Process Manual MR
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EPATHUSA PROCESS MANUAL - MR Issue No: 01 Date: September 15, 2017 Revision/Version: 1.0 Date: September 15, 2017 Approval Details Designation Prepared By Issued & Controlled By Approved By Process expert team Hari Anitha Copy Holders / File Access Authority Copy No Designation 1 Management Representative (Master Copy) 2 Director 3 Solution Delivery Head 4 Network & System Administrator 5 Manager – HR 6 Manager – Purchase Process Manual - MR CONTENTS Sl. No 1 2 3 4 5 6 7 8 Procedure Name DOC No 0 Version Status 1 2 3 4 5 QUALITY SYSTEM PROCEDURES QSP for Control of Documents QSP/EPATHUSA/MR/ • 01 QSP for Control of Records QSP/EPATHUSA/MR0 • 2 QSP for Management Review QSP/EPATHUSA/MR/ • 03 QSP for Internal Audit QSP/EPATHUSA/MR/ • 04 QSP for Corrective & Preventive QSP/EPATHUSA/MR/ • Action 05 DOCUMENTS Master List of Documents -Internal DOC/EPATHUSA/MR/ • 01 Master List Of Documents – External DOC/EPATHUSA/MR/ • 02 Master List Of Records DOC/EPATHUSA/MR/ • 03 9 Document Change Request 10 Document Issue Register 11 12 13 14 File Label File Index Management Review Meeting Minutes Internal Audit Plan 15 Internal Audit Schedule 16 Internal Audit Check List 17 Audit Non-Conformity Report 18 Internal Audit Summary Report 19 Corrective and Preventive Action Report FORMATS QF/EPATHUSA/MR/0 1 QF/EPATHUSA/MR/0 2 NA NA QF/EPATHUSA/MR/0 3 QF/EPATHUSA/MR/0 4 QF/EPATHUSA/MR/0 5 QF/EPATHUSA/MR/0 6 QF/EPATHUSA/MR/0 7 QF/EPATHUSA/MR/0 8 QF/EPATHUSA/MR/0 9 Page 2 of 16 • • • • • • • • • • • Rev.:00,Dt.: Process Manual - MR REVISION HISTORY DCR No ❖ ❖ Date Nature of Change Brief Reason for Change Page / Section Where Changes Made New Revision No Definitions and Acronyms ACRONYM/ TERM DEFINITION/ DESCRIPTION MR Management Representative MD Director QSM Quality System Manual QSP Quality System Procedure QF Quality Format IA Internal Audit MRM Management Review Meeting NCR Non Conformity Report CAPA Corrective Action & Preventive Action Activity / Responsibility Matrix NO 01 02 03 04 ACTIVITY Document Changes Internal Audit Plan & Scheduling Conducting MRM Closing of NCRs MD I R MR R R I R R – Responsible; I - Involved Page 3 of 16 Rev.:00,Dt.: QSP for Control of Documents ❖ Purpose To control all documents and data to ensure their availability of pertinent issues, at removal of obsolete documents, from all locations ❖ Scope This procedure covers all internal & external documents. Internal Documents 1st Level: Quality System Manual (QSM) 2nd Level: Process Manual 3rd Level: Records External Documents a) Information Technology Act b) STPI Guidelines c) Requirements from Clients d) Client Information or Data e) Reference Documents or User Manuals used in project execution f) ISO 9001:2008 ❖ Responsibility Management Representative (MR) is responsible to ensure that this procedure is implemented & maintained ❖ Action & Method ➢ Identification Document Name Quality System Manual &Process Manual depts. Identification Version Indicator By Unique No in On each page (QSM/EPATHUSA/SL NO) after 15 Revisions format Issue no is incremented and Revision is set to ZERO Quality System By Unique No in On Each page Procedures (QSP/EPATHUSA/DEPT/SL NO) format Documents/ Work By Unique No in On Each page Instructions / Guide (DOC/EPATHUSA/DEPT/SL lines NO/ Rev no) format Forms / Templates By Unique No in By Effective Date (QF/EPATHUSA/DEPT/SL given in Master List of NO/Rev No) format Records External Identified by document owner Identified with number Documents given no/ name given by authority and organization ensures latest revision is under usage Page 4 of 16 Issue No On cover page of the manual, after 15 revisions in any one page of manual issue no is incremented by one number Not Applicable Not Applicable Not Applicable NA Rev.:00,Dt.: Approval & Issue Document Name Quality System Manual Process Manual Project Documents Forms / Templates Approved By Director Director Director Director Issued & Controlled By Management Representative Management Representative Management Representative Management Representative *** Besides above rules, respective approving authority can authorize in writing any position / executive of the organization to approve any document ➢ Control and Issue of Documents Documents are maintained and controlled in 2 ways i.e. one is by Soft copy and second is Hard copy (Optional) Soft Copy Control • All approved documents are placed in a server with a folder name EPATHUSA QMS. • As per given list of copyholders on cover page of each document, the system admin personals are configured the folder for access. • Except MR, all the copyholders are allowed to access the document in read only format • Documents available in