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Quality and Environment Manual

Quality and Environment Manual


Revision N 28

Validity: December 2018

VALVES

Revisión Fecha de revisión: Prepared by : Approved by:

15/12/2018
28

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Quality and Environment Manual

Contenido

Chapter 0: Changes in relation to the previous version. ........................................................... 3


Chapter 1: Presentation of Valmec S.A. ...................................................................................... 3
1.1 Review of the company ...................................................................................................... 3
1.2 Scope of the quality management system .......................................................................... 4
1.3 Context of the Organization. .............................................................................................. 4
1.4 Leadership ......................................................................................................................... 4
Chapter 2: Functional structure and processes ......................................................................... 5
2.1 Functional organization chart ............................................................................................. 5
2.2 Description of the processes of the quality management system ....................................... 6
Chapter 3: Documentation requirements .................................................................................... 7
3.1 Documentation requirements ............................................................................................. 7
Chapter 4: Management responsibility ....................................................................................... 9
4.1 Commitment of management ............................................................................................. 9
4.2 Focus on the client ............................................................................................................. 9
4.3 Integral Policy .................................................................................................................... 9
4.4 Planning............................................................................................................................. 9
4.5 Responsibility, authority and communication.................................................................... 10
4.6 Review of the SGI ............................................................................................................ 10
Chapter 5: Resource management ............................................................................................ 11
5.1 Provision of resources ..................................................................................................... 11
5.2 Human resources............................................................................................................. 11
5.3 Infrastructure.................................................................................................................... 11
5.4 Work environment ............................................................................................................ 11
Chapter 6: Realization of the product........................................................................................ 12
6.1 Planning the realization of the product ............................................................................. 12
6.2 Processes related to the client ......................................................................................... 12
6.3 Design and development ................................................................................................. 13
6.4 Purchasing ....................................................................................................................... 15
6.5 Production ....................................................................................................................... 16
6.6 Monitoring of tracking and measuring devices ................................................................. 18
6.7 Processes that require validation ..................................................................................... 18
Chapter 7: Measurement, analysis and improvement .............................................................. 19
7.1 General ............................................................................................................................ 19
7.2 Monitoring and measurement .......................................................................................... 19
7.3 Control of nonconforming product .................................................................................... 20
7.4 Data analysis ................................................................................................................... 21
7.5 Improvement .................................................................................................................... 21
Chapter 8: Procedures of the quality and environmental management system .................... 23

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Chapter 0: Changes in relation to the previous version.

The whole quality manual is adapted to incorporate requirements of ISO 14001: 2015 and to unify
the quality management system with the environmental one

Main changes

1.1 Company review


2.1 Functional organization chart

Chapter 1: Presentation of Valmec S.A.

1.1 Company review

Valmec S.A. is a company created in 1977 as a family business which, in the course of time has
incorporated professionals that currently form part of a team highly specialized in the design and
manufacturing of ball valves.
It began its industrial activity producing three-piece forged bronze ball valves, and currently
assigns its production capacity to the production of:

¼" to 18" normal way or full way ball valves:


series 800, 1500 and 2500 with threaded ends and welding ends
flanged valves series 150, 300, 600, 900, 1500 and 2500 RF, FF y RJ
½” to 4” integral valves.
Butterfly valve S150: 2”,4”,6”,8”, 10” y 12”.
Retention valves: 2”, 4”, 6”, 8”. Series 150, 600 and series 800 with threaded ends.
Bridge sets injections wellhead, measurement and production for the petroleum industry.
Valve drivers with reduction boxes
.

Also manages the marketing and sales of pneumatic and electrical actuators, accessories for
automation and the marketing and sales of butterfly valves, duo-check, globe, and needle retention
valves.

The Valmec valves are manufactured in accordance to API, ASME, ANSI and BSI international
standards, in carbon steel , stainless steel and bronze (as standard production), and in accordance
to international standards for ASTM materials. They are also manufactured to meet other
standards in other materials depending on the orders issued by customers, In agreement with
contract requirements or, for special purposes.

The specific design of these valves allows their use in most applications. Currently, Valmec S.A.
operates both, in the international and domestic market.

Valmec counts with a staff of around 90 people and also has important computerized numerical
control equipment which, together with the conventional equipment, reaches an installed power
capacity of around 1.600 HP.

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1.2 Scope of the quality management system

Comply with both quality and environmental requirements to:

Design, production, and sales of ball valves, retention valves, butterfly valves and kit
production for the petroleum industry. It also includes the technical assistance for these
products.

Sales and technical support in terms of butterfly valves, gate valves, globe, needle and
retention valves; and also in terms of components for automation, control and valve
complementation.

There are no exclusions to any international ISO 9001:2015/14001:2015 standards.


Additionally, the requirements specified in ANSI/API Q1, ninth edition, June 2013 have also been
considered.

1.3 Context of the Organization.

Comprensión de la Organización y su contexto.

