Outsourcing a Core Process

[sadamson]

We are a medical store that procures, stores and distributes products. We are ISO 9001 certified.

We have now outsourced the warehousing and distribution function. Procurement / finance / QA / overall management stays with the store.

My question is how does the outsourcing fit into our QMS.

For example: Document control and SOP's

Do we insist that our current SOP's are to be used and that the outsourced body can modify but that the changes, structure of the documents and the control of such are done through the store management or do we let them have their own system.

My concern with the latter is that there are a lot of interactions between the store and the outsourced body e.g invoices flow between receiving and finance department. To follow the process one would have to look at their SOP up to a certain point and then look at the stores SOP to continue the process of invoice payment.

It may also arise that if the outsourced body makes changes the store may not know and vice verse and soon there would be a bit of a mess. How would we know that they comply with ISO requirements without extensive audits?

Same with training / auditing / corrective action / strategy development etc. Do we insist that the outsourced body fits into our QMS or do we insist that they develop their own QMS?

I would appreciate guidance, thanks.

 

[Colin]

Section 8.2 of the standard may be a good place to start - monitor and measure. You may want to consider auditing the process quite often - clause 8.2.2 mentions the status and importance of the activities to be audited - it doesn't get more important for you.

Also, monitor and measure the processes (clause 8.2.3), look at the effectiveness of the process - how often do they let you down, wastage, returns, late deliveries, out of stocks, etc.

Perhaps you have service level agreements with them which define certain parameters which are important to you.

Perhaps more than these, communication. Keep in touch with them regularly.

As for whose quality system? They are less likely to follow a system which is forced upon them rather than one which they have developed themselves. However, make sure that you audit their system to make sure it complies with your needs too.