QUALITY SYSTEM MANUAL
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EPATHUSA QUALITY SYSTEM MANUAL (QSM/ EPATHUSA /01) Issue No: 01 Date: September 15, 2017 Revision: 01 Date: September 15, 2017 Designation Prepared By Issued & Controlled By Approved By Process expert team Hari Anitha TABLE OF CONTENTS 1.0 REVISION HISTORY 3 2.0 INTRODUCTION & SCOPE 3 2.1 2.2 2.3 2.4 3 3 4 4 INTRODUCTION EPATHUSA IT CORPORATE PROFILE SCOPE EXCLUSIONS 3.0. TERMS & DEFINITIONS 5 4.0. QUALITY MANAGEMENT SYSTEM 7 4.1 GENERAL 4.1.1 SEQUENCES OF INTERACTION OF IDENTIFIED PROCESSES 4.2 DOCUMENTATION REQUIREMENTS 4.2.1 GENERAL 4.2.3 CONTROL OF DOCUMENTS PROJECT/ FUNCTIONAL DOCUMENT AND DATA CONTROL 4.2.4 CONTROL OF QUALITY RECORDS 7 7 8 8 9 9 10 5.0. MANAGEMENT RESPONSIBILITY 11 5.1 MANAGEMENT COMMITMENT 5.2 CUSTOMER FOCUS 5.3 QUALITY POLICY 5.4 PLANNING 5.4.1 QUALITY OBJECTIVES 5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING 5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION 5.5.1 RESPONSIBILITY AND AUTHORITY 5.5.2 MANAGEMENT REPRESENTATIVE 5.5.3 INTERNAL COMMUNICATION 5.6 MANAGEMENT REVIEW 5.6.1 MANAGEMENT REVIEW MEETINGS 5.6.2 REVIEW INPUT (AGENDA) 5.6.3 REVIEW OUTPUT 11 11 12 13 13 13 14 14 15 15 16 16 16 16 6.0. RESOURCE MANAGEMENT 17 6.1 PROVISION OF RESOURCES 6.2 HUMAN RESOURCES 6.2.1 GENERAL 6.2.2 COMPETENCE, TRAINING AND AWARENESS 6.3 INFRASTRUCTURE 6.4 WORK ENVIRONMENT 17 17 17 17 17 17 7.0. PRODUCT REALIZATION 18 7.1 PLANNING OF REALIZATION 7.2 CUSTOMER RELATED PROCESSES 7.2.1 DETERMINATION OF THE REQUIREMENTS RELATED TO THE PRODUCT 18 18 18 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) 7.2.2 REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT 7.2.3 CUSTOMER COMMUNICATION 7.3 DESIGN AND DEVELOPMENT PLANNING 7.4 PURCHASING 7.4.1 PURCHASING PROCESS 7.4.2 PURCHASING INFORMATION 7.4.3 VERIFICATION OF THE PURCHASED PRODUCT 7.5 PRODUCTION AND SERVICE PROVISION 7.5.1 CONTROL OF PRODUCTION & SERVICE PROVISION 7.5.2 VALIDATION OF PROCESS FOR PRODUCTION & SERVICE PROVISION 7.5.3 IDENTIFICATION AND TRACEABILITY 7.5.4 CUSTOMER PROPERTY 7.5.5 PRESERVATION OF PRODUCT 7.6 CONTROLLING OF MEASURING & MONITORING EQUIPMENTS 19 19 19 20 20 20 21 21 21 21 21 22 22 22 8.0. MEASUREMENT, ANALYSIS AND IMPROVEMENT 23 8.1 GENERAL 8.2 MONITORING AND MEASUREMENT 8.2.1 CUSTOMER SATISFACTION 8.2.2 INTERNAL AUDIT 8.2.3 MONITORING AND MEASUREMENT OF PROCESSES 8.2.4 MONITORING AND MEASUREMENT OF PRODUCT 8.3 CONTROL OF NONCONFORMING PRODUCT 8.4 ANALYSIS OF DATA 8.5 IMPROVEMENT 8.5.1 CONTINUAL IMPROVEMENT 8.5.2 CORRECTIVE ACTION 8.5.3 PREVENTIVE ACTION 23 23 23 23 24 24 24 25 25 25 25 26 ANNEXURE I - SEQUENCE AND INTERACTION OF PROCESS 27 ANNEXURE – II ORGANIZATION CHART 28 ANNEXURE – III REFERENCES 30 ANNEXURE IV - QUALITY OBJECTIVES 31 Page 2 of 32 Rev.:1.0, Dt: March 15, 2018 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) 1.0 REVISION HISTORY Date Nature of Change Brief Reason for Change 15/sep/2017 Baseline document Page / Section Where Changes Made New Revision No 1.0 2.0 INTRODUCTION & SCOPE 2.1 INTRODUCTION The Organization’s Quality Management System Manual describes its unique and specific conformance to the requirements of 9001, Quality Management Systems - Requirements. Each section represents organization’s vision of quality as seen through the requirements of the standard, needs of customers and internally defined quality goals and objectives. 2.2 EPATHUSA IT CORPORATE PROFILE Attach Corporate Profile Page 3 of 32 Rev.:1.0, Dt: March 15, 2018 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) 2.3 SCOPE SCOPE OF ISO 9001:2015 CERTIFICATION IS IT Application support and staffing services 2.4 EXCLUSIONS NIL Page 4 of 32 Rev.:1.0, Dt: March 15, 2018 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) 3.0. TERMS & DEFINITIONS Term Definition Acceptance Criteria Defined limits based on characteristics, materials, products or services Audit A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives. Conformance Compliance with specified requirements. Control To exercise authority over and regulate. Control Feature A Documented activity to ensure conformance with specific requirements. Corrective Action Measures taken to rectify conditions adverse to quality and to minimize recurrence CAPA A form used to document corrective, preventive and improvements plans. Effect The Non – fulfillment of intended requirements. Documentation Recorded Information Failure Any condition which prevents the product or service from meeting Specification Finding Objective evidence that a control feature of the approved quality program was not implemented Testing Activities such as measuring, examining, testing. Gauging one or more characteristics of a product or service and comparing these with specified requirements to determine conformity. Non Conformity The non – fulfillment requirements Observation Evidence that a survey able/ auditable element exists which is not contrary to documented requirements but may warrant further qualification or improvement. System Procedure A document that specifies or describes how an activity is to be performed. It may include methods to be used, equipment to be used and sequence of operations Quality Conformance to requirements. Quality Assurance All those Planned and systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirements for quality Quality Control The operational Techniques and activities that are used to fulfill requirements for quality. Page 5 of 32 Rev.:1.0, Dt: March 15, 2018 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) Quality System The Organizational structure, responsibilities, procedures, process and resources for implementing the total management system Quality System Top management performs a formal evaluation of the status and adequacy of Review the quality system in relation to the quality policy and new objectives resulting from changing circumstances Specification A document that prescribes the requirements with which the product or service has to conform Traceability The Ability to trace the history, application or location of