QUALITY MANUAL

DOC NO: QM0997, REVISION 27.0 , JANUARY 02, 2018

PARVEEN INDUSTRIES PRIVATE LIMITED,

MAHARASTRA – 400 701,
INDIA.
Email: parveen@vsnl.com,
Website: www.parveen.in.

PREPARED BY

REVIEWED BY

APPROVED BY
 INDEX

1.0 DISTRIBUTION LIST

2.0 AMENDMENTS
PART – I

3.0 INTRODUCTION
4.0 QUALITY MANAGEMENT SYSTEM
5.0 MANAGEMENT RESPONSIBILITY
6.0 RESOURCE MANAGEMENT
7.0 PRODUCT REALIZATION
8.0 MEASUREMENT, ANALYSIS & IMPROVEMENT
PART – II (Annexure)

A.1 SEQUENCE AND INTERACTION OF QMS PROCESSES

A.2 RESPONSIBILITY, AUTHORITY & COMMUNICATION
A.3 API MONOGRAM PROGRAM
A.4 CE MONOGRAM PROGRAM
PART – III (Enclosure)

E.1 CROSS REFERENCE OF API Q1 9TH ED WITH QUALITY MANUAL

E.2 CROSS REFERENCE OF ISO 9001:2015 WITH QUALITY MANUAL
Sections of QM CONTENTS PAGE NO
1.0 DISTRIBUTION LIST 1
2.0 AMENDMENTS 2
PART-I
3.0 INTRODUCTION 3
4.0 QUALITY MANAGEMENT SYSTEM REQUIREMENTS
4.1 General requirements 5
4.2 Documentation requirements 7
4.2.1 General 7
4.2.2 Content of quality manual 8
4.2.3 Control of documents 9
4.2.4 Control of records 10
5.0 MANAGEMENT RESPONSIBILITY
5.1 Management commitment 11
5.2 Customer focus 12
5.3 Quality policy 12
5.4.1 Quality objectives 13
5.4.2 Quality management system planning 14
5.4.a.n Management of Change 15
5.5.1 Responsibility & authority 16
5.5.2 Management representative 17
5.5.3 Internal communication 17
5.6 Management review 18
6.0 RESOURCE MANAGEMENT
6.1 Provision of resources 20
6.2 Human resources 20
6.2.2 Human resources – competence & awareness 20
6.3 Infrastructure 22
6.4 Work environment 23
7.0 PRODUCT REALIZATION
7.1 Planning of products realization 24
7.1.a.n Risk assessment & Management 25
7.2 Customer related processes 26
7.2.1 Determination of requirements related to the product 26
7.2.2 Review of requirements related to the product 26
7.2.3 Customer communication 27
7.3.1 Design & development planning 28
7.3.2 Design & development inputs 29
7.3.3 Design & development outputs 29
7.3.4 Design & development review 30
7.3.5 Design & development verification 30
7.3.6 Design & development validation and approval 31
7.3.7 Control of design & development changes 31
7.3.a.n Contingency Planning 32
7.4.1 Purchasing process 32
7.4.2 Purchasing information 34
7.4.3 Verification of purchased product 35
7.5.1 Control of production , processes and service provision 35
7.5.2 Validation of processes for production and service provision 38
7.5.3 Identification & traceability 39
7.5.4 Customer property 40
7.5.5 Preservation of product 41
7.6 Control of monitoring & measuring equipment 42
7.6.a.n Preventive Maintenance 44
8.0 MEASUREMENT, ANALYSIS & IMPROVEMENT
8.1 General 45
8.2.1 Customer satisfaction 45
8.2.2 Internal audit 47
8.2.3 Monitoring & measurement of processes 48
8.2.4 Monitoring & measurement of the product 49
8.3 Control of non-conforming product 51
8.4 Analysis of data 53
8.5.1 Continual improvement 54
8.5.2 Corrective action 54
8.5.3 Preventive action 55
PART – II (Annexure)
A.1 SEQUENCE AND INTERACTION OF QMS PROCESSES 57
A.2 RESPONSIBILITY, AUTHORITY AND COMMUNICATION 60
A.3 API MONOGRAM PROGRAM 90
A.4 CE MONOGRAM PROGRAM 92
PART – III (ENCLOSURE)
E.1 CROSS REFERENCE OF API Q1 9TH ED WITH QUALITY MANUAL 96
E.2 CROSS REFERENCE OF ISO 9001:2015 WITH QUALITY MANUAL 99
 QUALITY MANUAL

1.0 Distribution List:

Director
Plant - Head
Marketing - Head
Quality - Head
Design - Head
Manufacturing - Head
Production Planning - Engineer
Production – In-charge
Outsourcing – In-charge
Maintenance – In-charge
Human Resource - Head
Purchase & Inventory - Head
Store – In-charge
Marking In-charge
Marketing technical support – In-charge
Marketing In-charge
Phosphating – In-charge
Assembly & Testing – In-charge
Painting, Packing & Dispatch – In-charge

Note: The above copies are controlled soft copies and are distributed in, revised or
replaced through a controlled procedure to ensure that document reflects all
current requirements.

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2.0 Amendments:
Section / Content
sub-section
3.0 Location specified as “Navi Mumbai” is removed.
removed Scope of Rabale unit &
Igatpuri unit is determined.
Annexure Location specified as “Navi Mumbai” is removed and determined as “API
“
A.3 Monogram shall be applied within the facility”.

Note:
1. The bar notations in the margins identify the portions of this quality Manual
that have been changed from the previous revision.
2. The requirement of API Q1 9th edition is isolated inside the box.

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3.0 INTRODUCTION:

This is the Quality manual for the PARVEEN INDUSTRIES PVT. LTD.
This Quality Manual provides a Quality Policy statement, the objective as well as
description of the quality program. It also outlines documents needed to ensure
effective planning, operation and control of its processes & the products and
records to be maintained as per ISO 9001-2015 5th edition / API Q1 9th edition.

The Quality Manual has been prepared to achieve a systematic approach in

company’s various programs. ORGANIZATION has adopted a process approach
when developing, implementing and improving the effectiveness of the Quality
Management System, with a view to enhance customer satisfaction by meeting
Customer requirements. Process approach is defineddefined by any activity, using
resources which are managed in order to transform inputs into outputs. Often
output from one process directly forms the input to the next. The application of a
system of process within ORGANIZATION together with identification and a
interaction of these processes and their management can be termed as the
“PROCESS APPROACH”. Such a process approach provides the ongoing control
on the linkage between individual process within the system of processes as well as
over their combination and interaction.
Such a process approach will ensure:
a) Better understanding and meeting customer requirements.
b) Need to consider process in terms of added value.
c) Obtaining results of processes performance and effectiveness.
d) Continual improvement of process based on measurement.

The Organization’s Quality Program uses guidance provided by API Specification

Q1 9th Edition and ISO 9001-2015
9001 5th Edition and is applicable to all Oil Field
Equipment & other items manufactured under various API specifications.

Rabale unit - Scope of Quality Management System includes Design,

Manufacturing, Supplying & Servicing of Oil Field Equipment such as Casing and
Tubing Heads; Cross-Over
Over Connectors; Tubing Head Adapters; Top Connectors;
Tees and Crosses; Adapter and Spacer Spools; Casing and Tubing Hangers; Valves;
Chokes; Flanged Connectors; Threaded Connectors; Other End Connectors;
Actuators; Ring Joint Gaskets; Back Pressure Valves; Bull plugs; Valve Removal
Plugs,, Casing or Tubing Pup Joints, Couplings
C & its accessories,
s, Packers; Bridge
Plugs , Subsurface Safety Valves, Kellys; Drill Stem Subs; Drill Collars; Threading
for Rotary Shouldered
houldered Connections, Line pipe threader,, running & pulling tools,
kick over tools, latches, etc.
etc

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 QUALITY MANUAL
Igatpuri unit – Scope of Quality Management System includes Design,
Manufacturing, Supplying & Servicing of Oil Field Equipment such as Casing and
Tubing Heads; Cross-Over
Over Connectors; Tubing Head Adapters; Top Connectors;
Tees and Crosses; Adapter and Spacer Spools; Casing
Casing and Tubing Hangers; Valves;
Chokes; Flanged Connectors; Threaded Connectors; Other End Connectors;
Actuators; Ring Joint Gaskets; Back Pressure Valves; Bull plugs; Valve Removal
Plugs, Casing or Tubing Pup Joints, Couplings & its accessories, Packers; Landing
nipple, Lock Mandrel,, etc.

PARVEEN has determined that the all all requirements of ISO 9001:2015 & API
Specification Q1, 9th Edition June, 2014, are applicable to the organization at
above site irrespective of type, size and product produced.

The design and development is excluded w.r.t. following products.

1. API Spec 5CT, all products and activities;
2. API Spec 5L,, all products and activities;
3. API Spec 6A, Tees and Crosses; Ring Joint Gaskets; Top Connectors;
Flanged Connectors (except
(except Type 6B); Threaded Connectors;
Adapter and Spacer Spools; Bull plugs; and Valve Removal Plugs.
4. API Spec 7-1,
1, all products except kelly valves;

They are excluded because API Product specifications defines completely the
requirements related to product characteristics, inspection
inspection and testing criteria and
this is allowed as per API advisory 6.

The program described herein is supported by documented QUALITY

QUA SYSTEM
PROCEDURES & WORK INSTRUCTIONS for implementation of the Quality
Program.

All copies of the Quality manual shall be controlled & distributed; revision and
replacement shall be done under controlled procedure to ensure that the
document is updated
ted and reflects current requirements of items manufactured
under API and other specifications.

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4.0 Quality Management System
4.1 General Requirements:
Quality Management System (QMS) shall be established, documented and
maintained in the organization and its continual improvement shall be ensured in
its effectiveness meeting the requirements of ISO-9001-2015 15 5th edition and API
Q1 9th Edition.
Plant - Head will ensure following major processes in the plant. Each Process is
inter-dependent on the next process.
a. Customer’s requirements and complete specifications are faithfully
converted into design drawings and work instructions.
b. That raw materials are purchased from identified source to meet customer’s
requirements fully and are duly inspected.
c. That raw materials are converted into the final product as per design
drawing ensuring stage inspections and final inspection & testing by Quality
- Head.
d. That all inspection gauges and test equipment are periodically calibrated to
ensure their accuracy.
e. That product is delivered to the customer duly painted, packed and
preserved well in time meeting customer’s delivery schedule.
f. That timely provision of resources such as Human Resources (who are duly
trained & competent)
competent and infrastructure and a proper work environment for
carrying out the aforesaid processes.
g. That internal audit is in place to analyze the Quality Management System
process to determine if the planned results are being realized and continual
improvement is achieved.
h. That after sales
es service is provided in the field as & when required.
The above processes shall be considered to be effective only if the customer is fully
satisfied not only towards the quality of the product but also its timely delivery.
Periodic feedback from customer
custom is necessary for this.
Plant - Head will ensure continual improvement of all the processes outlined
above, emphasizing defect prevention and reduction of waste.
NOTE: i) Any activity where input is converted into an
n output by using a resource is
a process. Outlined above
bove are only major processes. Detailed processes are
covered in following sections
ii) An “Outsourced Process” is a process that the organizations needs for its quality
management system and which the the organization chooses to have performed by an
external party.
The type and extent of control to be applied to these outsourced processes can be
influenced by factors such as:

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i. The potential impact of the outsourced process on organization’s capability
to provide product that conforms to requirements.
ii. The degree to which the control of the process is shared.
iii. The capability of achieving the necessary control through the application of
7.4.
Process needed for the quality management system as referred to above include
processes for management activities, provision of resources, product realization,
measurement, analysis and improvement.
Organization may outsource the following processes depending upon the
requirements.
• Proof Machining, CNC Machining
• Heat Treatment
• Welding
• Deep Hole Drilling
• Grinding / Honing
• Electro Plating / Coating
• Non Destructive Testing
esting (NDT),
(NDT) Calibration services & Material testing
• Fumigation
• Transportation / Logistics
The level of outsourcing for products which are applicable to API monogram
marking is defined as under:
under
- Outsourcing of maanufacturing (machining) process and inspection activities
such as dimension, hardness, NDT etc should not exceed more than 75 %.
The importance of meeting customer, Legal statutory & regulatory requirements
such as
- Taxation / duties, Transport permits, Mandatory certification, approval from
relevant authorities, customs requirements, etc
- Applicable standard requirements such as API,
API, NACE, ASME, ASTM, etc and
- Factory act, Employees Provident funds and miscellaneous provision act,
Employees state insurance act with ESI (central) Rules, The electricity act &
rules, Water (prevention & control of pollution) act & rules, Air (prevention
(preven
& control of pollution) act & rules, Noise pollution (Regulation & Control)
rules, etc.
will be communicated throughout the organization on a continuous basis via the
employee-training
training program and implementation of the ever evolving Quality
Management System.
4.1.1 The organization shall maintain responsibility for product conformance to
specified requirements when processes are outsourced.
4.1.1.n Records such as Purchase Order / Instruction sheet and Test certificate /
Test report etc shall be maintained.

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4.1.2 Understanding the needs & expectation of interested parties:
“Interested parties” are those stakeholders who receive our Products /Services,
who may be impacted by them, or those parties who may otherwise have a
significant interest.
The interested parties (which includes both internal & external) who are relevant to
the quality management system and their requirements shall be determined and
assessed. During assessment if any discrepancy found, then action plan shall be
proposed
oposed to address the specific needs & expectations of interested parties in
consultation with top Management. Also the responsibility to implement those
action plans shall be defined against respective parameter and communication
shall be done to concerned
concerned personnel. In the next assessment, the effectiveness of
action taken shall be verified. The status of fulfillment of those requirements shall
be assessed periodically i.e. every six months, documented and communicated to
concerned personnel.
During assessment
ssment wherever applicable changes shall be done w.r.t change in
requirement of interested parties. This process makes the organization to
demonstrate its ability to consistently provide products and services that meet
customer and applicable statutory and regulatory requirements, and aims to
enhance customer satisfaction.
4.2. Documentation Requirements:
4.2.1 General:
The documentation of the organization’s Quality Management System shall
include a documented statement of the Quality Policy to include quality
objectives, this Quality Management System Manual, documented procedures &
records required by ISO 9001:2015
9001 5th edition and API Q1 9th edition and
documents, including records required
required to ensure effective planning, operation &
process control. The organization shall determine the knowledge necessary for the
different processes and activity to ensure product conformity. Documents related
to knowledge shall be maintained and made available
available to extent of requirement.
Updation of knowledge will be based on the current knowledge and source of
addition knowledge shall be identified.
NOTE: The Quality system procedures / documented procedures specified in this
Manual and work instructions made for related activity / process shall be
established, documented, implemented and maintained
maintained for continued suitability

A single document may address the requirements for one or more procedures. A
requirement for documented procedures may be covered by more
mor than one
document.

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As the quality management system continually evolves, the extent of the

documentation required will be dependent upon how the organization’s business
mission and size of the organization changes.

4.2.2. Content of Quality Manual:

The scope of the quality management system is Design, Manufacturing, Supplying

& Servicing of Oil Field Equipment (see introduction). The system includes all the
9001-2015 5th edition & API Q1 9th edition with no exclusion
requirements of ISO-9001
thereof. Quality Manual will be drawn up by Quality- Head.. For guidance of all
concerned in the plant and will be reviewed by Plant- Plant Head and approved by
Director. Quality Manual will lay down the Organization’s
Organization s Policy, Mandatory
Objectives and System Procedures and outline the structure of documentation as
per ISO-9001-2015 5th edition & API Q1 (9th Edition).The The scope of the QMS
including details of and justification for any exclusions are mentioned in section 4.1
General Requirements. The references
references of documented procedures established for
the QMS is included in relevant section of the Quality Manual. Quality System
Procedures are drawn up by Q.C. / Q.A. Engineer’s,, reviewed by Quality- Head &
approved by Plant - Head. Work Instructions will define implementation
procedures meaning thereby as to how the mandatory objectives as laid down in
Quality Manual are to be implemented on the shop floor. For easy implementation
of Q.M.S various formats will be designed and used. Quality manual and Quality
System Procedure will be so designed that it is easy to make changes /
modifications in the procedures / work instructions.
instruction

The different processes including processes that require validation in Quality

Management System have been identified.

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Technical
nical working of the organization involves preparation of technical drawings,
manufacturing of products ordered etc. Flow diagrams depicting the sequence of
all actions and responsibilities of different sections are given in Annexure - A.1.
Organization has as established, documented, implemented, and maintained a
quality Management system and will continually improve the effectiveness of its
QMS in accordance with the requirements of the applicable ISO 9001:2015 9001:20 5th
edition /API Q1 9th Edition.
Edition

Any activity or set of activities that uses resources to transform inputs to outputs
can be considered as a process. Often the output from from one process will directly
from the input for the next process. Management identifies processes needed to
realize products to satisfy the requirements of customers. Identifying,
understanding and managing inter related processes as a system contribute to the
Organization’ effectiveness and efficiency in achieving its objectives.
Organization manages processes needed for the QMS, which includes
Documentation, Management Activities, Provision of Resources, Purchasing and
Quality Assurance Function. Organization has identified and ensured the control
over outsourced processes that affects product conformity with requirements of
the ISO 9001:2015 5th edition /API Q1 9th Edition standard.

4.2.2.1 The Quality Manual identifies the manner in which organization addresses
each specific requirement of API Q1 9th
9th edition including both the requirements of
ISO 9001-2015 5thth edition and the supplemental requirements.

4.2.3 Control of Documents:

Documented procedure (QSP-01)

( ) has been established and implemented and it
will be followed to control documents required by organizations Quality
Management System. The Procedure shall address the following issues:

- Identification and description i.e. title,

itle, date, author, reference number is
appropriate in the document.
- Approval of documents for adequacy prior to issue.
- Review, update as required, and re-approval
re approval of documents by the original
functions.
- Master list of documents will identify the current revision level of the
document and revision date. Documents of external origin shall be
maintained along with its master list.
- Updates in API product or other external specification,
specification, addenda, errata,
e etc
shall be integrated in relevant processes such as design,
design manufacturing,
quality, etc.
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- To ensure that relevant versions of applicable documents are available at
point of use and time of work.
work
- To ensure that documents remain legible and readily identifiable.
identifiable.
- To ensure that documents of external origin determined by organization to
be necessary for the planning and operation of the quality management
system are identified and their distribution controlled.
- To prevent the unintended use of obsolete documents, and to apply suitable
identification to them if they are retained for any purpose.
- To protect adequately from loss of confidentiality, improper use and loss of
integrity.
- Format (eg: Language,
anguage, software version, graphics)
graphics) and media (eg: Paper,
electronic) are defined & appropriate.

4.2.3.1 A master list will be used to identify the documents required by the
quality management system, and their current revision status.

4.2.3.2 Changes to documents will be reviewed and approved by the same

functions
ions that performed the original review and approval.

4.2.3.n Quality System Procedures, Work instructions and forms / formats shall
be controlled as per (QSP
QSP-01)

4.2.4 Control of Records:

Organization has established and implemented documented procedure (QSP-02) (

and will be maintained to provide evidence of conformity and of the effective
operation of its Quality Management System and these records shall be
controlled. This procedure will provide controlscontrols for identification, storage,
protection, retrieval, retention time, and disposition. It also ensures that quality
records are legible, readily identifiable, and retrievable. Records shall be protected
from unintended alterations.
4.2.4.1 Procedure QSP-02
QSP 02 identifies different functions responsible for the
collection and maintenance of records. Records will be maintained
maintain for at least a
period of ten (10)) years. But whenever a particular API Spec or other industry
standard requires maintenance records for longer periods, that clause of
specification / standard will be adhered to.

