Corrective & Preventative Actions- GMP102

• Site conducted

  Derby

  Bengaluru

  Mazeres

• Conducted on

  Date

• Auditor

• Process

• Part number

Corrective Actions

• Is there a procedure that details the control of Corrective Actions?

  Yes

  No

  N/A

• Does the procedure identify control of Internal, Supplied and External non-conformance?

  Yes

  No

  N/A

• Are parts that require Corrective Actions quarantined or segregated pending investigations?

  Yes

  No

  N/A

• Does the procedure clearly identify when Corrective Actions are required?

  Yes

  No

  N/A

• Are NCR's raised as part of the investigation

  Yes

  No

  N/A

• Do the above clearly define the "Corrective Actions" needed?

  Yes

  No

  N/A

• Have the NCR's been agreed/approved by the Quality Manager/Representative?

  Yes

  No

  N/A

• Are Corrective actions closed out within timescales determined?

  Yes

  No

  N/A

• Is there a Corrective Action Log available?

  Yes

  No

  N/A

• Does the procedure identify method of capturing Corrective Actions following Audits?

  Yes

  No

  N/A

• Are Corrective Actions periodically analys

  Yes

  No

  N/A

Preventative Actions

• Is there a procedure for Preventive Action?

  Yes

  No

  N/A

• Does the procedure define what constitutes as Preventive?

  Yes

  No

  N/A

• Does the procedure define the responsibility for this process?

  Yes

  No

  N/A

• Does the procedure provide details of methods of addressing Preventative Actions?

  Yes

  No

  N/A

• Does the procedure detail what format is used to capture such actions?

  Yes

  No

  N/A

• Are there records of Preventative Actions being performed?

  Yes

  No

  N/A

• Are Preventive Actions continually monitored?

  Yes

  No

  N/A

• Auditor

  Sign

• Name of Auditee

• Signature of Auditee. Any NCRs have been accepted as a true reflection of any findings

  Sign