an item or activity, or similar items or activities, by means of recorded identification Verify To determine conformance to specified requirements. ABBREVIATIONS: BD Business Development DOC Document HOD Head Of The Department HR Human Resource Development IA Internal Audit MR Management Representative MRM Management Review Meeting PROJ Projects PUR Purchase QA Quality Assurance QF Quality Format QMS Quality Management System QSM Quality System Manual QSP Quality System Procedure EPATHUSA EPATHUSA N&S Network and System Administration Admin Administration MD Director PL Project Leader SDH Solution Delivery Head Page 6 of 32 Rev.:1.0, Dt: March 15, 2018 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) 4.0. QUALITY MANAGEMENT SYSTEM 4.1 GENERAL EPATHUSA has established documented and implemented a quality management system, maintains the same and continually improves its effectiveness in accordance with the requirements of ISO 9001:2015. Following general requirements have been taken care of: • Processes needed for the quality management system and their application throughout the organization have been determined. • Sequences of interaction of these processes have been determined. • Criteria and methods needed have been determined to ensure that both the operations and control of these processes are effective. • The top management ensures the availability of resources and information necessary to support the operation and monitoring of these processes • The organization monitors, measures and analyzes these processes. • Actions necessary to achieve planned results and continual improvement of these processes are implemented • Processes needed for the quality management system as determined are managed by the organization in accordance with the applicable appropriate requirements of ISO 9001:2015. Quality System in EPATHUSA covers the processes in the following sections: ❖ Top Management ❖ Business Development ❖ Projects ❖ Quality Assurance (Testing) ❖ Network & Administration ❖ HR ❖ Support Services (Purchase) ❖ Internal Audit ❖ Management Review ❖ Corrective and Preventive Action 4.1.1 SEQUENCES OF INTERACTION OF IDENTIFIED PROCESSES Refer Annexure I Page 7 of 32 Rev.:1.0, Dt: March 15, 2018 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) 4.2 DOCUMENTATION REQUIREMENTS 4.2.1 GENERAL The EPATHUSA Quality Management System has been defined in three levels. Level 1 is the EPATHUSA Quality Management System Manual (this document). This Manual documents the company policies and provides the relationship of the organization’s Quality Management System to the requirements of ISO 9001:2015. Level 2 is the Process Manual contains quality system standard operating procedures (SOPs), work instructions / guidelines that may be issued as required. Level 3 is various records used in the system that may be maintained as required. The depth and detail required for the documentation is determined by Management and is dependent upon the complexity and interaction of the processes and the skills and training needed by personnel performing the activity. ISO 9001 Documentation Hierarchy 1ST Level QUALITY MANUAL PROCESS MANUAL 2nd Level (Procedures, guidelines and Forms & Formats) RECORDS Page 8 of 32 3rd Level Rev.:1.0, Dt: March 15, 2018 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) 4.2.2 QUALITY MANUAL EPATHUSA has established and maintains a quality System manual (this manual of which this portion is a part), which includes; • Scope of the quality management system, including details of and justification for any exclusions (see Section-2) • The system procedures for the quality management system as required by ISO 9001:2015. • A description of the interaction between the processes of the quality management system (see chapter 4.1.1) 4.2.3 CONTROL OF DOCUMENTS Management Representative controls the preparation, revision, review, approval and release of the QMS documents. All QMS documents, new and revised are reviewed and approved prior to release. Director authorizes the all level of QMS documents A new version of QMS Documents is released afresh after changes have been identified. MR controls the distribution and issue of QMS documents and ensures that the pertinent versions of the documents are available for use and obsolete documents are withdrawn from copyholders and dispose them as documented in procedure for control of documents Project/ Functional Document and Data Control Project/ Functional documents are reviewed by a designated reviewer and approved by the Functional Heads. The approved documents are released after authorization by the Functional head. Documents are released afresh after a practical number of changes have been made. The nature of changes is identified using a revision list, where practicable. The MR/ Functional heads are responsible for the control, distribution and issue of documents and to ensure that: • The pertinent versions of the documents are available for use • Obsolete documents are withdrawn • The Master List of project documents is available for reference • Document and data changes System Administration Department looks after data security and safety aspects. Backups are taken at regular intervals to provide safety in the event of any untoward incident or calamity. The group ensures access to confidential information, files and directories on the network based on appropriate access authority. MR / Director/ Functional heads decide the permissions for access to all project/ departmental related documents/ data and intimate the N&A group. Reference: QSP for Control of Documents - Process Manual MR Page 9 of 32 Rev.:1.0, Dt: March 15, 2018 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) 4.2.4 CONTROL OF QUALITY RECORDS Quality records established to prove evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled. Project Quality Records are created and maintained by the Solution Delivery Head/TL while the project is in progress. After the completion of the project, SDH maintains the archives of the project records For an ongoing maintenance