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Quality System Manual (ISO 9001: 2000) : Hi-Tech Engineering Corporation India Pvt. LTD
Quality System Manual (ISO 9001: 2000) : Hi-Tech Engineering Corporation India Pvt. LTD
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1 1.1 1.2 1.3 1.4 1.5 1.6 1.7 2 2.1 3 3.1 3.2 4 4.1 4.2 4.3 4.4 5 5.1 5.2 5.3 5.4 5.5 5.6
GENERAL Table of Contents Caution Notice Manual Distribution List Manufacturing Layout Map Quality Policy Quality Objectives Purpose & Scope NORMATIVE REFERENCES Normative References TERMS, DEFINITIONS & ABBREVIATIONS Terms & Definitions List of Abbreviations QUALITY MANAGEMENT SYSTEM General Requirements Of QMS Documentation Requirements Control Of Documentation Control Of Records MANAGEMENT RESPONSIBILITY Management Commitment Customer Focus Quality Policy Planning Responsibility & Authority Management Review
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6 6.1 6.2 6.3 6.4 7.0 7.1 7.2 7.3 7.4 7.5 7.6 8 8.1 8.2 8.3 8.4 8.5
RESOURCE MANAGEMENT Provision of Resources Human Resources Infrastructure Work Environment SERVICE REALISATION Planning of Service Realization Customer-related Processes Design & Development Purchasing Serviceion & Service provision Control of Monitoring and measuring Devices MEASUREMENT, ANALYSIS & IMPROVEMENT General Monitoring and Measurement Control of Non-conforming Service Analysis of Data Improvement
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Mr. S. Awate
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Design ,Manufacturing and selling of Food Processing Plant and Machineries (Turnkey sugar plants, Steam generator, Co-generation Plants and Switchyards)
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CONTENTS Quality Management Systems: Fundamental and Vocabulary Quality Management Systems: Requirements Quality Management and Quality System Elements (guidelines for performance Improvements).
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Preventive action: Action to eliminate the cause of a potential nonconformity or other undesirable potential situation. Validation: Conformation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled. Quality Plan: Document specifying which procedures and associated resources 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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4.1.2 These processes are managed by the organization in accordance with the requirements 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 Procedures c. Reference Documents for providing necessary information
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d. Work instructions e. Formats for collection of data. f. Records to ensure effectiveness of the system The Extent of QMS documentation are derived from the ~ a. b. c. d. e. f. g. Size of the organization Types of activities Complexities of the processes Legal requirements Customer requirements Interaction of the processes 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 and activities within the processes. Quality Procedures describing ways to carry out sub-processes or activities within the function. It describes what to do, where to do, when to do, why to do, who is to do and how to do. Where required, Work Instructions are documented to describe how specific activity or sub- process is performed. All documents are listed in Master list of System 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 to define 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 at points of use. e. Ensure that documents of external origin (standards, supplier specifications and 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 suitable identification 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 and disposition of records. Records are established and maintained to provide evidence of conformity to requirements and of effective operation of the QMS (Refer HEC/RD/03 Master list of Records). Records are stored suitably to maintain their legibility and to make retrievable. Records are prepared in such a way, so that they are readily identifiable. REFERENCE: Procedure for Control of Documents HEC/QP/001 Procedure for Control of Records Process Identification & Interaction Master List of Quality Documents Master List of Records HEC/QP/002 HEC/RD/001 HEC/RD/002 HEC/RD/003
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5.2 CUSTOMER FOCUS Top management has determined customer requirements and is met with the aim of enhancing customer satisfaction. This is achieved through effective implementation of quality policy, quality objectives, measuring customer satisfaction, 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 Engineering Corporation India Pvt Ltd., after discussing the points related to purpose of the organization sharing with them the dreams. Policy is documented as Quality Policy 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 continually improve 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 at all 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 are established within the organization. Refer section 1.6 of Quality Manual HEC/QM/001. The quality objectives are Measurable, specific, achievable, realistic time bound and consistent with the quality policy. The quality objectives are reviewed and quantified before every Management Review Meeting through Quality Objective Tracking Sheet. Appropriate measures are taken to ensure that the 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 requirements given in Section 4.0 of Quality Manual HEC/QM/001 as well as quality objectives. The integrity of the QMS is maintained when changes to the QMS are planned and implemented. 5.5 RESPONSIBILITIES, AUTHORITY AND COMMUNICATION Top management has defined and documented responsibilities of all concerned employees 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 hierarchy of personnel who are at Functional In-charge level. 2. Responsibility Matrix (HEC/RD/005) describes QMS responsibilities of personnel assigned for the processes as primary and secondary.
