Mark Hammar AS9100 Rev D has introduced new requirements for identifying and placing control for product safety into your aerospace Quality Management System (QMS), but these requirements can be confusing for many companies that have not identified product safety issues in the past.
This article tells you how to interpret the product safety clause and some ways to implement it in a small business – this article is an excerpt from chapter 9 of my book Applying AS9100 Rev D: The hassle-free approach to implementing an aerospace QMS for small business.
Product safety (Clause 8.1.3)
Since product safety has become ever more important in the aerospace industry, the AS9100 Rev D standard has added new requirements for this critical concept. While the clause is short, the significance of understanding how to use these requirements for your product cannot be overstated. Here we will look at the entire clause and how to interpret and apply it.
Purpose/Inputs. This is a short clause that requires you to think about your product or service throughout its entire lifetime, and determine if there are safety risks that need to be addressed. After this assessment, it is up to the organization to determine what, if anything, needs to be done to address any safety hazards and/or risks. It may very well be that your product or service has no safety risks and, in this case, you would have no processes to put in place.
Options/Decisions. The AS9100 standard itself gives some examples of what processes may be implemented to address product safety. Depending on your product or services, you may need to include all, some, or none of these processes. Since this is an “as appropriate clause” of the standard, it is up to you to determine if anything needs to be done. Some process options from AS9100 include:
- Assessing hazards and managing risks
- Managing safety critical items
- Analyzing when safety events occur
- Safety communication and training
Documentation. This clause has no requirements for documented information, but this is likely because many of the ways you would document this information is already captured elsewhere in the standard. For instance, safety critical items would be captured in product information such as drawings or performance plans. Likewise, assessment of safety hazards and managing the risks will be controlled through operational risk management while communication and training regarding safety events will be documented as part of your QMS communications
Example: This example could be for any electronics manufacturer that performs the design of motors for an aerospace application. The example will help you to understand the use of the product safety requirements for this type of product. A small motor has been designed, and a safety risk has been assessed: the integral battery could pose a risk. The following processes are put in place to address the hazards throughout the lifetime of the product:
- Batteries are procured in safety sealed packaging so that contacts will not be inadvertently touched during assembly
- Safety training has been put in place for operators who will install the batteries
- Process documentation includes warning information at the process step of installing the battery.
- The design has ensured that, once installed, the battery is not a risk during subsequent assembly
- Labels on the motor include risk warnings in case the assembly is opened and the battery exposed
- Notification about the battery is included in delivery to the customer, which outlines the risks if the assembly is not handled correctly
The goal of the product safety requirements
As you can see, the requirements of the standard, while not extensive, do require you to consider how product safety applies to all of the life stages of your product. One important thing to remember is that for a complex product with many risks, this may take a lot of time to identify and control; however, for a simple product such as a small machined part, this may simply include a safety assessment that identifies that there are no product safety risks to address. This is why the requirements are not extensive – the product safety assessment will need to be applicable to your specific product, and for many simpler products, this may not be as onerous as you may have first thought.
This article is an excerpt from the book Applying AS9100 Rev D The hassle-free approach to implementing an aerospace QMS for small business – click here to see the Table of contents from the book.
