QUALITY SYSTEM ANALYSIST

PROCEDURE FOR POISON TEST FOR VISUAL QUALITY INSPECTOR 1.  Poison test shall be conducted for all visual inspector to verify their skill on timely basis 2.  To verify Skill,  QA Head shall prepare poison Test plan for all the visual inspector at a frequency of 1 month. 3.  Poison test shall be conducted by respective supervisor for inspector and record of test shall be maintained in Poison Test Sheet. 4.  Passing Criterion is 100% 5.  In case of any failure is observed immediate retraining shall be given and record to be kept in same training sheet. 6.  Effectiveness of training shall be verified on same day in Poison Test Sheet

PROCEDURE FOR OPERATORS OBSERVANCE AS PER MACE 1.  Operator Observance shall be conducted for all operator to verify their daily working as per set standard on timely basis. 2.  Production Head shall prepare Operator Observance plan for all operators at a frequency of 1 month.  Passing Criteria is 100 % 3.  Operator Observance shall be conducted by respective supervisor as per Operator Observance Sheet. 4.  In case of any failure retraining shall be planned on same day. 5. Effectiveness Monitoring will be done and record to be maintained in Training Attendance Sheet.

IATF16949 {8.5.1.3} Verification of job set-ups The organization shall: a) verify job set-ups when performed, such as an initial run of a job, material change over or job change that requires a new set-up; b) maintain documented information for set-up personnel; c) use statistical methods of verification, where applicable; d) perform first-off/last-off part validation, as applicable; where appropriate, first-off parts should be retained for comparison with the last-off parts; where appropriate, last-off-parts should be retained for comparison with first-off parts in subsequent runs; e) retain records of process and product approval following set-up and first off/last-off part validations. EXPLAINATION-  PROCEDURE FOR JOB SET UP APPROVAL Ensure that the setting layout are accessible and understood by the concerned operators.    Carry out component setting as per Operational Control Procedure.   Carry out Job set up verification on the following occasions: a.  Ini...

IATF16949(ISO9001) 6.1 Actions to address risks and opportunities - Explained 6.1.1 and 6.1.2  See ISO 9001:2015 requirements. 6.1.1 When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to: a) give assurance that the quality management system can achieve its intended result(s); b) enhance desirable effects; c) prevent, or reduce, undesired effects; d) achieve improvement. 6.1.2 The organization shall plan: a) actions to address these risks and opportunities; b) how to:1) integrate and implement the actions into its quality management system processes (see 4.4);  2) evaluate the effectiveness of these actions. Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services. NOTE 1 Options to address risks can include avoiding ...

IATF16949(ISO9001) {9.3} Management Review 9.3.1 General See ISO 9001:2015 requirements . Top management shall review the organization quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization. 9.3.1.1 Management review - supplemental Management review shall be conducted at least annually. The frequency of management review(s) shall be increased based on risk to compliance with customer requirements resulting from internal or external changes impacting the quality management system and performance-related issues. 9.3.2 Management review inputs  See ISO 9001:2015 requirements . The management review shall be planned and carried out taking into consideration: a) the status of actions from previous management reviews; b) changes in external and internal issues that are relevant to the quality management system; c) information on the performance and effectiveness of the q...

IATF16949(ISO9001) {6.2} Quality Objectives and Planning to achieve them See ISO 9001:2015 requirements. 6.2.1 The organization shall establish quality objectives at relevant functions, levels and processes needed for the quality management system. The quality objectives shall: a) be consistent with the quality policy; b) be measurable; c) take into account applicable requirements" d) be relevant to conformity of products and services and to enhancement of customer satisfaction; e) be monitored; f) be communicated; g) be updated as appropriate The organization shall maintain documented information on the quality objectives. 6.2.2 When planning how to achieve its quality objectives, the organization shall determine: a) what will be done; b) what resources will be required; c) who will be responsible; d) when it will be completed;  e) how the results will be evaluated 6.2.2.1 Quality objectives and planning to achieve them — supplemental Top management shall ensure that quality obje...

IATF16949 {8.4.2.1} Type and extent of control —   supplemental The organization shall have a documented process to identify outsourced processes and to select the types and extent of controls used to verify conformity of externally provided products, processes, and services to internal (organizational) and external customer requirements. The process shall include the criteria and actions to escalate or reduce the types and extent of controls and development activities based on supplier performance and assessment of product, material, or service risks . Explanation -  You can refer below Procedure for Controlling Outsourced Process or Service  What is Outsourced Process? The process or services chooses to do with outside resource because of unavailability of resource or lack of capacity to existing resource or due to breakdown of existing resource like Production Line, Calibrations, Testing, Internal Audits, Second Party Audits, etc. will treated as a Outsourced Processes...

