Part 1: Product Safety
By: Mohsen N. Movahed August 2017
One of the new requirements of IATF 16949 standard is expressed on clause 184.108.40.206 about product safety. At first view, it sounds an originally new and fresh requirement which needs a lot to do in implementation. But reviewing the requirement it makes reader to -ask a principal question: “Does this new requirement about product safety mean that ISO/TS16949 was an unripe specification about product safety?” What does ISO/TS 16949 have about product safety?
In ISO/TS16949 there is no explicit and straight forward indication to product safety. 220.127.116.11 of ISO/TS16949, defines term of “special characteristic” as product characteristic or manufacturing process parameter which can affect safety or compliance with regulations, fit, function, performance or subsequent processing of product.
Figure 1 shows how special characteristics instructed by other ISO/TS16949 requirements.
Special characteristics that could be product characteristic or process parameter are managed through combination of separated ISO/TS 16949 requirements as shown in figure 1 and that way product safety requirements are taken into account as a kind of special characteristics.
18.104.22.168 states all those separate ISO/TS 16949 product safety requirements in an integrated top level requirement in addition to a few originally new requirements. This new IATF 16949 requirement tries to integrate minimum requirements to ensure product safety is highlighted and is taken into account in overall product developments. Items such as special approvals for design FMEA, special approval of control plan and process FMEA, definition of escalation process, trainings for personnel involved in product-safety related products and associated manufacturing processes and lessons learned for new product introduction are somehow almost new requirements for product safety. The organization shall have a documented procedure for the management of product-safety related products and manufacturing processes including whatever controls that minimize organization risk for product safety.
In auditing this clause requirement in any 3rd party audit:
1) Team should pay more attention that this requirement is located in context of organization layer besides requirements for system scope, external and internal issues review, interested parties needs and expectations, customer specific requirements, quality management system processes. Verifying availability of a documented process in addition to review and verification of minimum risk for product safety using provided documented process should be reviewed.
2) IATF 16949 needs top management involvement in product safety process and therefore audit team should check if it happens.
3) Team should plan product safety related audit trials to make sue documented process is implemented and is effectively and properly working.