project, the Technical Leader maintains Quality Records related to maintenance requests for the period specified in “Document & Data Control Process” after acceptance of the completion by the client. Following the completion of all contractual obligations, the organization retains project Quality Records for a minimum period of 1 Year along with all other Project assets before they are disposed off. The MR maintains internal audit plans and records for a period of three years QMS Documents, QMS Review Records are retained till next version released The respective Functional Head maintains Quality Records generated by the functions. The period of retention is specified in the Document “Master List of Quality Records” maintained by the MR. All records should be legible and protected from loss or damage. Access to Project Quality Records during their retention period is granted to the client, if the Contract provides for such access. Reference: QSP for Control of Records - QSP/ EPATHUSA/MR/02 in Process Manual MR Page 10 of 32 Rev.:1.0, Dt: March 15, 2018 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) 5.0. MANAGEMENT RESPONSIBILITY 5.1 MANAGEMENT COMMITMENT Top management has been actively involved in implementing the quality management system (QMS). 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 will do the following. • Communicate the importance of meeting customer, statutory, and regulatory requirements • Establish quality objectives • Establish the quality policy • Conduct periodical management reviews, and • Ensure the availability of resources. 5.2 CUSTOMER FOCUS The organization ensures that customer satisfaction requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1). The Organization focusing on customer by identifying their needs and requirements through customer satisfaction survey reports collected frequently. Currently the organizations identifies customer needs as below based on past experience, ❖ In time delivery ❖ Best Service and Support ❖ Error/ Bug free applications. The customer needs are reviewed frequently, normally in every management review meetings or after periodical meetings with customer by top management. Page 11 of 32 Rev.:1.0, Dt: March 15, 2018 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) 5.3 QUALITY POLICY EPATHUSA management has established the following quality policy, ensuring that it provides a framework for establishing and reviewing quality objectives. Vision: To be the most reliable outsourcing partner in the world Mission: To help customers in effectively outsourcing their services to India by making deliveries on time, within budget, exceeding quality goals and totally customized to the IT & Business requirements of our customers Quality Policy: To be competitive and flexible in providing services by continually striving to exceed customer expectations Objectives: ✓ Meet and exceed customer expectations ✓ Continuously develop the competence of the associates ✓ Continuously measure process performance and initiate improvements ✓ Deliver services on time & with in budget ✓ Ensuring and enhancing customer satisfaction Rev.: 1.0 Date: March 21, 2018 Director EPATHUSA EPATHUSA management ensures that the quality policy is communicated and understood by all employees and that the policy is implemented throughout the company. Quality Policy is communicated to employees through the New Employee Orientation Program, the Quality Management System Manual and posters located throughout the organization premises. The Quality Policy is reviewed for continued suitability at Management Review Meetings. Page 12 of 32 Rev.:1.0, Dt: March 15, 2018 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) 5.4 PLANNING 5.4.1 QUALITY OBJECTIVES The organization ensures that quality objectives, including those needed to meet requirements for [see 7.1], are established at relevant functions and levels within the organization. The quality objectives are required to be measurable and consistent with the quality policy. The management review committee or the Director will identifies relevant functions and levels and establish measurable objectives for them within the overall framework of the quality policy. Refer: Quality Objectives Annexure IV 5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING Organization ensures that • Planning of Quality Management System is carried out in order to meet the requirements given in 4.1 as well as the quality objectives. • The integrity of quality management system is maintained when changes to the QMS are planned and implemented • Quality planning within EPATHUSA is an integral part of several Quality Procedures culminating in establishing the Quality Objectives. • Data presented in management review meetings is used to provide input for quality planning and continual improvement. Quality planning may include o Quality objectives o The process of the quality management system o The resources needed o Continual improvement of the system Reference: QSP for Management Review (QSP/ EPATHUSA/MR/03) Given in Process Manual - MR QSP for Corrective and Preventive Action – QSP/ EPATHUSA/MR/05 Given in Process Manual - MR Page 13 of 32 Rev.:1.0, Dt: March 15, 2018 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) 5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION 5.5.1 RESPONSIBILITY AND AUTHORITY The organization has defined the responsibilities, authorities and their interrelationship in this QSM and communicated the same within the organization through this manual. S S S S S S Define Quality Policy & Objectives 5.3, 5.4.1 P P S S S S S S 5.5.1 P 5.5.2 P 5.5.3 S P S S S S S S Management Review 5.6 P P S S S S S S Provision of resources 6.1 P S 6.2.2 S P Infrastructure 6.3 S S Work Environment 6.4 P P S Customer Related Process 7.2 S S P Design and Development 7.3 Purchasing 7.4 Control of Production and Service 75.1 Process Validation 7.5.2 Product Identification and Traceability 7.5.3 P S Handling & Customer Property 7.5.4 P S Responsibility Assignment Nomination of the representative Internal