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OIL &GAS INTERNATIONAL FZE

QUALITY SYSTEM MANUAL Rev 4 Mar 2016


Documented & Reviewed By QHSE Manager Approved By Managing Director

Revision History

New Rev Status Description of Changes Revision Date


4 Manual rewritten to meet ISO 9001: 2015 03.04.2016

3 Clauses and sub-clauses rearranged to meet API Q1 9th 25.05.2014


edition requirements
2 Manual rewritten to meet API Q1 9th edition requirements 15.01.2014

1 7.5.3- Identification and Traceability- Full Section has 20.09.2013


been revised to meet the applicable AP1Q1 requirements.

1 7.5.5- Preservation of Product- Full section has been 20.09.2013


revised to meet the applicable APIQ1 requirements.

1 8.3- Control of Nonconforming Product- Full section has


been revised to meet the Applicable APIQ1 requirements. 20.09.2013

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QUALITY SYSTEM MANUAL Rev 4 Mar 2016


Documented & Reviewed By QHSE Manager Approved By Managing Director

1. INTRODUCTION.

1.1 Organizational Identity, Quality Policy, Mission and Objectives.

Organizational Identity : Oil & Gas International FZE (OGI) is a privately held company which
manufactures, repairs and does servicing of critical oilfield equipment and tools to the petroleum
and natural gas industry.

Mission and Objectives: It is the mission of Oil & Gas International FZE to constantly strive to
provide superior oilfield equipment with outstanding value at the time the customer needs it. We
will make every effort to maximize customer satisfaction by:

Ensuring that all of our products comply with customer and industry requirements, as well as
relevant safety and regulatory requirement;
Providing the highest level of customer services before, during, and after the sale;
Establishing manufacturing and quality objectives, and measuring our performance in order to
continuously improve the product, the processes, and our service.
Further, it is the mission of management to ensure that our employees understand the business and
take personal ownership in what they do, realizing the impact of our products and services to our
customer’s success. Therefore, in order to support the mission of the organization, we will hire
qualified employees and provide sufficient training to ensure that they become valuable resources
with an outstanding level of knowledge and skills that will set us apart from our competition.
It is the mission of the organization to continually improve our processes, systems, and technology
to provide higher product quality, lower costs, and reduced lead time to maximize our customers’
success.

1.2 SCOPE of QMS

1.2.1 This OGI Quality Management System is established and maintained in order to
define and provide an overview of the Quality Management System (QMS)
documented and implemented at OGI to ensure conformance with the following
industry standards:
API Specification Q1 9th Edition – Specification for Quality management
System Requirements under Manufacturing for the Petroleum and Natural Gas
Industry.
ISO9001-2015–Quality Management Systems–Requirements
Therefore, this manual, providing an over view of the OGI QMS divided into
eight (6) sections, modeled for API Specification Q1 9th Edition requirements.
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Documented & Reviewed By QHSE Manager Approved By Managing Director

Each subsection of this manual defines general policies and basic principles
pertinent to the OGI processes, summarizes responsibilities and methods, and
references relevant MSPs, SOPs and other required documents.

1.2.2 Further, this manual is established and maintained to identify the processes at OGI
and define the interactions of these processes, and their management, to produce and
distribute oilfield equipment which satisfies specified requirements.

1.2.3 This manual is established and maintained to demonstrate management’s


commitment to quality, ensuring that both the operation and control of processes are
effective; ensuring the availability of resources and information necessary to support
the operation and monitoring of these processes; to monitor, measure, where
applicable, and analyze these processes, and implement actions necessary to
achieved planned results and continually improve these processes.

1.2.4 This manual is established and maintained to define and demonstrate how OGI
consistently manufacturers and/or distributes product that meets customer and
applicable statutory and regulatory requirements; and aims to enhance customer
satisfaction through the effective application of, and continuous improvement of the
OGI Quality Management System.

1.3 Application

1.3.1 This QMS manual, all interrelated procedures (MSPs), work instructions (WIs),
Quality Assurance Plans (QAPs) and associated forms and records is applicable to
OGI management and personnel with assigned responsibilities having the potential
to affect product and/or service quality.

1.3.2 The QMS applies to all services, products manufactured or outsourced, distributed
by OGI, and includes, where applicable the design, manufacture, measurement, and
distribution of all products, and is established and maintained to demonstrate the
ability of OGI to consistently provide product and services that meets customer
requirements, as well as the ISO 9001 and API Q1 industry standards. For
certification/licensing purpose, scope is defined specially as under:

“Manufacturing, repair and Remanufacturing of Down Hole Drilling Equipment” for


Oil and Gas Exploration.
1.3.3 The QMS is established and maintained to enhance customer satisfaction through the
effective application of the system, specifically including processes for continual
improvement of the system, and the assurance of conformity to customer
requirements and industry standards.

1.3.4 Exclusions : OGI does not herein claim or justify any exclusion except 7.3 from the
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clauses of the ISO 9001 and 5.4 from the clauses of API Q1 9th edition
requirements. OGI Manufactures products with dimensional Drawings as per API or
customer specifications with Quality plans or work instructions and route cards

1.4 Quality System Control

1.4.1 This Quality Manual, along with Quality System Procedures (MSPs), Work
Instructions (WIs), Quality Assurance Plans (QAPs), Forms and Drawings will be
maintained under document control.

1.4.2 Document Distribution: The controlled copies of current revision level of each
controlled document will be made available to applicable OGI staff. Quality
Manger/Management Representative maintains a list of the distributed controlled
documents, along with the recipients.

1.4.2.1 Controlled documents are not distributed outside of the organization.


Uncontrolled copies, however, of this manual may be distributed outside of
OGI (i.e., to a customer), and this will not be updated with subsequent
revisions.

1.5 Quality System Changes

1.5.1 Notification of Changes, including Management change Organization Structure,


Change of Facility, substantive changes to the Quality System Manual, will be
provided in writing to OGI staff through the formal change control process, defined
in MSP01–Document Control.

2. NORMATIVE REFERENCES

The following referenced documents are in dispensable for the application of the OGI Quality
Management System. For dated references, only the edition cited applies. In the event of an
undated reference, the latest edition of the referenced document (including any amendments)
applies.

2.1 Industry Standards for Quality Management Systems

APISpecificationQ1–Specification for Quality Management System requirements under


Manufacturing for the Petroleum and Natural Gas Industry
ISO9001-2015–Quality Management Systems–requirements
ISO 9000- Quality Management- Fundamentals and vocabulary

2.2 Guidance Standards

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ISO9000-2005–Quality Management Systems–Fundamentals and Vocabulary


ISO19011–Guidelines for quality and / or environmental management systems auditing

3. TERMS, ABBREVIATIONS&DEFINITIONS

3.1 The OGI QMS uses the same internationally recognized terms, vocabulary and definitions
given in ISO 9000..

The specific definitions below, from API Q1 and specifically relating to the petroleum,
petrochemical, and natural gas industries:
 Top Management
The Directors of Oil & Gas International FZE
 General/Country/Senior Management
The Most Senior Manager at the OGI Facility.

Acceptance criteria-specified limits of acceptability applied to process or product


characteristics

Acceptance inspection-demonstration through monitoring or measurement that the


product with specified requirements

Calibration-comparison and adjustment to a standard of known accuracy

Collection-Process of obtaining, assembling and/or organizing applicable


information with the intent of meeting the requirements of 4.5

Compliance: Act or Process of satisfying the legal and other applicable requirements
of a regulation or a regulatory body.

Critical-that deemed by the organization, product specification, or customer as


mandatory, indispensable r essential, needed for a stated purpose or task and requiring
specific action

Delivery-point in time and physical location at which the agreed transfer of ownership
takes place

Design acceptance criteria- defined limits placed on characteristics of materials,


products, or services established by the organization, customer, and/or applicable
specifications to achieve conformity to the product design

Design validation-process of proving a design by testing to demonstrate conformity of


the product to design requirements
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Design verification- process of examining the result of a given design or development


activity to determine conformity with specified requirements

First Article- Representative sample of product component or output from a process used to
verify that prescribed activities have satisfied the requirements as specified by the
organization.

Key Performance Indicator: Quantifiable measure that an organization uses to gauge or


compare performance.

Legal Requirement-Obligation imposed on an organization, including those that are statutory


or regulatory

Management-person or group of people as defined by the organization who directs and


controls all or part of a facility, location, department or other function; has the fiscal
responsibility for the organization, and is accountable for ensuring compliance with legal and
other applicable requirements.

