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QUALITY SYSTEMMANUAL
(ISO 9001: 2000)
FOR
HI-TECH ENGINEERING CORPORATION INDIAPVT. LTD.
Address G16,G17 MIDC BARAMATI
DIST. PUNE MAHARASHTRA
Phone Lines
Fax
02112 244488, 244252 , 243646
02112 - 243229
Email hi_purchase@yahoo.com
Website www.hi-tech.net.in
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1.1 TABLE OF CONTENTS
SECTIONNO.
DESCRIPTIONISSUE
NO.ISSEDATE
REVNO
REV.DATE
PAGENO
1 GENERAL
1.1 Table of Contents 01 01.10.08 00 01.10.08
1.2 Caution Notice 01 01.10.08 00 01.10.08
1.3 Manual Distribution List 01 01.10.08 00 01.10.08
1.4 Manufacturing Layout Map 01 01.10.08 00 01.10.08
1.5 Quality Policy 01 01.10.08 00 01.10.08
1.6 Quality Objectives 01 01.10.08 00 01.10.08
1.7 Purpose & Scope 01 01.10.08 00 01.10.08
2 NORMATIVE REFERENCES
2.1 Normative References 01 01.10.08 00 01.10.08
3 TERMS, DEFINITIONS &ABBREVIATIONS
3.1 Terms & Definitions 01 01.10.08 00 01.10.08
3.2 List of Abbreviations 01 01.10.08 00 01.10.08
4 QUALITY MANAGEMENTSYSTEM
4.1 General Requirements Of QMS 01 01.10.08 00 01.10.084.2 Documentation Requirements 01 01.10.08 00 01.10.08
4.3 Control Of Documentation 01 01.10.08 00 01.10.08
4.4 Control Of Records 01 01.10.08 00 01.10.08
5 MANAGEMENTRESPONSIBILITY
5.1 Management Commitment 01 01.10.08 00 01.10.08
5.2 Customer Focus 01 01.10.08 00 01.10.08
5.3 Quality Policy 01 01.10.08 00 01.10.08
5.4 Planning 01 01.10.08 00 01.10.08
5.5 Responsibility & Authority 01 01.10.08 00 01.10.085.6 Management Review 01 01.10.08 00 01.10.08
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6 RESOURCE MANAGEMENT
6.1 Provision of Resources 01 01.10.08 00 01.10.08
6.2 Human Resources 01 01.10.08 00 01.10.08
6.3 Infrastructure 01 01.10.08 00 01.10.08
6.4 Work Environment 01 01.10.08 00 01.10.08
7.0 SERVICE REALISATION
7.1 Planning of Service Realization 01 01.10.08 00 01.10.08
7.2 Customer-related Processes 01 01.10.08 00 01.10.08
7.3 Design & Development 01 01.10.08 00 01.10.08
7.4 Purchasing 01 01.10.08 00 01.10.08
7.5 Serviceion & Service provision 01 01.10.08 00 01.10.08
7.6 Control of Monitoring andmeasuring Devices
01 01.10.08 00 01.10.08
8 MEASUREMENT, ANALYSIS& IMPROVEMENT
8.1 General 01 01.10.08 00 01.10.08
8.2 Monitoring and Measurement 01 01.10.08 00 01.10.08
8.3 Control of Non-conformingService
01 01.10.08 00 01.10.08
8.4 Analysis of Data 01 01.10.08 00 01.10.08
8.5 Improvement 01 01.10.08 00 01.10.08
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1.2 CAUTION NOTICE
Copying of this document and / or giving it to others and the use orcommunication of the contents thereof, are forbidden without expressauthority. Offenders are liable to strict disciplinary action, and the paymentof damages.
Subject to PUNE Jurisdiction.
MANAGEMENT OF Hi-Tech Engineering Corporation India Pvt Ltd.
