E2C-QMP-001 Quality Management Manual

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Quality Management System

Quality Manual
Document No. E2C-QMP-001

TABLE OF CONTENTS

I. Quality Policy Statement ……………………………………………………………………………………………………. 3


II. Introduction ……………………………………………………………………………………………………………………….. 3
1. Background …………………………………………………………………………………………………………………… 3
2. Purpose ………………………………………………………………………………………………………………………… 4
3. Scope ……………………………………………………………………………………………………………………………. 4
III. Responsibility and Organizational Chart ……………………………………………………………………………. 4
IV. Quality Management System ……………………………………………………………………………………………. 7
1. General Requirements………………………………………………………………………………………………… 7
2. Organizational goals …………………………………………………………………………………………………… 8
3. Documentation requirements ………………………………………………………………………………………. 8
3.1 General …………………………………………………………………………………………………………………. 8
3.2 Quality manual ……………………………………………………………………………………………………… 9
3.3 Control of documents ……………………………………………………………………………………………. 9
3.4 Control of quality records ……………………………………………………………………………………… 9
V. Quality Assurance and Quality Control ……………………………………………………………………………… 9
VI. Customer Satisfaction ………………………………………………………………………………………………………. 10
VII. Staff Feedback ……………………………………………………………………………………………………………………11
VIII. Management Responsibility ……………………………………………………………………………………………. 11
1. Management commitment ………………………………………………………………………………………… 11
2. Customer focus …………………………………………………………………………………………………………… 11
3. Quality policy ………………………………………………………………………………………………………………. 11
4. Planning ……………………………………………………………………………………………………………………… 12
4.1 Quality objectives …………………………………………………………………………………………………. 12
4.2 Quality management system planning …………………………………………………………………. 12
5. Responsibility, authority and communication ……………………………………………………………… 12
5.1 Responsibility and authority …………………………………………………………………………………. 12
5.2 Management representative ………………………………………………………………………………… 13
5.3 Internal communication ……………………………………………………………………………………….. 13
6. Management review …………………………………………………………………………………………………… 13
6.1 General …………………………………………………………………………………………………………………. 13
6.2 Review input …………………………………………………………………………………………………………. 13
6.3 Review output ………………………………………………………………………………………………………. 14
IX. Resource Management …………………………………………………………………………………………………….. 14
1. Provision of resources …………………………………………………………………………………………………. 14
2. Human resources ………………………………………………………………………………………………………… 14
2.1 General ………………………………………………………………………………………………………………… 14
2.2 Competence, awareness and training …………………………………………………………………… 15
E2C-QMP-001 Page 1 of 22
3. Infrastructure ……………………………………………………………………………………………………………… 15
4. Work environment ……………………………………………………………………………………………………… 15
X. Design Realization (Work Processes) ………………………………………………………………………………… 16
1. Planning of realization processes ……………………………………………………………………………….. 16
2. Customer-related processes ……………………………………………………………………………………….. 16
2.1 Determination of requirements related to the design …………………………………………… 16
2.2 Review of requirements related to the design ……………………………………………………... 16
2.3 Customer communication …………………………………………………………………………………….. 17
3. Design and development …………………………………………………………………………………………….. 17
3.1 Design and development planning ……………………………………………………………………….. 17
3.2 Design and development inputs …………………………………………………………………………… 17
3.3 Design and development outputs …………………………………………………………………………. 18
3.4 Design and development review …………………………………………………………………………… 18
3.5 Design and development verification ……………………………………………………………………. 18
3.6 Design and development validation ……………………………………………………………………… 18
3.7 Control of design and development changes ………………………………………………………… 19
4. Purchasing ………………………………………………………………………………………………………………….. 19
4.1 Purchasing process ……………………………………………………………………………………………….. 19
4.2 Purchasing information ………………………………………………………………………………………… 19
4.3 Verification of purchase …………………………………………………………………………………..…… 20
XI. Measurement, Analysis and Improvement ………………………………………………………………………. 20
1. General ………………………………………………………………………………………………………………………. 20
2. Monitoring and measurement ……………………………………………………………………………………. 20
2.1 Customer satisfaction …………………………………………………………………………………………… 20
2.2 Internal audit ……………………………………………………………………………………………………….. 20
2.3 Monitoring and measurement of processes …………………………………………………………. 21
2.4 Monitoring and measurement of design ……………………………………………………………… 21
3. Control of non-conforming design ……………………………………………………………………………… 21
4. Analysis of data ………………………………………………………………………………………………............. 21
5. Improvement ……………………………………………………………………………………………………………… 22
5.1 Continual improvement ……………………………………………………………………………………….. 22
5.2 Corrective action ………………………………………………………………………………………………….. 22
5.3 Preventive action ………………………………………………………………………………………………….. 22

Rev. No. Rev. Date Description of Revision Revised by Approval


00 25/Feb/2016 New JBG KIA
01 05/Mar/2018 3 Years Cycle Revision JBG KIA

PROPRIETARY & CONFIDENTIAL


This document and the information contained herein is E2C proprietary know-how. This document or any part
therefore should not be reproduced stored in a retrieval system or transmitted by any means, electronic or
otherwise, or divulged without permission of E2C.