Valmec S.A. determines the external and internal issues that are relevant to your
Scope and its strategic direction and that affect its ability to achieve the expected results by
monitoring and reviewing all available information. It is carried out annually as minimum and the
result is recorded in the forms F102 "Contexto" and F103 "Partes interesadas".

1.4 Leadership

Leadership and commitment

The top management maintains its commitment to the Integral Management System and its
continuous improvement, expressed in its Integral policy, also ensures that all necessary resources
are available and allocated to satisfy the client's requirements, normative, legal and regulatory.
Top management, based on the Integral Policy, establishes the quality and environmental
objectives that are communicated to the rest of the organization.
Promotes and constantly communicates the importance of risk-based thinking and the results of
the objectives through various channels, such as meetings in the company, internal
communications, billboards, etc.
At least annually the SGI review is carried out, which is kept in a meeting minutes signed by all the
participants.
The management ensures that the requirements of the SGI are integrated into the business
processes of the company and that these are developed in accordance with those requirements

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Chapter 2: Functional structure and processes

2.1 Functional organization chart

Valmec S.A. It is structured and organized according to the diagram of the organization presented
below:

FUNCTIONAL ORGANIZATIONAL CHART AND ALLOCATION OF RESPONSIBILITIES

PRESIDENT

Leandro Tercic

MANAGMENT
REPRESENTATIVE

Gustavo Battagliero

MAN. ENSAMBLED AND


MAN. INTEGRAL SISTEM MAN. ENGINEERING MAN.MACHINIG MAN. PURCHANSING MAN. SALES MAN. ADMINISTRATION MAN. MAINTENANCE
TESTED

Gabriel Garaventa Pablo Muñoz G.Battaglier (interino) Carlos Cháves David Ybañez Daniel Zappala Daniel Caminos Ricardo Mainardi

AUX ENSAMBLED M.CANO Aux Mantenimiento


AUX ENGINEERING AUX MACHINIG
MAN. STOCK MAN. RRHH A.GRINSBERG
MAN. QUALITY CONTROL P.MASSUTTI AUX ENSAMBLED A.CASTAGNOLA
Lui s Ga una Dario Barrios
J.NAVARRO V.TERRAZAS

MAN . DISPACH A.FIGUEROA

Obs Rev DATE

05 DECEMBER 2018
ELABORATE APPROVED BY

Note: The organization maintains in an updated form an organization chart that indicates the
identity of the members that occupy each one of the positions in the organization.

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2.2 Description of the processes of the quality management system


The following graphic shows the processes identified as necessary for the integral management
system. They have been established respecting the requirements and guidelines of ISO 9001:
2015, API Q1 9th and 14001: 2015.

FLOW CHART
CUSTOMER (REQUIREMENTS)

MANAGEMENT REVIEW

RESOURCE MEASUREMENT AND


MANAGEMENT CONTINUAL MONITORING
IMPROVEMENT

CUSTOMER
SALES / REVISION OF AGREEMENT SATISFACTION
SURVEY

PLANNING DESIGN INTEGRAL MANAGEMENT

SUPPLIERS WASTE QUALITY


SUPPLIERS

PURCHASE ASSESSMENT MANAGEM CONTROL


ENT

RECEPTION PRODUCTION ASSEMBLY TESTING DELIVERY

MAINTENANCE

PROCESSES THAT REQUIRE VALIDATION


-END
-WELDING
-SURFACE TREATMENT ENP
ASSESSMENT OF
SUPPLIERS
INTEGRAL MANAGEMENT FOLLOW UP/ MEASUREMENT OF PRODUCTS / PROCESSES

FLOW OF PRODUCTS AND MAIN PROCESSES


FLOW OF DATA AND INFORMATION AND SECONDARY PROCESSES

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Chapter 3: Documentation requirements


A quality management system has been established, documented and implemented in accordance
with the guidelines of the ISO 9001: 2015 standard and the API Q1 Ninth Edition specification and
an environmental management system in accordance with the guidelines of the ISO 14001: 2015
standard. .
The processes, their sequence and interaction have been identified and the criteria and methods of
monitoring, control, measurement and analysis of these processes have been established to verify
that the planned results are achieved and to continuously improve their operation and
effectiveness.
The necessary resources for the operation and control of the processes are evaluated, established
and facilitated.

3.1 Documentation requirements

The documentation related to the environmental management system is as follows.

Declaration of the integral policy (of the quality and environment): Stated by the direction and
periodically revised for its adaptation.

Comprehensive objectives: Describe, according to the quality and environmental policy, the
goals (in this case environmental) that the organization intends to achieve over time.

Quality and Environment Manual: Describes the quality management system of Valmec S.A.

General (PG), quality (PGC) and environmental (PGA) procedures: Describe how activities,
tasks and responsibilities are carried out.

Third level documentation: Includes work instructions, operational guides, plans, standards,
specifications, manufacturing plans, inspection and testing, specific plans, and any other
documentation, linked to general procedures, quality, environment and containing requirements
specific to operate, control, evaluate and improve the processes achieved by the integral
management system.