PROCEDURE FOR INITIAL PRODUCTION PART(IPP) Quantity considered for Initial Part /Pilot Lot for submitting to the customer is as required by Customer. First Production Parts (Initial Part /Pilot Lot) are identified by special identification tag called Initial Part Tag to differentiate those from normal parts for in-house (Identified by Internal IPP Tag) and at Customer End (IPP Tag). All Characteristics specified in drawing are checked for minimum 5 parts each lot & recorded in IPP Inspection Report & list of all Initial Parts are recorded in Initial Part Log Book. Inspection Reports and other reports as per Customer Requirement for each initial part/lot if any is kept properly and submitted to Customer and approval is taken if required. If Samples /IPP gets rejected by Customer, then the non-conformity procedure will be applicable and parts will be scrapped both at in-house and Customer end. Machine used for production of Initial Parts to be identified with IPP Board. Initial P...

PROCEDURE FOR INITIAL PRODUCTION CONTROL (IPC) Quality Head will announce start of IPC by updating the part in IPC logbook and call the CFT meeting for informing about IPC part and decide targets for the IPC periods in IPC Monitoring sheet. Quality Head further provide training to concerned person regarding the IPC part IPC starts from SOP at Customer End to - - New Part: 3month/3lot/5000 parts whichever is later or as required by Customer - ECN : 1month/2lot/1000 parts whichever is later or as required by customer  - PCN : 1month/2lot/1000 parts whichever is later or as required by customer During the IPC period, Stricter Control shall be followed from incoming to final like increase in sample size/frequency, 200% Visual Inspection in Final Change in inspection method shall also be done from attribute to variable gauge if possible or required by Customer. Pre-launch control plan shall be used during the IPC period with defined Stricter Inspection as mentioned above for monitoring ...

IATF16949 {6.1.2.3} Contingency Plans The organization shall:   a) identify and evaluate internal and external risks to all manufacturing processes and infrastructure equipment essential to maintain production output and to ensure that customer requirements are met; b) define contingency plans according to risk and impact to the customer; c) prepare contingency plans for continuity of supply in the event of any of the following: key equipment failures. (alsoseeSection8.5.6.1.1); interruption from externally provided products. processes, and services; recurring natural disasters; fire; utility interruptions; labour shortages; or infrastructure disruptions;   d) include, as a supplement tothe contingency plans,a notification process to the customer and other interested parties for the extent and duration of any situation impacting customer operations; e) periodically test the contingency plans for effectiveness(e.g simulations, as appropriate);  f) conduct contingency plan ...

IATF16949 {8.5.1.4} Verification after shutdown The organization shall define and implement the necessary actions to ensure product compliance with requirements after a planned or unplanned production shutdown period EXPLAINATION - PROCEDURE FOR VERIFICATION AFTER MAJOR SHUTDOWN If any planned or unplanned shutdown is more than 30 Days then verify the production facility.  Ensure that the production process outputs are complying with the necessary product requirements as per the control plan or process plan as necessary and as applicable depend on shut down time and nature of shutdown  by   following ways, 1. Job Set up Approval Report 2. By checking plant facility and layout condition 3. By revalidating the processes. 4. By doing manufacturing process audit 5. By doing product audit 6. By submitting sample lot to customer for verification  7. By taking functional feedback from customer for sample lot. 8. By doing Machine fitness test if any.   Take necess...

FAILURE MODE AND EFFECTS ANALYSIS (FMEA) Entire process of FMEA development, either design or process, uses a common approach to address as per the guidelines provided in the AIAG Reference Manual: IV Edition of FMEA. NEW PRODUCT DEVELOPMENT OF PROCESS FMEA:   Prepare a flow chart. This Flow chart should identify the Product/ Process Characteristics associated with each operation as finalized by CFT at the time of product realization process. Carry out risk assessment and conduct FMEA for all high risk Process steps. Copy of Flow Chart/ risk assessment should accompany the process FMEA. Document the Potential failure and their consequences in the FMEA format. The usage of this format is given below with number correlating with number given on the format. Following items to be considered while forming FMEA •  Troubles in the past of Similar Part. •  Defect items expected (PFMEA Matrix) •  Defect items unable to capture at customer end •  Defect items difficu...