1.3 DOCUMENT DISTRIBUTION LIST
Document Reference Director Head ofManufacturing
& QualityAssurance
Head ofDepartments
Quality Manual & Procedures,Reference documents &
Formats
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1.4COMPANY PROFILE
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1.5 QUALITY POLICY
We at Hi-Tech Engineering Corporation India Pvt Ltd, as an Organisation and as
individuals commit ourselves to supply Cost effective Quality Machineries in
Sugar Industries ,Steam generators and Co-generation Plants, accordingly to
Customer needs and Provide services to their expectations through our
experienced team, skills and innovative technology.
Quality and its implementation is an integral part of our overall activities.
The Management is committed to ensure that every body in organization
understands & implements the Quality Policy and contributes in continual
improvement of the Quality Management System.
Mr. S. Awate
Managing Director01.10.2008
1.6 QUALITY OBJECTIVES
1. To achieve Customer satisfaction index upto min 80%
2. On time Project Execution
3. Customer complaints resolution within 48 Business hours.
4. Zero Accidents at works centre
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1.7 PURPOSE & SCOPE OF QUALITY MANUAL
PURPOSE
This manual is issued to describe the Quality System deployed at Hi-TechEngineering Corporation India Pvt. Ltd. This manual and the system and processes it
describes serves to ensure:
Conformance to customer requirements _Implementation of Hi-Tech Engineering
Corporation India Pvt Ltd.
Quality policy.
Conformance to ISO 9001:2000 standard.
Scope of Quality Manual:
Design ,Manufacturing and selling of Food Processing Plant and Machineries
(Turnkey sugar plants, Steam generator, Co-generation Plants and Switchyards)
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2.1 NORMATIVE REFERENCE
The following normative document contains provisions of this InternationalStandard. It is ensured that most recent edition of this document is applied andmaintained.
S.No. REFERENCE CONTENTS
01 ISO 9000:2000 Quality Management Systems:Fundamental and Vocabulary
02 ISO 9001:2000 Quality Management Systems:Requirements
03 ISO 9004:2000 Quality Management and Quality SystemElements (guidelines for performanceImprovements).
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3.0 TERMS, DEFINITIONS & ABBREVIATIONS
3.1 Terms & Definitions :
Quality : Degree to which a set of inherent characteristics fulfilsrequirements.
Process : Set of interrelated or interacting activities which transformsinputs into outputs
Service: Result of a set of interrelated or interacting activities whichtransforms inputs into outputs.
Customer satisfaction: Customers perception of the degree towhich customers requirements have been fulfilled.
Management system: system to establish policy and objectives andto achieve those objectives.
Quality Policy: Overall intentions and direction of and organizationrelated to quality as formally expressed by top management
Quality Objective: Something sought, or aimed for, related to quality.
Top Management: Person or group of people who direct and controlan organization at the highest level.
Quality Planning: Part of quality management focused on settingquality objectives and specifying necessary operational processesand related resources to fulfil the quality objectives.
Quality Improvement: Part of quality management focused onincreasing the ability to fulfil quality requirements.
Continual improvement: recurring activities to increase the ability tofulfil requirements.
Effectiveness: Extent to which planned activities are realized and
planned results achieved. Efficiency: Relationship between the result achieved and the
resources used.
Correction: Action to eliminate a detected nonconformity.
Corrective action: Action to eliminate the cause of a detectednonconformity or other undesirable situation.
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Preventive action: Action to eliminate the cause of a potentialnonconformity or other undesirable potential situation.
Validation: Conformation, through the provision of objectiveevidence, that the requirements for a specific intended use orapplication have been fulfilled.
Quality Plan: Document specifying which procedures and associatedresources shall be applied by whom and when to a specific project,Service, process or contract.
Competence: Demonstrated ability to apply knowledge and skills.
Capability: Ability of an organization, system or process to realize a
Service that will fulfil the requirements for that Service.
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3.2 LIST OF ABBREVIATIONS
SLNO
ABBREVIATION EXPLAINATION
1 CAR NO. Corrective action report number
2 Rev Revision
3 QMS Quality management system
4 QC Quality control
5 QA Quality assurance6 QM Quality manual
7 QMP Quality management programme
8 QMR Quality management record
9 PM Process mapping
10 C Chart
11 QP Quality procedure
12 WI Work instructions
13 FM Format
14 RD Reference Document
15 ISO International organization for Standardization
16 MR Management representative17 REF Reference
18 CAPA Corrective Action & Preventive Action
19 OJT On Job Training
20 ROI Return on Investment.
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4.1GENERAL REQUIREMENTS:
4.1.1 Quality Management System is established, documented, implemented,and maintained as per requirements of ISO 9001:2000. All efforts aremade to ensure its continual improvement through out the organization.
