Standard Operating Procedure - SOP

Name of institution

Nonconforming Event Management ID Code:

Ap 19

Topic & Purpose: Review Period:

Explains how to manage nonconforming events 1 year

Location: Distribution:

Version number: Annex:

V 1.0 None

Written by:

Name(s), Date(s) and Signature(s) of the Author(s)

Reviewed by:

Name(s), Date(s) and Signature(s)

Authorized by:

Name, Date and Signature

Replaces the version:

Not applicable (1st version)

Changes to the last authorized version:

Not applicable (1st version)
Institution: Version: 1.0 Date: Number of pages: Name of ID Code: Ap19
3 procedure:
Nonconforming QM chapter: 11
Event
Management
Procedure

Nonconforming Event Management Procedure

Application...............................................................................................................2
Objective.................................................................................................................2
Definitions...............................................................................................................2
References..............................................................................................................2
Responsibilities.......................................................................................................2
Operating mode......................................................................................................3
Related documents.................................................................................................3

Application
This procedure ensures proper management of occurrences or nonconforming
events.

Objective
This procedure explains how occurrences or nonconforming events are managed
in the laboratory.

Definitions
Nonconforming event or Nonconformity: Non-fulfilment of a requirement.

Occurrence: An event, accident or circumstance that happened without intent,

volition or plan.

Reportable nonconforming event or occurrence: Nonconforming event or

occurrence to be reported in accordance with the reporting criteria defined in the
SOP Occurrence Report.

References
To be filled in if necessary

Responsibilities
All staff share the responsibility for quality. Therefore, all staff share the authority
and responsibility of:
 identifying non-compliances or possible improvements;

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Institution: Version: 1.0 Date: Number of pages: Name of ID Code: Ap19
3 procedure:
Nonconforming QM chapter: 11
Event
Management
Procedure

 recording nonconforming events so that corrective actions can be

taken in order to correct the immediate situation and prevent
recurrence.

The Laboratory Director:

 approves the Nonconforming Event Management system.

The Quality Committee:

 administers the Nonconforming Event Management system;
 discusses potential corrective actions for nonconforming events that
impact laboratory quality.

The Quality Manager:

 ensures verification of the effectiveness, efficiency, and adequacy of the
Nonconforming Event Management system;
 discusses with staff the direct implications of nonconforming events
concerning quality;
 helps in quick resolution of nonconforming events that negatively impact
quality;
 decides if a nonconforming event is reportable, and fills in the notification
report following the SOP Occurrence Report, if needed;
 carries out investigation to resolve any quality discrepancies;
 ensures that action is taken in order to improve processes/activities.

The Biosafety Committee:

 takes part in discussions of potential corrective actions for all significant
nonconforming events concerning biosafety.

The Biosafety Officer:

 discusses with the staff the direct implications of nonconforming events
concerning biosafety;
 helps in quick resolution of nonconforming events concerning biosafety;
 decides if a nonconforming event concerning biosafety is reportable, and
fills in the notification report following the SOP Occurrence Report, if
needed;
 carries out investigation to resolve any biosafety discrepancies;
 ensures that action is taken in order to improve biosafety
processes/activities.

Operating mode
Describe here the laboratory Nonconforming Event Management system

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Institution: Version: 1.0 Date: Number of pages: Name of ID Code: Ap19
3 procedure:
Nonconforming QM chapter: 11
Event
Management
Procedure

Related documents
SOP Occurrence Report Ref XXX