Hello Daron, in my laboratory we are not a lot people total only 14 staff. Mostly as our experience we do it together depends on that NCE related to who's responsible:
Who is the witness, that person should provide information or record NC form and or he/she can record by his/herself or report to lab manager or quality officer to record it.
Immediate or remedially action it depends on who does what at that situation.
Corrective action: should be leaded by the responsible of that task/activity.
Root cause analysis mostly is the lab manager / managers and quality officer do it together.
Trend analysis of all NCEs for the management review is performed by quality officer and others staff related if needed.
In our laboratory practice , it is the responsibility of the one who identify the NC to register ,report & take immediate action . If it need further CA or RCA it is section supervisor and/or quality officer responsibility depending on the type of NC .The standard not put who is responsible but require documented procedure and appropriate measure to manage the NC.
It should be anyone who identifies the NCs However ISO 15189:2022 Clause 7.5 (a)requires the responsibilities and authorities for the management of nonconforming work to be specified; In our Lab we stated that anyone can identify and document NCs and institute immediate action However it must be presented to Quality Officer who will document it in the NC log , conduct risk assessment and assign someone to conduct root cause and corrective action , Quality Officer has the ultimate responsibilities for management all NCs
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Hello Daron, in my laboratory we are not a lot people total only 14 staff. Mostly as our experience we do it together depends on that NCE related to who's responsible:
In our laboratory practice , it is the responsibility of the one who identify the NC to register ,report & take immediate action . If it need further CA or RCA it is section supervisor and/or quality officer responsibility depending on the type of NC .The standard not put who is responsible but require documented procedure and appropriate measure to manage the NC.
It should be anyone who identifies the NCs However ISO 15189:2022 Clause 7.5 (a)requires the responsibilities and authorities for the management of nonconforming work to be specified; In our Lab we stated that anyone can identify and document NCs and institute immediate action However it must be presented to Quality Officer who will document it in the NC log , conduct risk assessment and assign someone to conduct root cause and corrective action , Quality Officer has the ultimate responsibilities for management all NCs