IATF product safety procedure will help to identify the safety related aspect of product development.
Product safety is more important in the automotive industry.
Now a days automotive products are more and more complex in design. So it is important to consider the safety aspects of the product.
This article is explaining the detailed guide on how you can deal with the safety related to product and manufacturing processes.
Let’s start with standard requirement of the procedure,
IATF 16949:2016 standard mentions the mandatory processes, and this is one of the mandatory procedure every company must have who are deal with the safety related product.
What is Product Safety?
According to IATF definition of product safety, it is the standard for the design and manufacturing of the product which does not cause harm or hazard to the user.
IATF Product safety requirement
IATF 16949:2016 Clause 4.4.1.2 explaining the product safety requirement.
“The organization shall have documented processes for the management of product-safety related products and manufacturing processes…”
It says that the organization must have a documented process to manage the product safety related to product and manufacturing processes.
And the documented process must include product safety related statutory and regulatory requirements, also related customer requirement notifications. There must include the Design FMEA approval if your organization is responsible for the design.
The procedure should include Product safety related characteristics, approval of control plans and Process FMEAs including the reaction plans. Organization should define the responsibilities, escalation process and the information flow which includes the management and customer.
The training identification, change management and traceability should be implemented for the safety related product. And finally to achieved continuous improvement process organization must captured the lesson learnt.
Why Product safety is important?
Today the automobile vehicle has a lot of sub systems and products in it. Also the complete vehicle is more complex than the older days.
Therefore there are the higher chances of malfunction of the vehicle due to fault in the product. In recent days you heard lot of news related to vehicle recall because of so and so problem with small components or product in the vehicle.
Also due to such problems there is a risk to the user.
So, to avoid such problems we need to design a safer product and systems. And the standards will help us to provide the guideline to develop the safe product.
How to fulfill the product safety requirement?
The Product Safety Procedure is the solution for fulfill this IATF requirement. The organization who involves into the safety related product, they must have such procedure in place.
Also beyond the IATF standard one separate standard released by the ISO body is ISO 26262. The ISO 26262 is applicable for the functional safety topics for Electrical and electronics systems in the automotive industry.
Other remaining products should follow the product safety procedure. IATF has given a guidelines on what should include in your procedure and depends on the organization and product scope you can add more to it.
Let’s go through the complete product safety procedure.
Product Safety Procedure Example
1.0 Purpose
To establish a product safety procedure for safety-related products considering the development and manufacturing. This will ensures the product functions according to intended use without any harm or damage.
2.0 Scope
Applicable for all safety-related parts, which are design and manufactured within an organization.
3.0 Users or Responsibility
Engineering function owners are responsible to fulfill all safety requirement during development cycle and Production and Quality function owners are responsible during serial production.
4.0 Definition/abbreviation
Nil: No Definitions
5.0 Process of Handling Product safety
5.1 Identification of product safety requirements
The safety related requirements are consider during initial development stage. This includes the interested parties (customer, statutory and regulatory) safety critical requirements related to product which is been design and/or manufactured within organization.
The requirements are generally taken from below inputs,
- Customer Specific requirements (CSR)
- Government regulations related to product and its functions (Country specific)
- Product Design and manufacturing feasibility study.
5.2 Identification of Safety related Characteristics
Identify the special characteristics based on safety requirements. Those requirements are captured in the form of design feature in the drawings.
Those safety characteristics are highlighted with special symbols in the drawings.
5.3 Control of safety related characteristics
Further the safety related characteristics are now controlled in the downline documents and process.
5.3.1 Safety related characteristics in Documents
Identify and highlighted those safety characteristics into the Design FMEA. The detailed risk analysis of those safety critical points are carried out with the help of CFT team.
The same characteristics are documented and communicated to down level documents such as Process FMEA and Control plan.
Control plan will reflect all those related product and process safety critical characteristics. Which mentioned how to control those characteristics and if not then the reaction plan is used.
Reaction Plan: initiate a reaction plan as per control plan and analyze for impact on safety characteristics that are either not capable or are unstable.
5.3.2 Customer Communication
If required the customer communication is done for the safety related requirement and updates. The safety related test reports and results are communicate and submit to the customer.
5.3.3 Training Identification
Well trained personal should be placed for the design and manufacturing of safety related products.
The organization should identify the training before design and manufacturing of safety related product which ensures the competent people involved in the process.
The reference for the training and skill level is as per skill matrix. The minimum skill level 3 is mandatory for the persons who involved in safety related product processes.
If there is any non-conformity observed then reaction plan implemented as per 4.3.1.
5.3.4 Change Management
Changes in the product and process manage by the change management process. Where all related documents and customer approval is mandatory before implementation.
The important documents are the change request and ECN (Engineering Change Note)
FMEA Risk assessment should be done prior to evaluate the impact on product safety.
5.3.5 Requirements transfer flow
Organization have the responsibility to transfer the safety related characteristics from the customer to self and with supplier. This will ensure the product safety is achieved throughout supply chain.
Some safety related requirements and characteristics are applicable for the supplier parts. Therefore the supplier communication and transfer of those safety related characteristics should done effectively.
Review of supplier risk assessment and safety related characteristics control must done by the organization.
5.3.6 Product Traceability control
The Safety relate product is identify by unique ID marked as traceability system. Which ensures the tracking of any non-conformity throughout the product lifecycle.
The traceability have the details of production date and the processes confirmation including inspection status related details.
Note: The traceability method may vary organization to organization. So write the correct traceability method that your organization is following.
5.4 Lesson learnt and assessment
All the failures and problem happened in the development and manufacturing processes have to record in the lesson learn database. This process ensures the use of these lesson learn in the future development to avoid the same failure risk in future.
6.0 Reference documents
- IATF 16949:2016 Standard
- ISO 9001:2015
- Change Management Procedure
- Training Procedure
7.0 Records
| QF-QA-01 | MASTER LIST OF FAILURE MODE & EFFECTS ANALYSIS | 01-02-2018 |
8.0 Change History
| Rev. No. | Rev. Date | Description | Done By | Approved by |
| 00 | XX.XX.XXXX | Product Safety Procedure released | Mr. John | Mr. Michael |
Product Safety Procedure Template Download
Conclusion
This is the complete product safety procedure align to IATF guidelines and practical exposure in the organization. It is one of the important process of IATF mandatory processes.
Also have a look on the other QMS documentation and formats to do the hands on experience of this.
As a quality engineer you should be more focus on maintaining the product safety and standardize it into the organization culture.
Now a days automotive car having more and more complex systems. If we take example of electric steering system, then there is high chances of harm to user due to malfunction of system. Therefore this product and its safety requirements belongs to product safety clause.
By ensuring our product and process developement using IATF & ISO industry guidelines and standards.
The product safety requirement consist of the intended safety function that the product should perform by maintaining the component specification requirement.
