A
I have checked through the posts and haven't found a previous response specific to my question.
I think I'm fighting one of those "perceived" or "presumed" requirements.
I interpret the standard to require traceability to the level required by the customer. That's pretty much it.
I am currently working on a conversion and I am getting some feedback that we need to control traceability down to the smallest detail of the component.
Some people believe that we need to know the source of all of the components in an assembly (i.e. where the hardware came from, circuit boards, etc.).
I say we only need to control traceability to the requirements of the customer. Traceability can include many things as noted in the standard. However, I don't see where the standard "requires" detailed traceability of all of the BOM components.
Comments? Feedback?
Where traceability is a requirement, the organization shall control the unique identification of the product and maintain
records (see 4.2.4).
NOTE Traceability requirements can include
- identification to be maintained throughout the product life,
- the ability to trace all products manufactured from the same batch of raw material, or from the same
manufacturing batch, to the destination (e.g., delivery, scrap),
- for an assembly, the ability to trace its components to the assembly and then to the next higher assembly,
and
- for a product, a sequential record of its production (manufacture, assembly, inspection/verification) to be
retrievable.
I think I'm fighting one of those "perceived" or "presumed" requirements.
I interpret the standard to require traceability to the level required by the customer. That's pretty much it.
I am currently working on a conversion and I am getting some feedback that we need to control traceability down to the smallest detail of the component.
Some people believe that we need to know the source of all of the components in an assembly (i.e. where the hardware came from, circuit boards, etc.).
I say we only need to control traceability to the requirements of the customer. Traceability can include many things as noted in the standard. However, I don't see where the standard "requires" detailed traceability of all of the BOM components.
Comments? Feedback?
Where traceability is a requirement, the organization shall control the unique identification of the product and maintain
records (see 4.2.4).
NOTE Traceability requirements can include
- identification to be maintained throughout the product life,
- the ability to trace all products manufactured from the same batch of raw material, or from the same
manufacturing batch, to the destination (e.g., delivery, scrap),
- for an assembly, the ability to trace its components to the assembly and then to the next higher assembly,
and
- for a product, a sequential record of its production (manufacture, assembly, inspection/verification) to be
retrievable.