In order to achieve the above, the Organization has ensured that:
4.1.1.1 The process needed for the QMS are identified covering all functions ofthe organization. (Refer HEC/RD/001-Section 1.1 to1.7)
4.1.1.2 Sequence and interaction of these processes are determined anddocumented. (Refer HEC/RD/001 Section 1.8)
4.1.1.3 Criteria and methods needed to ensure that the operation and controlof these processes are determined.
4.1.1.4 Resources and information needed to support the operation andmonitoring of these processes are made available.
4.1.1.5 These Processes are monitored, Measured and analyzed.
4.1.1.6 Action necessary to achieve planned results and continualimprovement of these processes are implemented.
4.1.2 These processes are managed by the organization in accordance with therequirements of ISO 9001-2000 standard.
4.1.3 Outsourcing processes are not involved as per the nature of activities..4.2 DOCUMENTATION REQUIREMENTS
4. 2. 1 General
The QMS documentation include following ~
a. Quality Manual containing description of ISO 9001-2000 clauses 1 to 8,including documented statements of Quality Policy and Quality Objectives.
b. Quality Proceduresc. Reference Documents for providing necessary information
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d. Work instructionse. Formats for collection of data.f. Records to ensure effectiveness of the system
The Extent of QMS documentation are derived from the ~
a. Size of the organizationb. Types of activitiesc. Complexities of the processesd. Legal requirementse. Customer requirementsf. Interaction of the processes
g. Competence of the personnel
The documentation is primarily on hard prints. Additionally,electronically this may be kept & protected with passwords.
4. 2. 2 Quality Manual
Quality system is established and maintained. It includes following:
a. Quality Manual with references of related documents & procedures,
b. Quality Procedures showing interactions of the sub-processes andactivities within the processes.
Quality Procedures describing ways to carry out sub-processes or activities withinthe function. It describes what to do, where to do, when to do, why to do, who is todo and how to do.
Where required, Work Instructions are documented to describe how specificactivity or sub- process is performed. All documents are listed in Master list ofSystem Documents, (Refer HEC/RD/002)
All the Documents required for the QMS are controlled.
4.2.3 Control of Documents
A documented quality procedure HEC/QP/001 is established and documented todefine the controls as follow:
a. Approve documents for adequacy prior to issue
b. Review and update as necessary and re-approve documents.
c. Decide method for identifying the changes and current revision status.
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d. Ensure that relevant versions of applicable documents are available atpoints of use.
e. Ensure that documents of external origin (standards, supplier specificationsand customers data) are identified and their distribution is controlled
f. Ensure that documents are legible and are readily identifiable
g. Prevent the intended use of obsolete documents and try to apply suitableidentification mark if they are retained for specific purpose.
. 2. 4. Control of Records~
A documented quality procedure HEC/QP/002 is established to define controls
needed for the identification, storage, protection, retrieval, retention time anddisposition of records.
Records are established and maintained to provide evidence of conformity torequirements and of effective operation of the QMS (Refer HEC/RD/03 Masterlist of Records). Records are stored suitably to maintain their legibility and to makeretrievable. Records are prepared in such a way, so that they are readilyidentifiable.
REFERENCE:
Procedure for Control of Documents HEC/QP/001
Procedure for Control of Records HEC/QP/002
Process Identification & Interaction HEC/RD/001
Master List of Quality Documents HEC/RD/002
Master List of Records HEC/RD/003
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5.1 MANAGEMENT COMMITMENT:
Top management is committed to the development and implementation of
the quality management system and continually improving its effectiveness
by :
Communicating employees the importance of meeting customer through
training programs and meetings.
