ISO 13485 Audit Nonconformance written against 6.3 Infrastructure

[Jkc3usc12]

NC was written - The Requirements for Infrastructure have not been fully documented because despite the fact that there is a governing procedure, the requirements themselves have not been clearly defined and documented.

The building, hvac, security, pest control - is all handled by contract services. In are contract we have scheduled visits for service/ maintenance.

Process equipment - we do not manufacture anything strictly a distributer of product. We simply check and rebox.

Supporting - we have a fork lift and van all serviced again by a 3rd party contract.

I showed the auditor the records of service performed and this is not good enough?

Any help on what exactly is needed? I need to update or create a form to show the schedules of the service/maintenance performed?

 

[Marcelo]

You need to define all requirements (including infrastructure requirements) for each process in something like a quality plan.

 

[Jkc3usc12]

Being just the distributer - a warehouse shipping product- to define all requirements seems a bit much. Can I just create a list documenting the requirements for the product to meet conformity. Temperature, storage, security?

 

[Marcelo]

Being just the distributer - a warehouse shipping product- to define all requirements seems a bit much. Can I just create a list documenting the requirements for the product to meet conformity. Temperature, storage, security?

I'm not sure what being a distributer (or whatever other role) has to do with the requirement.

As a distributor, you have to "document the infrastructure needed to achieve conformity to product requirements, prevent product mix-up and ensure orderly handling of product" during the time the product is with you (your processes).

 

[Marcelo]

And they obviously should be based on the manufacturer's requirements, such as the ones mentioned for environmental aspects, for example.

 

[Jkc3usc12]

I provided all service contracts with statements showing the infrastructure is being maintained. The records of contracts, visits, and bills are all maintained.

So I guess what im trying to understand is what else might he be looking for? To just update my governing procedure to state all that is done. The HVAC is maintained with scheduled visit every 6 months. Roof is checked yearly. Etc

 

[Marcelo]

I provided all service contracts with statements showing the infrastructure is being maintained. The records of contracts, visits, and bills are all maintained.

What you mention are the results, the auditor wants the requirements.

 

[Jkc3usc12]

Last question. So I acquire the product requirements and can back track off that.

 

[Marcelo]

I think we are confusing things here. It's not "product requirements"only. it's the requirements of your QMS processes to "achieve conformity to product requirements, prevent product mix-up and ensure orderly handling of product".

For example, what do your processes have as infrastructure for preventing products mix-up? Different shelves? different internal identification? Someone checking if the product going out is the one it should be going out? So, the answer to these questions 9and others) are the requirements of your processes to prevent product mix-up.

 

[Jkc3usc12]

In the governing procedure we state most of this. We have an ERP system for tracking, shelves, a layout for product, NC area, shipping we have freight service, we have QC sheets for pulling and packing product verification, when installed verification forms as well, etc.

So again I'm a bit confused.

The NC he wrote - The Requirements for Infrastructure have not been fully documented because despite the fact that there is a governing procedure, the requirements themselves have not been clearly defined and documented.

Does anyone have an example of a procedure I could review?