E2C-QMP-001 Page 2 of 22
I. Quality Policy Statement

Ensiab Engineering Consulting (E2C) policy is to provide technical design and engineering services which
meet the customer’s specified project requirements and comply with all statutory and regulatory
requirements. We are totally committed to setting and achieving quality, and in all respects, the specified
requirements and reasonable expectations of our customers.

Ensiab Engineering Consulting (E2C) shall develop and maintain a Quality Management System and
maintain a consistently high quality in all work we undertake. Our Quality Management System shall
ensure that proper communication, work control and accountable records are generated for all work
undertaken.

Ensiab Engineering Consulting (E2C) staff are charged with promoting these aims and are required to
familiarize themselves with the contents of this quality manual which defines the Quality Management
System that has been established and adopted as the means for achieving these declared objectives.
Everyone connected with Ensiab Engineering Consulting (E2C) shall be supported according to their
individual needs for personal development, training and facilities.

Total Quality Management shall be applied to every aspect of our activity and quality shall be the
responsibility of everyone, in every activity, throughout Ensiab Engineering Consulting (E2C). E2C
accomplishes this by adhering to quality management and operational system that recognize customer
satisfaction as a primary goal.

II. Introduction
1. Background

Ensiab Engineering Consulting (E2C) was established in 2015, an engineering design and consulting firm
with the following specialist services and expertise:
• Front End Engineering Design
• Equipment Design
• Piping Engineering
• Electrical Engineering
• Detailed Engineering Design
• Machinery Engineering
• Civil/Structural Engineering
• Instrumentation Engineering
• Building Design

E2C is customer focused to provide quality engineering design at the right price and time schedule.

Ensiab Engineering Consulting (E2C) aim is to provide value for money engineering consultancy in support
of our customer’s design and services. We take pride in being reliable and friendly in day-to-day dealings
with our customers, good communication equates to the delivery of improved design quality.

E2C-QMP-001 Page 3 of 22
2. Purpose
The purpose of this quality manual is to establish and state the general policies and objectives
governing Ensiab Engineering Consulting (E2C) Quality Management System. These policies and
objectives define management’s intended arrangements for managing operations and activities in
accordance with E2C plans or protocol for achieving quality assurance and client satisfaction.

All changes to policies and objectives are reviewed to ensure that there no conflicts with the policies
stated in this Quality Manual (QM).

3. Scope
This Quality Manual defines:
• The overall quality policy and objectives adopted by E2C.
• The management effort that has been developed to implement this quality policy.
• Identifies the activities, processes and procedures used to manage the project’s quality
management.
• The continuous improvement of activities and processes utilized by Ensiab Engineering
Consulting (E2C).

III. Responsibility and Organizational Chart

E2C-QMP-001 Page 4 of 22
1. Managing Director
Managing Director is responsible for the overall management of E2C. He is responsible for the overall
and final success of all contracts undertaken, for providing guidance on all major issues and for
ensuring that all E2C design and consulting services are produced and delivered to the highest possible
level.
Managing Director is responsible for:
• Supervising the day to day running of E2C.
• The overall progress of the work with which he has been entrusted and the budget placed at
his disposal.
• Controlling budget, time schedules, Quality plans, resources and quality within the company
• Approving changes to agreed time schedules, resources and budgets.
• Ensuring that management will meet the customer business requirements and objectives as
well as keeping to the agreed time schedule.
• Maintaining overall responsibility for all projects.

2. Engineering Manager
Engineering Manager is responsible for the overall engineering activities of E2C. He is responsible for
the overall project management process and delivery timelines to keep projects on schedule and on
budget. Confronts and solves performance/operational issues to improve development efficiency.
Leads and develops the engineering team.
Engineering Manager report directly to Managing Director and his tasks are included:
• Identify the resource requirements
• Establish the team for work execution
• Set tasks and targets to the teams
• Provide technical support
• Monitor progress to ensure timely and cost-effective execution
• Ensure implementation of the QMS
• Identify areas for improvement
• Train the staff to maintain technical competently

3. Project Engineer
Project Engineer is appointed by Managing Director, and are responsible for the delivery of a project,
for organizing the project work, and distributing this work between the project staff according to the
directives, procedures and instructions making up the E2C QMS whilst duly observing the
requirements of E2C.
Project Engineer report directly to Managing Director and his tasks are included:
• Responsibility for the general progress of the work of the project
• Controlling the time schedules, work packages, resources and quality of the tasks allocated to
the project
• Ensuring that the project will meet the objective of the customer and the business needs of
E2C.
• Directing the studies of the project with the constant aim of achieving an accelerated and
sustained tempo of the project within the scope of their own particular quality plan and
individual work packages.

