Elements Of Documented Iatf 16949 Product Safety Process

By Author: niha
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ISO/TS 16949, is developing with the publication of a new global industry standard by the International Automotive Task Force (IATF). ISO/TS 16949 from 2009, a technical specification for automotive sector quality management systems, has become one of the most commonly used international standards in the automotive industry, harmonizing the different assessment and certification systems in the automotive supply chain.
On October 3, 2016, IATF 16949:2016 was published by the IATF and therefore succeeds and replaces the ISO/TS 16949:2009, defining the requirements of a Quality Management System for organizations in the automotive industry. A survey of ISO/TS 16949 certification at the end of 2015 shows that in spite of the global recession, the number of companies that have applied an ISO/TS 16949 Quality Management System still shows a general positive trend globally.
What are the Elements of documented IATF 16949 Product safety process?
The management of product safety requires a document process. These IATF 16949 documents process address all the elements of product safety. The following elements necessity ...
... to be comprised in the documented product safety process:
• Statutory and regulatory requirements for product safety: The organization wants to classify all legal and other requirements related to product safety. This can contain the methods of identification and assessment of this information.
• Customer requirements regarding product safety: This information is obviously specified by the customer, but there are always some requirements that are implied and are part of the bullet above.
• Safety-related characteristics of the product: Considering the lifecycle of the product and how it is used, the organization wants to identify those characteristics that are appropriate for product safety.
• Product safety-related controls at the point of manufacture: The organization wants to establish appropriate process controls to confirm that the product meets safety requirements.
• Special approval of process FMEA and control plans: Special approval is additional approval by the function that is responsible for approving such documents with safety-related content.
• Reaction plans: These generally include containment of the product and 100% inspection if required.
• Responsibilities: It Includes the growth plan and flow of information to the top management and the customer.
• Training for the personnel: It involves in the product safety and manufacturing process; training necessities can come from the organization itself or from the consumer.
• Approval of the changes in the product or process: It includes assessment of the effects of the changes on the product safety.
• Transfer of the product safety requirements: It can be throughout the supply chain, with customer-designated sources.
Why IATF 16949 is Important?
IATF 16949:2016 is the global technical specification and quality management standard for the automotive industry based on ISO 9001:2015. It is considered to be used in combination with ISO 9001, and contains supplemental requirements specific to the automotive industry rather than being a stand-alone QMS.
IATF 16949:2016 carries together standards from across Europe and the U.S., outlining everything that need to know about achieving best practice when designing, developing, manufacturing, installing, or servicing automotive products. It is intended to be used by organizations of any size, and can be used by any company. As an international standard, it is recognized as the basis for any company to create a system to confirm customer satisfaction and improvement, and as such, many companies demand this as the minimum requirement for an organization to be a supplier.
Because of auditing processes, as well as having a certification body audit them, customers themselves do not want to audit company. Because of this IATF 16949 has become a necessity for many companies to compete in the market.
Why product Safety?
The explanation given by the IATF for expansion of these requirements was to address current and emerging issues faced by the automotive industry associated to product and process safety. While some of these changes incorporate present customer-specific requirements, others obviously are intended to drive improved awareness of safety-related issues throughout the automotive supply chain.
The new standard also needs identification and review of safety targets as part of the product design inputs. Product identification and traceability have been extended to confirm clear start and stop points for the product received by the consumer, or in the field, that may contain quality and safety-related nonconformities, with the same requirements extended to externally provided products with safety characteristics. The IATF stated that this requirement was strengthened to support industry lessons learned associated to field issues.
Control of reworked product is a new requirement in the 2016 revision of the standard. Within this new clause, the organization is essential to obtain approval from the consumer prior to commencing rework of any the safety and regulatory characteristics associated to the product.
Disposition of nonconforming product is another scope expansion of the new standard, demanding product not meeting safety and regulatory requirements to be scrapped and rendered unusable prior to disposal. Lastly, the management review inputs are essential to include a review of actual field failures and their impact on safety or the environment.