Documented Information & Traceability- GMP101

• Site conducted

  Derby

  Bengaluru

  Mazeres

• Conducted on

  Date

• Auditor

• Process

• Part number

Documented Information

• Is there a procedure to control the Documents & Records?

  Yes

  No

  N/A

• Does the procedure state who is the responsible person for Records & Documents?

  Yes

  No

  N/A

• Does the procedure allow for review of documents by their customer and others?

  Yes

  No

  N/A

• Does the procedure state what constitutes as "Documents & Records"?

  Yes

  No

  N/A

• Does the procedure identify control of the Quality Manual and changes?

  Yes

  No

  N/A

• Does the procedure identify the distribution of the QMS and Documents?

  Yes

  No

  N/A

• Are documents issued to Sub-Contractors/Suppliers?

  Yes

  No

  N/A

• Does the procedure identify what documents are retained as hard copies and as scanned?

  Yes

  No

  N/A

• Does the procedure identify how documents are kept updated?

  Yes

  No

  N/A

• Does the procedure identify the control of Computer based storage?

  Yes

  No

  N/A

• Is there a record of specifications held and how they are updated?

  Yes

  No

  N/A

Traceability

• Is there a procedure for the control of Goods In?

  Yes

  No

  N/A

• Is incoming material identified?

  Yes

  No

  N/A

• Is incoming material held in clearly defined area pending acceptance?

  Yes

  No

  N/A

• Is the material documentation checked prior to acceptance & by authorised personnel?

  Yes

  No

  N/A

• Is the material checked for size/qty/weight etc?

  Yes

  No

  N/A

• Are additional material tests required following receipt?

  Yes

  No

  N/A

• Has a stock record number been assigned to the material?

  Yes

  No

  N/A

• Has the material documentation been suitably endorsed with stamp and date?

  Yes

  No

  N/A

• Is there a designated area for material that cannot be accepted?

  Yes

  No

  N/A

• Has the material been suitably identified?

  Yes

  No

  N/A

• Has material that’s been accepted been placed in designated area?

  Yes

  No

  N/A

• Is there a procedure for the control of customer supplied material?

  Yes

  No

  N/A

• Is there a procedure to control Full Release Delegation of material?

  Yes

  No

  N/A

• Auditor

  Sign

• Name of Auditee

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

  Sign