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QMS Manual Code TG-QMS-MAN001

Level 1 Iss. Date 01/08/2021


Revision 03
Quality Management System Manual Rev. Date 01/11/2022
Page 1 of 50

TECNOGROUP

QMS MANUAL

LEVEL 1
QMS Manual Code TG-QMS-MAN001
Level 1 Iss. Date 01/08/2021
Revision 03
Quality Management System Manual Rev. Date 01/11/2022
Page 2 of 50

This document forms part of the official Quality Policy of TECNOGROUP. It has been
compiled to meet the requirements of API Q1_9th, API 6A_21th, & ISO 9001;2015.

Revision Date History of Changes

00 01/08/2021 A New Document covering the TECNOGROUP Activities


01 01/03/2022 Updating and reviewing the document
• New Document TG-QMS-P027 (QC Personnel Qualifications) covering a
02 20/05/2022 TECNOGROUP Activity.
• Updating and reviewing the document.
• Change Quality Records in clause 4.7.c.
03 01.11.2022
• Change Internal Audit interval in clause 6.3.1.h

Issued By Reviewed By Approved By

Management Rep. Management Rep. Managing Director

Mostafa Diab Mostafa Diab Hazem Talaat


QMS Manual Code TG-QMS-MAN001
Level 1 Iss. Date 01/08/2021
Revision 03
Quality Management System Manual Rev. Date 01/11/2022
Page 3 of 50

Table of Contents
1 Scope 6
1.1 General ........................................................................................................................................................... 6
1.2 Permissible Exclusions .................................................................................................................................. 6
2 Normative References 6
3 Terms, Definitions, and Abbreviations 6
3.1 Terms and Definitions ................................................................................................................................... 6
3.1.1 Acceptance criteria ............................................................................................... 6
3.1.2 Acceptance inspection ......................................................................................... 6
3.1.3 Calibration ............................................................................................................ 6
3.1.4 Collection ............................................................................................................. 7
3.1.5 Compliance .......................................................................................................... 7
3.1.6 Critical .................................................................................................................. 7
3.1.7 Delivery ................................................................................................................ 7
3.1.8 Design acceptance criteria DAC .......................................................................... 7
3.1.9 Design validation .................................................................................................. 7
3.1.10 Design verification ................................................................................................ 7
3.1.11 First article ............................................................................................................ 8
3.1.12 Key performance indicator KPI ............................................................................ 8
3.1.13 Legal requirement ................................................................................................ 8
3.1.14 Management [noun] ............................................................................................. 8
3.1.15 Manufacturing acceptance criteria MAC .............................................................. 8
3.1.16 Outsource [outsourced activity] ............................................................................ 8
3.1.17 Preventive maintenance....................................................................................... 8
3.1.18 Procedure ............................................................................................................. 8
3.1.19 Risk ...................................................................................................................... 8
3.1.20 Service ................................................................................................................. 8
3.1.21 Service Quality Plan ............................................................................................. 8
3.1.22 Servicing .............................................................................................................. 9
3.1.23 Interested parties ................................................................................................. 9
3.1.24 Service-related product ........................................................................................ 9
3.1.25 Supplier ................................................................................................................ 9
3.1.26 Documented information ...................................................................................... 9
3.1.27 Abbreviations ....................................................................................................... 9
4 Context of TECNOGROUP 10
4.1 Understanding the Organization and Its Context .................................................................................... 10
4.2 Understanding the Needs and Expectations of Interested Parties .......................................................... 10
4.3 Quality Management System Requirements ............................................................................................. 11
4.3.1 Quality Management System ............................................................................. 11
4.3.2 Quality Policy ..................................................................................................... 12
4.3.3 Quality Objectives .............................................................................................. 14
4.3.4 Planning ............................................................................................................. 14
4.3.5 Communication .................................................................................................. 15
4.4 Management Responsibility, Leadership, and commitment .................................................................... 16
4.4.1 Leadership and commitment .............................................................................. 16
4.4.2 Customer focus .................................................................................................. 17
4.4.3 Responsibility and Authority ............................................................................... 17
4.4.4 Management Representative ............................................................................. 18
QMS Manual Code TG-QMS-MAN001
Level 1 Iss. Date 01/08/2021
Revision 03
Quality Management System Manual Rev. Date 01/11/2022
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4.5 TECNOGROUP Capabilities .................................................................................................................. 18


4.5.1 Provision of Resources ...................................................................................... 18
4.5.2 Human Resources ............................................................................................. 19
4.5.3 Organizational Knowledge ................................................................................. 21
4.5.4 Environment ....................................................................................................... 21
4.6 Documentation Requirements .................................................................................................................... 22
4.6.1 GENERAL .......................................................................................................... 22
4.6.2 Quality Management system ............................................................................. 22
4.6.3 Control of Documents ........................................................................................ 23
4.6.4 Use of External Documents in Product Realization ........................................... 24
4.7 Control of Records ...................................................................................................................................... 24
5 Product Realization / Realization and service-related product 25
5.1 Contract Review .......................................................................................................................................... 25
5.1.1 General............................................................................................................... 25
5.1.2 Customer Communication.................................................................................. 25
5.1.3 Determination of Requirements ......................................................................... 25
5.1.4 Review of Requirements .................................................................................... 26
5.1.5 Changes to requirements for products ............................................................... 27
5.2 Planning of Product realization or service-related product provision.................................................... 27
5.3 Risk Assessment and Management ............................................................................................................ 28
5.4 Design and Development of product(s)/service(s) ..................................................................................... 28
5.4.1 General................................................................. Error! Bookmark not defined.
5.4.2 Design and development planning ....................... Error! Bookmark not defined.
5.4.3 Design and development inputs ........................... Error! Bookmark not defined.
5.4.4 Design and development outputs ........................ Error! Bookmark not defined.
5.4.5 Design and development review .......................... Error! Bookmark not defined.
5.4.6 Design and development verification and final review ........ Error! Bookmark not
defined.
5.4.7 Design and development validation and approval .............. Error! Bookmark not
defined.
5.4.8 Design and development changes ....................... Error! Bookmark not defined.
5.5 Contingency Planning ................................................................................................................................. 28
5.6 General ......................................................................................................................................................... 28
5.6.1 Planning Output ................................................................................................. 28
5.7 Purchasing.................................................................................................................................................... 29
5.7.1 Purchasing Control............................................................................................. 29
5.7.2 Purchasing Information ...................................................................................... 30
5.7.3 Verification and control of Purchased Products or services related to products,
externally provided processes, and Activities .................................................... 31
5.8 Production Provision ................................................................................................................................... 32
5.8.1 Control of Production ......................................................................................... 32
5.8.2 Product Quality Plans......................................................................................... 33
5.8.3 Identification and Traceability ............................................................................ 34
5.8.4 Product Inspection/Test Status .......................................................................... 34
5.8.5 Customer-supplied Property .............................................................................. 35
5.8.6 Preservation of product ...................................................................................... 35
5.8.7 Inspection and Testing ....................................................................................... 36
5.8.8 Validation of product .......................................................................................... 36
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Level 1 Iss. Date 01/08/2021
Revision 03
Quality Management System Manual Rev. Date 01/11/2022
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5.8.9 Preventive maintenance, inspection, and test program (PMITP) ...................... 36


5.9 Control of Testing, Measuring, Monitoring, and detection Resources ................................................... 37
5.9.1 General............................................................................................................... 37
5.10 Product Release ........................................................................................................................................... 38
5.11 Control of Non-conformities ....................................................................................................................... 39
5.11.1 General............................................................................................................... 39
5.11.2 Non-conforming Product .................................................................................... 39
5.11.3 Release of Non-conforming Product under Concession .................................... 40
5.11.4 Verification and Documentation ......................................................................... 40
5.11.5 Customer Notification ......................................................................................... 40
5.11.6 Records .............................................................................................................. 40
5.12 Management of Change and planning for change .................................................................................... 40
5.12.1 General............................................................................................................... 40
5.12.2 MOC Implementation ......................................................................................... 41
6 QMS Monitoring, Measurement, Analysis, Evaluation, and Improvement 41
6.1 General ......................................................................................................................................................... 41
6.2 Monitoring, Measuring, and Improvement............................................................................................... 42
6.2.1 Customer Satisfaction ........................................................................................ 42
6.3 Internal Audit .............................................................................................................................................. 42
6.3.1 General............................................................................................................... 43
6.3.2 Performance of audits ........................................................................................ 43
6.3.3 Audit review and closure .................................................................................... 43
6.3.4 Process Evaluation ............................................................................................ 44
6.3.5 Analysis of Data and Evaluation ........................................................................ 44
6.4 Improvement................................................................................................................................................ 44
6.4.1 General............................................................................................................... 44
6.4.2 Corrective Action ................................................................................................ 45
6.4.3 Preventive Action ............................................................................................... 45
6.5 Management Review ................................................................................................................................... 46
6.5.1 General............................................................................................................... 46
6.5.2 Input Requirements ............................................................................................ 46
6.5.3 Output Requirements ......................................................................................... 47
6.6 Continual Improvement .............................................................................................................................. 47
7 Appendixes 47
7.1 Appendix I: Use of API Monogram by Licensees as per API Q1 ............................................................ 47
7.1.1 Quality Management System Requirements ..................................................... 47
7.1.2 Control of the Application and Removal of the API Monogram per API Q1 ...... 48
7.2 Process Interaction ...................................................................................................................................... 49
QMS Manual Code TG-QMS-MAN001
Level 1 Iss. Date 01/08/2021
Revision 03
Quality Management System Manual Rev. Date 01/11/2022
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1 Scope

1.1 General
This document specifies the Quality Management System of TECNOGROUP.

The systems requirements of this manual are aimed at achieving customer satisfaction by
consistently providing a conforming product or service-related product and meeting or
exceeding customer and applicable regulatory requirements through the application of the
system, continual improvement, and the prevention of nonconformity.

This document ensures that TECNOGROUP adequately identifies customer requirements,


through all Quality Management System processes, to achieve customer satisfaction with a
closed-loop Process Model methodology.

This document applies to the product categories mentioned below and satisfies API Q1_9th, API
6A_21th,& ISO 9001;2015.

1.2 Permissible Exclusions


TECNOGROUP excludes the design and development package from the scope.

2 Normative References
The following referenced document is indispensable for the application of these specifications of
API Q1_9th, API 6A_21th & ISO 9001;2015, Quality Management System.

3 Terms, Definitions, and Abbreviations

3.1 Terms and Definitions


For this specification, the terms, and definitions are given in
ISO 9001: 2015 and the following when identical terms are defined in
ISO 9001: 2015 and this specification, the following definitions shall apply.

3.1.1 Acceptance criteria


Specified limits of acceptability applied to process or product characteristics

3.1.2 Acceptance inspection


Demonstration through monitoring or measurement that the product conforms to specified
requirements.

3.1.3 Calibration
Comparison to a standard of known accuracy and making any needed adjustment(s).
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3.1.4 Collection
Process of obtaining, assembling, and/or organizing applicable information with the intent of meeting
the requirements of Clause 4.5. Control of Record.

3.1.5 Compliance
Act or process of satisfying the legal and other applicable requirements of regulation or regulatory
body.

3.1.6 Critical
That is deemed by the organization, product specification, or customer as mandatory,
indispensable, or essential, needed for a stated purpose or task and requiring specific action.