Communication Management Competence, training and awareness Handling, Storage and Preservation of Product / Goods Instrument Calibration Admin P S S P S Excluded From The System 7.5.5 S P 7.6 P Excluded From The System Internal Audit 8.2.2 Measurement of Process 8.2.3 Measurement of Product 8.2.4 S P Control of non conforming product 8.3 S P P Data Analysis 8.4 P P P P P 8.5.2, 8.5.3 P P P P P Page 14 of 32 S P 8.2.1 P: Primary S S P Customer Satisfaction Corrective and Preventive action HR P N& A S QA 4.2.3, 4.2.4 BD Control of documents and Records MR ISO Cl Ref. No Top Mgmt INTER RELATIONSHIP MATRIX Description Projects Organization chart and roles & responsibilities refer annexure II S P S P P P P P P P P P P P P P P P S: Support Rev.:1.0, Dt: March 15, 2018 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) 5.5.2 MANAGEMENT REPRESENTATIVE (She is authorized to nominate officers to assist him in this job from amongst the officers of the company. These appointees shall carry out the assigned responsibilities under his direction and guidance) Sayed Naved is hereby appointed as the Management Representative for the quality management system covered under this manual and its associated documents. The authority and responsibility of the MR is defined in the Responsibility & Authority section (See sec. 5.5.1 of this QSM). The duties of MR can be summarized under the following statements of responsibility: • Ensuring that processes needed for the quality management system are established, implemented and maintained • Reporting to top management on the performance of the quality management system and any need for improvement • Ensuring the promotion of awareness of customer requirements throughout the organization. • Interacting with external parties (certification body and the consultant) on matters relating to quality management system. 5.5.3 INTERNAL COMMUNICATION The organization has ensured that appropriate communication processes have been established within the organization and that communication takes place regarding the effectiveness of quality management system (Refer Table given below). There are other communication forums and means available like internal mailing, various management meetings, team briefings and use of circulars, notice board etc. HR N& A Admin QA BD Projects MR Information to communicate Top Mgmt COMMUNICATION MATRIX Internal Audit Plan and Schedule A O I I I I I MRM Minutes A O I I I I I I Customer Complaints I NR I O D NR NR NR Training Intimation A A O I I I I O Project Conformation A NR D O I NR I NR Project Planning A NR OD I I NR I NR A - Approved Page 15 of 32 O – Origin D – Destination I- Information NR – Not Required Rev.:1.0, Dt: March 15, 2018 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) 5.6 MANAGEMENT REVIEW 5.6.1 MANAGEMENT REVIEW MEETINGS Management review meetings are conducted at least once in every 6 months at the end of each internal audit, or more frequently when required by the Director involving all functional heads responsible for quality management to ensure the continuing suitability, adequacy and effectiveness of the quality management system. The main purpose of conducting the reviews of the quality management system is to assess opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Records of management review are maintained. 5.6.2 REVIEW INPUT (Agenda) • Follow-up actions from previous management reviews. • Results of internal/external audits. • Customer feedback (including grievances/complaints) • Performance of Suppliers • Process performance and conformity • Status of corrective and preventive actions • Changes that could affect the quality management system, and • Recommendations for improvement. • Any other agenda with the consent of the Director / Participants • Resource Needs • Quality Policy Suitability • Quality Objective Analysis • Trainings Records Note: Meeting points discussed in periodic other meetings (such as performance review and Team meetings conducted by Director are considered as having been discussed in the MR. Meeting. The records of such meeting are considered part of the management review records. 5.6.3 REVIEW OUTPUT The output from the management review and other meetings, which is recorded as minutes, includes any decisions and actions related to; • Improvement of the effectiveness of the quality management system and it’s processes, • Improvement of related to customer requirements, and • Resource needs. • Training Needs Reference: QSP for Management Review (QSP/ EPATHUSA/MR/03) in Process Manual MR QSP for Corrective and Preventive Action (QSP/ EPATHUSA/MR/05) in Process Manual MR Page 16 of 32 Rev.:1.0, Dt: March 15, 2018 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) 6.0. RESOURCE MANAGEMENT 6.1 PROVISION OF RESOURCES The organization has determined and provided the resources, which includes people, infrastructure, work environment, information, suppliers, material and financial resources needed for implementing and maintaining the quality management system and continually improve its effectiveness and enhancing customer satisfaction by meeting customer requirements. 6.2 HUMAN RESOURCES 6.2.1 GENERAL All employees, including members of management, performing work that affects the quality of any service related to the organizations are hired on the basis of appropriate education, training, skills and experience. Appropriate procedures have been established for the recruitment of permanent and temporary staff. Verification of candidate qualifications and/or experience normally precedes confirmation of an appointment. Staff orientation, appraisal, training and development are carried out and recorded in accordance with documented procedures to ensure that the Organization: • Employs staff with relevant qualifications and experience; • Enhances and up-dates the skills of its staff; 6.2.2 COMPETENCE, TRAINING AND AWARENESS a) Determine the necessary competence for personnel performing work affecting conformity to product requirements b) Provide training or take other action to achieve the