Manual Calidad
Manual Calidad
Manual Calidad
VALVES
15/12/2018
28
Contenido
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
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:
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.
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.
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
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
Valmec S.A. It is structured and organized according to the diagram of the organization presented
below:
PRESIDENT
Leandro Tercic
MANAGMENT
REPRESENTATIVE
Gustavo Battagliero
Gabriel Garaventa Pablo Muñoz G.Battaglier (interino) Carlos Cháves David Ybañez Daniel Zappala Daniel Caminos Ricardo Mainardi
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.
FLOW CHART
CUSTOMER (REQUIREMENTS)
MANAGEMENT REVIEW
CUSTOMER
SALES / REVISION OF AGREEMENT SATISFACTION
SURVEY
MAINTENANCE
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.
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
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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Quality and Environment Manual
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.
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
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.
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.
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.
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.
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.
5.3 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.
Changes in requirements are kept under control after accepting a contract, reviewing them again,
modifying the relevant documentation and informing all involved.
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
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.
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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Quality and Environment Manual
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.
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.
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.
• 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.
7.5 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
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
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