3.1.7 Delivery
Point in time and physical location at which the agreed transfer of ownership takes place.

3.1.8 Design acceptance criteria DAC


Defined limits placed on characteristics of materials, products, or services established by the
organization, customer, and/or applicable specifications to achieve conformity to the product
design.

3.1.9 Design validation


Process of proving a design by testing to demonstrate the conformity of the product to design
requirements.
NOTE: Design validation can include one or more of the following (this is not an all-inclusive list):

a. Prototype tests,
b. Functional and/or operational tests of production products,

c. Tests specified by industry standards and/or regulatory requirements,


d. Field performance tests and reviews.

3.1.10 Design verification


Process of examining the result of design and development output to determine conformity with
specified requirements.
NOTE: Design verification activities can include one or more of the following (this is not an all-inclusive
list):

a. Confirming the accuracy of design results through the performance of alternative calculations,
b. Review of design output documents independent of activities of design and development,
c. Comparing new designs with similar proven designs.
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Level 1 Iss. Date 01/08/2021
Revision 03
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3.1.11 First article


A representative sample of a product, component, or output from a process is used to verify that
prescribed activities have satisfied the requirements as specified by the organization.

3.1.12 Key performance indicator KPI


Quantifiable measure that an organization uses to gauge or compare performance.

3.1.13 Legal requirement


Obligations imposed on an organization, including those that are statutory or regulatory.

3.1.14 Management [noun]


Person or group of people, as defined by the organization, who directs and controls all or part of
a facility, location, department, or other function; has the fiscal responsibility for the
organization, and is accountable for ensuring compliance with legal and other applicable
requirements.

3.1.15 Manufacturing acceptance criteria MAC


Defined limits placed on characteristics of materials, products, and services established by the
organization to achieve conformity to the manufacturing or servicing requirements.

3.1.16 Outsource [outsourced activity]


Function or process that is performed by an external supplier on behalf of the organization.

3.1.17 Preventive maintenance


Planned action to minimize the likelihood of equipment failure and unscheduled interruptions to
planned events

3.1.18 Procedure
Organization’s documented method for performing an activity under controlled conditions to
achieve conformity to specified requirements.

3.1.19 Risk
Situation or circumstance that has both a likelihood of occurring and a potentially negative
consequence.

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

3.1.21 Service Quality Plan


The document establishes procedures, resources, processes, and any required sequence of
activities identifying and controlling the quality requirements.
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3.1.22 Servicing
Product maintenance, adjustment, repair, and/or on-site installation when installation is required by
applicable product specifications.

3.1.23 Interested parties


A stakeholder person or organization that can affect, be affected by or perceive itself to be
affected by a decision or activity. For example; customers, owners, people in an organization,
providers, bankers, regulators, unions, partners, or society can include competitors or opposing
pressure groups.

3.1.24 Service-related product


Materials, equipment, and software used in the execution of a service.

3.1.25 Supplier
External provider, that is not part of the organization which provides products, or service-
related products. For example; a Producer, distributor, retailer, or vendor of a product or
service-related products.

3.1.26 Documented information

Information required to be controlled and maintained by an organization and the medium on


which it is contained

Note 1: Documented information can be in any format and media and from any source.

3.1.27 Abbreviations
For this specification, the following abbreviations shall apply.

API American petroleum institute

QMS Quality Management System.

DAC Design Acceptance Criteria

BD Business Development

HR Human resources

HSE Health, safety, and environment

ITP Inspection Test Plan

KPI Key Performance Indicator

MAC Manufacturing Acceptance Criteria

MD Managing Director

MOC Management of Change


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MPS Manufacturing Process Specification

MR Management Representative

MSGM Management system General manager

PCP Process Control Plan

QA Quality Assurance

QHSE QUALITY, Health, Safety, and Environment

QM Quality Manual

QP Quality Plan

PMITP Preventive maintenance, inspection, and test program.

4 Context of TECNOGROUP

4.1 Understanding the Organization and Its Context


TECNOGROUP has reviewed and analyzed key aspects of itself and its stakeholders to
determine the strategic direction of the company. This requires understanding internal and
external issues that are of concern to our clients and their interested parties (as per 4.2 below);

These issues arise from the legal, technological, competitive, market, cultural, social, and
economic environments, whether international, national, regional, or local.

TECNOGROUP monitors and updates such issues as appropriate. Also, these issues are
discussed in the management review meetings.

4.2 Understanding the Needs and Expectations of Interested Parties


The issues which are determined as per 4.1 above are identified through an analysis of risks facing
TECNOGROUP and its interested parties such as:

TECNOGROUP Customers’ requirements, Training Requirements, TECNOGROUP owners,


TECNOGROUP employees, TECNOGROUP external providers, regulators such as Egyptian Legal and
statutory requirements and/or other states as applicable requirements, unions, partners, or society that can
include competitors or opposing pressure groups.

TECNOGROUP continuously monitors and reviews all the information of those mentioned
interested parties and their requirements.

TECNOGROUP demonstrates its ability to consistently provide products that meet customer
and applicable statutory and regulatory requirements and aims to enhance customer
satisfaction.
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All this information is then used by senior management to determine the company’s strategic
direction. This is defined in records of management review and periodically updated as
conditions and situations change.

4.3 Quality Management System Requirements

4.3.1 Quality Management System

4.3.1.1 General

TECNOGROUP establishes, implements, maintains, and continually improves a Quality


Management System including the processes needed and their interactions per ISO 9001:2015,
and this is done through a Quality Programme with incorporated Quality Manual, which
comprises a Quality System Manual, Quality Procedures, Work Instructions, and Quality Forms.

TECNOGROUP quality program is based upon the requirements of API Q1 9th Edition, and
ISO 9001:2015, TECNOGROUP determines: -

d. The processes needed for the quality management system and their application throughout
TECNOGROUP maintain the documented information to support the operation of its
processes and retain the documented information to have the confidence that the processes
are being carried out as planned.
e. The inputs required and the outputs expected from these processes.
f. The sequence and interaction of these processes.
g. And apply the criteria and methods (including monitoring, measurements, and related
performance indicators) needed to ensure the effective operation and control of these
processes.
h. The resources needed for these processes and ensuring their availability.
i. Assigns the responsibilities and authorities for these processes.
j. And addresses the risks and opportunities as determined per the requirements.
k. And evaluates these processes and implements any changes needed to ensure that these
processes achieve their intended results.
l. And improves the processes and the quality management system.

TECNOGROUP maintains documented information to support all the operation of its


processes and retains documented information to have confidence that the processes are being
carried out as planned

4.3.1.2 Scope of Work

Based on an analysis of the above issues of concern, requirements, interests of stakeholders,


and in consideration of its products, TECNOGROUP has determined the scope of the
management system as follows:
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The scope of TECNOGROUP is covering; the Provision of Wellhead and Christmas Tree
Equipment (Blind and Test Flanges).

4.3.1.3 Health, Safety, and Environment (HSE)

TECNOGROUP ensures that HSE requirements are complied with by providing facilities,
equipment, and training to promote HSE in the workplace for all employees. TECNOGROUP
ensures that employees are fully aware (as per TG-QMS-P011 Competency Training and
Awareness Procedures) of all HSE requirements.

4.3.1.4 Security

All Customer supplied information shall be maintained as confidential. All internal information of
sensitive nature shall be treated as confidential.

All property and buildings of TECNOGROUP are to be secured to prevent any compromise of
security and confidentiality.

4.3.2 Quality Policy

TECNOGROUP, as a leading provider of Specialised Equipment and Engineering Services to


the oil and gas industry, is committed to the development and maintenance of economic and
effective processes and systems designed to meet or exceed the needs and expectations of our
customers.

The Company provides quality products to fulfill our customer’s requirements as well as to
satisfy applicable regulatory and statutory requirements.

To ensure the effectiveness of this policy and for measurable quality objectives to be achieved,
the commitment, support, and involvement of management and all personnel within the
company are assured.

4.3.2.1 TECNOGROUP ensures that the Quality policy: -

a. Is appropriate to the purpose and context of TECNOGROUP and supports its strategic
direction.
b. Is available, maintained as documented information, communicated, understood, and applied
within TECNOGROUP.
c. Is available to relevant interested parties, as appropriate.
d. Provides a framework for setting quality objectives.
e. Includes a commitment to satisfy applicable requirements.
f. Includes a commitment to continual improvement of the quality management system.
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4.3.2.2 Policy Statement

TECNOGROUP operations is an entity engaged in the machining services for the manufacture
of Flanges (Blind and Test).

TECNOGROUP accepts responsibility for the complete satisfaction of its customers. We


exercise this responsibility through adequate training of our employees, adherence to proven
procedures, total commitment to meet API Q1_9th, API 6A_21th & ISO 9001;2015 standards
and customer requirements, and to maintain an organizational culture that fosters continuous
improvement.

Committed ourselves to achieve the highest quality standards levels and reliabilities to serve
and satisfy our client's requirements according to the recommended relevant standards and
guidelines through the following: -
Commitment to comply and continually improve the quality management system.

Train and qualify the employees according to international levels and standards to develop
their capabilities and skills and reward their achievements.

Ensure that the employees are familiar with and implement all Co. Policies, Standard
Operation Procedures (SOP), and Original Equipment Manufacturer (OEM) instructions.

Achieve working techniques and equipment continually updating and improving.

Achieve a competitive and high degree of quality performance to meet the present and future
requirements of the accreditation bodies and exceed the expectations of our clients.
To maintain Quality Management System (QMS) effective, controlled, and updated, the
Company had established and implemented. This system is complying with the requirements
of the international standards of API Q1_9th, API 6A_21th & ISO 9001;2015. The company
keeps its functionality, effectiveness, continuous improvement, and reviewing for suitability as
well as its objectives; by insuring implementation, deployment, and development of the quality
policy throughout the Organization.

Signed

Hazem Talaat
Managing Director
Dated: 01st MAR. 2022
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4.3.3 Quality Objectives

The quality objectives are established at relevant functions and levels within TECNOGROUP
and measurable, consistent with TECNOGROUP quality policy, take into account applicable
requirements,

are relevant to the conformity of products or service-related products and the enhancement of
customer satisfaction, are monitored, are communicated to all dep, and finally are updated as
appropriate.

TECNOGROUP plans how to achieve its quality objectives as per Management Review and
also determines what will be done; what resources will be required; who will be responsible;
when it will be completed and finally how the results will be evaluated.

4.3.3.1 The Quality Objectives of TECNOGROUP are:

a. To manage and improve the effectiveness and efficiency of the Quality Management System.
b. To provide effective assurance that all products meet or exceed the contractual implied, or
regulatory requirements and other applicable (as per TG-QMS-P022 Customer Satisfaction
Procedure).
c. To achieve maximum reliability in such products.

4.3.4 Planning

Actions to address risks and opportunities

When planning for the quality management system, TECNOGROUP considers the issues
referred to in 4.1 and the requirements referred to in 4.2 and determines the risks and
opportunities that need to be addressed to:

Give assurance that the quality management system can achieve its intended result(s),
enhance desirable effects, prevent, or reduce, undesired effects and finally achieve
improvement.

TECNOGROUP plans:

a. Actions to address these risks and opportunities.


b. How to integrate and implement the actions into its quality management system processes
and evaluate the effectiveness of these actions.
All actions taken to address risks and opportunities shall be proportionate to the potential impact
on the conformity of products.

