M-IRM-001 - Quality Management Manual - Rev.13

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QUALITY MANAGEMENT SYSTEM

Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
13 1 de 40

REVISION CONTROL
REVISION DATE DESCRIPTION
0 15/10/09 Initial Issue.
General Revision for Adaptation, Integration and Implementation for NBR ISO
1 01/09/10
9001/2008.
2 02/12/10 General Pre-Audit Review.

3 01/07/11 General Periodic Review.


Initial Issue (Adaptation of previous Integrated Management Manual. The
4 01/12/11 adaptation was done to be according to company’s reality that has only ISO 9001
certification)

5 17/02/12 General Pre-Audit Review.


6 03/07/12 General Review after restructuring of the Quality Assurance Department.
7 05/04/13 Overhaul for adequacy of the Quality Policy revised IMS Policy.
8 25/11/13 Inclusion of codes of procedures Management System
Revision item 2.3.1 to update the Scope of ABNT NBR ISO9001 Certification.
9 16/07/14 Revision item 5.5.2 to appointment the Quality Assurance Coordinator as MR and
revision item 5.3.3 to fix the term of IMS Policy. Revision item 5.5.1.4 to update the
Org Chart.
10 27/07/15 General Revision
11 16/09/16 General Revision for API Specification Q1 requirements.
12 17/11/16 Revision of 1.2 and 1.3.
13 16/01/17 Revision of 5.9 to review procedure P-DS-003.
Revision of 5.4 to change Design & Development procedure code.

THIS DOCUMENT IS CONFIDENTIAL AND IRM PROPERTY. COPIES DISTRIBUTION ARE


CONTROLLED AND IT IS FORBIDDEN TO REPRODUCE PARTIALLY OR TOTALLY WITHOUT
QUALITY DEPARTMENT AUTHORIZATION.

IRM NAME SIGNATURE DATE


DEVELOPED Nathália Neves / Aline Matos 16/01/2017

APPROVED Rosemari Prandini / Lorena da Mata 01/12/2011

IRM SERVIÇOS EIRELI.


Avenida Prefeito Aristeu Ferreira da Silva, 1205, Galpão C. Granja dos Cavaleiros,
Macaé - RJ, CEP: 27930- 070. Tel/Fax.: 22 21052800
www.irmserv.com.br
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SUMMARY
Item Title
1 PRESENTATION OF IRM SERVICES AND SCOPE
1.1 General Data
1.2 Clarify the needs and expectations of interested parties
1.3 Identify and understand IRM SERVICES and its unique context
1.4 IRM Vision
1.5 IRM Mission
1.6 IRM Values
1.7 Introduction
1.8 Purpose
1.9 Scope
1.10 Exclusions

2 NORMATIVE REFERENCES

3 DEFINITIONS, ABBREVIATIONS AND REFERENCE DOCUMENTS


3.1 Definitions
3.2 Abbreviations
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4 QUALITY MANAGEMENT SYSTEM


4.1 Quality Management System
4.1.1 General
4.1.2 Quality Policy
4.1.3 Quality Goals and Objectives
4.1.4 Planning
4.1.5 Communication
4.1.5.1 Internal
4.1.5.2 External

4.2 Management Responsibility


4.2.1 General
4.2.2 Responsibility and Authority
4.2.3 Management Representative

4.3 Organization Capability


4.3.1 Provision of Resources
4.3.2 Human Resources
4.3.2.1 General
4.3.2.2 Personnel Competence
4.3.2.3 Training and Awareness
4.3.3 Work Environment

4.4 Documentation Requirements


4.4.1 General
4.4.2 Procedures
4.4.3 Control of Documents
4.4.4 Use of External Documents in Product Realization

4.5 Control of Records

5 PRODUCT REALIZATION
5.1 Contract Review
5.1.1 General
5.1.2 Determination of Requirements
5.1.3 Review of Requirements

5.2 Planning

5.3 Risk Assessment and Management

5.4 Design and Development


5.4.1 Design and Development Planning
5.4.2 Design and Development Inputs
5.4.3 Design and Development Outputs
5.4.4 Design and Development Review
5.4.5 Design and Development Verification and Final Review
5.4.6 Design and Development Validation and Approval
5.4.7 Design and Development Changes
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5.5 Contingency planning
5.5.1 General
5.5.2 Planning Output

5.6 Purchasing
5.6.1 Purchasing Control
5.6.1.1 Procedure
5.6.1.2 Initial Supplier Evaluation-Critical Purchases
5.6.1.3 Initial Supplier Evaluation-Noncritical Purchases
5.6.1.4 Supplier Re-evaluation
5.6.1.5 Supplier Evaluation-Records
5.6.1.6 Outsourcing
5.6.2 Purchasing Information
5.6.3 Verification of Purchased products or Activities

5.7 Production and Servicing Provision


5.7.1 Control of Production and Servicing
5.7.1.1 Production
5.7.1.2 Servicing
5.7.1.3 Process Control Documents
5.7.1.4 Product Realization Capability Documentation
5.7.1.5 Validation of Process for Production and Servicing
5.7.2 Product Quality Plans
5.7.3 Identification and Traceability
5.7.4 Product Inspection / Test Status
5.7.5 Customer-Supplied Property
5.7.6 Preservation of Product
5.7.6.1 General
5.7.6.2 Storage and Assessment
5.7.7 Inspection and Testing
5.7.7.1 General
5.7.7.2 In-process inspection and Testing
5.7.7.3 Final inspection and Testing
5.7.8 Preventive Maintenance

5.8 Control of Testing, Measuring and Monitoring Equipment

5.9 Product Release

5.10 Control of Nonconforming Product


5.10.1 General
5.10.2 Nonconforming Product
5.10.3 Release of Nonconforming product under Concession
5.10.4 Customer Notification
5.10.5 Records

5.11 Management of Change (MOC)


5.11.1 General
5.11.2 MOC Implementation
5.11.3 MOC Notification
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6 QMS MONITORING, MEASUREMENT, ANALYSIS & IMPROVEMENT


6.1 General
6.2 Monitoring, Measuring and Improving
6.2.1 Customer Satisfaction
6.2.2 Internal Audit
6.2.2.1 General
6.2.2.2 Performance of Internal Audit
6.2.2.3 Audit Review and Closure
6.2.3 Process Evaluation
6.3 Analysis of Data
6.4 Improvement
6.4.1 General
6.4.2 Corrective Action
6.4.3 Preventive Action
6.5 Management Review
6.5.1 General
6.5.2 Input Requirements
6.5.3 Output Requirements

7 API MONOGRAM / MARKING


7.1 Responsibility
7.2 Records

8 REGISTERS
8.1 Not applicable.

9 APPENDIX
9.1 Not applicable.
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PRESENTATION OF IRM SERVICES
1.1 General Data
Company Name: IRM SERVIÇOS EIRELI.
Trade Name: IRM SERVICES.
CNPJ: 07.932.094/0001-86
State Registration: 78.212-497
Municipal Registration: 0200-93
Address: Av. Prefeito Aristeu Ferreira da Silva – 1205 - Galpão C - Granja dos Cavaleiros - Macaé -
RJ, ZIP CODE: 27930-070.
Site: www.irmserv.com
E-mail: qualidade@irmserv.com.br
Phone/Fax:(22) 2105 - 2800

1.2 Identify and understand IRM SERVICES and its unique context
IRM SERVICES, founded in October 2, 2007 is a genuine Brazilian company, providing
expertise and innovative techniques to the Oil, Gas, Marine and Energy Industries, possessing high-
level professionals with knowledge and expertise proven in Services Of Inspection, Conventional
Industrial And Naval Repair And Maintenance And Rope Access & Threading and Gauging of
Rotary Shouldered Thread Connections and Drill Stem Elements.

Currently, we are among of the top four companies in the segment and we are developing strategies
to keep ourselves competitive through new certifications and intensified development of employee
competencies.

IRM SERVICES has been in the forefront of developing multidisciplinary range of services, and has
two major operations:
 OCTG, applying various inspection techniques for non-destructive testing, maintenance and
repair of tubular products and fittings made onshore
 Offshore, with the application of diverse inspection techniques for non-destructive tests,
maintenance and repair of tubular products and accessories carried out in marine or offshore
environments.

IRM SERVICES has been in the forefront of developing multidisciplinary range of services, providing
benefits to the client, resource optimization, reduced costs, improved efficiency and full compliance
with the contract, all these essentials for successful projects.
Capitalizing on the increasing use of Rope Access technique onshore and offshore, the company is
gaining a leadership position in the performance of services in areas of difficult or limited access. In
parallel, the development of similar capabilities in the underwater environment is seen by IRM
SERVICES as a workplace that offers the same degree of challenge for a workforce that is competent
and focused on high performance results.