E2C-QMP-001 Page 5 of 22
4. Safety
To manage & identify hazards/aspects and risk associated to employee, client and the impact
on the environment. Prevents incidents and injuries with a focus on the integrity of
operations.
Safety report directly to Managing Director and his tasks are included:
• Participates in the necessary measurement and evaluation of the effectiveness of any
assigned safety management programs or procedures developed or modifications necessary
to achieve optimum results.
• Reviews technological developments and equipment to keep up to date on the devices and
techniques designed to eliminate or minimize hazards and determines whether these
developments and techniques have application in E2C.

5. Quality Administrator
To provide high standard of administrative support to enable the Quality team to work within a
framework of continual Quality Improvement. To coordinate the quality system continual
development and improvement, manage lessons learned and customer feedback as well yearly
internal audits.
Quality Administrator report directly to Managing Director and his tasks are included:

• To lead E2C team Quality systems to ensure that the team are equipped to drive forward the
Quality Improvement Strategy. Lead E2C efforts for ISO certification.
• To investigate, resolve and report on all complaints and compliments at E2C with regards to
customers and stakeholders.

6. Financial Control or Accountant


Accountable for the accounting operations to include the production of periodic financial reports,
maintenance of an adequate system of accounting records, and a comprehensive set of controls and
budgets designed to mitigate risk, enhance the accuracy of the reported financial results, and ensure
that reported results comply with local and generally accepted accounting principles.
Financial Control or Accountant report directly to Managing Director and his tasks are included:
• Prepares asset, liability, and capital accounts entries by compiling and analyzing account
information.
• Recommends financial transactions by analyzing accounting options. Summarizes current
financial status by collecting information; preparing balance sheet, profit and loss statement,
and other reports.

7. Admin Assistant/Document Controller


Manage all documents for the company. Implement processes, provide system reports, maintain and
update electronic information system, distribute documents, and ensuring their accuracy, and
safeguarding of documentation.
Admin Assistant/Document Controller report directly to Engineering Manager and his tasks are
included:
• Assign and control drawings/documents numbers, equipment numbers, pipeline number,
instrument numbers, electrical equipment number requested by projects.
• Archive hard copy of project records and project files of completed clients site projects.

E2C-QMP-001 Page 6 of 22
• Coordinate softcopy uploading/publishing of project records and completed client site project
with Electronic Document Management System (EDMS) specialist.

8. Cost & Control Engineer


Provide direct engineering support to clients and/or various project and able to analyze the
requirements, specification of a project and determine the costs involved to launch such a project.
Report all cost functions on a project from the planning state, concept, forecasting, preliminary &
detailed engineering throughout construction.
Cost & Control Engineer report directly to Engineering Manager and their tasks are included:
• Responsible for establishing the cost report requirements for the overall project. Works with
the project scheduler/planner in the office and the field base project control team at remote
engineering offices and the construction site.
• Prepares the associated cost structure of the assigned project. Prepares and implement the
change management plan. Knowledge of accounting activities, financing, and the need of
estimation.
• Provide planning and cost controlling support for all projects which includes variation
reporting, monitoring of milestone progress to the preparation of customer billing processes,
etc.

9. Discipline Engineers & Designer/Draftsmen


Discipline Engineers & Designer/Draftsmen carry out the accepted tasks assigned by the Project
Engineers. Discipline Engineers & Designer/Draftsmen provides technical support to the Managing
Director and Project Engineer on the project. Discipline engineers & Designer/Draftsmen must:
• Establish and execute technical policies, processes, and procedures to ensure adherence for
defined quality standards. Identifying and escalating any critical project issues to the project
engineer. Identifying project standards and metrics.
• Establishing reporting standards that provide findings from quality measurements on a
periodic basis identifying business, technical, and/or management quality objectives that
being or not being met.
• Establish and maintain a repository for quality measurement and tracking.

IV. Quality Management System


1. General Requirements
E2C Quality Management System (QMS) structure is organized of responsibilities, activities, resources
and events that together provide procedures and methods of implementation to ensure the capability
of E2C meets the quality requirements of our customers. The system is designed to result in
continually improving the effectiveness of Ensiab Engineering Services in operation of the quality
management system and the ability to satisfy the customer requirements.

E2C-QMP-001 Page 7 of 22
E2C Quality Loop:

Staff & Internal &


Customer External
Feedback Audits

Project Performance
Review & Analysis

Update processes & Project Close-out


procedures per review findings Process

Project Bidding & Payment & Change


Scoping Order

Conceptual Design As-Built Documentation


Process

Engineering / QA-QC

Within E2C an effective QMS ensures that all activities are fully understood, controlled and
documented and that everyone knows exactly what and how to execute a task following one of the
E2C Work Procedures, processes or Instructions.

2. Organizational goals
The primary goal of E2C is the quality of the final design and services (at all times). To succeed, E2C
must be able to offer design and services that:
• Satisfy the customer’s requirements, standards and expectations.
• Comply with applicable local and Royal Commission standards and specifications.
In order to meet these goals, E2C is organized in such a way that technical, administrative and human
factors affecting the quality of E2C design and services are always under control.