NOTE 1 Options to address risks can include avoiding risk, taking a risk to pursue an opportunity,
eliminating the risk source, changing the likelihood or consequences, sharing the risk,
or retaining risk by informed decision.
NOTE 2 Opportunities can lead to the adoption of new practices, launching new products, opening
new markets, addressing new customers, building partnerships, using new technology,
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and other desirable and viable possibilities to address TECNOGROUP or its


customer’s needs.

As per the TG-QMS-P008 Quality Risk Management Procedure and Quality Plan as per TG-
QMS-P006 Guideline for Quality Plan shall be developed, maintained, and controlled for major
jobs whenever necessary, which shall detail the process, documents, and responsibilities
required to provide the correct product against any given customer specification/ requirement.

If the customer requires additional or specialized quality-related operations

to be performed, which are not specified in the generic one, then a specific quality plan shall be
produced for that particular contract or order.

All the quality plans whenever necessary will be documented, reviewed, and approved by
designated quality and operation personnel, thus maintaining the integrity of the Quality
Management System. (As per TG-QMS-P022 Customer Satisfaction Procedure, TG-QMS-P008
Quality Risk Management, TG-QMS-P004 Internal Audit Procedure).

4.3.5 Communication

4.3.5.1 General
TECNOGROUP determines the internal and external communications relevant to the quality
Management system, including:
a. On what it will communicate?
b. When to communicate?
c. With whom to communicate?
d. How to communicate?
e. Who communicates?

4.3.5.2 Internal Communication

a. TECNOGROUP management establishes an effective communication system between


management and employees/ stakeholders (TG-QMS-P018 Communication, Consultation,
and Participation).
b. Internal communication methods may include: -
1. Meetings (periodic, scheduled, and/or unscheduled) to discuss aspects of the QMS.
2. Use of corrective and preventive action processes to report nonconformities or
suggestions for improvement.
3. Use of the results of analysis of data.
4. Use of the results of the internal audit process.
5. Regular company meetings with all employees.
6. Internal emails, and memos to employees.
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c. The controlled copies of the Quality Manual will be distributed to the various departments
concerned for effective implementation.
d. The management representative or delegate is responsible for the revision and issue of work
instructions and forms to reflect the current work practices and maintain records in
consultation with departmental personnel, with the approval of the MD.
e. Management review meetings and others shall facilitate two-way communication to enhance
QMS effectiveness.
f. All customer requirements and legal and other applicable requirements are communicated at
relevant levels within TECNOGROUP.
g. Regular Operations meetings shall be held and documented as per TG-QMS-AD-F004
Minutes of Meeting form to enable closer coordination between TECNOGROUP's different
departments.
h. Results of analysis of data (as per TG-QMS-P017) are communicated at relevant levels and
functions within TECNOGROUP.

4.3.5.3 External Communication

a. TECNOGROUP implements a process to ensure the execution of inquiries, contracts, order


handling, and amendment (TG-QMS-P023 Contract Review and TG-QMS-P018
Communication).
b. Provision and control of Products related products, information including product
nonconformities identified after delivery, and the Quality Plan and its subsequent changes.
c. Feedback and customer complaints as per TG-QMS-P022 Customer Satisfaction procedure
and this point is being discussed in TECNOGROUP analysis of data and Management
Review.

4.4 Management Responsibility, Leadership, and Commitment

4.4.1 Leadership and commitment

a. Top Management of TECNOGROUP shall ensure the availability of resources essential to


establish, implement, maintain and improve the quality management system. Resources
include human resources, specialized skills, TECNOGROUP infrastructure, financial
resources, technology, etc.

b. Top Management shall provide evidence of their commitment to the development and
implementation of the quality management system and continually improve its effectiveness
by:
1. Taking accountability for the effectiveness of the quality management system.
2. Ensuring that the quality policy and quality objectives are established for quality
management.
3. System and are compatible with the context and strategic direction of
TECNOGROUP.
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4. Ensuring the integration of the quality management system requirements into


TECNOGROUP business processes.
5. Promoting the use of the process approach and risk-based thinking.
6. Ensuring that the resources needed for the quality management system are
available.
7. Communicating the importance of effective quality management and of conforming
to the quality management system requirements.
8. Ensuring that the quality management system achieves its intended results.
9. Engaging, directing, and supporting persons to contribute to the effectiveness of the
quality management system.
10. Promoting improvement.
11. Supporting other relevant management roles to demonstrate their leadership as it
applies to their areas of responsibility.
12. Conducting management reviews (as per TG-QMS-P007 Management Review).

4.4.2 Customer focus


TECNOGROUP Managing Director adopts a customer-first approach which ensures that
customer needs and expectations are determined, converted into requirements, and met to
enhance customer satisfaction. This is accomplished by assuring:
a. Customer and applicable statutory and regulatory requirements are determined, understood,
and consistently met.
b. The risks and opportunities that can affect the conformity of products and the ability to
enhance customer satisfaction are determined and addressed.
c. The focus on enhancing customer satisfaction is maintained.

4.4.3 Responsibility and Authority

a. TECNOGROUP Top management ensures that the responsibilities and authorities for
relevant roles are assigned, communicated, and understood within TECNOGROUP. Top
management assigns the responsibility and authority for:
1. Ensuring that the quality management system is established, implemented,
maintained, and conforms to the requirements of the International Standards API
Q1_9th, API 6A_21th, & ISO 9001;2015.
2. Ensuring that the processes are delivering their intended outputs.
3. Reporting on the performance of the quality management system and opportunities
for improvement in particular to top management.
4. Ensuring the promotion of customer focus throughout TECNOGROUP.
5. Ensuring that the integrity of the quality management system is maintained when
changes to the quality management system are planned and implemented.
6. Initiating action to minimize the likelihood of the occurrence of nonconformities.
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b. TECNOGROUP Chart (as per Appendix VI TECNOGROUP Organization Chart) shows


the staff positions and lines of responsibility and it is established and maintained by the QA
Manager.
c. The identification of resource requirements and provision of adequate resources including
assigning trained personnel for management, the performance of work, and verification
activities including internal audits.
d. The HR Manager or his delegate shall maintain a file of Job Descriptions for each staff
position identified on the TECNOGROUP Organization Chart. These Job Descriptions
clearly define general and specific quality responsibilities, reporting routes, interfaces, and
co-coordinating measures (as per TG-QMS-HR-F001 Job Description Form in TG-QMS-P024
Selection and Hiring Procedures)

4.4.4 Management Representative


a. The QA Manager has been designated as the Management Representative (MR) by Top
Management. The Management Representative or his delegate is responsible for the
administration and monitoring of the Quality System, as per the flow chart detailed in this
Quality System Manual.
b. The Management Representative shall identify in-house verification requirements and ensure
that resources in terms of trained personnel and documented procedures are adequate for
verification activities. Such activities will include monitoring the products provided.
c. The Management Representative or his delegate shall provide on-request, facilities, and
access to a customer’s representative, as to ensure that the Quality System established in
compliance with ISO 9001:2015 and API Q1 9th Edition is effective.
d. It is the responsibility of the Management Representative or his delegate to ensure the
effective implementation of the documented Quality System including the Quality System
Manual, Quality Procedures, any additional instructions, and/or Quality Plans.
e. The Management Representative or his delegate shall report the performance and
effectiveness of the QMS to Top Management.
f. The Management Representative or his delegate shall be responsible for initiating action(s)
required to minimize the likelihood of the occurrence of non-conformities.

4.5 TECNOGROUP Capabilities

4.5.1 Provision of Resources

a. TECNOGROUP Top management determines, allocates, and provides the necessary


resources needed:
1. To establish, implement and maintain the management system and continually
improve its effectiveness.
2. To enhance customer satisfaction by meeting customer requirements.
b. Resource allocation is done with consideration of the capability and constraints on existing
internal resources, as well as needs related to the external providers' expectations.
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c. Resources and their allocation are assessed and also discussed during management reviews
and before each new project or contract is awarded as per TG-QMS-P007 Management
Review Procedure.

4.5.2 Human Resources

4.5.2.1 General

a. TECNOGROUP ensures that it provides sufficient staffing for the effective operation of the
Quality Management System, as well as its identified processes as per TG-QMS-P011
Competency, Training and Awareness Procedure and as per TG-QMS-P024 Selection and
Hiring Policy Procedure.
b. It is the responsibility of the Operation Manager to ensure that personnel performing work
affecting product quality shall be competent based on appropriate education, training, skills,
and experience. To assess the competency of personnel, the following aspects will be
considered: Qualifications, Experience, Performance Evaluation, Transfer, Promotion,
Induction for New Employees, Job-related QMS requirements, Customer Feedback, Annual
Appraisals, etc. The Operation Manager, in conjunction with the MR, shall ensure that the
Company’s Quality policy and the Quality system are understood, implemented, and
maintained at all levels with TECNOGROUP.
c. Personnel Competency
As per TG-QMS-P011 Competency, Training, and Awareness Procedure.

d. TECNOGROUP determines the necessary competence of a person doing work under its
control which affects the performance and effectiveness of the quality management system.

e. TECNOGROUP ensures that all personnel whose work shall directly or indirectly affect the
quality of the product shall be competent based on appropriate education, training, skills, and
experience to meet customer requirements as per TG-QMS-P011 Competency, Training, and
Awareness Procedures.
f. TECNOGROUP ensures that where applicable, take actions to acquire the necessary
competence, and evaluate the effectiveness of the actions taken.
g. The MD General Manager or the Management Representative or his delegate with the HR
Manager retains appropriate documented information as evidence of personnel competency.
h. The applicable actions can include, for example, the provision of training to, the mentoring
of, or the re-assignment of currently employed persons; or the hiring or contracting of
competent persons.

4.5.2.2 Training and Awareness


As per TG-QMS-P011 Competency, Training, and Awareness Procedures.
a. Personnel training is based on the various job requirements and will be subject to
consideration at Management Review Meetings, so the Operations Manager or his delegate
or the HR Manager ensures to provide job training of TECNOGROUP personnel and
contractors who affect the provision of products, the execution of service-related products.
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b. It is the responsibility of the Operation Manager or his delegate to ensure that training is
provided and completed per Company requirements and contractual obligations. Appropriate
QMS training will be given to the employees as required by circumstances, but at least one
full cycle of such training will be provided annually.
c. The operation Manager or his delegate or the HR Manager ensures that the frequency and
the content of training are identified and comply with legal and other applicable requirements.
d. The operation Manager or his delegate or the HR Manager identifies and provides training on
legal and other applicable requirements.
e. The operation Manager or his delegate or the HR Manager ensures that customer-specified
training and/or customer-provided training if required is included in the training program.
f. All training related to the Quality System is the responsibility of the QA Manager or his
delegate in conjunction with the Operation Manager and HR Manager. They shall ensure that
all personnel assigned specific responsibilities related to the Quality System are given training
on the QMS related to these responsibilities. The purpose of such training is to raise the
awareness of this personnel of the importance of their activities and their contribution to the
achievement of the Quality objectives. The effectiveness of the training provided will be
assessed through employee appraisals.
g. The operation Manager or his delegate or the HR Manager maintains appropriate records of
education, training, skills, and experience.
h. When any member of staff requires a particular skill or training, the Operation Manager shall
consider the use of: -
1. In-house training courses
2. Visiting specialists.
3. External training courses.
4. Arrangement for the trainee to work alongside someone with the required skills.
i. New employees shall be given instruction appropriate to their job function (after taking into
account their prior experience and qualifications) to ensure that they are capable of satisfying
both TECNOGROUP and customer requirements.
j. Where a sub-contractor is called upon to provide skilled services, the QA Manager with the
HR Manager shall ensure that the sub-contractor has appropriate qualifications to perform
the job concerned.

k. TECNOGROUP through the training and the subsequent communication ensures that
persons doing work under TECNOGROUP control are aware of: -
1. The quality policy;
2. Relevant quality objectives;
3. Their contribution to the effectiveness of the quality management system, including
the benefits of improved performance;
4. The implications of not conforming with the quality management system
requirements.
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4.5.3 Organizational Knowledge

a. TECNOGROUP also determines the knowledge necessary for the operation of its
processes and to achieve conformity of products. This may include knowledge and
information obtained from:
1. Internal sources (e.g., intellectual property, knowledge gained from experience,
lessons learned from failures and successful projects, capturing and sharing
undocumented knowledge and experience, the results of improvements in
processes, products)
2. External sources (e.g., standards; academia, conferences, gathering knowledge from
customers or external providers)
b. This knowledge shall be maintained, and made available to the extent necessary. When
addressing changing needs and trends, TECNOGROUP shall consider its current
knowledge and determine how to acquire or access the necessary additional knowledge.

