Strahinja Stojanovic Surprisingly, most of the questions I receive every day regarding IATF 16949 are not about core tools, or any other aspect of the standard, but rather about the product safety. One of the many additions brought about by the new version of the standard involves new and expanded requirements regarding product and process safety. In the ISO/TS 16949:2009 version of the standard, safety was mentioned seven times and was only included in one requirement (6.4.1 Personnel safety to achieve conformity to product requirements). The 2016 revision of the standard mentions safety 23 times, with a specific clause on Product safety and expansion to existing clauses defined in the 2009 revision of the standard.
What is new?
Requirements for product safety are located in clause 4.4.1.2, which introduces the following:
- This is a new section with enhanced requirements that address current and emerging issues the automotive industry is facing related to product and process safety.
- Organizations (suppliers) are required to have documented processes to manage products and processes related to product safety.
- This section includes identification of statutory requirements; identifying and controlling product safety-related characteristics, both during design and at the point of manufacture; defining responsibilities, escalation processes, reaction plans, and the necessary flow of information including top management, suppliers, and customers; receiving special approvals for FMEAs and Control Plans; product traceability measures; and cascading of requirements throughout the supply chain.
What does the standard require?
The new clause, titled “Product safety,” requires a documented process for the management of product safety. The following elements need to be included in the documented product safety process:
- Statutory and regulatory requirements for product safety – the organization needs to identify all legal and other requirements related to product safety. This can include the methods of identification and review of this information.
- Customer requirements regarding product safety – usually, this information is clearly stated 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 needs to identify those characteristics that are relevant for product safety.
- Product safety-related controls at the point of manufacture – the organization needs to establish appropriate process controls to ensure that the product meets safety requirements.
- Special approval of process FMEA and control plans – special approval is additional approval by the function (usually the customer) that is responsible for approving such documents with safety-related content.
- Reaction plans – these usually include containment of the product and 100% inspection if necessary.
- Responsibilities, including the escalation plan and flow of information to the top management and the customer.
- Training for the personnel involved in the product safety and manufacturing process (training requirements can come from the organization itself or from the customer).
- Approval of the changes in the product or process, including evaluation of the effects of the changes on the product safety.
- Transfer of the product safety requirements throughout the supply chain, including customer-designated sources.
The new standard also requires identification and review of safety targets as part of the product design inputs.
Product identification and traceability have been expanded to ensure clear start and stop points for the product received by the customer, or in the field, that may contain quality- and/or safety-related nonconformities, with the same requirements extended to externally provided products with safety/regulatory characteristics. The IATF stated that this requirement was strengthened to support industry lessons learned related 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 required to obtain approval from the customer prior to commencing rework of any the safety and regulatory characteristics related to the product.
Disposition of nonconforming product is another scope expansion of the new standard, requiring product not meeting safety and regulatory requirements to be scrapped and rendered unusable prior to disposal.
Lastly, the management review inputs are required to include a review of actual field failures and their impact on safety or the environment.
Why product safety?
The justification given by the IATF for expansion of these requirements was to address current and emerging issues faced by the automotive industry related to product and process safety. While some of these changes incorporate present customer-specific requirements, others clearly are intended to drive increased awareness of safety-related issues throughout the automotive supply chain.
Considering the number of requirements in clause 4.4.1.2, and the numerous mentions of product safety throughout the standard, it is clear that this has become one of the priorities in automotive manufacturing, and that the safety of the product is a vital part of its quality.
Use this free IATF 16949:2016 Implementation Diagram to include product safety requirements in your IATF 16949:2016 implementation.