3. Documentation requirements
3.1 General
E2C QMS documentation includes:
• Statements regarding quality policy and quality objectives.
• Documented procedures, which clearly describe the sequence of processes necessary to
ensure conformance with ISO 9001:2008.
• Documented instructions to ensure the effective operation and control of processes and
quality records.

E2C-QMP-001 Page 8 of 22
3.2 Quality Manual
This Quality Manual includes the scope of Ensiab Engineering Consulting (E2C) quality system.
Each section of this manual references the appropriate QM procedures. Interactions between
procedures are defined in this Quality Manual or in the Quality Procedures.
a. Policy and Objectives
E2C established and maintains a Quality Manual (QM) which includes:
• Details of any ISO 9001:2008 exclusions.
• Details of associated documented procedures.
• Their sequence and interaction.
b. Responsibility
Project Engineer is responsible for operating the QMS, ensuring that the Quality Manual (QM)
is fully and effectively implemented and for coordinating the writing availability of the
necessary processes, procedures and instructions.

3.3 Control of documents


a. Policy and Objectives
E2C established QMS level procedures for controlling documents required for the operation
of the QMS. These procedures ensured that:
• Documents are approved for adequacy prior to release.
• Documents are reviewed, updated as necessary and re-approved.
• The relevant versions of documents are available at locations where activities
essential to the effective functioning of the QMS are performed.
• Obsolete documents are removed from all points of issue and use, or otherwise
controlled to prevent unintended use.
• Any obsolete documents retained for legal or knowledge-preservation purposes are
suitably identified.

b. Responsibility
Project Engineer is responsible for the overall planning of document control procedures
throughout E2C.

3.4 Control of quality records

a. Policy and Objectives


E2C maintained quality records appropriate to the company to demonstrate conformance to
the requirements and the effective operation of the QMS. E2C established and maintains QMS
level procedures for the identification, storage, retrieval, protection, retention time, and
disposition of quality records.
b. Responsibility
Project Engineer is responsible for maintaining quality records demonstrating conformance to
the requirements and the effective operation of the QMS.

V. Quality Assurance / Quality Control

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E2C established and maintains a QA/QC system as a means of ensuring that the services we provide our
customers conform to specified requirements. This QA/QC system are included:
• Documented quality system procedures and instructions to ensure that all activities are
performed in accordance with established requirements.
• Effective management support to ensure compliance and the use of the QA/QC procedures and
instructions.

All E2C employees are strived to improve the quality of design and services to our customers. The QA/QC
program is a process of continuous improvement which requires input from everyone in the organization.
Everyone in the organization shall comply and endeavor to improve the process where possible. An
effective QA/QC program consist of the following key components:
• Established QA/QC procedures and instructions that comply with generally accepted industry
standards, Royal Commission, Saudi Government and local regulating authorities, and the project
specifications and standards establish by the customer;
• The identification and timely issuance to the project team any required controls, processes,
inspection equipment, fixtures, tools, materials and labor skills needed to properly execute the
project.
• Updating, as necessary, of quality control, inspection and testing techniques, including the
development of new methods and procedures.
• Identification of any commitments made which exceeds available resources in sufficient time to
properly acquire the required resources.
• Clarification of the standards of acceptability as required to support the overall QA/QC program
and our customer’s objectives.
• Review of the project process, technical design and service, inspection and test procedures to
ensure that applicable documentation reflects how activities are performed.
• Effective maintenance of quality records to document and track performance and improvement.

VI. Customer Satisfaction


From the customer’s point of view, E2C QMS must provide them with a level of confidence in the ability
of E2C to deliver the desired quality as well as the consistent maintenance of that quality.

To be effective, E2C QMS ensures:


a. That objective evidence is provided, (in the form of information and data), concerning the quality of
the system and the quality of E2C technical design and engineering services.
b. Consideration has been given to the risks related to deficient technical design and engineering
services.
c. Consideration has been given to the risks pertaining to the health and safety of people.
d. Costs due to design deficiencies (including rework, re-processing and loss of production) have been
considered.

E2C QMS is designed and structured so that:

a. It meets the customer needs and expectations.


b. It provides an effective management resource in the optimization and control of quality in relation to
risk, cost and benefit considerations.
c. The system is well understood and effective.

E2C-QMP-001 Page 10 of 22
d. Emphasis is placed on problem prevention rather than dependence on detection after occurrence.

VII. Staff Feedback


Ensiab Engineering Consulting (E2C) will ensure that all staff are involved in the process of evaluation and
planning for improvements based upon feedback from questionnaires, reviews, monitoring, complaints
and/or comments. Staff feedback will be secured through:
a. Weekly Staff meeting to review the preceding week’s performance and share any relevant information
and updates.
b. Monthly review meetings with managing director which will follow an agreed agenda including
reviewing performance against set targets and identifying any support required by staff members and
setting targets.
c. Formal annual appraisal designed to provide an objective view of performance. This will include
discussion with the staff member regarding training needs and agreeing measurable targets.
Appraisals are a two-way process where staff are encouraged to share their views and identify the
support and training that they require to achieve their targets and objectives as well as receiving
feedback from managing director.