4.5.4 Environment

a. TECNOGROUP management provides a congenial work environment to enhance the


ability of employees to perform effectively and ensure quality. The elements of a proper work
environment are a combination of human and physical factors such as:
1. Physical (e.g., temperature, heat, humidity, light, airflow, hygiene, noise).
2. Psychological (e.g., stress-reducing, burnout prevention, emotionally protective).
3. Social (e.g., non-discriminatory, calm, non-confrontational),

b. TECNOGROUP assures the availability of the following environment for employees to fulfill
the work and achieve conformity of products:
1. Employee involvement and participation.
2. Good Housekeeping.
3. Toilet and washroom facilities.
4. Restroom facilities.
5. Appropriate Health, Safety, and Environment systems, procedures, and practices,
including First Aid facilities.
6. Ergonomically arranged work areas.
7. Pollution control includes recycling and reduction.
8. Interaction and two-way communication.

4.5.4.1 Infrastructure
TECNOGROUP management assesses, establishes, and maintains necessary infrastructure
for Quality system implementation in terms of necessary buildings, offices, workshops and yard,
equipment including hardware and software, transportation resources, information, and
communication technology and support products, etc. to carry out work as per plan to fulfill
requirements and achieve conformity of products.
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a. Process equipment and its maintenance as per TG-QMS-P012 Inspection and Test
Equipment's Procedures.
b. Supporting Products
1. Vehicle(s) for the movement of tools and equipment.
2. Adequate transportation facilities for the personnel.
3. Communication facilities shall include a central server, telephone, fax, and the
Internet.

4.6 Documentation Requirements

4.6.1 GENERAL
The QMS documentation consists of:

a. Statements of quality policy and quality objectives.


b. The quality manual addresses each requirement of this specification and includes:
1. The scope of the quality management system, including a justification for any
exclusions to specific quality management system elements.
2. A description of the sequence and interaction between the processes of the quality
management system as per appendix V Process interaction.
3. Identification of processes that require validation.
4. Reference to documented procedures that control the quality management system
processes.
c. Documented procedures established for the quality management system.
d. Documents and records to ensure the effective planning, operation, and control of its
processes and compliance with specified requirements.
e. Identification of legal and other applicable requirements to which TECNOGROUP claims
QMS compliance that is needed to achieve product conformity such as:
1. Egyptian legal and statutory requirements and/or other states as applicable
requirements.
2. International standards (such as HSE Standards, API, ASME, ASTM, etc.).
Clients’ requirements such as (EGPC, KHALDA, AGIBA, BPETCO, GE, SCHLUMBERGER,
Halliburton etc.).

3. Training Requirements.

4.6.2 Quality Management system


There are four documentation levels in the TECNOGROUP Quality Management system, as
follows:
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Level 1 -The Quality Management System Manual (TG-QMS-MAN001) which clearly states
TECNOGROUP quality policy and indicates how TECNOGROUP will address the
requirements of API Q1_9th, API 6A_21th, & ISO 9001;2015.
Level 2 -Consists of Quality Procedures (TG-QMS-PXXX), which detail the procedures to be
followed to fulfill TECNOGROUP's stated quality objectives.
Level 3 -These documents are Work Instructions (TG-QMS-WIXXX), which detail the
methodology to be followed in performing a particular process, inspection, calibration, or work
function.
Level 4 -Consists of Quality Forms which when completed provide a record to show
TECNOGROUP implementation of and adherence to the documented Quality System. (TG-
QMS-FXXX).
The general serial numbering of documents is as above and detailed as below;
Tecnogroup-Quality Management System-Procedure/Work Instruction/Form-Sequence Number.

4.6.3 Control of Documents


As per TG-QMS-P001 Document Control procedure.

4.6.3.1 Document Approval and Issue


a. The QA Manager or his delegate shall ensure that all internal and external documents and
data, forming part of the Quality System have been the subject of review and approval for
adequacy before issue (as per TG-QMS-P001 Control of Document procedure).
b. A Master Document Register (Matrix Documentation Register TG-QMS-LD and List of
procedures & working instructions) of Quality System documentation is produced and held by
the QA Manager or his delegate, to identify the current revision status of documents.
c. For each document held on the Master Document Register, the Quality Assurance Manager
or his delegate shall form a Distribution Control List. He shall ensure using regular audits and
a document change control system, that only pertinent issues of appropriate documents are
available at all locations where operations essential to the effective functioning of the Quality
System are performed.
d. All controlled documents are defined with; Code, Issue Date, Revision Number and Revision
Date.
e. in All obsolete documents will be disposed of or replaced by the controlled copy holders when
the revised documents are received.
f. Documents of external origin will be identified and recorded as per External Documents
Register TG-QMS-QA-F007, and their distribution controlled in the same manner. Any other
external specification requirements, including addenda, errata, and updates, are used in the
design or manufacture of the product. TECNOGROUP shall maintain a documented
procedure for the integration of these requirements into the product realization process and
any other affected processes.
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g. If the QA Manager or delegate retains obsolete documents for legal and/or preservation
purposes, the documents shall be identified by the word ‘obsolete ‘written/stamped on them
and stored securely to avoid inadvertent use.

4.6.3.2 Document Changes / Modification


a. All changes to Quality System documents shall be reviewed and approved by the
management representative who performs the original review and approval unless
specifically designated otherwise by the management.
b. All controlled copies of the first level Quality System Manual and all other levels of controlled
Quality documents will be revised and distributed per the TECNOGROUP TG-QMS-P001
Control of Document procedure.
c. It will be the responsibility of the QA Manager or his delegate to maintain a list of all the levels
of Quality Manuals issued giving details of Copy Number, Holder, Date of Issue, Issue Status,
and whether it is a “controlled” copy.
d. For documents, which have been the subject of revision, the change is identified in the area
of revision History the revised/modified part. This shall be the responsibility of the person
revising the document.
e. Newly issued or amended pages will be forwarded to controlled copy holders accompanied
by a document transmittal form, a signed copy of which will be returned to the sender verifying
receipt.
f. It is the QA manager’s responsibility to incorporate such changes or additions into the Quality
Manual under the changed/added controls.
g. The Manager Director and/or the QA Manager or his delegate will review and issue the Quality
System Manual in response to changing work scope, International Standards, amendments,
or whenever he may consider it appropriate. The minimum frequency for review of the Quality
System Manual is 12 months. All other lower-level documents will be reviewed as and when
deemed necessary by the Management Representative and issued by the Department
Heads. All levels of the documents will be authorized by the Management Systems General
Manager (MSGM) or Managing Director.

h. All valid documents used by TECNOGROUP are listed in TG-QMS-LD Matrix Documents
Register. The Matrix Documents Register shows the issue date, revision number, revision
date and history of changes performed, as well as the correct identification number.

4.6.4 Use of External Documents in Product Realization


When API product or other external specification requirements, including addenda, errata, and
updates, manufacture of the product, TECNOGROUP maintains a documented procedure for
the integration of these requirements into the product realization process and any other affected
processes, as per TG-QMS-P021 Management of change.

4.7 Control of Records


As per TG-QMS-P002 Quality Records Control Procedure
a. A system has been established as defined in TG-QMS-P002 Control of Records, for recording
and storing observed data, showing that contractual requirements have been met.
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b. Records, including those originating from outsourced activities, shall be established and
controlled to provide evidence of conformity to requirements and the TECNOGROUP quality
management system.
c. All records are considered as Quality records. Quality records are maintained for all activities
in the QMS.
d. Quality Records will be retained for a minimum period of 10 years or as required by the
customer, legal, and other applicable requirements whichever is longer. The Customer or his
representative may review these upon an agreement with TECNOGROUP.
e. Records are maintained as evidence of conformity and shall be protected from unintended
alteration.
f. Records are stored in a manner to allow easy access. The records are also stored in an
environment to prevent deterioration or loss in a hard or soft copy.

5 Product Realization / Realization and service-related


product

5.1 Contract Review

5.1.1 General
TECNOGROUP has established and implemented a documented procedure (As per TG-
QMS-P023 Contract Review) for the review of the requirements related to the provision of
products, and the execution of service-related products.

5.1.2 Customer Communication


TECNOGROUP has implemented effective communication with customers concerning:
a. Providing information relating to products or service-related products.
b. Handling inquiries, contracts, or orders, including changes.
c. Obtaining customer feedback relating to products, including customer complaints.
d. Handling or controlling customer property.
e. Establishing specific requirements for contingency actions, when relevant.

5.1.3 Determination of Requirements


As per TG-QMS-P023 Contract Review procedure. The following customer requirements shall
be determined (where applicable) before providing the products and, the execution of service-
related products.
a. Explicit customer requirements including delivery and post-delivery activities.
b. Implied customer requirements necessary for specified or intended use.
c. Requirements are related to product planning, execution, and evaluation.
d. Where the customer provides no documented statement of the requirements, the customer
requirements are confirmed by TECNOGROUP, and records are maintained.
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e. Any applicable statutory and regulatory requirements.


f. Additional requirements are determined by TECNOGROUP.

g. TECNOGROUP can meet the claims for the products it offers.


h. This review shall be undertaken by the Tendering Manager, and where necessary, other
management positions on accepting the Contract on behalf of TECNOGROUP and
conforming to the Customer Satisfaction as per TG-QMS-P022 Procedure.

5.1.4 Review of Requirements


As per TG-QMS-P023 Contract Review procedure
a. The Tendering Manager shall ensure that appropriate contents of each contract are reviewed
before TECNOGROUP Organizational commitment, relating to supply provision of products
to customers, to ascertain that the requirements are satisfactorily defined and documented.

b. The Tendering Manager shall review all the requirements specified by TECNOGROUP and
the requirements not stated by the customer, but necessary for the specified or intended use
when known.
c. The Tendering Manager shall review all the statutory regulatory requirements applicable to
the product.
d. The Tendering Manager shall review the requirements specified by the customer, including
the requirements for delivery and post-delivery activities.
e. The Tendering Manager shall ensure that all requirements differing from those previously
identified are resolved before committing to the contract.
f. Contract or order requirements differing from those previously expressed.
g. The final review of tenders shall involve the following categories of personnel where
appropriate – the Manager Director, Operation Manager Financial Controller, other
Department Heads, and the Legal department or delegates. The final review will include
aspects of the contract, which relate to commercial and statutory, and regulatory
requirements applicable to the products.
h. The Tendering Manager and the Operation Manager have the responsibility of evaluating
technical aspects of contracts that require their input as well as ensuring that
TECNOGROUP can satisfy contractual requirements by assessing current capability and
equipment availability together with available suitable, experienced, and qualified manpower.
i. The particulars of a confirmed Contract will be recorded, referring to the Customer details,
Job or Contract Number, Type of Order, Date Required, and Location, where appropriate
j. Amendments to contracts are approved and distributed by the Contract Holder, normally after
consulting Department Heads.
k. All orders/contracts and amendments reviewed and confirmed will be communicated to the
person concerned.
l. MR shall ensure that all records of review and actions shall be maintained as per TG-QMS-
P002 Control of Records.
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5.1.5 Changes to requirements for products


TECNOGROUP ensures that relevant documented information is amended and those relevant
persons are made aware of the changed requirements when the requirements for products are
changed.

