public.
Executive Order 13526, Classified National Security Information -
Prescribes the Government-wide system for classifying, safeguarding, and
declassifying NSI.
Public Law 105-261, Section 3161, Protection Against Inadvertent Release
of Restricted Data and Formerly Restricted Data - Requires every
Government agency implementing the automatic declassification provisions
of section 3.3 of Executive Order 12958 to follow procedures (i.e., a plan)
to prevent the inadvertent release of records containing RD or FRD.
Public Law 106-65, Section 3149, Supplement to Plan for Declassification
of Restricted Data and Formerly Restricted Data - Extends the plan
requirements developed under section 3161 of Public Law 105-261 to apply
to records already processed under section 3.3 of Executive Order 12958.
Public Law 106-398, Section 3193, Frequency of Reports on Inadvertent
Releases of Restricted Data and Formerly Restricted Data - Requires the
Secretary of Energy to submit a report on inadvertent releases to specified
congressional committees and the Assistant to the President on a quarterly
basis.
DOE Order 475.2A - Identifying Classified Information - Establishes
requirements for managing the DOE program including details for
classifying and declassifying information, documents, and material
classified under the Atomic Energy Act [Restricted Data (RD) and
Formerly Restricted Data (FRD)] or Executive Order 13526 [National
Security Information (NSI)], so that it can be protected against unauthorized
dissemination.

8.0 DOCUMENTATION & CHANGE CONTROL

All documentation utilized within the Company related to the management


system itself, or to the execution of individual customer contracts is controlled to
ensure that it is issued to the appropriate personnel, under the correct level of
authority, is revised and reissued as necessary, and all obsolete versions are removed
from the point of use.

Such documentation typically includes:

 Specifications,
 Customer Orders,
 Plans/ Drawings, 
 Quality Assurance Manual/ Operating Procedures, 
 National/ International Standards and Codes of Practice.

The Quality Assurance Manual, Procedures and Quality Plans are maintained by
the Quality Manager who ensures that the appropriate items, at the correct revision
levels, are issued to all who need them within the Company. National/ International
Standards, Codes of Practice are maintained by the Support Engineers who ensure
that appropriate documents are available within the Company, and are issued at the
correct revision levels.

All changes to documents are reviewed and approved by the person responsible
for the original issue and, where appropriate, the nature of the change is indicated on
the document. Master copies of the revised documents are retained as records of the
changes and renewed as necessary to ensure clarity.
9.0 RECORDS

Storage facilities are allocated which ensure that all stored records are identifiable
and retrievable, and the storage areas are free from damp and other agents which
could cause premature deterioration.

Where records are maintained on computer magnetic media, and these are
subject to "back-up" at regular intervals, with the "back-up" information being stored
in a protected location to ensure security from loss/ damage of active data. All
records are retained for a minimum of 2 year

10.0 TRAINING

Software Quality Assurance Training

DOE is committed to provide qualified staff to assist, guide, direct, oversee


and evaluate its safety software. The Department’s Safety Software Quality
Assurance Functional Area Qualification Standard (FAQS) establishes common
functional area competency requirements for its personnel.  Additionally, specific
Office/Facility-Specific Qualification Standard supplements the technical FAQS and
establishes unique operational competency requirements.

One of the first steps undertaken in July 2003 was the issuance of DOE
Notice 411.1, Safety Software Quality Assurance Functions, Responsibilities, and
Authorities (FRA) for Nuclear Facilities and Activities. This notice assigned roles
and responsibilities for the improvement of safety software quality assurance (SQA).
DOE Order 414.1C superseded DOE Notice 411.1

The U.S. Department of Energy’s (DOE) Federal Technical Capability


Program Policy, P 426.1, issued by the Secretary in December 1998, commits DOE
to continuously strive for technical excellence and establishes the Technical
Qualification Program (TQP). The TQP, along with the supporting technical
Functional Area Qualification Standards, complements the personnel processes that
support DOE's drive for technical excellence. Detailed operating requirements for the
TQP and Functional Area Qualification Standards are described in the Federal
Technical Capability Manual, DOE M 426.1-1.

To ensure that DOE personnel possess and maintain the appropriate level of
competency required for their positions, DOE has committed to provide training for
its personnel.  Public courses on software quality engineering were researched and
compared with the technical qualifications.  The American Society for Quality
(ASQ) Software Quality Engineering (SQE) course, that is based upon industry
accepted practices in SQE, best matches DOE-STD-1172-2003, Safety Software
Quality Assurance Functional Area Qualification Standard, competencies
requirements.  This course has as its foundation, ASQ’s SQE body of knowledge that
has been used to certify hundreds of software quality engineers across the United
States since 1997.A crosswalk was done between the Safety Software Quality
Assurance competency Requirements and the ASQ Software Engineering course for
competencies satisfied by this course.

