How to connect NCMR, Deviations and Change Control ?

SGquality

Quite Involved in Discussions
#1
I am faced with a big confusion - we have Nonconforming material reports, Deviations (Planned and Unplanned) and Change Control in our system.

When all these were introduced, little did was realized to the enormous confusion that we are in now; so we plan to overhaul the system.

The confusion comes when there is a nonconfreming material - what do we raise - a NCMR or a Unplanned Deviaition and likewise in case of any prospective changes, do we raise a Planned Deviation or a Change Control ?

Could you pls advice on path forward from a medical device perspective ?

:thanx:
 
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I

isoalchemist

#2
:2cents:I've always thought of NCMR as material that has been made and needs to be handled. Tis would include unplanned deviations, because if they were unplanned you probably made the material.

Planned deviations were documented with rational (risk) and updated instructions as required if the change was to be temporary.

Change Control was reserved for permanent changes.
 

John Broomfield

Leader
Super Moderator
#3
I am faced with a big confusion - we have Nonconforming material reports, Deviations (Planned and Unplanned) and Change Control in our system.

When all these were introduced, little did was realized to the enormous confusion that we are in now; so we plan to overhaul the system.

The confusion comes when there is a nonconfreming material - what do we raise - a NCMR or a Unplanned Deviaition and likewise in case of any prospective changes, do we raise a Planned Deviation or a Change Control ?

Could you pls advice on path forward from a medical device perspective ?

:thanx:
isoal,

Product nonconformity results in product design change per clause 7.3.7 if dispositioned as repair or use as is. Scrap or rework to the original spec are not product design changes but may be costly enough to invoke corrective action.

Product, process or system nonconformity may result in corrective action per clause 8.5.2 to stop recurrence.

Planned process deviations are process design changes and will need the rigor of clause 7.3.7 (incl validation) to prevent the change from resulting in nonconforming product.

You could further simplify by removing the M from NCMR and using your NCR procedure for all instances of nonconforming product.

John
 
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