necessary competence. The Head HR with the help of other respective department heads, Determines the necessary competence for personnel performing work affecting product quality, • Provides training or take other actions to satisfy these needs, • Ensures effectiveness of the action taken • Ensures that its personnel are aware of the operation and importance of their activities and how they contribute to the achievement of quality objectives, and • Maintains appropriate records of education, training skills and experience. Reference: Reference: Process Manual – Human Resources 6.3 INFRASTRUCTURE The organization has determined, provided and maintains the infrastructure needed to achieve conformity to product requirements. This includes: a) Buildings, work space and associated utilities, b) Process equipment (both hardware and software), and c) Supporting services such as transport, communication or information systems (EPBX, PHONES etc). Reference: Reference: Process Manual – Network & Administration 6.4 WORK ENVIRONMENT The human and physical factors of the work environment needed to achieving conformity to product requirements are determined and managed. Consideration of such factors includes health and safety conditions, work methods, handling methods, and ambient working conditions and other factors (such as noise, temperature, and humidity, lighting or weather). These considerations are also reviewed during Management Review Meetings Page 17 of 32 Rev.:1.0, Dt: March 15, 2018 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) 7.0. PRODUCT REALIZATION 7.1 PLANNING OF REALIZATION The planning for realization is accomplished by implementing quality standards during contract review, purchasing, project Development, testing and delivery in accordance with established procedures and guidelines These activities include the following to achieve the required level of quality: • Determining Quality objectives • Review/acceptance criteria for customer orders, tender submittals and contracts, • The need to establish processes and documents and to provide resources specific to product • Required verification, validation, monitoring, measurement inspection and test activities specific to the product and the criteria for product acceptance • Identification, control, and calibration of process and test equipment, • Establishment of product identification and traceability, • Identification of handling, storage, packaging and shipping requirements, • Assignment and training of qualified personnel, and • Identification and preparation of quality records. The quality management system documented in this QSM and referred documents represent the Quality Plan for realization of the service presently provided by the organization. Important processes of this plan have been listed in chapter 4 of this manual and described in this manual or it’s associated documents appropriately. As and when new activities or services are added, either this documentation shall be updated, or specific quality plan shall be prepared specifying the processes and the resources to be applied if the present documentation is not found sufficient to that end. References: (Following documents represent output of the planning for the current activities) • This QSM of which this chapter is a part • Quality System Procedures & Guidelines • Quality Records 7.2 CUSTOMER RELATED PROCESSES 7.2.1 DETERMINATION OF THE REQUIREMENTS RELATED TO THE PRODUCT All enquiry / order received, or lead generated by BD personnel; they meet MD to determine the requirements specified by the customer In this meeting the following points are taken as input, • Requirements specified by the customer, including the requirements of delivery and post-delivery activities include, for example, action under warranty provisions, contractual obligations such maintenance services, and supplementary services as recycling or final disposal, • Requirements not stated by the customer but necessary for specified use or known intended use (from past experience with the customers), • Statutory and regulatory requirements applicable to the product (from governmental requirements and applicable Standards), and • Any additional requirements considered necessary by the organization. Page 18 of 32 Rev.:1.0, Dt: March 15, 2018 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) 7.2.2 REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT The Organization reviews the requirements related to projects and service before submitting the proposal or accepting the order or changes or amendments to the orders. The MD / SDH reviews the requirements to ensure that: • Project requirements / deliverables are clearly defined, • Contract or order requirements differing from those previously expressed are resolved, and • The organization has the ability to meet defined requirements. Changes to product requirements have to be in writing and the same shall be communicated to concern departmental heads 7.2.3 CUSTOMER COMMUNICATION The Director / Business Development Personnel / Projects Team communicate with the customer organization regarding; a) Enquiries, contracts or order handling, including amendments, and b) Clarifications regarding project during development c) Customer feedback including customer complaints Refer: Reference: Process Manual – Business Development 7.3 DESIGN AND DEVELOPMENT PLANNING 7.3.1 DESIGN AND DEVELOPMENT PLANNING Once project confirmation received from business development, project team prepares project planning in which detailed scheduling is done for design and development Project Manager in consulting with SDH identifies the team. In the course of addressing technical, logistical/managerial and financial concerns that impact project design-process activities, the organization consistently exercises its organizational interfaces. 7.3.2 DESIGN AND DEVELOPMENT INPUT The design input is collected from the specification provided by client or from the output of the study made by the Project Team. The Software Requirement Specification (SRS) is prepared which is reviewed and approved by the SDH. SRS forms the basis for the subsequent design and construction phases. The SDH effects any changes to approved SRS, only after due impact analysis is done and approval of the changes. 