Manufacturing acceptance criteria-defined limits placed on characteristics of materials,


products and services established by the organization to achieve conformity to the
manufacturing or service requirements

Outsource: Function or process that is performed by an external supplier (External provider)


on behalf of the organization.

Preventive Maintenance: Planned action to minimize the likelihood of equipment failure


and unscheduled interruptions.

Procedure (Control feature)-Organizations documented method for performing an activity


under controlled conditions to achieve conformity to specified requirements

Risk: Situation or circumstance that has both a likelihood of occurring and a


potentially negative consequence.

Service: Performance of an activity by one function or organization for another.

Servicing-Product maintenance, adjustment, repair, and/or onsite installation is required by


applicable product specifications

Field non conformity- product on conformity that is detected after delivery or such as started
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Tender-offer made by an organization in response to an invitation to provide a product

3.2 LIST OF Abbreviations used throughout the QSM & MSP’s

ANSI – American National Standard Institute.

API - American Petroleum Institute

ASME- American Society of Mechanical Engineers

CAR- Corrective Action Request

ECR- Engineering Change Request

HR – Human Resource

ISO – International Organization for Standardization

OGI – Oil & Gas International

NCR – Non Conformance Report

NDE- Non Destructive Examination

DAC- Design Acceptance Criteria

ITP- Inspection and Test Plan

KPI- Key Performance Indicator

MAC- Manufacturing Acceptance Criteria

MOC- Management Of Change

MPS- Manufacturing Process Specification

PCP- Process Control Plan

QAC- Quality Activity Plan

QSM- Quality System Manual

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QMS- Quality Management System

NIST- National Institute of Standards and Technology.

PO – Purchase Order

PR- Purchase Requisition

QA- Quality Assurance

QC –Quality Control

WI –Work Instruction

SOP- Standard Operating Procedure

MSP- Management System Procedure

4. QUALITY MANAGEMENT SYSTEM REQUIREMENTS /CONTEXT OF THE


ORGANIZATION

4.1 Quality Management System

4.1.1 General Requirements

OGI has established and maintains a QMS as a system of inter related processes.
All main activities of the system are defined as “Quality System Processes”
documented in Quality System Procedures (MSPs), and are grouped in to the
following categories:
a) Customer Requirements, including requirements of Industry Standards (ISO
9001/APIQ1): Identify the processes needed for the Quality Management
System and their application throughout the organization.
b) Management Responsibility : ensure the availability of resources and
information necessary to support the operation and monitoring of these
processes;
c) Resource Management : Monitor and analyze these processes.
d) Product Realization: Determine the sequence and interaction of these
processes;
e) Outsourced Processes : The type and extent of control to be applied to
outsourced processes (e.g., tissue recovery organizations, laboratories
performing dose audits, infectious disease testing laboratories, irradiation
facilities, etc.) shall be defined within the Quality Management System;
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f) Measurement, Analysis and Improvement : Determine the criteria and


methods needed to ensure that both the operation and control of these
processes are effective;
g) Continual Improvement : Implement actions necessary to achieve planned
results and continuing improvement of these processes.
h) Ensuring Control of all sub-contracted activities.

These process categories are organized into a “Plan-Do-Check-Act”


continuous loop to ensure the implementation of a process of continual
improvement.

Context of the Organization


OGI has determined the external and internal issues that are relevant to the organization
and its strategic direction that affect its ability to achieve the intended result of the
management system. OGI shall monitor and review the information about these external
and internal issues both positive and negative factors and condition relevant to the
Management system which required consideration. This may include external issues arising
from legal, technological, competitive, market, cultural, social and economic environments
and security with in the applicable geographical boundaries.

4.1.2 Quality Policy:

“It is the policy of Oil & Gas International FZE to meet and/or exceed our
customer requirements by on-time delivery of the highest quality of oil field
equipment, in strict compliance with safety and regulatory requirements,
while providing maximum value and superior customer service during and
after the sale of products.”
OGI Management is committed to its policy that is defined, documented and
approved by OGI’s Top management. OGI’s Top Management continuously
reviews the quality policy to ensure its suitability on the basis of development of
Quality Objectives. The Top Management shall ensure the Quality policy is
available to relevant interested parties, as appropriate OGI Top management is
committed to communicate its Quality Policy and objectives and ensure that it is
understood, Implemented and maintained at all relevant interested parties in OGI.
OGI’s Quality policy includes commitment to comply with requirements and
continually improve the effectiveness of OGI’s Quality Management System.

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4.1.3 Quality Objective and Planning to Achieve Them:

Quality Objectives, consistent with the Quality Policy, are established throughout
OGI in order to meet requirements for products and processes, and to improve the
quality system and quality performance. Top Management is responsible for
establishing and communicating quality objectives to relevant functions within OGI.
Quality objectives are:
a) Quantitative and measureable;
b) Attainable and realistic;
c) Consistent with the Quality Policy;
d) Controlled by the relevant functions;
e) Monitored. Measured, communicated and updated

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Inputs into the process of establishing quality objectives may include relevant
findings from management reviews, current product inspection/test results,
customer satisfaction ratings, customer complaints, and process monitoring
results.
On Quality objective plan OGI shall determine “What will be done, what
resources will be required, who will be responsible, when it will be
completed, how the result will be evaluated”

4.1.4 Quality Management System Planning:

The ISO 9001:2015 and API Q1 requirements are the primary in-puts in
determining the requirements of the QMS.
QMS processes are planned to ensure that the QMS is appropriate for its
intended purpose, and that it is effectively implemented and managed.

The Quality Assurance Manager / Management Representative is responsible


for ensuring that the QMS process required are implemented, and that the
sequence and interaction of these processes are identified. Processes are
documented and controlled and monitored through:

a) Quality System Procedures


b) Work Instructions, where specified
c) Quality Assurance Plans
d) Manufacturing Drawings
e) Display Charts

The output of Quality System Planning is documented in this Quality


Manual, in Quality System Procedures (MSPs), and on Quality Records
designed to provide a complete history of activities.

Changes to the QMS are planned and controlled in accordance with MSP 01,
and are reviewed for adequacy before implementation.

4.1.5 Communication:

OGI has established and maintains MSP 31–Communication process to address


formal communication processes to both Internal & External parties ensuring the
effectiveness of quality management system, including “on what it will
communicate, when to communicate, with whom to communicate, how to
communicate, who communicate”.

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4.1.5.1- Internal:

OGI’s Top Management shall ensure that suitable communication processes are
established within OGI. Management shall ensure that the effectiveness of the
Quality Management System is communicated properly within OGI.
OGI shall establish methods to ensure importance of meeting customer, legal, and
other applicable requirements is communicated at all relevant functions within
OGI and results of analysis of data are communicated at relevant levels and
functions within OGI.

4.1.5.2- External:

OGI has determined and implemented a method for communicating with external
organizations and customers to ensure that the requirements are understood
throughout contract execution and product realization that addresses
1) Execution of enquiries, contracts, handling of orders and amendments.
2) Provision of product Information, including any product nonconformities that
are identified after delivery to the customer.
3) Any feedback and Customer complaints.
4) When required by contract, providing information required by product quality
plans and subsequent changes to these plans.
5) Handling or controlling customer property.
6) Establishing specific requirements for contingency actions, when relevant.

4.2 Management Responsibility/Commitment and Leadership

4.2.1 General

At OGI, Top Management’s commitment to the highest quality of products and


services to our customers is evidenced in the leadership, development and
implementation of the Quality Management System in conformance with the
requirements of ISO9001:2015 and API Specification Q1 – Quality Management
System Requirements, as well the establishment of processes to monitor, measure,
and continually improve its effectiveness by:

a) Communicating to the organization the importance of meeting customer, as well as


statutory and regulatory requirements;
b) Ensuring the quality policy and quality objectives are established for the quality
management system and are compatible with the context and strategic direction of
the organization.
c) Ensuring that quality objectives are established including Key Performance
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Indicators (KPI) for use in analysis of data.


d) Conducting management reviews to routinely evaluate the suitability, effectiveness,
and degree of implementation of the QMS;
e) Ensuring the availability of resources that includes human resources and specialized
Skills, Organizational infrastructure, financial resources and technology.
f) Taking accountability for the effectiveness of the quality management system.
g) Ensuring the integration of the quality management system requirements into the
organization’s business process.
h) Engaging directing and supporting persons to contribute the effectiveness of the
quality management system.
i) Promoting improvements and supporting other relevant management roles to
demonstrate their leadership as it applies to their areas of responsibility.

