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Goal of the standard Common system problems Examples of system Eight Quality Management Principles Process Approach Permissible Exclusions ISO/TS 16949 standard requirements Advanced Product Quality Planning Production Part Approval Process Failure Mode & Effect Analysis Statistical Process Control Measurement System Analysis Internal Audit
Procedure
(Specified way to carryout an activity or a process-may be documented or not) Effectiveness of process (Ability to achieve desired results)
Process
Output
Requirement s
Resource Management
Management Responsibility
Product Realization
4.2.3.1 Engineering Specifications Customer Engineering Changes - Timely review, distribution and implementation. Maintain record of date on which change is implemented (Timely review shall not exceed two working weeks)
4.2.4.1 Records Retention Identify minimum statutory & regulatory and customer requirements and establish retention period as per requirement Note: Disposition Includes disposal & customer specified records
Top management shall ensure that customer requirements are determined and fulfilled with the aim of enhancing customer satisfaction
5.4.2 Quality Management System Planning QMS Process Planning Quality objectives Integrity to be maintained during QMS changes
5.6.1.1 Quality Management System performance Includes all elements of Quality System and its performance as an essential part of the continual improvement process Monitoring of quality objectives Reporting and evaluation of the cost of poor quality Minimum evidence for the achievement of objectives specified in the quality policy Objectives specified in the business plan Customer satisfaction with product supplied
To implement and maintain the QMS and continually improve its effectiveness To enhance customer satisfaction
6.2 Human Resources 6.2.1 General Qualification on the basis of appropriate education, training, skills and experience
Note:- Conformity to product requirements can be affected directly or indirectly by personnel performing any task within the QMS
6.2.2.2 Training
Documented procedures for identifying training needs and achieving competence Specific assigned tasks Qualifications Training Records to be maintained Special attention to satisfy customer specific requirements
6.3 Infrastructure
Identify, provide and maintain the infrastructure (workspace and associated facilities, equipment, hardware and software, supporting services such as transport , communication or information systems ) to achieve product conformity.
Note : Post delivery activities include, for example , actions under warranty provisions , contractual obligation such as maintenance services , and supplementary services such as recycling or final disposal.
7.2.1.1 Customer designated special characteristics Demonstrate conformity to customer requirements documentation and control of special characteristics for designation,
Review during tenders, orders and amendments to ensure the following Product requirements are defined Differences resolved Ability to meet the defined requirements confirm verbal requirements before acceptance and communicate changes to relevant personnel
7.2.2.1 Review of requirements related to the product supplemental
Investigate, confirm and document the manufacturing feasibility of the proposed products in contract review process including risk analysis
7.2.3 Customer Communication
Identify and implement arrangements for communicating to customers regarding : Product information Enquiries, contracts or order handling including amendments Customer feedback, including customer complaints
Design and development chart (APQP timing plan/chart) which includes Stages of design and development process Review, verification and validation activities Responsibility and authority for design and development activities Interfaces between different groups Planning output shall be updated, as the design and development progresses 7.3.1.1 Multidisciplinary approach
Form a MDT Team or APQP team for product realization process, review of FMEAs, identification of special characteristics, review of control plan, etc.
7.3.4.1 Monitoring
Define measurements at specified stages of design and development, analyze and report as an input for management review. Measurements include quality risk, cost, lead-time, critical paths as appropriate
7.3.5 & 7.3.6 Design and development verification & validation
Verification to be performed to ensure the output meets the input requirements and records shall be maintained. Validation to be performed to confirm that resulting product is capable of meeting the requirements for the intended use in accordance with planned arrangements and records shall be maintained.
Packaging and preservation of equipment, tooling and gauging, Availability of replacement parts for key manufacturing equipment, Documenting, evaluating and improving maintenance objectives
customer
Establish and maintain a procedure for communication of information on service concerns . Verify the effectiveness of Service centers Special purpose tools or measuring equipment Training of servicing personnel
7.5.2 Validation of processes for production and service provision
Validate the production and service processes where the resulting output cannot be verified by subsequent measurement or monitoring and demonstrate the ability of the processes to achieve planned results. System to consider: Criteria for review and approval of process Approval of equipment and qualification of personnel Use of specific methods and procedures Requirements for records Re-validation Above requirements apply to all processes for production and service provision