The great difference of the company is the application of these techniques in an innovative way,
respecting the legal and contractual parameters and with maximum security and quality.
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1.3 Clarify the needs and expectations of stakeholders

In our production and service chain, we have as stakeholders:

 Clients, who expect high quality technical performance and maximum safety, in compliance with
applicable legislation and standards;

 Employees, who expect to be recognized and paid in an adequate way and who can grow
professionally;

 External providers, who expect to maintain long-term and profitable partnerships;

 Owner, who expects to have the company recognized as a Brazilian leader and a world reference
in the follow-up of Inspection, Repair and Maintenance, in addition to reference of quality of life and
valorization of its employees;

 Society, which expects the generation of job opportunities and action in a sustainable way in social
and environmental parameters;

 Government, which has the expectation of an action in accordance with the legislation.

1.4 IRM Vision


“The Vision of IRM SERVICES is to be Brazilian leader and worldwide reference in the segment of
Inspection, Repair and Maintenance and benchmark for life quality and valuing its employees.”

1.5 IRM Mission


“The Mission of IRM SERVICES is to work with quality, maximum safety and social-environmental
responsibility in the Inspection, Repair and Maintenance at the Oil & Gas, Energy and Marine
activities, applying innovative conventional techniques and with Rope Access, adding value and
providing full customer satisfaction.”

1.6 IRM Values


Integrity in the Commitment
Respect for Clients, Employees and Society
Motivation for Success for All
Safety, Health and Environment in All Operations
Ethics in Relationships
Responsibility Shared
Value the Life in All Its Forms

1.7 Introduction
This manual establishes the requirements to guarantee the services provided by IRM SERVICES,
specified quality levels, consistent with the requirements and needs of its customers, aiming primarily
to prevent nonconformity at all stages of implementation processes as well as the full satisfaction of
its customers.
The Quality Management System described in this Manual is structured to meet the requirements
established in Standards API Specification Q1 and ISO 9001/20015.
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1.8 Purpose
The purpose of this Manual is to establish structure of Quality Management System, describing its
main components, their interaction and reference to associated documents, as well as the Policies of
IRM SERVICES for Quality and strategies for implementation and operationalization of the system.
The Quality Management System aims to meet the full satisfaction of its customers and meet the
requirements established by API Specification Q1 and ISO 9001/20015, customer requirements,
legal requirements and other requirements applicable to services provided by IRM SERVICES.

1.9 Scope
The scope of this Manual is defined by IRM SERVICES in the following range certifiable:

IRM Services provides products and services to the oil, gas, energy & marine industries,
including:
- Inspection, Repair and Maintenance services including non-destructive testing
conventional & rope access methods.
- Rental of equipment specifically for services provided.
- Threading and Gauging of Rotary Shouldered Thread Connections and Drill Stem
Elements.

1.10 Exclusions
There is no exclusion to any section of API Specification Q1 and ISO9001:2015, latest edition.

2. Normative references

The following referenced documents are indispensable for the application of this specification. The
latest edition of the referenced documents (including any amendments) applies.
- API Specification Q1 – Specification for Quality Management System Requirements for
Manufacturing Organizations for the Petroleum and Natural Gas Industry
- ISO 9000 – Quality Management Systems – Fundamentals and Vocabulary
- ISO 9001 - Quality Management Systems – Requirements

3. Definitions, abbreviations and reference documents

3.1 Definitions
3.1.1 Top Management – Person or group of people who directs and controls the IRM SERVICES
at the highest level.

3.1.2 Top Management Critical Analysis – Formal evaluation by Administrative Management of


system state and adequacy in relation to Policy and its objectives.

3.1.3 Quality Management System Audit – Systematic, documented and, where possible,
independent examination destined to determine whether the activities and results related are in
accordance with the provisions planned, and if these provisions are implemented effectively and are
appropriate for the achievement of IRM SERVICES Policy and Objectives.

3.1.4 Quality Management Manual – A document that specifies the Quality Management System
of IRM SERVICES.
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3.1.5 Improvement – Actions implemented throughout the company, in order to increase
effectiveness, efficiency of the activities and processes, to provide additional benefits to both the
company and customers.

3.1.6 Target – Detailed performance requirement, quantified where applicable to IRM SERVICES
resulting Quality objectives, which needs to be established and attended to ensure that these
objectives are achieved.

3.1.7 Nonconformance – The requirement was not attended.

3.1.8 Objective – Purpose of Quality established by IRM SERVICES, with the goal to be achieved
that should be quantified where possible.

3.1.9 Policy – Intentions and overall guidelines of IRM SERVICES, formally expressed by Top
Management, related to quality, exposing its intentions and principles in relation to its overall
performance, which provides a framework for action and goal definition.

3.1.10 Process – Series of resources or interrelated activities that transform inputs into products.

3.1.11 Product/ Service – The result of activities or processes.

3.1.12 Planning – Part of management focused on goals establishment and specification of


operational processes and resources related to them so the goals are achieved.

3.1.13 Quality Management System – QMS – Management System destined to direct and control
the IRM SERVICES with respect to quality, including organizational structure, planning activities,
responsibilities, practices, procedures, processes and resources for developing, implementing,
achieving, reviewing and maintaining the Policy.

3.2 Abbreviations

F – IRM Forms.
R – IRM Records.
I – IRM Work Instructions.
M – IRM Quality Management Manual.
P – IRM Procedure.
QCP – IRM Quality Control Plan.
PG – IRM Program.
API – American Petroleum Institute.
DAC – Design Acceptance Criteria.
ISO – International Organization for Standardization.
KPI – Key Performance Indicator.
MAC – Manufacturing Acceptance Criteria.
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MOC – Management of Change.
MPS – Manufacturing Process Specification.
QM – Quality Manual.
QMS – Quality Management System.

4. QUALITY MANAGEMENT SYSTEM (QMS)

4.1 QUALITY MANAGEMENT SYSTEM

4.1.1 General
4.1.1.1 Context

IRM Services is a Brazilian company in the field of Inspection, Repair and Maintenance of construction
ships, with a focus on the Oil and Gas industry. We operate in Brazil and our services are
concentrated in the Campos bay.
Our goal is to be a Brazilian leader and the world reference in inspection, repair and maintenance
market. We are currently among the top four companies in the industry and are developing strategies
for our development, new skills and efforts development.
IRM Services has two major operations: OCTG, with application of various inspection techniques for
nondestructive testing, maintenance and repair of tubular products and accessories made offshore,
with an application of various inspection techniques for non-destructive testing, maintenance and
repair of tubular products and fittings performed in marine or offshore environments The great
differential of the company is an application of innovative training techniques, respecting the legal and
contractual requirements and with maximum safety and quality.
IRM SERVICES has established, documented, implemented, and maintains at all times a QMS for all
products and servicing provided for use in the oil, gas, energy & marine industries industry and
measures and improves upon the effectiveness of the QMS in accordance with the requirements of
this Quality Manual as per QMS Process Flow Interaction and IRM Macro Flow.
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IRM Processes Macro Flow (Figure 1)

Management Policy, Customer and Stakeholders


Vision/ Mission/ Values/ Conduct Code Expectations and needs

Objectives and goals

MANAGEMENT
PROCESSES
MANAGEMENT
Resources PROCESSES SUPPORT
Management PROCESSES

Comercial
Documents and Administrative
Register Control

Planning
Non-conforming Customer
Financial
product control Satisfaction
Supply Chain

Training and
Information
Competence Continual
Technology
Logistics Improvement
Measuring and
Monitoring of Customer
satisfaction for Accounting
Materials
products & services

Internal Audit
Legal
Measuring Devices Service and
Control and Products
Operational Technical
Control / Engineering

HSE and Legal Requirements


Management

Corrective & Preventive actions / Opportunities for Improvement Data Analysis

Performance Evaluation

Top Management Review


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4.1.2 Quality Policy
IRM SERVICES’s Quality Policy has been defined, documented, and approved by top management.
This policy is communicated, understood, implemented, and maintained at all relevant functions and
levels within IRM SERVICES. The policy includes a commitment to comply with requirements and
continually improve the effectiveness of the QMS.
To implement Quality Policy and to keep them updated and understood, the following exposure
measures can be taken:
a) Notice Boards situated in appropriate locations, in order to keep them permanently
exposed;
b) Corporate website and e-mails;
c) Induction Training.
d) Meetings with IRM SERVICES team, to explain how the policies should be understood
and practiced by the Organization;

