yf02055 said:
I have more specific questions on "outsourced processes":
> Do companies typically identify the specific suppliers of outsourced processes within their QS, such as on the Approved Supplier List?
> If a company outsources calibration and record retention, would these fall under the category of an outsourced process?
> What are examples of additional/appropriate controls applied to outsourced processes?
If a company or person provides an important service to you, they should be on your Approved Supplier List. Unless it's not a critical supply such as one you could get readily (we look at office supplies such as paper, pens, toner, etc. as non-critical, hence not a critical supplier). You should also collect information and review it on a scheduled basis to make sure they are providing you with the service you need. For companies such as a calibration source, maybe this is a very limited file. Do they calibrate to NIST standards. This should be a "yes". Do they have any certifications? Such as ISO or other? That would be nice. If not, how do you know they are providing the service you need? Maybe providing them with a questionnaire to show that they have procedures they follow when they do the calibration would help. How are they qualified to provide the service? Do they have a quality manual? Do they have a quality control department? Do they have a quality assurance department? Do they control records? Do they monitor complaints? How do they maintain traceability to NIST standards?
If the process is more complicated, the records needed for the outsourcing become more complex. For example, we are going to have a company make a product for us that we will label with our name. They will design it, they will validate it, they will manufacture it. Now, we need to make sure they provide us with product according to ISO13485 standards. Design controls must be applied, they need to have procedures for producing the product, we need to provide them with specifications in a form of a contract, we will need to apply some sort of acceptance procedure to ensure the product is what we expect it to be. The list goes on......
Whatever you would need to show that the service, if done in your facility, complies with ISO13485---that's what proof you need that the outsourcing company provides the same degree of assurance.