Meeting all the applicable statutory and regulatory requirements, such asSales & Income Tax, Government Registrations etc. as identified in MasterList of Statutory & regulatory Requirements. (HEC/RD/004)
Establishing, explaining, and reviewing the quality policy.
Ensuring that quality objectives are established, implemented and achieved.
Conducting management reviews as per the planned arrangements.
Ensuring the review and availability of resources.
Participating in improvement projects, searching for better technology,equipments, methods, materials, etc.
5.2 CUSTOMER FOCUS
Top management has determined customer requirements and is met with the aimof enhancing customer satisfaction. This is achieved through effectiveimplementation of quality policy, quality objectives, measuring customersatisfaction, training, and communicating employees for customer satisfaction,taking corrective and preventive action etc.
5.3 QUALITY POLICY
Quality Policy is established by top management of Hi-Tech EngineeringCorporation India Pvt Ltd., after discussing the points related to purpose of theorganization sharing with them the dreams. Policy is documented as QualityPolicy statement, which is given in Section 1.5 of Quality Manual (HEC/QM/001)
It is ensured that the quality policy statement is -
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a. Is appropriate to the purpose of the organization,b. Includes a commitment to comply with requirements and continuallyimprove the effectiveness of the QMS.
c. Provides a framework for establishing and reviewing quality objectives.d. Is communicated within the organization by displaying it in local language
for everybody to read and by conducting suitable awareness programs atall levels.
e. Is reviewed for continuing suitability in every management review meeting.
5.4 PLANNING
5.4.1 Quality Objectives
Quality Objectives including those needed to meet requirement for Service areestablished within the organization. Refer section 1.6 of Quality ManualHEC/QM/001. The quality objectives are Measurable, specific, achievable,realistic time bound and consistent with the quality policy. The quality objectivesare reviewed and quantified before every Management Review Meeting throughQuality Objective Tracking Sheet. Appropriate measures are taken to ensure thatthe quality objectives are met.
5.4.2 Quality Management System Planning
Top Management has established the system to ensure that
The planning of the QMS is carried out in order to meet the requirementsgiven in Section 4.0 of Quality Manual HEC/QM/001 as well as qualityobjectives.
The integrity of the QMS is maintained when changes to the QMS areplanned and implemented.
5.5 RESPONSIBILITIES, AUTHORITY AND COMMUNICATION
Top management has defined and documented responsibilities of all concernedemployees as per Organization Chart and is communicated to all concerned.Following documents are established for the same.
1. Organization Chart(HEC/RD/005) defines inter-relationship and hierarchyof personnel who are at Functional In-charge level.
2. Responsibility Matrix (HEC/RD/005) describes QMS responsibilities ofpersonnel assigned for the processes as primary and secondary.
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Job Descriptions are established to describe authorities given andresponsibilities assigned to perform their duties with clear accountabilities, referHEC/RD/005 Annexure A
5. 5. 2. Management Representative
MR has been appointed as member of management who, over and above otherresponsibilities, has responsibility and authority that include:
1. Ensuring that processes needed for the QMS are established implementedand maintained.
2. Reporting to the top management on the performance of the QMS and anyneed for improvement.
3. Ensuring the promotion of awareness of customer requirements throughoutthe organization.
Note- Mr. Shah Sunil, Head of Manufacturing and Quality assurance is havingthe added responsibility of MR. The formal appointment letter has been issuedfor this MR appointment letter (Annexure A of HEC/RD/005)
5. 5. 3 Internal Communications:
Top management has ensured that appropriate communication processes are
established within the organization, so that relevant information is available to thepersonnel at the work place. Also, communication is taking place regarding theeffectiveness of the QMS. Inter Office communication (HEC/FM/001) is done.In addition to this verbal communication also happens through telephones,day to day meetings, and/or through display boards. No Records are kept forthis.
5.6 MANAGEMENT REVIEW
5. 6. 1 General
Top Management under Director Reviews the organizations QMS with the
committee consisting of personnel of different functions at least once in threemonths.
Review committee comprises of following members a) Managing Director (Chairperson)b) Management Representative
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c) HODsAny other participant as per suggestion of top management.