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Job Descriptions are established to describe authorities given and responsibilities assigned to perform their duties with clear accountabilities, refer HEC/RD/005 Annexure A 5. 5. 2. Management Representative MR has been appointed as member of management who, over and above other responsibilities, has responsibility and authority that include: 1. Ensuring that processes needed for the QMS are established implemented and maintained. 2. Reporting to the top management on the performance of the QMS and any need for improvement. 3. Ensuring the promotion of awareness of customer requirements throughout the organization. Note- Mr. Shah Sunil, Head of Manufacturing and Quality assurance is having the added responsibility of MR. The formal appointment letter has been issued for 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 the personnel at the work place. Also, communication is taking place regarding the effectiveness 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 for this. 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 three months.
Review committee comprises of following members a) Managing Director (Chairperson) b) Management Representative
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c) HODs Any other participant as per suggestion of top management. 5. 6. 2 Review Input During the Management Review meetings, Hi-Tech Engineering Corporation India Pvt Ltd. shall consider the following inputs to evaluate efficiency as well as effectiveness of Quality management System. . a. Review of previous minutes of meetings and actions scheduled and taken on 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 improvement i. Quality Policy & Quality objectives reviews 5. 6. 3 Review Output The purpose of the review is to ensure continuing suitability, adequacy, and effectiveness of the QMS. Process outputs, customer feedbacks, performance measures, Service conformity reports, action plans, corrective and follow up action reports are taken as input to the management review. Review output includes decisions, actions and resources related to improvement of the effectiveness of critical processes and enhancement of customer satisfaction (MRM Minutes - HEC/FM/004) REFERENCE: Organization Chart Responsibility Matrix Job Descriptions MRM Minutes HEC/RD/005 HEC/RD/006 HEC/RD/006 HEC/FM/004
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6.1 PROVISION OF RESOURCES Top management ensures that the resources essential to the implementation of strategy and the achievement of the organizations objectives are identified and made available. This includes resources for operation, improvement of the quality management system, Service performance to meet specified requirements and to enhance customer satisfaction. Resources considered are trained manpower, buildings, machinery, measuring and 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 improve effectiveness and efficiency of the organization including quality management system. For this, management ensures that competence of people performing work; affecting quality is developed with appropriate education, Training, skills and experience.
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It is ensured that competent personnel are performing work affecting the process quality. (Employee Competency - HEC/RD/007). If found inadequate, training is provided based on their job requirement for their continual improvement. Record of the same is maintained by MR. The effectiveness of the training provided is monitored by analyzing the quality objective 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 their activities, which leads to achievement of quality objectives 6.3 INFRASTRUCTURE
Infrastructure necessary for the realization Services is identified after knowing requirements of interested parties. Infrastructure includes workspace, Service equipment, instruments and tools, utilities, buildings, information and communication services, computers and other office equipment etc. Infrastructure is kept functional through adequate Preventive & Breakdown Maintenance 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 to Service requirements. Following considerations are made while determining work environment 1. Creative work methods & processes. 2. Legal requirement related Service environment and process performance 3. Aspects like light, sound, air flow etc. considering human safety 4. Aspects like hygiene, cleanliness, temperature, pollution etc considering health. 5. Safety requirements 6. Economics
REFERENCE: Employee Competency Procedure for Preventive Breakdown Maintenance HEC/RD/007 & HEC/QP/010
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In planning Service realization (Project execution), the organization determines the following: 1. Quality objectives and requirements for the Service as per customers needs & expectations. The process sequence, documents and resources to provide specific to the Service 2. 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 Service realization (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) is established and documented for identifying different activities performed to implement the process and to mention their interaction. It is ensured that the requirements specified by customer including the requirements necessary for specified or intended use are understood. The applicable Statutory and regulatory requirements 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 is ensured that all verbal instruction are mutually agreed and recorded. Review is done by Director to ensure that the customer had defined all the Service requirements and Hi-Tech Engineering Corporation India Pvt Ltd has capability to meet the assignment or order requirements. Also review is done to ensure that the Service satisfies the customer needs. Amendments to contracts, if any, are recorded in writing and informed to the persons 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 in the form of signed agreement / contract. While describing the procedure, customer considered is following sub processes are determined and implemented ~
1. 2. 3. 4.
Order Planning & Contract with customer Contract Review Customer Feedback Handling of customer complaints
7. 2. 3 Customer Communication Hi-Tech Engineering Corporation India Pvt Ltd has established arrangement for communication with customer in mentioned areas for effective Quality Management System in the organization. a. Service Information by means of Verbal discussions as well as through Brochures. b. Enquiries, contracts or work assignments, including amendments reviewed and 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 the design and development of projects During the design and development planning, Hi-Tech has determined a) 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 in design and development to ensure effective communication and clear assignment of responsibility. Planning output is updated, as appropriate, as the design and development progresses.