Top Management shall demonstrate leadership and commitment with respect to


customer focus by ensuring that customer and applicable statutory and regulatory
requirements are determined and understood and consistently met, the risk and
opportunity can affect the conformity of the product and services and ability to
enhance customer satisfaction are determined and addressed, the focus on
enhancing customer satisfaction is maintained.

4.2.2 Organization Roles, Responsibility and Authority:


Top Management shall ensure Roles, Responsibilities, authorities, and
accountabilities of personnel within the scope this manual is defined,
documented, communicated and understood throughout OGI.

Top management shall ensure that the responsibility and authority for
ensuring that the QMS confirms to the requirement of ISO9001-2015 and
Q1 9th Edition, process are delivering their intended outputs, reporting on
the performance of the QMS and on opportunities for improvement in
particular to top management, promotion of customer focus throughout the
organization and integrity of the QMS is maintained when changes to the
QMS are planned and implemented.
4.2.2.1 Inter relationship of all personnel who manage, perform and verify work affecting
conformity to product requirements is identified in an Organizational Chart (see
below).

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ORGANIZATIONSTRUCTURE

OilandGasInternationalFZE

4.2.2.2. All departments and functions in the company are responsible for implementing,
maintaining and improving the Quality Management System.
Authorities and responsibilities for specific processes of the QMS are defined:

- Throughout this Quality Manual and in every Management system


Procedure/Standard operating Procedure where the specific quality
system process or activity is documented
- In Job Travelers
- In job descriptions, where applicable.

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4.2.3 Management Representative:

OGI Top Management has appointed the Quality Manager to be the Management
Representative of the QMS, who irrespective of other responsibilities has
responsibility and authority which includes:

- Ensuring that the QMS is established, implemented, maintained, and continually


improved;
- Ensuring that processes needed for the QMS are established implemented and
maintained;
- Promoting quality, regulatory and customer awareness throughout the
organization;
- Reporting to top management on the performance of the QMS, including
recommendations for improvement;
- Generating, in conjunction with personnel concerned, procedures and instructions
defining the organization’s general processes, and where necessary;
- Controlling, updating and issuing the organization’s MSPs;
- Ensuring that there is a system of verification and audits independent of the
person or authority carrying out the functions;
- Analyzing all reported quality problems and ensuring corrective action(s) are
taken;
- Coordinating communication with external parties on matters relating to the
Quality Management Systems.
- Ensuring the promotion of awareness of customer requirements throughout the
organization.
- Ensuring initiation of actions to minimize the likelihood of the occurrence of
nonconformities.

4.3 Organization Capability:

4.3.1 Resources

Top management determines and provides the resources necessary to implement and
maintain the quality management system and for its continuous improvement, as
well as for the resources necessary for enhancing customer satisfaction through
meeting or exceeding customer requirements (including human resources,
infrastructure, work environment, process equipment, monitoring & measuring
equipment).

OGI shall consider the capacities of, and constraints on, existing resources; what
need to be obtained from external providers.

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4.3.2 Human Resources:

4.3.2.1 General:

OGI has established and maintains MSP 03–Competence Awareness and Training
to guide the process of determining and providing sufficient personnel of the
appropriate education, skills, experience and training to perform work affecting
conformity to product requirements.

OGI has established and maintains job descriptions for each position affecting
conformity to product requirements, which identify appropriate education, skills,
experience and training for the position.

4.3.2.2 Personnel Competence

a) Ensuring personnel are competent on the basis of appropriate education,


training skills and experience to meet product and customer requirements.
b) Ensuring evidence of the determination of personnel competence is recorded.
c) Ensuring that minimum competence levels are determined.

4.3.2.3 Training and awareness

a) Ensuring training is provided on Quality Management System and on the job


for personnel activities.
b) Ensuring the frequency of Training, Further training or refresher training is
defined within the QMS.
c) Ensuring that any customer specified training and or Customer provided
training is included in OGI’s training program when required.
d) Ensuring training is provided or other measures are taken to satisfy these needs
e) Evaluating the effectiveness of Training.
f) Ensure records (documented information) of Education, Training, Skills and
Experience are maintained

g) Ensuring that Personnel are aware of the relevance and importance of their job
and how they contribute to the achievement of the objectives set out in the
QMS. This includes information on the Consequences to the Customer and the
Company as a result of non-conformance on product or procedure.
h) Ensuring that Training needs is identified for Quality and that those needs are
provided for. This Includes situations where new job activities are introduced
or existing job activities are modified.

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4.3.3 Work Environment and Infrastructure:

OGI has established and maintains MSP 04–Facilities and Equipment Maintenance,
in order to assign responsibility and define the process at OGI for the identification,
maintenance and control of all facilities, machines and equipment, including material
handling equipment, used in support of OGI’s product realization processes.
Infrastructure includes, as applicable:

a) Buildings, workspace and associated facilities;


b) Process equipment (both hardware and software); and
c) Supporting services (such as information systems).
d) Top management is responsible to ensure that OGI facilities are of suitable size,
construction, and location with adequate control systems to facilitate operations.
e) Top management is responsible to ensure that facilities are maintained in a good
state of repair.
f) Preventive Maintenance of essential facilities and equipment is planned,
implemented and documented.
g) Department managers/supervisors are responsible for identifying the need and
requirements for new and/or modification or repair to existing infrastructure and
facilities. Requests for changes are submitted to the General Manager for review
and approval.
h) Maintenance of facilities and equipment is performed by internal personnel,
where specified, and by outside contracted services.
i) Infrastructure requirements are evaluated as a component of Management Review.

4.3.4 ORGANIZATIONAL KNOWLEDGE

OGI shall determine the knowledge necessary for the operation of its process and its to
achieve conformity of product and services. This knowledge shall be maintained and be
made available to the extend necessary. When addressing changing needs and trends, the
organization shall consider its current knowledge and determine how to acquire or access
any necessary additional knowledge required updates.

Organizational knowledge is knowledge specific to the organization, it is generally gained


by experience .This information is used and shared to achieve the organization’s objectives.
Organizational knowledge can based on the internal sources like intellectual property ,
gained from experience , lessons learned from failure and successful project, capturing and
sharing undocumented knowledge and experience , the result of improvements in
processes/product/services And external sources like standards, academia, conferences,
gathering knowledge from customers or external providers.

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4.4 Documentation/Documented Information Requirements:

4.4.1 General

1) OGI’s Quality Management system includes documented information required by


ISO 9001-2015 and API Q1 9th Edition and documented information determined
by the organization as being necessary for the effectiveness of QMS and includes
defining statements of Quality Policy and Quality Objectives.

2) When creating and updating documented information, NAPESCO shall


ensure appropriate identification and description (title, date, author, or reference
number), format and media , review and approval for suitability and adequacy

3) OGI’s Quality Manual addresses each requirement of APIQ1 Specification includes


a) Scope of Quality Management System including justification for exclusion.
b) Defining the sequence and interaction between the processes of the Quality
Management System.
c) Identifying the process that requiring Validation.
d) OGI’s Quality Manual that reference to Management System Procedures (MSP)
that controls the QMS process.
e) Establishing Management System Procedures for QMS
f) Documents and records (Documented Information) to ensure effective planning,
operation and control of the process and compliance to specified requirements.
g) Identifying legal and other applicable requirements that needed to achieve product
conformity.

4.4.1.1 Documentation

The documents and records required by the ISO 9001:2015 and API Specification
Q1 Quality Management System standards, and those determined by OGI to be
necessary to ensure the effective planning, operation, and control of processes. The
figure below illustrates the OGI Documentation Structure:

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QUALITY SYSTEM DOCUMENTATION STRUCTURE

Policy Statement and Organization


Responsibilities

Operating Guidelines

Step-by-step instructions
(When required)

Objective evidence of
completed processes,
Inspections & Tests

4.4.1.2 Quality System Manual (QSM):

This top- level document defines OGI’s quality policy, defines the scope of the
QMS; describes the overall quality system, its processes, and their sequence and
inter relationships; and further references applicable Management System
Procedures (MSPs). Further, the Quality System Manual identifies the manner in
which OGI addresses each specific requirement of ISO 9001:2008 and API
Specification Q1.