EPATHUSA QMS folder are only valid and this procedure is applicable. Hard Copy Control • All approved documents shall be stamped as “MASTER COPY’ (normally in Blue Color) on the back side of each page. • Copied are allowed only from Master Copy and the same copies are issued as per distribution list given in manuals or as per requirement and stamped as “CONTROLLED COPY” in Red on the front side each page • Document Issue Register is maintained for Hard copy issues ➢ Document and Data Change Any Department Head can request for a change in Document through Document Change Request (DCR) – QF/EPATHUSA/MR/01 and it can be forwarded to MR by email or hard copy Once DCR is received, MR reviews the request and ensures that changes are not affecting integrity of quality management system. Take approval from approving authority of respective document (Refer Approval & Issue table) Once DCR is approved, Change the respective document as requested and update version number & effective date of respective document. Method of Version number increment Quality System Manual Version number is changed only of respective page in which changes are made Documents in Process Manual Version number of all pages in entire document will be changed even if changes are made in one page Also update the version status and effective date of document in other relevant documents where the modified document is referred. Ex.: Master List of Documents, Master List of Records etc. For Soft Copies, latest version documents shall be placed in the QMSDOC folder and old version documents are moved to Obsolete Documents folder. Page 5 of 16 Rev.:00,Dt.: For Hard Copies, Issue the modified document to all copy holders through Document Issue Register (QF/EPATHUSA/MR/01) and take back the old copies and file them in obsolete documents file after stamping as “OBSOLETE DOCUMENT” in Red ➢ External Documents MR identifies specific documents of external origin and maintains a list in Master List of External Documents (DOC/EPATHUSA/MR/02) identifying version/release or issue date/period information and issue records if more than one copy of the same document is in circulation. Solution Delivery Head (SDH) is the custodian of External documents MR controls the distribution and applicable version information to ensure that updates when available can be circulated to all points of use. ➢ Obsolete Documents To prevent the unintended use of obsolete documents, MR / Approving Authority collects the obsolete documents from copyholders and dispose them as per disposal action given in table below. Document Name Disposal Action for Controlled Copy Quality System Manual Destroy by Tear off or by fire Quality System Procedures Destroy by Tear off or by fire Or can retain as SUPERCEEDED COPY Destroy by Tear off or by fire Or can retain as SUPERCEEDED COPY Destroy by Tear off or by Burning Work Instructions / Guide lines/ Specifications Forms / Templates ❖ Retention Time of Master Copy One Year One Year One Year One Year References Nil ❖ ❖ Documents - Master List of Documents - Internal – DOC/EPATHUSA/MR/01 - Master List of Documents - External– DOC/EPATHUSA/MR/02 Formats and Records - Document Change Request – QF/EPATHUSA/MR/01 - Document Issue Register – QF/EPATHUSA/MR/02 Page 6 of 16 Rev.:00,Dt.: QSP for Control of Records ❖ Purpose To control quality records in order to demonstrate conformance to specified requirement and effective operation of quality management system ❖ Scope This procedure covers the records relating to quality management system. ❖ Responsibility Management Representative and all HoDs are responsible to ensure that this procedure is implemented & maintained ❖ Action & Method Quality records essential for the operation of quality system have been identified and listed in various procedures. The record formats are given unique identification code called form number All Quality records are controlled in two ways, i.e. soft copy and hard copy (if any record maintained in hard copy mode then soft copy of that record holds no value) Procedure for Soft copy control Identification, Storage, Protection and Retrieval Directory structure along with naming conventions is the methodology used for identification of individual components/ files. The directory folder names and organisation of folders is left to the discretion of the Function Heads with the condition that any file can be retrieved at any point of time without delay. The directory structure should specify RW, RO permissions and to whom it is made access. Access is restricted in the directory where such records are maintained. Completeness of Records All the sections of the records are to be completed in all respects and legible. In case of a section not applicable, the