Product safety is managing the design and manufacture of a product so that it does not cause harm or hazard to the user. It is a standalone topic in the automotive quality management system and brings additional controls on top of normal quality requirements.
The distinction should be drawn like this: when a product does not conform to customer requirements, the result is scrap, rework or a customer complaint. When a safety-related characteristic deviates, the result may be injury, recall and legal liability. This is why safety-related products and processes are managed separately from the rest.
What does IATF 16949 require?
Product safety is addressed in IATF 16949 under clause 4.4.1.2. The standard requires the topic to be managed through a documented process. In summary, this process is expected to cover:
- Identification of statutory and regulatory product safety requirements
- Identification of safety-related product characteristics and their control at the point of manufacture
- Special approval mechanisms for documents such as the FMEA and control plan
- Reaction plans, defined responsibilities and an escalation process
- A defined notification flow to top management and the customer
- Training and competence of the relevant personnel
- Evaluation of product and process changes for their safety impact before implementation
- Cascading of requirements to the supply chain and lot-level traceability
In practice this clause really comes down to two things: safety-related characteristics having been identified one by one, and it being written down in advance who informs whom, and within what time, when a deviation occurs. The point most often struggled with in audits is an escalation process that exists only on paper.
PSCR (Product Safety and Conformity Representative)
The PSCR (Product Safety and Conformity Representative) is the trained and appointed person who carries the defined responsibility for product safety in the organization. It originates from the German VDA approach.
The text of IATF 16949 does not mandate the appointment of a PSCR by name; the obligation arises through customer-specific requirements (CSRs). Particularly in supply chains working for German OEMs, the requirement to have a certified PSCR is widespread and is cascaded to lower tiers as well. Even if you do not hold an IATF 16949 certificate, the obligation applies to you if your customer requires it.
Frequently confused points
Product safety is not occupational health and safety. ISO 45001 protects the worker; product safety protects the person using the product. Since both concepts share the word “safety,” they are often confused.
Safety and conformity are not the same thing. A product can be safe without being compliant with legislation, and compliant without being safe. This is why both words appear together in the name of the PSCR.
A procedure alone is not enough. Product safety is a topic that must be embedded in the FMEA, control plan, traceability, change management and corrective action processes. Writing a separate document and not touching the other processes is one of the most visible gaps in an audit.
To place product safety obligations correctly in your system, see our IATF 16949 and VDA training programmes.