ADVANCED PRODUCT QUALITY PLANNING (APQP) Scope : The following procedure will be carried out in below conditions 1.  Any Similar part which has not produced earlier 2.  Any Similar part which has produced earlier 3.  Existing Product ECN /PCN 4.  Plant location Change. 5.  If part is from Automotive Customer •  Entire Procedure of product development is carried out as per guidelines provided in the AIAG Reference Manual: APQP (2nd Edition) •  The activity to be done with respect to respective responsible person are defined in APQP Matrix. •  APQP Timing plan shall be made based on category defined in APQP Matrix •  APQP Timing plan shall be made based on category defined in APQP Responsibility Matrix •  Review Frequency: CFT: Every 15 days Top Management along with CFT: Monthly and at phase end. During those review customer milestones shall be discussed •  NPD Head will be over all responsible for implementation of the requirements ...

IATF16949 {8.5.1.1} Control Plan The organization shall develop control plans (in accordance with Annex A)at the system, subsystem, component, and/or material level for the relevant manufacturing site and all product supplied, including those for processes producing bulk materials as well as parts. Family control plans are acceptable for bulk material and similar parts using a common manufacturing process. The organization shall have a control plan for pre-launch and production that shows linkage and incorporates information from the design risk analysis (if provided by the customer),process flow diagram, and manufacturing process risk analysis outputs( such as FMEA). The organization shall, if required by the customer, provide measurement and conformity data collected during execution of either the pre-launch or production control plans. The organization shall include in the control plan: a) controls used for the manufacturing process control, including verification of job set-ups; b)...

EXTERNAL AND INTERNAL ISSUES AS PER IATF 16949:2016 & ISO 9001:2015 The following external issues are identified which are having positive and negative impacts on quality management system Requirements of statutory bodies. Requirements stated by IATF 16949:2016 and ISO 9001:2015 standards.  Legal Requirements of Factory Inspector and Labour Commissioner.  Customer requirements of product quality and quality management system.   Following internal issues are identified which are having positive and negative impacts on quality management system. Rejection Index  Customer Delivery Requirements  Storage Condition  Maintaining  safety Requirements during manufacturing   Employee Competence  Extraneous material flow 

INTERESTED PARTIES AS PER IATF 16949:2016 AND ISO 9001:2015 External Interested Parties :  Customers  External Providers  Transporters  Competitors  Stakeholders  Gujarat Pollution Control Board (GPCB)  Directorate of Industrial Health and Safety (DISH) Office of Labour Commissioner Employees State Insurance Corporation(ESIC) Internal Interested Parties :  Employees  Board of Directors  Contractors & Contract Workers  Security Contractor and Security Staff

IATF16949 {4.4.1.2} Product safety The organization shall have documented processes for the management of product-safety related products and manufacturing processes, which shall include but not be limited to the following, where applicable: a) identification by the organization of statutory and regulatory product-safety requirements; b) customer notification of requirements in item a); c) special approvals for design FMEA; d) identification of product safety-related characteristics;  Identification and controls of safety-related characteristics of product and at the point of manufacture; f) special approval of control plans and process FMEAs: g) reaction plans (seeSection9.1.1.1); h) defined responsibilities, definition of escalation process and flow of information, including top management, and customer notification; i) training identified by the organization or customer for personnel involved in product-safety related products and associated manufacturing processes; j) changes o...

ROADMAP FOR IMPLEMENTATION OF IATF 16949:2016 A. TRAININGS   1  Awareness Training to a Employee including Contracted people in batches 2  Internal auditing Training 3  Departmental scope and applicable requirements 4  Customer Specific Requirements 5  Training about Basics of Core Tools (SPC, FMEA, MSA,PPAP, APQP), Control Plan, Cost of Poor Quality,OEE,MTTR, MTBF B. DOCUMENTATIONS   1  Departmental Process Manuals 2  Quality Manuals 3  Process Wise Turtle chart preparation & Training 4  New Formats as per the requirements. 5  Modifications in exisiting formats if any 6  Formation of SOP C. IMPLEMENTATIONS   1  To ensure preparations of all records 2  To ensure preparations of records as per the Manuals 3  To conduct monthly review 4  To make necessary changes in the format 5  12 Month Data preparations. 6  Various action plan preparations. D. INTERNAL AUDIT  1  To conduct ...

IATF16949 {7.2.1} Competence—supplemental 7.2.1 Competence—supplemental The organization shall establish and maintain a documented process(es) for identifying training needs including awareness(see Section7.3.1) and achieving competence of all personnel performing activities affecting conformity to product and process requirements. Personnel performing specific assigned tasks shall be qualified, as required, with particular attention to the satisfaction of customer requirements. EXPLANATION -  Organization must have procedure for Training Needs Identification and Training  for all Employees. Training Needs Identification -  Identification of Training Topics by Department Head for his team members which is required to perform tasks. Employee should have competency regarding Product and Process which he/she dealing with in an organisation. He/she should be qualified to perform tasks for which he/she was appointed by Organisation. If he/she is not qualified then Organisation...