same is to be indicated as “Not applicable”. Procedure for Hard copy control All files (except floppies/CDs’s) have a label in prescribed format, which shows identification (by name and file number), retention period and storage location. The identification as on the labels can be checked with the file List Register Storage & Protection The files are stored in closets after use (filing cabinets, steel/wooden almirhas, side racks, table drawers’ etc.) The closets are located in dry place and preserved from damaging influences such as termites, dust or excessive heat. This is usually verified during internal audits. Retrieval Access to hard file location is through file list, which identifies location. From storage location the file can be retrieved quickly through a system of storage location numbering. The ease of access is practically verified during audits. Page 7 of 16 Rev.:00,Dt.: Retention Period & Disposition The period from the “time of creation” to moving a document/ quality record to “time of archival” status is known as “retention period till Archival”. All the documents/ Quality records are to be maintained till the Project closure and subsequently will be archived. The retention period of the records (soft copy or hard copy) vary and depends mostly on the type, period of the project, legal requirements (if any) and any contractual requirements with the customer or internal policy requirements. The suggested minimum retention period after archival for all the documents/ records is for a minimum period of 6 months. The archived documents/ records are retained for the specified minimum retention period and later Functional heads may suitably decides either to retain them or dispose / (destroy) them depending on the need/contractual obligation. Each project documents the retention period is maintained as mentioned in the respective Master List or List of Records. (DOC/EPATHUSA/MR/03) Disposition After the retention period is over, MD / SDH / HoD take decision for disposal of the record files. Pending such decisions the files are stored in archives. ❖ References Nil ❖ Documents ❖ Master List of Records – DOC/EPATHUSA/MR/03 Formats and Records - File Labels Files List in each department Page 8 of 16 Rev.:00,Dt.: QSP for Management Review ❖ Purpose To Review the implementation and effectiveness of QMS in regular intervals by top management ❖ Scope This procedure covers all the activities covered under quality management system ❖ Responsibility MR is responsible to plan and organize the management review meeting and maintain the minutes ❖ Action Method Process Flow Diagram • Agenda Points as per Section 5.6.2 of QSM Input (QSM/ ePATHUSA/01) Resource Needs Suitability of Quality Policy Quality Objectives Analysis Process Trend Analysis • • • • Process / Sub Process MR arranges MRM once in 6 months, and MD conducts meeting in accordance with 5.6.2 of QSM and review all agenda points, resource needs, quality policy suitability and current data trend analysis submitted by HODs • • • Monitor MRM minutes Output Quality System Implementation & Maintenance o o o o o All Agenda Points Covered Resource Needs Reviewed Action Plan Prepared and Responsibilities allotted Suggested corrective / preventive action points Management Decisions Resource Allocations New / Renewed Quality Objectives MRM Minutes Corrective & Preventive Action Page 9 of 16 Rev.:00,Dt.: ❖ Process Description ➢ Frequency Management review meeting will be carryout once in 6 months (normally after each round of internal audit) or more frequently as required by the Director ➢ Intimation MR communicates to all the department heads about meeting date and time through Inter Office Memo or by internal mail along with agenda points at least 3-4 days before the planned date. ➢ Conducting Meeting Director chairs the meeting and conduct meeting as per input / agenda given below. ➢ Participants • MR • Manager Business Development • Solution Delivery Head • System Administrator • Manager - HR • Manager – Admin • Other Team As required by MD or Functional heads ➢ Agenda / Input for MRM 1. Follow-up actions from previous management reviews. Review the status of Points discussed and planned corrective actions in last MRM 2. Results of internal/external audits. Data to be submitted by MR Non-conformities (NCs) raised in last internal audit and also external audit held before this MRM to be reviewed as per data submitted by MR. During review comparison of current NCs with last audit NCs are recommended 3. Customer feedback (including grievances/complaints) Customer complaints/ queries received against projects developed during last 6 months are reviewed to minimize or eliminate the complaints in future. Customer Satisfaction / Feedback data collected through customer satisfaction survey is reviewed Other issues related to customers observed during interaction by organization personal are also reviewed 4. Project Status Status of projects under developed / completed during last 3 months shall be reviewed as per data submitted by SDH . 