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...