7.3.3 DESIGN AND DEVELOPMENT OUTPUT Organization captures design-output data in design review minutes and customer reviews, as needed. These reviews are performed specifically to verify that design-output meets or exceeds design-input requirements. The design document is prepared by Project Leader (PL) in which design output, pseudo code is documented. Design document is approved by SDH and same is forwarded to customer for review revision history is maintained for any changes made after approval. Page 19 of 32 Rev.:1.0, Dt: March 15, 2018 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) 7.3.4 DESIGN AND DEVELOPMENT REVIEW Design document is reviewed by customer. During periodical review meetings SDH reviews the project status to conform whether the output is meeting the design requirements Follow up actions are identified and initiated against the review output and the action plan is communicated to team members by internal email/Team meetings. Records of these reviews are maintained by team leader 7.3.5 DESIGN AND DEVELOPMENT VERIFICATION Design is verified during testing of project by QA team, test reports are prepared and if any failed cases found the same shall be handled by project team. Test reports / bug reports are reviewed by SDH Periodically to ensure that bugs are handled properly. 7.3.6 DESIGN AND DEVELOPMENT VALIDATION Testing the project as per test plan prepared during project management plan validates design. Testing team tests the project thoroughly and raises the failed cases in design and performance of the project. Design and development team handles the errors raised by test team. Until testing team gives clearance the project is not delivered to customer. 7.3.7 CONTROL OF DESIGN AND DEVELOPMENT CHANGES All design changes either initiated by organization or requested by the customer are reviewed and implemented. The review of design changes includes evaluation of the changes on project performance and function. The SDH is authorized to approve the design changes. Reference: QSP Project Execution (QSP/ EPATHUSA/PR/02) in Process Manual PROJECTS 7.4 PURCHASING 7.4.1 PURCHASING PROCESS Organization’s purchasing processes are defined and controlled. Admin department makes efforts to obtain high quality systems or peripherals on time by ensuring that the required technical specifications defined in the purchasing documents provided to suppliers. All suppliers are evaluated periodically for their ability to deliver quality products on a time. Suppliers who cannot meet the contractual requirements for quality and delivery may be removed from the Approved Suppliers List. Records of the results of evaluation and subsequent action arising from such evaluation shall be maintained. 7.4.2 PURCHASING INFORMATION Purchasing information describes that are to be purchased, including where appropriate; • Requirement for approval of product, procedures, processes and • Quality management system requirements The organization ensures the adequacy of specified requirements prior to their communication to the supplier. Page 20 of 32 Rev.:1.0, Dt: March 15, 2018 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) 7.4.3 VERIFICATION OF THE PURCHASED PRODUCT The inspection and other activities to ensure that the purchased product meets specified technical requirements are carried out. Where applicable, the verification is done at supplier’s premises by the organization which is intimated to the supplier in the purchasing information along with the method of release. Reference: Process Manual –Purchase 7.5 PRODUCTION AND SERVICE PROVISION 7.5.1 CONTROL OF PRODUCTION & SERVICE PROVISION The Organization plans and executes the activities under controlled conditions. These conditions include, as applicable or necessary: • Information describing requirements of the project • Guidelines and templates where necessary • Reviewing the project status periodically • Evaluating competence of the team and provide trainings for skill up gradation • Preparing Test plan and testing the project as per plan • Release, delivery and post delivery activities Reference: Process Manual – Projects 7.5.2 VALIDATION OF PROCESS FOR PRODUCTION & SERVICE PROVISION This clause is excluded from system. Refer section 2.4 for details 7.5.3 IDENTIFICATION AND TRACEABILITY The organization shall identify the product status with respect to monitoring and measuring requirements throughout product realization. Where traceability is a requirement, the organization shall control the unique identification of the product and maintain records (see 4.2.4) Identification of Assets (Computers, Network Components, ACs etc) Each equipment in the organization is identified with unique number and same is dEPATHUSAayed on the asset / equipment Project Codification Once the contract is signed or order received from customer, SDH allocates project code to the project and the same code is used in all relevant records. This project code is referred in all correspondences with customer regarding this project as well in internal communications and mails The following format is used to codify the each project AAAA-BBB-CCC-MON-YY AAAA- Customer Short Name BBB- Project Number CCC- Project Short Name MON-Month YY- Year Page 21 of 32 Rev.:1.0, Dt: March 15, 2018 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) 7.5.4 CUSTOMER PROPERTY Customer supplied products (Could be Hardware, Software, Tools, Documents and intellectual property if any) are inspected for suitability and functionality by the SDH/ Project Manager before use and those found unsuitable for use are recorded and reported to the client for suitable action. The SDH maintains the records of all customer-supplied products being used in the project. On completion of the project, client-supplied products are returned to the client or disposed of as mutually agreed upon. 