Quality Assurance Manual-Praga Marine Pvt Ltd

PRAGA MARINE PVT. LTD

Quality Assurance Manual

Version: 1.0

Head Office: KAMALA VILLA, 24 ABDUL RAHIM ROAD, RACE COURSE, COIMBATORE 641 018, TAMILNADU, INDIA

E- mail : [email protected] Tel: 0422 2220230 Fax: 0422 2220170 Boat Yard: INDUSTRIAL DEV. AREA, AROOR P.O, ALAPUZHA DIST, KERALA 688 534, INDIA Tel: 0478 2872390 Fax: 0478 2873313

Quality Assurance Manual Fiberglass Reinforced Plastics Boats

CONTROLLED COPY

This manual is confidential and assigned to Praga Marine Pvt.Ltd. It may not be duplicated or altered by other any person or company without written consent from

Praga marine Pvt.Ltd.


1

TABLE OF CONTENTS

Contents

TABLE OF CONTENTS .................................................................................................... 1

Section1. PURPOSE ........................................................................................................... 5

1.1 Introduction ............................................................................................................... 5

1.2: Purpose ..................................................................................................................... 6

Section 2: Scope .................................................................................................................. 6

2.1 Type of Manufacture ................................................................................................. 7

2.2 Quality Policy ............................................................................................................ 7

2.3 Applicable Specifications and Standards .................................................................. 7

Section 3: Organisational Structure .................................................................................... 8

Section 4: Quality Management System ............................................................................. 9

4.1 General requirements ................................................................................................ 9

4.2 Documentation Requirements ................................................................................... 9

4.2.1 General ................................................................................................................ 9

4.2.2 Quality Manual ................................................................................................. 10

4.2.3 Control of Documents ...................................................................................... 10

4.2.4 Control of Quality Records............................................................................... 11

Section 5: Management Responsibility ............................................................................ 12

5.1 Management Commitment ...................................................................................... 12

5.2 Customer Focus ....................................................................................................... 12

5.3 Quality Policy .......................................................................................................... 13

5.4 Planning ................................................................................................................... 13

5.4.1 Quality Objectives ............................................................................................ 13

5.4.2 Quality Management System Planning ............................................................ 13

5.5 Responsibility, Authority and Communication ....................................................... 14

5.5.1 Responsibility and Authority ............................................................................ 14

5.5.2 Management representative .............................................................................. 14


2 5.5.3 Internal Communication ................................................................................... 14

5.6 Management Review ............................................................................................... 15

5.6.1 General .............................................................................................................. 15

5.6.2 Review Input..................................................................................................... 15

QUALITY MANUAL ............................................................................................... 15

5.6.3 Review Output .................................................................................................. 15

Section 6: Resource Management ..................................................................................... 16

6.1 Provision of Resources ............................................................................................ 16

6.2 Human Resources .................................................................................................... 16

6.2.1 General .............................................................................................................. 16

6.2.2 Competence, Awareness and Training ............................................................. 16

6.3 Infrastructure ........................................................................................................... 17

6.3.1 Facility .............................................................................................................. 17

6.3.2 LAY OUT PLAN OF THE PLANT ................................................................. 18

6.4 Work Environment .................................................................................................. 19

Section 7: Product Realization .......................................................................................... 19

7.1 Planning of Product Realization .............................................................................. 19

7.2 Customer-Related Processes ................................................................................... 19

7.2.1 Determination of Requirements Related to the Product ................................... 19

7.2.2 Review of Requirements Related to the Product .............................................. 20

7.2.3 Customer Communication ................................................................................ 20

7.3 Design and Development ........................................................................................ 21

7.3.1 Design and Development Planning .................................................................. 21

7.3.2 Design and Development Inputs....................................................................... 22

7.3.3 Design and Development Outputs .................................................................... 22

7.3.4 Design and Development Review .................................................................... 23

7.3.5 Design and Development Verification ............................................................. 23

7.3.6 Design and Development Validation ................................................................ 23

7.3.7 Control of Design and Development Changes ................................................. 24

7.4 Purchasing ............................................................................................................... 24

7.4.1 Purchasing ........................................................................................................ 24

7.4.2 Purchasing Information .................................................................................... 24

7.4.3 Verification of Purchased Product .................................................................... 24

7.5 Production ............................................................................................................... 25

7.5.1 Control of Production ....................................................................................... 25


3 7.5.2 Validation of processes for production ............................................................. 25

7.5.3 Identification and Traceability .......................................................................... 25

7.5.4 Customer Property ............................................................................................ 26

7.5.5 Preservation of Product .................................................................................... 26

7.6 Control of Monitoring and Measuring Equipment .................................................. 26

Section 8. Measurement, analysis and improvement ....................................................... 27

8.1 General .................................................................................................................... 27

8.2 Monitoring and Measurement ................................................................................. 27

8.2.1 Customer Satisfaction ....................................................................................... 27

8.2.2 Internal Audit .................................................................................................... 28

8.2.3 Monitoring and measurement of processes ...................................................... 28

8.2.4 Monitoring and measurement of product ......................................................... 28

8.3 Control of nonconforming product ......................................................................... 29

8.4 Analysis of data ....................................................................................................... 29

8.5 Improvement ........................................................................................................... 30

8.5.1 Continual Improvement .................................................................................... 30

8.5.2 Corrective action ............................................................................................... 30

8.5.3 Preventive action .............................................................................................. 30

Section 9. QUALITY ASSUARANCE ............................................................................ 31

9.1 GENERAL INSPECTION PROCEDURES ........................................................... 31

9.1.1 Purpose ............................................................................................................. 31

9.1.2 Application ....................................................................................................... 31