4.2.4.1.n Records originated from outsource activities such as test certificates,

certif
inspection reports etc shall be controlled in order to provide evidence of
conformity to the requirements related to the product and organizations quality
management system.
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5.0 Management Responsibility:

Responsibility:

5.1 Management Commitment:

Top management shall commit to development and implementation of quality

management system and continually improves its effectiveness by taking
accountability for fulfillment of customer’s needs and requirements.

The quality policy and the quality objectives so laid down by the top management
will be such so as to evolve a quality management system which ensures the
availability of necessary resources and trained personnel to fulfill the customer’s
needs and requirements as well as statutory and regulatory requirement
re at all
times.

The Director of the organization will establish a quality – Management System

which not only satisfies ISO 9001-2015
9001 5th edition but also API Q1 9th Edition. He
will lay down Quality Policy and Quality Objectives and ensure that all
al personnel of
the Plant are fully aware of customer’s needs and requirements as well as statutory
and regulatory requirements, such as API Specs, Health, Safety, Environmental,
Factory Act as applicable. He will also ensure that proper resources are available
avai to
make the system effective and there is continuous improvement in the
implementation of the Quality Management System. The effectiveness of the
system is assessed periodically by carrying out management reviews.

He will outline the structure of the

the Quality Management System which serves as a
reference in the implementation and maintenance of the system and integrate
QMS into organization’s business process. He will promote the use of process
approach and risk based thinking.
thinking

He will ensure that Quality Manual lays down organizational policy, covers all
mandatory objectives and outlines procedure for guidance of all concerned. He
will provide resources required for QMS. He will promote improvement and
support, engage & direct the employees to ensure that QMS achieves its desired
results. Plant - Head with Quality - Head will also lay down Quality System
Procedure and Work Instruction and implement them so that mandatory
objectives as laid down in the manual are implemented on the shop floor.

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5.2 Customer Focus:

Plant - Head who is responsible to Director for the efficient functioning of the
organization will outline, the needs of the customers
customer in the country and
a abroad, it’s
their requirements including statutory and regulatory requirements related to the
product, requirements of delivery and post delivery activities, their expectations
and how to give confidence to them.. He will also ensure that such needs of the
customers are communicated
mmunicated throughout the organization and consistently met.
met
The risks and opportunities
opportunit that can affect conformity of products & services and
enhancement of customer satisfaction shall be determined and addressed.

Plant will be run scientifically and in an efficient manner to ensure that the
customers get quality product at very competitive prices and within the delivery
schedules.
All product related information such as product quality plans, technical
specifications, etc shall be provided to customers if required and changes /
amendments shall be done as per customer’s requirement if necessary.
necessary
After sales, service will also be provided to the customers either by the personnel
of the plant or through the agents wherever required. Management focus will wil be
the customer satisfaction and the maintenance of its enhancement.
enhancement Customer’s
perception about ORGANIZATION whether it has fully met their requirements will
be obtained periodically and analyzed for effecting improvements of Quality
Management System.
ystem. All customer’s complaints will be documented, analyzed
and resolved to the customer satisfaction.

5.3 Quality Policy:

“Parveen’s quality policy is to constantly foster “customer first” and “how to

do it better” attitude in all employees. All activities
ivities should meet “customer
satisfaction” at optimum cost and applicable statutory & regulatory
requirements. The continual improvement of the Quality Management
System is of utmost importance”.

Mr. Prakash Kumar, 19th January 2015

Director

Quality policy is the basic objective of the organization and each employee is
responsible for understanding and implementing quality policy at his own level and
continuously improves its effectiveness. Top management of the organization will

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ensure by means of the training program, internal audits,
audits, the management review
meeting and the awareness of customer needs that the quality policy is:

- Appropriate to the purpose of organization.

- Includes a commitment to comply with requirements and continually
improve the effectiveness of the Quality Management System and satisfy
applicable requirements.
requirements
- Provides
vides a framework for establishing and reviewing quality objectives.
- Is communicated and understood within the organization and available for
relevant interested parties as appropriate.
appropriate
- Is reviewed for continuing suitability.

5.3.1 Quality Policy Approval:

The aforesaid Quality Policy is duly approved by the Director of the organization.
organization

5.4 Planning

5.4.1 Quality Objectives:

Organization’s Quality objectives, in line with the Quality Policy, will be addressed
as following.
Quality objectives are identified and quantified for various departments and
consistent with applicable API, ASTM, NACE and ISO standards as a applicable to Oil
Field Equipment and services will be monitored and communicated throughout the
organization.

Plant - Head, Marketing g- Head, Quality- - Head, Design- Head,

Head Manufacturing -
Head, Purchase & Inventory - Head etc. will individually define and document
quality objectives for the activities for which they are responsible. These may
pertain to various products
product or processes. These quality objectives should be
measurable,, relevant to conformity of products & services and consistent with
other objectives in the organization to ensure enhancement of customer
satisfaction. Periodically these objectives will be assessed and upgraded by
various department heads and / or In-charge
In against the actual achievements.

Quantified quality objectives for various departments are to be decided in every

Management Review Meeting & effectiveness of the same shall be reviewed in the
next Management
ement Review Meeting.

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To achieve quality objective, a necessary planning shall be done which will

determine:
- Required activity to achieve it
- Required resources
- Responsible person
- Time frame for achievement
- Evaluation method of achieved results.
resul

5.4.2. Quality Management System Planning:

Quality Manual, Quality System Procedure and Work Instructions will be drawn up
for guidance of all concerned in the plant and will have the approval of Director.
Director
Plant- Head will identify all the processes such as Marketing, Design,
Manufacturing, Quality Audit, Purchase and Storekeeping etc. For each such
activity methodology of PDCA (Plan, Do, Check, Act) will be applied. PLANNING
will involve establishing of this objective
objective and process necessary to deliver results in
accordance with customer requirement; “DO” will involve implementing the
process. “CHECK” will involve maintaining the process and product against policies
and objective and “ACT” will involve taking action to continually improve the
process. Below is a model of a process based upon Quality Management System.

CONTINUAL IMPROVEMENT OF QUALITY

MANAGEMENT SYSTEM

CUSTOMER’S MANAGEMENT
RESPONSIBILITY

MEASUREMENT
ANALYSIS
CUSTOMER’S
RESOURCES
MANAGEMENT IMPROVEMENT SATISFACTION

REQUIREMENTS
INPUT OUTPUT

PRODUCT PRODUCT
REALIZATION

KEY Value Adding Activities

Information Flow

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Plant - Head will ensure that quality planning as documented is appropriate in

meeting the specified requirements for products / contracts to be executed in the
plant and will cover the following aspects:-
aspects:

Preparation of Quality Assurance Plans

Ensuring identification and acquisition of controls, special processes,
inspection equipment, JIGS & fixtures, resources and skilled and trained
manpower to achieve required quality of the product.

Ensuring compatibility of the design, development, production,
product inspection &
testing procedures and the necessary documentation.

Updating necessary quality control, inspection and testing techniques
including of development of new instrumentation if required.

Identification of any uncommon measurement requirement involving
capability that needs to be developed and suitable verification methods.

Clarification of standards of acceptability for all features and requirements
including those, which contain subjective element.

Identification and preparation of quality records.
re

5.4.a.n
.n Management of change (MOC):

5.4.a.n.1 General:

MOC defines “thethe change in person or group of people, as defined by the

organization, who directs and controls all or part of a facility, location, department
or other functions and persons who are responsible for fiscal responsibility for the
organization and is accountable for ensuring compliance with legal and other
applicable requirements””. Organization shall maintain a process of MOC. Once the
organization experienced the MOC the following
following shall be ensured:
- Relevant changes in the quality management system are planned, implemented
and integrity of QMS is maintained.
- Identification of potential risks associated with the changes and its elimination /
mitigation.
- The integrity of the QMS
MS, availability of the resources and allocation or
reallocation
eallocation of responsibilities & authorities are considered.
- Maintenance of records of MOC activities.

Introduction of changes shall be done only after getting approval from top
management / relevant committee or personnel.

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5.4.a.n.2
.n.2 MOC Implementation:

Organization shall use MOC process when the associated risk due to changes have
negative impact on integrity of quality management system. The changes may be
of following types:

- Changes in the organization structure

- Changes in key / essential personnel
- Changes in critical suppliers
- Changes to QMS documented procedure including the changes resulting from
corrective and preventive actions.

5.4.a.n.3
.n.3 MOC notification:
The requirement
equirement of changes may be initiated by the organization or requested by
customer. Such changes and residual or new risk due to the changes shall be
notified to the concerned/ relevant personnel including the customer (if
applicable).

Documented procedure QSP-23

QSP details the process of MOC

5.5 Responsibility, Authority and Communication:

5.5.1 Responsibility and Authority:

Quality Management System integrate the top management of the organization

and ensures the responsibilities, authorities
authorities & their inter relation are defined &
communicated and QMS conforms to ISO 9001:2015 & API Q1 9th edition standard.
Quality- Head will lay down detailed Quality System Procedures, which will be
reviewed by Plant- Head so that the objectives laid down will be met and various
processes meet the intended output.
output. The organizational structure will be so
evolved that Quality Management System will be implemented effectively and
promotion of customer focus throughout the organization is ensured and integrity
integrit
of QMS is maintained when changes in QMS is planned and implemented. Plant-
Head will be the Management Representative who acts as liaison officer with
external parties on matters relating to Quality Management System.
Organization chart and responsibility & Authority matrix cum roles of key
personnel
onnel is detailed in Annexure –A.2

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5.5.2 Management Representative:
Representative

Plant- Head a member of the organization’s management is detailed as

Management Representative. He will report directly to Director. He will have basic
responsibilities of ensuring that: -
i. Quality System requirements are established, implemented and maintained
in accordance with ISO-9001-2015
ISO 5th edition & API – Q1 (9( th Edition).
ii. Reporting on the performance of the Quality System to Director as a result
of external and internal audits for a review, which will form the basis for
improvement for the Quality System.
iii. MR’s input for the Management review will includeinclude the recommendations
for improvement of the Quality System.
iv. Analysis of customer satisfaction including customer feedback information.
v. Liaise with external bodies such as ISO certification body, API or their
representatives relating to the Quality System
System and arrange external audits.
vi. Arrange periodical internal audits / surprise audits of the Quality System in
the organization.
vii. To ensure initiation of action (s) from each & every function to minimize the
potential of occurrence of non-conformities
non in their
ir related activity / process.
and to check the continual improvement of Quality Management System.
viii. The promotion of awareness of customer requirements throughout the
organization. He will also ensure that during internal audits, the auditor
does check on this and records his observations.

5.5.3 Internal Communication:

The effectiveness of the Quality Management System in meeting the objectives

and customer’s requirements shall be reviewed at Top Management,
Departmental and process level meetings. The results of analysis of data; review
and decisions on actions
tions for continual improvement shall be communicated to all
concerned personnel through circulars or display in notice boards at strategic
locations or briefing all concerned during the daily, weekly and monthly process
performance / production review meetings.
meetings Information shall be communicated
via. Paper or electronic documents, such as the Quality Manual, Work instructions,
specifications, quality records, reports, and through Emails, verbal
communication, training and awareness programs, etc.

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5.6. Management Review:

5.6.1. General:
Management review of the Quality System is carried out to control the assurance
of Quality program. It periodically asses continuing suitability, adequacy and
effectiveness and alignment with the strategic direction of the organization. It also
assess the need for changes in Qualityy policy, Quality objectives. Records
R from
management reviews shall be maintained in accordance with QSP -02.

5.6.1.1 Management Review of the Quality System shall be preferably done after
the closure of internal audit NCRs by the Department heads.. M.R.M followed by
internal audit shall be done in every six months.

5.6.2 Review Input:

Management review will include the following as review input:

i.Review
Review of Quality Policy
ii.Review
Review & monitoring of Quality objectives
iii.Review
Review of Quality functions.
iv.Review
Review of Internal & External Audits.
v.Review
Review of process performance & product & service conformity.
vi.Review
Review of customer’s complaints and customer’s feedback from
customer / relevant interested parties.
parties
vii.Process
Process performance
viii.Results
Results of risk assessment
ix.Corrective
Corrective & Preventive actions taken to deal with product
non-conformities
conformities and process performance.
x.Analysis
Analysis of supplier performance.
xi.Review
Review of Trends of non-conformities
non conformities & analyze the continual
improvement if any.
xii.Status & Follow-up
Follow up actions from previous Management Review.
xiii.Changes
Changes in specified API Standards / Oil
Oil and Gas Industry Standards /
ISO Standards.
xiv.Recommendations
Recommendations for improvement.
xv.Reports
Reports and analysis of field non conformities.
xvi.Adequacy
Adequacy of resources
xvii.Effectiveness
Effectiveness of action taken to address risks and opportunities.
xviii.Opportunities
Opportunities for improvement.
xix.Monitoring
Monitoring & measurement results.

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5.6.3 Review Output:

The output to management review shall include any decisions and actions related
to:
i. Opportunities for Improvement of the effectiveness of the quality
management system and its processes.
ii. Opportunities for Improvement of product related to customer
requirements and
iii. Resource needs.
iv. Any need for changes to the Quality Management system.

Result of review will be documented, implemented by department head and

monitored by Management Representative (MR).

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6.0 Resource Management:
6.1 Provision of Resources:
Top management shall provide resources by means of employee training program
and criteria described in resource requirements, the resources needed to:

- Implement and maintain the Quality Management System.

- Continually improve its effectiveness.
- Enhance
ce customer satisfaction by meeting customer requirements.

Plant- Head will identify and ensure adequate resources including qualified &
trained personnel for Management work, for manufacturing, for internal quality
audits, for testing, for design reviews
reviews & verification are available in the plant at all
times.

6.2 Human Resources:

6.2.1 General:
Employees of the organization who perform work affecting conformity to product
requirements will be considered competent for the job assigned based on
appropriate
te education, training, skills, or previous experience. Training will be
given to the employee at the following stages:

- Training for newly recruited employee

- Refresher training for the Upgradation of knowledge and skill
- Specialized training for any specialized field.

Documented procedure QSP-03

QSP details the above trainings as a whole. The entire
training program will be planned annually.

6.2.2 Human Resources – Competence & Awareness:

Organization will ensure that all personnel engaged in activities which affect
conformity to product requirements are trained in their jobs to make them more
effective and competent in their performance. Selection of personnel,
recruitment, training and development of skills will be done with a view to achieve
achiev
organizational goals.

Necessary details of Individual personnel’s qualification, experience complying

with the organizations requirement shall be documented and maintained.

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Qualification and competence necessary in employees to achieve organizational
goals will be identified and all selection of personnel, recruitment, training and
development of skills and ongoing education will be done accordingly.

All Department heads have a key role to play in building awareness and motivating
employees and planninging organizational values and goals and they will ensure that
all members of the organization are aware of the relevance & importance of their
activities and how they contribute to the achievement of quality objectives.

HR Head will devise training programs in the following manner

- Identify training needs of employees
- Develop training plans to address defined needs to various employees.
- Conformance of training program to regulatory or organizational
requirement.
- Documentation of training course.
- Periodical skill evaluation of employees.
- Customer specified training and/or customer provided training.

All personnel who manage to perform or verify activities as outlined in this Quality
Manual will be well qualified for their function
function and shall have the necessary
education and training, passed examinations and have necessary experiences as
per established minimum requirements. Qualification of each of the personnel will
be documented by HR Executive and keep in record.

Persons workingng for organizations should be aware of Quality policy, relevant

quality objectives.. They shall also know their contribution to the effectiveness of
QMS and implication of not conforming the QMS requirements.

HR Head will keep himself abreast of various specified

specified course being run by various
variou
institutions in the country or abroad in particular fields. He will identify the needs
and frequency of training of various groups and arrange the training of the
employee for short / long courses
co as per annual training plan to achieve necessary
competence. Training for all personnel in the plant will be coordinated centrally
c by
HR head.

Effectiveness of training imparted will be evaluated after the training is imparted.

All training records will be maintained
ma by HR Executive.

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6.2.2.1. Documented procedure QSP-03 will establish control features for
identifying training needs and providing for training of personnel who perform
activities addressed in the quality management system. The training requirements
shall provide for quality management system training and for fo job training of
personnel. The frequency of training shall be defined in Annual training plan.

Organization will provide adequate training for personnel in any new or modified
job affecting product quality. Organization will ensure to measure the extent
exten to
which personnel are aware of the relevance and importance of their activities and
how they contribute to the achievement of the quality objectives. Personnel whose
work can affect quality will be informed about the consequences to the customer
of nonconformity
onformity to quality requirements.

6.3 Infrastructure:

Organization will identify in-house

in house infrastructure such as machine tools /
equipment. buildings and working space, hardware and software, transport
system, storage, tele communication system, communication
communi services or
information system etc. tools and services, standards and facilities and their
adequacy to meet the organization’s products and services.

Organisation shall ensure that the infrastructure as defined above which is vital to
achieve organization’s
nization’s quality management program is available, is reliable and is
adequately maintained.

Plant- Head will define and document the aforesaid infrastructure configuration,
the functions that they perform and services they provide in the work instructions.
instructi
The infrastructure requirements will include infrastructure needs specified in terms
such as functionality, performance, safety, security availability, space, equipment.
cost, time constraint & transport or communication facilities or information
system etc.

Infrastructure configuration will be documented and the extent to which such

infrastructure elements should be kept under configuration management should
also be identified and documented. Plant- Head will also devise a maintenance
program ensuring g that the infrastructure continues to meet the requirements. The
maintenance document will specify the type and frequency of maintenance and
verification of operation of cash element.

Plant- Head will also devise and document an evaluation program which will
include: -
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- Evaluation of infrastructure requirements ensuring that it addresses all
the organization infrastructure needs.
- Evaluation of infrastructure configuration ensuring that it meets all the
infrastructure requirements.
- Evaluation of infrastructure maintenance ensuring that infrastructure is
maintained as needed.
- How often and when and evaluation should be done will be laid down.

6.4 Work Environment:

Organization will define, document, implement maintain and evaluate the t human
and physical aspects of the work environment needed to ensure the quality of the
product and service. Human and physical aspects do influence the characteristics
of the product as well as the efficiency of the organization. These aspects do alter
al
the work environment. The organization’s objective is to assure ideal work
environment to ensure quality of product.

Human aspects which do motivate people and enhance their performance are: -
a) Career planning and development.
b) Recognition and rewards for achievement and improvement.
c) Safety rules and procedures.
d) Creative work methods and opportunities for greater involvement to
realize the maximum potential of every member of the organization.
e) Understanding of the objectives to be achieved
achieved and how they affect
quality.

Physical aspects which are important for the uniformity and the efficiency are:
- Auxiliary materials and utilities such as water, electric power, stand-by
stand
generator, compressed air, fuel, chemicals used for processing.
- Temperature,
perature, humidity, and cleanliness.
- Calm & quiet, non-discriminatory
non and non-disturbing
disturbing place.
- Stress reducing, burnout prevention and emotionally protection.

Plant- Head will lay down and define all the human and physical aspects in the
Work Instructions and define procedures for implementation, maintenance and
periodic evaluation of the same. Aim should be to identify any aspect which casts
negative effect on the work environment
environment whether inside or outside the
organization’s premises.