5.2 Planning of Product realization or service-related product


provision
TECNOGROUP identifies, develops, and plans the processes and documents needed for
product realization and the execution provision of service-related products.
Planning of product realization and the execution provision of service-related products shall be
consistent with the requirements of the other processes of the quality management system.
Such planning considers the information related to the context of TECNOGROUP, current
resources, and capabilities, as well as the Products or Services requirements.

In planning, TECNOGROUP shall address the following:


a. Required resources and work environment management Determining the resources needed
to achieve conformity to the Product or service-related products requirements.
b. Establishing criteria for the processes and the acceptance of the Products or service-related
products.
c. Product or service-related product requirements
d. Customer-specified requirements.
e. Legal and other applicable requirements.
f. Contingencies based on risk assessment.
g. Implementing control of the processes per the criteria, required verification, validation,
monitoring, measurement, inspection, and test activities specific to the product and the criteria
for product acceptance.
h. Management of change (MOC); and
i. Records are needed to provide evidence that the product realization processes meet
requirements.
j. Key performance indicators.
k. The output of planning is documented and updated as changes occur. The plans are
maintained in a structure suitable for the TECNOGROUP method of operations.

l. TECNOGROUP maintains and retains all the documented information which demonstrates
that all the processes have been carried out as planned; demonstrates the conformity of
products to their requirements.

m. TECNOGROUP controls and reviews all the planned changes and reviews the
consequences of unintended changes, taking action to mitigate any adverse effects, as
necessary (as per TG-QMS-P021 Management of change and TG-QMS-P008 Risk
Management & Contingency plan).
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5.3 Risk Assessment and Management


a. TECNOGROUP established TG-QMS-P008 Risk Management & Contingency plan
procedure to identify and control risk associated with the impact on delivery and quality of
products and the execution provision of service-related products.
b. The risk assessment associated with the product and the execution provision of service-
related products delivery shall include:
c. Facility/equipment availability and maintenance.
d. Supplier performance and material availability/supply.

e. Identification of risks (potential or real) associated with service-related products.


f. Identification of risk management tools and techniques.
g. TECNOGROUP Selects, communicates, and implements all the mitigation or preventive
control measures to reduce or avoid exposure to loss; and
h. Notifies the customer of remaining risks that may impact the service.
i. Delivery of non-conforming products.
j. Availability of competent personnel.
k. The MR shall ensure the maintenance of all records related to Risk Assessment as per TG-
QMS-P002 Control of Records.

5.4 Design and Development of product(s)/service(s)


The design package is excluded from the scope of TECNOGROUP.

5.5 Contingency Planning


As per TG-QMS-P008 Risk Management and Contingency Plan Procedure.

5.6 General
TECNOGROUP maintains a documented procedure for contingency planning needed to
address risk associated with impact on delivery and quality product and
or provision of service-related products.
Contingency planning shall be based on assessed risks and output shall be
documented and communicated to the relevant personnel and updated as required.

5.6.1 Planning Output


a. The MR along with Operation Manager shall identify risks as mentioned in Risk
Assessment and Management, associated with the impact on delivery and quality of
product and/or service.
b. Taking the results of the risk assessment, the MR and operation Manager or
delegates shall prepare a contingency plan to mitigate the results of these risks and mitigate th
e effect of disruptive incidents.
c. Contingency planning output shall include, but is not limited to:
1. Actions required to mitigate significant risk scenarios.
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2. Responsibilities and authorities_to ensure proper execution of the contingency


planning.
3. Internal and external communications controls.

5.7 Purchasing
As per TG-QMS-P009 Purchasing Procedure, TECNOGROUP ensures that externally
provided processes and products conform to requirements.
a. TECNOGROUP is determining the controls to be applied to externally provided processes,
and products when:
1. Products or service-related products from external providers are intended for
incorporation into TECNOGROUP 's products and services.
2. Products and services are provided directly to the customer(s) by external providers
on behalf of TECNOGROUP, in this case, there will be a technical representative
from TECNOGROUP while delivering the mentioned.
3. A process, or part of a process, is provided by an external provider as a result of a
decision by TECNOGROUP.

b. TECNOGROUP determines, applies criteria, and maintains records for the evaluation,
selection, monitoring of performance, and re-evaluation of external providers, externally
provided processes, based on their ability to provide processes or products or service-related
products per requirements.

5.7.1 Purchasing Control


As per TG-QMS-P009 purchasing procedure and TG-QMS-WI-003 Approval of suppliers.
Through these mentioned procedures: -
a. It is the responsibility of the Operation Manager and/or Purchasing Manager or delegate, to
ensure that the correct specification(s) are provided for all purchased items and that these
items are accepted after necessary tests/ inspection.

b. Only sources satisfying TECNOGROUP requirements as defined in TG-QMS-P009


Purchasing procedure and included in the list of Approved Suppliers are selected for the
supply of products or service-related products That are critical to the quality of
TECNOGROUP activities.
c. Criteria for initial selection, evaluation, and re-evaluation will be established based on their
ability to supply products or service-related products per TECNOGROUP requirements and
results are recorded.
d. The Manager Director or The Management Representative or his appointed delegate shall
identify the criteria and controls applied to suppliers based on the criticality of the product or
the service supplied.
e. The Manager Director The Management Representative or his appointed delegate is
responsible for identifying the scope, frequency, and methods used for the reassessment of
the suppliers.
f. The Purchasing Manager shall keep an updated and approved list of approved suppliers.
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5.7.1.1 Initial Supplier Evaluation – Critical Purchases


As per TG-QMS-WI-003 Approval of Suppliers Working Instructions.
a. The Purchasing Manager with The Quality Assurance Manager shall verify that suppliers of
critical purchases adopt a quality management system that conforms with TECNOGROUP's
stated requirements.
b. The MR shall assess all suppliers of critical purchases to ensure capabilities to meet
TECNOGROUP's purchased requirements by:
1. Performing an on-site evaluation of relevant activities, or
2. Performing first article inspection to ensure conformance to stated requirements, or.
3. Identify how the supplied product or service and externally provided processes,
conforms to stated requirements when limited by proprietary, legal, and/or contractual
arrangements.

5.7.1.2 Initial Supplier Evaluation – Noncritical Purchases


As per TG-QMS-WI-003 Approval of Suppliers Working Instructions.
a. The Purchasing Manager with The Quality Assurance Manager shall verify that suppliers of
non-critical purchases (Products, components or activities, or service-related products) adopt
a quality management system that conforms with TECNOGROUP stated requirements, or
b. The MR or his delegate shall assess all suppliers of non-critical purchases to ensure
capabilities to meet TECNOGROUP's purchased requirements, or
c. The Quality Assurance Manager or his delegate shall assess the products or service-related
products upon delivery or activity upon completion.

5.7.1.3 Supplier Re-evaluation

a. For re-evaluation of all suppliers, critical or noncritical, TECNOGROUP implements the


requirement specified in the item as above mentioned.

b. TECNOGROUP maintains TG-QMS-PUR-F006 Approved Foreign Supplier List and


c. TG-QMS-PUR-F005 Approved Local Supplier List, in which all suppliers are categorized and
the frequency of evaluation is mentioned.

5.7.1.4 Supplier Evaluation - Records


The MR ensures that all records resulting from the supplier’s evaluation and re-evaluation are
maintained as per TG-QMS-P002 Quality Records Control.

5.7.2 Purchasing Information


TECNOGROUP establishes and communicates adequate purchasing requirements for:
a. Its externally provided processes, products, or service-related products.
b. Requirements for approval of supplier’s Products or service-related products procedures,
processes, equipment, methods, and the release of products.

c. The applicable version of specifications, drawings, process requirements, inspection


instructions, traceability, and other relevant technical data.
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d. Requirements for competency and qualification of supplier’s personnel; and


e. The external providers' interactions with the TECNOGROUP.
f. Requirements for acceptance criteria of externally provided processes, Products, or service-
related products.
g. Control and monitoring of the external providers' performance to be applied by
TECNOGROUP.

h. Verification or validation activities that TECNOGROUP, or its customer, intends to perform


at the external providers' premises.
i. Quality management system requirements.

5.7.3 Verification and control of Purchased Products or services related to


products, externally provided processes, and Activities

a. TECNOGROUP maintains a documented procedure for ensuring that the externally


Provided processes, purchased products, or service-related products activities meet
specified purchase requirements.
b. TECNOGROUP ensures and provides evidence that the externally provided processes,
purchased products or service-related products activities conform to the
specified requirements.

c. TECNOGROUP takes into consideration:


1. The potential impact of the externally provided processes, products, or services-
related products on TECNOGROUP's ability to consistently meet customer and
applicable statutory and regulatory requirements.
2. The effectiveness of the controls applied by the external provider.
j. When any purchased material or equipment and or service-related products arrive at
TECNOGROUP premises, the concerned Supervisor or delegates checks them for
condition and conformance to the Purchase order. He shall ensure that appropriate
certification has been received if mentioned on the purchase order, complete with Goods
Received Note and appropriate inspection work is carried out in accordance TG-QMS-P009
Purchasing.
k. When equipment returns from the service location, it shall be tagged and subject to the
necessary inspection and maintenance servicing as stated in documented procedures.
l. If any items are non-conforming, they will be subject to the procedures outlined in TG-QMS-
P003 Control of Nonconforming Products Procedure and tagged, labeled, or otherwise
identified as having a non-conforming inspection status.
m. All equipment is inspected before it is held as a stock item or dispatched. The exception to
this is where a customer has indicated that exceptional circumstances constitute an
operational emergency, requiring the equipment to be dispatched immediately, even though
inspection has not been performed due to time constraints. Under these circumstances, the
Operation Manager, Supervisor, or their delegates for the positive recall will register the
product.
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n. Where TECNOGROUP or its customer intends to perform verification at the supplier's


premises, TECNOGROUP states the intended verification arrangements and method of
product release in the purchasing information.
o. The MR keeps the records of the verification activities as per TG-QMS-P002 Control of
Records.

5.8 Production Provision


As per TG-QMS-P015 Product Provision Realization procedure

5.8.1 Control of Production

5.8.1.1 Production
TECNOGROUP maintains a documented procedure (As per TG-QMS-P015 Product Provision
Realization procedure) that describes controls associated with the production of products. The
procedure shall address the following:
a. The availability of information that describes the characteristics of the product and the
activities to be performed and the results to be achieved.
b. Implementation of the product quality plan, when applicable.
c. The availability and use of suitable production, testing, monitoring, and measurement
equipment.
d. The availability of work instructions, when applicable.
e. Process control documents.
f. The use of suitable infrastructure and environment for the operation of processes.
g. The validation, and periodic revalidation, of the ability to achieve planned results of the
processes for production, where the resulting output cannot be verified by subsequent
monitoring or measurement.
h. The appointment of competent persons, including any required qualification.
i. The implementation of actions to prevent human error.
j. Implementation of monitoring and measurement activities at appropriate stages to verify that
the criteria for control of processes or outputs, and acceptance criteria for products have been
met; and
k. Implementation of product release, including applicable delivery and post-delivery activities.

