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OIL &GAS INTERNATIONAL FZE
1. INTRODUCTION.
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.
1.2.1 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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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.
1.2.4 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:
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
1.4.1 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.
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.
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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.
Compliance: Act or Process of satisfying the legal and other applicable requirements
of a regulation or a regulatory body.
Delivery-point in time and physical location at which the agreed transfer of ownership
takes place
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.
Field non conformity- product on conformity that is detected after delivery or such as started
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HR – Human Resource
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PO – Purchase Order
QC –Quality Control
WI –Work Instruction
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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“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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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”
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.
Changes to the QMS are planned and controlled in accordance with MSP 01,
and are reviewed for adequacy before implementation.
4.1.5 Communication:
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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.
4.2.1 General
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:
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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:
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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4.3.2.1 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.
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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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:
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.
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4.4.1 General
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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Operating Guidelines
Step-by-step instructions
(When required)
Objective evidence of
completed processes,
Inspections & Tests
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.
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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.
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.
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.
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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,
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
5.2 Planning
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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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:
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:
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.
The process for determining the required design and development inputs is defined in
MSP 06, including, but not limited to:
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.
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:
5.4.3.1 Design outputs will be documented, and usually result in a manufacturing drawings or
specifications.
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:
5.4.4.3 The final design shall be reviewed and approved by top management, other
than the Engineer who developed the design.
5.4.6.1 The result so fall design validation will be documented and reviewed
throughout the validation cycle.
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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.
5.4.7.1 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.
5.5.1 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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5.6.1.1 Procedure
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.
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.
5.6.1.6 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.
OGI has established and maintains MSP 07 to describe the product being purchased,
including where appropriate:
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.
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.
5.6.3.2 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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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.
5.7.1.1 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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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.
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
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.
5.7.6.1 General
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.
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
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.
5.8.1 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.
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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 also defines the systems at OGI for controlling employee owned and
customer-owned gages.
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
5.10.1 General
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
5.11.1 General
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
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.
6.2.2.1 General
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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
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:
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.
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:
6.5.2.1 The purpose of Management Reviews is to evaluated collected data from the
Following sources.
- Achievements on Objectives.
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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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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