Testing & Inspection & Shipment Release QMSP - Internal Audit

• Site conducted

  Select

• Conducted on

  Date

• Prepared by

• Location
  Address

• Reference 'Testing, Inspection and Shipment Release' QMSP

• Ref ISO 9001 QMS Requirements - Clause 8.4.1 a and b/Clause 8.6 a and b/Clause 9.1.3 a

Goods-In Inspection

• Ref ISO 9001 QMS Requirements - Clause 8.4.1 a

• Reference 'Primary Goods in Inspection & Quality Control 'SOP

• Reference 'CHU Goods In' SOP

• Are reagents awaiting inspection appropriately labeled

  Yes

  No

  N/A

• Is the goods-in inspector wearing appropriate PPE

  Yes

  No

  N/A

• Have all Primary QC checks been implemented and entered into the Reagent Database

  Yes

  No

  N/A

• Has lot/batch expiry date been entered if applicable

  Yes

  No

  N/A

• Have H&P phrases been checked against the reagents database

  Yes

  No

  N/A

• Is the Inspector aware of the secondary QC Quarantine on receipt protocol

  Yes

  No

  N/A

• Are CHU and the goods-in inspector aware of the procedure for handling QC failed material

  Yes

  No

  N/A

• are QC passed reagents appropriately labeled

  Yes

  No

  N/A

Good-In Inspection

• Reference 'Secondary Quality Control' SOP'

• Can chemists demonstrate the ordering process for reagents that require secondary QC

  Yes

  No

  N/A

• Are compounds for secondary QC correctly labeled and Quarantined

  Yes

  No

  N/A

• are reagents destined for secondary QC assigned allocated a Quarantine location in the reagents database

  Yes

  No

  N/A

• are secondary QC passed reagents appropriately labeled

  Yes

  No

  N/A

• are secondary QC failed reagents appropriately labeled and quarantined

  Yes

  No

  N/A

• are analytical results appropriately annotated 'QC Passed'

  Yes

  No

  N/A

COA Requests and Non Urgent Purity Checks

• Reference 'Analytical samples' SOP

• are compounds correctly labeled and Quarantined

  Yes

  No

  N/A

• are the results of the checks recorded and actioned

  Yes

  No

  N/A

Goods-Out Quality Control

• Ref ISO 9001 QMS Requirements - Clause 8.6 a and b

• Reference 'Order Packing, Goods Out & Quality Control 'SOP

• Reference 'Order Processing' SOP'

• Are CHU staff checking compound appearance and state during the order picking process

  Yes

  No

  N/A

• are shipment release checks carried out by CHU prior to handing to Customer Services for shipping

  Yes

  No

  N/A

• is the shipment release form completed by CHU

  Yes

  No

  N/A

• are CHU pre-shipping checks completed

  Yes

  No

  N/A

• are office pre-shipping checks completed

  Yes

  No

  N/A

• is all pre-shipping paperwork complete and stamped 'QC Passed'

  Yes

  No

  N/A

General

• are staff aware of the procedure for reporting QC fails using the CRM Cases procedure

  Yes

  No

  N/A

• are Chemistry staff aware that QC Passed labels should be on containers received via the Primary and Secondary QC procedures

  Yes

  No

  N/A

• Yes

  No

  N/A

Finished Product Inspection

• Ref ISO 9001 QMS Requirements - Clause 9.1.3.a

• Reference 'Analytical Dept Quality Control' SOP

• Reference 'Analysis for COA' SOP'

• Reference 'Analytical Batch Data' SOP

• Is QC passed NMR data annotated 'QC passed' by the Analytical Dept

  Yes

  No

  N/A

• are test results stored in the correct locations

  Yes

  No

  N/A

• do CHU check test results are annotated 'QC passed'

  Yes

  No

  N/A