VIII. Management Responsibility


1. Management commitment
a. Policy and Objectives
E2C management & staff (Managing Director, Engineering Manager, Project Engineer, Safety,
Quality Admin, Financial Control, Admin Asst./Document Controller, Cost & Control Engineer,
Discipline Engineer and Designer/Draftsmen) demonstrates their commitment by:
• Carrying out regular management reviews of the QMS and its associated documentation
aimed at ensuring the continual improvement of the system.
• Establishing the quality policy and quality objectives.
• Ensuring the availability of necessary resources.
• Ensuring adequate focus on customer requirements throughout E2C.
• Ensuring that all staff are aware of the importance of meeting customer, regulatory and
legal requirements.
b. Responsibility
Managing Director is responsible for demonstrating their commitment to quality and for
supporting management in achieving that commitment.

2. Customer focus
a. Policy and Objectives
With the overall aim of achieving customer satisfaction, E2C will ensure that:
• Customer needs and expectations are determined and converted into requirements
• Customer requirements are fully understood and met
• Customer satisfaction is enhanced
b. Responsibility
E2C management has overall responsibility for establishing, implementing and maintaining this
activity.

3. Quality policy
a. Policy and Objectives
E2C-QMP-001 Page 11 of 22
E2C established its quality policy and ensure that it:
• Is appropriate for the needs of E2C and its customers
• Includes a commitment to meeting requirements and continual improvement
• Provides a framework for establishing and reviewing quality objectives
• Is communicated, understood and implemented throughout E2C
• Is regularly reviewed for continuing suitability
b. Responsibility
E2C management has overall responsibility for establishing, implementing and maintaining this
activity.

4. Planning
4.1 Quality objectives
a. Policy and Objectives
E2C established quality objectives at each relevant function and level. These quality objectives
will be consistent with the quality policy and the commitment to continual improvement. Quality
objectives are included those needed to meet design and service requirements.
b. Responsibility
E2C management has overall responsibility for establishing, implementing and maintaining this
activity.

4.2 Quality Management System planning


a. Policy and Objectives
E2C will identify and plan the activities and resources needed to achieve quality objectives. This
planning will be consistent with other requirements of the QMS and the results will be
documented.
Planning covers the:
• Processes required in the QMS (and any reduction in scope of this international standard)
• Realization processes and resources needed, identifying quality characteristics at
different stages, to achieve the desired results.
• Verification activities, criteria for acceptability and the quality records needed
Planning will ensure that organizational change is conducted in a controlled manner and that the
QMS is maintained during this change.
b. Responsibility
E2C management has overall responsibility for establishing, implementing and maintaining this
activity.

5. Responsibility, authority and communication


5.1 Responsibility and authority
a. Policy and Objectives
E2C defined the roles and their interrelations, responsibilities and authorities in order to facilitate
effective quality management and this information will be communicated throughout E2C.
b. Responsibility
E2C Management has overall responsibility for establishing, implementing and maintaining this
activity.

5.2 Management representative


E2C-QMP-001 Page 12 of 22
a. Policy and Objectives
Managing director appointed a member of the management who, irrespective of other
responsibilities, and defined authority that includes:
• Ensuring that the E2C QMS is implemented and maintained.
• Reporting to E2C management on the performance of the QMS, including needs for
improvement.
• Ensuring awareness of customer requirements throughout E2C.
b. Responsibility
Project Engineer has the overall responsibility for ensuring that the policies set out in this QMS
are understood, implemented and maintained at all levels in the organization and the company
works towards achieving its vision and key objectives. He is responsible for ensuring that the
system is effectively implemented and maintained, and reports on the performance of the QMS
at management review meetings.

5.3 Internal communication


a. Policy and Objectives
E2C established and maintains procedures for internal communication between the various levels
and functions regarding the QMS and its effectiveness.

b. Responsibility
Managing Director has overall responsibility for establishing, implementing and maintaining this
activity.

6. Management review
6.1 General
a. Policy and Objectives
E2C established a process for the periodic review of the QMS. It shall be reviewed to ensure its
continuing suitability, adequacy and effectiveness. The review evaluated the need for changes to
E2C QMS, including policy and objectives and continues to provide customer satisfaction.
b. Responsibility
Project Engineer is responsible for ensuring that quality records are maintained in a systematic
and presentable form.
All staff are responsible for ensuring that they provide the necessary records as required from
their involvement in implementing the quality systems.