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7.0 Product Realization:
7.1. Planning of Product Realization:
Organisation shall identify,
identify plan and develop the processes, resources, documents
and records that are associated with the effective and efficient achievement of its
policy, objectives and product realization. Organisation shall plan and ensure that
all processes in the plant operate as an efficient network, resources are available to
set up these processes, documents are available for a specific product and records
provide evidence in product realization. The organization should undertake
analysis of how all processes, inputs and outputs interrelate and how the product
can be realized to entire satisfaction of customer. The same applies to product
requirements including design & development inputs / outputs provided from
external source.
a) In conduct of the analysis and subsequent actions emphasis will wil be given
to:-
i) Processes which produce outputs directly related to customer’s
requirements/ products.
ii) Legal statutory, regulatory and other applicable standard
Legal,
requirements
iii) Contingencies made on the basis of risk assessment.
ii) Resources are made available
available for setting up the above processes.
iii) All documents for a particular product realization are available in
the plant.
iv) Appropriate verification, validation, monitoring, measurement
inspection and test activities specific to a product are
established.
v) Changes in organizational structure, key personnel, supplier,
standard requirements, process / activity, etc.
vi) Records to provide evidence in the product realization are
available.
b) Effectiveness and efficiency of process interaction for product realization
r
will be achieved by establishing: -
i) Criteria for necessary process performance and robustness.
ii) Methods of verifying that interface between processes operate
effectively.
iii) Making control Quality Assurance Plans ns for each product.
iv) Knowing customer requirements specified by him including
delivery & post delivery and customer’s statuary and regulatory
requirements etc.
v) Feedback loop that facilitates continuous improvement across
all processes.

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API product or other external specification requirements, including addenda,
errata, and updates, shall be used in the design or manufacture of the product.
Documented Procedure QSP-01 QSP 01 details about the integration of these
requirements into the product realization process and and any other affected
processes.
7.1.1 Same applies if product requirements are provided from external source.

7.1.1.n The output of planning shall be documented and updated with respect to
the changes involved.

7.1.a.n. Risk Assessment and Management:

The management of risk is based on identification, assessment, & elimination /
mitigation of risk. Risk Management is a control program where identification of
risk & opportunities and its potential consequences of risk associated with impact
on delivery and
nd quality of the product are the key elements.
element Organization shall
demonstrate their action for addressing risk & opportunities in various processes
and evaluate their effectiveness. Documented Procedure QSP--19 shall identify the
techniques, tools for identification, assessment and elimination / mitigation. This
procedure shall also include risk assessment considering the severity, method of
identifying risk and potential / probability of occurrence of non-compliance.
non Risk
assessment shall be categorized into two types:
- Risk assessment based on product delivery and product quality

Risk assessment based on product delivery shall include the following:

- Equipment availability such as machines, measuring devices, assembly &
testing fixtures, etc and their proper functioning w.r.t. their specification.
specification
- Supplier performance on supplying quality products on timely basis.
- Raw material or Bought out items availability and its supply on timely basis.

Risk assessment based on product quality shall include the following:

- Supply / delivery of quality product compliance to customer requirements.
- Availability of competent personnel involved in the process / activity which will
affect the quality of the product.

Risk assessment
sment activity shall have an
a inline relationship with corrective and/or
preventive action. Contingency plans shall be developed by considering the
identified risks, and its outcome.

Records detailing the identification, assessment and action taken for elimination /
mitigation of risk shall be documented and maintained.

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7.2 Customer related Process:

7.2.1 Determination of requirements related to the product:

Organization shall determine

- The
he specified requirements of the customer including delivery & post delivery
activities such as warranty provisions, contractual obligations like
maintenance services and supplementary services such as recycling or final
disposal, etc.
- Unspecified requirements of customers but necessary for the use of the
product or system.
- Statutory & regulatory requirements applicable to the product and any
additional requirements not specified by customer as considered necessary
by the organization as given in the contract in writing or verbally.

7.2.2. Review of requirements related

rela to the product:

Organisation shall ensure that

i. Requirements given in the supply order relating to product or otherwise are
adequately defined and documented and are within the scope of applicable
API specs. Even on receipt of verbal supply orders, organization
anization will ensure
that order requirements are agreed. Where there is no documented
requirement / procedure from the customer, necessary / related specification
to be provided to customer for their acceptance.

ii. Necessary clarifications from the customer will be obtained where necessary
and if required drawings or specification for approval will be sent to the
customer and Plant-
Plant Head will be advised to get on with the manufacture.

iii. Any requirements in the contract including statutory and regulatory

requirements
irements which differ from those given in the tender are resolved by
communication with the customer by issue of amendments to the contract
and its transfer to the concerned departments of the organization.

iv. Organization is able to meet the requirements of the product such as product
specification, delivery date & post delivery requirements. Product
requirement includes
ncludes customer stated requirement, unstated requirement
but necessary for specified use and requirement specified by the organization
itself.

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Contract review will involve scrutiny: -

a) As a result of review if the contract needs any amendments then

these will be sought and will be transferred to respective functional
heads in the organization.

b) Record of results of contract review and action arising

aris from the
contract review will be maintained. When requirements of product
are changed, Organization shall ensure that relevant document like
material specification, inspection / test procedure, drawings are
amended and the users of those documents are made aware of the
change / amendment.

Note: For internet sales, review will cover relevant product information as given in
catalogue or in advertising material.

7.2.2.1 Documented Procedure QSP-04 shall establish control features to review

requirements related to product.

7.2.3. Customer Communication:

Organization will communicate with customer directly or via customer satisfaction

surveys in connection with product information, Enquiries, order handling, and
changes / amendments, customer feedback, including Customer complaints.

This communication will be in the form of a questionnaire sent to customers on a

random basis. Information derived from the questionnaires will be used to assess
customer
mer satisfaction and will provide data that may be used for continual
improvement of the Quality Management System.

Organization will also communicate with customer regarding handling or

controlling customer property and relevant requirement for contingency plan.

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7.3 Design & Development:
7.3.1. Design & Development planning:
planning

Organization shall plan and control the design and development of the new
product through proper interfacing at various levels at minimum time and cost.

During design and development planning,, following shall be determined /

considered:
- The design and development stages,
- The review, verification and validation that is appropriate to each design
and development stage and
- The responsibilities and authorities for design and development.
- The nature, duration and complexity of the design & development.
- The internal and external resource needs of the product & services.
- The need for involvement of customer, users and the level of control
expected by customer, relevant interested parties.

The interfaces between different groups involved in design and development to be

ensured for effective communication and clear assignment of responsibility.

Planning output will be documented and it will be updated,

updated, as appropriate, as the
design & development progresses.

NOTE: Design and developmental review, verification and validation have distinct
purposes. They can be conducted and recorded separately or in any combination,
as suitable for the product.

7.3.1.1 Documented procedure QSP-05 will establish control features for the
design of the product.
When design and development activities are carried out at different location and
the location is within the organization
organizati then QSP-05 05 shall determine the control
features to control the activity to meet the requirements.
If any Design & development activities are outsourced, organization shall ensure
the supplier meets the requirements of 7.3 and provide objective evidence that the
supplier has met these requirements.
requirem

7.3.1.2 Design documentation will include the methods, assumptions, formulas

and calculations.

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7.3.2 Design & Development inputs:

Organization shall identify and determine the design input requirements relating
to the product. Records of those shall be maintained in “Design Package”.

These design inputs shall include the following:

- The functional specification and performance requirements in API / other
relevant standard
tandard shall be identified, documented, and considered as Design
input.

- Statutory, API, Industry, regulatory requirements shall be taken into

account.

- Where applicable, information derived from previous similar designs and

Other requirements
equirements essential for design and development shall be
considered.

- Head
d Design or any officer so designated
designated will review and select the
requirement for their adequacy.
adequacy

- In case of any ambiguity, incompleteness or complicating requirement,

matter will be discussed with customer and resolved.

- Organization shall ensure that design input requirements are complete as

per specifications and are clear and precise so that there is no ambiguity.

- Results / outcome of risk assessment shall also be considered.

7.3.2.1. Organization will identify, document and review the product design input
requirements. Design and development inputs will include customer specified
requirements.

7.3.3 Design & Development Outputs:

Design & development output shall be made in a form suitable for verification
ve
against design & development input and shall be approved prior to release.
release Design
output must meet specifications and the qualitative requirements of the product
against design input.

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Design & development output should provide necessary information for
purchasing, production and for service provision (which may include preservation
of product if applicable).

Final design review shall be carried out & documented & approved by an officer so
nominated and he will be the person other than whowho has developed the design.
Design output must include / refer appropriate monitoring & measuring
requirement and the acceptance criteria of the product and that the characteristics
of the product that are crucial to safe and proper functioning of the product.
prod
Design and development output shall include results of applicable calculations.
Any criticality related to the component / product in the manufacturing process
shall be identified / determined in the design output documents.
7.3.3.1 Design & development output shall be documented in “Design Package”.

7.3.4 Design & Development Review:

At appropriate stages and systematic reviews of design and development will be

conducted to evaluate the ability of the results of design and development to fulfill
requirements and to identify any problems and propose necessary actions or
solutions. Participations in such reviews shall include representatives of functions
concerned with the design and development stage(s) being reviewed. Records of
the resultss of the reviews and any necessary shall be maintained.

7.3.4.1. A final design review shall be conducted and documented in “Design

Package”.. Individual(s) other than the person or persons who developed the design
shall approve the final design.

7.3.5 Design
esign & Development verification:

Organization shall verify the design at appropriate stages in the development of a

new product and shall plan, establish & document measures for verifying the
Design to ensure that design output meets design input requirement.
require Design
verification results and any necessary actions shall be recorded.
The design of a product will be verified by one or more of the following:
- Confirming
rming the accuracy of design results through the performance of
alternative calculations;
- Review of design output documents independent of design and
development review
- Comparing new designs to similar proven designs.

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7.3.6. Design and development

evelopment validation and approval:

Design and development validation shall be performed in accordance with the

documented functional testing requirements and the applicable testing procedure
to ensure that the resulting product or system is capable of fulfilling the
requirements for the specified
specified or intended use or application. Wherever
practicable, validation will be completed prior to the delivery or implementation of
the product or system. Testing will be documented in “Design Package “and
approved by Head design.

Design validation includes

des one or more of the following:
- Prototype tests;
- Function and/or operational tests of production products;
- Tests specified by industry standards and/or regulatory requirements;
- Field performance tests and reviews.
Once validation is completed, the final design of the product shall be approved by
Competent / key personnel(s) other than the persons who developed the design.

All appropriate documentation related to designing & development of the product

shall be compiled in Design package. Such design packages shall be maintained as
per the requirements mentioned in A.1 API monogram program section l.

7.3.7
.3.7 Control of design and development changes:

Design and development changes shall be identified and recorded in the “Design
Package”. Changes
anges shall be reviewed,, verified and validated, as appropriate, and
approved prior to implementation and shall be controlled and monitored as the
original design to include the supporting documentation. The review of design and
development changes shall include
include evaluation of the effect of the changes on
constituent parts and products already delivered. Records of the results of the
review of changes,, the results of changes, es, the results of the reviews,
reviews the
authorization of the changes, the actions taken to prevent adverse impacts and
any necessary actions shall be maintained in “Design Package”.
7.3.7.1 Design and development changes including changes to design documents
shall be controlled in the same
same manner as the original design and development,
and design documentation.

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7.3.a.n.
n. Contingency Planning:

The outcome / results of risk assessment will be the base for contingency planning.
The planning shall be done to eliminate / mitigate the risk associated with / based
on delivery & quality of the product.
pro Documented procedure QSP-19
QSP shall address
the risk associated and its impacts on delivery and quality of the product and
documentation requirements of planning & its output. The documented outcome
outco
of the contingency planning shall be communicated to the key personnel for
further implementation / action. Any changes / inclusion in the planning shall be
updated as well.

7.3.a.1.n Planning Output:

The contingency planning output shall include the following:

- Proposed
osed action / plan against significant risk identified during risk
assessment.
- Identification of Responsibilities and authorities of the key personnel for the
mitigation / elimination of risk.
- Communication control of the above (both internal
internal & external).

7.4 Purchasing:
7.4.1. Purchasing Process:

Organization shall establish adequate control in the purchasing processes and

supplier’s selections to procure raw materials / bought out items for execution of
the supply orders in the plant or for stocking of items. The control on all purchase
activities will be exercised to ensure that purchased product and services
servic which
affect compliance with customer requirements conform to specified purchase
requirements.
a) Evaluation of Suppliers
ppliers will be done by Purchase & Inventory - Head on the
basis of their ability to meet the specified requirements of the material being
purchased including quality, their past demonstrated performance and
capabilities. List of such suppliers will be maintained.

b) Purchase & Inventory - Head will ensure that the suppliers have adequate
quality system controls, & have a reputation of quality & their ability to
supply materials confirming to API specifications.

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c) Information related to supplier’s
s facilities and capabilities shall be collected
with the help of checklist available with the organization and if feasible
supplier facility shall be visited and assessed. Plant - Head / Quality- Head
have the authority for selection & approval of suppliers.
suppliers

d) Suppliers shall be rated & re-evaluated

re periodically for their consistency in
supply of quality goods within the time frame, compatible with least cost.
Records of the results of evaluation and any necessary actions arising from
the evaluation will be maintained.
maintaine

7.4.1.1 Organization’s documented procedure QSP-06 establishes control

features for the purchasing process and supplier selection. Purchased products
above include all products and services that affect compliance with customer
requirements.

This procedure shall address the following:

- The
he criticality of the activities / components or products which are applicable to
conformance to product or customer specification shall be determined.
- Based on the criticality, the type & extent of control applied
applied to the supplier shall
also be included.
- Scope of approval of any supplier based on the criticality & maintenance of
approved supplier list shall be detailed.

7.4.1.2 Criteria for the selection, evaluation and re-evaluation

re evaluation of suppliers shall
include one or more of the following:

- Inspection of supplier’s final product by organization at the supplier

facility.
- Inspection of supplier’s final product by organization upon
upo delivery.
- Surveillance of supplier’s conformance to Organization’s purchasing
requirements.
- Verification that the supplier’s quality management system conforms to an
internationally recognized quality management system standard /
technical specification.

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7.4.1.2.n In addition to the above, the criteria for initial evaluation of identified
suppliers who supplies critical products, components or activities shall be site-
site
specific for individual supplier and it shall also include the following:

- Performance of first article inspection shall be done for the product,

component or activity to ensure the compliance to the requirement.
- Identification of conformance of supplied product, component or activity
with the requirements of proprietary, legal and/or a contractual
arrangements.

The criteria for initial evaluation of non-critical

non critical products, components or activities
shall be as per the requirements mentioned in section 7.4.1.2

7.4.1.3 Whenever any process that requires validation will be chosen to outsource,
o
Purchase & Inventory - Head should ensure that the supplier should comply the
requirements laid down in 7.5.2.

7.4.2 Purchasing Information:

All purchase orders will clearly outline the specifications of the product being
purchased, requirement of approval of product, procedure, process and equipment
along with requirement of qualification / competence of the personnel. Monitoring
exercised by the organization, verification / inspection of the organization or the
customer by their own or through TPI shall be specified. The title no and issue of
the quality system standard to be adhered to will also be specified.

Purchase requirements shall be reviewed

re and approved for adequacy prior to the
communication to the supplier.

7.4.2.1 Purchase orders containing purchasing information issued to supplier shall

be documented. It will describe the product to be purchased including as in 7.4.2
and other relevant technical data like type, class, grade, etc. or other precise
identification andd positive identification, applicable specification, drawings,
process requirements, inspection
nspection instruction and of other relevant/
relevan necessary
technical data.. Purchase orders for items which require third party inspection to
ensure the effectiveness of controls applied by suppliers wherever possible /
feasible. All incoming materials will bebe duly inspected and suppliers
s who are
continuously supplying good quality material to laid down specs and have proved
trust worthy, may be asked to supply materials with their own test certificates.

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7.4.3. Verification of Purchased product:

Quality- Head shall establish adequate control for the inspection / verification of all
incoming materials / purchased product. If the organization or if the customer so
desires (specification in contract), authorized representative
resentative will be given all
facilities to verify the supplied product confirming to specified requirement, at the
supplier’s premises. This clause of verification arrangement and method of
product release shall be specified in the purchase order. However this will not
absolve ORGANIZATION the responsibility for supplying the acceptable product.

Besides above, the organization shall also

- Ensure
nsure that outsourced processes remain within the control co of
organization’ss QMS.
- Define both the controls which will apply for supplier and supplied product
/ service.
- Take into consideration the potential impact of outsourced processes,
purchased products / services on organization’s ability to meet customer
and statutory & regulatory requirements

7.4.3.1. Documented procedure QSP-07 will establish control features for the
verification of purchased product. Records of this verification will be maintained.

7.5 Production and Service provision:

7.5.1. Control of product

roduction, processes and Service provision:
provision

Organization shall plan and carryout the customer related processes such as
production, installation and servicing in a manner that these are done under
controlled conditions and operate as an efficient network, for the benefit of the
customer.
To ensure that quality at all stages of manufacture, installation and servicing is
achieved and following will be established.
a) Criteria for necessary process performance
b) Methods to verify that interface between processes operate effectively.
c) Method to identify time and cost reduction in various processes.
d) Feedback loops for continuous improvement.
e) To attain above key responsibilities for development, operation and control
of quality related processes their
their limits of authority and reporting structure
will be laid down.

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Controlled conditions will include the following as they apply to the product or
assembly:
- The availability of information that describes the characteristics of the
product through the availability
availability of product catalogue, complete drawing, bill
of material, etc.
- Determination and implementation of product quality plan wherever
applicable.

- Ensuring the compliance to design requirements and its relative changes

whenever applicable.

- The availability of material specification work instructions for different

manufacturing process, product testing, markings, assembly, inspection,
etc.

- The use of suitable manufacturing machines and work environment to

carryout different operation during product realization.

- The availability and use of monitoring and measuring equipment such

su as
material testing machines / other dimension measuring instruments, thread
gauges, hydro test devices, etc.

- Availability of process control techniques & documents.

doc
- The appointment of competent persons, including any required
qualifications.

- The implementation of monitoring and measurement by the organization.

- Compliance to applicable standards, codes, quality plans, or documented

procedures.

- Controlled conditions will also include any records for qualified processes,
equipment and personnel.

- The implementations of actions to prevent human error.

- The implementation of product release, delivery, and post-delivery

post activities.

- Ensuring the requirements of identification and traceability requirements

throughout the servicing process.
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Delivery will be as specified by the customer. Any required post-delivery

post activities
will be addressed during the contract review process.

Servicing on equipment supplied by organization shall be provided in the field as

and when asked by the customer during the warranty period. The extension / issue
of warranty period after servicing shall be provided based on customer’s customer
requirement / organization
zation’s decision. Type and extent of service to be provided
will be defined and every day activity planning
p will be done accordingly. Records of
such servicing will be maintained and verified whether such services met the user’s
requirements. Instructions
Instructions for use in dealing with the spares or parts lists will be
outlined. Servicing also includes recertification
recertification of customer product / equipment.
equipment
The planning of such activity shall be done based on type of product / equipment,
inspection and testing involved for recertification.

7.5.1.1 Documented procedure QSP-08 will establish control features that

describe the control of production and service activities performed.

7.5.1.2 Process controls shall be documented in routings, travelers, checklists,

process sheets, or other types of control features and shall include requirements
for verifying compliance with product quality plans, API product specifications,
customer requirementsts and /or other applicable product standards / codes.
The process control documents shall include or reference instructions,
workmanship and acceptance criteria for processes, tests, inspections, and
customer’s inspection hold or witness points.

7.5.1.n Product Realization capability documentation:

Product realization documentation is the evidence of the capability of the

organization to manufacture products. Organization shall develop and maintain
documentation which shall include the following:
- Product realization plans
- Records of review, verification, validation, monitoring, measurement,
inspection, and test activities.
Test activities include the product acceptance criteria to satisfy specified product
and /or servicing requirements.