9.1.3 Definitions ........................................................................................................ 31

9.2. DEPARTMENT OF QUALITY ASSURANCE ................................................... 32

9.2.1 Engineering ....................................................................................................... 32

9.2.2 Material Control ............................................................................................... 32

9.2.3 Production Manager ......................................................................................... 33

9.2.4 Shipping (Post Production) ............................................................................... 33

9.3 Quality Assurance ................................................................................................... 33

9.4. INSPECTION PROCEDURES: QUALITY ASSURANCE ................................. 34

9.4.1 Purchased Materials .......................................................................................... 34

9.4.2 Purchased Material Control .............................................................................. 34

9.4.3 Molds ................................................................................................................ 35

9.4.4 Sub-Assembly Part (FRP heads, bottoms, and shell(s)) ................................... 35

9.5 Component Parts .................................................................................................... 35


4 9.6 Loading and Documentation ................................................................................... 36

9.7. INSPECTION PROCEDURES: COATINGS ....................................................... 36

9.7.1 Purchased Materials .......................................................................................... 36

9.7.2 Purchased Materials Control ........................................................................... 37

9.7.3 Surface Preparation ........................................................................................... 37

9.7.4 Coating Material Preparation ............................................................................ 37

9.7.5 Coating Application .......................................................................................... 37

9.7.6 Handling and Curing of Coatings ..................................................................... 38

9.7.7 Coating Final Inspection .................................................................................. 38

9.8. INSPECTION PROCEDURES: FINAL ................................................................ 38

9.9 SHIPPING PROCEDURE ..................................................................................... 38

9.10 COMPUTER TECHNOLOGY ............................................................................ 39

9.10.1 Administration ................................................................................................ 39


5 Section1. PURPOSE

1.1 Introduction

Praga marine Pvt.Ltd. developed and implemented a Quality Management System in

order to document the company’s best business practices, better satisfy the requirements

and expectations of its customers, and improve the overall management of the company.

The Quality Management System (QMS) of Praga marine Pvt.Ltd. addresses the design,

development, production, installation, and servicing of the company’s products.

The manual is divided into nine sections that correlate to the Quality Management

System. Each section begins with a policy statement expressing Praga marine Pvt.Ltd.

obligation to implement the basic requirements of the referenced Quality Management

System section. Each policy statement is followed by specific information pertaining to

the procedures that describe the methods used to implement the necessary requirements.

This manual describes the Quality Management System, delineates authorities, inter-

relationships, and responsibilities of the personnel responsible for performing within the

system. The manual also provides procedures or references for all activities comprising

the Quality Management System to ensure compliance to the necessary requirements of

the standard.

This manual is used internally to guide the company’s employees through the various

requirements of the ISO standard that must be met and maintained in order to ensure

customer satisfaction, continuous improvement, and provide the necessary instructions

that create an empowered work force.

This manual is used externally to introduce our Quality Management System to our

customers and other external organizations or individuals. The manual is used to

familiarize them with the controls that have been implemented, and to assure them that


6 the integrity of the Quality Management System is maintained and focused on customer

satisfaction and continuous improvement.

1.2: Purpose _____________________________________________________________

The purpose of this quality manual is to establish and state the general policies governing

Praga marines’ Quality Management System. These policies define management’s

intentional provision for managing our operations and activities. These are the top-level

policies representing the company's plans or protocols for achieving quality assurance

and customer satisfaction. All departmental or functional policies and written procedures

must conform and parallel these policies. All changes to policies and procedures are

required to be reviewed to ensure that there are no conflicts with these policies stated in

this Quality Manual.

Section 2: Scope

__________________________________________________________

The policies stated in this manual apply to all operations and activities at Praga marine

Pvt.Ltd.

It is the responsibility of all department managers to help define, implement, and

maintain the procedures required by this manual and to ensure all processes conform to

these requirements. It is the responsibility of all employees to follow procedures that

implement these policies and to help strive for continuous improvement in all activities

and processes of Praga marine Pvt.Ltd.

The scope of Praga marine’s activities under Quality is: The Design, Manufacture, and Sale of proprietary and custom fiber glass boats


7 2.1 Type of Manufacture

Praga marine Pvt.Ltd. design & manufacture Fibre glass Boats the products includes

Sailing dinghies, yachts, water sports boats, power boats, Ribs, work boats &

Catamarans.

2.2 Quality Policy

All employees of Praga marine Pvt.Ltd. are expected to strive to completely satisfy the

customer's needs. We are committed to delivering products, services, as well as technical

information that will meet or exceed the requirements and expectations of all our

customers. As our business relationship grows with our customers, each customer will be

assured of consistent performance from all our employees.

2.3 Applicable Specifications and Standards

ASTM D790, ISO 178 Standard Practice for Determining Flexural strength for the

Glass- Reinforced Plastic Laminate.

ISO 1172 Standard Practice for Determining Glass content for the Glass- Reinforced

Plastic Laminate

ISO 527-4, ASTM A370 Standard Practice for Determining Ultimate Tensile strength

for the Glass- Reinforced Plastic Laminate.


8 Section 3: Organisational Structure

DIRECTOR

MANAGER PRODUCTION

MANAGER PURCHASE

MANAGER ACCOUNTS

MANAGER QUALITY

SUPERVISOR MOULDING

SUPERVISOR FITOUT

SUPERVISOR ELECTRICAL/ INSTRUMENTATION

G.M.


9 Section 4: Quality Management System

4.1 General requirements

Praga Marine limited has established, documented, and implemented a Quality

Management System in accordance with the requirements of ISO 9001:2008. The system

is maintained and continually improved through the use of the quality policy, quality

objectives, internal & external audit results, analysis of data, corrective and preventive

action and periodic management reviews.

