This question is a bit of a twist on Toll Mfg.
Here is the question.
The Manufacturing sites ( One main and two remotes) have only one customer that is another business in their corporate body.
The corporate body is made up of 8 independent business units.
The scope of the QMS being certified is that of the chemical manufacturing unit (3 sites) which acts as a toll manufacturer for its sole customer, the chemical sales unit.
Corporate functions include purchasing, IT, finance and warehousing group that receives raw materials and ships finished products for all of corporate's eight business units.
The chemical manufacturing unit has no input or control over vendor selection, purchase price, materials purchased, R&D, customer interaction or shipping of finished goods. These processes are under the control of the chemical sales unit.
The chemical manufacturing units' finished goods are transferred to the corporate warehouse by the corporate logistics group under the direction and control of the chemical sales group. On some occasions the chemical sales group will arrange for drop shipments of finished product to be picked up at the manufacturing site or remote locations totally under the control of the sales group..
The question of concern during the Stage 1 was if the purchasing process in scope or out of scope? The purchasing group services the other seven out of scope business units not just the one going through certification to ISO 9001.
If the raw materials were to be considered "customer owned materials", I believe the case could be made to keep purchasing out of scope as the manufacturing unit is acting as an independent tolling processor.
Once raw materials are on site, their local inventory and manufacturing controls are in place to cover all requirements under 8.5.3. Typical purchasing controls under 8.4.1(a) applying to raw materials are addressed using receipt of Certificates of Analysis of the chemical used in the processes. This control has been agreed and accepted by the R&D, part of the chemical sales group as adequate. Under 8.4.2(c)(2) and (d), the chemical group does monitor its own processes and finished product batches to assure the provided raw materials performed as expected.
Please note the (finished) chemical sales group is the customer of the chemical manufacturing unit and the provider of the chemical raw materials.