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7.3.2 Design and development inputs Inputs relating to product requirements are determined and records are maintained. These inputs are a) b) c) d) functional and performance requirement, applicable statutory and regulatory requirements, where applicable, information derived from previous design, and 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 enables verification against the design and development input and has to be approved prior 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, and d) 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 been performed in accordance with planned arrangements a) to evaluate the ability of the results of design and development to meet requirements, and b) to identify any problems and propose necessary actions. Participants in such reviews were representatives of functions concerned with design and development stage(s) being reviewed. Records of the results of the reviews 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 that the design and development outputs have met 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 was performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation was completed prior to the delivery or implementation 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. The changes are reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes has included evaluation of the effect of the changes on constituent parts and product already delivered. Records of the results of the review of changes and any necessary actions are maintained. 7.4 PURCHASING 7. 4. 1 Purchasing Process The organization has determined the purchasing process, which is planned and monitored. Purchasing process has been established and documented for ensuring that purchased Service conforms to specified purchase requirements. Hi-Tech Engineering Corporation India Pvt Ltd will evaluate and approve the suppliers. The Approved Suppliers list (HEC/RD/009) will be maintained. The control over those suppliers along with criteria for their selection, evaluation, and re-evaluation has been established.
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7. 4. 2 Purchasing information A purchase order is released to the supplier along with Supply schedule if required. The Purchase Order (HEC/FM/014) contains following data as appropriate 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 of purchased 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. itself intends 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) is established and documented for identifying different activities performed to implement 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 postdelivery / 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 output cannot be verified by subsequent monitoring or measurement. This includes any processes where 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. For these special processes, the organization ensure that a) b) c) d) e) defined criteria for review and approval of the processes , approval of equipment and qualification of personnel, use of specific methods and procedures, requirements for records and Revalidation.
7. 5. 3 Identification and traceability The Services are identified by suitable means (like designated area, adequately identified by boards) throughout the Service realization. Only where traceability is a requirement, the company control and records the unique 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 the organization when it is under there control. Wherever applicable, records of customer property will be maintained. 7. 5. 5 Preservation of Product & Service This ensures preservation of Service during internal processing and delivery to the intended destinations. Following sub processes are determined and implemented. 1. Product & Service handling 2. Product & Service storage 3. Inventory Control 4. Product & Service Preservation 5. Product & Service delivery
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7.5
Hi-Tech Engineering Corporation India Pvt Ltd has determined the monitoring and measurement devices needed to provide evidence of conformity of the Product & Service to the requirements. Hi-Tech Engineering Corporation India Pvt Ltd ensures 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 and storage Records of calibration, validity of previous measuring results are maintained in the Calibration History Card (HEC/FM/0036). The company does not have nay computer software for the monitoring and measuring devices.
CROSS REFERENCE: Processes for Service Provision Quality Assurance Plan Approved Suppliers list Calibration History Card Purchase Order HEC/QP/007 HEC/RD/008 HEC/RD/009 HEC/FM/036 HEC/FM/014
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The audit intervals are planned as per the status and importance of various processes. The auditors independence and clarification of auditor responsibilities are found in Quality system audit schedule. Audit reports are maintained as per procedure HEC/QP/004. Audit findings are discussed in Management Review Meeting Results of the audits are recorded as per HEC/QP/004 to take timely corrective action.
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8.2.3 Monitoring and Measurement of Processes Suitable methods are applied for monitoring and where applicable, measurement of the QMS process. These methods demonstrate the ability of the processes to achieve the planned results. When planned results are not achieved then corrective and preventive Actions are taken as appropriate to ensure conformity of the 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 is maintained. Records indicate the person(s) authorizing release of Service. Project Co-ordinator is only authorized to release the Service along with DIRECTOR. Service is not dispatched until the planned arrangements are satisfactorily completed or approved by DIRECTOR. Evidence of conformity with the acceptance 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 is identified and controlled to prevent its unintended use or delivery. Refer procedure HEC/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 the suitability and effectiveness of the QMS and to identify the areas for continual improvement 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 quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review. If required Continuous Improvement Project is initiated for identified problem, so that problems are identified, actions are taken and respective corrective / preventive actions are initiated. Progress is reviewed in all Management review meeting. 8.5.2 Corrective Action Actions are taken to eliminate the cause of nonconformities in order to prevent recurrence. They are appropriate to the effects of the nonconformities encountered. 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 in order to prevent their occurrence. Preventive actions are appropriate to the effects of the potential problems. Refer procedure on Preventive Action (HEC/QP/006) Preventive actions are discussed in Management Review meeting.
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