To design and implement the QMS, Praga Marine Pvt Limited has:

Identified the processes needed for the QMS and their application throughout the

organization.

1) Determined the sequence and interaction of these processes.

2) Determined criteria and methods needed to ensure that the operation and control

of the processes are effective.

3) Ensured the continuing availability of resources and information necessary to

achieve planned results and continual improvement of these processes.

4) Established systems to monitor, measure and analyze these processes.

5) Established processes to identify and implement actions necessary to achieve

planned results and continual improvement of these processes.

6) Established control processes to identify and implement actions necessary to

achieve planned results of outsourced processes.

7) Determined the criteria and information necessary to ensure that required

regulations and standards are met.

4.2 Documentation Requirements

4.2.1 General

The QMS documentation includes:


10 1) Documented Quality Policy.

2) Quality Manual.

3) Documented Procedures.

4) Documents identified as needed for the effective planning, operation and control

of our processes.

5) Quality Records.

4.2.2 Quality Manual

This Quality Manual has been prepared to describe Praga Marine Pvt Limited QMS. The

scope and permissible exclusions of the QMS are described in section one of this manual

4.2.3 Control of Documents

All of the QMS documents are controlled according to the Document Control

Management System This procedure defines the process for:

1) Approving documents for adequacy prior to issue.

2) Reviewing and revising as necessary and ensuring proper approval of new

revisions.

3) Ensuring that changes and current revision status of documents are identified.

4) Ensuring that relevant versions of applicable documents are available at points of

use.

5) Ensuring that documents remain legible and readily identifiable.

6) Ensuring proper access control.

7) Identifying the retention period of quality records.

8) Ensuring that documents of external origin are identified and their distribution

controlled.

9) Preventing the unintended use of obsolete documents and to apply suitable

identification to them if they are retained for any purpose.


11

4.2.4 Control of Quality Records

Quality records are maintained to provide evidence of conformity to requirements and of

the effective operation of the QMS. The records are maintained according to the Control

of Quality Records Procedure. This procedure requires that quality records remain

legible, readily identifiable and retrievable. The procedure defines the controls needed for

identification, storage, protection, retrieval, retention time and disposition of quality

records


12 Section 5: Management Responsibility

5.1 Management Commitment

Top management has been actively involved in implementing the Quality Management

System. It has provided the vision and strategic direction for the growth of the QMS, and

established quality objectives and the quality policy.

To continue to provide leadership and show commitment to the improvement of the

QMS, management has done the following.

a) Communicated the importance of meeting customer, statutory, and regulatory

requirements.

b) Established quality objectives.

c) Ensured that the quality policy is communicated throughout the organization.

d) Conducted periodic management reviews.

e) Ensured the availability of resources.

5.2 Customer Focus

Praga Marine Pvt Ltd., Inc. strives to identify current and future customer needs, to meet

customer requirements and exceed customer expectations.

Top management ensures the focus on improving customer satisfaction is maintained by

setting and reviewing objectives related to customer satisfaction at Management Review

Meetings.

Top management ensures that customer requirements are understood and met. Customer

requirements are understood, converted into internal requirements, and communicated to

the appropriate personnel in our organization.


13

5.3 Quality Policy

Top management ensures that the quality policy is communicated to all employees. It is

included in new employee training and training on the QMS. It is posted on the

organization intranet to maintain high standards within our organization.

Management reviews the quality policy during management review meetings to

determine the policy’s continuing suitability for our organization.

5.4 Planning

5.4.1 Quality Objectives

Quality objectives are established to support our organization’s efforts in achieving our

quality policy and reviewed annually for suitability. Quality objectives are measurable,

and reviewed against performance goals during periodic management reviews.

5.4.2 Quality Management System Planning

The quality system has been planned and implemented to meet our quality objectives and

the requirements of 4.1 of the ISO 9001 standard. Quality planning takes place as

changes that affect the quality system are planned and implemented.


14 5.5 Responsibility, Authority and Communication

5.5.1 Responsibility and Authority An organizational structure has been established to show the interrelation of personnel in

the organization. Job descriptions define the responsibilities and authorities of each of the

positions. Job descriptions and the organizational structure are reviewed and approved by

top management for adequacy. These documents are available throughout the

organization to help employees understand responsibilities and authorities

5.5.2 Management representative

The Quality Assurance and Regulatory Affairs Manager has been appointed as the ISO

Management Representative. As Management Representative, he has the following

responsibility and authority:

a) Ensure that processes needed for the quality management system are established

and implemented.

b) Report to top management on the performance of the quality management system,

and note needed improvements.

c) Promote awareness of customer requirements throughout the organization.

d) Act as a liaison with external parties such as customers or auditors on matters

relating to the QMS.

5.5.3 Internal Communication

In line with Praga Marine Pvt Ltd.’ policy of leadership through employee involvement,

Praga Marine Pvt Ltd.’ personnel policies have established open communication

throughout the organization.

The effectiveness of our quality management system is evident through Internal Audit

results, Corrective and Preventive Actions, Customer satisfaction results, and the

departmental performance measures. Internal Audit results, Customer Satisfaction Survey

results, Corrective Actions and Preventive Actions are shared at departmental meetings as

appropriate.


15 5.6 Management Review

5.6.1 General Top management reviews the QMS periodically at management reviews to be executed a

minimum of twice per year. A schedule of Management Reviews will be published at the

beginning of each year. This review assesses the continuing QMS suitability, adequacy

and effectiveness, identifying opportunities for improvement and needed changes.

Records are maintained for each management review meeting.

