What are the rules on Purchase Orders in Medical Device Quality Systems

#1
Dear Coves

can some one provide guidance on what are the rules on the purchase orders within the QMS for a medical device manufacturing ?

does the purchase order process covered by CAPA process ?

QE.
 
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SteveK

#2
Dear Coves

can some one provide guidance on what are the rules on the purchase orders within the QMS for a medical device manufacturing ?

does the purchase order process covered by CAPA process ?

QE.
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. :2cents:

Steve
 
Likes: QE

somashekar

Staff member
Super Moderator
#4
Dear Coves

can some one provide guidance on what are the rules on the purchase orders within the QMS for a medical device manufacturing ?

does the purchase order process covered by CAPA process ?

QE.
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.
 

Ajit Basrur

Staff member
Admin
#5
Dear Coves

can some one provide guidance on what are the rules on the purchase orders within the QMS for a medical device manufacturing ?

does the purchase order process covered by CAPA process ?

QE.
Can you be more specific on your question like what do you mean by "rules" ? Are you looking for the pre-requsites before issuing a PO ?

Yes, why not - I would cover PO process by CAPA.
 
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