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7.5.2 Validation of processes for Production & service provision:

Organization shall validate processes for production and service provision where
the resulting output cannot be verified by in-process
in process monitoring or measurement.
This includes processes where deficiencies
deficiencies will become apparent only after the
product is in use or the services have been delivered. Continuous monitoring and
control of process parameters as per applicable specification will be carried out.
Validation will demonstrate the ability of those processes to achieve their planned
results. Organization will establish validation for these processes on an individual
basis to include the following as it applies to the product or assembly being
provided. Special process such as Welding,elding, Heat treatment, NDT ND (Magnetic
Particle Inspection, Ultrasonic testing and Radiographic testing),
testing) Phosphating, and
Painting will be controlled and verified or qualified as follows;
- Criteria for review and approval of the processes shall be defined in
accordance with applicable standard such as API, ASTM, ASME, etc.
NOTE: NDE procedures will be reviewed and approved in accordance with
the applicable API specification and by an NDT
ND Level III.

- Approval of equipment and qualification

qualification of personnel shall be done as per
applicable standard.
NOTE: NDT will be conducted by atleast level II NDT
ND personnel qualified in
accordance with ASNT TC-1A.
TC

- Specific methods and procedures shall be used. Work instructions for

specific processes shall be used.

- Requirements for records shall be identified and maintained.

- Revalidation of these processes shall be carried out at specific interval.

Since Welding, Heat treatment, NDTND are outsource process, the organization
shall ensuree that the supplier conform to these validation requirements.

7.5.2.1 Organization will validate those processes identified by the applicable

product specification as requiring validation. Wherever these processes are not
identified, or there is no product
produc specification involved,, the processes requiring
validation shall include, as a minimum, non-destructive
non destructive examination, welding and
heat treating, if applicable to the product. Reference documented procedure is
QSP-09.

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7.5.2.a.n
n Product Quality Plans:

Product quality plan / Quality control plan specifies the entire processes of the
quality management system including the product realization processes and the
resources to be applied to a product. Product quality plan shall be developed based
on the requirement
rement by customer, third party, etc. The minimum parameters which
are to be addressed in the Product quality plan are as follows:

- Detail description / specification of the product to be manufactured such as

size, pressure rating, component / product name as per applicable standards
/ codes, etc.
- Processes involved for manufacturing including machining, heat treatment,
phosphating , inspections, tests, etc. such details shall be documented and
records / supporting documents to evident the conformance of product
p with
requirements shall be maintained.
- Identification of outsource processes / activities involved and its references.
- Document references such as procedures, specifications, work instructions,
etc against each activity or processes.
- Mentioning of hold,
old, witness, monitor, and document review points.
points

Product quality plans for individual products shall be documented with individual
identification number and revision status. These documents shall be updated /
changes shall be done as per customer/ standard
standard requirements and such
documents shall be approved by competent / key personnel to ensure the
compliance with all relevant needs and requirements.

When required these quality plans shall be shared to concern personnel i.e
customers, third parties, etc.
etc

7.5.3 Identification and Traceability:

Organization shall establish and maintain procedures for identifying the material /
product from applicable drawings, specifications and other documents during all
stages of procurement, production, delivery and installation.

This procedure is intended not only to trace back the defective stores pertaining to
a particular batch / lot easily from thee relevant documents but also for maintaining
the product’s identity during production, delivery and installation at the customer’s
site.

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a) Each item/ component during its course of manufacturing will be identified
right from the raw material stage (by a particulars batch no. / heat no.
identification marking) till the finished stage.

b) All components and sub-assemblies

sub assemblies of a particular assembly will have
traceability makings so that they can be traceable to the main assembly.

c) Final product shall also be marked for identification.

d) Job card used for manufacturing process for each job manufactured and
color coding for identification of non-conforming
non conforming material will identify the
product status during the process of manufacturing.

e) Records of identification & traceability shall be maintained.

7.5.3.1 Documented procedure QSP-10 will establish control features for

identification and traceability of the product by suitable means from receipt and
during all stages of production, delivery and installation, as required
requ by the
organization, the customer,
customer, and the applicable product specifications.
7.5.3.1.n QSP-1010 shall also include the conformity or non-conformity
conformity of the
product with respect to inspection anda / or tests performed.

7.5.3.2 Control features shall include requirements for maintenance or

replacement of identification and traceability marks, and records.

7.5.3.3 Documented procedure QSP-10 will also establish control features for the
identification of product status.

uirements of API monogram & CE monogram marking are addressed in

The requirements
this Quality Manual section Annexure A.3 and A.4 respectively.

7.5.4. Customer Property:

Organization will establish procedure for verification, storage and maintenance of

items such as material, component, tools, gauges (including intellectual property
and personal data) supplied by the customer or supplier for use or incorporation
into the product. Allll items supplied by the customer for use and incorporation in
the product (including
uding intellectual property and personal data) shall be ensured
that they are kept in safe custody, so that they are not lost or damaged or mixed
with other items.

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Material received from the customer i) for incorporation of it into the product ii) for
servicing
vicing or repairing or processing or testing and intellectual property such as
drawing, specification, procedure shall also be considered as customer property.

Items received from the customer will be taken on ledger by the Store Keeper and
kept in safe custody
ustody in a separate area earmarked in the stores. Intellectual
property (such as manufacturing drawings etc.) received from the customer shall
also be kept in safe custody.

All items at the incoming stage will be duly inspected and verified to ensure that
they are in proper / serviceable condition.

Any loss /damage or unsuitability for use of customer supplied items shall be
immediately recorded
ed and reported to the customer
customer and records shall be
maintained.

7.5.4.1. Documented procedure QSP-11 will establish control features for the
verification, storage,, maintenance and control of customer property.

7.5.5 Preservation of Product:

Organization shall establish, document & maintain procedures for preservation

which includes Identification, Handling, Contamination control, Storage, Packing,
Protection and Delivery of product and post delivery services. Organization will
ensure that the product during its internal processing,
processing till the time it is delivered to
the customer is handled in a most effective manner so that the item reaches the
customer in a serviceable condition.

A system for identification of the finished product shall be established &

maintained,, its preservations
preservations avoid deterioration in transit, its segregation to avoid
its mixing up with other stores.

Finished product will be packed and preserved properly to avoid damage during
storage, transit and delivery to the destination. As applicable, this preservation will
also include constituent parts of products as well as any customer specified
requirements.

7.5.5. n Designated area or stock room shall be used to avoid / prevent damages or
deteri0riation of product or component.

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7.5.5.1 Documented procedure QSP-12 shall establish control features which
describes the methods used to preserve the conformity of products for the
activities related to 7.5.5

7.5.5.2 All stores in stock will be assessed for their condition at specified intervals
to detect deterioration andnd preserved.

7.5.5.2.n The interval of assessment shall be appropriate to the product or

component. Records of the results of assessments shall be maintained.

7.5.5. a.n.1 Post delivery activity:

The organization shall determine the extent of post delivery activities required and
meet the same. The organization shall consider the following:
- Statutory & regulatory requirements.
- The potential undesired consequences of products
product & services.
- The nature, use & intended life time of its products & services.
services.
- Customer requirements & feedback.

7.6 Control of Monitoring & Measuring Equipment:

Organization shall establish documented procedures to control calibration and

maintenance of inspection, measuring and test equipment to provide evidence of
conformity to determined requirements and they are suitable for the specific type
of monitoring and measuring activities. Also they are maintained to ensure their
continuing fitness for their purpose.

The procedure is intended to provide

provide guidelines in periodic inspection and
calibration
ration of inspection, measuring and test equipment that is capable of
maintaining necessary accuracy and precision. Organization will determine the
monitoring and measurement with these instruments will be carried out in a
manner that is consistent with the monitoring and measuring equipment.

Quality- Head will identify all inspection, measuring and test equipment and other
devices along with inspection & measuring process, which can affect product
quality. These will be calibrated and adjusted at required intervals or prior to use
against reference equipment which has relationship to National or International
recognized standards. Where no such standard exists, the basis used for
calibration or verification
on shall be defined & recorded.

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Quality- Head will coordinate all the activities on calibration of inspection,
measuring and test equipment in the plant and maintain all calibration records.
When inspection, measuring and test equipment is found to be out ou of calibration,
he will assess and document the validity of pervious inspection and test results.

Calibration will be done in temperature controlled place. All measuring

instruments / gauges will be stored in dust free cabinets.
cabinets

All measuring & test gauges will be taped or tagged with due date of next
calibration to indicate calibration status.

Handling equipment like cranes, hoists and compressors will also be got
periodically calibrated.

Environmental
nvironmental conditions will be ensured suitable for calibration,
ration, inspection,
measurement and tests to be carried out.

Procedure
rocedure for calibration, acceptance criteria shall be developed and actions to be
taken when calibration results are unsatisfactory.

When any measuring equipment is found not to conform to requirements

requirements during
calibration, all the inspection reports in which this measuring equipment was used
will be verified and the corresponding products will be re-verified
re verified for their
conformance. Suitable action will be taken if the products to be found not to t
conform to the requirement. Handling,
andling, preservation and storage of inspection,
measuring and test equipment will be such that accuracy & fitness for use is
maintained. Records of all calibration and verification results shall be maintained.
When used in the monitoring and measurement of specified requirements, the
ability of computer software to satisfy the intended application will be confirmed.
This will commence prior to initial use and reconfirmed as necessary.

7.6.n Organization shall verify the reliability / suitability,

suitability, evidence of conforms to
the requirements of the equipment which are procured or borrowed from external
agencies such as third party, customer, supplier, laboratory, other facility, etc.

Unique identification shall

shall be provided to testing, measuring and monitoring
equipment and a registry shall be maintained for traceability & to have effective
control.

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7.6.1 Documented procedure QSP-13 will establish control features to control,
calibrate and maintain monitoring and measuring equipment. Control features
shall include equipment type, unique identification, and location,
location frequency of
checks, check method, and acceptance criteria.

7.6.2 Environment conditions:

Organization will ensure that the environmental conditions are suitable for
the calibrations, inspections, measurements and tests being carried out.
Records of the calibration / verification activity for all gauges, measuring and
test equipment, needed to provide evidence of conformity of product to
determined
ermined requirements, including employee and customer-owned customer
equipment should include:
- Equipment identification, including the measurement standard
against which the equipment is calibrated.
- Revisions following engineering changes,
- Any out of specification readings as received for calibration /
verification,
- An assessment of the impact of out of specification condition, and
- Notification to the customer if suspect product or material has been
shipped.

7.6.a.n Preventive Maintenance:

Preventive maintenance for equipment used in product realization will be based on

risk, system reliability, usage history, experience, industry recommended
practices, relevant codes and standards, original equipment manufacturers
guidelines or other applicable requirements. Documented Procedure QSP-20
identifies the requirements
ments of the following:

- Type of equipments for which preventive maintenance is required / applicable.

- Frequency for individual equipment based on its usage & reliability.
reliability
- Responsibility of the personnel for making preventive maintenance program
& execution
n as per plan.

Record to comply the above mentioned requirements shall be maintained.

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8.0 Monitoring and Measurement:
8.1 General:

Organization shall collect, analyze summaries and disseminate the pertinent

information and data needed to monitor its QMS performances. Measurement and
analysis process for verifying the results of products, processes, system and
customer satisfaction measures shall be established and maintained to provide for
effective management and improvement of Quality System.

Type location and frequency of measurement, which shall be dependent upon the
importance of the characteristic, level of delivered quality as perceived by
b the
customer, the economics of quality and the ease of verification during processing,
will be defined.

Procedures for internal audits, process audit, audits such as receiving, in-process
in
and final inspection and testing, product audits, handling, storage,
stora packing and
delivery of product, control and calibration of measuring and test
est equipment will
be outlined.

Plant- Head will review and revise the measurements, their location or frequency
as appropriate based upon occurrence of non-conformities
non conformities as perceived by the
customer or as discussed in the plant
pl through in-process,
process, final inspection or
product audit. Measurement including
including of revisions shall be approved by
authorized personnel and documented appropriately.

The
he applicable methods including statistical techniques for measurement and
analysis processs and the extent of their usage shall be determined.

Training, customer feedback and management review shall be in place to

continually improve the effectiveness of the Quality Management System.

8.2 Monitoring and measurement:

8.2 .1 customer satisfaction:

Organization will ensure that product is fit for customer’s use; and it will
continuously monitor and get feedback on customer satisfaction or
dissatisfactions at appropriate stages of product realization.

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Frequency of review of customer satisfaction improvement goals and how

objectivity and validity are assured shall be specified.. The effectiveness of
measures implemented shall be periodically evaluated.

For determination of customer satisfaction regarding a product, Marketing-

Marketing Head
will address quality, service and price for value provided on a continuous basis.
Elements associated with quality in marketing will include.

i. Complementary services
ii. Analysis of competitor’s activities in pricing and performance of
their products.
iii. On benchmarking inside and outside the organizations
commodity and industry.
iv. Review of national
national and international standards and codes that
govern the product, health safety and environment.
v. Analysis and review of customer’s requirements,
requirements contract
information and dissemination of the same to other department
heads.
vi. Consultation within the organization
organization with various heads to
confirm their commitments and ability to meet specified
requirements.
vii. Ongoing research to examine changing market needs new
technology and impact of competition.
viii. New products and new process technology.

Marketing - Head will look for how best the data can be collected on customer
satisfaction / dissatisfaction in accordance with the nature of report study on
delivery deadlines, current technology and available field result.
Documented Procedure QSP-21QSP address about the measurement of customer
satisfaction and its frequency.
Customer’s satisfaction can be analyzed by reviewing the following records:

- Customer’s Comments on MOM

- Customer’s visit / Witness report
- No of repeat orders from the customer
- Responses from the customer though e-mail,
mail, phone call, fax and
other form of communication.
- Customer feedback forms or Key performance indicators (KPIs)from
(KPIs)
shortlisted customers,
customers etc

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Performance reports will be obtained when a new item will be supplied or o the
items for the first time will be supplied to the customer. Such feedbacks will be
reviewed by the Marketingting - Head and it will be highlighted in Management
Review.

The records of the results of customer satisfaction information shall be

maintained.

8.2.2 Internal Audit:

Organization carry out a comprehensive system of planned and documented

internal audit of the quality management system.

Internal audit will verify whether quality management system & activities as
carried out in the plant, comply with planned arrangements as defined in Quality
Manual / Quality System Procedure and to see it is effectively
effectively implemented and
maintained.

All processes of the quality management system required to meet API Q1

requirements shall be audited prior to
to claiming conformance to the requirements.
Outsourced activities (including activities which are performed both inside and
outside the premises) which will affect the quality of the product shall be included
under the scope of audit relating with the relevant functions / activity.

Documented procedure QSP-14

QSP is implemented to conduct internal audit of the
Quality Management System.

The internal audit will be done by qualified personnel who have Engineering
background and have minimum of 2 years manufacturing
facturing experience and who
have done recognized lead Assessor / Internal Audit Courses.

Scheduled audits will cover all the elements of Quality System as per ISO 9001
900 –
2015, 5th
th Edition / API Q1 9th
9 Edition, as defined in this Quality
uality Manual.

Internal auditors will carry out the audits on the area / department in which they do
not have any direct responsibilities.

Audit will be scheduled based on the status and importance of the activity as well
as the results of the previous audit. Before audit, all concerned groups will be
informed in advance. Such internal audit will encompass the process audit.

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All findings observed during the audit should have the same priority and will be
recorded by internal auditors and Plant-
Plant Head will be informed. All groups
grou /
management personnel of the area will take suitable remedial measures on the
deficiencies found by the audit.

Follow up activities shall be done without any undue delay. Audits will be closed
only after verification of necessary corrections and corrective
corrective actions taken and the
results of verification it shall be recorded.

8.2.2.1 Internal audits will be scheduled and conducted half yearly by personnel
independent of those who performed or directly supervised the activity being
audited.
8.2.2.2 Response
se times for addressing detected nonconformities will be maximum
of 60 days.

8.2.3. Monitoring and measurement of processes:

Organization shall establish and maintain a program for periodic management

process audits so as to verify the effectiveness of implemented process control.
It will be ensured that processes are being performed consistently and in
accordance with planned process design and result in outputs that meet the
specified requirements.

The
he scope and frequency of various management system processes audit will be
based on Quality System Procedure and work instructions. Personnel doing the
process audits will be independent of the particular process being audited.

Where the results of processes cannot be directly verified and process deficiencies
may become apparent only after the process has been in usage, such processes
require qualification to ensure process capability and control of all critical variables
during process operation.

Process audit program shall be based on the status and importance of the process
to be audited, the results of the previous audit and of other quality measures. The
program will define the scope and frequency of process audits. If the audit reveals
the planned results are not achieved, suitable correction
correction and corrective action has
to be taken and if process change is required, then effective dates of process
change is to be maintained.

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8.2.4. Monitoring and measurement of product:
product

Organisation shall establish and maintain documented procedures to identify

ide
adequate statistical techniques monitor and measure its products in order to verify
that the specified requirements for the product are met with special attention on
crucial characteristics, where non-compliance
non compliance could affect product safety or
quality of subsequent manufacturing operations.

It is to be ensured that required inspection and testing activities are established so

that no incoming materials is processed unless it has been inspected against
specified requirements, that the manufacturing is processed under controlled
conditions to make sure of quality and that final inspection and tests are done as
per acceptance criteria specified . All such activities are to be carried out as per
documented procedures to make sure that product requirements
requirements are met.

uitable sampling techniques for establishing, controlling and verifying product

Suitable
characteristics to ensure zero defects shall be identified.

Quality Assurance Plans will outline the required inspection and testing to be done
for a product and
nd records to be established.

No incoming materials will be issued for manufacture unless they are inspected
and cleared.. This applies to even those materials, which have been inspected by
third party at the supplier’s place or manufactured by the supplier
suppli with API
monograms.

In such cases type & nature of inspection will be decided accordingly to ensure that
the material is as per documented procedures after giving due consideration to the
amount of control exercised at supplier’s premises. The incoming quality system
shall use one or more of the following methods

(i) Receipt and evaluation of statistical

statistical data or material test report.
(ii) Receiving inspection and or testing (sampling based on
performance).
(iii) Third party audit.

Customer’s inspectors or appointed third party on behalf of the customer or

organization’s Q.C inspectors shall be associated foror inspections at the supplier’s
place if required or specified in the contract. Generally if the supplier is API
approved or the supplier has a reliable quality system so that it can be depended
upon, the supplier shall be allowed to deliver their goods withith their own certificate.
certificate
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When incoming product is released without incoming inspection for urgent
production purposes it will be identified and recorded in order to permit recall and
replacement in the event of non-conformance
non conformance to specified requirements.

Each
ach production center will do its own inspection
inspection at each stage of manufacture.
Q.C. inspectors also carry out the inspection in the planned stages
stage of
manufacturing or as outlined by the Q.A.P for each product to ensure product
conforms to specified requirements,
requirements, that inspection & tests have been completed
or necessary reports have been received and verified except when product is
released under positive recall procedures.

Final inspection and testing shall be conducted as per the Q.A.P

Q.A.P / product quality
plan and/or documented procedure to complete the evidence of conformance of
the furnished product to the specified requirements. Quality system procedure
QSP – 22 is established to ensure that the manufactured product is satisfactorily
completed with respectct to planned arrangements fulfilling the customer
requirements. Such products shall be released after getting approval from relevant
/ competent authority and where applicable by customer also. Records
determining the compliance and release of product by authorized personnel shall
be maintained.

No product shall be dispatched by the packing & dispatch in-charge

charge until all the
activities specified in the Q.A.P
Q. have been satisfactorily completed and the
associated data and documentation are available and authorized. Once the item
has gone through final tests, final inspection report signed by the inspector, items
marked as per API instruction or with API Monogram by QC inspector, and then
only items will be released for despatch.

All records of inspection / test which will give evidence that the product has passed
inspection & tests at each stage with defined acceptance criteria shall be
maintained.. Such records / certificates will be produced on inspections conducted
by third party / Customer’s Rep. etc.