5.6.2 Review Input

Assessment of the QMS is based on a review of information inputs to management

review. These inputs include the following:

a) Results of audits.

b) Customer feedback.

c) Process performance and product conformity.

d) Company level quality data.

QUALITY MANUAL

a) Status of preventive and corrective actions.

b) Follow-up actions from previous management reviews.

c) Planned changes that could affect the quality management system.

d) Recommendations for improvement.

5.6.3 Review Output

During these review meetings, management will identify appropriate actions to be taken

regarding the following issues:

a) Improvement of the effectiveness of the quality management system and its

processes.

b) Improvement of product related to customer requirements.

c) Resource needs.


16

Responsibilities for required actions are assigned to members of the management review

team. Any decisions made during the meeting, assigned actions, and their due dates are

recorded on the management review presentation.

Section 6: Resource Management

6.1 Provision of Resources During planning and budgeting processes and as needed throughout the year, Top

Management will determine and ensure that the appropriate resources are available to

implement and maintain the quality management system, and continually improve its

effectiveness and enhance customer satisfaction by meeting customer requirements.

6.2 Human Resources

6.2.1 General

To ensure competence of our personnel, job descriptions have been prepared identifying

the qualifications required for each position that affects conformity to product

requirements. Conformity to product requirements can be affected directly or indirectly

by personnel performing any task within the QMS. Qualifications include requirements

for education, skills and experience. Appropriate qualifications, along with required

training, provide the competence required for each position.

6.2.2 Competence, Awareness and Training

Qualifications are reviewed upon hire, when an employee changes positions or the

requirements for a position change. Human Resources maintain records of empemployee

qualifications. If any differences between the employee’s qualifications and

therequirements for the job are found, training or other action is taken to provide the

employee with the necessary competence for the job. The results are then evaluated to


17 determine if they were effective. Training and evaluation are conducted according to the

training procedure.

All employees are trained on the relevance and importance of their activities and how

they contribute to the achievement of the quality objectives.

6.3 Infrastructure

Praga Marine Pvt Ltd. provides the infrastructure necessary to achieve conformity to

product requirements. During the budgeting and strategic planning processes; buildings,

equipment, workspace, and associated utilities are evaluated and provided. When new

personnel are added, hiring managers coordinate activities to ensure appropriate process

equipment including hardware and software if required and supporting services such as

telephones etc. are available based on information provided on the Personnel Requisition.

6.3.1 Facility

State-of-the-art building in excess of 40,000 square feet, which includes Two Air

conditioned Moulding shops of 200 square meters each, which enables us to mould our

boats under controlled environmental condition.

State-of-the-art building in excess of 40,000 square feet, constructed in 1995. It consist of

the following.

1) Sales/Marketing

2) New Product Development

3) Engineering

4) Tool Shop

5) Maintenance

6) Manufacturing

7) Quality

8) Warehouse

9) Offices, common area, kitchen, mechanical, rest rooms


18 6.3.2 LAY OUT PLAN OF THE PLANT

Backwaters

Work shop 500 m2

OFFICE

Fit out shop 270 M2

Store 120 m2

WOOD WORK

SHOP 150 m2

Moulding shop 200m2 A/c-11T

Moulding shop 2 200 m2 A/c-11 T

OFICE

Glass cutting area

NH 47 HIGH WAY N

Boat jetty

Slipway


19 6.4 Work Environment A safe work environment suitable for achieving product conformance is maintained.

Requirements are determined during quality planning. The work environment is managed

for continuing suitability. Data from the quality system is evaluated to determine if the

work environment is sufficient for achieving product conformance, or if preventive or

corrective action related to the work environment is required.

Section 7: Product Realization

7.1 Planning of Product Realization

Quality planning is required before new products or processes are implemented. During

this planning, management or assigned personnel identify:

The quality objectives and requirements for the product are developed during the

New Product Development Process.

Processes, documentation and resources required and stored in IFS.

Verification, validation, monitoring, inspection and test requirements.

Criteria for product acceptance.

Requirements for applicable risk management during product realization.

The output of quality planning includes documented quality plans, resource requirements,

processes, equipment requirements, procedures, test data, and design

7.2 Customer-Related Processes

7.2.1 Determination of Requirements Related to the Product

Praga Marine Pvt Ltd., Inc. determines customer requirements before acceptance of an

order. Customer requirements include the following:


20 Previous customer requirements which pertain to current part numbers being

ordered.

Required for delivery and post-delivery activities.

Not stated by the customer but necessary for specified use or known and intended

use.

Statutory and regulatory requirements related to the product.

Additional requirements determined by Praga Marine Pvt Ltd., Inc.

Customer requirements are determined according to the Customer Related Processes

Procedure.

7.2.2 Review of Requirements Related to the Product

Prior to committing to the customer, Praga Marine Pvt Ltd., Inc. has a process in place

for the review of requirements related to the product. The review is conducted before the

order is accepted. The process ensures that:

Product requirements are defined and documented.

Contract or order requirements differing from those previously expressed are

resolved.

Praga Marine Pvt limited, has the ability to meet the defined requirements.

Records are maintained showing the results of the review and any actions arising

from the review.

Where a customer does provide a documented statement of requirement, the

customer requirements are confirmed before acceptance.

When product requirements are changed, The organization communicates

changes to relevant personnel and amends relevant documents.

7.2.3 Customer Communication


21 Praga Marine Pvt limited, Inc. has implemented procedure for communicating with

customers in relation to:

In keeping with our commitment to customer satisfaction, Praga Marine Pvt Ltd.

views effective customer communication as an essential element of customer

satisfaction.

