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To which part of 13485 does this refer?

01mercy

Involved In Discussions
#1
Hi all,

I would like to know to which part of 13485 this refers.

Say you make an anesthesia formulation. If you produce it you want the formulation to be correct of the materials that go into the formulation.
So on production you make a record of the materials that go into it, volumes etc and signoff for correct production and possible review of it.
In short you want to have evidence that the formulation of the product is correct and can be used.

To which part of the 13485 does this relate? Record control in combination with production process risk assessment?
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Hello 01mercy,

Am I correctly assuming you are in production stage and not the design stage?

If so, this falls under 7.5.1 Control of production and service provision
Production and service provision shall be planned, carried out, monitored and controlled to ensure that product conforms to specification...
a) documentation of procedures and methods for the control of production (see 4.2.4)
 

01mercy

Involved In Discussions
#3
Hello 01mercy,

Am I correctly assuming you are in production stage and not the design stage?

If so, this falls under 7.5.1 Control of production and service provision
Yes that's correct, thank you it makes indeed sense that chapter.
The amount of/which controls needed based on the risk involved which is drawn from the PFMEA correct?
 

Tidge

Trusted Information Resource
#4
The amount of/which controls needed based on the risk involved which is drawn from the PFMEA correct?
Some controls may be required by applicable regulations, other may come from business needs.

Generally, for medical device manufacturing you will also identify necessary controls as part of a 14971-compliant risk management process which considers patient/user risk... there can be other stakeholders too, such as "environment", but 14971 is primarily concerned with the finished device and I am not aware of any medical devices failing certification due to unacceptable environmental risks. If anyone knows of some please let me know!

I leave it to others to offer suggestions about achieving compliance to 14971, but broadly speaking a PFMEA is only going to help analyze risks to/from a specific manufacturing process. Some processes can be critical to safety (sterilization is an ur-example) but for many manufacturers the plant processes or more about making a device that meets an approved Device's Master Record (subject to regulations and business needs).
 
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