5. 6. 2 Review Input
During the Management Review meetings, Hi-Tech Engineering Corporation IndiaPvt Ltd. shall consider the following inputs to evaluate efficiency as well aseffectiveness of Quality management System. .
a. Review of previous minutes of meetings and actions scheduled and takenon it.
b. Review of results of audits.
c. Review of customer feedback and complaints.d. Review of process performance and Service conformity.e. Review of preventive and corrective actions.f. Training aspects.g. Review of changes that could affect Quality management System.h. Recommendations for improvementi. Quality Policy & Quality objectives reviews
5. 6. 3 Review Output
The purpose of the review is to ensure continuing suitability, adequacy, andeffectiveness of the QMS. Process outputs, customer feedbacks, performance
measures, Service conformity reports, action plans, corrective and follow upaction reports are taken as input to the management review.
Review output includes decisions, actions and resources related to improvementof the effectiveness of critical processes and enhancement of customersatisfaction (MRM Minutes - HEC/FM/004)
REFERENCE:
Organization Chart HEC/RD/005
Responsibility Matrix HEC/RD/006
Job Descriptions HEC/RD/006MRM Minutes HEC/FM/004
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6.1 PROVISION OF RESOURCES
Top management ensures that the resources essential to the implementation ofstrategy and the achievement of the organizations objectives are identified andmade available.
This includes resources for operation, improvement of the quality managementsystem, Service performance to meet specified requirements and to enhancecustomer satisfaction.
Resources considered are trained manpower, buildings, machinery, measuringand testing facilities, office, equipment, utilities, work environment, and suppliers.
Resources are planned considering following:1. Opportunities and constraints.2. Support facilities to meet customer/employee requirements.3. Improvement in competence levels of people through on job training.4. Controlled use of natural resources.5. Control on pollution prone process controls.6. Encouragement of continual improvement.
6.2 HUMAN RESOURCES
6. 2. 1 General
Management encourages involvement and support of people to improveeffectiveness and efficiency of the organization including quality managementsystem. For this, management ensures that competence of people performingwork; affecting quality is developed with appropriate education, Training, skills andexperience.
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COMPETENCE, AWARENESS AND TRAINING
It is ensured that competent personnel are performing work affecting the processquality. (Employee Competency - HEC/RD/007). If found inadequate, training isprovided based on their job requirement for their continual improvement. Recordof the same is maintained by MR.
The effectiveness of the training provided is monitored by analyzing the qualityobjective data and their continual improving tends to achieve the targets.
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It is ensured that personnel are aware of the relevance and importance of theiractivities, which leads to achievement of quality objectives
6.3 INFRASTRUCTURE
Infrastructure necessary for the realization Services is identified after knowingrequirements of interested parties.
Infrastructure includes workspace, Service equipment, instruments and tools,utilities, buildings, information and communication services, computers and otheroffice equipment etc.
Infrastructure is kept functional through adequate Preventive & BreakdownMaintenance as described in HEC/QP/010 (Procedure for Preventive &breakdown Maintenance)
6.4 WORK ENVIRONMENT
Suitable work environment is determined and managed to achieve conformity toService requirements.
Following considerations are made while determining work environment1. Creative work methods & processes.
2. Legal requirement related Service environment and process performance3. Aspects like light, sound, air flow etc. considering human safety4. Aspects like hygiene, cleanliness, temperature, pollution etc considering
health.5. Safety requirements6. Economics
.
REFERENCE:
Employee Competency HEC/RD/007
Procedure for Preventive &Breakdown Maintenance HEC/QP/010
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7.1 PLANNING OF SERVICE REALIZATION
The Management has planned and developed the processes needed for Servicerealization (Project execution). Planning of the Service realization is consistent withthe requirements of the other processes of the quality management system.
In planning Service realization (Project execution), the organization determinesthe following:
1. Quality objectives and requirements for the Service as per customers
needs & expectations. The process sequence, documents and resources toprovide specific to the Service2. Required verification, validation, monitoring, inspection, and test activities
specific to the Service and the criteria for Service characteristics.3. Records needed to provide evidence that the realization process and
resulting Service meet requirements.