Registries: Generated by the integral system and intended to demonstrate compliance, control
and / or measurement of processes.

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3.1.2 Quality and Environment Manual

This Manual describes the quality and environmental management system of Valmec S.A.
It is approved by the representative of the management of Valmec S.A. and controlled by the
person in charge of integral management, according to the procedure of control of documents and
data.
3.1.3 Control of documents

The documents of the environmental management system are controlled by documented


procedures that ensure their availability in the sectors where they are used and in the current
revisions, while the obsolete editions are removed from circulation.
The control includes the maintenance of controlled copies through control and distribution lists. The
checklist lists, for each type, the totality of the documents that make up the integral management
system in its current revision status.
The preparation, review, approval, issuance and updating of the documents originated in the
organization is in charge of trained members and defined in the documented procedures.
It is ensured that the changes in the documents of the management systems are reviewed and
approved by the same managers who made their revision and approval originally.
The organization ensures that documents are always legible and easily identifiable
The external documentation (standards, specifications and others) is controlled through
documented procedures that ensure its use in its updated revision and its availability in the places
of use, in legible and identifiable conditions.
The changes made to the documents are recorded, allowing an easy appreciation of the
modifications made.
Control of obsolete documents is maintained by removing them from their places of use or by
destroying them to prevent unintentional use, or by appropriately identifying them when they must
remain available for any purpose.

3.1.4 Control of records

Documents are established to identify, store, protect, recover, maintain and dispose of the records
related to management systems.
The organization identifies, develops and maintains the necessary forms for the effective operation
of its management systems, which are accessible to users in the type of support suitable for their
use.
As a result, records, data, and all information related to the environment, perfectly identified, are
maintained to demonstrate that the established requirements have been met and that the quality
management system and the environment management system are effective.
The forms in which the records are supported have been coded and classified in order to facilitate
their identification and location, and are available to the client within the established period. During
this period, established in each of the procedures that give rise to it, the records remain archived,
after the deadline is eliminated according to the procedures.
The support used for the proper maintenance of the records is paper and / or magnetic records,
the latter with backup copies made periodically.
Documented procedures identify the functions responsible for completing and maintaining records
as well as file conditions.
Two instances of file are established, the file itself in which the record is kept in the place of origin
or use and in accessible form, and the retention that, for physical reasons, can be done in different
places and whose disposition can be then immediate or not.
The records required by the applicable industry standards or that provide evidence of compliance
with the requirements of the product or its manufacture, must be kept for a minimum of ten or as
indicated by those standards, whichever is greater.
The minimum retention time of the records that provide evidence of compliance with the
requirements and the effective operation of the quality management system is ten years or
permanent
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Chapter 4: Management responsibility

4.1 Commitment of management


The top management of Valmec S.A. is fully committed to the development, implementation and
continuous improvement of management systems. For it:
• Permanently communicates to all members of the organization about the importance of customer
satisfaction and reduce environmental risks,
• Establishes the comprehensive policy and reviews its adequacy,
• Ensures that the general objectives of quality and environment are established,
• Reviews the quality and environmental management systems periodically to assess their
adequacy, consistency and effectiveness,
• Ensures the availability of resources.

4.2 Focus on the client

The top management of Valmec S.A. verifies and ensures that the requirements of customers are
met, while transmitting to the members of the company the need to achieve and increase customer
satisfaction.

4.3 Integral Policy

The top management of Valmec S.A. defines the integral policy, verifies that it incorporates the
need to comply with the requirements, which points to the continuous improvement of the
management systems and that is the most appropriate for the purpose of the organization.
It is ensured that the comprehensive policy provides a frame of reference to establish and review
the objectives of both systems.
The top management of Valmec S.A. communicates the policy to all levels of the company, making
sure it is understood, and periodically reviews it to ensure its adequacy.
The integral policy of Valmec S.A is published as "Declaration of top management" and its
approval is evidenced by the signature of the head of the organization, at the foot of the document.

4.4 Planning

4.4.1 Integral Objectives

The top management of Valmec S.A. defines the general objectives of quality and environment
and ensures that intermediate, measurable, adequate and compatible objectives are established at
the intermediate levels, with the general objectives and with the established overall policy.

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4.4.2 Planning of the integral management system

The top management of Valmec S.A. it is ensured that the planning of the integral management
system is carried out to comply with the requirements of ISO 9001: 2015, and ISO 14001: 2015,
with the additional requirements of the API specification Q1 Ninth Edition, as well as with the
objectives of quality and environment, and that when planning or implementing changes in it, its
integrity is maintained.

4.5 Responsibility, authority and communication

The top management of Valmec S.A. establishes the responsibilities and authority of the
intermediate levels and communicates them to each sector. It also ensures that communications
between the sectors are adequate and effective for the operation of the integral management
system.
In particular, it establishes a management representative who is responsible for the SGI, who
responds directly to senior management and who has defined, among others, responsibility and
authority to:

a) Ensure that the processes necessary for the quality management system and environmental
management system are established, applied and maintained.
b) Inform the management about the course of the quality management system and the
environmental management system and the detected deviations of both systems.
c) Promulgate awareness of compliance with customer requirements and the need to achieve full
satisfaction.