IATF16949 {8.4.2.3.1} Automotive product-related software or automotive products with embedded software The organization shall require their suppliers of automotive product-related software, or automotive products with embedded software, to implement and maintain a process for software quality assurance for their products. A software development assessment methodology shall be utilized to assess the supplier's software development process. Using prioritization based on risk and potential impact to the customer, the organization shall require the supplier to retain documented information of a software development capability self-assessment. EXPLANATION:  Organization should have procedure for Quality Inspection of their Supplier who is providing automotive products-related software or automotive products with embedded software. Embedded Software -   A software/firmware which is installed in product to connect electronics system and mechanical system.  Organization sho...

What is IATF 16949:2016? IATF 16949:2016 is the International Standard for Automotive Quality Management Systems.  This standard was jointly developed by The International Automotive Task Force (IATF) members and submitted to the International Organization for Standardization (ISO) for approval and publication. IATF 16949 emphasizes the development of a process oriented quality management system that provides for  Continual Improvement, Defect Prevention and Reduction of Variation and Waste in the Supply Chain . The goal is to meet customer requirements efficiently and effectively. Who are the IATF? The IATF is a group of automotive manufacturers and their respective trade associations, formed to provide improved quality products to automotive customers worldwide. Who is it applicable to? The standard is applicable to any organization that manufactures components, assemblies and parts for supply to the automotive industry.

IATF16949(ISO9001) {8.5.6} Control of changes See ISO 9001:2015 requirements. The organization shall review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements. The organization shall retain documented information describing the results of the review of changes, the person( s) authorizing the change, and any necessary actions arising from the review. 8.5.6.1 Control of changes — supplemental The organization shall have a documented process to control and react to changes that impact product realization. The effects of any change, including those changes caused by the organization, the customer, or any supplier, shall be assessed. The organization shall: a) define verification and validation activities to ensure compliance with customer requirements; b) validate changes before implementation; c) document the evidence of related risk analysis; d) retain records of verification and validation.Changes, including...

IATF16949(ISO9001) {7.5.3} Control of documented information 7.5.3.1 and 7.5.3.2 See ISO 9001:2015 requirements. 7.5.3.1 Documented information required by the quality management system and by this International Standard shall be controlled to ensure: a) it is available and suitable for use, where and when it is needed; b) it is adequately protected (e.g. from loss of confidentially ,improper use or loss of integrity). 7.5.3.2 for the control of documented information the organization shall address the following activities, as applicable: a) distribution, access, retrieval and use; b) storage and preservation, including preservation of legibility c) control of changes (e.g. version control) d) Retention and disposition.  Documented information of external origin determined by the organization to be necessary for the planning and operation of the quality management system shall be Identified as appropriate, and be controlled. Documented information retained as evidence of conformity...

IATF {8.6.2} Layout Inspection and Functional Testing A layout inspection and a functional verification to applicable customer engineering material and performance standards shall be performed for each product as specified in the control plans. Results shall be available for customer review. NOTE 1Layout inspection is the complete measurement of all product dimensions shown on the design record(s). NOTE 2 The frequency of layout inspection is determined by the customer. Explanation  - Please refer below Layout Inspection Procedure PROCEDURE FOR LAYOUT INSPECTION AND FUNCTIONAL TESTING   A Preparation 01 Review the Monthly Production Plan 02 From Monthly Production Plan, Identify the product for Layout Inspection 03 Refer to the contract review documents and determine if the customer has specified any frequency for the Layout inspection and functional testing. 04 If customer has not specified any frequency, then decide the same as follows. 4.1 If in the whole year the product i...

IATF16949 {7.1.4} Environment for the Operation of Processes See ISO 9001:2015 requirements The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services. NOTE A suitable environment can be a combination of human and physical factors, such as: a) social (e.g. non-discriminatory, calm, non-confrontational); b) psychological (e.g. stress-reducing, burnout prevention, emotionally protective); c) physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise). These factors can differ substantially depending on the products and services provided . NOTE Where third-party certification to ISO 45001 (or equivalent) is recognized, it may be used to demonstrate the organization's conformity to the personnel safety aspects of this requirement. 7.1.4.1 Environment for the operation of processes — supplemental The organization shall maintain its premises in astateoforder, cleanl...