AS9100D para 8.1.3 requires organizations to plan, implement, and control the processes needed to assure product safety during the entire product life cycle.
So what is Product Safety?
Product safety as defined by the AS9100D paragraph 3.4 is:
The state in which a product is able to perform to its designed or intended purpose without causing unacceptable risk of harm to persons or damage to property.
The only way a product can perform to its designed intended purpose is to have been planned and cared for during every step of the manufacturing process. Planning, implementation and controlling processes to assure product safety is paramount.
Awareness is also a key element in assuring product safety, as required by AS9100D para 7.3:
The organization shall ensure that persons doing work under the organization’s control are aware of g) their contribution to product safety.
One of my favorite questions to ask someone on the manufacturing floor, supervisors and managers included, during an internal or external audit is: “What is product safety? What is your contribution to product safety?”
Sometimes I get surprisingly great answers. Such as: “I follow my procedures completely, I try to keep the product safe by following ESD protocols (ie. wrist/heel straps etc), covering the product to keep FOD (Foreign Object Debris) out, and handling the product very carefully.” I consider this to be a great answer by the way!
Sometimes I get the deer in the headlights look with a “Can you repeat the question?” and then a stab in the dark answer, such as: “Well I try to work safely by wearing my safety glasses and other PPE.” While safety is absolutely important and is part of the concept of product safety, (“causing unacceptable risk of harm to persons”) it is not the whole story. This type of answer prompts me to ask if there has been proper training about Product Safety. Many times organizations fail to train or fail to ensure that people are refreshed in this important concept of Product Safety.
Another important AS9100D requirement related to product safety falls under paragraph 8.1 Operational Planning and Control. Good practices of personal and product safety should include robust manufacturing process instructions, inspection requirements, instructions for prevention, detection, and removal of foreign objects (FOD), handling, packaging, and preservation.
Suppliers also play a significant role in assuring product safety. AS9100D 8.4.3 Information for External Providers states:
The organization shall communicate to external providers its requirements for: m. ensuring that persons are aware of: their contribution to product safety.
It is essential that these requirements are flowed down to the supplier.
Remember to consider and address these requirements for awareness, planning, and suppliers as you think through ensuring product safety. Contact us for more information on product safety or if you would like to schedule a training on the requirements of product safety.