Quality Policy
IRM SERVICES is a Brazilian company that offers innovative techniques in Inspection, Repair and
Maintenance at the Oil & Gas, Energy and Marine activities, establishes, maintains and publishes
their policy of Integrated Management System - IMS and agrees to:
 Working carefully for excellence, maintaining the best practices on issues related to Quality,
Health, Safety and Environment compliance with the legislation, with the contractual requirements,
statutory and regulatory requirements applicable to their activities, satisfying the needs and
improving customer satisfaction.
 Establishing and reviewing the results and the goals and objectives consistents with their
policy aimed at continuous improvement of the effectiveness of the management system.
 Conduct their operations preserving the environment, preventing pollution in all their ways,
using products ecologically appropriate, rationalizing the use of non-renewable resources, applying
recycling programs, minimizing the generated waste and mitigating environmental impacts.
 Prevent the occurrence of injuries and work diseases related to their activities, promoting a
proper workplace to their employees.
All managers and supervisors are responsible to lead for the example the employees working
under your supervision, conducting operations safely at all times, involving and motivating the
employees to commit in keeping the best rates in HSEQ.
All the IRM SERVICES personnel, regardless of the position, has expressed authority to suspend
any operation that constitutes a risk to the life and safety of any person, the environment or
surrounding communities.
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4.1.3 Quality Goals and Objectives
As part of the Management Review process top management establishes measurable Quality
Objectives, including those needed to meet customer and product requirements, consistent with the
Quality Policy at relevant functions and levels within IRM SERVICES.
The objectives must be extracted from IRM SERVICES Policies and deployed in organizational
goals for the relevant processes. Achieving these goals and objectives must be demonstrated,
where possible, by using indicators, that are quantifiable forms of representation of variables to be
assessed, according to Performance Metrics Spreadsheet (F-QUA-034), established annually,
always seeking continuous improvement and attendance to the requirements applicable to services.
The quality level of services provided should also be monitored through customer satisfaction
survey.
Objectives of the Quality Management System IRM are:
- Increase the satisfaction of the Client;
- Reduce the number of non-compliances identified by customers;
- Continually improve the management system;

Customer Focus
IRM SERVICES establishes the Quality Management Procedures - Marketing, Planning and
Service Performance (P-PLAN-001a) – and - Measurement and Monitoring of Customer
Satisfaction, Processes and Products (P-QUA-009) -, through areas: Operational, Commercial
Planning and Quality, to ensure understanding and meeting the customers' needs.
During the performance of the services, where possible, Technical/Operational area seeks to
identify the additional requirements from the customer, working toward implementing them.

4.1.4 Planning
The Planning of Quality Management System of IRM SERVICES is outlined in the documents
components of the System that describe and define the activities, equipment used and the resources
available, indicating the stages of measurement and monitoring and specifying the criteria of
acceptance to ensure that the System is adequate and its goals understood, and that they are
efficient and effective.

The purpose of planning of the Quality Management System of IRM SERVICES is to comply with
the Quality Policy and with the objectives established, to ensure and demonstrate the abilities to
satisfy customers and applicable legal and regulatory requirements and to develop continuous
improvement.

The documents components of the Quality Management System that substantiate the
implementation of processes and activities planned are: Quality Management Procedures, Programs,
Work Instructions, Quality Plans, Forms and Registers, and any other eventual.
The resources needed to fulfill the objectives are identified and specified in the respective Action
Plans, when applicable.
The planning is established in such way as to meet the objectives, providing, also, that any
change in QMS to be made in a controlled manner in accordance with the actions defined in the
Action Plans, while maintaining its integrity.
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4.1.5 Communication
IRM SERVICES establishes the Quality Management Procedures Organizational Knowledge
Management (P-GA-001).

4.1.5.1 Internal
IRM SERVICES ensures that appropriate communication processes are established within IRM
SERVICES and the effectiveness of the QMS is communicated.
IRM SERVICES has established processes to ensure that the:
a) importance of meeting customer, legal, and other applicable requirements is communicated at
relevant functions within IRM SERVICES, and that the
b) results of analysis of data (see 6.3) are communicated at relevant levels and functions within
IRM SERVICES.

4.1.5.2 External
IRM SERVICES has determined and implemented a process for communicating with external
organizations, including customers, to ensure requirements are understood throughout contract
execution and product realization. The communication process addresses:
a) execution of customer inquiries, contracts, order handling, and amendments (see 5.1);
b) provision of product information, including product nonconformities identified after delivery to the
customer (see 5.10.4);
c) feedback and customer complaints (see 6.2.1); and
d) when required by contract, the provision of information required by Product Quality Plans and
subsequent changes to those plans (see 5.7.2).

4.2 MANAGEMENT RESPONSIBILITY

4.2.1 General
IRM SERVICES ensures the availability of resources essential to establish, implement, maintain, and
improve the QMS.
Resources can include human resources and specialized skills, organizational infrastructure,
technology, and financial resources.
IRM SERVICES provides evidence of its commitment to the development and implementation of the
QMS and the continual improvement of its effectiveness by:
a) ensuring that Quality Objectives are established, including KPIs, for use in data analysis; and
b) conducting Management Reviews (see 6.5).
c) Management Commitment
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The Management Board of IRM SERVICES demonstrates, through the implementation of QMS and
monitoring of its performance, the level of commitment that maintains with its development and
improvement.

The commitments of IRM SERVICES are:


a) Disseminate the importance of full compliance with the requirements of stakeholders and the legal
and statutory regulations in relation to quality requirements; and
b) Direct and implement a critical analysis subjecting the tasks and processes in place, with focus
on quality, national and international standards applicable;
c) Ensure that a part of human resources is regularly applied to the improvement of IRM
SERVICES; and
d) Show the best of its efforts to ensure the availability of resources of any kind, necessary for the
implementation of Policy established.

4.2.2 Responsibility and Authority


The entire workforce is responsible for reporting issues related to QMS for Management
Representative.
Responsibilities, authorities, and accountabilities of personnel within the scope of this Quality Manual
are defined in the form of an Organization Chart and Job Descriptions documented and
communicated throughout IRM SERVICES.

IRM SERVICES has its organizational structure as Corporate Organogram (Figure 2) IRM Corporate
Organogram.

DIRECTORS

Management
Representative

Board Strategic
Management

Administrative Operations Quality


Supply Chain Controllership HSE
Management Assurance

Equipment Human Business OCTG Quality


Laboratory Materials Purchase IT Facilities Fiscal Accounting Financial Development Operations Quality Control OCTG Reports
Inspection Resources Operations Assurance

Materials Management, Onshore


Warehouse Personnel Administrative Offshore Technical Maintenance Inspection Valve Shop Machine Shop
Logistics Training & Reports Logistics
Management Management
Development

The QMS documents Responsibilities and Authority are correlated on the QMS Responsibility
and Authority Matrix.
All the documents of the QMS of IRM SERVICES are correlated in the Master List of
Documents (R-QUA-010).
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Figure 3 – QMS Responsibility and Authority Matrix

RESPONSIBILITY / AUTHORITY
DOCUMENT

D R A P

DR – QUALITY DR – QUALITY
QUALITY MANAGEMENT MANUAL DIRECTORS ALL THE EMPLOYEES
RESPONSIBLE RESPONSIBLE

DR – QUALITY
DOCUMENTS OF PROCESS FOR DR – QUALITY
RESPONSIBLE / DIRECTORS ALL INVOLVED
QUALITY ASSURANCE RESPONSIBLE
QUALITY DEPARTMENT

DR – QUALITY
DOCUMENTS RELATED TO THE HR DEPARTMENT / HR RESPONSIBLE /
DIRECTORS ALL INVOLVED
PROCESSES OF HUMAN RESOURCES RESPONSIBLE QUALITY
DEPARTMENT

OPERATIONS
DR – QUALITY
DOCUMENTS RELATED TO THE DEPARTMENT / DIRECTORS /
RESPONSIBLE /
PROCESSES OF PLANNING / OPERATIONS DESIGNATED ALL INVOLVED
QUALITY ASSURANCE
OPERATIONS MANAGER / PERSON
DEPARTMENT
DESIGNATED PERSON

SUPPLY CHAIN
DOCUMENTS RELATED TO THE DR – QUALITY
DEPARTMENT / SUPPLY DIRECTORS ALL INVOLVED
PROCESSES OF SUPPLY CHAIN RESPONSIBLE
CHAIN RESPONSIBLE