Appropriate handling of communications can reduce customer dissatisfaction in

situations and in many cases turn a dissatisfying scenario into a satisfying

experience.

The Customer Service and Sales department are responsible for establishing

communication methods to ensure inquiries, contracts or order handling,

including amendments, and customer feedback, including customer complaints

which are handled expeditiously and professionally.

All customer complaints are classified as Support Issues, which are maintained in

IFS.

The Sales and Marketing departments’ primary responsibility is directing the

business acquisition, retention and product development efforts of the Company,

including external communications.

Marketing, Sales and Customer Service are the primary customer contacts for

product information.

The QA department is committed to addressing all documented customer inquires

that reside within the organization’s ERP system.

The QA department has the primary responsibility to address all customer related

issues in regard to the quality of our products and services.

The QA department is the key contact in regard to questions pertaining to the

company’s QMS.

Lastly, the Sales department is responsible for initiating the appropriate Return

Material Authorization (RMA) documentation for approved product returns.

7.3 Design and Development

7.3.1 Design and Development Planning

Product design and development projects are planned and controlled.


22 During design and development planning, our organization determines:

a) The stages of the design and development project,

b) The review, verification and validation activities appropriate to each design and

development stage, and

c) The responsibilities and authorities for design and development.

The Interfaces between different groups involved in design and development projects are

managed to ensure effective communication and clear assignment of responsibility.

Planning output is updated, as appropriate, as the design and development progresses.

Praga Marine Pvt. limited may at times verify and or validate design control and review

in combination or independently as suited for product or process as needed.

7.3.2 Design and Development Inputs

Inputs relating to product requirements are determined and records maintained. These

include:

a) Functional and performance requirements,

b) Applicable statutory and regulatory requirements,

c) Where applicable, information derived from previous similar designs, and

d) Other requirements essential for design and development.

The inputs are reviewed for adequacy. Requirements are complete, unambiguous and not

in conflict with each other.

7.3.3 Design and Development Outputs

The outputs of design and development are in a form suitable for verification against the

design and development input and are approved prior to release.

Design and development outputs:


23 a) Meet the input requirements for design and development,

b) Provide appropriate information for purchasing, production and service provision,

c) Contain or reference product acceptance criteria, and

d) Specify the characteristics of the product that are essential for its safe and proper

use.

Information for production and service provision may include details for preservation of

product.

7.3.4 Design and Development Review

At suitable stages, systematic reviews of design and development are conducted to:

a) Evaluate the ability of the results of design and development to fulfill

requirements, and

b) Identify any problems and propose necessary actions.

Participants in such reviews include representatives of functions concerned with the

design and development stage(s) being reviewed. Records of the results of verifications

and any necessary actions are maintained.

7.3.5 Design and Development Verification

Verification is performed to ensure that the design and development outputs have

satisfied the design and development input requirements. Records of the results of the

verification and any necessary actions are maintained.

7.3.6 Design and Development Validation

Design and development validation are performed to ensure that the resulting product is

capable of fulfilling the requirements for the specified or known intended use or

application. Wherever practicable, validation is completed prior to the delivery or

implementation of the product. Records of the results of validation and any necessary

actions are maintained.


24 7.3.7 Control of Design and Development Changes

Design and development changes are identified and records maintained. Changes are

reviewed, verified and validated, as appropriate, and approved before implementation.

Review of design and development changes includes evaluation of the changes on

constituent parts and delivered product. Records of the results of the review of changes

and any necessary actions are maintained.

7.4 Purchasing

7.4.1 Purchasing

Praga Marine Pvt Ltd. ensures that purchased product conforms to specified purchase

requirements. The type and extent of control applied to the supplier and the purchased

product is dependent upon the effect of the purchased product on subsequent realization

or the final product. Praga Marine Pvt Ltd. evaluates and selects suppliers based on their

ability to supply product in accordance with the organization's requirements. Criteria for

selection, evaluation and re-evaluation are established. Records of the results of

evaluations and any necessary actions arising from the evaluation are maintained.

7.4.2 Purchasing Information

Purchasing information describes the product to be purchased, including where

appropriate:

a) Requirements for approval of product, procedures, processes and equipment,

b) Requirements for qualification of personnel, and

c) Quality management system requirements.

Praga Marine Pvt Ltd. ensures the adequacy of specified purchase requirements prior to

their communication to the supplier.

7.4.3 Verification of Purchased Product

Praga Marine Pvt Ltd. identifies and implements inspection or other activities necessary

for ensuring that purchased product meets specified purchase requirements.


25 Praga Marine Pvt Ltd. or its customer intends to perform verification activities at the

supplier's premises, our organization states the intended verification arrangements and

method of product release in the purchasing information.

7.5 Production

7.5.1 Control of Production

Praga Marine Pvt Ltd. plans and carries out production under controlled conditions.

Controlled conditions include, as applicable

a) The availability of information that describes the characteristics of the product,

b) The availability of work instructions,

c) The use of suitable equipment,

d) The availability and use of measuring and monitoring equipment,

e) The implementation of monitoring and measurement, and

f) The implementation of product release, and delivery.

7.5.2 Validation of processes for production

Praga Marine Pvt Ltd. validates production processes where the resulting output cannot

be verified by subsequent monitoring or measurement and as a consequence, deficiencies

become apparent only after the product is in use or the service has been delivered.

Validation demonstrates the ability of these processes to achieve planned results.

Praga Marine Pvt Ltd. makes arrangements for these processes including, as applicable:

a) Defined criteria for review and approval of the processes,

b) Approval of equipment and qualification of personnel,

c) Use of specific methods and procedures,

d) Requirements for records, and

e) Revalidation.