4.6 Review of the SGI


The top management of Valmec S.A. reviews the quality management system and the
environmental management system at least once a year, considering especially the opportunities
for improvement, and including the need to adapt the policy, and the integral objectives and their
monitoring.

The entry information for the review by the top management includes:
a) The results of audits,
b) Customer feedback,
c) The performance of the processes and the conformity of the product, and of the non-
conformities and their trends, including the reports of non-conformities detected after dispatch,
d) The status of corrective and preventive actions,
e) Follow-up actions by previous management,
f) Changes that could affect the SGI, including changes in the rules applicable to the petroleum,
petrochemical and natural gas industry.
g) Recommendations for improvement.
The results of the management review include all decisions related to:
a) The improvement of the efficiency of the management systems and their processes,
b) The improvement of the product in relation to the requirements of the client.
c) The need for resources.

The records used, as well as those resulting from the review by the management, are kept
permanently.

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Chapter 5: Resource management

5.1 Provision of resources

The top management of Valmec S.A. determines and provides the necessary resources to:

• Implement and maintain the IMS and improve its effectiveness continuously, and increase
customer satisfaction by meeting their requirements.

For this, those responsible for the intermediate levels identify and establish the needs of each
sector and keep the management informed, who ensures that the necessary resources are
available in a timely manner.

5.2 Human resources


The organization ensures that personnel who perform tasks that affect compliance with product
requirements or that have an impact on the performance of the quality management system
processes, are competent based on their education, training, skills And experience.
Those responsible for all sectors determine, based on the profiles to be met, the level of
competence of the personnel and training needs or any other action to achieve the necessary
competence in their work. Training is provided in the workplace, to new personnel, or when an
activity that has an impact on the quality of the product is modified.
The actions necessary to meet the training and personnel training needs are planned annually, and
the effectiveness of their results is evaluated. The records that provide evidence of the planning of
these actions, of the evaluation of their effectiveness, and of the education, training, skills and
experience reached are kept.
Through dissemination, induction, and other communication actions, which are given by the
management, the IMS responsible and those responsible for the different sectors, it is ensured
that the staff is aware of the relevance and importance of their activities, how they contribute to the
achievement of the integral objectives, and the consequences of non-compliance with the
requirements of the clients.

5.3 Infrastructure
Both the management and those responsible for each of the sectors determine the needs of
infrastructure, buildings, equipment and services. In accordance with these needs and taking into
account priorities and availability, management provides the most appropriate infrastructure.

5.4 Work environment


The work environment necessary to achieve compliance with the product requirements is
determined and managed. A competent security and environment service periodically evaluates
the conditions of the work environment according to the current regulation and taking into account
the needs of the organization, actions are taken on the observed deviations.

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Chapter 6: Realization of the product

6.1 Planning the realization of the product


The management of Valmec SA, and those responsible for integral management, engineering,
manufacturing and assembly, plan and develop the necessary processes for the realization of the
product according to the integral policy, attending to the needs of the other processes of the
management system of the quality and the environmental management system.
The planning takes into account the quality objectives and the requirements and specifications of
the products.
During planning, it is determined:
• Needs for product documentation and production processes,
• Resource needs for production,
• Processes that due to their characteristics require prior validation,
• Verification, inspection and testing needs.
• The data that should be recorded as evidence of monitoring during production and the most
appropriate way to do so.
When the product requirements come from an external source, there are documented procedures
that are applied to ensure that these requirements are incorporated into the product's realization
process.

6.2 Processes related to the client

6.2.1 Determination of requirements related to the product


The organization determines:
a) the requirements specified by the client, including those applicable to the delivery and
subsequent to it (such as guarantees, assistance for installation or use, maintenance, etc.),
b) the requirements that, without being established by the client, are necessary for the specified or
foreseen use, provided this is known,
c) the legal and regulatory requirements applicable to the product and the environment, and
d) any additional requirements that the organization considers necessary.

6.2.2 Review of requirements related to the product


The organization reviews the requirements related to the product before the acceptance of a
contract, in order to ensure that:
a) the product requirements are defined,
b) the differences between the contract requirements and those previously defined were resolved,
and the organization has the capacity to comply with the defined requirements.
There are documented procedures to review the product requirements and records of the review
and the actions that derive from it are kept.
It is ensured that the requirements that have not been documented by the client are confirmed
before accepting the contract.

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Changes in requirements are kept under control after accepting a contract, reviewing them again,
modifying the relevant documentation and informing all involved.

6.2.3 Communication with the client


The organization implements, through documented procedures, effective arrangements to
establish communication with customers in relation to:
a) Information about the product,
b) queries, contracts or order attention, including modifications, and
c) Customer feedback, including their complaints.