5. Process performance and product conformity All HoDs should submit the data of their individual departmental objectives (Current status) in graphical or tabular format for review. The points regarding process such as project compliance, technical issues, resource problems shall be discussed 6. Status of corrective and preventive actions Status of following shall be reviewed a) Corrective / Preventive actions initiated against internal audit / External audit NCRs and based on MRM discussions and should be reviewed. b) Bug Report of each project and its corrective action shall be reviewed 7. Changes that could affect the quality management system Any changes which affects the QMS documentation or implementation flow like change of departmental heads, adding new products / services are to be discussed here and decisions are taken. Page 10 of 16 Rev.:00,Dt.: 8. Recommendations for improvement. Any recommendations by committee to improve the effectiveness of QMS implementation shall be discussed here 9. Any other agenda with the consent of the Director / Participants Apart from QMS, any points related to organization activities can be discussed here, like expansion planning’s, participation in exhibitions or events etc. 10. Resource Needs Resource needs like staff requirements or any infrastructure requirements are to be discussed here. 11. Quality Policy Suitability Quality policy of the company should be reviewed for its awareness among the staff and its suitability to the organization’s activity. 12. Quality Objective Analysis MR submits the current stand of quality objectives for review, the committees reviews the data and take decision on goals whether to continue with same goals or modify them 13. Trainings Records Manager HR submits the trainings conducted during last 3 months and their effectiveness on the participants. New trainings shall also be identified here. ➢ Recording Minutes MR records review meeting minutes in Management review meeting minutes. Minutes are recorded agenda point wise discussions and suggestions accepted by committee. The responsibility and target date to implement action plan also recorded in minutes. ➢ Follow up for Action points MR will follow up with departmental heads (who ever assigned responsibility to implement the action points) for action initiated and status. Once point is implemented, MRM minutes are updated with action taken date and close the status of respective document. ❖ References ❖ Documents ❖ Quality System Manual – QSM/EPATHUSA/01 QSP for Corrective and preventive Action – QSP/EPATHUSA/MR/05 Nil Formats and Records - Inter Office Memo / Internal Mails Management Review Meeting Minutes – (QF/EPATHUSA/MR/03) Page 11 of 16 Rev.:00,Dt.: QSP for Internal Audit ❖ ❖ ❖ ❖ Purpose To carry out audit periodically, to verify whether quality activities and related results comply with planned arrangement and to determine effectiveness of the quality management system. Scope This procedure covers all functions in comprising the quality management system. Responsibility MR is Responsible is to ensure that this procedure is implemented and maintained. Action & Method Process Flow Diagram INPUT • • • • • • • • ISO 9001:2015 Requirements Quality System Requirements Customer Feedback and complaints Statutory & regulatory Requirements Company’s Quality Objectives Documentation of QMS Previous Audit Results Data Analysis Trends Corrective & Preventive Action Record Audit Findings Finalize report MR Prepares Audit Plan and Schedule and selects audit team (Ref. Procedure for Internal Audit) MR Reviews Audit Report Auditors Conduct Audits in following manner • Prepares Audit Check List • Compare documentation against requirements • Compare practice against documentation • Record Non-compliances with objective evidence o o o OK? No Audit covered all areas CA plan against NC’S Sign of auditee & auditors Yes Follow up to close the NC by MR / Auditors Non-Compliance Found? Yes Output o o No Assessment Summery Matrix NC Reports Management Review Page 12 of 16 Rev.:00,Dt.: ❖ Process Description ➢ Audit Plan MR Prepares Internal audit plan (QF/EPATHUSA/MR/04) for every calendar year, Internal Audit Schedule (QF/EPATHUSA/MR/05) is issued before each round of audit. Each function is audited at least once in 6 months. While scheduling, MR considers last audit findings, corrective action status and importance of activities of respective