Records of inspection & test will identify the inspection authority responsible for
the release of the products.

Inspections which will be done based on sampling techniques will follow sampling
plan.
Where the product fails to pass any inspection or test, the procedure for control of
non-conforming
conforming product will apply.

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8.2.4.1 Documented procedure QSP-15 will establish control features to monitor

and measure the characteristics of the product.

8.2.4.2 Personnel other than those who performed or directly supervised the
production of the product shall perform final acceptance inspection at planned
stages of the product realization process.

8.3 Control of Nonconforming product:

Documented procedure QSP-16

QSP has been implemented and established to ensure
that product that does not conform to specific requirements is prevented from
inadvertent use. QSP-1616 also defines the controls and related responsibilities and
authorities for dealing with non-conforming
non product. This procedure is intended
to have
ave control that shall provide identification documentation, evaluation,
segregation, and disposing of non-conforming
non conforming product (either in the plant during
manufacture or in the field where API monogrammed / non on monogrammed
product may be under usage) and for for notification to the sections concerned.

In order to deal with non--conformance

conformance material, component or product in the
plant or API monogrammed
onogrammed / non monogrammed product in the field, effectively,
and expeditiously and also to provide feedback to avoid their
their usage in future, a
proper system of handling and controlling is issued.

All field non-conformance

conformance reports on API monogrammed / non
on monogrammed
products will be recorded.
recorded

Where applicable, Organization will process nonconforming product by one or

moree of the following ways and in accordance with the above referenced
procedure to prevent unintended use or delivery.

- Take action to eliminate the detected nonconformity; the action may be

- Authorize its use, release by a relevant authority and,, where applicable, by
the customer.
- Take action to preclude its original intended use or application.
- By taking action appropriate to the effects, or potential effects, of the
nonconformity when nonconforming product is detected after delivery or
use has started.

The disposition of the non conforming product shall be done by the following
methods.
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- Repair or rework in compliance to the design requirements & quality of the
component / product.
- Regrade for alternative application.
- Release under concession
concession / “use as it is” after satisfying the requirements
stated in section 8.3.1.
- Reject or scrap.

Note: Products that do not meet API criteria will not receive the API monogram.

Records of the nature of nonconformities and any subsequent actions taken,

including concessions obtained, will be maintained by the Quality Department.
The Quality- Head will also be responsible for review and disposition of
nonconforming product.

When nonconforming product is corrected, it will be subject to re-verification

re to
demonstrate conformity to the requirements. When nonconforming product is
detected after delivery or use has started, Organization will take action
appropriate to the effects,
effects, or potential effects, of the nonconformity.

conformance, either in the plant or in the field will be decided by

Each case of non-conformance,
a committee comprising Plant- Head, Manufacturing - Head / Production-
Production in-
charge, Quality- Head where Plant- Head will preside.
ide. In case of design failure,
Head Design will also be part of this committee. For field non-conformance,
non conformance,
investigation may have to be done in the field, based on customer’s complaint, by
deputing a representative and then in the plant if necessary after
afte withdrawing the
product from the field.

8.3.1 Release or acceptance of nonconforming product:

All cases of non conformities will be reviewed to take actions. The process of
evaluation, release and acceptance of nonconforming product shall include one or
o
more of the following.
a) Accepting products that do not satisfy manufacturing acceptance criteria
provided that
• Products satisfy the design acceptance criteria,
• The violated manufacturing acceptance criteria are categorized as
unnecessary to satisfy the design
esign acceptance criteria, or
• Products are repaired or reworked to satisfy the design acceptance
criteria;

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b) Accepting products that do not satisfy the original design acceptance
criteria provided that

• The original design acceptance criteria are changed per 7.3.7,

7. and
• The materials or products satisfy the new design acceptance criteria.

8.3.2 Field nonconformity analysis:

The procedure for nonconforming product (QSP-16)
( ) will include requirements for
identifying, documenting and reporting incidents of field nonconformities or
product failures. The documented procedure will ensure the analysis of field
nonconformities, provided the product or documented evidence supporting
supportin the
nonconformity is available to facilitate the determination of the cause.

8.3.3 Customer Notification:

Organization shall notify customers in the event that product which does not
conform to design acceptance criteria has been delivered to the customer. Records
of such notifications shall be maintained.

8.4 Analysis of Data:

Organization shall determine, collect and analyze appropriate data in relation to
the following issues in order to demonstrate the suitability and effectiveness of the
Quality Management System and to evaluate where continual improvement can
be made. Analysis of data will be done using statistical technique such as bar chart,
pie chart, Pareto chart, histogram Trend analysis;; etc. The analysis of data shall
provide information relating to:
a) Customer satisfaction
b) Conformity to product & service requirements
c) non conformities and product failures identified after delivery or
use, provided the product or documented evidence is available to
facilitate the determination of the cause
d) Characteristics and trends of processes and products including
opportunities for preventive action and
e) Suppliers performance
f) Quality objectives
g) Performance & effectiveness of Quality Management system
h) Implementation of planning effectively
effect
i) Effectiveness of action taken to address risk & opportunities
j) The need for improvement of Quality Management system.
Results derived from the analysis will be presented to the top management of the
organization and may be used as the basis to set quality objective.
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8.4.1. Documented procedure QSP-17 will establish control features for the
identification and use of the techniques for the analysis of data.

8.5 Improvement:

8.5.1 Continual Improvement:

The organization will ensure continual improvement to the effectiveness of

“Quality Management System by reviewing and addressing the Quality Policy,
Quality Objectives, Audit Results, Analysis of Data, Corrective and Preventive
action, and Management Review outcomes. The organization shall also determine
and select opportunities for improvement and implement any necessary actions
action to
meet customer requirement and enhance customer satisfaction by
- Improving products & service not only to meet requirements but to
address future
futu needs & expectations.
- Correcting, preventing or reducing undesired efforts.
- Improving the performance and effectiveness of QMS.

The Quality Policy and Quality Objectives are the commitment of management to
the QMS. The results from Internal Audits, Analysis
Analysis of Data, Corrective Action, and
Preventive action will be evaluated in terms of meeting management's
commitment. In addition monitoring & measurement of process and product will
be considered. Conducting Management Review, the above issues will be assessed
as
and evaluated to determine where opportunity exists and where improvement is
needed or has occurred with respect to product, process, or resources.
Implementation of training program in the organization will ensure the desired
improvement. Management
Management review will highlight the continual improvement,
which has taken place in the organization.

8.5.2 Corrective Action:

Organization shall take action to eliminate the cause of non conformities in order
to prevent recurrence. Corrective action taken shall be appropriate to the effects of
the non conformities encountered. Documented procedures QSP-18QSP has been
established and defines requirements for

a) Determining and implementing the corrections.

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b) Reviewing and analyzing the nonconformities (including customer
complaints).
c) Determining the root causes of nonconformities
d) Evaluating the need for action to ensure that nonconformities do not
recur
e) Determining if similar non-conformities
non conformities exist or could potentially occur.
f) Determining and implementing action needed
ne
g) Records of the results of action taken
h) Reviewing the effectiveness of corrective action taken
i) To identify new or changed control required for corrective action due to
MOC.
j) Making changes to the quality management system if necessary.
k) Updating risk & opportunities determined during planning if necessary.
Note:
e: Records shall identify the activities performed to verify effectiveness of the
corrective action taken.
8.5.2.1 Organization shall ensure that all corrective actions
action are effectively
implemented.
8.5.2.2 Corrective action shall be addressed within the response time identified by
the responsible person of the organization.

8.5.3 Preventive Action:

Organization shall determine actions to eliminate the cause of potential non
conformance in order to prevent their occurrence.. Preventive actions shall be
appropriate to the effects of the potential problems or non conformance.
Documented procedure QSP-18
QSP has been established and implemented to define
requirements for

a) Identifying opportunities for improvement.

b) Determining potential nonconformities and their causes
c)) Evaluating the need for preventive action,, including short term action to
prevent occurrence of nonconformities
d)) Determining and implementing action needed
e)) Time frame and responsible person(s) for implementing a preventive
action.
f)) Records of results of action taken
l) Reviewing, the effectiveness of the preventative action taken
h) To identify new or changed control required for preventive action due to
MOC.

8.5.3.1 Organization shall ensure that all preventive actions

action are effectively
implemented.

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PART – 2
(ANNEXURES)

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Annexure – A.1 Sequence and interaction of
processes of QMS:

Every Supply Order is handled by different sections. The actions taken by various
sections from its receipt to dispatch. The following four flow diagrams include the
description of the interaction between the processes of the Quality Management
system.
a) Sequence & interaction of QMS system process
b) Sequence & interaction of Product Realization process
c) Sequence & interaction of Manufacturing process
a) sequence and interaction of QMS system process:

5. Top Management Processes

Establishment of the following:
• Quality Manual, Quality policy,
Quality objectives
• Focus on customer requirements
• Internal & external
communication
• Control of documents & records,
• Periodic Management review
8. Measurement, Analysis and
Improvement Processes

Internal Audit
6. Resource Management
Control of Nonconforming
Processes Product
4. QUALITY
Evaluation of Customer
• Human Resource MANAGEMENT Satisfaction
• Training SYSTEM
Corrective & Preventive action
• Infrastructure PROCESSES
Continuous Improvement
• Work Environment
Statistical process control

Analysis of data

Risk Assessment &
Management

Process Validation
7. Product Realization Processes
Management of Change
• Contract review
• Planning
• Design & Development
• Contingency Planning
• Purchasing & outsourcing process
• Production & Service Provision
• Handling, preservation, storage &
assessment
• Inspection & testing
• Control of testing, measuring &
monitoring equipment
• Product Release

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b) Sequence & interaction of Product Realization process:

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c) Manufacturing Process / Prototype Development Process:

Raw material

Cutting

Rough Machining

Heat Treatment

Finish Machining

Deburing Rework

Quality Checks includes NDE

Marking

Phosphating/
Plating Ok
Not Ok Review Reapplication
End of
warranty
Assembly period
Reject Scrap
Receipt of
Payment

Hydro Testing + Ok Painting Packing

functional Testing

Complete Dispatch Closure of S/O file

Production design
package Supply Order Processing

Prototype development

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ANNEXURE A.2 – RESPONSIBILITY, AUTHORITY,
ACCOUNTABILITY AND COMMUNICATION
QUALITY
ENGINEER

QUALITY
QUALITY HEAD
INSPECTOR

QUALITY
EXECUTIVE

HR HEAD HR EXECUTIVE

PRODUCTION
PLANNING
ENGINEER MACHINE
MACHINE
GROUP
OPERATOR
PRODUCTION INCHARGE
INCHARGE
PRODUCTION
ENGINEER

PHOSPHATING PHOSPHATING
INCHARGE ASSISTANT

ASSEMBLY &
ASSEMBLY &
TESTING
TESTING FITTER
INCHARGE

MANUFACTURI OUTSOURCING OUTSOURCING

-NG HEAD INCHARGE EXECUTIVE

MARKING MARKING
PLANT HEAD & INCHARGE ASSISTANT
DIRECTOR
M.R.
PACKING &
DISPATCH
PAINTING, PACKING ASSISTANT
& DISPATCH
INCHARGE
PAINTER

MAINTENANCE
ENGINEER
MAINTENANCE
INCHARGE
MAINTENANCE
ASSISTANT
DESIGN
ENGINEER
DESIGN HEAD
DESIGN
DRAUGHTMAN

STORE STORE
STORE KEEPER
PURCHASE & INCHARGE ASSISTANT
INVENTORY
HEAD PURCHASE
EXECUTIVE
MARKETING MARKETING
TECHNICAL TECHNICAL
SUPPORT- SUPPORT -
MARKETING INCHARGE ENGINEER
HEAD
MARKETING MARKETING
INCHARGE EXECUTIVE

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A.2.1 ROLES:

Director: Assures
ssures the financial growth of the company by supporting departments to ensure quality of company services. He Defines the Quality Policy
and ensures the communication and understanding of the Quality Policy throughout the organization. Provides
Provide the resources necessary to facilitate the
development and implementation of QMS.

Marketing Head: - Responsible

ble for all sales & service function e.g. making quotation, doing contract reviews, dealing with field non-conformities
non and
finding new customers in India and abroad.d. Reports directly to Plant Head.

Marketing In-charge: - Assist Marketing - Head for proper

prop functions of Marketing/Sales activities. . He /she will respond & clear the customer
enquiries / queries and attend customer complaints and ensure the Customer Satisfaction.

Marketing – Executive:- Approach

pproach the customer directly to keep the track of marketing functions. He will report to Marketing Incharge.
Incharge

Marketing Technical Support – In-charge: Reports to Marketing head. Responsible to support marketing function by providing technical support to
marketing department by providing technical data / tendering drawing during the enquiry stage of sales order. He / she also involved in the review of
technical requirements in sales order where ever applicable.

Marketing Technical support – Engineer: Report

eport to Marketing Technical support – Head and assist in compiling / providing the necessary documents
during tendering / enquiry stage.

Plant - Head: - Reports to Director and responsible for efficient functioning of the whole organization and for preventing
preventing the occurrence of any non-
non
conformities relating to products, processes & quality system, to control further processing or delivery of non-confirming
non confirming product until the non-
non
conforming condition has been corrected and timely delivery of customer’s orders.
or

Management Representative: - Reports to Director. Responsible for arranging Quality Audits by API/ Certifying body and also Internal Audits.
Responsible for issuing and updating Quality System Procedures & Work Instructions and also Internal Audits Responsible for issuing and updating
other procedures for implementation.

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Manufacturing - Head: Reports to Plant- Head and responsible for effective functioning of the whole manufacturing plant & execution of orders. or He /
She ensure safe operations, on-time
time delivery and controls factors affecting the quality of the job. He / She is also responsible for expediting the timely
delivery of material to customer and co-ordination
ordination of production planning & Production activity.
act

HR - Head: - Associated with legal matters, conducts training & assists Plant-
Plant Head in HR activity.

HR – executive:- Assist HR-head

head in Training & awareness activity.

Production – In-charge: - Reports to Manufacturing - head responsible for planning and execution of orders as per the committed date, programming,
programming
Tooling and associated works of CNC machines.

Production – Engineer:- Reports to Production – Incharge, responsible for effective functioning of machining shop.

Machine Group In-charge:- Reports to Production In-charge

charge,, responsible for effective utilization of machine in production by providing necessary
documents, toolings, etc.

Maintenance – In-charge: - Reports to Manufacturing - Head. All preventive & breakdown maintenance works of shop floor are carried out under his
direct Guidance / Supervision.

Maintenance – Engineer: -Reports to Maintenance – head. Assist maintenance In-charge in executing the planned maintenance activity.

Production Planning - Engineer: -Reports

Reports to Manufacturing-
Manufacturing Head and will be responsible for allll the Production planning and Control functions such
as opening, progressing and closing of work orders, machine loading etc. Responsible for conducting Delivery Planning Meeting, Weekly Wee Review
Meeting against the supply order files. He / she shall ensure the timely delivery of material to the customers.

Quality - Head: - Reports to Plant head has inline

line functions with Production Group, Head Design & Marketing-
Marketing Head and recommend corrections to
responsible management levels, verify corrective actions, tests to be done and records to be kept, control non-conforming
non conforming materials/products &
processes and also he / she will be the coordinator for Quality related matters / concerns.

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Quality - Engineer: - Reports to Quality - Head. He / She is responsible for updating Quality Manual and Quality System Procedures whenever
required. He / She also establish & adapt necessary changes in the QMS to achieve quality as per customer / standard specifications. He / She
effectively measures & monitors the process & product during different stages of manufacturing. Responsible for making Q.A. Plans, doing Quality
checks and identifying problems attacking quality, selection of inspection points, devise
devise sampling plans and calibration of inspection, gauges and test
equipment. He /She also monitor the shop floor inspection activities.

Quality Inspector: Assist & report to Quality head in various activities related to quality control i.e. inspection of components / products w.r.t Design /
Manufacturing drawing.

Purchase & Inventory - Head: - Reports to plant head and responsible

responsible for all purchases, supplier development, organize inspections at supplier’s place
and inspections on arrival of stores at the plant, stocking, preserving and issue of stores, packing preserving of stores and related functions.

Purchase – Executive:- Reports to Purchase & Inventory – Head. Responsible for issuing purchase orders as per requisition for execution of sale orders
& for procuring required consumable items, toolings, etc for various departments.

Store – In-charge: - Reports to Purchase & Inventory - Head.

Head Responsible for efficient functioning of stores section.

Store – Keeper:- Reports to Store – In-charge. Responsible

esponsible for issuing required raw material, Bought out item, consumable items wherever necessary,
products / product components to functions like assembly & testing, machining shop, etc.

Outsourcing – In-charge:- Reports to Manufacturing Head.

Head Responsible le for controlling the outsourcing activities such as machining, heat treatment,
etc and arrange the material on time by effective follow up with the vendors.

Design - Head: - Reports to Plant - Head and responsible for design and development functions, updating of drawings, amendment to drawings, issue
of drawings for manufacturing as well as for tenders, preparing procedures and controlling all design and development work.

Design - Engineer:- Reports to Design Head. Involved nvolved in design and development
development of new product as per relevant specs to meet customer
requirements and will ensure that design development is reviewed and verification done by appropriate personnel appointed by head design. He / she
also verifies any changes / modification in the drawings
ngs is controlled and effectively communicated & documented.

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Design - Draughtsman:- Reports to Design Head. Involved
nvolved in providing the necessary design related documents such as Design drawing, Bill of
material, etc for manufacturing.

Assembly & Testing – In-charge: - Responsible

esponsible for assembly and final testing shop and its activities and will report directly to Manufacturing - Head.
Responsible for effective utilization of man power in assembly & testing related activity by providing necessary documents & fixtures, toolings, etc.

Marking In-charge: Reports to manufacturing – head and he /she will ensure the effective functioning of marking activity.

Phosphating – In-charge: - Responsible

esponsible for Phosphating activity in the plant and directly report to Manufacturing- Head.

Painting, Packing & Dispatch – In-charge: - Responsible

esponsible for painting and packing of final equipment and assists in dispatch of material. Reports
directly to Manufacturing – Head.

Machine Operator: Responsible to do machining of components

comp / products w.r.t Design / Manufacturing drawings.

Assembly & Testing Fitter: Responsible to do assembly & testing of final product w.r.t work instructions / assembly & testing procedures/technical /
operational manual etc.

Marking Assistant: Reports to Marking In-charge & responsible

esponsible to do marking of components / products w.r.t instruction.

Painter: Reports to painting & Dispatch In-charge & responsible

esponsible to do painting of products w.r.t instruction.

Packing & Dispatch Assistant: Reports to Painting,, Packing & Dispatch In-charge & responsible
esponsible to do packing of components / products w.r.t
instruction.

Outsourcing Executive: Reports to Outsourcing In-charge

charge & controls the outsourcing activities. Responsible for issuing work orders as per requisition
for execution of outsourced activity on-time.

Maintenance Assistant: Reports to Maintenance In-charge

charge & assist him to complete the activities related to maintenance function.

Quality Executive: Reports to Quality Head & responsible

esponsible to prepare
pr Inspection & Test certificate.
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Phosphating Assistant: Reports to Phosphating In-charge

charge & assist him to complete the activities related to phosphating function.

Store Assistant: Reports to Store Keeper & assist him to complete the activities related to store function.

A.2.2. RESPONSIBILITY, ACCOUNTABILITY & AUTHORITY:

Responsibility means having an obligation to do something (or) being the primary cause of something, so able to be blamed or credited for it.
In other words, duty assigned to a person or obligation to perform a duty as required by the superior.
Note: Responsibility cannot be delegated. If the subordinate does a poor job, the superior cannot evade the responsibility by stating that the poor
performance is the fault of subordinate.