6.2.4 Services
The only services that Valmec offers are for the repair of complaints or claims from customers who
are in the warranty period. Process information for product repair is found in the procedures

6.3 Design and development


The organization carries out the design and development of the product in accordance with
documented procedures, and the entry data, the activities executed and the results of them are
recorded.
6.3.1 Design and development planning
The organization plans and controls the design and development of the product. The planning
allows to determine:

a) the stages that the design and development must meet,


b) the revision, verification and validation that will be applied in each stage, and
c) the responsible parties who will intervene in each one.

Effective communication is ensured among the responsible parties involved in the design and
development and a clear assignment of responsibilities.
As the design and development progresses, the results of the planning are updated, and
compliance is verified, taking the necessary actions in case of deviations.
The design documentation includes the methods, assumptions, formulas and calculations that are
used during the design.
6.3.2 Input elements of the design and development
The input elements related to the product requirements are determined, which include:
a) functional and performance requirements,
b) the applicable legal and regulatory requirements,
c) when possible, information from previous similar designs, and
d) any other essential requirement for the design and development.
The input elements are checked to verify that they are adequate, complete, and do not contain
ambiguities or contradictions.
The design requirements of the product are identified, documented and reviewed and, when
appropriate, the requirements specified by the client are also included.

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Records of the input data are kept.


6.3.3 Design and development results
The results of the design and development are provided in an appropriate manner for the
verification with respect to the input elements and are approved before their release.
It ensures that the results of the design and development:
a) meet the requirements of the input elements,
b) provide adequate information for the purchase and production,
c) make reference to the acceptance criteria of the product,
d) specify the characteristics of the product that are essential for safe and correct use, and
e) are documented properly and in an appropriate manner.

6.3.4 Design and development review


As planned, the design and development is systematically reviewed at the appropriate stages, to:
a) assess the ability to meet the requirements, the design and development results, and
b) identify any problem and propose the necessary actions.
The reviews involve representatives of the functions related to the stage (s) of the design and
development being reviewed, and records are kept of both the results of the reviews and any
action taken.
A final design review is carried out whose results are documented. It is ensured that the people
who review and approve the final design, are not the same people who have developed the design.

6.3.5 Verification of design and development


The design and development verification is carried out as planned to ensure that its results meet
the requirements of the input elements. Records of the verification and any action that is necessary
are kept.

6.3.6 Design and development validation


As planned, validation is performed to ensure that the resulting product is capable of satisfying the
requirements for its specified application, or, where known, of the intended use. Where possible,
the validation is carried out before the delivery or implementation of the product. Validation records
and any action derived from it are kept.
In general, validation through one or more of the following ways:
a) tests and tests in the Valmec plant, according to standards, functional and / or operational tests
on prototypes or on production pieces
b) tests established by industrial standards or regulations or applicable regulatory requirements, by
sending samples to external product certification laboratories.
c) in special products designed and developed at the request of the customer, and when possible,
the assembly, maintenance, performance and durability characteristics of the design can be
validated through in-service evaluation carried out by the client or by Valmec personnel in the
facilities of that one.
6.3.7 Control of design and development changes

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Changes in design and development, including changes in design documents, are made under the
same controls and design documentation of the original design and development.
Changes in design and development are identified and recorded appropriately. The changes are
reviewed, verified and validated, as appropriate, and approved before their implementation. The
revision of the changes includes the evaluation of the effect of the changes in the constituent parts
and in the product.
Records are kept of the results of the revision of the changes and of any action that may be
necessary.

6.4 Purchasing
6.4.1 Purchasing process
It ensures that the product or service purchased meets the specified purchase requirements. To
this end, a type and degree of control of the supplier and the product or process purchased is
established based on the impact that this product or service has on the subsequent realization of
the product and the final product.
Suppliers are evaluated and selected based on their ability to supply products and services in
accordance with the requirements of Valmec S.A. There are documented procedures and
established criteria for selection, evaluation and re-evaluation, and records of evaluations and any
necessary action are maintained.
The criteria for the selection, evaluation or re-evaluation of the suppliers can be one or more of the
following:
a) Final inspection of the product supplied by the supplier in its facilities.
b) Final inspection of the product supplied by the supplier after dispatch.
c) Follow-up of the supplier's compliance to satisfy the requirements of Valmec S.A.
d) Verification of compliance with recognized international standards of the supplier's quality
management system.
In case Valmec chooses to contract externally any process that affects the conformity of the
product with the requirements, it makes sure to control such processes.
When a process is subcontracted, Valmec maintains the responsibility for product compliance.
When a process that requires validation is purchased from a supplier, Valmec requires compliance
with this requirement to its supplier to the extent applicable.
6.4.2 Purchasing information
For products or services established as having a relevant impact on the quality of the final product,
purchase orders reviewed and approved by competent personnel are prepared.
The purchase order, in addition to describing the product to be purchased, when appropriate,
includes (or refers to):
a) the type, class, grade or other precise identification,
b) the title or any other positive identification, and the applicable edition of specifications, drawings,
process requirements, inspection instructions and any other relevant technical data,
c) the requirements for the approval of the product or service, procedures, processes and
equipment.
d) the requirements for the qualification of the personnel, and
e) the requirements of the quality management system.
It ensures that the specified purchase requirements are adequate before communicating them to
the supplier.
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6.4.3 Verification of purchased products


The purchased products are inspected in accordance with the applicable procedures, plans and
instructions to ensure they meet the specified purchase requirements. Records of the verification of
the purchased product are kept.
If Valmec S.A. or your client wants to carry out the verification at the supplier's plant, the purchase
order establishes the provisions for such verification and the method to release the product.