5.8.1.2 Process Control Documents


a. The Operation Manager or delegate/department Supervisor shall document the process
controls in the shape of route sheets, and ITPs.
b. The process control documents shall include the requirement for verification of conformance
with applicable quality plans, procedures, API specification(s), customer requirements, and/or
other applicable standards and codes, as well as acceptance criteria and required customer
inspection or witness points.
c. Personnel Qualifications:
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1. TECNOGROUP maintains a documented procedure as per Quality Control


Personnel Qualifications (TG-QMS-P027) that specify the minimum requirements for
Quality control personnel qualification to visual examinations (NDE) that shall be
performed, as necessary, during the fabrication and erection of components to
provide verification that the design and WPS requirements are being met.

5.8.1.3 Product Realization Capability Documentation


TECNOGROUP maintains documentation such as product realization plans and records of
review/verification, validation, monitoring, measurement, inspection, and test activities, including
criteria for product acceptance that demonstrates the capability of TECNOGROUP to satisfy
specified product requirements.

5.8.1.4 Validation of Processes for Production


a. The QA Manager and the Operation Manager or delegates shall ensure that validation of
these processes shall demonstrate the ability of these processes to achieve the planned
results.

b. Where TECNOGROUP chooses to outsource a process that requires validation,


TECNOGROUP requires that the supplier conforms to these requirements.

c. TECNOGROUP maintains a documented procedure to address methods for review and


approval of the processes as per TG-QMS-P012 Inspection and Test Equipment Procedure:
1. Required equipment.
2. Qualification of personnel.
3. Use of specific methods.
4. Identification of acceptance criteria.
5. Requirements for records.
6. Revalidation.

d. TECNOGROUP validates those processes identified by the applicable product specification


as, heat treatment, welding, and non-destructive examination, and if applicable to the product.

5.8.2 Product Quality Plans


When required by contract, TECNOGROUP develops a Product Quality Plan (As per TG-QMS-
P006) that specifies the processes of the quality management system (Including the product
realization processes) and the resources to be applied to a product. The product quality plan
required by the contract shall address each of the following as a minimum:

a. Description of the product to be manufactured or done.


b. Required processes, activities, and documentation, including required inspections, and
records, for conformance with customer requirements.

c. Identification and reference to control of outsourced activities and subcontractors.


d. Identification of each revision procedure, specification, or other document referenced or used
in each activity.
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e. Identification of the required hold, witness, monitor, and document review points to perform
acceptance for the representative of TECNOGROUP and the customer.
f. Identification of the required deliverables, and identification of the required records.
g. Identification and controls of risk.
h. Identification of functions responsible for each activity, including external parties.
These product quality plans and any revisions to them are documented and approved by The QA
Manager to ensure customer requirements are met. These product quality plans and any revisions
shall be updated and communicated to the customer.

5.8.3 Identification and Traceability

a. TECNOGROUP maintains a documented procedure for identification and traceability of


service-related products and the product is under the control of TECNOGROUP as required
by TECNOGROUP as per TG-QMS-P020.
b. The procedure includes identification controls at all stages of delivery, activities, and
installation required by TECNOGROUP and the customer.
c. The procedure includes requirements for maintenance or replacement of identification and
traceability marks, verification, protection, and safeguarding of customers' or external
providers' property provided for use or incorporation into the products.
d. Product and critical service-related products are identified, and traceable to preventive
maintenance, inspection, and test program (PMITP).
e. The Product provided at the customer premises is identified by reference to the Customer
details operation work log sheet.
f. The Quality Assurance Manager establishes an identification system that uses color codes
to indicate the current status of a product or service-related products.
g. When it is not practical to operate a labelling Procedure, the inspection status shall be
indicated by appropriate marking on the product or service-related products themselves,
which will be backed up by necessary records in agreement with the Quality Assurance
Manager or delegate.
h. Control features are established to include requirements for the maintenance or replacement
of the identification and traceability marks, and records.
i. Each item/ Product shall be identified and traceable through all stages, of manufacture.
j. All Measurement Equipment is affixed with a label that shows equipment serial no. and when
it is due for calibration.
k. The Quality Assurance, Head Department or delegate, and the storekeeper shall keep copies
of all records related to identification and traceability as per TG-QMS-P002 Control of
Records.

5.8.4 Product Inspection/Test Status


As per TG-QMS-P016 Inspection and Testing Procedure.
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a. The Quality Control Manager or delegate shall identify the process of product inspection
and/or test status throughout the process.
b. The Quality Control Manager or delegate shall ensure the implementation of the inspection
and/or test process throughout the process.
c. The Quality Control Manager or delegate shall ensure that only products or Service-related
product status that meet the requirements shall be released. Non-conforming products o
Service-related products shall be dealt with as per TG-QMS-P003 Control of Nonconforming
Products or Service-related product Procedure.

5.8.5 Customer-supplied Property


As per TG-QMS-P025 Customer Property Procedure.
a. All Customer supplied items for the use in the product and/or with the service-
related product, including intellectual property and data, received by
TECNOGROUP will be inspected upon receipt by the storekeeper and the relevant
Supervisor or his delegate for the service per TG-QMS-P020
Identification and Traceability and TG-QMS-P025 Customer Property. These items
shall be identified, verified, protected, safeguard, and stored, also these items shall
be maintained and processed into the system after the such inspection had been undertaken.
b. Customer's or external provider's property can include materials, components, tools
and equipment, premises, intellectual property, and personal data.
c. When the property of a customer or external provider is lost, damaged, or otherwise
or otherwise found to be unsuitable for use, the items concerned shall be placed in
quarantine, TECNOGROUP reports this to the customer who will be asked to provide a
written instruction on further action required. In the event of a non-conformance, an
NCR (Non-Conformance Report) will be raised and processed.
d. The QA or The QC, respective Department heads,andthe Storekeeper Maintains
records for the control and disposition of customer-supplied property.

5.8.6 Preservation of product


As per TG-QMS-P010 Storing, Handling procedure, and Material Specification (MSPEC).
a. Preservation of Product shall be limited to customer property supplied for manufacture at the
TECNOGROUP yard and this preservation includes identification and traceability marks,
storage, handling, and protection.
b. Storage and assessment (as per TG-QMS-P010 Storing, Handling procedure, and (MSPEC)
Material Specification, these procedures include identification, handling, contamination
control, packaging, storage, transmission or transportation, and protection.
c. TECNOGROUP identifies the requirements for storage and assessment.

d. TECNOGROUP uses designated storage areas to prevent damage or deterioration of


Product or service-related products, pending use or delivery.
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e. To prevent the deterioration, TECNOGROUP maintains records, procedures, and intervals


that shall be appropriate to the Products or services related products or constituent parts
being assessed Customer supplied Product or service-related products shall be dealt with as
per TG-QMS-P015 Product Provision and Realization.

5.8.7 Inspection and Testing


As per TG-QMS-P016 Inspection and Testing Procedure.

5.8.7.1 General
TECNOGROUP maintains a documented procedure (TG-QMS-P016 Inspection and Testing
Procedure) for inspecting and testing to verify that the product or service-related product
requirements have been met.
The process shall include the in-process and final inspection and testing. Records shall be
maintained as per TG-QMS-P002 Control of Records.

5.8.7.2 In-process Inspection and Testing


a. The QC manager shall define inspection and test points during the process, The Operation
Manager shall ensure that the in-process inspection and testing are as per the quality plan,
and process control document procedure.
b. The Operation Manager or delegate shall ensure that these inspections and testing are taking
place as planned. The QA or QC Manager maintains Records as per TG-QMS-P002 Control
of Records.

5.8.7.3 Final Inspection and Testing


c. The QC Manager shall ensure that final inspection and testing shall take place as described
in the Quality plan (as per TG-QMS-P006).
d. The QC Manager shall ensure that personnel other than those who did the process are
conducting the final inspection and testing.

5.8.8 Validation of product


Validation of the products or services-related products is completed before the execution of the
service and records of the results of this process of validation when performed are maintained.

5.8.9 Preventive maintenance plan (PMP)


As per TG-QMS-P019 Preventive Maintenance Equipment Procedure.
a. The QA Manager and the Maintenance Manager develop and maintain a documented
procedure (As per TG-QMS-P019) for the (PMP) preventive maintenance plan for all
equipment used in TECNOGROUP activities.
b. The plan shall identify requirements for:
1. Type of equipment.
2. Frequency of maintenance.
3. Responsibility.
c. As a minimum, the PMIP shall include:
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1. Actions that address preventive maintenance.


2. Reports that document usage history, repairs or redress, modifications,
remanufacturing, inspection, and test activities that allow direct verification for reuse
of the product.
3. List of critical spare parts requirements by the customer and/or technical
requirements including those recommended by the original equipment manufacturer;
and
4. Controls that ensure equipment integrity to original performance requirements and
design acceptance criteria are maintained.
NOTE; The PMP is also based on the risk, system reliability, usage history,
experience, industry recommended practices, relevant codes, and standards, original
equipment manufacturing guidelines, or other applicable requirements.
d. Records of PMP preventive maintenance shall be maintained, tested and
inspection program.
e. Original performance requirements that cannot be met shall undergo the MOC
process for continued use.

5.9 Control of Testing, Measuring, Monitoring, and detection


Resources

5.9.1 General
As per “TG-QMS-P012 Inspection and Test Equipment” Measuring, Monitoring, and detection
Equipment and Calibration Instruction.
a. TECNOGROUP determines and provides the resources needed to ensure valid and reliable
results when monitoring or measuring is used to verify the conformity of products to
requirements. TECNOGROUP ensures that the resources provided:
1. Are suitable for the specific type of monitoring and measurement activities being
undertaken.
2. Are maintained to ensure their continuing fitness for their purpose,
TECNOGROUP retains appropriate documented information as evidence of fitness
for purpose of the monitoring and measurement resources.
b. A calibration and maintenance system will be employed to ensure that the quality of
TECNOGROUP equipment and product is consistently maintained and documented. The
system shall encompass all inspection and measuring, Monitoring, and detection equipment,
used in TECNOGROUP activities, as explained in TG-QMS-P012 Inspection and Test
Equipment.
c. The QA Manager or his delegate shall have final responsibility for the calibration system. The
QA or his delegate is responsible for the maintenance of measuring and test equipment and
the update of documentation related to calibration, repair, and certification, QA or his delegate
is also responsible for the identification of calibration or inspection methods including
adjustments or the re-adjustment.
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d. The accuracy of all measuring equipment should be traceable to National and/ or International
Standards.
e. Inspection, measuring, Test, monitoring, and detection equipment shall be calibrated at
quarterly intervals established by stability and usage. All equipment will have unique labels
affixed to it, which provide the serial number, and the due date for the next calibration.

f. TECNOGROUP ensures that the environmental conditions are suitable for the calibrations,
inspections, measurements, and tests being carried out. A temperature range of 15 to 25
degrees Celsius has been adopted as the suitable temperature required for calibration. This
is ensured with the aid of a thermometer placed in the room where the calibration process is
carried out.
g. Each item of inspection, measuring, and test equipment has been recorded in the Calibration
Register and each instrument has its Calibration Record and status that lists the previous
calibration history instrument.

h. TECNOGROUP assesses and records the validity of the previous measuring results when
the equipment is found not to conform to requirements. The equipment used by the QA/QC
Inspectors is entered in the Inspection Report so that the products inspected by any
equipment can be traced.
i. Before being put into use, every instrument is checked against slip gauges or the standard
setting rods to ensure that the measuring equipment is not out of calibration.

j. TECNOGROUP takes appropriate action on the measuring equipment and any product
affected by the equipment, the discrepant measuring equipment would be referred for re-
calibration. However, if the equipment cannot be re-calibrated, it shall be marked as “beyond
repair” in the Calibration Register and shall be removed from service. Similar observations
will be recorded in the Calibration Record of the discrepant measuring equipment.
k. The acceptance criteria for any measuring equipment have been detailed in Calibration
Instruction.
l. The Quality Assurance Manager or delegate will ensure that where sub-contractors are
utilized, they conform to all Company requirements concerning inspection, measuring, and
test equipment.
m. when used in the testing, measurement, monitoring, and detection of specified requirements,
the ability of computer software to satisfy the intended application is confirmed. This is
undertaken before initial use and reconfirmed as necessary.
n. when specified, technical data of measuring equipment will be made available to the customer
or their representative for verification so that such equipment is functionally adequate.
o. The measuring equipment will be maintained well to safeguard its integrity and avoid misuse
as well as protected during handling, maintenance, and storage.