Accountability
untability is the obligation of an individual to report formally to his supervisor about the work done to discharge the responsibility.
respo
In other words, answerability for the consequences of the delegated activities. Accountability is the liability created to the use of authority.
Note: The person accepting responsibility is accountable for the performance of assigned duties. Everyone is accountable for job assigned to him.

Authority means it is the right / power assigned to a person in-order

in to achieve certain organization objectives.
Superior transfers the responsibilities to the subordinate and also gives necessary authority for performing with responsibility.
responsibil

SR. RESPONSIBILITY AUTHORITY ACCOUNTABILITY

DESIGNATION
NO
4.1.2 Quality policy Approving of Quality Policy Board of directors
Defining & documenting commitment to quality Approving of Quality Manual & External parties
Review of quality policy periodically to ensure that it is Approving of Management review report
1 Director
appropriate to the organization Appointment of Management
4.2.3 Management representative representative Board of directors
Appointing & maintaining a Management representative & External parties
4.1.5 Communication Appointment of new employee Board of directors
Ensuring appropriate communication process are Approving of outside / specialized training & External parties
2 Plant Head
established within the organization Decision on Non-conforming
conforming product
Ensuring the effectiveness of the QMS is communicated (internal & external)
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4.2.Management responsibility Approving of Design & development Board of directors
Ensuring the availability of resources essential to establish, Validation & External parties
implement, maintain, and improve the QMS. Appointment of new employee
Ensuring responsibilities, authorities and accountabilities of Approving of Outside / specialized training
all employees are defined, documented & communicated Approving of Annual training plan
throughout the organization Approving of Contingency planning
4.3 Organization capability Design & development validation & Board of directors
Allocation of resources needed to implement, maintain, and approval & External parties
improve the effectiveness of the requirements of the QMS Decision on Non-conforming
conforming product
Ensuring customer specified training and / or customer (internal & external)
provided training is included in the training program
Ensuring frequency & content of training is identified
Ensuring personnel are aware of the relevance
relevan & importance
of their activities & how they contribute to the achievement
of quality objectives.
Providing, Managing & maintaining the work environment
needed to achieve conformity applicable to the manufacture
of the product.
4.3.3 Work Environment Board of directors
Determining, providing, managing & maintaining the work & External parties
environment needed to achieve conformity applicable to the
manufacture of product.
5.2 Planning Board of directors
Identification & planning the processes & documents & External parties
needed for product realization.
realization
Annexure A, section A.7 Board of directors
Ensuring the compliance with the requirements of the & External parties
applicable API product specifications and/or standards.
5.10 Control of Non-conforming
conforming Product Board of directors
Authorizing NC product’s use, release, or acceptance under & External parties

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concession
4.1.1 General Approving of Management of Change Board of directors
Measure the effectiveness and improve upon the QMS in Approving of Contingency planning & External parties
accordance with the requirement of API Q1 Approving of Quality System Procedure
4.1.2 Quality policy Approving of Quality Objective Board of directors
Ensuring Quality policy is communicated, understood, Closure of external (certifying agency & & External parties
implemented and maintained at all relevant functions and Customer) audit NCR
levels within the organization Closure of internal Audit
4.1.3 Quality objectives Board of directors
Ensuring quality objectives are established at relevant & External parties
functions and levels within the organization.
4.1.4 Planning Board of directors
Ensuring criteria & methods needed for the operation & & External parties
control of all quality management system processes are
determined, managed and effective.
Management
3 Ensuring planning of QMS is carried out in order to meet the
Representative
requirements of API Q1 & ISO 9001.
4.2.Management responsibility
esponsibility Board of directors
Ensuring that quality objectives are established including & External parties
KPI for use in Data analysis
Conducting Management reviews
4.2.3 Management representative Accountable to
Ensuring adherence to all the requirements director
4.3 Organization capability Board of directors
Ensuring personnel are aware of the relevance & importance & External parties
of their activities & how they contribute to the achievement
of quality objectives.
4.4 Documentation Requirements Board of directors
Implementation of all the requirements & External parties
4.4.3 Control of Documents Board of directors

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 QUALITY MANUAL
Ensuring the implementation of all the requirements & External parties
(QSP-01)
4.4.4 Use of external documents in product realization Board of directors
Implementation of the requirements of API product or other & External parties
external specification including addenda, errata, and
updates are integrated into the product realization process
and any other affected processes. (QSP-24)
4.5 Control of records Board of directors
Ensuring the implementation of all the requirements & External parties
(QSP-02)
5.3 Risk assessment & Management Board of directors
Ensuring the implementation of all the requirements & External parties
(QSP-19)
5.5 Contingency Planning Board of directors
Ensuring the implementation of all the requirements & External parties
(QSP-19)
5.11 Management of change Board of directors
Ensuring the implementation of all the requirements & External parties
(QSP-23)
6.2.2. Internal Audit Board of directors
Ensuring the implementation of all the requirements & External parties
(QSP-14)
6.2.3 Process Evaluation Board of directors
Ensuring the implementation of all the requirements & External parties
(QSP-15)
6.3 Analysis of Data Board of directors
Ensuring the implementation of all the requirements & External parties
(QSP-17)
6.5 Management Review Board of directors
Ensuring the implementation of all the requirements & External parties

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(QSP-08)
4.4.3 Control of Documents Approving of internal audit plan Accountable to MR
Ensuring adherence to all the requirements (QSP-01) Approving of Calibration calendar
4.4.4 Use of external documents in product realization Approving of work instructions Accountable to MR
Ensuring adherence to all the requirements (QSP-24) Approving of Inspection Test Certificate
4.5 Control of records Approving of Quality Assurance Plan Accountable to MR
Ensuring adherence to the requirements such as records Approving of in-house
house calibration certificate
shall remain legible, identifiable & retrievable and those Closure of customer complaint
records shall be retained for specified period. Closure of discrepancy report
5.3 Risk assessment & Management Closure of NCR raised to suppliers Accountable to MR
Maintaining the records of risk assessment and Closure of evaluation of effectiveness of
management including actions taken. C.A. taken
5.6.3 Verification of Purchased products or activities Decision on disposal of Quality Records Board of directors
Implementation of all the requirements (QSP-08) Approving of Supplier (critical & non-
non & External parties
5.7.1.1 Production critical) NDT, material Testing and Board of directors
4 Quality Head Ensuring the availability & use of suitable, measurement calibration agency & External parties
equipment Approving of Validation of Process
Implementation of monitoring & measurement activities Approving of Product release
Implementation of product release including applicable Approving of Supplier (critical & non-
non
delivery & post – delivery activities critical)
al) Logistics & transportation
5.7.1.2 Servicing Approving of Supplier (critical & non-
non Board of directors
Ensuring the availability & use of suitable, measurement critical) Raw material, Bought out items, & External parties
equipment servicing (machining, Heat treatment,
Implementation of monitoring & measurement activities welding) & consumables
Ensuring the requirements for release of the product that To do changes in the record
was serviced are in compliance
5.7.1.5 Validation of Processes for production & servicing Board of directors
Ensuring the implementation of all the requirements & External parties
(QSP-09)
5.7.2 Product Quality Plans Board of directors

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Ensuring the implementation of all the requirements & External parties
(QSP-15,22)
5.7.4 Product Inspection / Test status Board of directors
Ensuring the implementation of all the requirements & External parties
(QSP-15)

5.7.7. Inspection & Testing Board of directors

Ensuring the implementation of all the requirements & External parties
(QSP-15)
5.8 Control of Testing, Measuring and monitoring Board of directors
equipment & External parties
Ensuring the implementation of all the requirements
5.9 Product Release Board of directors
Ensuring the implementation of all the requirements & External parties
(QSP-22)
5.10 Control of Non-conforming
conforming Product Board of directors
Ensuring the implementation of all the requirements & External parties
(QSP-16)
6.4 Improvement Board of directors
Ensuring the implementation of all the requirements & External parties
(QSP-17)
Annexure A section A.5 Control of the Application and Board of directors
removal of the API Monogram & External parties
Ensuring the implementation of all the requirements
4.3.2 Human resources Closure of training effectiveness evaluation Board of directors
Documenting the effectiveness of the training Closure of skill evaluation & External parties
Maintenance of evidence of the determination of Arrangement of In-house
house training
5 HR Head
competence of personnel. Closure of On-Job
Job Training record
Providing QMS training and job training Closure of Introductory training record
Maintenance of appropriate records of education, training, To do changes in the record

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skills and experience.
4.5 Control of records Accountable to MR
Ensuring adherence to the requirements such as records
shall remain legible, identifiable & retrievable and those
records shall be retained for specified period.
5.3 Risk assessment & Management Accountable to MR
Maintaining the records of risk assessment and
management including actions taken.
4.5 Control of records Approving of Preventive Maintenance Accountable to MR
Ensuring adherence to the requirements such as records schedule
shall remain legible, identifiable & retrievable and those Issue off Product planning sheet
records shall be retained for specified period. Approving of DPM sheet
5.3 Risk assessment & Management Approving of product realization capability Accountable to MR
Maintaining the records of risk assessment and documentation
management including actions taken Issue of packing list
5.7.1.1 Production Issue of Raw material requisition slip Board of directors
Ensuring the implementation of all the requirements Issue of Raw material cutting list & External parties
(QSP-08) Approving order review
Manufacturing 5.7.1.2 Servicing (for Job work) Board of directors
6 To do changes in the record
Head Ensuring the implementation of all the requirements & External parties
(QSP-08)
5.7.1.3 Process control documents Board of directors
Ensuring the implementation of all the requirements & External parties
(QSP-08)
5.7.1.4 Product realization capability documentation Board of directors
Ensuring the implementation of all the requirements & External parties
(QSP-08)
5.7.8 Preventive Maintenance Board of directors
Ensuring the implementation of all the requirements & External parties
(QSP-20)

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6.3 Analysis of Data Accountable to MR
Ensuring adherence to all the requirements (QSP-17)
4.5 Control of records Approving of design drawing Accountable to MR
Ensuring adherence to the requirements such as records Approving of work instructions
shall remain legible, identifiable & retrievable and those Approving of design & development input
records shall be retained for specified period. & output
5.3 Risk assessment & Management Approving off Design & Development Accountable to MR
Maintaining the records of risk assessment and planning
7 Design Head management including actions taken. Approving of Design & Development
5.4 Design & Development changes Board of directors
Ensuring the implementation of all the requirements Approving of Bill of material & External parties
(QSP-04) To do changes in the record
5.7.5 Customer – supplied property (only documents) Board of directors
Ensuring the implementation of all the requirements & External parties
(QSP-11)
4.5 Control of records Approving of Purchase order Accountable to MR
Ensuring adherence to the requirements such as records Approving of Periodic assessment of stock
shall remain legible, identifiable & retrievable and those To do changes in the record
records shall be retained for specified period.
Purchase &
5.3 Risk assessment & Management Accountable to MR
8 Inventory -
Maintaining the records of risk assessment and
Head
management including actions taken.
5.6 Purchasing (exclusive of 5.6.3) Board of directors
Ensuring the implementation of all the requirements & External parties
(QSP-06)
5.7.3 Identification & Traceability Board of directors
Implementation of all the requirements (QSP-10) & External parties
5.7.5 Customer – supplied property Board of directors
(exclusive of documents) & External parties
Implementation of all the requirements (QSP-11)

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5.7.6 Preservation of Product Board of directors
Implementation of all the requirements (QSP-12) & External parties
6.3 Analysis of Data Accountable to MR
Ensuring adherence to all the requirements (QSP-17)
4.5 Control of records Approving of contract review Accountable to MR
Ensuring adherence to the requirements such as records Approving of customer satisfaction survey
shall remain legible, identifiable & retrievable and those analysis report
records shall be retained for specified period. Issue of customer satisfaction survey form
5.3 Risk assessment & Management To do changes in the record Accountable to MR
Maintaining the records of risk assessment and
9 Marketing Head management including actions taken.
5.1 Contract Review Board of directors
Ensuring the implementation of all the requirements & External parties
(QSP-04)
6.2.1 Customer Satisfaction Board of directors
Ensuring the implementation of all the requirements & External parties
(QSP-17)
4.4.3 Control of Documents Approving the verification report of Accountable to
Ensuring adherence to all the requirements (QSP-01) purchased product Quality Head
4.4.4 Use of external documents in product realization Individual serial number to measuring Accountable to
Ensuring adherence to all the requirements (QSP-24) equipment Quality Head
4.5 Control of records Issue of master list of instrument Accountable to
Ensuring adherence to the requirements such as records Approving furnace calibration report Quality Head
Quality
10 shall remain legible, identifiable & retrievable and those Approving calibration report from outside
Engineer
records shall be retained for specified period. agency.
5.3 Risk assessment & Management Approving of assembly marking slip Accountable to
Maintaining the records of risk assessment and Approving of Hardness test report Quality Head
management including actions taken. Approving of Dimensional report
5.6.3 Verification of Purchased products or activities Clearance of component / product after Accountable to
Ensuring adherence to all the requirements (QSP-07) painting process Quality Head

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5.7.1.1 Production Clearance of component / product after Accountable to
Ensuring the availability & use of suitable, measurement packing process Quality Head
equipment Clearance of component / product after
Implementation of monitoring & measurement activities outsourcing process
Implementation of product release including applicable Clearance of component / product after
delivery & post – delivery activities machining process
5.7.1.2 Servicing Clearance of component / product after Accountable to
Ensuring the availability & use of suitable, measurement marking process Quality Head
equipment Clearance of Bought out Items
Implementation of monitoring & measurement activities Clearance of Raw material
Ensuring the requirements for release of the product that Approving of packing / Dispatch inspection
was serviced are in compliance report cum log sheet
5.7.1.5 Validation of Processes for production & servicing To do changes in the record Accountable to
Implementation of all the requirements (QSP-09) Quality Head
5.7.2 Product Quality Plans Accountable to
Implementation of all the requirements (QSP-22) Quality Head
5.7.3 Identification & Traceability Accountable to
Ensuring adherence to all the requirements (QSP-10) Quality Head
5.7.4 Product Inspection / Test status Accountable to
Implementation of all the requirements (QSP-15) Quality Head
5.7.7. Inspection & Testing Accountable to
Implementation of all the requirements (QSP-15) Quality Head
5.8 Control of Testing, Measuring and monitoring Accountable to
equipment Quality Head
Implementation of all the requirements (QSP-13)
5.9 Product Release Accountable to
Ensuring adherence to all the requirements (QSP-15,22) Quality Head
5.10 Control of Non-conforming
conforming Product Accountable to
Ensuring adherence to all the requirements (QSP-16) Quality Head
6.4 Improvement Accountable to

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Ensuring adherence to all the requirements (QSP-17) Quality Head
Annexure A section A.5 Control of the Application and Accountable to
removal of the API Monogram Quality Head
Ensuring adherence to all the requirements (Annexure A.3)
4.5 Control of records Approving of assembly marking slip Accountable to
Ensuring adherence to the requirements such as records Approving of Hardness test report Quality Head
shall remain legible, identifiable & retrievable and those Approving of Dimensional report
records shall be retained for specified period. Clearance of component / product after
5.6.3 Verification of Purchased products or activities painting process Accountable to
Ensuring adherence to all the requirements. Clearance of component / product after Quality Head
5.7.1.1 Production packing process Accountable to
Ensuring the availability & use of suitable, measurement Clearance of component / product after Quality Head
equipment outsourcing process
Implementation of monitoring & measurement activities Clearance of component / product after
Implementation of product release including applicable machining process
delivery & post – delivery activities Clearance of component / product after
Quality 5.7.1.2 Servicing marking process Accountable to
11 Clearance
rance of Bought out Items
Inspector Ensuring the availability & use of suitable, measurement Quality Head
equipment Clearance of Raw material
Implementation of monitoring & measurement activities Application and removal of Monogram
Ensuring the requirements for release of the product that Approving of packing / Dispatch inspection
was serviced are in compliance report cum log sheet
5.7.2 Product Quality Plans To do changes in the record Accountable to
Ensuring adherence to all the requirements (QSP-15,22) Approving of NDT repots Quality Head
5.7.3 Identification & Traceability Accountable to
Ensuring adherence to all the requirements (QSP-10) Quality Head
5.7.4 Product Inspection / Test status Accountable to
Implementation of all the requirements (QSP-15) Quality Head
5.7.7. Inspection & Testing Accountable to
Implementation of all the requirements (QSP-15) Quality Head

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5.8 Control of Testing, Measuring and monitoring Accountable to
equipment Quality Head
Ensuring adherence to all the requirements (QSP-13)
5.9 Product Release Accountable to
Ensuring adherence to all the requirements (QSP-22) Quality Head
5.10 Control of Non-conforming
conforming Product Accountable to
Ensuring adherence to all the requirements (QSP-16) Quality Head
Annexure A section A.5 Control of the Application and Accountable to
removal of the API Monogram Quality Head
Ensuring adherence to all the requirements (Annexure A3)
4.5 Control of records Issue of Inspection & test certificate to Accountable to
Ensuring adherence to the requirements such as records customer. Quality Head
Quality shall remain legible, identifiable & retrievable and those To do changes in the record
12
Executive records shall be retained for specified period.
5.9 Product Release Accountable to
Ensuring adherence to all the requirements (QSP-22) Quality Head
4.3.2 Human resources Closure of training effectiveness evaluation Accountable to HR
Ensuring adherence to all the requirements (QSP-03) Arrangement of In-house
house training head
4.5 Control of records To do changes in the record Accountable to HR
Ensuring adherence to the requirements such as records head
13 HR Executive shall remain legible, identifiable & retrievable and those
records shall be retained for specified period.
5.3 Risk assessment & Management Accountable to HR
Maintaining the records of risk assessment and head
management including actions taken.
4.5 Control of records Issue of Product planning sheet Accountable to
Production Ensuring adherence to the requirements such as records Issue of Raw material requisition slip Manufacturing
14 Planning shall remain legible, identifiable & retrievable and those Issue of Raw material cutting list head
Engineer records shall be retained for specified period. Photocopying of design drawing
5.3 Risk assessment & Management To do changes in the record Accountable to

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Maintaining the records of risk assessment and Manufacturing
management including actions taken. head
5.7.1.1 Production Accountable to
Ensuring adherence to all the requirements (QSP-08) Manufacturing
head
5.7.1.3 Process control documents Accountable to
Implementation of all the requirements (QSP-08) Manufacturing
head
5.7.1.4 Product realization capability documentation Accountable to
Implementation of all the requirements (QSP-08) Manufacturing
head
5.7.3 Identification & Traceability Accountable to
Ensuring adherence to all the requirements (QSP-10) Manufacturing
head

4.5 Control of records Approving of Machine work load chart Accountable to

Ensuring adherence to the requirements such as records Approving of Process sheet Manufacturing
shall remain legible, identifiable & retrievable and those Closure of Machine trouble order head
records shall be retained for specified period. Issue of component Job card
5.3 Risk assessment & Management Approving of Daily production report Accountable to
Maintaining the records of risk assessment and Approving of Discrepancy product analysis Manufacturing
management including actions taken. report – Manufacturing head
Production In- 5.7.1.1 Production Photocopying of design drawing Accountable to
15
charge Ensuring adherence to all the requirements (QSP-08) To do changes in the record Manufacturing
head
5.7.1.3 Process control documents Accountable to
Implementation of all the requirements (QSP-08) Manufacturing
head
6.3 Analysis of Data Accountable to
Ensuring adherence to all the requirements (QSP-08) Manufacturing