REPORTS
DEPARTMENT / DR – QUALITY
DOCUMENTS RELATED TO THE OPERATIONS RESPONSIBLE /
DIRECTORS ALL INVOLVED
PROCESSES OF REPORTS DEPARTMENT / QUALITY ASSURANCE
OPERATIONS DEPARTMENT
MANAGER
DR – QUALITY
DOCUMENTS RELATED TO THE HSE DEPARTMENT / RESPONSIBLE /
DIRECTORS ALL INVOLVED
PROCESSES OF HSE SAFETY ENGINEER QUALITY ASSURANCE
DEPARTMENT
DR – QUALITY
DOCUMENTS RELATED TO THE ADMINISTRATIVE RESPONSIBLE /
DIRECTORS ALL INVOLVED
PROCESSES OF IT RESPONSIBLE QUALITY
DEPARTMENT
CONTROLLERSHIP DR – QUALITY
DOCUMENTS RELATED TO THE DEPARTMENT / RESPONSIBLE /
DIRECTORS ALL INVOLVED
PROCESSES OF CONTROLLERSHIP CONTROLLERSHIP QUALITY ASSURANCE
RESPONSIBLE DEPARTMENT
OPERATIONS DR – QUALITY
DOCUMENTS RELATED TO THE DEPARTMENT / RESPONSIBLE /
DIRECTORS ALL INVOLVED
PROCESSES OF LOGISTICS OPERATIONS QUALITY ASSURANCE
MANAGER DEPARTMENT
FACILITIES DR – QUALITY
DOCUMENTS RELATED TO THE DEPARTMENT / RESPONSIBLE /
DIRECTORS ALL INVOLVED
PROCESSES OF FACILITIES ADMINISTRATIVE QUALITY ASSURANCE
RESPONSIBLE DEPARTMENT
COMMERCIAL DR – QUALITY
DOCUMENTS RELATED TO THE DEPARTMENT / RESPONSIBLE /
DIRECTORS ALL INVOLVED
PROCESSES OF COMMERCIAL OPERATIONS QUALITY ASSURANCE
MANAGER DEPARTMENT

D – Development; R – Revises; A - Approve; P - Participates.


* MR – Management Representative

Note: The remaining departments and their managers presented in chart should prepare their documents, submit to the Quality
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Assurance Department for review and the director for approval.

4.2.3 Management Representative


Top management has appointed the Quality Assurance responsible as the Management
Representative who has responsibility and authority that includes:
a) ensuring that processes needed for the QMS are established, implemented, and maintained;
b) reporting to top management on the performance of the QMS and any need for improvement;
c) ensuring initiation of action(s) to minimize the likelihood of the occurrence of nonconformities
(see 6.4.3); and ensuring the promotion of awareness of customer requirements throughout IRM
SERVICES.

4.3 ORGANIZATION CAPABILITY

4.3.1 Provision of Resources


IRM SERVICES defines material and human resources needed for planning, implementation and
verification of activities related to QMS.
At the Top Management review meetings, the internal requirements of IRM SERVICES must be
determined and / or reassessed for the management of its QMS, indicating the resources needed
for its maintenance and improvement of its effectiveness, as well as the increase of customers
satisfaction for their service and product requirements.

4.3.2 Human Resources

4.3.2.1 General
IRM SERVICES establishes the Quality Management procedure – Competences Development
(P-TD-002) - and the specific instructions which defines how the process of competence
development, training and awareness should be performed.
Each person who works for IRM SERVICES, whatever the function he performs, has
responsibilities in QMS such as monitoring, correction and corrective and / or preventive actions of
QMS.
To properly perform their duties, employees should be aware of their importance and share the
contribution for the achievement of goals.
To enable them to perform their responsibilities, training must be conducted. The effectiveness of
the training should be evaluated by monitoring performed by Coordinators / Managers of involved
areas.
IRM SERVICES must maintain appropriate records of education, training, skills and experience.

4.3.2.2 Personnel Competence / 4.3.2.3 Training and Awareness


IRM SERVICES establishes the Quality Management procedure – Competences Development
(P-TD-002) - and the specific instructions which defines how the process of competence
development, training and awareness should be performed.
Each person who works for IRM SERVICES, whatever the function he performs, has
responsibilities in QMS such as monitoring, correction and corrective and / or preventive actions of
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QMS.
To properly perform their duties, employees should be aware of their importance and share the
contribution for the achievement of goals.
To enable them to perform their responsibilities, training must be conducted. The effectiveness of
the training should be evaluated by performance monitoring by Coordinators / Managers of involved
areas.
IRM SERVICES must maintain appropriate records of education, training, skills and experience.

4.3.3 Work Environment


IRM SERVICES determines, provides, manages, and maintains the work environment needed to
achieve conformity to product requirements. Work environment includes:
a) buildings, workspace, and associated utilities;
b) process equipment and its maintenance (both hardware and software) (see 5.7.8);
c) supporting services (for example, transport, communication, information systems); and
d) conditions under which work is performed such as physical, environmental, or other factors.
To increase the performance and develop a process of continuous improvement, IRM SERVICES
ensures that working environment has a positive influence on motivation, satisfaction and
performance of its personnel, through motivational trainings and facilities compatible with the work to
be performed.

4.4 DOCUMENTATION REQUIREMENTS

4.4.1 General
The Documentary Structure (Figure 3) of IRM SERVICES is structured in four hierarchical levels.
These levels are developed in such way that the activities and responsibilities are available to its
users, in the language and necessary amount appropriate to necessary methods and criteria, to
ensure the effective operation of the Quality Management System processes.
Other than documentation in figure 3, IRM SERVICES uses an external software to identify legal and
other applicable requirements to which the organization claims compliance that are needed to achieve
product and service conformity.

Figure 3 – Documentary Structure

QUALITY FILE STRUCTURE

Levels

Quality
Management
1 Manual

Management of Quality
Programs and Procedures
2
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Work instructions
and Quality Plans

Forms and Registers


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4.4.2 Procedures
The main definitions of the documents that are part of QMS are listed below:
a) Level 1 – Quality Management Manual – M. Document that defines and sets out the Policy and
describes the Quality Assurance Department, showing how the processes should be performed by
IRM SERVICES to meet the requirements of the Quality Management System, covering the scope
certifiable.
b) Level 2 – IRM Quality Management Procedures – P and IRM Programs - PG. Documents that
describe the processes of IRM SERVICES defining what to do and, when appropriate, how to do,
meeting the requirements established by the standard API Q1 and ISO 9001/2015 and other specific
standards.
c) Level 3 – IRM Work Instructions - I and IRM Quality Control Plans - QCPs – objectively establish
the methodology of a Level III process.
d) Level 4 – IRM Forms – F; IRM Registers – R;
Registers and Forms are the objective evidence that shows that the planned activities are being
performed.

4.4.2.1 Quality Management Manual – M


This Manual - Quality Management Manual describes the Quality Management System based on
API Q1 and ISO 9001/2015.
The Quality Management Manual should be controlled in accordance with the procedures of IRM
SERVICES and defines, among other:
a) The scope of the QMS IRM SERVICES, exclusions and justifications as API Q1 and ISO
9001/2015.
b) Reference to the Quality Work Instructions and other applicable documents Management
Procedures.
c) description of the sequence and interaction of the processes included in the QMS;
d) Statement of the documented Quality Management System policy and related objectives;

All procedures referenced within this Quality Manual are established, documented, implemented, and
maintained for continued suitability. A single document can address the requirements of one or more
procedures. A requirement for documented procedures can be satisfied by more than one document.

4.4.3 Control of Documents


4.4.3.1 IRM SERVICES establishes the Quality Management Procedures Document Control (P-
QUA-001) - for control of all the documents that define how the QMS works, including documents of
external origin. The documents should be critically reviewed and approved by authorized
personnel prior to issue, and their distribution is defined in order to ensure that they are also
available at the points of use, in the updated version. Obsolete documents retained for historical
purposes should be suitably identified as obsolete, to prevent unintended use.
4.4.3.2 Document Master List must be maintained identifying the current revision of the documents
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and if they are readily available in order to avoid the use of invalid and / or obsolete documents.
4.4.3.3 The QMS documents to be kept legible, readily identifiable and retrievable to provide
evidence of compliance with the requirements and the effective operation of QMS.
4.4.3.4 Changes to QMS documents to be promptly made after Quality Department critical analysis
and the nature of the change identified.

4.4.4 Use of External Documents in Product Realization


When API product or other external specification requirements, including addenda, errata and
updates, are used in the design or manufacture of the product, IRM SERVICES maintains a
documented procedure P-QUA-001 - Document Control for the integration of these requirements
into the product realization process and any other affected processes.