5.10 Product Release


As per TG-QMS-P016 Inspection and Testing Procedure.
a. The QA Manager shall ensure that the final product or service-related product shall not be
released until all final inspections and testing have been conducted at appropriate stages,
with evidence of conformity with the acceptance criteria and proved satisfactory of planned
arrangements and with the traceability to the person who authorized the release.
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b. In case final inspection and testing were not applicable, the Quality Assurance Manager shall
arrange with relevant authorities and/or customer to authorize release.
c. Records of final inspection and testing, Evidence of conformity with acceptance criteria and/or
authorization of relevant authorities or customers, and identification of individual releasing
products are maintained.

5.11 Control of Non-conformities

5.11.1 General
As per TG-QMS-P003 Nonconformance Control Procedure.
a. The Quality Assurance Manager and Operation Manager or delegates maintain (TG-QMS-P003
Nonconformance Control Procedure.) to identify the controls and related responsibilities and
authorities for addressing non-conformances cases.
b. In case the non-conformance case has been identified during the product realization, controls
should address:
1. Product or service-related product realization to prevent unintended use or delivery.
2. Addressing the detected non-conformance.
3. Correction.
4. Segregation, containment, return, or suspension of the provision of products.
5. Informing the customer.
6. Corrections by Taking action(s) to preclude its original intended use, and
7. Obtaining Authorization for its use, release, or acceptance under concession by a
relevant authority and/or by a customer.
c. In case the non-conformance case has been identified after delivery, controls should address:
1. Identifying, documenting, and reporting non-conformances identified after delivery.
2. Ensuring the analysis of non-conformance or failure.
3. Taking action(s) appropriate to the effects, or potential effects of the non-
conformance.

5.11.2 Non-conforming Product


As per TG-QMS-P003 Nonconformance Control Procedure.
a. The Quality Assurance Manager and the Operation Manager shall identify the disposition of
the non-conformance, including:
1. Repair or rework with a subsequent inspection to meet specified requirements, or
2. Re-grade for alternative applications, or
3. Release under concession, or
4. Reject and/or scrap.
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5.11.3 Release of Non-conforming Product under Concession


The evaluation and release under concession of non-conforming servicing that does not satisfy
manufacturing acceptance criteria shall be permitted when TECNOGROUP's relevant authority
and the customer have authorized the release, providing that it does not affect or contradict the
design acceptance criteria:
a. If the products continue to satisfy the applicable customer criteria; or
b. The violated MAC is categorized as unnecessary to satisfy the applicable customer criteria.

5.11.4 Verification and Documentation


When nonconforming products or service-related products are corrected they shall be subject to
verification to demonstrate conformity to the requirements.
Records of the nature of nonconformities and any subsequent actions taken, including concessions
obtained, are maintained.

5.11.5 Customer Notification


a. The Quality Assurance Manager or delegate shall notify the customer of product or service-
related product non-conformance to contract requirements.
b. Records shall be maintained.

5.11.6 Records
The Quality Assurance Manager shall ensure that all records related to non-conformances are
maintained as per TG-QMS-P002 Control of Records Procedure.

5.12 Management of Change and planning for change


As per TG-QMS-P021 Management of Change Procedure which describes the MOC’s processes
and describes the results, impact, and effect of the changes, it describes also the persons who
authorize the change and any necessary actions arising from the change.

5.12.1 General

a. TECNOGROUP maintains a procedure (TG-QMS-P021 Management of Change


Procedure) for the process of Management of Change. When TECNOGROUP determines
the need for changes to the quality management system, the changes shall be carried out in
a planned manner. TECNOGROUP considers the following: -
1. The purpose of the changes and their potential consequences.
2. The integrity of the quality management system.
3. The availability of resources.
4. The allocation or reallocation of responsibilities and authorities.
b. The Quality Manager, HSE Manager, and Operation Manager or delegates shall evaluate the
Request for Change, taking into consideration the potential Risks associated with this change
that may have a negative impact on the quality of the Product and the integrity of the
Management System.
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c. All the MOCs are registered as per TG-QMS-P021 in the Management of Change Register
TG-QMS-HSE-F004.

5.12.2 MOC Implementation


a. Department heads are allowed to submit a Request for Change that may affect negatively the
Quality of product, and the quality of serviced related products such as:
1. Changes and proposed changes in TECNOGROUP organizational structure, or
2. Changes in key or essential personnel, whose absence or departure could negatively
impact the quality of the Product.
3. Changes in critical suppliers whose absence or departure could negatively impact
the quality of the Product. or
4. Changes to Management System procedures, and work instructions, including
changes resulting from corrective and preventive action.
5. Changes to original equipment manufacturer’s specifications, applications, and/or
software for a product or service-related products.
6. Changes in approved design including those that were originally agreed upon by the
customer and those required by changes in legal and other applicable requirements.
b. The Quality Assurance Manager shall notify relevant personnel, including the customer, when
applicable (as per TG-QMS-P018 Communication), of the changes and any residual risk due
to the changes that have either been initiated by TECNOGROUP or requested by the
customer.

6 QMS Monitoring, Measurement, Analysis, Evaluation, and


Improvement

6.1 General
a. The monitoring, measurement, analysis and improvement processes need to be planned
and implemented by TECNOGROUP to ensure conformity of the product or service-
related product and their continual improvement. TECNOGROUP determined:
1. What needs to be monitored and measured?
2. The methods for monitoring, measurement, analysis and evaluation are needed to
ensure valid results.
3. When the monitoring and measuring shall be performed.
4. When the results from monitoring and measurement shall be analyzed and
evaluated.
TECNOGROUP evaluates the performance and effectiveness of the quality management
system.
TECNOGROUP retains appropriate documented information as evidence of the results.
b. The applicable methods and techniques for data analysis are Based upon data collected in
our Customer related processes, Control of production or service-related product, and
Purchasing, TECNOGROUP develops and maintains the capability to monitor Servicing,
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Personnel, Safety, Environment, Cost of Conformance, Cost of Non-conformance,


Equipment and Sales Products to help prevent and detect problems before they occur.
c. Corrective/ preventive action requests initiated by TECNOGROUP personnel and input
from customers shall be reviewed and considered as a contributing factor to changes or
refinements to TECNOGROUP activities or QMS Reference-TG-QMS-P005 Corrective
and Preventive Actions Procedure.

6.2 Monitoring, Measuring, and Improvement

6.2.1 Customer Satisfaction


a. TECNOGROUP maintains a procedure to measure customer satisfaction as per TG-QMS-
P022 Procedure.
b. TECNOGROUP obtains feedback from the customers after the completion of a job in a
standard format to monitor the customer’s perception of the degree to which their needs
and expectations are fulfilled, which will be measured, monitored, and analyzed for
continuous improvements.
c. Customer complaints are logged as non-conformances and treated in the same manner as
TECNOGROUP's non-conformances, Key performance indicator KPIs are information
used by TECNOGROUP, Investigation will be carried out to find the root causes, and
necessary corrective and preventive actions are taken to avoid recurrence and thus
enhance customer satisfaction.
d. The methods for obtaining and using this information include:
1. Recording customer complaints and customer feedback on delivered products
provided.
2. Product rejections or returns.
3. Repeat orders for products.
4. Market share analysis and compliments.
5. Warranty claims and dealer reports.
6. Customer survey through meeting and Site visit survey.
7. Changing volume of orders for product.
8. Trends in on-time delivery.
9. Obtain customer scorecards from certain customers.
10. Submittal of customer satisfaction surveys.
e. The corrective and preventive action system shall be used to develop and implement plans
for customer satisfaction improvement that address deficiencies identified by these
evaluations, and assess the effectiveness of the results.

6.3 Internal Audit


As per TG-QMS-P004 Internal Audit Procedure.
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6.3.1 General
a. TECNOGROUP maintains a documented procedure (TG-QMS-P004 Internal Audit Procedure)
in which are defined all responsibilities for planning, conducting, and documenting internal audits
at planned intervals.
b. A system for quality audit is established. The audits are performed per a specified plan, which
states on which activities an audit is to be undertaken, and when it is to be carried out to ensure
that: -
1. The quality management system is effectively implemented and maintained.
2. Conforms to TECNOGROUP’s requirements for its quality management system.
3. Conform to the requirements of the International Standards API Q1_9th, API
6A_21th, API 6D_24th & ISO 9001;2015.
c. TECNOGROUP plans to establish, implement, and maintain an internal audit program that
includes the audit criteria, scope, frequency, responsibilities, planning requirements, and
reporting and methods.
d. The Outsourced activities that impact the quality of the product or service-related product and
which are performed at TECNOGROUP’s facility are included as part of the internal audit of
TECNOGROUP.
e. TECNOGROUP performs and follows up Audits on areas where a Non-conformance has been
detected to verify and record the implementation and effectiveness of the corrective and/ or
preventive actions taken.
f. Results from audits will be reported to the relevant Management and subject to review in the
Management Review meeting (as per TG-QMS-P007 Management Review).
g. The results from the previous audit and the changes affecting TECNOGROUP shall be taken
into consideration during the next audit.
h. The internal audits shall be scheduled and conducted (as per TG-QMS-QA-F008 Internal Audit
Plan) at least every 6 months to ensure that all processes of the quality management system
conform with requirements.

6.3.2 Performance of audits


Suitably selected trained personnel, following TG-QMS-P004 Internal Audit who is not directly
responsible for performing the activity or operation, will perform the audit to ensure objectivity and
the impartiality of the audit process.
a. The results of the audits are documented on an Audit Summary Report (as per TG-QMS-
QA-F009 Internal Audit Summary Report) and corrective action is initiated without undue
delay where required by the auditee/management of the area audited.
b. All processes of the quality management system required to meet this specification shall be
audited before claiming conformance to the requirements of this specification.