6.2 Review input


a. Policy and Objectives
The review input of the QMS shall include (but not be limited to):
• Results and follow-up actions from earlier management reviews.
• Results of previous internal, customer and third-party audits.
• Self-assessment results.
• Analysis of customer feedback.
• Analysis of process performance.
• Analysis of product conformance.
• The current status of preventive and corrective action.
• Supplier performance.
E2C-QMP-001 Page 13 of 22
• Changes that could affect the QMS.
• Recommendations for improvement.
b. Responsibility
Project Engineer is responsible for ensuring that quality records are maintained in a systematic
and presentable form.
All staff are responsible for ensuring that they provide the necessary records as required from
their involvement in implementing the quality system.

6.3 Review output


a. Policy and Objectives
The output of the management review includes:
• Improved design and process performance.
• Confirmation of resource requirements and organizational structure.
• Market needs.
• Risk management.
• Change control.
• Continued compliance with the relevant statutory and regulatory requirements.

Result of management reviews are recorded.

b. Responsibility
Project Engineer is responsible for ensuring that quality records are maintained in a systematic
and presentable form.
All staff are responsible for ensuring that they provide the necessary records as required from
their involvement in implementing the quality system.

IX. Resource Management


1. Provision of resources
a. Policy and Objectives
E2C determine and provides in a timely manner, the resources needed to establish and maintain
(and continually improve) their QMS so as to enhance customer satisfaction by meeting customer
requirements.
b. Responsibility
Project Engineer has overall responsibility for establishing, implementing and maintaining this
activity.

2. Human resources
2.1 General
a. Policy and Objectives
E2C assigned personnel who are competent (e.g. education, training, skills and experience, etc.).
b. Responsibility
Project Engineer has overall responsibility for establishing, implementing and maintaining this
activity.

2.2 Competence, awareness and training

E2C-QMP-001 Page 14 of 22
a. Policy and Objectives
E2C established and maintains system level procedure to:
• Determine competency and training needs.
• Provide training to address identified needs.
• Evaluate the effectiveness of training at defined intervals.
• Maintain appropriate records of education, training, skills, and experience.
• Ensure that the necessary expertise and levels of skills, etc. are available to handle the
expected workload and range of activities.
E2C established and maintains procedures to make its employees at each relevant function and
level aware of:
• The importance of conformance with the quality policy, and with the requirements of the
Quality Management System
• The significant impact of their work activities on quality, actual or potential.
• The benefits of improved personal performance.
• Their roles and responsibilities in achieving conformance with the quality policy and
procedures and with the requirements of the Quality Management System.
• The potential consequences of departure from specified procedures.

b. Responsibility
Project Engineers are responsible for ensuring that appropriate training is carried out and that all
staff involved in their projects are aware of the requirements, rules and procedures to which they
are to conform and against which they will be audited.

3. Infrastructure
a. Policy and Objectives
E2C developed and maintained the infrastructure to achieve design requirements regarding (but
not limited to) the following:
• Workspace and associated facilities.
• Hardware and Software.
• Tools and Equipment.
• Communication Facilities.
• Supporting Services.
b. Responsibility
Project Engineer has overall responsibility for establishing, implementing and maintaining this
activity.

4. Work environment
a. Policy and Objectives
E2C defined and managed those human and physical factors of the work environment needed to
achieve conformity of design.
This are included:
• Health and Safety conditions.
• Work methods.
• Work ethics.
• Ambient working conditions.

E2C-QMP-001 Page 15 of 22
b. Responsibility
Project Engineer has overall responsibility for establishing, implementing and maintaining this
activity.

X. Design Realization (Work Processes)


1. Planning of realization processes
a. Policy and Objectives
E2C ensured these processes are operated under controlled conditions and produce outputs,
which meet customer requirements. E2C determined how each process affects the ability to meet
design requirements:
• Establish methods and practices relevant to these processes, to the extent necessary, to
achieve consistent operation.
• Determine and implement the criteria and methods to control processes, to the extent
necessary, to achieve design conformity with the customer requirements.
• Verify and validate that processes can be operated to achieve design conformity with
customer requirements.
• Determine and implement arrangements for measurement, monitoring and follow-up
actions, to ensure processes continue to operate to achieve planned results and outputs.
• Ensure the availability of the information and data necessary to support the effective
operation and monitoring of the processes.
• Maintain as quality records the results of process control measures, to provide evidence
of effective operation and monitoring of the processes.

b. Responsibility
E2C management has overall responsibility for establishing, implementing and maintaining this
activity.

2. Customer-related processes
2.1 Determination of requirements related to the design
a. Policy and Objectives
E2C established a process for identifying customer requirements that determine the:
• Completeness of the customer’s design and/or service requirements.
• Requirements not specified by the customer but necessary for fitness for purpose.
• Statutory, regulatory and legal requirements.
• Customer requirements for availability, delivery and support of product and/or service.

b. Responsibility
Managing Director, assisted by Project Engineers, has overall responsibility for establishing,
implementing and maintaining this activity.