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head

4.5 Control of records Clearance of component / product after Accountable to

Ensuring adherence to the requirements such as records phosphating process Manufacturing
shall remain legible, identifiable & retrievable and those Issue of monthly maintenance & control head
records shall be retained for specified period. record
5.3 Risk assessment & Management Approving titration chart (Phosphating)
(Phosphati Accountable to
Maintaining the records of risk assessment and To do changes in the record Manufacturing
Phosphating In-
16 management including actions taken. head
charge
5.7.1.1 Production Accountable to
Implementation of all the requirements (QSP-08) Manufacturing
head
5.7.1.3 Process control documents Accountable to
Implementation of all the requirements (QSP-08) Manufacturing
head
4.5 Control of records Approving of Hydro & functional test report Accountable to
Ensuring adherence to the requirements such as records Clearance of component / product after Manufacturing
shall remain legible, identifiable & retrievable and those assembly & testing process
rocess head
records shall be retained for specified period. Issuing Assembly & Testing Job card
5.3 Risk assessment & Management Approving of traceability chart Accountable to
Maintaining the records of risk assessment and Approving of Assembly & Testing log sheet Manufacturing
Assembly &
management including actions taken. To do changes in the record head
17 Testing In-
5.7.1.1 Production Accountable to
charge
Implementation of all the requirements (QSP-08) Manufacturing
head
5.7.1.2 Servicing Accountable to
Implementation of all the requirements (QSP-08) Manufacturing
head
5.7.1.3 Process control documents Accountable to

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 QUALITY MANUAL
Implementation of all the requirements (QSP-08) Manufacturing
head
6.3 Analysis of Data Accountable to
Ensuring adherence to all the requirements (QSP-17) Manufacturing
head
4.5 Control of records Approving the Instruction sheet to suppliers Accountable to
Ensuring adherence to the requirements such as records for processing Manufacturing
shall remain legible, identifiable & retrievable and those Approving the supplier performance head
records shall be retained for specified period. assessment report
5.3 Risk assessment & Management To do changes in the record Accountable to
Maintaining the records of risk assessment and Manufacturing
management including actions taken. head
Outsourcing In- 5.6 Purchasing Accountable to
18
charge Implementation of all the requirements (QSP-06) Purchase &
Inventory head
5.7.1.3 Process control documents Accountable to
Implementation of all the requirements (QSP-08) Manufacturing
head
6.3 Analysis of Data Accountable to
Ensuring adherence to all the requirements (QSP-17) Manufacturing
head
4.5 Control of records Approving the requisition issue voucher Accountable to
Ensuring adherence to the requirements such as records To do changes in the record Manufacturing
shall remain legible, identifiable & retrievable and those Can communicate with Quality Inspector for head
records shall be retained for specified period. any clarification
Marking In-
19 5.3 Risk assessment & Management Accountable to
charge
Maintaining the records of risk assessment and Manufacturing
management including actions taken. head
5.7.1.1 Production Accountable to
Implementation of all the requirements (QSP-08) Manufacturing

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head
5.7.1.3 Process control documents Accountable to
Implementation of all the requirements (QSP-08) Manufacturing
head
4.5 Control of records Issue of packing list Accountable to
Ensuring adherence to the requirements such as records Approving the requisition issue voucher Manufacturing
shall remain legible, identifiable & retrievable and those To do changes in the record head
records shall be retained for specified period. Communicate with Quality Inspector for
5.3 Risk assessment & Management any clarification Accountable to
Painting,
Maintaining the records of risk assessment and Can assist / advise store personnel to get Manufacturing
Packing &
20 management including actions taken. Items for dispatch head
dispatch In-
5.7.1.1 Production Accountable to
charge
Implementation of all the requirements (QSP-08) Manufacturing
head
5.7.1.3 Process control documents Accountable to
Implementation of all the requirements (QSP-08) Manufacturing
head
4.5 Control of records Approving Machine history card Accountable to
Ensuring adherence to the requirements such as records Closure of MTO cum closure report. Manufacturing
shall remain legible, identifiable & retrievable and those To do changes in the record head
records shall be retained for specified period.
5.3 Risk assessment & Management Accountable to
Maintaining the records of risk assessment and Manufacturing
Maintenance
21 management including actions taken. head
In-charge
5.7.8 Preventive Maintenance Accountable to
Implementation of all the requirements (QSP-20) Manufacturing
head
6.3 Analysis of Data Accountable to
Ensuring adherence to all the requirements (QSP-17) Manufacturing
head

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4.5 Control of records Approving of product requirement sheet Accountable to
Ensuring adherence to the requirements such as records Issue Design drawings & Bill of material Design head
shall remain legible, identifiable & retrievable and those To do changes in n the record
records shall be retained for specified period Can assist / advise other function personnel
5.3 Risk assessment & Management during design & development of new Accountable to
Design
22 Maintaining the records of risk assessment and product Design head
Engineer
management including actions taken
5.4 Design & Development Accountable to
Implementation of all the requirements (QSP-05) Design head
5.7.5 Customer – supplied property (only documents) Accountable to
Implementation of all the requirements (QSP-11) Design head
4.5 Control of records Issue Design drawings & Bill of material Accountable to
Ensuring adherence to the requirements such as records To do changes in the record Design head
Design shall remain legible, identifiable & retrievable and those
23
Draughtsman records shall be retained for specified period.
5.4 Design & Development Accountable to
Implementation of all the requirements (QSP-05) Design head
4.5 Control of records Issue of material requisition cum purchase Accountable to
Ensuring adherence to the requirements such as records slip Purchase &
shall remain legible, identifiable & retrievable and those Approving daily raw material cutting – log Inventory head
records shall be retained for specified period sheet
5.3 Risk assessment & Management Issuing material against Requisition issue Accountable to
Maintaining the records of risk assessment and voucher Purchase &
24 Store In-charge management including actions taken To do changes in the record Inventory head
5.7.3 Identification & Traceability Accountable to
Implementation of all the requirements (QSP-10) Purchase &
Inventory head
5.7.5 Customer – supplied property Accountable to
(Exclusive of documents) Purchase &
Implementation of all the requirements (QSP-11) Inventory head

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5.7.6 Preservation of Product Accountable to
Implementation of all the requirements (QSP-12) Purchase &
Inventory head
4.5 Control of records Communication with concerned personnel Accountable to
Ensuring adherence to the requirements such as records to get necessary purchasing information Purchase &
shall remain legible, identifiable & retrievable and those To do changes in the record Inventory head
records shall be retained for specified period Issue of work instruction to supplier as
Purchase 5.6 Purchasing purchasing information Accountable to
25
Executive Implementation of all the requirements (QSP-06) Purchase &
Inventory head
6.3 Analysis of Data Accountable to
Ensuring adherence to all the requirements (QSP-17) Purchase &
Inventory head
4.5 Control of records Communication with concerned personnel Accountable to
Ensuring adherence to the requirements such as records to get necessary purchasing information Outsourcing In-
shall remain legible, identifiable & retrievable and those Issue of work instruction to supplier as charge
records shall be retained for specified period purchasing information
5.6 Purchasing To do changes in the record Accountable to
Implementation of all the requirements (QSP-06) Outsourcing In-
Outsourcing
26 charge
Executive
5.7.1.3 Process control documents Accountable to
Implementation of all the requirements (QSP-08) Outsourcing In-
charge
6.3 Analysis of Data Accountable to
Ensuring adherence to all the requirements (QSP-17) Outsourcing In-
charge
Marketing 4.5 Control of records Communication with customer to get more Accountable to
technical Ensuring adherence to the requirements such as records information related to the product Marketing head
27
support shall remain legible, identifiable & retrievable and those To do changes in the record
Incharge records shall be retained for specified period

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5.3 Risk assessment & Management Accountable to
Maintaining the records of risk assessment and Marketing head
management including actions taken
5.1 Contract Review Accountable to
Implementation of all the requirements (QSP-04) Marketing head

4.5 Control of records Issue of customer satisfaction survey form Accountable to

Ensuring adherence to the requirements such as records To do changes in the record Marketing head
shall remain legible, identifiable & retrievable and those Can assist / advise Marketing – technical
records shall be retained for specified period support personnel during
5.3 Risk assessment & Management Accountable to
Maintaining the records of risk assessment and Marketing head
Marketing In-
28 management including actions taken
charge
5.1 Contract Review Accountable to
Implementation of all the requirements (QSP-04) Marketing head
6.2.1 Customer Satisfaction Accountable to
Implementation of all the requirements (QSP-17) Marketing head
6.3 Analysis of Data Accountable to
Ensuring adherence to all the requirements (QSP-17) Marketing head
4.5 Control of records Approving of Daily production report Accountable to
Ensuring adherence to the requirements such as records To do changes in the record Production In-
shall remain legible, identifiable & retrievable and those Can assist / advise other machine group charge
records shall be retained for specified period personnel
Machine Group
29 5.7.1.1 Production Issue of requisition of consumable item Accountable to
In-charge
Implementation of all the requirements (QSP-08) used in machining process Production In-
charge
5.7.1.3 Process control documents Accountable to
Implementation of all the requirements (QSP-08) Production In-
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charge
4.5 Control of records Issue of component Job card Accountable to
Ensuring adherence to the requirements such as records Photocopying of design drawing Production In-
shall remain legible, identifiable & retrievable and those To do changes in the record charge
records shall be retained for specified period Can assist / advise PPC personnel
5.3 Risk assessment & Management Accountable to
Maintaining the records of risk assessment and Production In-
management including actions taken charge
Production 5.7.1.1 Production Accountable to
30
Engineer Implementation of all the requirements (QSP-08) Production In-
charge
5.7.1.3 Process control documents Accountable to
Implementation of all the requirements (QSP-08) Production In-
charge
6.3 Analysis of Data Accountable to
Ensuring adherence to all the requirements (QSP-17) Production In-
charge
4.5 Control of records Can hold phosphating process in case of Accountable to
Ensuring adherence to the requirements such as records incompleteness
pleteness in process control Phosphating In-
shall remain legible, identifiable & retrievable and those documents charge
records shall be retained for specified period To do changes in the record
Phosphating 5.7.1.1 Production Accountable to
31
assistant Implementation of all the requirements (QSP-08) Phosphating In-
charge
5.7.1.3 Process control documents Accountable to
Implementation of all the requirements (QSP-08) Phosphating In-
charge
Fitter – 4.5 Control of records Can communicate the shortage / necessity Accountable to
32 Assembly & Ensuring adherence to the requirements such as records of bought item to store In-charge
charge Assembly &
Testing shall remain legible, identifiable & retrievable and those Can assist / advise store assistant Testing In-charge

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records shall be retained for specified period

5.7.1.1 Production Accountable to

Implementation of all the requirements (QSP-08) Assembly &
Testing In-charge
5.7.1.2 Servicing Accountable to
Implementation of all the requirements (QSP-08) Assembly &
Testing In-charge
5.7.7.3 Final Inspection & Testing Accountable to
Implementation of all the requirements (QSP-15,22) Assembly &
Testing In-charge
4.5 Control of records Can communicate with Quality Inspector for Accountable to
Ensuring adherence to the requirements such as records any clarification Marking In-charge
shall remain legible, identifiable & retrievable and those
Marking records shall be retained for specified period.
33 .7.1.1 Production Accountable to
Assistant
Implementation of all the requirements (QSP-08) Marking In-charge

5.7.1.3 Process control documents Accountable to

Implementation of all the requirements (QSP-08) Marking In-charge
4.5 Control of records Can communicate with Quality Inspector / Accountable to
Ensuring adherence to the requirements such as records Assembly & Testing personnel for any Packing & dispatch
shall remain legible, identifiable & retrievable and those clarification In-charge
Packing & records shall be retained for specified period.
34 dispatch 5.7.1.1 Production Accountable to
Assistant Implementation of all the requirements (QSP-08) Packing & dispatch
In-charge
5.7.1.3 Process control documents Accountable to
Implementation of all the requirements (QSP-08) Packing & dispatch
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In-charge
4.5 Control of records Can communicate with Quality Inspector / Accountable to
Ensuring adherence to the requirements such as records Assembly & Testing for any clarification Painting In-charge
shall remain legible, identifiable & retrievable and those Can assist / advise packing & dispatch
records shall be retained for specified period. assistant
35 Painter
5.7.1.1 Production Accountable to
Implementation of all the requirements (QSP-08) Painting In-charge
5.7.1.3 Process control documents Accountable to
Implementation of all the requirements (QSP-08) Painting In-charge
4.5 Control of records To do changes in the record Accountable to
Ensuring adherence to the requirements such as records Can communicate with h Production In-
In Maintenance In-
shall remain legible, identifiable & retrievable and those charge / Production Engineer related to charge
records shall be retained for specified period. Maintenance activity
Maintenance 5.7.8 Preventive Maintenance Accountable to
36
Engineer Implementation of all the requirements (QSP-20) Maintenance In-
charge
6.3 Analysis of Data Accountable to
Ensuring adherence to all the requirements (QSP- 17) Maintenance In-
charge
4.5 Control of records Can assist / advise machine operator Accountable to
Ensuring adherence to the requirements such as records Maintenance In-
shall remain legible, identifiable & retrievable and those charge
Maintenance
37 records shall be retained for specified period.
Assistant
5.7.8 Preventive Maintenance Accountable to
Implementation of all the requirements (QSP-20) Maintenance In-
charge
4.5 Control of records Clearance of component / product after Accountable to
Ensuring adherence to the requirements such as records cutting process Store In-charge
38 Store Keeper
shall remain legible, identifiable & retrievable and those Issue of component Job card
records shall be retained for specified period. Issue of material requisition cum purchase
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 QUALITY MANUAL
5.7.3 Identification & Traceability slip Accountable to
Implementation of all the requirements (QSP-10) Photocopying of design drawing Store In-charge
5.7.5 Customer – supplied property To do changes in the record Accountable to
Implementation of all the requirements (QSP-11) Store In-charge
5.7.6 Preservation of Product Accountable to
Implementation of all the requirements (QSP-12) Store In-charge
4.5 Control of records To do changes in the record Accountable to
Ensuring adherence to the requirements such as records Can communicate
mmunicate with marketing Marketing
Marketing shall remain legible, identifiable & retrievable and those personnel to get clarification related to technical support
technical records shall be retained for specified period. customer requirement In-charge
39
support 5.1 Contract Review Accountable to
engineer Implementation of all the requirements (QSP-04) Marketing
technical support
In-charge
4.5 Control of records Issue of customer satisfaction survey form Accountable to
Ensuring adherence to the requirements such as records To do changes in the record Marketing In-
shall remain legible, identifiable & retrievable and those Can communicate with customer to get charge
records shall be retained for specified period. clarification related to customer
5.1 Contract Review requirement Accountable to
Implementation of all the requirements (QSP-04) Marketing In-
Marketing
40 charge
Executive
6.2.1 Customer Satisfaction Accountable to
Implementation of all the requirements (QSP-17) Marketing In-
charge
6.3 Analysis of Data Accountable to
Ensuring adherence to all the requirements (QSP-17) Marketing In-
charge
4.5 Control of records Can assist / advise Maintenance personnel Accountable to
Machine
41 Ensuring adherence to the requirements such as records Can do first article inspection Group In-charge
operator
shall remain legible, identifiable & retrievable and those Can assist / advise other machine operators

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records shall be retained for specified period.
5.7.1.1 Production Accountable to
Implementation of all the requirements (QSP-08) Group In-charge

5.7.1.3 Process control documents Accountable to

Implementation of all the requirements (QSP-08) Group In-charge
42 Store assistant 4.5 Control of records Can communicate with Quality Inspector / Accountable to
Ensuring adherence to the requirements such as records Assembly & testing personnel for any Store Keeper
shall remain legible, identifiable & retrievable and those clarification
records shall be retained for specified period.
5.7.3 Identification & Traceability Accountable to
Implementation of all the requirements (QSP-10) Store Keeper
5.7.5 Customer – supplied property Accountable to
Implementation of all the requirements (QSP-11) Store Keeper
5.7.6 Preservation of Product Accountable to
Implementation of all the requirements (QSP-12) Store Keeper
43 Field service 4.5 Control of records To do changes in the record Accountable to his
Engineer Ensuring adherence to the requirements such as records Can communicate with Marketing / her Superior
shall remain legible, identifiable & retrievable and those personnel to get clarification related to
records shall be retained for specified period. customer requirements
5.7.1.2 Servicing Can communicate with Plant head / Director Accountable to his
Ensuring adherence to all the requirements (QSP-08) for any decision making / her Superior
5.7.1.3 Process control documents Accountable to his
Implementation of all the requirements (QSP-08) / her Superior
44 Field service 4.5 Control of records Can communicate with Marketing Accountable to his
technician Ensuring adherence to the requirements such as records personnel to get clarification related to / her Superior
shall remain legible, identifiable & retrievable and those customer requirements
records shall be retained for specified period.
5.7.1.2 Servicing Accountable to his
Ensuring adherence to all the requirements (QSP-08) / her Superior

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 QUALITY MANUAL
5.7.1.3 Process control documents Accountable to his
Implementation of all the requirements (QSP-08) / her Superior
45 Inspection 4.5 Control of records To do changes in the record Accountable to
Service Ensuring adherence to the requirements such as records Can communicate with Marketing Quality Head
Engineer shall remain legible, identifiable & retrievable and those personnel to get clarification related to
records shall be retained for specified period. customer requirements
5.7.2 Product Quality Plans Can communicate with Plant head / Director Accountable to
Implementation of all the requirements (QSP-15,22) for decision making Quality Head
5.7.7. Inspection & Testing Accountable to
Implementation of all the requirements (QSP-15, 22) Quality Head
46 Operator – NDT 4.5 Control of records To do changes in the record Accountable to
& Visual Ensuring adherence to the requirements such as records Can communicate with Quality Inspector / Quality Head
Inspector shall remain legible, identifiable & retrievable and those Quality Engineer for any clarification
records shall be retained for specified period.
5.7.7. Inspection & Testing Accountable to
Implementation of all the requirements (QSP-15, 22) Quality Head
47 Internal Auditor 4.5 Control of records To do changes in the record Accountable to MR
Ensuring adherence to the requirements such as records Can communicate with MR for any
shall remain legible, identifiable & retrievable and those clarification
records shall be retained for specified period.
6.2.2 Internal Audit Accountable to MR
Ensuring adherence to all the requirements

Note: In Accountability “External Parties” implies not limited to customer, Legal Statutory & Regulatory bodies, etc.

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Annexure A.3
A.3 - API Monogram Program
Organization will define API monogram Program requirements to enable it to acquire and
maintain API licenses to use Monograms on the products that are manufactured in the plant
as per API specs. It will be ensured that only those products that have passed quality system
requirements of API Specs Q1 (9th
( th Edition) in accordance with API Product specs and
requirements contained in API License agreements are are stamped with API Monogram.
Application of the API Monogram on the products manufactured in the plant shall be
controlled as per following: -

a) API Monogram shall be applied only on the products for which Organization has a API
License.

b) API Monogram shalll be applied within the facility.

c) Only Quality inspectors are authorized to apply the API Monogram on the above
product.

d) Quality inspectors will apply the monogram, License no. and date of manufacture (two
digits representing the month and two digits representing
representing the year unless otherwise
stipulated in the applicable API product specification(s) or standard(s)) to
monogrammed products as per marking procedure specified by the applicable API
product specification.

e) Monogram may be applied any time during the production process.

process In case the product
does not comply the requirement of the applicable API product specification(s) and / or
standard(s) and API monogram program at any stage, Quality inspectors are
authorized to remove the monogram from the product.
produc

f) Location of API Monogram marking will be as per API product specs but when this is
not given, the location of API Monogram marking will be on the maximum OD of the
product or as defined in accordance with marking procedure of the product. API
monogram marking will be done by die stamping / engraving. In addition to that paint
stenciling on product or printing on the name plate shall be done wherever applicable.
applicable

g) If the product is found to be in non conformance with API specified requirements, then
t
monogram will not be applied.

h) If the product is not manufactured by the organization, API monogram shall not be
applied.