7.5.5 PRESERVATION OF PRODUCT The process for handling, packaging, storage, preservation and delivery have been established and maintained to prevent damage, deterioration or unintended use during internal processing and delivery of product. Hardware Peripherals Hardware peripherals are stored in identified locations and controlled by administration department. Original Software CDs Original software such as operating systems and other languages are maintained and controlled by SDH / N&A team. The CDs are properly labeled for easy identification and stored in secured racks and while deciding storage location it is ensured that the location is waterproof and shock proof etc. List of software available is maintained by N&A personnel for information Project Backups N&A personnel control the project backup CDs with proper labeling. Director / SDH takes decision to dispose the OLD backup CDs. Once in a month the full project backup is taken and the CD is stored in safe place to protect the data from any damage Reference: Process Manual – Network & Administration Process Manual – Project Execution 7.6 CONTROLLING OF MEASURING & MONITORING EQUIPMENTS This clause is excluded from QMS. Ref Sec 2.4 for Details Page 22 of 32 Rev.:1.0, Dt: March 15, 2018 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) 8.0. MEASUREMENT, ANALYSIS AND IMPROVEMENT 8.1 GENERAL The organization plans and implements the monitoring, measurement, analysis and improvement processes needed; • To demonstrate the conformity of the product, • To ensure conformity of the quality management system, and • To continually improve the effectiveness of the quality management system. This includes determination of applicable methods including statistical techniques and 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, the organization monitors information relating to customer perception as to whether the organization has fulfilled customer requirements. Once in 3 months/after completion of project Customer Satisfaction Survey (CSS) report is received, SDH analyze the rating given by client. If rating is below satisfaction level, the issue is discussed in management review meeting and corrective actions are initiated. Reference. : Process Manual – Business Development 8.2.2 INTERNAL AUDIT The organization conducts internal audits once in 6 months to determine whether the quality management system; a) b) Conforms to the planned arrangements, to the requirements of this International standard and to the quality management system requirements established by the organization, and Is effectively implemented and maintained. An audit program is planned, taking into consideration the status and importance of the processes and areas to be audited, as well as results of previous audits. The audit criteria, scope, frequency and methods are defined. Selection of auditors and conduct of audits ensures objectivity and impartiality of the audit process. Auditors do not audit their own work. The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records are defined in a documented procedure. The management responsible for the area being audited ensures that actions are taken without unjustified delay to eliminate detected nonconformities and their causes. Follow-up activities include the verification of the actions taken and the reporting of verification results. Reference: QSP for Internal Audit QSP/ EPATHUSA/MR/04 in Process Manual -MR Page 23 of 32 Rev.:1.0, Dt: March 15, 2018 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) 8.2.3 MONITORING AND MEASUREMENT OF PROCESSES The organization has applied suitable methods for monitoring, and where applicable, measurement of 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 actions are taken, as appropriate to ensure conformity of the product. Following Quality management system processes have been identified for monitoring and measurement as appropriate: o Customer Satisfaction o Internal Audit of Quality Management System o Project Analysis o Supplier Performance o Process Measurements as given in individual department process maps 8.2.4 MONITORING AND MEASUREMENT OF PRODUCT The organization’s quality assurance team (testing team) test the project before delivery to client or intermediate stages of development based on test plan prepared while design planning. The QA team gives the detailed report on project and design and development team handle the bugs and again re-build is submitted to testing team for final conformation. Product/ project is not released for delivery or further processing until all planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority, and where applicable, by the customer. 8.3 CONTROL OF NONCONFORMING PRODUCT Non-conformance reported in products / projects is documented. The software items that are impacted by the non-conformances are identified. If required, persons using the product are notified. The impact of the non-conformances is evaluated. If required, access to the non-conforming software items is restricted and they are prevented from further use. The non-conforming product is disposed of, in one of the following wayso Reworking and correcting the defect o Deferring it to a further release o Obtaining a concession from the client or as provided in the contract o Rejecting the existing product and redeveloping it afresh a) By taking action to eliminate the detected nonconformity, b) By authorizing its use, release or acceptance under concession by appropriate authority and, when applicable, by the customer, c)By taking action to preclude its original intended use or application. Non-conformity with QMS/ Project Management Plans Non-conformities are raised during Internal Audits, Surprise Audits, and External Audits or on occurrence of difference in the QMS processes and implementation. The SDH/Project Manager where the non-conformity Report (NCR) is raised identifies the corrective and preventive action. MR tracks to closure all NCR's raised and ensures effective implementation of corrective and preventive actions agreed. The NCR trends and