4.5 CONTROL OF RECORDS


IRM SERVICES maintains a documented procedure P-QUA-002 - Control of Records to identify the
controls and responsibilities needed for the identification, collection, storage, protection, retrieval,
retention time, and disposition of records.
Records, including those originating from outsourced activities (see 5.6.1.6), are established and
controlled to provide evidence of conformity to requirements and operation of IRM SERVICES’s
QMS.
Records remain legible, identifiable, and retrievable. Records are retained for a minimum of ten years
or as required by customer, legal, product specifications, and other applicable requirements,
whichever is longer.

5 PRODUCT REALIZATION

5.1 CONTRACT REVIEW

5.1.1 General
IRM SERVICES maintains a documented procedure P-PLAN-001a - Marketing, Planning and
Realization of Services and P-PLAN-001b - Marketing Planning and Realization of Services
OCTG for the review of requirements related to the provision of products and required servicing.

5.1.2 Determination of Requirements


IRM SERVICES determines:
a) requirements specified by the customer;
b) legal and other applicable requirements; and
c) requirements not stated by the customer but considered necessary by IRM SERVICES for the
provision of the product.
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Where the customer provides no documented statement of the requirements, the customer
requirements are confirmed by IRM SERVICES and records maintained (see 4.5).
5.1.3 Review of Requirements
IRM SERVICES reviews the requirements related to provision of products. This review is conducted
prior to IRM SERVICE´s commitment to deliver product to the customer and ensures that:
a) requirements are identified and documented;
b) requirements differing from those previously identified are resolved; and
c) IRM SERVICES has the capability to meet the documented requirements.
Where contract requirements are changed, IRM SERVICES ensures that relevant documents are
amended and that relevant personnel are made aware of the changed requirements.
Records of the results of the review, including resulting actions, are maintained (see 4.5).

IRM SERVICES employees are empowered to meet any doubt related to services that are
performed as well as to attend the complaints and measurement of customer satisfaction
according to Quality Management Procedure – Measurement and Monitoring of Customer
Satisfaction and Processes (P-QUA-009).

5.2 PLANNING
IRM SERVICES identifies and plans the processes and documents needed for product realization.
Planning of product realization is consistent with the requirements of the other processes of the QMS
(see 4.1.4). In planning, IRM SERVICES addresses the following:
a) required resources and work environment management (see 4.3);
b) product and customer-specified requirements (see 5.1);
c) legal and other applicable requirements;
d) contingencies based on risk assessment (see 5.3 and 5.5);
e) design and development requirements (see 5.4);
f) required verification, validation, monitoring, measurement, inspection, and test activities specific
to the product and the criteria for product acceptance;
g) management of change (see 5.11); and
h) records needed to provide evidence that the product realization processes meet requirements
(see 4.5).
The output of planning is documented and updated as changes occur. The plans are maintained in a
structure suitable for IRM SERVICES’s method of operations, in accordance with procedure - P-
PLAN-001 - Marketing, Planning and Service Realization of Services.
The purpose of planning of the Quality Management System of IRM SERVICES is to comply with
the Quality Policy and with the objectives established, to ensure and demonstrate the abilities to
satisfy customers and applicable legal and regulatory requirements and to develop continuous
improvement.
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5.3 RISK ASSESSMENT AND MANAGEMENT


IRM SERVICES maintains a documented procedure P-QUA-013 - Risk Analysis Management and
Contingency Plan to identify and control risks associated with impact on delivery and quality of
product. The procedure identifies the techniques, tools, and their application for risk identification,
assessment, and mitigation.
Risk assessment can include consideration of severity, detection methods, and probability of
occurrence.
Risk assessment associated with product delivery includes:
a) facility/equipment availability and maintenance
b) supplier performance and material availability/supply
Risk assessment associated with product quality includes, as applicable
a) delivery of nonconforming product (see 5.10.1)
b) availability of competent personnel
Records of risk assessment and management including actions taken are maintained (see 4.5).
The output of risk assessment may be used in the development of contingency plans (see 5.5).
Risk assessment can be an activity associated with corrective and/or preventive action.

5.4 DESIGN & DEVELOPMENT


5.4.1 Design and Development Planning
IRM SERVICES maintains a documented procedure P-CTO-ENG-001 - Design & Development to
plan and control the design and development of the product.
This procedure identifies the:
a) plan(s), including plan updates, used for design development;
b) design and development stages;
c) resources, responsibilities, authorities, and their interfaces to ensure effective communication;
d) review, verification, and validation activities necessary to complete each design and
development stage; and
e) requirements for a final review of the design (see 5.4.5)
When design and development activities are performed at different locations within IRM SERVICES,
the procedure identifies the controls required to ensure that the designs meet the requirements of 5.4.
In the event that IRM SERVICES outsources any aspect of the design and development process it
ensures that the supplier meets the requirements of 5.6.1.6.
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Design and development review, verification, and validation each have distinct purposes but can be
conducted and recorded separately or in any combination, as suitable for the product and the
organization.
5.4.2 Design and Development Inputs
Inputs are identified and reviewed for adequacy, completeness, and lack of conflict.
Inputs include functional and technical requirements and the following, as applicable:
a) customer-specified requirements (see 5.1);
b) requirements provided from external sources, including API product specifications;
c) environmental and operational conditions;
d) methodology, assumptions, and formulae documentation;
e) historical performance and other information derived from previous similar designs;
f) legal requirements; and
g) results from risk assessments (see 5.3).
Records of design inputs are maintained (see 4.5).

5.4.3 Design and Development Outputs


Outputs are documented to allow verification against the design and development input requirements.
Outputs:
a) meet the input requirements for design and development;
b) provide appropriate information for purchasing, production, and servicing;
c) identify or reference design acceptance criteria (DAC);
d) include identification of, or reference to, products and/or components deemed critical to the
design;
e) include results of applicable calculations; and
f) specify the characteristics of the product that are essential for its safe and proper use.
Records of design outputs are maintained (see 4.5).
Identification of criticality of products and/or components can be maintained outside of the design and
development process.

5.4.4 Design and Development Review


At suitable stages, review(s) are performed to:
a) evaluate the suitability, adequacy, and effectiveness of the results of design and development
stages to meet specified requirements; and
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b) identify any problems and propose necessary actions.


Participants in such review(s) include representatives of functions concerned with the design and
development stage(s) being reviewed.
Records of the results of the review(s) and any necessary actions are maintained (see 4.5).

5.4.5 Design and Development Verification and Final Review


To ensure that the design and development outputs have met the design and development input
requirements, design and development verification and a final design review is conducted and
documented in accordance with planned arrangements (see 5.4.1).
Records of design verification and the final design review are maintained (see 4.5).

5.4.6 Design and Development Validation and Approval


Design validation is performed in accordance with planned arrangements (see 5.4.1) to ensure that
the resulting product is capable of meeting the specified requirements. When possible, validation is
completed prior to the delivery of the product.
After validation the completed design is approved by competent (see 4.3.2.2) individual(s) other than
the person or persons who developed the design.
Records of the design validation, approval, and any necessary actions are maintained (see 4.5).

5.4.7 Design and Development Changes


Design and development changes are identified, reviewed, verified, and validated, as appropriate,
and approved before implementation.
The review of design and development changes includes an evaluation of the effect of the changes
on product and/or their constituent parts already delivered.
Design and development changes, including changes to design documents, require the same controls
as the original design and development activities.
Records of design and development changes, reviews of those changes, and any necessary actions
are maintained (see 4.5).

5.5 CONTINGENCY PLANNING


5.5.1 General
IRM SERVICES maintains a documented procedure P-QUA-013 - Risk Analysis Management and
Contingency Plan - for contingency planning needed to address risk associated with impact on
delivery and quality of product.
Contingency planning is based on assessed risks (see 5.3) and output is documented and
communicated to the relevant personnel and updated as required.
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5.5.2 Planning Output


Contingency plans include:
a) actions required in response to significant risk scenarios to mitigate effects of disruptive
incidents;
b) identification and assignment of responsibilities and authorities; and
c) internal and external communication controls (see 4.1.5).

5.6 Purchasing

IRM SERVICES maintains a documented procedure P-COM-001 – Purchasing - to implement the


process of purchasing goods and services. The records must be kept for the results of purchases
and for any necessary actions to the process, including the product characteristic when applicable.