6.5 Production
6.5.1 Production control
The manufacturing and assembly processes are planned and carried out under controlled
conditions. These controlled conditions include:
a) the availability of information describing the characteristics of the product (plans),
b) the availability of instructions when necessary (instructions or specific procedures),
c) the use of appropriate equipment,
d) the availability and use of monitoring and measuring equipment,
e) the implementation of monitoring and measurement, and
f) the implementation of the release of the product in the appropriate stages of production.
The control of the processes is described in documented form in the procedures and work
instructions, operative work guides and plans of manufacture, inspection and tests; they establish
the requirements for verification and compliance with quality plans, specific requirements of
customers, control procedures, inspection and testing and those of applicable standards.
Process control documents refer to applicable instructions, qualification of the workforce and
acceptance criteria for processes, tests, inspections, and customer inspections.
6.5.2 Validation of production processes
The production processes are validated to demonstrate their ability to achieve the planned results,
in the following cases:
a) when the resulting products can not be verified by subsequent monitoring or measurement and
deficiencies may appear when the product is being used,
b) when it is established in the applicable product specifications that they require validation, and
c) when validation is appropriate, even if it is not specified or if there is no applicable product
specification, at least it applies to welding processes, heat treatment, and inspection through non-
destructive tests, if any of them is applicable to the product.
The validation demonstrates the ability of the processes to achieve the planned results.
The organization establishes provisions for these processes that include, when applicable:
a) Defined criteria to review and approve the processes,
b) The approval of equipment and the qualification of the personnel, the use of specific methods or
procedures,
c) The requirements of the registers, and
d) Revalidation.

6.5.3 Identification and traceability


The products are identified, by appropriate means in the reception, during all its realization and
until the delivery to the client.
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It has an identification system through cards and cards of different colors that also allow to
determine the state of inspection and testing of materials, components and / or products during the
different stages of its realization. In some of these stages, the product is marked to show its status
in accordance with the requirements.
For those components and products that have been defined as traceable, batch identification is
also applied, which, through appropriate records, allows to relate the serial number of the products
with their compliance data of the product requirements and the monitoring of the process , even
raw materials.
There are documented procedures to ensure the identification and traceability from the reception,
during all the stages of the realization and until the dispatch, according to the own requirements of
the organization, those of the clients and the applicable of the specifications of the product. These
procedures establish the methods for marking, maintenance, replacement and registration of
identification and traceability.
The finished product is identified according to documented procedures and, where they exist, to
the requirements of the applicable standards (for example: API 6D point 13). In the products in
which the license for the use of the API monogram is held, the identification also includes said
monogram, the license number and the date of manufacture (month and year of production).
The assembling chief under the control of the integral management manager is the one who must
apply the corresponding identification to the product under API monogram in those products where
said identification corresponds.
There are procedures to carry out in a controlled manner the removal of the API monogram from
those products found not in compliance with some of the requirements applicable in the API 6D
standard. The removal of the API monogram is executed under the responsibility and control of the
Integral Management Manager.
6.5.4 Client property
Valmec S.A. ensures, through documented procedures, that the goods owned by the client are
cared for while they are under their control or use. The materials and parts supplied by the
customer that are used in the provision of products that are manufactured and / or assembled at
Valmec for the customer itself, or products that enter the plant due to claims or repair and must be
returned to the customer, are identified , they are verified, stored, protected and safeguarded, and
controlled by methods similar to those used with our own products.
The procedures also include records of any damage or loss suffered by the product supplied by the
customer, or its ineptitude for the specified or intended use, communication to the customer and
record keeping.
6.5.5 Preservation of the product
The product is preserved, through documented procedures, during the internal process and
delivery to the intended destination, in order to maintain compliance with the requirements.
The procedures establish the methods to preserve the conformity of the product and its constituent
parts during identification, handling, packaging, storage and protection.
Evaluations of stored parts and products are carried out, at established intervals, to check their
conformity status and detect deteriorations or transgressions to established methods that could
cause damage or loss of quality.