department. Apart from scheduled audits, certain functions are selected for more frequent auditing, depending on their status, importance and past compliance history ➢ Audit Team Personal assigned to carry out audits are independent of those having direct responsibility for the audited department. Audit activity can be out sourced to proven competent people. On such audits company people also participate. ➢ Preparing for Audit Auditors prepare for an audit by fully familiarizing themselves with the ISO 9001 standard, refreshing their knowledge of the quality system manual and relevant procedures, reviewing nonconformity reports of last audit and corrective action files and preparing questions/check lists. ➢ Conducting and Reporting the Audit MR is responsible for the distribution of prepared audit scheduled to auditee at least one week / or in advance. The acknowledgement from auditee is also taken. The audit is conducted against the requirements of ISO-9001: 2008 as addressed by the company along with all associated documents including customer and statutory requirements where applicable. Audit is conducted on a sampling basis by following internal audit check list (QF/EPATHUSA/MR/06) and evidence of implementation is checked by assessment of objective evidence. The audits findings are recorded in Audit Non-conformity Report (QF/EPATHUSA/MR/07) The Auditee write the proposed corrective actions (in consultation with the internal auditor to avoid subsequent conflict of understanding). MR reviews audit reports and inform the results of internal audits through internal audit summary report (QF/EPATHUSA/MR/08) for management review. ➢ Corrective Action and Follow Up Once nonconformity is identified and documented, the responsible auditee investigates the cause of the nonconformity, proposes a corrective action to be taken and indicates the date by which the corrective action will be fully implemented. The auditor reviews and approves the proposed action. On or immediately after the due date for the implementation of corrective action, the auditor follow up with an inquiry or an audit to determine if the corrective action has been implemented and if it is effective, the nonconformity report is closed. If more work needed to fully implement the action, a new follow-up date is agreed upon and the same is recorded on report Page 13 of 16 Rev.:00,Dt.: ❖ References ❖ Quality System Documentation ISO 9001 : 2015 Standard ISO 19001 – Standard for Internal Audit Documents - List of Qualified Internal Auditors – DOC/EPATHUSA/MR/04 ❖ Formats and Records - Internal Audit Plan (QF/EPATHUSA/MR/04) - Internal Audit Schedule (QF/EPATHUSA/MR/05) - Internal Audit Check List (QF/EPATHUSA/MR/06) - Audit Non-Conformity Report (QF/EPATHUSA/MR/07) - Internal Audit Summary Report (QF/EPATHUSA/MR08) Page 14 of 16 Rev.:00,Dt.: QSP for Corrective & Preventive Action ❖ ❖ ❖ ❖ Purpose To carry out corrective action for eliminating the causes of actual and potential non-conformities and prevent occurrence / reoccurrence of non-conformities Scope This procedure covers system and product related non-conformities found in entire process and quality system. Responsibility All HoDs, and MR are responsible to ensure that this procedure is implemented and maintained. Action & Method Process Flow for Corrective Action INPUT • • • • • • • Customer Feedback Customer Complaints Internal & External Audit Results Bugs during project testing Process Performance Indicators Quality Objective Analysis Project Analysis Reviewing & Determining Causes for NonConformities Evaluating the need for Corrective action to ensure that nonconformities do not recur Determining resources requirement appointing a person to implement Action Review Action Taken and • • OUTPUT • Effectiveness of Corrective Action taken Further Actions Needed to close the issue Corrective and Preventive Action Report – QF/Puyenpa/MR/09 Page 15 of 16 Rev.:00,Dt.: Process Flow for Preventive Action • • • • • • INPUT Customer Feedback & Complaints Internal & External Audit Results Trend Analysis Quality Objective Analysis Bug report by QA Team Project Analysis Identifying and Reviewing Causes for Potential Non-Conformities Evaluating the need for Preventive action to ensure that nonconformities do not occur Determining resources requirement and appointing a person to implement Action • • Review Action Taken OUTPUT ❖ • Corrective and Preventive Action Report – QF/ISPL/MR/09 References ❖ • Time of Completion Effectiveness of Preventive Action taken Further Actions Needed to close the issue Nil Documents - Nil ❖ Formats and Records - Corrective and Preventive Action Report – QF/EPATHUSA/MR/09 Page 16 of 16 Rev.:00,Dt.:
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