4.4.2 Management System Procedures (MSPs):

Establishing, documenting and implementing Management System Procedures (MSP)


referenced to Q1 Specification is maintained for continued suitability. This can be
implemented by addressing the requirements of one or more procedures in a Single
document or the requirements for procedures can be in the form of more than one
document.
The purpose of MSPs is to guide personnel in the performance of OGI processes,
such as carrying out and controlling processes, handling products, maintaining and
calibrating monitoring & measuring equipment, conducting tests and inspections, etc.

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MSPs are listed below:

MSP Category Document Description


MSP01 Document Control
MSP02 Control of Records
MSP03 Competence, Training, and Awareness
MSP04 Facilities and Equipment Maintenance
MSP05 Identification and Review of Product Requirements
MSP06 Design and Development
MSP07 Supplier Evaluation, Selection and Purchasing
MSP08 Purchased Product Verification
MSP09 Job Planning
MSP10 Product Identification and Traceability
MSP11 Control of Customer Property
MSP12 Product Handling, Storage, Packaging, Preservation, & Delivery
MSP13 Control of Inspection, Measuring, and Test Equipment
MSP14 Customer Satisfaction and Complaint Handling
MSP15 Internal Audit
MSP16 Monitoring and Measurement of Product
MSP17 Control of Non-conforming Product
MSP18 Analysis of Data
MSP19 Corrective Action
MSP20 Preventive Action
MSP21 Management Review
MSP22 API Monogram Program
MSP23 Processes Requiring Validation
MSP24 Risk Assessment and Management
MSP25 Contingency Planning
MSP26 Management of Change
MSP27 Preventive maintenance
MSP28 Product Quality Plans
MSP29 Product Inspection and Test Status
MSP30 Product Release
MSP31 Communication Process
MSP32 Improvement

4.4.3 Document Control/ Control of Documented Information

OGI has established and maintains MSP01–Document Control for identification,


distribution and control of documents to define the controls needed to:
a) Document approval for adequacy prior to issue together with review, Update
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and re-approval
b) Ensuring that changes and the current revision of documents are identified.
c) Ensuring that current revisions of documents available at all relevant
locations.
d) Ensuring that documents remain legible and readily identifiable.
e) Preventing the Unintended use of obsolete documents, ensuring that they are
identified as obsolete when they are retained for reference or other purposes.
f) A Master list identifying all the documents required by the QMS together with
their revision status.
g) Changes to the documents will be reviewed and approved by the same
functions/ Organisation as original documents.
h) Ensuring control of required procedures, work instructions and forms required
by QMS.

4.4.4 Control of External Documents:

OGI has established and maintains MSP-01 Document Control to define the
integration and use of external documents for the design or manufacture of the
products.
MSP-01 defines integration and uses of API product or other specification
Requirements including addendum, errata and updates into the product realization
process and any other affected processes when needed.

4.5 Control of Records:

OGI documents activities / processes in records that are established and maintained
to provide objective evidence of conformity to requirements and of the effective
operation of the QMS.

OGI has established and maintains MSP 02 – Control of Records to define the
system utilized at Oil & Gas International, for the identification, maintenance,
indexing, storage and control of quality records.

a) Records shall remain legible, readily Identifiable and retrievable.


b) Identification, Collection, Indexing, access, Filing, Storage, Maintenance and
disposition of QMS records.
c) Records are stored and maintained in such a way to provide a suitable
Environment to prevent damage or deterioration or loss
d) The responsibility for collection and maintenance of record is defined.
e) Retention time for records (Documented information) are not less than
regulatory, legislative, specific Industry product standard or 7 years
whichever is longer.
f) Records including outsourced activities provide evidence of conformity.

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5 PRODUCT REALIZATION/ OPERATION


.
5.1 Contract Review

5.1.1 General

OGI has established and maintains MSP 05– Identification and Review of Product
Requirements to define how OGI identify and reviews requirement related to the product
and servicing,

5.1.2 Determination of contract review requirements/Requirements for Product and


Services.

MSP-05 ensures that OGI determines following:


a) All requirements are specified by the customer.
b) Legal and other applicable requirements are defined if any
c) Where the customer provides no documented statement of requirement (i.e.,
verbal orders), the requirements are documented by OGI as verbal order
before acceptance.
d) OGI can meet the claims for the product and services it offers

5.1.3 Review of Requirements

MSP 05 ensures that, a review is conducted by OGI for customer requirements, prior to the
organization’s commitment to supply a product to the customer. Review will ensures
following

a) Product requirements are appropriately defined, identified and documented


including the delivery and post-delivery activities.
b) Contract, or order requirements, differing from those previously expressed
are resolved; and
c) OGI has the ability to meet the defined requirements;
d) Requirements not stated by the customer, but necessary for the specified or
intended use, when known.
e) Requirements specified by OGI.
f) Statutory and Regulatory requirements applicable for the product and
service.
g) Contract or order requirements differing from those previously expressed
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Contract review and actions is documented and retained as a quality record;


When product requirements are changed, OGI ensures that relevant documents are amended
and that relevant personnel are made aware of the changed requirements.

5.2 Planning

In order to establish processes and responsibilities at OGI for performing planning


to ensure all applicable customer and other external and internal product
requirements are identified and satisfied, The planning shall also consider relevant
internal and external issues, relevant needs and expectation of interested parties OGI
has established and maintains MSP09– Job Planning, which defines how OGI
determines the following:
a) Resources required and Work environment.
b) Product and Customer defined requirements.
c) Required verification, validation, monitoring, measurement, inspection and test
activities specific to the product, and the criteria for product acceptance;
d) Legal & other applicable requirements.
e) Contingency based on the assessment of risks.
f) Design and Development, of this manual for verification how OGI determine show
and when Design and Development requirements apply to specific products.
g) Management of Change process.
h) Ensuring records needed to provide evidence that the product realization processes
meet requirements.
i) The output of this planning shall be the product processing sequence, documented on
the Job Traveler, which specifies the processes and resources to be applied to a
specific product and shall be updated with changes and suitable for OGI’s Quality
Management System.
j) Determination of Requirements Related to the Product of this manual for processes
for an evaluation of how OGI defines the methods and establishes control features
when product requirements are provided from the customer, or from other external
sources.
k) Job Travelers are maintained.
l) OGI shall ensure that the outsourced process are controlled.

5.3 Risk Assessment and Management/Action to Address to Risk and Opportunity.

OGI has established and maintains MSP 24– Risk Assessment and Management to
identify and control risk and opportunity associated with relevant internal and
external issues and the relevant requirement of the relevant interested parties
(Include impact on delivery, quality of product and Identification of techniques),
Tools and their application for Risk identification, assessment and mitigation. OGI’s
Risk assessment system includes consideration of severity detection methods and
probability occurrence. This procedure ensures the following.
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a) Facility, Equipment availability and Maintenance.


b) Vendor Performance and Material availability and Supply.
c) Delivery of Nonconformance product.
d) Availability of Competent Personnel
OGI shall ensure that records (Documented information) of these assessments
including action taken shall be maintained. During development of contingency
plans OGI use results of output of Risk assessment and these assessments may be an
activity associated with corrective and or preventive actions.

5.4 Design and Development

5.4.1 Design and Development Planning

OGI has established and maintains MSP 06 – Design and Development. This Quality system
procedure defines the process for Design and Development Planning, including the process
at OGI for determining:

a) Required design and development stages;


b) Requirements for design review, verification, and valid action appropriate
to each design and the development stage;
c) The responsibilities and authorities for design and development.
d) Controls for other Organization design locations that impact design and
controls over outsourced designed activities.

5.4.1.1OGI provides equipment and tool solutions to our customers. Some customers
describe, in purchase orders, drawings and specifications, the exact characteristics of
their designs. In those cases we do not perform design and development activities as
described in the standard, and such customer designs are not within the scope of
section 5.4 of this QMS.

5.4.1.2 OGI also furnishes equipment produced by manufacturers other than OGI.
Such items are not within the scope of section 5.4 of this QMS. The following
system of controls, as further defined in 5.6 – Purchasing of this manual has been
established at OGI to ensure that out sourced products conform to specified
requirements:

a) MSP 07 – Supplier Evaluation to evaluate and ensure that OGI Approved


Suppliers are capable of producing products that conform to specifications.
b) MSP16–Monitoring and Measurement of Product, which defines how OGI
performs incoming inspection on all outsourced products.
c) OGI requires that Approved Suppliers of products manufactured and
distributed by OGI provide a Certificate of Conformance, documenting how
the Supplier has ensured that the product has been manufactured and verified
to conform to specified requirements.
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d) When required, OGI may elect to perform a site audit of Suppliers to verify
that they are capable of supplying products that conform to specifications

5.4.1.3 OGI also designs, manufactures and delivers equipment and tool solutions to our
customers that fall wholly within the requirements of this section. MSP 06 details the
requirements for design and development activities.