5.6.1 Purchasing Control

5.6.1.1 Procedure
IRM SERVICES maintains documented procedures P-COM-001 – Purchasing and P-COM-002 -
Selection, Classification, Evaluation and Supplier Registration - to ensure that purchased
products or outsourced activities and registration, evaluation and re-evaluation of vendors conform to
specified requirements.
This procedure addresses:
a) determination of the criticality of the activities or products as they are applicable to conformance
to product or customer specifications;
b) initial evaluation and selection of suppliers based on their ability to supply products or activities
in accordance with IRM SERVICES’s requirements (see 5.6.1.2 and 5.6.1.3);
c) type and extent of control applied to the supplier based on the criticality of the product or
activity;
d) criteria, scope, frequency, and methods for re-assessment of suppliers;
e) maintaining a list of approved suppliers and scope of approval; and
f) type and extent of control to be applied to outsourced activities (see 5.6.1.6).

5.6.1.2 Initial Supplier Evaluation – Critical Purchases


For purchase of critical products, components, or activities that impact product realization or the final
product, the criteria for the initial evaluation of suppliers is site-specific for each supplier and include
the following:
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a) verification that the supplier’s QMS conforms to IRM SERVICES’s specified quality system
requirements; and
b) assessment of the supplier to ensure its capability to meet IRM SERVICES’s purchasing
requirements by:
I performing an on-site evaluation of relevant activities; or
II performing first article inspection to ensure conformance to stated requirements; or
III identifying how the supplied product conforms to stated requirements when limited by
proprietary, legal, and/or contractual arrangements.

5.6.1.3 Initial Supplier Evaluation – Noncritical Purchases


For purchase of noncritical products, components, or activities that impact product realization or the
final product, the criteria for evaluation of suppliers meets the requirements of 5.6.1.2 or satisfies one
or more of the following:
a) verification that the supplier’s QMS conforms to IRM SERVICES’s specified quality system
requirements; or
b) assessment of the supplier to meet IRM SERVICES’s purchasing requirements; or
c) assessment of the product upon delivery or activity upon completion.

5.6.1.4 Supplier Re-evaluation


For re-evaluation of all suppliers (critical and noncritical), the requirements of 5.6.1.3 apply.

5.6.1.5 Supplier Evaluation – Records


Records of the results of all evaluations and any necessary actions arising from the evaluations are
maintained (see 4.5).

5.6.1.6 Outsourcing
When IRM SERVICES chooses to outsource any activity within the scope of its QMS, it ensures that
all applicable elements of its QMS are satisfied and maintains responsibility for product conformance
to specified requirements, including applicable API product specifications associated with product
realization.
Records of outsourced activities are maintained (see 4.5).

5.6.2 Purchasing Information


IRM SERVICES ensures the adequacy of specified purchasing information prior to their
communication to the supplier. Purchasing information provided to the supplier is documented and
adequately describes the product or activity to be purchased, including acceptance criteria, and where
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appropriate:
a) requirements for approval of supplier’s procedures, processes, and equipment;
b) applicable version of specifications, drawings, process requirements, inspection instructions,
traceability, and other relevant technical data;
c) requirements for qualification of supplier’s personnel; and
d) QMS requirements.

5.6.3 Verification of Purchased Products or Activities


IRM SERVICES identifies the verification or other activities necessary for ensuring that purchased
products or activities meet specified purchase requirements in documented procedures P-COM-001 –
Purchasing, I-LAB-003 - Receiving Inspection of Measuring Equipment and I-MAT-001 -
Materials Receipt.
When IRM SERVICES or its customer intends to perform verification at the supplier’s premises, it
states the intended verification arrangements and method of product release in the purchasing
information.
IRM SERVICES ensures and provides evidence that purchased products and activities conform to
specified requirements.
Records of verification activities are maintained (see 4.5).

5.7 PRODUCTION AND SERVICING PROVISION


5.7.1 Control of Production and Servicing
5.7.1.1 Production
IRM SERVICES maintains a documented procedure P-DS-001 – Production - that describes controls
associated with the production of products. The procedure addresses the following:
a) availability of information that describes the characteristics of the product;
b) implementation of the Product Quality Plan, when applicable (see 5.7.2);
c) ensuring design requirements and related changes are satisfied, when applicable (see 5.4);
d) availability and use of suitable production, testing, monitoring, and measurement equipment;
e) availability of work instructions when applicable;
f) process control documents (see 5.7.1.3);
g) implementation of monitoring and measurement activities; and
h) implementation of product release (see 5.9), including applicable delivery and post-delivery
activities

5.7.1.2 Servicing
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IRM SERVICES maintains a documented procedure P-PLAN-001a - Marketing, Planning and


Realization of Services and P-PLAN-001b - Marketing, Planning and Realization of Services
OCTG that describes the controls associated with the servicing (see 3.1.20) of products. This
procedure addresses the following:
a) review and implementation of IRM SERVICES, customer-specific product servicing, and other
servicing requirements;
b) the availability and use of suitable servicing, testing, monitoring, and measurement equipment;
c) the availability of procedures when applicable;
d) maintenance of identification and traceability requirements throughout the servicing process;
e) the implementation of monitoring and measurement activities;
f) process control documents (see 5.7.1.3); and
g) requirements for release of the product that was serviced (see 5.9).

5.7.1.3 Process Control Documents


Process controls are documented on checklists, forms, or equivalent controls required by IRM
SERVICES and include requirements for verifying conformance with applicable Product Quality Plans
(see 5.7.2). These controls include requirements for API product specifications, customer
requirements, and/or other product standards/codes when applicable.
The process control documents include or reference instructions and acceptance criteria for
processes, tests, inspections, and when applicable, customer’s inspection hold or witness points.

5.7.1.4 Product Realization Capability Documentation


IRM SERVICES develops and maintains documentation that includes but is not limited to product
realization plans (see 5.2) and records of review/verification, validation, monitoring, measurement,
inspection, and test activities, including criteria for product acceptance that demonstrate its capability
to satisfy specified product and/or servicing requirements.
Product realization documentation is evidence of the capability of the organization to manufacture
products or families of products and does not extend to every work order or individual product
manufactured.

5.7.1.5 Validation of Processes for Production and Servicing


IRM SERVICES validates processes for production and servicing where the resulting output cannot
be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become
apparent only after the product is in use or the servicing has been delivered. These processes include
nondestructive examination, welding and heat treating when applicable to the product. Validation
demonstrates the ability of these processes to achieve planned results.
IRM SERVICES has identified nondestructive examination and welding as those processes that
require validation for production and servicing.
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Where it chooses to outsource a process that requires validation, IRM SERVICES requires that the
supplier conform to these requirements (see 5.6.1.6).
IRM SERVICES maintains a documented procedure P-QUA-015 - Validation of Special Processes
- to address methods for review and approval of special processes including:
a) required equipment;
b) qualification of personnel;
c) use of specific methods, including identified operating parameters;
d) identification of acceptance criteria;
e) requirements for records (see 4.5); and
f) revalidation.

5.7.2 Product Quality Plans


When required by contract, IRM SERVICES develops a Product Quality Plan that specifies the
processes of the QMS (including the product realization processes) and the resources to be applied
to a product.
When required by contract the Product Quality Plan addresses each of the following:
a) description of the product to be manufactured;
b) required processes and documentation, including required inspections, tests, and records for
conformance with requirements;
c) identification and reference to control of outsourced activities;
d) identification of each procedure, specification, or other document referenced or used in each
activity; and
e) identification of the required hold, witness, monitor, and document review points.

Product Quality Plans and any revisions to them are documented and approved by IRM SERVICES to
ensure customer requirements are met. Product Quality Plans and any revisions are communicated to
the customer.
A Product Quality Plan may make references to other QMS documents.

5.7.3 Identification and Traceability


IRM SERVICES maintains a documented procedure P-DS-002 - Identification & Traceability for
identification and traceability while the product or and service is under its control throughout the
product/service realization process, including applicable delivery and post-delivery activities. This
procedure includes requirements for maintenance or replacement of identification and/or traceability
marks.
Records of identification and traceability are maintained (See 4.5).
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5.7.4 Product Inspection / Test Status


IRM SERVICES ensures the identification of product inspection and/or test status throughout the
product realization process which indicates the conformity or nonconformity of product with respect to
inspections and/or tests performed as identified in documented procedure (P-DS-MS-014 Inspection
and Testing). It ensures that only product that meets requirements or is authorized under concession
(see 5.10.3) is released.

5.7.5 Customer-Supplied Property


IRM SERVICES maintains a documented procedure P-DS-003 – Receiving, Handling, Storage,
Packaging and Delivery of Equipment - for the identification, verification, safeguarding,
preservation, maintenance, and control of customer-supplied property, including intellectual property
and data, while under its control. This procedure includes requirements for reporting to the customer
any loss, damage, or unsuitability for use of customer-supplied property.