7.5.3 Identification and Traceability

Where appropriate, Praga Marine Pvt Ltd. identifies the product by suitable means

throughout production realization.

Praga Marine Pvt Ltd. identifies the product status with respect to monitoring and

measurement requirements throughout the product realization.


26 Where traceability is a requirement, our organization controls and the unique

identification of the product and maintains records.

7.5.4 Customer Property

Praga Marine Pvt Ltd. exercises care with customer property while it is under the

organization's control or being used by the organization. Our organization identifies,

verifies, protects and safeguards customer property provided for use or incorporation into

the product. If any customer property is lost, damaged or otherwise found to be

unsuitable for use, Praga Marine Pvt Ltd. will report this to the customer and maintain

records. Customer property includes intellectual property and personal data.

7.5.5 Preservation of Product

Praga Marine Pvt Ltd. preserves the product during internal processing and delivery to

the intended destination in order to maintain conformity to requirements. As applicable,

preservation includes identification, handling, packaging, storage and protection.

Preservation also applies to the constituent parts of a product.

7.6 Control of Monitoring and Measuring Equipment

Praga Marine Pvt Ltd. determines the monitoring and measurement to be undertaken and

the monitoring and measuring equipment needed to provide evidence of conformity of

product to specified requirements.

Praga Marine Pvt Ltd. establishes processes to ensure that monitoring and measurement

can be carried out and are carried out in a manner that is consistent with the monitoring

and measurement requirements.

To ensure valid results, measuring equipment is:

a) Calibrated and verified, or both, at specified intervals, or prior to use, against

measurement standards traceable to international or national measurement

standards. Where no such standards exist, the basis used for calibration or

verification are recorded,

b) Adjusted or re-adjusted as necessary,

c) Have identification in order to determine its calibration status,

d) Safeguarded from adjustments that would invalidate the measurement result, and


27 e) Protected from damage and deterioration during handling, maintenance and

storage.

In addition, Praga Marine Pvt Ltd. assesses and records the validity of previous

measuring results when the equipment is found not to conform to requirements. Praga

Marine Pvt Ltd. takes appropriate action on the equipment and any product affected.

Records of the results of calibration and verification are maintained.

When used in the monitoring and measurement of specified requirements, the ability of

computer software to satisfy the intended application is confirmed. This is undertaken

prior to initial use and reconfirmed as necessary.

Confirmation of the ability of computer software to satisfy the intended application

would typically include verification and Configuration management to maintain its

suitability for use.

Section 8. Measurement, analysis and improvement

8.1 General

Praga Marine Pvt Ltd. plans and implements the monitoring, measurement, analysis and

improvement processes needed to:

a) Demonstrate conformity to product requirements,

b) Ensure conformity of the quality management system, and

c) Continually improve the effectiveness of the quality management system.

This includes the determination of applicable methods, including statistical techniques,

and the extent of their use.

8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction

As one of the measurements of performance of the quality management system, Praga

Marine Pvt Ltd. monitors information relating to customer perception as to whether Praga

Marine Pvt Ltd. has fulfilled customer requirements. Praga Marine Pvt Ltd. determines

the methods for obtaining and using this information.


28 8.2.2 Internal Audit

Praga Marine Pvt Ltd. conducts internal audits at planned intervals to determine whether

the quality management system:

a) Conforms to the planned arrangements, to the requirements of “ISO 9001: Latest

Revision of Standard and to the quality management system requirements

established by our organization, and

b) Is effectively implemented and maintained.

Our audit program is planned, taking into consideration the status and importance of the

processes and areas to be audited, as well as the results of previous audits. The audit

criteria, scope, frequency and methods are defined. The selection of auditors and conduct

of audits is accomplished so as to ensure objectivity and impartiality of the audit process.

Auditors are not assigned to audit their own work.

Praga Marine Pvt Ltd.’s audit procedure defines responsibility and requirements for

planning and conducting audits, establishing records and reporting results.

Records of audits and their results are maintained.

The management responsible for the area being audited shall ensure that any necessary

corrections or corrective actions are taken without undue delay to eliminate detected

nonconformities and their causes. Follow-up activities include verification of actions

taken and reporting of verification results.

8.2.3 Monitoring and measurement of processes

Praga Marine Pvt Ltd. applies suitable methods to monitor, and where applicable,

measure the quality management system processes. These methods demonstrate the

ability of the processes to achieve planned results. When planned results are not

achieved, correction and corrective action is taken, as appropriate.

When necessary, Praga Marine Pvt Ltd. will consider the type and extent of monitoring

and measurement for each of its processes in relation to their impact on the conformity to

product requirements and on the effectiveness of our quality management system.

8.2.4 Monitoring and measurement of product


29 Praga Marine Pvt Ltd. monitors and measures product characteristics to verify that

product requirements are fulfilled. This is carried out at appropriate stages of the product

realization process in accordance with planned arrangements and maintains evidence of

conformity to the acceptance criteria.

Records indicate the person(s) authorizing release of product for delivery to the customer.

The release of product and service delivery to the customer does not proceed until all the

planned arrangements have been satisfactorily completed unless otherwise approved by a

relevant authority and, where applicable, by the customer.

8.3 Control of nonconforming product

Praga Marine Pvt Ltd. ensures that product which does not conform to product

requirements is identified and controlled to prevent its unintended use or delivery. A

documented procedure has been established and defines the controls and related

responsibilities for dealing with and isolating nonconforming product.