2.2 Review of requirements related to the design


a. Policy and Objectives

E2C-QMP-001 Page 16 of 22
The customer requirements, including any requested changes, will be reviewed before a
commitment to supply a design is provided to the customer (e.g. submission of a tender,
acceptance of a contract or order).
This Contract Review will ensure that:
• Customer requirements are clearly defined for design and/or service
• Where the customer provides no written statement of requirement, the customer
requirements are confirmed before acceptance through email.
• Contract or order requirements differing from those previously expressed, (e.g. in a
tender or quotation), are resolved.
• E2C can meet the customer requirements for the design and/or service.
The results of the review and subsequent follow-up actions are recorded, and the information
disseminated to all the relevant personnel.
b. Responsibility
Project Engineer has overall responsibility for establishing, implementing and maintaining this
activity.

2.3 Customer communication


a. Policy and Objectives
E2C determined and implemented arrangements for customer communication with the overall
aim of meeting customer requirements. E2C defined communication requirements relating to:
• Design and services information.
• Enquiries and order handling, including amendments.
• Customer complaints and actions relating to non-conforming design.
• Customer responses relating to design performance.

b. Responsibility
Managing Director has overall responsibility for establishing, implementing and maintaining this
activity.

3. Design and development


3.1 Design and development planning
a. Policy and Objectives
E2C plan and control the design and development of a product which are includes:
• Stages of the design and development process.
• Required review, verification and validation activities.
• Responsibilities and authorities for design and development activities.
b. Responsibility
Project Engineers have overall responsibility for establishing, implementing and maintaining this
activity

3.2 Design and development inputs


a. Policy and Objectives
E2C defined and recorded the requirements to be met by the design and/or service. These are
included:
• Functional and performance requirements from customer or market.
E2C-QMP-001 Page 17 of 22
• Applicable statutory, regulatory and legal requirements.
• Applicable environment requirements.
• Requirements derived from previous similar designs.
• Any other requirements essential for design and development.
These inputs are reviewed for adequacy and incomplete, ambiguous or conflicting requirements
are resolved.
b. Responsibility
Project Engineers have overall responsibility for establishing, implementing and maintaining this
activity.

3.3 Design and development outputs


a. Policy and Objectives
Design and development output:
• Meet the design and development input requirements.
• Contain or make referenced to design and/or service acceptance criteria.
• Be approved before being released.
b. Responsibility
Project Engineers have overall responsibility for establishing, implementing and maintaining this
activity

3.4 Design and development review


a. Policy and Objectives
At suitable stages, systematic reviews of design and developments are conducted to:
• Evaluate the ability of a design to fulfill requirements for quality.
• Identify problems.
• Propose follow-up actions.
Participants of these reviews are included representative of functions concerned with the design
stage being reviewed.
Results of the review and subsequent follow-up actions are recorded
b. Responsibility
Project Engineers have overall responsibility for establishing, implementing and maintaining this
activity

3.5 Design and development verification


a. Policy and Objectives
A verification process was planned and implemented to ensure that the design and development
output meets the design and development input. The results of the verification and subsequent
follow-up actions are recorded.
b. Responsibility
Project Engineers have overall responsibility for establishing, implementing and maintaining this
activity.

3.6 Design and development validation


a. Policy and Objectives
Design and development validation was performed to confirm that resultant design and/or service
is capable of meetings the particular requirements for specific intended customer use.
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Wherever applicable, validation was defined, planned and completed prior to the delivery or
implementation of the design and/or service. Where it is impossible to undertake full validation
prior to delivery or implementation, partial validation of the design or development output was
undertaken to the maximum extent practical.
The results of the validation and subsequent follow-up actions are recorded.
b. Responsibility
Project Engineers have overall responsibility for establishing, implementing and maintaining this
activity

3.7 Control of design and development changes


a. Policy and Objectives
E2C identified the document and control of all design and development changes, and evaluated
the effect of these changes and/or medications on:
• The interaction between the elements of the design and development.
• The interaction between the component parts of the resulting design and/or service.
• The need for carrying out re-verification or re-validation for all or part of the design and
development outputs.

b. Responsibility
Project Engineers have overall responsibility for establishing, implementing and maintaining this
activity

4. Purchasing
4.1 Purchasing Process
a. Policy and Objectives
E2C evaluated and selects suppliers based on their ability to supply in accordance with E2C
requirements. Evaluation, re-evaluation and selection criteria for suppliers will be established. The
results of evaluations and subsequent follow-up actions are recorded.

E2C system for control of all purchased or subcontracted services are ensured those services
purchased and received conform to specified requirements and include provision for the assessment
of suppliers and subcontractors. It also established rules for the specification of requirements for
purchased documents and the verification of services received.

b. Responsibility
Managing Director has overall responsibility for establishing, implementing and maintaining this
activity.

4.2 Purchasing Information


a. Policy and Objectives
Purchasing documents will contain information clearly describing the service ordered, including
where appropriate:
• Requirements for approval or qualification of service, procedures, processes, equipment
and personnel.
• Any QMS requirements
E2C-QMP-001 Page 19 of 22
b. Responsibility
Managing Director has overall responsibility for establishing, implementing and maintaining this
activity.