analysis is presented in the Management Review meeting for review and organization level action required if any. Page 24 of 32 Rev.:1.0, Dt: March 15, 2018 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) Reference: QSP for Purchase QSP for Network & System Administration QSP for Testing 8.4 ANALYSIS OF DATA The organization 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. This includes data generated as a result of monitoring and measurement and from other relevant sources. The analysis of data provides information relating to; • Customer satisfaction,(see 8.2.1) • Conformance to requirements, (see 8.2.4) • Characteristics and trends of processes and products including opportunities for preventive actions, and Against Process Measurements given in Annexure II, the trends are prepared either in tabular or graphical format periodically, preferably before each round of Internal Audit and HoDs submit the data in MRM for review Internal Audits Internal Audit Summary Reports is prepared by MR after each round of Internal Audit and submits in Management Review. Supplier performance (7.4) Reference: QSP for Management Review (QSP/ EPATHUSA/MR/03) in Process Manual MR QSP for Corrective and Preventive Action (QSP/ EPATHUSA/MR/05) in Process Manual MR 8.5 IMPROVEMENT 8.5.1 CONTINUAL IMPROVEMENT The organization continually improves the effectiveness of the quality management system through the use of quality policy, quality objectives, and audit results, analysis of data, corrective and preventive actions and management review. 8.5.2 CORRECTIVE ACTION The organization takes corrective actions to eliminate the cause of nonconformities in order to prevent recurrence. Corrective actions taken are appropriate to the effects of nonconformities encountered. A documented procedure has been established to define requirements for; a. Reviewing nonconformities (including customer complaints) b. Determining cause of nonconformities, c. Evaluating the need for action to ensure that nonconformities do not recur, d. Determining and implementing action needed, e. Records of the actions taken (see 4.2.4), and f. Review of the effectiveness corrective actions taken Reference: QSP for Corrective & Preventive Action (QSP/ EPATHUSA/MR/05) in Process Manual MR Page 25 of 32 Rev.:1.0, Dt: March 15, 2018 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) 8.5.3 PREVENTIVE ACTION The organization determines action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions taken are appropriate to the effects of potential problems. A documented procedure has been established to define 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. Records of results of actions taken (see 4.2.4), and e. Review of the effectiveness preventive actions taken Reference: QSP for Corrective & Preventive Action (QSP/ EPATHUSA/MR/05) in Process Manual MR Page 26 of 32 Rev.:1.0, Dt: March 15, 2018 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) ANNEXURE I - SEQUENCE AND INTERACTION OF PROCESS CUSTOMER REQUIREMENT MANAGEMENT RESPONSIBILITY(Management Review) RESOURCE MANAGEMENT PRODUCT REALIZATION Business Development Purchase Project management Contract Review, Complaints Handling & Collecting Feedback Testing Network Administration Review Customer Requirements and project planning Purchasing Against Indents from N & A and Projects depts. Project Execution (Coding, Database Design and Unit Testing) HR Recruitment Testing by manual testing Network Support & Systems Maintenance Training Delivery / Uploading MEASUREMENT, ANALYSIS AND IMPROVEMENT Review PPI Review PPI and Supp Performance Review PPI Review PPI Review PPI Review PPI and Training Effectiveness INTERNAL AUDIT CORRECTIVE AND PREVENTIVE ACTION Page 27 of 32 Rev.:1.0, Dt: March 15, 2018 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) ANNEXURE – II ORGANIZATION CHART Page 28 of 32 Rev.:1.0, Dt: March 15, 2018 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) Responsibilities & Authorities Page 29 of 32 Rev.:1.0, Dt: March 15, 2018 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) ANNEXURE – III REFERENCES Sl. No Document Name Document Number 1. QSP for Control of Documents QSP/EPATHUSA/MR/01 2. QSP for Control of Records QSP/EPATHUSA/MR/02 3. QSP for Management Review QSP/EPATHUSA/MR/03 4. Process Manual – HR (QSP for HR) QSP/EPATHUSA/HR/01 5. Process Manual – Business Development QSP/EPATHUSA/BD/01 6. Process Manual – Purchase (QSP for Purchase) QSP/EPATHUSA/PUR/01 7. Process Manual – Projects NA 8. Process Manual – Network & Administration(QSP for QSP/EPATHUSA/N&A/01 Network &System Administration) 9. QSP for Internal Audit QSP/EPATHUSA/MR/04 10. QSP for Corrective & Preventive Action QSP/EPATHUSA/MR/05 Page 30 of 32 Rev.:1.0, Dt: March 15, 2018 QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) ANNEXURE IV - QUALITY OBJECTIVES Organizational Objectives OBJECTIVE GOAL TIME FRAME RECORDS TO REFER Customer satisfaction 90% 1 Year Customer complaints Nil 1Year Delivery schedule adhence 80% 1Year Customer satisfaction Survey reports Customer complaints register reports Daily work report Departmental Objectives Marketing OBJECTIVE GOAL TIME FRAME RECORDS TO REFER Customer satisfaction 90% 1 Year Number of customer to be added 5 1 Year Customer satisfaction Survey reports Customer list Production OBJECTIVE GOAL TIME FRAME RECORDS TO REFER Delivery schedule adhence 80% 1Year Daily work report Maintenance OBJECTIVE GOAL TIME FRAME RECORDS TO REFER Break down Hour 2% of total working hours 1Year Break down register HR OBJECTIVE GOAL TIME FRAME RECORDS TO REFER To Provide trainings to employees At least 4 Hours Qtr for each staff member 6 months Training register MR OBJECTIVE GOAL TIME FRAME RECORDS TO REFER Number of Repeated (Same Nature) NC to be minimized Number of NCs on Document control in external / internal audits – Max 1 1Year Internal audit report 1Year Internal audit report New technology Internal Audit Effectiveness Document Control Effectiveness Page 31 of 32 Rev.:1.0, Dt: March 15, 2018
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