Does The Company We Rent Space To Fall Under Our Quality System?

[horqua]

We are soliciting opinions: We are an existing contract manufacturer certified to ISO 13485. We've begun to rent space in our building to a start-up company that distributes a product unrelated to our own product line or customer base. The start-up has their products shipped to our facility and they are warehoused here for distribution to their clients. The start-up provides its own employee to manage all aspects of handling and distributing their products. We do not touch the product or perform services for the start-up other than providing a facility in which to conduct business.

Our questions are: In your opinion, does the start-up company fall under our quality system? If you think yes, we know what to do. If no, what do you think are the minimum quality requirements that they need to operate under in this circumstance? (Such as receiving inspections, status labeling, lot number traceability, quarantine, doc control) How much responsibility/liability do we posses with the start-up working out of our facility?

This is new territory to us and we (the Quality department) want to be sure we are in control of our situation. Thanks for your opinions.

 

[Wes Bucey]

Re: Relationship between Existing Company and Start-Up

Whether they fall under your quality system is dependent on the contract terms between your company and theirs. If it is strictly an arm's length situation where your organization is landlord and they are tenant, no connection. If, as is often the case, one or more of the officers or principals in YOUR organization are also officers or principals in the startup, outsiders (customers and suppliers) need firm, unequivocal notice the two organizations are, indeed, separate or those other folks could "assume" the startup is under your QMS umbrella to their detriment. If the startup falls down, there could be repercussions which affect your organization.

The landlord/tenant relationship would hold whether there are walls separating your warehouse from theirs or merely imaginary lines on the floor.

In my company, I sometimes borrowed our next door neighbor's heavy duty fork truck to unload a large load of steel bar stock to my dock if our own was out of service - that did NOT put his fork truck under my QMS except to the extent I assured the fork truck operator (neighbor's or my own employee) was competent to operate it. Similarly, you won't have responsibility for inspecting and confirming tenant's receiving any more than your next door neighbor at home is responsible for confirming the contents of your UPS package (which he takes in to keep it out of rain or snow) fit the invoice and are undamaged.

 

[DannyK]

Re: Relationship between Existing Company and Start-Up

If I was the auditor of your facility for ISO 13485, I would want to ensure their products are segregated and well identified and do not interfere with your operations. Since it is not part of the scope of the audit, that would be all that I would be looking for.
For the employees of the start-up that are handling the product, make sure that they are doing their jobs in a safe manner and if possible set boundaries about where they can and cannot go.

Danny

 

[Ajit Basrur]

Re: Relationship between Existing Company and Start-Up

As long as the scope of your QMS is clearly spelt out and proper segregation maintained to demarcate the boundaries, it should not be a concern at all.

In fact in developing countries, there are huge industrial buildings and individual companies share couple of rooms each in that building. Some have common warehouses with segregated stuff for differentiation.

 

[Coury Ferguson]

Re: Relationship between Existing Company and Start-Up

We are soliciting opinions: We are an existing contract manufacturer certified to ISO 13485. We've begun to rent space in our building to a start-up company that distributes a product unrelated to our own product line or customer base. The start-up has their products shipped to our facility and they are warehoused here for distribution to their clients. The start-up provides its own employee to manage all aspects of handling and distributing their products. We do not touch the product or perform services for the start-up other than providing a facility in which to conduct business.

Our questions are: In your opinion, does the start-up company fall under our quality system? If you think yes, we know what to do. If no, what do you think are the minimum quality requirements that they need to operate under in this circumstance? (Such as receiving inspections, status labeling, lot number traceability, quarantine, doc control) How much responsibility/liability do we posses with the start-up working out of our facility?

This is new territory to us and we (the Quality department) want to be sure we are in control of our situation. Thanks for your opinions.

If I understand your question, you are saying that the Tennant of the same building (rented space) has no relationship with your company other than renting space. If this is so, they are a separate Business entity, and your Quality Management System would not apply to them.

Now, if they are a Business entity of your organization, and they operate under the umbrella of the Corporation, than yes parts or all of your QMS would apply depending on what the Scope of the registration states, in my opinion.

 

[Randy]

Without all the wherefore's and how to's ask a basic question.....

Do they or can they have an impact upon you achieving product conformity to customer requirements and customer satisfaction?

Your answer to that will determine your course of action.

 

[Stijloor]

Without all the wherefore's and how to's ask a basic question.....

Do they or can they have an impact upon you achieving product conformity to customer requirements and customer satisfaction?

Your answer to that will determine your course of action.

You can even ask a simpler question:

"If they went belly-up, would you and your customer be affected?"

 

[Kales Veggie]

Another view:

Do you share loading/shipping docks with your company ?
Do you share telephone systems ?
Does the start-up use your computer systems ?
Does mail get delivered to the same address ?
Any chance that start-up employee touch/handle your products ?
Would you use their employees in an emergency (call-ins, vacations)?
Can their customer/visitors enter your office area and warehouse ?

You might consider the above questions on how you going to answer it. You might look at your quality management system and see what the impacts and effects could be.