5.7.6 Preservation of Product


5.7.6.1 General
IRM SERVICES maintains a documented procedure P-DS-003 – Receiving, Handling, Storage,
Packaging and Delivery of Equipment - describing the methods used to preserve the product and
constituent parts throughout product realization and delivery to the intended destination in order to
maintain conformity to requirements. As applicable, preservation includes identification and
traceability marks, transportation, handling, packaging, and protection.

5.7.6.2 Storage and Assessment


This procedure P-DS-003 – Receiving, Handling, Storage, Packaging and Delivery of Equipment
- identifies the requirements for storage and assessment. Designated storage areas or stock rooms
are used to prevent damage or deterioration of product, pending use or delivery.
In order to detect deterioration, the condition of product or constituent parts in stock is assessed at
specified intervals identified by the procedure. The interval is appropriate to the products or
constituent parts being assessed.
Records of the results of assessments are maintained (see 4.5).
When on customer location, storage and assessment is customer responsibility.

5.7.7 Inspection and Testing


5.7.7.1 General
IRM SERVICES maintains a documented procedure (P-DS-MS-014 - Final Testing and Certificate)
for inspection and testing to verify that product requirements have been met. This procedure includes
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requirements for in-process, final inspection, and testing.


Records of required inspection and testing are maintained (see 4.5).

5.7.7.2 In-process Inspection and Testing


IRM SERVICES inspects and tests the product at planned stages as required by the Product Quality
Plan (see 5.7.2), process control documents (see 5.7.1.3), and/or documented procedures. Evidence
of conformity with the acceptance criteria is maintained.

5.7.7.3 Final Inspection and Testing


IRM SERVICES conducts final inspection and testing in accordance with the Product Quality Plan
and/or other production control documents to validate and document conformity of the finished
product to the specified requirements.
Personnel other than those who performed or directly supervised the production of the product
perform final acceptance inspection at planned stages of the product realization process.
For single step manufacturing processes (e.g., threading), in-process and final inspection and testing
can be performed as one activity.

5.7.8 Preventive Maintenance


IRM SERVICES maintains a documented procedure P-CTO-MAN-001 – Machine and Equipment
Maintenance - for the establishment of preventive maintenance for equipment used in product
realization. This procedure identifies requirements for:
a) type of equipment to be maintained;
b) frequency; and
c) responsible personnel.
Records of preventive maintenance are maintained (see 4.5).
Preventive maintenance can be based on risk, system reliability, usage history, experience, industry
recommended practices, relevant codes and standards, original equipment manufacturer’s guidelines,
or other applicable requirements.

5.8 CONTROL OF TESTING, MEASURING AND MONITORING EQUIPMENT


IRM SERVICES determines the testing, monitoring, and measurement requirements and the
associated equipment needed to provide evidence of conformity to those requirements, and maintains
a documented procedure P-LAB-001 - Equipment Control of Monitoring and Measurement - in
order to ensure that testing, measurement, and monitoring equipment is calibrated and maintained and
that the equipment is used in a manner that is consistent with monitoring and measurement
requirements.
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This procedure includes requirements for the specific equipment type that addresses:
a) unique identifier;
b) calibration status;
c) traceability of calibration standards used to international or national measurement standards;
d) frequency of calibration, at specific intervals or prior to use;
e) calibration or verification method, including adjustments and readjustments as necessary; and
f) acceptance criteria
This procedure also addresses:
a) the control of equipment identified as out-of-calibration in order to prevent unintended use;
b) assessment of the validity of previous measurements and necessary actions related to the
equipment and delivered product when the equipment is found to be out-of-calibration; and
c) maintenance of records and evidence of notification to the customer and to API, if applicable
(see 4.1.5.2).
Testing, measuring, and monitoring equipment is:
1) calibrated or verified, or both, against measurement standards (verification against identified
acceptance criteria is performed on non-adjustable equipment);
2) identifiable by the user as to its calibration status for the activities being performed at all times;
3) safeguarded from adjustments that would invalidate the measurement result or the calibration
status;
4) protected from damage and deterioration during handling, maintenance, and storage; and
5) used under environmental conditions that are suitable for the calibrations, inspections,
measurements, and tests being carried out.
When used in the testing, monitoring, or measurement of specified requirements, the ability of
computer software to satisfy the intended application is confirmed prior to initial use and reconfirmed
as necessary.
When monitoring and measuring equipment is provided from an external source, including third party,
proprietary, employee and customer-owned equipment, IRM SERVICES verifies that the equipment is
suitable and provides evidence of conformity to the requirements of this section 5.8.
IRM SERVICES maintains a list of the required testing, measurement, and monitoring equipment
used to determine product conformity to requirements that includes a unique identifier specific to each
piece of equipment.
Records of the results of calibration and verification are maintained (see 4.5).

5.9 PRODUCT RELEASE


IRM SERVICES ensures that release of product to the customer does not proceed until the planned
arrangements (see 5.7) have been satisfactorily completed, unless otherwise approved by a relevant
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authority and, where applicable, by the customer as identified in documented procedure P-DS-003 -
Receiving, Handling, Storage, Packaging and Delivery of Equipment.
Records are maintained to enable identification of the individual releasing the product (see 4.5).

5.10 CONTROL OF NONCONFORMING PRODUCT


5.10.1 General
IRM SERVICES maintains a documented procedure P-QUA-003 - Control of Nonconforming
Product - to identify the controls and related responsibilities and authorities for addressing
nonconforming product.
The procedure for addressing nonconforming product identified during product realization includes
controls for:
a) product identification to prevent unintended use or delivery;
b) addressing the detected nonconformity (see 5.10.2);
c) taking action to preclude its original intended use or delivery; and
d) authorizing its use, release, or acceptance under concession by relevant authority and, where
applicable, by the customer.
The procedure for addressing nonconforming product identified after delivery includes controls for:
a) identifying, documenting, and reporting nonconformances or product failure identified after
delivery;
b) ensuring the analysis of product nonconformance or failure, provided the product or
documented evidence supporting the nonconformity is available to facilitate the determination of the
cause (see 6.4.2); and
c) taking action appropriate to the effects, or potential effects, of the nonconformance when
nonconforming product is detected after delivery.

5.10.2 Nonconforming Product


IRM SERVICES addresses nonconforming product by performing one or more of the following:
a) repair or rework with subsequent inspection to meet specified requirements;
b) re-grade for alternative applications;
c) release under concession (see 5.10.3); and/or
d) reject or scrap.

5.10.3 Release of Nonconforming Product under Concession


The evaluation and release under concession of nonconforming product that does not satisfy
Manufacturing Acceptance Criteria (MAC) is permitted when IRM SERVICES Engineering and the
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customer (where applicable) have authorized the release provided that:


a) products continue to satisfy the applicable Design Acceptance Criteria (DAC) and/or customer
criteria; or
b) the violated MAC are categorized as unnecessary to satisfy the applicable DAC and/or customer
criteria; or
c) the DAC is changed and the product satisfies the revised DAC and associated MAC requirements.
Concession against API product specification requirements is not allowed for Monogram product.

5.10.4 Customer Notification


IRM SERVICES notifies customers of product not conforming to DAC or contract requirements that
has been delivered. IRM SERVICES also notifies API in the event that the nonconforming product
was monogrammed and does not conform to product specification requirements.
Records of any such notifications are maintained (see 4.5).

5.10.5 Records
Records of the nature of nonconformities and any subsequent actions taken, including concessions
obtained, are maintained (see 4.5).

5.11 MANAGEMENT OF CHANGE (MOC)


5.11.1 General
IRM SERVICES maintains a documented procedure P-QUA-014 - Management of Change - for
management of change (MOC). It ensures that the integrity of the QMS is maintained when changes
to the QMS are planned and implemented.
It identifies the potential risks (see 5.3) associated with the change and any required approvals prior
to the introduction of such changes.
Records of MOC activities are maintained (see 4.5).

5.11.2 MOC Implementation


IRM SERVICES uses the MOC process for any of the following that may negatively impact the quality
of the product:
a) changes in IRM SERVICES’s structure (see 4.3.2);
b) changes in key or essential personnel (see 4.3.2);
c) changes in critical suppliers (see 5.6.1); and/or
d) changes to the QMS procedures, including changes resulting from corrective and preventive
actions (see 6.4).
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5.11.3 MOC Notification


IRM SERVICES notifies relevant personnel, including the customer when required by contract, of the
change and residual or new risk due to changes that have either been initiated by it or requested by
the customer.
6 QMS MONITORING, MEASUREMENT, ANALYSIS, & IMPROVEMENT
6.1 GENERAL
IRM SERVICES maintains a documented procedure P-QUA-009 - Measuring and Monitoring
Customer Satisfaction Process and Product - to define plans and implements the monitoring,
measurement, analysis, and improvement processes needed to ensure conformity of the QMS to the
requirements of this Quality Manual and to continually improve the effectiveness of the QMS.
QMS monitoring, measurement, analysis, and improvement include determination of applicable
methods including techniques for the analysis of data and the extent of their use.