The output of this planning is in a form of Quality Assurance Plan for Servicerealization (Project execution). Refer HEC/RD/008.
7.2 CUSTOMER RELATED PROCESSES
7.2.1 Determination of requirement related to the Service
Processes for Project Execution / Service Realization (HEC/QP/007) isestablished and documented for identifying different activities performed toimplement the process and to mention their interaction. It is ensured that therequirements specified by customer including the requirements necessary forspecified or intended use are understood. The applicable Statutory and regulatoryrequirements are also understood & complied to.
7.2.2 Review of requirements related to the Service
The review of customers requirements is made. All differences, if any, in
understanding are resolved with customer prior to acceptance of order. It isensured that all verbal instruction are mutually agreed and recorded.Review is done by Director to ensure that the customer had defined all the Servicerequirements and Hi-Tech Engineering Corporation India Pvt Ltd has capability tomeet the assignment or order requirements. Also review is done to ensure that theService satisfies the customer needs.Amendments to contracts, if any, are recorded in writing and informed to thepersons responsible for the execution of these amendments in time.
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Records of review of requirements of the Service and amendments are maintained inthe form of signed agreement / contract.
While describing the procedure, customer considered is following sub processes aredetermined and implemented ~
1. Order Planning & Contract with customer2. Contract Review3. Customer Feedback4. Handling of customer complaints
7. 2. 3 Customer Communication
Hi-Tech Engineering Corporation India Pvt Ltd has established arrangement forcommunication with customer in mentioned areas for effective QualityManagement System in the organization.
a. Service Information by means of Verbal discussions as well as throughBrochures.
b. Enquiries, contracts or work assignments, including amendments reviewedand accepted by the companies.
c. Customer feedback including complaints and suggestions.
Mentioned areas are reviewed and timely action is taken for improvement.
7.3 DESIGN & DEVELOPMENT
7.3.1 Design and development planning
Hi-Tech Engineering Corporation India Pvt Ltd has planned and controlled thedesign and development of projects
During the design and development planning, Hi-Tech has determineda) the design and development stages,b) the review, verification and validation that are appropriate to each design and
development stage, and
c) The responsibilities and authorities for design and development.
The organization has managed the interfaces between different groups involved indesign and development to ensure effective communication and clear assignmentof responsibility.
Planning output is updated, as appropriate, as the design and developmentprogresses.
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7.3.2 Design and development inputs
Inputs relating to product requirements are determined and records aremaintained. These inputs are
a) functional and performance requirement,b) applicable statutory and regulatory requirements,c) where applicable, information derived from previous design, andd) other requirements essential for design and development.
These 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 provided in a form that enablesverification against the design and development input and has to be approvedprior to release.
Design and development outputs would
a) meet the input requirements for design and development,b) provide appropriate information for purchasing, production and for service
provision,c) contain or reference product acceptance criteria, andd) Specify the characteristics of the product that are essential for its safe and
proper use.
7.3.4 Design and development review
At suitable stages, systematic review of design and development has beenperformed in accordance with planned arrangements
a) to evaluate the ability of the results of design and development to meetrequirements, and
b) to identify any problems and propose necessary actions.
Participants in such reviews were representatives of functions concerned withdesign and development stage(s) being reviewed. Records of the results of thereviews and any necessary actions are being maintained.
7.3.5 Design and development verification
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Verification is performed in accordance with planned arrangement to ensure thatthe design and development outputs have met the design and development inputrequirements. Records of the results of the verification and any necessary actionsare maintained
7.3.6 Design and development validation
Design and development validation was performed in accordance with plannedarrangements to ensure that the resulting product is capable of meeting therequirements for the specified application or intended use, where known.Wherever practicable, validation was completed prior to the delivery orimplementation of the product. Records of the results of validation and any
necessary actions are maintained.
7.3.7 Control of design and development changes
Design and development changes are identified and records maintained. Thechanges are reviewed, verified and validated, as appropriate, and approvedbefore implementation. The review of design and development changes hasincluded evaluation of the effect of the changes on constituent parts and productalready delivered.
Records of the results of the review of changes and any necessary actions aremaintained.