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Note: Requirements
equirements related to outsourcing, for the products which are applicable to
API monogram marking are as under:
- Organization’s
on’s control on compliance to design requirements such as review,
verification & validation as per relevant API standard.
- In-house
house Assembly of product (if applicable).
- In-house
house hydro testing / functional testing of product (if applicable).
- Verification of compliance to API requirements.
- Compliance to level of outsourcing defined in section 4.1 general requirements.

i) If the non conformity is found during usage of the product in the field and
investigations reveal it to be true, then immediate action will
will be taken by Plant-
Plant Head /
Quality- Head to remove the API Monogram by grinding in case of die stamping &
engraving; by paint coating in case of paint stenciling and by removing the name plate
from the product in case of API Monogram marking is done on name plate.

j) Additional marking requirements of applicable API product specification(s) and / or

standard(s) shall be determined
etermined and controlled.

k) Records as per API Product specifications shall be retained for a period as specified
therein.. Records specified to demonstrate achievement of the effective operation of
the Quality system shall be maintained for a minimum period
period of 10 years.

l) It is necessary to maintain a design package for all of the applicable products that fall
under the scope of each Monogram license. The design package information shall
provide objective evidence that the product design meets the requirements
requireme of the
applicable and most current API product specification(s). The design package(s) shall
be made available at the facility.
In API monogrammed products if non conformance is observed in new product with API
requirements or if non conformity in the field failures observed due to API specs /
requirements then Plant- Head must report it to API.

Usage of API monogram symbol in Quality records, documents:

API Monogram symbol / logo should not be used on letterheads, buildings or other
structures, websites or in any advertising without an express statement of fact describing the
scope of Licensee’s authorization (license number and product specification), and further
provided that the organization should not use the API Monogram or the name AMERICAN
PETROLEUM INSTITUTE or the description “API” in any advertising or otherwise to indicate
API approval or endorsement of the Licensee’s products. This includes the use of the API
name, logo, or Monogram on any shipping documents, testing records, or contracts.

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Annexure A.4
A.4 - CE MONOGRAM PROGRAM

A.4.1 Scope:

To comply the requirements of Pressure Equipment Directive (PED) conformity assessment

Procedure Module H (Full Quality Assurance). Scope includes Design, Manufacturing,
Supplying & Servicing of Gate Valve & Choke Valves of different sizes, pressure & volume as
listed in document PARV/PED/01.

A.4.2 Control of Records:

The list of records to be maintained in order to comply with PED requirements and its control
is mentioned in Quality System Procedure
Procedur QSP-02.The
02.The retention time period is 10 years.

A.4.33 Quality Policy and Quality Objectives:

In addition to the compliance mentioned in section 5.3

Top management of the organization will ensure by means of the training program, internal
audits, the management
gement review meeting and the awareness of customer needs that the
quality policy includes a commitment to comply with PED requirements for “CE marking”
products.
In addition to the compliance mentioned in section 5.4.1.
Customer’s satisfaction consistent with PED and other relevant EN standards will be
evaluated on the basis of customer complaints and customer feedback on delivery product.
Those data’s shall also be considered while setting objectives for individual department /
functions.

A.4.4 Responsibility
bility and Authority:

In addition to the section 5.5 the additional responsibility of Management Representative,

Quality - Head, Design- Head to comply PED requirements are as follows:
Plant - Head (Management Representative (M.R.):
He will be in liaison with the notified body for arranging initial, surveillance and surprise
audits to verify the compliance of PED requirements.
Quality - Head:
He will authorize the PMA (Particular Material Appraisal), welding procedures (if applicable),
Welder qualification n (if applicable) and also responsible for getting them approved by
notified body. He will also be the authorized person to issue DOC (Declaration of
Conformance) against release of products complying to PED requirements.

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 QUALITY MANUAL
Design – Head:
He will review and authorize the ESR (Essential Safety Requirements) checklist to ensure that
PED requirements are complied.

A.4.55 Design and Development:

In addition to the compliance mentioned in Quality Manual section 7.3.2 and Quality System
Procedure QSP-05.
Design inputs shall include the following:
- Technical PED design specification, including other relevant EN standards shall be
identified, documented and considered as Design Input.

Design & development review, verification, validation, output and control of

o design and
development changes are covered in Quality Manual Section 7.3.3, 7.3.7 and in Quality
System Procedure QSP-05.
In addition to the compliance mentioned in Quality Manual and Quality System Procedure,
During the planning stage,
- it is necessary that the material selection or consideration shall comply with PED of
section 4 & section 7 of Annexure I
- Essential safety requirements mentioned in Annexure I shall be considered
and compliance to ESR shall be documented and maintained.
maintained

A.4.6 Purchasing:

In addition to compliance against purchasing process (section 7.4.1), for products under CE
certification, raw material (for which approved PMA is made) shall be purchased only from
the suppliers, whose QMS is certified by EU notifying
notifyin body.
PED requirements mentioned in Document PARV/PED/03 (on and above the corresponding
Organization’s material specification) shall be specified in the purchase order (refer section
7.4.2).

A.4.77 Control, Monitoring and measurement of manufacturing processes:

In addition to the compliance mentioned in Quality Manual and in relevant Quality System
Procedures it is necessary to comply the essential safety requirements mentioned in PED of
section 3.1 of Annexure I also.
Welding procedure and welder shall
shall be qualified by notified body or RTPO (Recognized Third
Party Organization).For non-destructi
destructive
ve testing of welding joints NDT personnel shall be ISO
9712 qualified. NDE shall be performed by Level II qualified and NDT procedure shall be
approved by Level III qualified personnel.

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A.4.8 Control of Monitoring & Measuring Equipment:

In addition to the compliance mentioned in section 7.6, the following points to be considered
while calibrating measuring equipments:
- Pressure gauges shall be calibrated by NABL / International accreditation body
approved testing agency.
Same is applicable for master gauges if calibration is done in-
in-house.

A.4.9
9 Monitoring and Measurement of Product:

In addition to the compliance mentioned

mentioned in section 8.2.4 and Quality System Procedure
QSP-15,
15, it is necessary to comply the essential safety requirements mentioned in PED of
section 3.2 of Annexure I also. After all inspection and verification of the product, Declaration
of Confirmation (DOC) C) shall be prepared and released after getting approval from authorized
personnel.

A.4.10
10 Measurement, Monitoring and Improvement:

The method of measurement, monitoring & improvement of Quality management system is

addressed in Quality Manual section 8.0
8.0 and related Quality System Procedure.

11 CE Monogram marking Program:

A.4.11

CE marking on products complied with PED requirements shall be done as per documented
procedure (PARV/PED/02).

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PART – 3
(Enclosures)

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Enclosure..E.1 CROSS REFERENCE OF

Enclosure
API Q1 9TH EDITION WITH QUALITY MANUAL

SR. NO API Q1, 9TH EDITION QUALITY MANUAL

4.1 QUALITY MANAGEMENT SYSTEM
4.1.1 GENERAL 4.1, 7.1, 8.5.1
4.1.2 QUALITY POLICY 5.1, 5.3
4.1.3 QUALITY OBJECTIVES 5.1, 5.4.1, 7.1
4.1.4 PLANNING 4.1, 5.4.2, 7.1
4.1.5 COMMUNICATION
4.1.5.1 INTERNAL 5.1, 5.5.3•
4.1.5.2 EXTERNAL 5.2•, 7.2.3
4.2 MANAGEMENT RESPONSIBILITY
4.2.1 ORGANIZATION STRUCTURE 4.1, 5.1
4.2.2 RESPONSIBILTY AND AUTHORITY 5.5.1
4.2.3 MANAGEMENT REPRESENTATIVE 5.5.2•
4.3 ORGANIZATION CAPABILITY
4.3.1 PROVISION OF RESOURCES 6.1, 7.1
4.3.2 HUMAN RESOURCES
4.3.2.1 GENERAL 6.2.2, 6.2.2.1
4.3.2.2 PERSONNEL COMPETENCE 6.2.1, 6.2.2 •
4.3.2.3 TRAINING AND AWARENESS 6.2.2 6.2.2.1
6.2.2•,
4.3.3 WORK ENVIRONMENT 6.3, 6.4
4.4 DOCUMENTATION REQUIREMENTS
4.4.1 GENERAL 4.1, 4.2.1•• , 4.2.2, 4.2.2.1, 7.1
4.4.2 PROCEDURES 4.2.1 •
4.4.3 CONTROL OF DOCUMENTS 4.2.3, 4.2.3.2, 4.2.3.n•
4.4.4 USE OF EXTERNAL DOCUMENTS IN PRODUCT 7.1.1
REALIZATION
4.5 CONTROL OF RECORDS 4.2.3, 4.2.4, 4.2.4.1, 4.2.4.1.n •
5 PRODUCT REALIZATION
5.1 CONTRACT REVIEW
5.1.1 GENERAL 7.2.2.1
5.1.2 DETERMINATION OF REQUIREMENTS 7.2.1, 7.2.2
5.1.3 REVIEW OF REQUIREMENTS 7.2.2
5.2 PLANNING 7.1, 7.1.1.n •
5.3 RISK ASSESSMENT AND MANAGEMENT 7.1.a.n •
5.4 DESIGN AND DEVELOPMENT
5.4.1 DESIGN AND DEVELOPMENT PLANNING 7.3.1, 7.3.1.1•
7.3.1.1 , 7.3.4.1
5.4.2 DESIGN AND DEVELOPMENT INPUTS 7.3.1.2, 7.3.2•,
7.3.2 7.3.2.1
5.4.3 DESIGN AND DEVELOPMENT OUTPUTS 7.3.1.2, 7.3.3•,
7.3.3 7.3.3.1
5.4.4 DESIGN AND DEVELOPMENT REVIEW 7.3.4
5.4.5 DESIGN AND DEVELOPMENT VERIFICATION AND 7.3.4, 7.3.4.1, 7.3.5
FINAL REVIEW
5.4.6 DESIGN AND DEVELOPMENT VALIDATION AND 7.3.4.1, 7.3.6•
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 QUALITY MANUAL
APPROVAL
5.4.7 DESIGN AND DEVELOPMENT CHANGES 7.3.7, 7.3.7.1
5.5 CONTINGENCY PLANNING
5.5.1 GENERAL 7.3.a.n •
5.5.2 PLANNING OUTPUT 7.3.a.1.n •
5.6 PURCHASING
5.6.1 PURCHASING CONTROL
5.6.1.1 PROCEDURE 4.1, 4.1.1, 7.4.1, 7.4.1.1•,
7.4.1.1 7.4.1.3
5.6.1.2 INTIAL SUPPLIER EVALUATION-CRITICAL
EVALUATION 7.4.1.2, 7.4.1.2.n •
PURCHASES
5.6.1.3 INTIAL SUPPLIER EVALUATION-NONCRITICAL
EVALUATION 7.4.1.2, 7.4.1.2.n •
PURCHASES
5.6.1.4 SUPPLIER REEVALUATION 7.4.1.2
5.6.1.5 SUPPLIER EVALUATION-RECORDS
EVALUATION 7.4.1
5.6.1.6 OUTSOURCING 4.1, 4.1.1, 4.1.1.n•
5.6.2 PURCHASING INFORMATION 7.4.2, 7.4.2.1
5.6.3 VERIFICATION OF PURCHASED PRODUCTS OR 7.4.3, 7.4.3.1
ACTIVITIES
5.7 PRODUCTION AND SERVICING PROVISION
5.7.1 CONTROL OF PRODUCTION AND SERVICING
5.7.1.1 PRODUCTION 7.5.1•, 7.5.1.1
7.5.1
5.7.1.2 SERVICING 7.5.1 7.5.1.1
7.5.1•,
5.7.1.3 PROCESS CONTROL DOCUMENTS 7.5.1.2, •
5.7.1.4 PRODUCT REALIZATION CAPABILITY 7.5.1.n •
DOCUMENTATION
5.7.1.5 VALIDATION OF PROCESSES FOR PRODUCTION 7.4.1.3, 7.5.2, 7.5.2.1
AND SERVICING
5.7.2 PRODUCT QUALITY PLAN 7.5.2.a.n •
5.7.3 IDENTIFICATION AND TRACEABILITY 7.5.3, 7.5.3.1, 7.5.3.2
5.7.4 PRODUCT INSPECTION/TEST STATUS 7.5.3, 7.5.3.3, 8.3, 7.5.3.1.n •
5.7.5 CUSTOMER SUPPLIED PROPERTY 7.5.4, 7.5.4.1
5.7.6 PRESERVATION OF PRODUCT
5.7.6.1 GENERAL 7.5.5.1
5.7.6.2 STORAGE AND ASSESSMENT 7.5.5.1, 7.5.5.2, 7.5.5.n•,
7.5.5.n 7.5.5.2.n
•
5.7.7 INSPECTION AND TESTING
5.7.7.1 GENERAL 8.2.4, 8.2.4.1
5.7.7.2 IN-PROCESS
PROCESS INSPECTION AND TESTING 8.2.4
5.7.7.3 FINAL INSPECTION AND TESTING 8.2.4.2 •
5.7.8 PREVENTIVE MAINTENANCE 7.6.a.n •
5.8 CONTROL OF TESTING, MEASURING, AND 7.6, 7.6.1, 7.6.2, 7.6.a.n
7.6. •
MONITORING EQUIPMENT
5.9 PRODUCT RELEASE 8.2.4, 8.2.4.1
5.10 CONTROL OF NON CONFORMING PRODUCT
5.10.1 GENERAL 8.3, 8.3.2
5.10.2 NON CONFORMING PRODUCT 8.3, •
5.10.3 RELEASE OF NON CONFORMING PRODUCT 8.3.1
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UNDER CONCESSION
5.10.4 CUSTOMER NOTIFICATION 8.3.3
5.10.5 RECORDS 8.3
5.11 MANAGEMENT OF CHANGE (MOC) 5.4.a.n
5.11.1 GENERAL 5.4.2, 5.4.a.n.1•
5.4.
5.11.2 MOC IMPLEMENTATION 5.4.a.n.2•
5.11.3 MOC NOTIFICATION 5.4.a.n.3•
6 QMS MONITORING, MEASUREMENT, ANALYSIS,
AND IMPROVEMENT
6.1 GENERAL 4.1, 8.1, 8.5.1
6.2 MONITORING, MEASURING AND IMPROVING
6.2.1 CUSTOMER SATISFACTION 6.1, 8.2.1, •
6.2.2 INTERNAL AUDIT
6.2.2.1 GENERAL 8.2.2
8.2.2•, 8.2.2.1

6.2.2.2 PERFORMANCE OF INTERNAL AUDIT 8.2.2•, 8.2.2.1

8.2.2
6.2.2.3 AUDIT REVIEW AND CLOSURE 5.6.2, 8.2.2•,
8.2.2 8.2.2.2
6.2.3 PROCESS EVALUATION 4.1, 8.2.3
6.3 ANALYSIS OF DATA 4.1, 8.4•,
8.4 8.4.1,
6.4 IMPROVEMENT
6.4.1 GENERAL 8.5.1
6.4.2 CORRECTIVE ACTION 8.5.2•,, 8.5.2.1, 8.5.2.2,
6.4.3 PREVENTIVE ACTION 8.5.3
8.5.3•, 8.5.3.1,
6.5 MANAGEMENT REVIEW
6.5.1 GENERAL 5.3, 5.6.1, 5.6.1.1
6.5.2 INPUT REQUIREMENTS 5.6.2, •
6.5.3 OUTPUT REQUIREMENTS 5.6.1, 5.6.2, 5.6.3

Note: • indicates the sections Q 9th edition are addressed.

ions where requirements of API Q1

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 QUALITY MANUAL
Enclosure E.2 - CROSS REFERENCE OF
ISO 9001:2015 5TH EDITION WITH quality manual
SR. NO ISO 9001:2015 Quality Manual
4.0 Context of the organization -
4.1 Understanding the organization and its context 4.1
4.2 Understanding the needs and expectations of 4.1
interested parties
4.3 Determining the scope of the quality management 4.2.2
system
4.4 Quality management system and its processes
4.4.1 4.2.1 •, 4.2.2
4.4.2 4.2.1•
5.0 Leadership -
5.1 Leadership and commitment -
5.1.1 General 5.1•
5.1.2 Customer focus 5.2•
5.2 Policy -
5.2.1 Establishing the quality policy 5.3• (5.3.1)
5.2.2 Communicating the quality policy 5.3 • (5.3.1)
5.3 Organizational roles, responsibilities and authorities 5.5.1 , 5.5.2
5.5.1•
6.0 Planning -
6.1 Actions to address risks and opportunities 7.1.a.n•
6.2 Quality objectives and planning to achieve them
6.2.1 5.4.1•
6.2.2 5.4.1 •
6.3 Planning of changes 5.4.a.n•
7.0 Support -
7.1 Resources -
7.1.1 General 6.1
7.1.2 People 6.2.1
7.1.3 Infrastructure 6.3
7.1.4 Environment for the operation of processes 6.4•
7.1.5 Monitoring and measuring resources -
7.1.5.1 7.6
7.1.5.2 7.6
7.1.6 Organizational knowledge 4.2.1
7.2 Competence 6.2.2•
7.3 Awareness 6.2.2•
7.4 Communication 5.1, 5.2,5.5.3,
5.2, 7.2.3
7.5 Documented information -
7.5.1 General 4.2.1
7.5.2 Creating and updating 4.2.3•
7.5.3 Control of documented information -
7.5.3.1 4.2.3 •, 4.2.4
7.5.3.2 4.2.3 4.2.4
4.2.3•,

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 QUALITY MANUAL
8.0 Operation -
8.1 Operational planning and control 7.1
8.2 Requirements for products and services -
8.2.1 Customer communication 7.2.3•
8.2.2 Determining the requirements for products and services 7.2.1
8.2.3 Review of the requirements for products and services 7.2.2•
8.2.4 Changes to requirements for products and services 7.2.2
8.3 Design & Development of products & services -
8.3.1 General 7.3.1•
8.3.2 Design and development planning 7.3.1
8.3.3 Design and development inputs 7.3.2
8.3.4 Design and development controls 7.3.4,7.3.5,7.3.6
8.3.5 Design and development outputs 7.3.3•
8.3.6 Design and development changes 7.3.7•
8.4 Control of externally Provided processes, products & -
services
8.4.1 General 7.4.1
8.4.2 Type and extent of control 7.4.3•
8.4.3 Information for external provider 7.4.2•
8.5 Production & service provision -
8.5.1 Control of production and service provision 7.5.1 •, 7.5.2•
8.5.2 Identification and traceability 7.5.3
8.5.3 Property belonging to customers or external providers 7.5.4•
8.5.4 Preservation 7.5.5•
8.5.5 Post-delivery activities 7.5.5.2.n1•
8.5.6 Control of changes 5.4.a.n
8.6 Release of products & services 8.2.4
8.7 Control of non-conforming
conforming outputs 8.3
9.0 Performance evaluation -
9.1 Monitoring, Measurement, Analysis & Evaluation -
9.1.1 General 8.2.3
9.1.2 Customer satisfaction 8.2.1
9.1.3 Analysis and evaluation 8.4•
9.2 Internal Audit 8.2.2
9.3 Management review -
9.3.1 General 5.6.1•
9.3.2 Management review inputs 5.6.2•
9.3.3 Management review outputs 5.6.3•
10.0 Improvement -
10.1 General 8.5.1•
10.2 Nonconformity and corrective action 8.5.2•
10.3 Continual improvement 8.5.1•

Note: • Indicates the sections where requirements of ISO 9001-2015

9001 2015 are addressed.

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