4.3 Verification of Purchased


a. Policy and Objectives
E2C determined and implements the procedures necessary for verification of purchased. Where
E2C or its customer proposes to perform verification activities at the supplier’s premises, E2C was
specified the required verification arrangements and method of product release in the purchasing
documents.
b. Responsibility
Managing Director has overall responsibility for establishing, implementing and maintaining this
activity.

XI. Measurement, Analysis and Improvement


1. General
a. Policy and Objectives
E2C to define, plan and implement measurement, monitoring, analysis and improvement
processes to ensure that the QMS, processes and products conform to requirements and will
ensure that:
• The type, location, timing and frequency of measurements and the requirements for
records are defined.
• The effectiveness of measures implemented is periodically evaluated (yearly).
E2C was identify and use appropriate statistical tools and the results of data analysis and
improvement activities will be an input to the management review process.
b. Responsibility
E2C management, assisted by Project Engineer, has overall responsibility for establishing,
implementing and maintaining this activity.

2. Monitoring and Measurement


2.1 Customer Satisfaction
a. Policy and Objectives
E2C monitored information on customer satisfaction and/or dissatisfaction as one of the
measurements of performance of the QMS. The methods and measures for obtaining and utilizing
such information and data was defined.
b. Responsibility
E2C management, assisted by Project Engineer, has overall responsibility for establishing,
implementing and maintaining this activity.

2.2 Internal Audit


a. Policy and Objectives
E2C will carry out objective audits in order to determine if QMS has been effectively implemented
and maintained and conforms to ISO 9001:2008. In addition, E2C shall carry out yearly audits to
identify potential opportunities for improvement.
The audit process, including the schedule, will be based on the status and importance of the
activities and/or areas to be audited and the results of previous audits.
E2C-QMP-001 Page 20 of 22
b. Responsibility
E2C management has overall responsibility for establishing, implementing and maintaining this
activity.

2.3 Monitoring and measurement of processes


a. Policy and Objectives
E2C monitored and measured processes to ensure that they continue to satisfy their intended
purpose.
b. Responsibility
E2C management, assisted by Project Engineer has overall responsibility for establishing,
implementing and maintaining this activity.

2.4 Monitoring and measurement of design


a. Policy and Objectives
E2C monitored and measured the characteristics of the design to verify that requirements for the
design and/or service are met.
Evidence conformance are documented and recorded. Records are indicating the authority
responsible for release of design.
b. Responsibility
E2C management, assisted by Project Engineer has overall responsibility for establishing,
implementing and maintaining this activity.

3. Control of non-conforming design


a. Policy and Objectives
E2C ensures that designs that do not conform to requirements are identified and controlled to
prevent unintended use or delivery. These non-conformities will be:
• Corrected or adjusted to conform to requirements and re-validated, or
• Accepted under concession, with or without correction or adjustment, or
• Re-assigned for alternative valid application, or
• Rejected as unsuitable
b. Responsibility
Managing Director, assisted by the Project Engineer, has overall responsibility for establishing,
implementing and maintaining this activity.

4. Analysis of data
a. Policy and Objectives
E2C analyzed all applicable data to determine the suitability, adequacy and effectiveness of the
QMS and use this to provide information relating to:
• Customer satisfaction and/or dissatisfaction
• Conformance to design requirements
• Characteristics of trends and opportunities for preventive action
• Suppliers
b. Responsibility
E2C management, assisted by Project Engineer has overall responsibility for establishing,
implementing and maintaining this activity.

E2C-QMP-001 Page 21 of 22
5. Improvement
1.1 Continual Improvement
a. Policy and Objectives
E2C planned and managed the processes necessary for the continual improvement of the QMS
through used of a system level procedure that describes the use of quality policy, objectives,
internal audits results, analysis of data, corrective and preventive action and management review
to facilitate continual improvement.

b. Responsibility
E2C management has overall responsibility for establishing, implementing and maintaining this
activity.

1.2 Corrective action


a. Policy and Objectives
E2C will define the requirements for:
• Identifying non-conformities (including customer complaints).
• Determination of the causes of non-conformity.
• Evaluating the need for actions to ensure that non-conformities do not recur.
• Implementing corrective action.
• Recording the results of actions taken.
• Reviewing that corrective action taken is effective and recorded.
b. Responsibility
E2C management, assisted by the Project Engineers, has overall responsibility for establishing,
implementing and maintaining this activity.

1.3 Preventive action


a. Policy and Objectives
E2C will define the requirements for:
• Identification of potential non-conformities
• Determination of the causes of the identified potential non-conformities
• Determination of preventive action needed to eliminate causes of potential non-
conformities
• Implementation of preventive action
• Recording the results of actions taken
• Reviewing that preventive action taken is effective

b. Responsibility
E2C management, assisted by the Project Engineers, has overall responsibility for establishing,
implementing and maintaining this activity.

E2C-QMP-001 Page 22 of 22

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