6.2 MONITORING, MEASURING AND IMPROVING


6.2.1 Customer Satisfaction
IRM SERVICES maintains a documented procedure P-QUA-009 - Measurement and Monitoring of
Customer Satisfaction, Processes and Products - to measure customer satisfaction. This
procedure addresses the frequency of measurement, method of obtaining customer feedback, Key
Performance Indicators (KPIs), and other information that it used to determine whether it has satisfied
customers in meeting identified requirements.

6.2.2 Internal Audit


6.2.2.1 General
IRM SERVICES maintains a documented procedure P-QUA-004 - Internal Audit - to define
responsibilities for planning, conducting, and documenting internal audits. These audits verify that the
QMS is effectively implemented and maintained and conforms to the requirements of this Quality
Manual, applicable API Specifications and ISO 9001 to supporting QMS documentation. The planning
of internal audits takes into consideration the results of previous audits and criticality of the process
being audited.
IRM SERVICES identifies the audit criteria, scope, frequency, and methods to ensure that all
processes of the QMS are audited at least every twelve months.
Outsourced activities that impact the quality of the product and that are performed at IRM
SERVICES’s facility are included as a part of the internal audit.

6.2.2.2 Performance of Internal Audit


Audits are performed by competent personnel (see 4.3.2.2) independent of those who performed or
directly supervised the activity being audited to ensure objectivity and impartiality of the audit process.
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Records of the audits provide objective evidence that the QMS is implemented and maintained (see
4.5).
All processes of the QMS required to meet the specifications of API Q1 and ISO 9001 and any other
applicable specifications are audited prior to claiming conformance to the requirements of these
specifications.
Product specification requirements may be embedded throughout the QMS processes and audited in
conjunction with one or more QMS processes.
6.2.2.3 Audit Review and Closure
IRM SERVICES identifies response times for addressing detected nonconformities in accordance with
the corrective action documented procedure. The management responsible for the area being audited
ensures that any necessary corrections and corrective actions follow the requirements of 6.4.2. The
results of internal audits and status of corrective actions are reported in the Management Review (see
6.5). Records of internal audits are maintained (see 4.5).

6.2.3 Process Evaluation


IRM SERVICES uses the internal audit and management review processes to evaluate the ability of
the QMS processes to achieve planned results, including conformity to product requirements. When
planned results are not achieved, corrective action is taken (see 6.4.2), as appropriate.

6.3 ANALYSIS OF DATA


IRM SERVICES maintains a documented procedure P-QUA-006 - Critical Analysis by Top
Management - for the identification, collection, and analysis of data to demonstrate the suitability and
effectiveness of the QMS. The analysis includes data generated from monitoring and measurement,
internal audits (see 6.2.2), management reviews (see 6.5), and other relevant sources.
The data analysis output provides information relating to:
a) customer satisfaction (see 6.2.1);
b) conformity to product 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 (see 5.10);
d) characteristics and trends of processes and products including opportunities for preventive
action (see 6.4.3);
e) supplier performance (see 5.6); and
f) quality objectives (see 4.1.3).
IRM SERVICES uses data to evaluate where continual improvement of the effectiveness of the QMS
can be made.

6.4 IMPROVEMENT
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6.4.1 General
IRM SERVICES continually improves the effectiveness of the QMS through the use of the quality
policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and
management review.

6.4.2 Corrective Action


IRM SERVICES maintains a documented procedure P-QUA-005 - Corrective and Preventive
Actions - to correct nonconformities and to take corrective actions, both internally and within the
supply chain, to eliminate the causes of nonconformities in order to minimize the likelihood of its
recurrence. Corrective actions are appropriate to the effect(s) of the nonconformity encountered.
Corrective action can apply to both QMS processes and nonconforming product trends.
This procedure identifies requirements for:
a) reviewing a process nonconformity (including customer complaints);
b) determining and implementing corrections;
c) identifying the root cause of the nonconformity and evaluating the need for corrective actions;
d) implementing corrective action to reduce the likelihood that a nonconformity recurs;
e) identifying the response time and responsible person(s) for addressing immediate correction,
root cause analysis, and corrective action plan;
f) verification of the effectiveness of the corrections and corrective action taken; and
g) MOC (see 5.11) when the corrective actions require new or changed controls within the QMS.
The implementation of corrective actions includes the treatment of customer complaints and non-
compliant service reports.
Records of the activities for control of a nonconforming process are maintained (see 4.5). Records
identify the objective evidence used to reach a conclusion of effectiveness of the corrective actions
taken.

6.4.3 Preventive Action


IRM SERVICES maintains a documented procedure P-QUA-005 - Corrective and Preventive
Actions - to determine and implement preventive actions, both internally and within the supply chain,
to eliminate the causes of potential nonconformities in order to minimize the likelihood of their
occurrence. Preventive actions are appropriate to the effect(s) of the potential problems.
Preventive action can apply to both QMS processes and product analysis.
This procedure identifies requirements for:
a) identifying opportunities for improvements;
b) identifying a potential nonconformity and its potential cause(s);
c) evaluating the need for preventive action, including any immediate or short term action required, to
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prevent occurrence of a nonconformity;


d) identifying the timeframe and responsible person(s) for addressing the immediate containment, root
cause analysis, and preventive action plan;
e) reviewing the effectiveness of the preventive action taken; and
f) MOC (see 5.11) when the preventive action requires new or changed controls within the QMS.
Records of the activities for control of potential process nonconformities are maintained (see 4.5).

6.5 MANAGEMENT REVIEW


6.5.1 General
IRM SERVICES’s QMS is reviewed at least every twelve months by its management to evaluate the
QMS’s continuing suitability, adequacy, and effectiveness. This review includes assessing
opportunities for improvement and the need for changes to the QMS, including the Quality Policy and
Quality Objectives, as describe in P-QUA-006 - Management Review.

6.5.2 Input Requirements


The input to Management Review includes:
a) effectiveness of actions resulting from previous Management Reviews;
b) results of audits (see 6.2.2);
c) changes that could affect the QMS, including changes to legal and other applicable
requirements (such as industry standards);
d) analysis of customer satisfaction, including customer feedback (see 6.2.1);
e) process performance;
f) results of risk assessment (see 5.3);
g) status of corrective and preventive actions (see 6.4.2 and 6.4.3);
h) analysis of supplier performance (see 5.6);
i) review of the analysis of product conformity, including nonconformities identified after delivery or
use (see 5.10); and
j) recommendations for improvement.

6.5.3 Output Requirements


The output from the Management Review includes a summary assessment of the effectiveness of the
QMS. The assessment also includes any required changes to the processes and any decisions and
actions, required resources, and improvement to products in meeting customer requirements (see
5.11).
Top management reviews and approves the output of Management Reviews. Management Reviews
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are documented and records of these reviews are maintained (see 4.5).

7. API MONOGRAM / MARKING


IRM SERVICES will establish API marking procedure as soon as applicable API Specifications are
approved and certified.
7.1 RESPONSIBILITY
7.1.1 Top management has appointed the Management Representative who, regardless of other
responsibilities, has the authority and responsibility for establishing, implementing, and maintaining
the API Monogram in accordance with API Specification Q1 and applicable API Specification
requirements
7.1.2 The Management Representative is responsible for monitoring IRM SERVICES’s conformance
with both API Specification Q1 and ANNEX A.

7.2 RECORDS
7.2.1 Documentation required for applicable API Specifications product compliance is maintained for
a minimum of ten (10) years following date of manufacture and/or the period specified contractually.
7.2.2 IRM SERVICES maintains a current design package for all the applicable products that fall
under the scope of monogram license. These design packages are available to API Representatives
upon request.
7.2.3 Newly manufactured products are identified by serial number, batch number, job number, or
other forms of identification as specified in the API Specifications or as appropriate to the newly
manufactured product. The listing also includes a description of the newly manufactured product and
the date of manufacture. The file is made available to API Representatives upon request.
7.2.4 Records supporting the effective operation of the IRM SERVICES’s QMS are maintained for a
minimum of ten (10) years.

8. REGISTER
8.1 Not applicable.

9. APPENDIX
9.1 Not required.

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