5.4.1.4 Design Documentation: The output of the design planning process will vary
depending upon the complexity of the design and its intended use, but shall include the
methods, assumptions, drawings and calculations required. Documentation will be
updated as needed during the design and development process, which will be
reviewed for adequacy.

5.4.2 Design and Development Inputs

The process for determining the required design and development inputs is defined in
MSP 06, including, but not limited to:

a) functional and performance requirements;


b) applicable regulatory and legal requirements;
c) applicable information derived from similar designs;
d) any other requirements essential for design and development;
e) customer-specified and External requirements.
f) Environmental and Operational conditions
g) Risk associated during Design and Development.

Inputs will be documented reviewed for adequacy to ensure that they are complete
unambiguous, and not conflicting with other requirements. Records of Design and
Development outputs shall be maintained.

5.4.3 Design and Development Outputs:

The process for determining the required design and development outputs, as verifiable
against the design inputs, is defined in MSP 06. Design outputs are developed to
ensure that they:

a) meet the input requirements for design and development;


b) provide appropriate information for purchasing, production and for service
provision.
c) contain product acceptance criteria;(DAC)
d) define the characteristics of the product that are essential to it’s safe and
proper use.
e) Include identification of or reference to products and /or components deemed
critical to the design.
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f) Include results of applicable Calculations.

5.4.3.1 Design outputs will be documented, and usually result in a manufacturing drawings or
specifications.

5.4.4 Design and Development Review

MSP 06 defines the process for determining and conducting and documenting Design
Reviews at appropriate stages, and in accordance with planned arrangements, as
determined by Engineering:

a) To evaluate the ability of the results of design and development to meet


requirements;
b) To identify any problems and propose necessary changes
5.4.4.1 Engineering will be responsible to identify the appropriate representatives of
functions concerned with the design and development stage being reviewed.

5.4.4.2 A final design review shall be conducted and documented.

5.4.4.3 The final design shall be reviewed and approved by top management, other
than the Engineer who developed the design.

5.4.5 Design and Development Verification and Final Review.

Design verification activities are conducted by Engineering in accordance with MSP


06, to ensure that design output meets the design input requirements. Records of the
verification activities and any necessary actions will be maintained.

Design verification activities include one or more of the following:


a) Conforming the accuracy of design results through the performance of
alternative calculations;
b) Review of design output documents independent of activities documented
during Design Review;
c) Comparing new designs to similar proven designs.

5.4.6 Design and Development Validation and Approval.

In accordance with MSP 06 ,the Engineering / QA Manager is responsible to ensure


that design validation is planned performed and results recorded to document that
product conforms to defined user needs and/or requirements, and yields the desired
results.

5.4.6.1 The result so fall design validation will be documented and reviewed
throughout the validation cycle.
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5.4.6.2 All completed designs shall be approved after Validation.

5.4.6.3 Review of results will include nonconformity and failure analysis. Multiple
validations may be required if there are different intended uses. Design
validation activities may include:
a) Proto type tests;
b) Functional and/or operational tests of product products which include
evaluation of performance, durability, safety, reliability, and
maintainability under expected storage and operational conditions;
c) Tests specified by industry standards and/or regulatory requirements;
d) Inspections to verify that design features conform to defined user
needs and that authorized design changes have been accomplished and
recorded.
e) Field performance tests.

5.4.7 Design and Development Changes.


In accordance with requirements documented in MSP 06, each design project
will document the specific procedures and responsibilities needed to control
the release, change, and use of documents and data that define the design
input and the design baseline (output), and for authorizing the necessary
work to be performed to implement changes and modifications.

5.4.7.1 Changes, if any required in the design and development will be identified,
documented, reviewed and approved.

5.4.7.2 Design changes will be controlled by the same functions as the Original Design.
Records are maintained.

5.4.7.3 Design changes will be controlled by the same functions as the original design. Records
are maintained.

5.4.7.4 An evaluation of design changes that affect the constituent parts and delivered. Product
is carried out.

5.5 Contingency Planning.

5.5.1 General
OGI has established and maintains MSP 25 – Contingency Planning
defining procedure for contingency planning needed to address risk
associated with impact on delivery and quality of product. The planning shall
be based on assessed risk and the planning output shall be documented and
communicated and relevant interested parties and updated as required
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5.5.2 Planning Output

Contingency plan shall include as a minimum


a) Actions required to in response to significant risk to mitigate effects of
disruptive incidents.
b) Identification and assessment of responsibilities and authorities.
c) Control of Internal and External communication.

5.6 Purchasing / Externally Provided Process, Product and Services

5.6.1 Purchasing Control

OGI ensures that purchased product conforms to specified purchase requirements.


The type and extent of control applied to the supplier and the purchased product
Procedures have been developed to evaluate the effect of the purchased product on
subsequent product realization or the final product. Procedure shall also been
established and maintained to evaluate and select supplies based on their ability to
supply product in accordance with specified requirements.

5.6.1.1 Procedure

OGI has established and maintains MSP 07 - Supplier Evaluation, Selection


and Purchasing to control the purchasing process to ensure that purchased
product that affects product quality conforms to specified purchased
requirements and shall include.
a) Determination of the criticality of the of the activities of products and
their conformance to product or customer specifications
b) Type and extent of control applied to the supplier (External providers)
based on the criticality of the product or activity.
c) Criteria, Scope, Frequency and methods for reassessment of suppliers
(External providers)
d) List of approved suppliers (External providers) and scope of approval
e) Type and extent of control to be applied to outsourced activities.

5.6.1.2 Initial Supplier Evaluation- Critical Purchases.

OGI has established and maintains MSP 07 to define the process and
establish criteria for initial evaluation of suppliers. OGI suppliers are
evaluated for adequacy shall include the following
a) Verification of the suppliers Quality Management System conforms to
the quality system requirements of OGI
b) Assessing supplier’s capability to meet OGI’s purchasing requirements
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by
i) Performing on-site audit of supplier’s (External providers) relevant
activities or
ii) Performing first article inspection to ensure conformance to OGI’s
requirements.
iii) Identifying conformance to requirements when limited by
proprietary, legal and /or contractual requirements.

5.6.1.3 Initial Supplier Evaluation – Non Critical Purchases.

OGI has established and maintains MSP 07 to define the process and
establish criteria for initial evaluation of suppliers for Noncritical purchases.
OGI suppliers are evaluated for adequacy shall include the following.
a) Verification of the suppliers Quality Management System conforms to
the quality system requirements of OGI or
b) Assessment of supplier to meet OGI’s Purchasing Requirements or
c) Assessment of the product upon delivery or activity upon completion.

5.6.1.4 Supplier Reevaluation

OGI has established and maintains system of reevaluation of critical and


Noncritical suppliers. OGI suppliers are reevaluated for adequacy shall
include the following.
a) Verification of the suppliers Quality Management System conforms to
the quality system requirements of OGI or
b) Assessment of supplier (External providers) to meet OGI’s Purchasing
Requirements or
c) Assessment of the product upon delivery or activity upon completion.

5.6.1.5 Records of Supplier evaluation

OGI ensuring that records of evaluations and actions raised during


evaluations are documented and maintained.

5.6.1.6 Outsourcing.

Where processes affecting product quality are outsourced, responsibility for the final
product shall be maintained by OGI, this requirement shall be met by implementing
controls to ensure suppliers of these outsourced process have the capability to
provide qualified personnel and procedures. The level of control shall be dictated by
the importance of the outsourced process on the final product. Records of outsourced
activities shall be maintained.

5.6.2 Purchasing Information


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OGI has established and maintains MSP 07 to describe the product being purchased,
including where appropriate:

a) Requirements for approval of product, procedures, processes, and equipment;


b) Requirements for qualification/ Competence of personnel;
c) Quality Management System requirements
d) The external providers interaction with OGI
e) Control and monitoring of external providers performance to be applied by
OGI
f) Verification or validation activities that the organization, or its customer,
intends to perform at the external providers premises.
5.6.2.1 MSP 07describes how the purchasing information provided to the approved
Suppler is documented in the Purchase Order, including where appropriate,
the type, class, grade, or other precise identification, and the title or other
positive identification of the product being purchased, including applicable
specifications drawings, process requirements, inspection instructions, and
other technical data.