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6.6 Monitoring of tracking and measuring devices


The monitoring and measurement to be carried out and the monitoring and measuring equipment
necessary to provide the evidence of the conformity of the product with the determined
requirements are determined.
It is ensured that monitoring and measurement are carried out in a manner consistent with the
monitoring and measurement requirements.
In order to ensure the validity of the results, there are documented procedures for:
a) calibrate and / or verify, as appropriate, the measurement equipment, at specified intervals or
before use, for which there is a list of equipment where the valid frequency for each one is
established based on its metrological characteristics, mode of use and measurement
requirements;
b) adjust or readjust them as necessary;
c) identify them in order to determine their calibration status;
d) protect them against undue interventions or adjustment changes that may invalidate the result of
the measurement;
e) establish, through documented procedures, the method to manipulate, maintain and store them
in order to prevent damage or deterioration, and the appropriate environmental conditions for these
activities and for their use.
If, during the verification, a device is found to be not in compliance with the requirements, the
previous measurements made with said equipment are verified and validated, and appropriate
actions are taken on the equipment and on the affected products, including communication to the
customer if it is suspected that a product dispatched may be non-conforming as a result of this
condition.
For internal calibrations, documented procedures are used that establish the verification methods
and the acceptance criteria of the measuring equipment, or refer to the applicable specifications.
These are carried out with the established frequency, using certified equipment calibrated
externally and traceable to recognized national or international standards, and under appropriate
environmental conditions.
As far as possible, external calibrations are carried out in laboratories or agencies that have the
proper certification of compliance with procedures under ISO 17.025 or similar, depending on the
type of instrument or equipment to be verified.
Records are kept of the calibration and / or internal verification, and certificates from external
calibrations, including if the qualification of equipment and personnel corresponds and the
traceability of the patterns used. In the records of each team consists the description of the
equipment, its individual identification, its location or destination, the frequency of verification and
the type of verification or calibration performed.

6.7 Processes that require validation


In cases where processes that require validation are involved in production, the requirements of
the API Q1 Ninth Edition standard must be followed, including those processes within the control of
the quality management system.

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Chapter 7: Measurement, analysis and improvement

7.1 General
Valmec S.A. plan, implement and determine the applicable methods in the monitoring,
measurement, analysis and improvement processes necessary to:
a) Demonstrate compliance with product and environmental requirements
b) Ensure IMS compliance
c) Continuously improve the effectiveness of integral management systems.

7.2 Monitoring and measurement


7.2.1 Customer satisfaction
The information regarding the client's perception with respect to the fulfillment of their requirements
by Valmec S.A.
For this, among other sources of analysis, periodic customer satisfaction surveys are conducted to
find out their opinion about the quality of the delivered product, compliance with their requirements,
the attention received from the organization during the commercial relationship, and suggestions
for the improvement.
The results of the surveys are analyzed and used by management during the review of the quality
management system.
7.2.2 Internal audit
At internal intervals, internal audits are carried out to determine if the quality management system:
a) is in accordance with the planned provisions, with the requirements of ISO 9001: 2015 and ISO
14001: 2015, with the requirements of the API specification Q1 Ninth Edition, and with the
requirements established by Valmec S.A.,
b) has been implemented and maintained efficiently.
An audit program is planned that takes into consideration the status and importance of the
processes and areas to be audited, as well as the results of previous audits. At least each process
and each area is audited once a year.
The audits are carried out with company personnel, independent of the person in charge of the
audited area and according to the scope, methods and criteria established in documented
procedures. Qualified external auditors, hired for this purpose, can also be used.
Internal auditors are selected according to their ability to perform the audit activity, in order to
ensure the objectivity and impartiality of the process.
The documented procedures also define the responsibilities and requirements for planning and
conducting the audits, and establish the records and how to report the results.
The development and results of the audits are recorded and the deviations detected generate the
immediate start of corrections and corrective actions to eliminate nonconformities and their causes,
which are implemented by the person in charge of the audited area.
The response times of the actions taken against the non-conformities detected by the audits are
identified.
Within the established deadlines, the actions taken are verified and the result is recorded.

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7.2.3 Monitoring and measurement of processes


Appropriate methods are applied for the follow-up, and when applicable, the measurement of the
processes of the integral management system, to demonstrate the capacity of these processes to
achieve the planned results.
The management representative and the person in charge of the management systems establish
the indicators of each process of the integral management system that are subject to monitoring or
measurement, according to their impact on the conformity with the requirements of the product and
on the effectiveness of the IMS.
As a consequence of the inadequate functioning of the process, corrections or corrective actions
are carried out to modify or correct the processes so that their correction and improvement allow
achieving the planned results.
7.2.4 Monitoring and measurement of the product
During the reception, manufacturing and assembly processes, inspection, self-control, control and
testing activities of the products are carried out, according to inspection and test plans, to verify
that the specified requirements are met.
The measurement and monitoring of the characteristics of the product is carried out by methods
established in documented procedures.
Records of the conformity of the product with the acceptance criteria are maintained. The records
indicate and retain evidence of the person (s) authorizing the release of the product.
The valves and assemblies are released for dispatch once all the tests and final tests have been
carried out with approved results, and traceability data and tests have been recorded. No product
is released for delivery to the customer before the planned provisions and environmental
requirements have been satisfactorily completed.
It is ensured that the personnel responsible for carrying out the final acceptance inspection of the
product are not the same as those who performed or supervised the production of the products.