6.3.3 Audit review and closure


TECNOGROUP identifies response times for addressing the detected nonconformities (as per TG-
QMS-QA-F012 NCR). The Manager responsible for the relevant area audited shall ensure that any
necessary corrections and corrective actions follow the requirements specified and all the results of
internal audits and the status of corrective actions taken shall be reported to the relevant
Management and discussed in the management review. Records of internal audits shall be
maintained (as per TG-QMS-P002 Control of Record Procedure).
QMS Manual Code TG-QMS-MAN001
Level 1 Iss. Date 01/08/2021
Revision 03
Quality Management System Manual Rev. Date 01/11/2022
Page 44 of 50

6.3.4 Process Evaluation


a. By maintaining databases and a suitable evaluation method TECNOGROUP can give Customer
guidelines for use and be able to improve processes through procedures. TECNOGROUP
evaluates this process to achieve the planned results in conformity to the product or service-
related product requirements.
b. The facility is provided for the customer to assess job performance after a job is done. In this
manner it is possible to analyze how well customers’ requirements are met continuously and if the
planned results are not achieved, the management makes corrections and corrective actions as
appropriate.

6.3.5 Analysis of Data and Evaluation


As per TG-QMS-P017 Data Analysis Procedure.
a. TECNOGROUP determines, collects, and analyses necessary data for the effectiveness
and continuous improvement of QMS. The data analysis is relevant to but not limited to
internal audits, management review, monitoring, and measurement and the results of the
analysis shall be used to evaluate:
1. Customer satisfaction degree.
2. The performance and effectiveness of the quality management system.
3. If the planning has been implemented effectively.
4. Conformity to product requirements.
5. Nonconformities and product failures are identified after delivery or use, provided the
product or documented evidence is available to facilitate the determination of the
Causes.
6. Characteristics and trends of processes, products, or a service-related product
including opportunities for addressing risks and opportunities and preventive action.
7. The effectiveness of the action taken.
8. The need for improvement.
9. The performance of external providers.
10. Quality objectives.
b. Statistical Techniques can be referenced from TG-QMS-P017 Data Analysis for the
improvement of the effectiveness of the quality management system.

6.4 Improvement

6.4.1 General
a. TECNOGROUP determines and selects opportunities for improvement and implements
any necessary actions to meet customer requirements and enhance customer satisfaction.
These shall include:
1. Improving products to meet requirements as well as to address future needs and
expectations.
2. Correcting, preventing, or reducing undesired effects.
3. Improving the performance and effectiveness of the quality management system.
QMS Manual Code TG-QMS-MAN001
Level 1 Iss. Date 01/08/2021
Revision 03
Quality Management System Manual Rev. Date 01/11/2022
Page 45 of 50

NOTE Examples of improvement can include correction, corrective action, continual


improvement, breakthrough change, innovation, and re-organization.

b. Quality policy, objectives, audit findings, data analysis, corrective/ preventive actions,
management reviews, customer feedback, etc. will be used as drivers to effect continual
improvement of TECNOGROUP QMS processes for the Production or service-related
products.

6.4.2 Corrective Action


a. As per TG-QMS-P005 Corrective and preventive action Procedure. A corrective action
system has been established to detect and correct any condition, which causes or may
cause non-conformance on-site, this corrective action is to eliminate or to minimize the
likelihood of its reoccurrence and shall be appropriate to the effect of the nonconformity. If
required as part of the corrective action, necessary revision is done to the documented
manual, procedure, instructions, forms, etc.
b. A documented Corrective action procedure TG-QMS-P005 includes: -
1. Reviewing the process of nonconformities including the customer complaints and
Investigations of the source to determine and implement corrections after identifying
the root cause of the non-conformity to eliminate the causes to prevent occurrence
on subsequent occasions.
2. Analysis of non-conforming products and quality-related documentation to determine
and eliminate potential causes and to reduce the likelihood that a non-Conformity
reoccurs.
3. Evaluate the need for action to eliminate the cause of the nonconformity, so that it
does not recur or occur elsewhere, by:
i. Reviewing and analyzing the nonconformity.
ii. Determining the causes of the nonconformity.
iii. Determining if similar nonconformities exist, or could potentially occur.
4. Implementing the actions needed.
5. Identifying the timeframe and the responsible person for addressing corrections and
corrective action.
6. Ensuring and reviewing Suitable controls to ensure that corrective actions are taken
and that they are effective.
7. MOC (as per TG-QMS-P021) when the corrective actions require new or changed
controls within the quality management system.
8. Update risks and opportunities determined during planning, if necessary.
9. The recording and implementing of procedural changes resulting from corrective
actions.

6.4.3 Preventive Action


As per TG-QMS-P005 Corrective and preventive action.
a. Preventive action as per documented Preventive Action procedure TG-QMS-P005 shall be
implemented as appropriate when information is obtained from process and work operations
QMS Manual Code TG-QMS-MAN001
Level 1 Iss. Date 01/08/2021
Revision 03
Quality Management System Manual Rev. Date 01/11/2022
Page 46 of 50

that affect product quality, audit results, quality records, and customer complaints, to detect,
analyze and eliminate potential causes of non-conformities.
b. Preventive action shall be applied as above and investigated for root cause analysis. Once
the cause has been determined, preventive measures shall be applied and the effectiveness
reviewed at an appropriate time.
c. Identifying the timeframe including any immediate or short time action required and the
responsible person for addressing the preventive action.
d. Ensuring and reviewing the effectiveness of corrective and preventive measures is reviewed
as required under Management Review TG-QMS-P007 Procedure.
e. TECNOGROUP has a preventive maintenance system in place guided by technical and
manufacturer's manuals, field experience, resolved non-conformities, and Quality control
procedures/instructions/forms.
f. MOC when the preventive actions require new or changed controls within the quality management
system.
g. The recording and implementation of procedural changes resulting from corrective actions are
recorded and maintained.

6.5 Management Review


As per TG-QMS-P007 Management Review Procedure.

6.5.1 General
TECNOGROUP reviews its quality management system at least every 12 months by the
management to evaluate the quality management system’s continuing suitability, adequacy,
effectiveness, and alignment with the strategic direction of TECNOGROUP.

This review shall include assessing opportunities for improvement and the need for changes to the
quality management system, including the quality policy and quality objectives.

6.5.2 Input Requirements


The input to management review shall include, as a minimum:
a. Effectiveness of actions resulting from previous management reviews.
b. The effectiveness of actions taken to address risks and opportunities.
c. Results of audits.
d. Changes that could affect the quality management system, include changes to legal and other
applicable requirements (such as industry standards) and changes in external and internal issues.
e. The extent to which quality objectives have been met.
f. Analysis of customer satisfaction, including customer feedback and feedback from relevant
interested parties.
g. Process performance.
h. The adequacy of resources.
i. Results of risk assessment.
j. Status of Non-conformities, corrective and preventive actions.
k. Analysis of the performance of the external providers.
QMS Manual Code TG-QMS-MAN001
Level 1 Iss. Date 01/08/2021
Revision 03
Quality Management System Manual Rev. Date 01/11/2022
Page 47 of 50

l. Review of the analysis of failures product or service-related product conformity, including


nonconformities identified after delivery or use and;
m. Recommendations for improvement.

6.5.3 Output Requirements


a. The output from the management review shall include a summary assessment of the effectiveness
of the quality management system. The assessment shall include:

1. Any required changes to the QMS and the processes and any decisions and actions
and;
2. Required resources, and;
3. Opportunities for improvement such as and are not limited to the Improvement of
products or service-related products in meeting customer requirements.
b. Top management reviews (as per TG-QMS-P007 Management Review procedure) and approves
the output of management reviews. Management reviews shall be documented and records of
these reviews shall be maintained.

6.6 Continual Improvement


Through the process effectiveness reviews, done as part of the Management Review,
TECNOGROUP works to continually improve the suitability, adequacy, and effectiveness of the
quality management system:
1. This includes seeking opportunities for improvement through.
2. Improving products to meet requirements as well as to address future needs and
expectations.
3. Correcting, preventing, or reducing undesired effects.
4. Improving the performance and effectiveness of the quality management system.

NOTE Examples of improvement can include correction, corrective action, continual


improvement, breakthrough change, innovation, and re-organization.

7 Appendixes

7.1 Appendix I: Use of API Monogram by Licensees as per API Q1

7.1.1 Quality Management System Requirements


TECNOGROUP develops, maintains, and operates at all times a quality management system
conforming to API Q1 9th Edition.
QMS Manual Code TG-QMS-MAN001
Level 1 Iss. Date 01/08/2021
Revision 03
Quality Management System Manual Rev. Date 01/11/2022
Page 48 of 50

7.1.2 Control of the Application and Removal of the API Monogram per API
Q1
TECNOGROUP shall control the application and removal of the API Monogram per the
following:
a. Products that do not conform to API-specified requirements shall not bear the API Monogram.
b. TECNOGROUP develops and maintains an API Monogram marking procedure (TG-QMS-P014
API Monogram Application) that documents the marking/monogramming requirements specified by
this annex and any applicable API product specification(s) and/or standard(s). The marking
procedure shall:

1. Define the authority responsible for the application and removal of the API
Monogram.
2. Define the method(s) used to apply the Monogram.
3. Identify the location on the product where the API Monogram is to be applied.
4. Require the application of TECNOGROUP’s license number and date of
manufacture of the product in conjunction with the use of the API Monogram.
5. Require that the date of manufacture, at a minimum, be two digits representing the
month and two digits representing the year (e.g., 09-21 for Sep. 2021) unless
otherwise stipulated in the applicable API product specification(s) or standard(s); and
6. Require controls for the application of the additional API product specification(s) and
/or standard(s) marking requirements, as applicable.
c. TECNOGROUP shall apply the API Monogram and its designated specification with the license
number to API Monogrammable products.
d. The API Monogram license, when issued, is site-specific and subsequently, the API Monogram
shall only be applied at that site-specific licensed facility location.
e. The API Monogram may be applied at any time appropriate during the production process but shall
be removed per the TECNOGROUP Monogram marking procedure TG-QMS-P014 API
Monogram Application if the product is subsequently found to be out of conformance with any of
the requirements of the applicable API product specification(s) and/or standard(s) and API
Monogram Program.
QMS Manual Code TG-QMS-MAN001
Level 1
Iss. Date 01/08/2021
Revision 03
Quality Management System Manual Rev. Date 20/05/2022
Page 49 of 50

7.2 Process Interaction


TOP MANAGEMENT MANAGEMENT REVIEW
Quality Policy Recommendations for Improvement
Resources Audit Results Customer Feedback
Risk based thinking
Leadership and commitment MEASUREMENT & ANALYSIS

Revenue Corrective & Preventive


Request for Quote CONTRACT REVIEW Actions

Process
Interested parties REQUIREMENT

Input for Tenders / Quotes Performance


CUSTOMER REQUIREMENT

Contracts
Resource Requirements

CUSTOMER SATISFACTION
Internal external issues • Support Process, KEY PROCESSES
resources and • Quality Risk Delivered Equipment Product
Contract Req. infrastructure. Equipment / Material • Control of Production, /or service-related product
Management
• Quotations and Servicing Execution and
Sales. Provision.
• Legal and
Job Req. • Local and Expenditure / Costs • Marking and traceability
other
International applicable • Inspection and testing
Purchasing. • Product Validation
TECNOGROUP Req. requirements Competency/awareness
• Administration and
Finance. • PMITP Training Plan
• Human Resources,
Statuary Regulatory Req.
Training and
awareness,
organizational
Knowledge

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