5.6.2.2 Purchase Orders for calibration services shall: specifically state the accuracy
required, either directly or by citation of a specification; include a
requirement for reporting out of tolerance conditions; include a requirement
that calibrations be traceable to NIST; include a requirement that a
calibration certificate be provided.

5.6.2.3 Purchase orders shall be reviewed and approved for accuracy and
completeness

5.6.2.4 When any special process is to be outsourced the Management shall ensure,
the supplier complies with the specified requirements.

5.6.3 Verification of Purchased Products or Activities.

OGI has established and maintains MSP 08 to document and define the
process of verification of product/service, to ensure that purchased product
meets specified purchase requirements and records of such verifications shall
be maintained.

5.6.3.1 OGI documents verification record of purchased product/service as per


procedure MSP-02 Control of Records.

5.6.3.2 Procedures ensure that “customer verification” shall not absolve OGI of the
responsibility for providing an acceptable product, or the responsibility for
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subsequent rejection, or the responsibility for effective quality control at OGI


and its subcontractors.

5.6.3.3 Where OGI, or its customer, intend stopper form verification at the supplier’s
premises, OGI will state the intended verification arrangements, and method
of product release on the Purchase Order.

5.7 Production and Service Provision

5.7.1 Control of Production and Service Provision

5.7.1.1 Production:
OGI has established and maintains MSP 09 Job Planning to define the
process and responsibilities at OGI for planning, scheduling, and carrying out
product processes under controlled conditions, including, as applicable:
a) The availability of information that describes the characteristics of the
product (i.e., drawing or specification ;)
b) The availability of work instructions, as necessary;
c) Implementation of Quality Plans as necessary
d) The identification and use of suitable equipment required for manufacture;
e) The availability and use of appropriate monitoring and measuring equipment;
f) The identification and implementation of appropriate inspections (including
first article inspection when required, in-process inspections, and final
inspection (as defined in MSP 16)
g) The implementation of product release, delivery, and post- delivery
requirements.
h) Procedure MSP 09 defines processes employed to ensure that product and
services meet the Quality objectives. Process controls are documented on
drawings, process routing sheets or Work order, Quality Plans etc listing the
verification activities, reference standards/drawing, acceptance criteria,
Inspection / Hold points, methods for Release, delivery and post-delivery
activities.
i) Satisfactory design requirements.
j) Availability of required process control documents.
k) The appointment of competent persons, including any required qualification.
l) Implementation of action to prevent human error
k) The required records are to be maintained.
5.7.1.2 Servicing:

OGI has established and maintains MSP 09 – Job Planning to define the
process and responsibilities at OGI for planning, scheduling, and carrying out
servicing of products under controlled conditions, including, as applicable:
a) Implementation of requirements related to Servicing of Products.
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b) Availability and use of Equipment


c) Availability of Work Instructions.
d) Availability of required process control documents
e) Ensuring necessary Identification and Traceability
f) The availability and use of appropriate monitoring and measuring equipment
g) Required procedure for release delivery and post-delivery activities of
Product.

5.7.1.3 Process Control Documents:

OGI has established and maintains MSP 09 to define the process and
responsibilities to control its process under controlled conditions by Routings,
Travelers, Check lists and Process Quality plans including external
specifications such as API or equivalent. Ensuring these documents are
clearly mentioned with acceptance criteria, hold or witness points.

5.7.1.4 Capability Documentation


OGI shall develop and maintain records to ensure Capability of facility to meet the specified
product/servicing requirements. Records which shall include from Planning, Reviews or
verification, Product validation, process monitoring, Measurement, Inspection and test activities.

5.7.1.5 Validation of Processes for Production and Servicing.

5.7.1.5.1. Processes identified as “Process for Validation” of all process


including outsourced processes and special processes where the
resulting output cannot be verified by subsequent monitoring or
measurement, including those where deficiencies only become
apparent after the product has been in use or service or has been
delivered. The validation shall demonstrate the ability of the process
to achieve planned results.
The organization shall establish arrangements for those processes
including as applicable,

a) Defined criteria for review and approval of the process;


b) Approval of equipment and qualification of personnel;
c) Use of specific methods and procedures (to recognized standards);
d) Requirements for records maintained in accordance with this manual
e) Re-validation, when required

5.7.1.5.2 When special processes are not identified by applicable product


specifications, the processes at OGI shall include, as a minimum, non-
destructive examination such as Magnetic Particle Inspection (MPI), welding
and heat treating, if applicable to the product.
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5.7.1.5.3 Welding and overlay is primarily performed in compliance with


internal specifications and specific customer requirements for process and
verification. Requirements may include physical testing, metallurgical
evaluation, magnetic particle inspection, process reporting and pressure
and/or performance testing. Records areas required by the customer or
maintained in accordance with MSP02.

Every individual application is reviewed and approved by competent


personnel, and is controlled by routings, procedures and industry standards.
Personnel are qualified through training and experience, and only qualified
personnel perform critical processes.

5.7.2 Product Quality Plan:

OGI has established and maintains MSP28 - Product Quality Plans to define the
process and responsibilities to control its process in the form of Quality Plans. OGI
shall ensure that current revisions of these Quality Plans are approved by authorized
personnel and communicated to the Customer.
Ensuring these Quality plans includes
a) Description of product to be manufactured.
b) Required processes including records
c) Control over Outsourced products
d) Identifying these procedures
e) Identifying hold and Witnessed points

5.7.3 Identification and Traceability

Procedure MSP 10 - Product Identification and Traceability details the


process to ensure Material / Product identification and traceability including
identification of product status. The Controls include
5.7.3.1 Maintaining Identification and Traceability from receipt to delivery and
Handover to the Customer.
5.7.3.2 Maintaining Material / Product Identification as required by the supplier/
Customer / Applicable Specification.
5.7.3.3 Retaining Material / Products under the unique job or reference number that
provides traceability to Purchase Order, Delivery note, Inspection report and
Certification as Applicable.
5.7.3.4 Replacement of Identification and Traceability marks and Identification
Records.
5.7.3.5 Products will be Traceable to Heat Number on Test Certificate.
5.7.3.6 Product status Identification with respect to monitoring and Measurement

5.7.4 Product Inspection and Test Status


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OGI shall maintain documented procedure MSP 29 - Product Inspection and Test
Status for identifying product Inspection and test status throughout the process
indicates conformity or non conformity of product with respect to the Inspections
and test carried out. OGI shall ensure that the product that is released under
concession meets all necessary requirements.

5.7.5 Customer Supplied Property.

OGI has established and maintains MSP 11 - Control of Customer Property/


property belongs to external providers to define the process to identify,
verify, store, maintain and control customer property including intellectual
property delivered to the organization for re-work, repair, re-furbishing, or
any other specified activity. Records of the control and disposition of
customer supplied property/ property belongs to external providers shall be
maintained.

5.7.5.1 MSP17– Control of Non-conforming Product describes how OGI will


document in the event customer property is lost, damaged, or otherwise
found to be unsuitable for use.

5.7.6 Preservation of Product and storage/ OUTPUTS OF PRODUCTION AND


SERVICE

5.7.6.1 General

Management ensures that products are maintained in conformance with the


customer requirements and the requirements of this Quality System Manual
through procedure MSP12 - Product Handling, Storage, Packaging,
Preservation, & Delivery, which details methods and controls for Handling,
identification, packaging, transportation, preservation & delivery of product.

5.7.6.2 Storage and assessment

OGI will maintain designated storage areas or stock rooms and all products pending
use or delivery will be assessed at specified intervals to prevent damage or
deterioration. Records of the results of assessment shall be maintained.

The Controls Include the Following.


a) Preservation of Constituent parts of a Product
b) Periodic Assessment of stock at defined intervals to detect deterioration.
c) The use of Inventory Management Systems.

5.7.7 Monitoring and Measurement of Product/(OUTPUTS)


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5.7.7.1 General

OGI has established and maintains MSP 16 for Monitoring and measurement of
product which includes requirements for in-process and final inspection and testing.
Management ensures that monitoring and measuring of products is planned and
carried out to under controlled conditions with documented procedures. Receipt and
release of goods is determined by Procedure. Record are maintained in accordance
with MSP02

Processes of Receiving Inspection.

a) Incoming Material / product is Inspected or otherwise verified as per


documented process controls.
b) Goods are released for further processing once they verified against
applicable Delivery notes and Inspection reports as applicable. Goods
released without verification are identified and recorded in order to permit
immediate recall. Release is by specified authority.