11.0 SERVICING

Quality Assurance Contacts:


Office of Quality Assurance and Assistance (HS-23)

Colette Broussard, Director (301) 903-5452 

Stacey Onley, Administrative Assistant (301) 903-8019 

Duli Agarwal, QA Technical Assistance/QA (301) 903-3919 


Analysis

Sonya Barnette, QA Technical Assistance/QA (301) 903-2068 


Web Liaison

Mary Haughey, QA Policy/Directives (301) 903-2867 

Subir Sen, HEPA Filter/Software QA (301) 903-6571 

Debbie Rosano, QA Technical Assistance/QA (301) 903-8177 


Communications
12.0 DESIGN CONTROL

All Design activities are strictly controlled to ensure that the design output
information complies with customer/ contract requirements, and all design input
data. Design activities are planned and normally executed by specialists and are
subject to regular management, review and verification by the Sales Director, and
where relevant, agreement with the Customer.

The design input and output items are documented, and where ambiguity exists, will
be clarified and documented. All items of design documentation and notes are
recorded in a design project file. Design output documentation is produced and
reviewed to ensure that it:

i. Meets the design input,


ii. References the design input or appropriate criteria,
iii. Identifies all of the characteristics which are critical to the safe and effective
operation of the system(s).

Design output is reviewed and approved by the Sales Director, and is also provided
to the Customer for approval prior to use. Validation of the design is achieved during
commissioning of the system to confirm compliance to the customer's requirements.
The designer is required to specify any inspections or tests which may verify the
design, by practical means, at the earliest possible stage of development. All changes
to the design criteria, input or output are subject to strict review and documentation
control procedures.

13.0 UNDERLYING QUALITY PRINCIPLES

These principles are consistent with Integrated Safety Management Policy, P 450.4
and support ISM implementation.

i. Ensure they are Understood and Accepted.


Management must set expectations for the organization as a whole before
employees can do their jobs, satisfy their customers, and strive to improve the
quality of their work. This is accomplished by developing and implementing
specific policies and objectives that reflect the operating philosophy of the
facility's management. Once these policies and objectives have been
established, all managers must take the necessary actions to ensure that each
employee shares their vision of the organization's purpose.

ii. Specify Roles and Responsibilities

Ensure they are Understood and Accepted.


Each employee must take responsibility for the work they perform. Everyone
contributes to the quality and to meeting the performance objectives
established by management. It is management's obligation to ensure that the
employees understand what is being asked of them. Individual and team
performance is the key to achieving management's objectives.

iii. Specify and Communicate Expectations

Identify and Allocate Resources to Achieve Them. Management must


identify resources and capable individuals for carrying out the organization's
work. Management must provide employees with the material and training
necessary to accomplish their tasks. Before taking responsibility for their
work, employees must possess the following:

1. Knowledge of management's expectations 


2. Knowledge of why the task is being performed 
3. Empowerment to carry out assigned tasks 

iv. Strive to Improve.

Management is responsible for creating an environment that encourages


employees to improve the quality of the work and work processes with which
they are associated. Employees must consistently seek new, more innovative
ways to increase quality, efficiency, and effectiveness.
v. Ensure People are Competent at the Work They Do.

Management must ensure that each employee is capable of performing


his/her assigned tasks. Employees should be afforded the appropriate
education and training, including professional development and on-the-job
training.

14.0 CONCLUSION

From our study, we can conclude Quality assurance is the main pillar of any
business. Whatever is the business, manufacturing, welding construction either
finances or a storage facility or any service, quality is the most important aspect,
which affects the level of success of the work. If your product or service does not
have standard quality, then a customer will never use it in future, even if it has the
lowest price. Thus, you have to assure the quality of your product or service by
conducting some scientific measures.

For most information developers, quality assurance represents a series of actions that
ensure that content is accurate, complete, and meets customer requirements. These
actions include:

i. Reviews by subject-matter experts


ii. Testing of content against product
iii. Editing for consistency, compliance with standards and focus on the
customer’s needs.

Each of these quality assurance actions is fraught with difficulties, especially when
project schedules are seriously curtailed as companies push developers to release
product more quickly. The pressure to meet the next deadline encourages
organizations at all levels to forsake quality assurance, including even basic testing
of products to ensure they perform as specified and contain minimal bugs.

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