When applicable, Praga Marine Pvt Ltd. deals with nonconforming product in one or

more of the following ways:

a) By taking action to eliminate the detected nonconformity,

b) By authorizing the use, release or acceptance under concession by a relevant

authority and, where applicable, by the customer,

c) By taking action to preclude its original intended use or application.

d) By taking action appropriate to the effects, or potential effects, of the

nonconformity when nonconforming product is detected after delivery or use has

started.

When nonconforming product is corrected it is subject to re-verification to demonstrate

conformity to the requirements.

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

concessions obtained, are maintained.

8.4 Analysis of data

Praga Marine Pvt Ltd. determines, collects and analyzes appropriate data to demonstrate

the suitability and effectiveness of the quality management system and to evaluate where

continual improvement of the quality management system can be made.


30 This includes data generated as a result of monitoring and measurement and from other

relevant sources.

The analysis of data provides information relating to:

a) Customer satisfaction,

b) Conformance to product requirements,

c) Characteristics and trends of processes and products including opportunities for

preventive action, and

d) Suppliers

8.5 Improvement

8.5.1 Continual Improvement

Praga Marine Pvt Ltd. continually improves the effectiveness of the quality management

system through the use of the quality

policy, quality objectives, audit results, analysis of data, corrective and preventive actions

and management review.

8.5.2 Corrective action

Praga Marine Pvt Ltd. takes action to eliminate the causes of nonconformities in order to

prevent recurrence. Corrective actions

are appropriate to the effects of the nonconformities encountered.

Our procedure for corrective action defines requirements for:

a) Reviewing nonconformities (including customer complaints),

b) Determining the causes of nonconformities,

c) Evaluating the need for action to ensure that nonconformities do not recur,

d) Determining and implementing action needed,

e) Recording the results of action taken, and

f) Reviewing effectiveness of the corrective action taken.

8.5.3 Preventive action


31 Praga Marine Pvt Ltd. takes action to eliminate the causes of potential nonconformities in

order to prevent their occurrence.

Preventive actions taken are appropriate to the effects of the potential problems.

Our procedure for Preventive Action defines requirements for:

a) Determining potential nonconformities and their causes,

b) Evaluating the need for action to prevent occurrence of nonconformities,

c) Determining and implementing action needed,

d) Recording results of action taken , and

e) Reviewing effectiveness of preventive action taken.

Section 9. QUALITY ASSUARANCE

9.1 GENERAL INSPECTION PROCEDURES

9.1.1 Purpose

To communicate the responsibilities and functions of personnel involved with Quality

Assurance and Control

9.1.2 Application

Applies to Quality Assurance personnel and those areas that are responsible for

manufacturing a product to specific standards

9.1.3 Definitions

a) Quality Assurance Manager: The Manager is responsible for overseeing

and directing work under the guidelines of the Quality Assurance Manual

b) Shop Managers: Shop Managers are responsible for directing production

and insuring quality control in the respective areas

c) Area Leader Man:Area Leader Man is responsible for heading a group of

workers in accomplishing productive and quality acceptable goals


32 9.2. DEPARTMENT OF QUALITY ASSURANCE

9.2.1 Engineering

The Engineering Department will follow these Quality Policies and Objectives as

standard requirements:

a. That all designs will be reviewed to ensure that the materials and dimensions

specified will meet the customer s specification

b. That all manufacturing methods will allow the specifications to be met.

c. That no changes in the design are made during production without Engineering s

approval

d. That all applicable drawings/prints are updated and controlled to assure

production has the latest revision

e. Develop the necessary procedures to implement these objectives

9.2.2 Material Control

The Materials Control Manager will follow these Quality Policies and Objectives as


a. Identify and thoroughly inspect all incoming materials to assure that

specifications are met

b. Tag all materials

c. Identify special materials based on special projects or products according

d. Tag defective material and remove from non-defective material storage to prevent

accidental usage

e. Work with the Quality Assurance Manager to determine whether or not materials

are usable or must be rejected

f. Develop the necessary procedures to implement these objectives


33 9.2.3 Production Manager

The Production Manager will follow these Quality Policies and Objectives as standard

requirements:

a) Control all applicable drawings/prints issued to their department to ensure that the

latest revision is received and earlier revision are removed

b) Ensure each production worker inspects work already complete prior to beginning

new task to uncover errors or non-conformance

c) Ensure supervisors have performed recorded inspection of all work completed

prior to final inspection by Quality Assurance Manager

d) Cease production of any product when non-conformance because apparent

e) Develop the necessary procedures to implement these objectives

9.2.4 Shipping (Post Production)

The Shipping (Post Production) Department will follow these Quality Policies and

Objectives as standard requirements:

a) No product will be loaded for shipment without completed inspection by Quality

Assurance Manager

b) No product will be released for shipment without completed Loading Inspection

report

c) Appropriate loading and offloading procedures and equipment must be used and

be available in all product shipments and/or deliveries

d) Develop the necessary procedures to implement these objectives

9.3 Quality Assurance

The Quality Assurance Manager will follow these Quality Policies and Objectives as


a) Advise and coordinate with all departments in development, as well as execution

of all Quality Policies and Objectives


34 b) Resolve any conflict that may exist between procedures and objectives developed

or executed by each quality department

c) Ensure that all practices are being followed by each department

d) Ensure that all specifications are met through inspections and documentation

e) Develop the necessary procedures to implement these objectives

9.4. INSPECTION PROCEDURES: QUALITY ASSURANCE

9.4.1 Purchased Materials

a) All incoming materials will be stored separate from in-stock materials until they

have been inspected and passed the receiving inspection

b) B. All materials that are rejected will be clearly tagged and separated from

accepted materials and returned to the vendor

c) No incoming materials will be used until they have passed the receiving

inspection

d) The receiving inspection will include, but is not limited to the following:

verify that received materials match the assigned purchase order

check of the shelf life to verify that is in within the date recommended by the

manufacturer

identify and document the type of material

identify and document the manufactured date

identify and document lot and batch number

identify and document date received

identify and document any shipping damage

9.4.2 Purchased Material Control

a) As purchased materials come in, the Shop Manager will property tag and date

materials


35 b) Dated purchased materials will be listed on the Material Certification Sheets

c) All purchased materials will be properly stored in accordance with the

manufacturers recommended practices

9.4.3 Molds

a) All molds will be built to meet all customer or engineering specifications,

requirements, and drawings

b) All molds will be inspected to ensure they are clean, smooth, and properly coated

prior to use

9.4.4 Sub-Assembly Part (FRP heads, bottoms, and shell(s))

a) All production materials and procedures will be inspected and evaluated to

insure that they were followed as stated on work order and all applicable

specifications

b) All production techniques used will be inspected and evaluated to insure

that they did not result in any defects, includes mold and equipment

inspection

c) All production materials will be inspected and evaluated to insure that the

required thicknesses were achieved

a) All production materials will be inspected and evaluated to insure that they are

clearly tagged with the job number to ensure proper use

b) All production materials will be documented as inspected

c) All production materials that are rejected will be clearly tagged as such

9.5 Component Parts


36 a) All production materials and procedures will be inspected and evaluated to insure

that they were followed as stated on work order and all applicable specifications

b) All production techniques used will be inspected and evaluated to insure that they

did not result in any defects, includes mold and equipment inspection

c) All production materials will be inspected and evaluated to insure that the

required thicknesses were achieved

d) All production materials will be inspected and evaluated to insure that they are

clearly

e) All production materials will be documented as inspected

f) All production materials that are rejected will be clearly tagged as such

9.6 Loading and Documentation

a) No product will be loaded until the final inspection has been completed and is

released by the Quality Assurance Manager.

b) All products loading supports and tie-down procedures must comply with any

applicable specifications and/or Praga marine Pvt.Ltd. standards set by the

Quality Assurance Manager.

c) No load will depart our facility without the Bill of Lading being signed by and

authorized quality assurance representative.

9.7. INSPECTION PROCEDURES: COATINGS

9.7.1 Purchased Materials

All coating materials will be checked for the following:

a) Shipping damage (punctures, broken lid seal)

b) Proper identification (type, manufacture date, batch number)

c) Within shelf life recommended by the manufacturer


37

9.7.2 Purchased Materials Control

a) As coating materials come in, the Shop Manager will property tag and date

materials

b) Dated coating materials will be listed on the Material Certification Sheets

c) All coating materials will be properly stored in accordance with the manufacturer

s recommended practices

9.7.3 Surface Preparation

a) Any contaminates will be removed from the surface using clean oil-free brushes,

filtered compressed air, water or vacuuming

b) Surfaces that are not be coated are to be adequately protected from the coating

procedures

9.7.4 Coating Material Preparation

All coatings will be mixed in accordance with the manufacturer s written instructions

9.7.5 Coating Application

a) Prior to application, the surface to be coated will be clean

b) The application method used shall be in accordance with the manufacturer s

written instructions

c) Temperature, humidity, and dew point will be monitored and will be within the

range indicated by the manufacturer s written instructions

d) A dry film thickness test will be conducted to insure that the proper mils have

been achieved

e) If the minimum thickness is not achieved, additional coats will be applied in

accordance to the manufacturer s written recoating instructions


38 9.7.6 Handling and Curing of Coatings

a) After each coat the minimum and maximum curing times before recoating will

conform to the manufacturer s written instructions

b) Equipment will be protected from condensation, contamination and weather until

coating has cured for exterior exposure

c) Equipment will not be moved, loaded for shipment, or shipped until the coating

has cured, except as necessary in turning for coating and drying purposes

9.7.7 Coating Final Inspection

a) Prior to calling Quality Assurance for final inspections, the Shop Manager will

insure the following has been properly performed:

b) All checklists are properly documented (see checklist for required items to be

checked)

c) All non-conformance documents are complete

9.8. INSPECTION PROCEDURES: FINAL

a) After all equipment is complete and assembled, the Quality Assurance Manager

will be called for a final inspection

b) The Quality Assurance Manager will:

Review all quality assurance documentation

Review all non-conformance reports

Issue a shipping release

Retrieve all documentation and place it in the customer main file

9.9 SHIPPING PROCEDURE

After a shipping release is issued from the Quality Assurance Manager, each Shop

Manager will insure that all equipment is loaded and/or packaged properly for shipping


39 9.10 COMPUTER TECHNOLOGY

9.10.1 Administration

(A) Work Order Processing and Control

1. After an order is placed, a work order is entered into our database system

2. Each work order created will contain the following information:

3. A unique work order ID number

4. A unique work order number

5. Customer shipping information

6. Customer purchase order number

7. Customer requested shipping dates

8. Work orders are then reviewed with the Quality Assurance Manager and the

appropriated Shop Manager

9. 4. Work orders will be tracked through our database to insure that the shipping

dates required are met

(B) Purchasing Order Processing and Control

1. All purchase orders will be entered into our database system

2. Purchase orders relating to a specific work order will be referenced to that work

order for material/purchasing control

3. Purchase orders will be tracked through our database to insure prompt delivery

dates

(C) Digital Pictures

1. After each work order is completed, digital pictures will be taken prior to and

after equipment is loaded for shipment, the pictures will then be stored in our

database and referenced to the work order

2. All repair work that is received will have digital pictures taken before, during and,

after the repair work

Quality Assurance Manual-Praga Marine Pvt Ltd

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