5.7.7.2 In-Process Inspection and Testing.

All In-process inspection & testing is carried out as per the documented
Quality plan/Procedure. In-Process products will be held until the required
inspection and test have been completed, except when released under
positive recall procedures.

5.7.7.3 Final Inspection and Testing.

a) The Final Inspection and Testing is carried out by personnel other


than those who performed or directly supervised the Manufacture of
the Product.
b) Final Inspection includes verifying that Inspection and Test, including
those specified on receipt, in-process and final, has been carried out
that the result meets the specified requirements in quality plan and/or
procedures.
c) No product will be released or dispatched until the activities specified
in the Quality Plan / Procedure is completed and the associated data
and documents are available and authorized by relevant authority.

5.7.7.4 Inspection and Test Records.

a) The Inspection and Test Records confirming conformity with the


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acceptance criteria are maintained and retained for 7 years as per


contract and Specification requirements if longer.
b) Records identify Inspection authority responsible for release of the
product.

5.7.8 Preventive Maintenance.


OGI has established and maintains MSP 27 for Preventive maintenance for
equipment used for product realization which includes
1) Type of equipment
2) Frequency of maintenance of equipment
3) Responsible personnel for preventive maintenance

OGI established preventive maintenance schedule for each equipment based on


equipment manufacturer’s guidelines, usage history, experience, industry
recommended practices, relevant codes and standards, risk, system reliability or
other applicable requirements as applicable.
Records of preventive maintenance are maintained in accordance with MSP02

5.8 Control of Monitoring and Measuring Equipment.

5.8.1 OGI has established and maintains MSP 13 to define the control systems for
identification, maintenance, and control of monitoring & measuring equipment. This
procedure defines the control features, including identification of equipment type,
unique identification of each instrument, location, frequency of calibration, methods
of calibration, and acceptance criteria.

During the process of Job Planning, as defined in MSP 09, OGI determines
the monitoring and measurement to be undertaken, and identifies the
monitoring measuring equipment needed to provide evidence of conformity
of product to specified requirements.

MSP 16 has been established and maintained to define the processes for
ensuring that monitoring and measurement can be carried out in a manner
that is consistent with the specified monitoring and measurement
requirements.

MSP 13 is established and maintained to ensure that monitoring & measuring


equipments are capable of rendering valid results. This procedure ensures
that these equipments shall:

a) Be calibrated or verified…or both…at specified intervals, or prior to

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use, against measurement standards traceable to international or


national measurement standards (e.g. NIST); where no such standards
exist, the basis used for calibration or verification shall be recorded;
b) Be adjusted, or re-adjusted, as necessary;
c) Have identification in order to determine it’s calibration status (i.e.,
calibration stickers applied to the instrument, or instrument case);
d) Be safeguarded from adjustments that would invalidate the
measurement result;
e) Be protected from damage and deterioration during handling,
maintenance and storage;

MSP 13 defines how OGI will assess and record the validity of the previous
measuring results when the equipment is found not to conform to
requirements. MSP13 also defines how OGI will take corrective action on the
equipment, and any product affected;

MSP 13 defines how OGI records and maintains the results of calibration.
Calibration records are defined as “quality records” and are maintained and
retained in accordance with MSP02. Records of calibrations shall be
maintained in such a manner as to ensure that QC Inspectors can always
verify the inspection status of the instrument.

MSP 13 defines how OGI maintains calibration register with unique


identification and test status for employee owned and customer-owned gages.

MSP 13 defines how OGI Verify/Review calibration certificate of externally


provided/calibrated equipment against the standards prior to its use

MSP 13 also defines the systems at OGI for controlling employee owned and
customer-owned gages.

Environmental Conditions for monitoring & measuring equipments: MSP 13 defines


the systems at OGI for ensuring that environmental conditions are suitable for the
calibrations, inspections, measurements, and tests being carried out
Records include the following.
a) Equipment Identification Including the Measurement standard against
which the Equipment is calibrated
b) Revisions following Engineering changes
c) Out of Spec readings as received for Calibration
d) Assessment of Impact of out of Specification condition
e) Notification to the Customer if suspected material or product has been
shipped.

5.9 Product Release


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OGI has established and maintains documented procedure MSP 30 for product
release. Procedure describes about product were inspected and passed in each stages
as per planned work instructions and quality plans before its delivery to the
customer.
OGI shall ensure all reports are reviewed and all stages are monitored
OGI shall ensure that the product that is released under concession is approved by a
relevant authority or by the customer.
OGI ensure all records are individually identifiable of each released product to the
customer and all records are maintained as per MSP02

5.10 Control of Nonconforming Product.

5.10.1 General

OGI has established and maintains Procedure MSP 17 Control of Non-


conforming Product to identify the controls and related responsibilities and
authorities for addressing nonconforming product.
Management ensures that -

 Nonconforming product is Identified and controlled to ensure its


unintended use.
 Disposition of Nonconforming product were done
 The use, release or acceptance under concession of
Nonconforming product only through permission from relevant
authority or by the customer
 Defining the authority and responsibilities for processing and
disposition of nonconforming product.

 Re verification of product conformity once the correction has


been concluded
 Nonconformity reported and documented of Nonconforming
product which identified after delivery
 Analyzing the failure of product with proper supporting
evidence to determine the actual cause of nonconformity.
 Appropriate action to the effects or potential effects when
detected after delivery or start of use.

5.10.2 Disposition of Nonconforming product

Disposition will be in one of the following ways.

 Repaired or reworked to meet the Specified requirements.


 Accepted with or without repair by concession.
 Re-graded for alternate applications.
 Scrapped.
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5.10.3 Release of Nonconforming product under Concession.

Product may only be accepted by documented concession under the following


conditions.
A. Accepting material/product that does not satisfy manufacturing acceptance criteria
provided.
1) Materials or products satisfy the design acceptance criteria OR
2) The violated manufacturing acceptance criteria is categorised as unnecessary
to satisfy the design acceptance criteria OR
3) Materials / Products are repaired or reworked to satisfy the design acceptance
criteria or manufacturing acceptance criteria.
B. Accepting materials or products that do not satisfy the original design acceptance
criteria shall satisfy the changed or new design acceptance criteria provided.
1) The Original design acceptance criteria is changed per section 5.4.7 AND
2) The materials or products satisfy the new design acceptance criteria.
The details of non-conformity and repairs are recorded, documented and maintained
to denote the actual condition.
Repaired and / or reworked product is re-inspected in accordance with the Quality
plan and/or documented procedures.
Corrective actions are initiated as per MSP 19, if any nonconformity is detected after
delivery of product or use by customers.

Field Non-conformity Analysis- MSP14 & MSP19 defines the process for
identifying, documenting, and reporting incidents of field nonconformities or
product failures. In most cases “field non conformities” will be reported to OGI as a
“customer complaint,” and be documented and investigated.
5.10.4 Customer Notification

OGI Customer Services is responsible for notifying customers in the event


that product which does not conform to design acceptance criteria has been
delivered. Records of such notifications are identified as “quality records”
and are maintained and retained.

5.10.5 Records of nonconformance

Records of nonconformance, corrective action, Concessions obtained are


identified as “quality records” and are maintained and retained.

5.11 Management of change /PLANNING OF CHANGE

5.11.1 General

OGI has established and maintains MSP26 defining procedure for


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Management of Change to ensure that the integrity of the quality


management system is maintained when changes to the QMS are planned
and implemented.
OGI will identify the potential risks associated with the changes and any
required approvals prior to the introduction of such changes. All
documentation relating to Management of change activities are considered as
“quality records” which must be maintained and retained.
OGI shall consider the purpose of the change, the availability of resources
and the allocation or reallocation of responsibilities and authorities.

5.11.2 Implementation of MOC

OGI uses MOC process for any of the following that may negatively impact the quality of
the product.
a) Changes in the organization structure
b) Changes in key or essential personnel
c) Changes in critical suppliers
d) Changes to the management system procedures, including changes resulting from
corrective and preventive actions

5.11.3 Notification of MOC

OGI will notify relevant personnel including customer when required by


contract, of the change and residual or new risk due to changes that have
either been initiated by OGI or requested by the customer.