7.4 PURCHASING
7. 4. 1 Purchasing Process
The organization has determined the purchasing process, which is planned andmonitored. Purchasing process has been established and documented forensuring that purchased Service conforms to specified purchase requirements.
Hi-Tech Engineering Corporation India Pvt Ltd will evaluate and approve thesuppliers. The Approved Suppliers list (HEC/RD/009) will be maintained. Thecontrol over those suppliers along with criteria for their selection, evaluation, andre-evaluation has been established.
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7. 4. 2 Purchasing informationA purchase order is released to the supplier along with Supply schedule if
required. The Purchase Order (HEC/FM/014) contains following data asappropriate
Description of Goods
Grade or class or other precise identification
Rate, payments Terms and other commercial information
Delivery schedule with instruction for 100 % time delivery.
Packing and Transport requirement.
Inspection instructions Requirement of approval of Service, process, equipment, procedures,
personnel qualification, and any QMS requirements.
Other relevant information, if any.
7. 4. 3 Verification of purchased Service
The organization has established and implemented procedure for inspection ofpurchased Services prior to put into manufacturing process. Refer Quality Assurance Plan (HEC/RD/008).
None of the customer of the Hi-Tech Engineering Corporation India Pvt Ltd. itselfintends to perform the verification of purchased Service at the suppliers premises.
7.5 SERVICE REALIZATION
7. 5. 1 Control of Service provision
Quality Procedure HEC/QP/007 (Processes for Service provision) isestablished and documented for identifying different activities performed toimplement the process and to mention their interaction. It ensures -
The availability of information that describes the characteristics of the Service.
The availability of work instructions, wherever necessary.
The use of suitable instruments
The availability of verification process
The implementation of monitoring and measurement.
The implementation of release, delivery activities.
Note: Hi-Tech Engineering Corporation India Pvt Ltd does not involve any post-delivery / post -warranty activities except if there is customer complaint etc.found.
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7. 5. 2 Validation of processes for Serviceion and service provision
Hi-Tech is validating processes for Project execution where the resulting outputcannot be verified by subsequent monitoring or measurement. This includes anyprocesses where deficiencies become apparent only after the product is in use orthe service has been delivered.
Validation demonstrates the ability of these processes to achieve planned results.
For these special processes, the organization ensure that
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 ande) Revalidation.
7. 5. 3 Identification and traceability
The Services are identified by suitable means (like designated area, adequatelyidentified by boards) throughout the Service realization.
Only where traceability is a requirement, the company control and records theunique identification of the Service by using respective IDs.
7. 5. 4 Customer property
Customers Property whatever it has been, are adequately taken care off by theorganization when it is under there control. Wherever applicable, records ofcustomer property will be maintained.
7. 5. 5 Preservation of Product & Service
This ensures preservation of Service during internal processing and delivery to theintended destinations.
Following sub processes are determined and implemented.1. Product & Service handling2. Product & Service storage3. Inventory Control4. Product & Service Preservation5. Product & Service delivery
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7.5 CONTROL OF MONITORING AND MEASURING DEVICES
Hi-Tech Engineering Corporation India Pvt Ltd has determined the monitoring andmeasurement devices needed to provide evidence of conformity of the Product &Service to the requirements. Hi-Tech Engineering Corporation India Pvt Ltdensures that all the measuring and monitoring equipment are
Calibrated at specified interval against national standards.
Adjusted or readjusted as necessary.
Identified by stickers to enable the calibration status to be determined.
Safeguarded from adjustment that would invalidate the measurement results.
Protected from damage and deterioration during handling, maintenance andstorage
Records of calibration, validity of previous measuring results are maintained inthe Calibration History Card (HEC/FM/0036). The company does not have naycomputer software for the monitoring and measuring devices.
CROSS REFERENCE:
Processes for Service Provision HEC/QP/007
Quality Assurance Plan HEC/RD/008Approved Suppliers list HEC/RD/009
Calibration History Card HEC/FM/036
Purchase Order HEC/FM/014
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!"#$%&$'()*#+",-#$%8.1 GENERAL
Hi-Tech Engineering Corporation India Pvt Ltd has planned and implementedprocesses for monitoring, measurement, analysis and improvement for thefollowing
To demonstrate the conformity of Service by using inspection report.