7.3 Control of nonconforming product


It is ensured, through documented procedures, that the product that is not in accordance with the
established requirements is properly identified, segregated and controlled to avoid inadvertent use
or the dispatch to the customer by mistake.
The procedures define the responsibility and authority for the treatment of non-conforming
products and their disposition.
The non-conforming product is available in one of the following ways:
a) eliminating the non-conformity, through the scrap provision or the return to the supplier, if
applicable, or the rework to take it within the established requirements,
b) authorizing the use in the state in which it is located, by releasing the pertinent authority, or, if
applicable, the client,
c) taking actions to prevent its originally intended use or application.
d) taking appropriate actions for the certain or potential effects of the nonconformity, if the same is
detected after the dispatch or when it is in use.
The analysis performed to evaluate a non-conforming product and resolve its acceptance, takes
into account that:
a) when a product that does not meet manufacturing acceptance criteria is accepted:
• it must be considered that the product satisfies, nevertheless, the acceptance criterion of the
design,

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• that the violation of the manufacturing acceptance criteria is unnecessary to satisfy the
acceptance criteria of the design, or
• that the product be repaired or reprocessed to meet the acceptance criteria of the design or
manufacture.
b) when a product that does not meet acceptance criteria of the original design is accepted:
• the acceptance criterion of the original design is changed following what is established in 6.3.7,
and
• The materials or products meet the new design acceptance criteria.
When a non-compliant product is corrected, it is checked again to demonstrate compliance with
the requirements.
Records of the non-conforming product are kept after its use began, to ensure that all the available
data of the incident and the nature of the failure that make it possible to determine its cause are
counted.
Records are kept of the nature of the non-conformities and of any action taken subsequently,
including the concessions that have been obtained.
Customers are notified when it is detected that a product not conforming to the acceptance criteria
of the design has been delivered. Records of these notifications are kept.
When a nonconforming product is detected after it has been dispatched or when its use has
begun, the organization takes appropriate actions to the effects or potential effects of the
nonconformity.
The procedures for the treatment of non-conformities of products include the identification,
documentation, registration of field non-conformities or product failures during use, in order to have
evidence that allows their analysis to determine the cause or origin of the product. detour or failure.

7.4 Data analysis


An appropriate series of data has been established, compiled and analyzed to demonstrate the
suitability and effectiveness of the management systems and to assess where the continuous
improvement of their effectiveness can be made. These data include the results of monitoring and
measurement and other relevant sources.
The data analysis provides information about:
a) customer satisfaction,
b) compliance with the product requirements,
c) the characteristics and trends of processes and products, including the opportunities to carry out
preventive actions, and
d) the suppliers.
e) The environmental requirements
There are documented procedures to identify and use different techniques for data analysis.

7.5 Improvement
7.5.1 Continuous improvement
Through the use of the integral policy, the objectives, the results of the audits, the data analysis,
the corrective and preventive actions and the review by the management, the management and
those responsible for each sector, they look for improvements in the processes on a daily basis. of
the IMS.
7.5.2 Corrective action

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Actions are taken to eliminate the causes of nonconformities in order to avoid recurrence. These
actions are appropriate for the purposes of the non-conformities found.
Through doc procedures

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Chapter 8: Procedures of the quality and environmental management system

Referencia en el
Título del procedimiento Código manual de la calidad
y medio ambiente
Control of purchases PGC-C01 6.4.1 - 6.4.2

Assessment of suppliers PGC-C02 6.4.1

6.3 - 6.3.1 - 6.3.2 - 6.3.3 -


Control of design PGC-E01
6.3.4 - 6.3.5 - 6.3.6 - 6.3.7

Management review PG-G01 4.1 - 4.6 – 7.4 – 7.5.1

Control of documents and data PG-G02 3.1 – 3.1.1 – 3.1.2 - 3.1.3

Control of quality records PG-G03 3.1 - 3.1.4

Internal audit PG-G04 7.2.2

Corrective/preventive actions PG-G05 7.5.2

Resources PG-G06 5 - 5.1 - 5.2 - 5.3 - 5.4 – 6.1

Plannig of IMS PG-G07 7.4

Communication internal-external PG-G08 4.5

Machining PGC-P01 6.5 - 6.5.1 - 6.5.2

Assembling PGC-P02 6.5 – 6.5.1

Preservation of product PGC-P03 6.5.5

Maintenance PGC-P04 6.5.1

Production planning PGC-P05 6.1

Inspection and Testing PGC-Q01 6.4.3 - 7.2.4

Nonconforming product PGC-Q02 7.3

Identification and traceability PGC-Q03 6.5.3

Equipment of inspection and testing PGC-Q04 6.6

Sales PGC-V01 6.2 - 6.2.1 – 6.2.2 - 6.2.3

Communication with customer PGC-V02 6.2.1 - 6.2.3

Customer property PGV-V03 6.5.4

Processes that require validation PGC-T01 6.7

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