It will depend a lot on what your purchasing procedure indicates and forms you use etc. It could be picked up via an audit for example, that you have been using the previous issue of a purchase order form. Within the requirements of document control, this should therefore cause a corrective action to be raised. Also a supplier corrective action report (SCAR) should be raised if the resulting order is defective etc – which is typically part of a CAPA system (well it is in mine). There is the traceability aspect to be considered also – i.e. matching the purchase order with goods received and then the route of the item purchased through a device build sequence. So although it can be somewhat subtle, there are process links.
Particular attention must be given to requirements of Process Validation and Work environment, hygiene and heath requirements that are necessary to ensure that the products purchased that have a direct bearing to performance and safety of your medical device are not effected by the lack of it. Where necessary such parameters must be tested and reported by the supplier for every supply made which stands traceable to your final device.
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