To ensure conformity of the Quality Management System
To continually improve the effectiveness of the Quality Management system.
8.2 MONITORING AND MEASUREMENT
8.2.1 Customer Satisfaction
Methods have been defined to monitor information related to customersperceptions, customers feedback for gauging satisfaction levels for customerswhereby appropriate and related information / comments/ Opinions of thecustomers are sought on a continuous basis (at least once in every 6 months) tounderstood that the organization has met customers requirements. Records ofCustomers feedback are maintained in the form of HEC/FM/019.
8.2.2 Internal Audit
Internal Audits are carried out once in a Three Months covering all the activities /Areas to determine that QMS is in operation and conform that QMS isimplemented as per the planned arrangements, to the requirements of ISO9001:2000 and the implementation is effective. Following sub-processes aredescribed in the procedure ~
1. Audit planning2. Auditing3. Initiating corrective actions4. Follow up audit5. Audit evaluation
The audit intervals are planned as per the status and importance of variousprocesses. The auditors independence and clarification of auditor responsibilitiesare found in Quality system audit schedule. Audit reports are maintained as perprocedure HEC/QP/004. Audit findings are discussed in Management ReviewMeeting Results of the audits are recorded as per HEC/QP/004 to take timelycorrective action.
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8.2.3 Monitoring and Measurement of Processes
Suitable methods are applied for monitoring and where applicable, measurementof the QMS process. These methods demonstrate the ability of the processes toachieve the planned results. When planned results are not achieved thencorrective and preventive Actions are taken as appropriate to ensure conformity ofthe Service.8.2.4 Monitoring and Measurement of Service
The Service characteristics are monitored and measured to verify that the Service
requirements are met. Evidence of conformity with the acceptance criteria ismaintained. Records indicate the person(s) authorizing release of Service. ProjectCo-ordinator is only authorized to release the Service along with DIRECTOR.Service is not dispatched until the planned arrangements are satisfactorilycompleted or approved by DIRECTOR. Evidence of conformity with theacceptance criteria are maintained as per Reference Document no. HEC/RD/008.
8.3 CONTROL OF NON-CONFORMING SERVICE
It is ensured that Service which does not conform to Service requirements isidentified and controlled to prevent its unintended use or delivery. Refer procedureHEC/QP/003 for the same. Non-conforming Service is identified, evaluated,documented, non-conformity disposed and notified to concerned department.DIRECTOR is responsible for controlling all kinds of Non-conformities.
8.4 ANALYSIS OF DATA
Appropriate data are determined, collected, and analyzed to demonstrate thesuitability and effectiveness of the QMS and to identify the areas for continualimprovement of the effectiveness of the QMS.
Data on the following characteristics are recorded and analyzed.
Defects in process outputs,
Customer complaints Quality Objectives. Supplier performance
The analysis of data provides information relating to
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Customer satisfaction, Conformity to Service requirements, Characteristics and trends of processes and Services including opportunities for preventive action, and Supplier
8.5 IMPROVEMENT
8.5.1 Continual Improvement
Effectiveness of the QMS is continually improved through the use of the qualitypolicy, quality objectives, audit results, analysis of data, corrective and preventive
actions, and management review.
If required Continuous Improvement Project is initiated for identified problem, sothat problems are identified, actions are taken and respective corrective /preventive actions are initiated. Progress is reviewed in all Management reviewmeeting.
8.5.2 Corrective Action
Actions are taken to eliminate the cause of nonconformities in order to preventrecurrence. They are appropriate to the effects of the nonconformitiesencountered.
Records of investigation of cause are maintained as per procedure HEC/QP/005.
8. 5. 3 Preventive action
Actions are determined to eliminate the cause of potential nonconformities inorder to prevent their occurrence. Preventive actions are appropriate to the effectsof the potential problems.
Refer procedure on Preventive Action (HEC/QP/006)Preventive actions are discussed in Management Review meeting.
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