QA&QC
QA&QC
QA&QC
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.
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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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 applies to the product categories mentioned below and satisfies API Q1_9th, API
6A_21th,& ISO 9001;2015.
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.
3.1.3 Calibration
Comparison to a standard of known accuracy and making any needed adjustment(s).
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Level 1 Iss. Date 01/08/2021
Revision 03
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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.
a. Prototype tests,
b. Functional and/or operational tests of production products,
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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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.
3.1.22 Servicing
Product maintenance, adjustment, repair, and/or on-site installation when installation is required by
applicable product specifications.
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.
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.
BD Business Development
HR Human resources
MD Managing Director
MR Management Representative
QA Quality Assurance
QM Quality Manual
QP Quality Plan
4 Context of TECNOGROUP
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.
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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Level 1 Iss. Date 01/08/2021
Revision 03
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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.
4.3.1.1 General
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.
The scope of TECNOGROUP is covering; the Provision of Wellhead and Christmas Tree
Equipment (Blind and Test Flanges).
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.
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.
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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Level 1 Iss. Date 01/08/2021
Revision 03
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TECNOGROUP operations is an entity engaged in the machining services for the manufacture
of Flanges (Blind and Test).
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 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
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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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.
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
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:
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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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.
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?
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.
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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Level 1 Iss. Date 01/08/2021
Revision 03
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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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Level 1 Iss. Date 01/08/2021
Revision 03
Quality Management System Manual Rev. Date 01/11/2022
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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.
4.5.2.1 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.
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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Level 1 Iss. Date 01/08/2021
Revision 03
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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
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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Level 1 Iss. Date 01/08/2021
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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.
4.6.1 GENERAL
The QMS documentation consists of:
3. Training Requirements.
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.
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.
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.
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.
5.1.1 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.
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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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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5.6 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.
5.7 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.
5.8.1.1 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.
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.
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.
5.8.7.1 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.
5.9.1 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.
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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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.
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.
5.11.1 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.
5.11.6 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.
5.12.1 General
c. All the MOCs are registered as per TG-QMS-P021 in the Management of Change Register
TG-QMS-HSE-F004.
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,
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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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.
6.4 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
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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.
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.
6.5.1 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.
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.
7 Appendixes
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
Process
Interested parties 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