6.0 QMS MONITORING, MEASUREMENT, ANALYSIS AND IMPROVEMENT.

6.1 General
The sections following in this manual and the referenced MSPs define how OGI has planned
and implemented monitoring, measurement, analysis, and improvement processes in order
to:
a) Demonstrate conformity to product requirements;
b) Ensure conformity of the QMS; and
c) Continually improve the effectiveness of the QMS

6.1.1 Statistical Techniques – OGI has established and maintains MSP 18, governing the
selection and use of statistical techniques, when required, to carry out planned
inspection and other product and process monitoring activities.

6.2 Monitoring, Measuring & Improving.


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6.2.1 Customer Satisfaction


As one of the measurements of performance of the QMS, OGI has established and
maintains MSP 14 to monitor information relating to customer perception as to
whether the organization has met customer requirements. This procedure identifies
the methods for obtaining and analyzing customer feedback, and for implementing
corrective action to continuously improves customer satisfaction by not only
meeting customer requirements, but exceeding them.

6.2.1.1 Customer Complaints are documented and investigated.

6.2.1.2 OGI seeks customer feedback by periodically requesting customers to


complete Customer Satisfaction Form, rating OGI’s performance in a number
of pertinent categories.
6.2.1.3 All documentation records relating to customer satisfaction must be
maintained and retained.

6.2.2 Internal Audit

6.2.2.1 General

Management is committed to performing and documenting Internal Audits of the full


Quality Management System at least annually – Procedure MSP15 will address
Internal Audits.

a) Internal Audits will be planned and implemented to verify compliance and


effectiveness of the Quality Management System.
b) The Scheduled Internal Audits will be conducted annually on all elements of
the QMS
c) The audit results will be recorded and communicated to take timely corrective
action on the deficiencies found during the audit. Response times will be
noted.
d) The Audit results are brought to the attention of the Personnel having
responsibility in the Area audited.
e) Follow up audits are carried out to ensure that the corrective action is
implemented and that is effective.
f) The auditor will check the results of previous audits.
g) When planning Internal audits results of previous audits will be taken into
consideration.
h) Outsourced activities that impact the quality of the product and that are
performed at the OGI facility shall be included as part of the internal audit
program.

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6.2.2.2 Performance of Internal Audit

Internal audit will be performed by trained auditors independent of those


having direct responsibility for the activity being audited to ensure objectivity
and impartiality of the audit process. Audit records will provide objective
evidence that quality management system is implemented and maintained.

All processes of quality management system required to meet API Q1/


ISO9001:2015 specifications shall be audited prior to claiming conformance to
the requirements of these specifications.

6.2.2.3 Audit Review and closure

OGI shall identify response times for addressing detected non-conformances.


The Management responsible for the area being audited shall ensure that any
necessary corrections without undue delay and corrective actions follow the
requirements of MSP19. The results of internal audits and the status of
corrective actions shall be reported in the management review meeting. All
documentation relating to internal audits is considered as “quality records”
which must be maintained and retained.

6.2.3 Process Evaluation


The company will monitor and evaluate processes related to the QMS to assess the
achievement of planned results, including conformity to product requirements.
Where planned results are not being achieved preventive and corrective action will
be implemented to ensure conformity of product and Service requirements. This will
be carried out through Internal Audits, Customer feedback, Non-conformance
records and the effectiveness of processes through management review meeting to
achieve the desired results.

6.3 Analysis of Data


6.3.1 MSP18 defines processes to determine, collect, and analyze appropriate data to
demonstrate the suitability and effectiveness of the QMS and to evaluate where
continual improvement of the effectiveness of the QMS can be made. This will
include data generated as a result of monitoring and measurement, internal audits,
management reviews and from other relevant sources.

The Analysis of data will provide information related to


a) Customer satisfaction
b) Conformity to product and Service requirements
c) Nonconformities and product failures identified after delivery or use, provided the
product or documented evidence is available to facilitate the determination of the
cause
d) Characteristics and trends of processes and products including opportunities for
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preventive action (the effectiveness of action taken to address risk and opportunity)
e) Performance of Supplier (external providers)
f) Quality objectives (The performance and effectiveness of Quality management
system)
h) If planning has been implemented effectively

The organization will use data to evaluate continual improvement and effectiveness
of the quality management system

6.4 Improvement

6.4.1 Continual Improvement.


OGI has established and maintains MSP32-Improvement to assess continual
improvement through review of quality policy, quality objectives, internal audit
results, customer feedback, Corrective and Preventive actions, analysis of data and
review of quality management system performance from minutes of management
review.
OGI shall consider the result of analysis and evaluation, and output from
management review, to determine there are needs or opportunities that shall be
addressed as part of continual improvement.

6.4.2 Corrective Action.

MSP 19 defines the process at OGI for taking action to eliminate the causes of
existing non conformities and to prevent recurrence of both QMS processes and
nonconforming product trends. This procedure has been established to define the
requirements for:

a) Reviewing non conformities (including customer complaints);


b) Determining the causes of nonconformities;
c) Evaluating the need for corrective action to ensure that nonconformities do
not recur;
d) Determining and implementing actions required;
e) Documenting the results of actions taking;
f) Reviewing the effectiveness of corrective action (s) implemented.
g) Update risk and opportunities during planning, if necessary
h) Management of Change, when the corrective action requires new or changed
controls with in the QMS

6.4.2.1 All documentation relating to corrective action is considered “quality


records” which must be maintained and retained.
6.4.2.2 Application of controls to ensure that Corrective action is taken and that is
effective.
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6.4.2.3 Response time: MSP 20 defines the system to ensure timely response to
requests for corrective action and implementation of actions to prevent the
problem’s recurrence.

6.4.3 Preventive Action.

MSP 20 defines the process at OGI for determining action(s) to eliminate the causes
of potential nonconformities in order to prevent their occurrence. This procedure has
been established to define the requirements for:

a) Identifying opportunities for improvements;


b) Identifying potential non conformities and their causes;
c) Evaluating the need for preventive action, including any immediate or short
term action required to prevent occurrence of nonconformity;
d) Identifying the time frame and responsible person for implementing a
preventive action;
e) Reviewing the effectiveness of preventive action(s) implemented.
f) Management of Change, when the preventive action requires new or
changed controls with in the QMS

6.4.3.1 All documentation relating to preventive action is considered “quality


records” which must be maintained and retained.
6.4.3.2 Application of controls to ensure that Corrective action is taken and that is
effective.

6.5 Management Review


6.5.1 General

Management review of the QMS is conducted annually, as a minimum, in order to


ensure the continuing suitability, adequacy and effectiveness of the QMS. Review
will include assessing opportunities for improvement and the need for changes to the
quality management system, including quality policy and quality objectives

6.5.2 Management Review Input

6.5.2.1 The purpose of Management Reviews is to evaluated collected data from the
Following sources.

- Effectiveness of actions resulting from Previous Management


Reviews.

- Results of Internal and External Audits.

- Customer feedback including Complaints and relevant


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communications from interested parties.

- Result of Risk assessments

- Process performance & Product conformity including Trends.

- Product delivery performance

- Status of Corrective and Preventive Actions

- Analysis of supplier (external providers) performances.

- Achievements on Objectives.

- Establishing New or Updating Objectives.

- Changes that could affect the QMS

- Reports & Analysis of Field Nonconformity.

- Changes to applicable legislation and standards including Oil & Gas


Industry Standards.

- Continued adequacy of Quality Policies.


- The adequacy of resources
- The effectiveness of action taken to address risk and opportunities
- Recommendations for Improvement.

6.5.3 Management Review Output

6.5.3.1 The output from Management Review includes decisions and actions relating
to:
a) Improvement of the effectiveness of the QMS and its
processes
b) Improvement of product related to customer requirements;
c) Required Resources
d) Establishment/revision of Quality Objectives

6.5.3.2 The output of management reviews are reviewed and approved by the Top
management. Management Review meetings are documented in minutes and
retained as Quality Records.

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7.0 API Monogram Management.

Procedure MSP 22 defines the process and controls for the management of API
Monogram at API Licensed facilities. The procedure includes the following.

a) Controls implemented to apply the Monogram, including License number and date of
Manufacture.
b) Subsequent removal of Monogram and License number on nonconforming product.
c) The Authority responsible for applying and removing the Monogram.
d) The method of applying monogram
e) Location for the marking.

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