04 - Internal Audit - Goods Inwards and Stock Management

• Site conducted

  Select

• Audit Number

• Conducted on

  Date

• Auditor

• Auditee

• Audit covering the controls of goods inwards and the storage, handing and traceability of stocked items. This audit covers the requirements of both ISO 9001 and ISO13485.

  Drawing

• Are you able to see what items are due into us?

• Can you see all open purchase orders?

• How are raw materials checked when they are received on site?

• What in formation is required to enable them to be booked in?

• How do you check that what was delivered matches the purchase order?

• How are these identified once booked in?

• Where are these stored once booked in?

• Check on the system some batches and make sure correct documentation is stored on the system?

• How are bought in parts received onsite?

• What checks if any are made on the items?

• What information is required to book these in?

• Should certain items be fully inspected?

  Yes

  No

  N/A

• How are these identified once booked in?

• Where are these stored?

• Check on the system some batches and make sure correct documentation is stored on the system?

• What do you do if the items are incorrect or poor quality?

• Can you see what has been rejected?

  Yes

  No

  N/A

• How are these returned to the supplier?

  Yes

  No

  N/A

• How are returned items booked back into stock?

  Yes

  No

  N/A

• Do rejected items change the suppliers performance?

  Yes

  No

  N/A

• Do you change the received date if the items were not booked in on the day of delivery?

Raw Materials / Bar Stores

• Is there anything waiting to be booked in?

  Yes

  No

  N/A

• Check that the documentation is available and correct?

  Yes

  No

  N/A

• Check the Bar stores, is the area tidy?

  Yes

  No

  N/A

• Are items stored correctly and safely?

  Yes

  No

  N/A

• Check some batches for the following? - Note the batches checked

• Correct material

  Yes

  No

  N/A

• Correct quantity

  Yes

  No

  N/A

• Correct location

  Yes

  No

  N/A

• System matches the physical batch

  Yes

  No

  N/A

• Documentation is available (Cast number / delivery note correct)

  Yes

  No

  N/A

Finished Goods / Bought in Parts

• Is there anything waiting to be booked in?

  Yes

  No

  N/A

• Check that the documentation is available and correct?

  Yes

  No

  N/A

• Check the store room, is the area tidy?

  Yes

  No

  N/A

• Are items stored correctly and safely?

  Yes

  No

  N/A

• Check some batches for the following? - Note the batches checked

• Correct Part number

  Yes

  No

  N/A

• Correct quantity

  Yes

  No

  N/A

• Correct location

  Yes

  No

  N/A

• System matches the physical batch

  Yes

  No

  N/A

• Can the raw materials be traced for the batch checked

  Yes

  No

  N/A

Raw Materials

• Is there any material waiting to be machined? (Check the shop floor)

  Yes

  No

  N/A

• Is this correctly identified?

  Yes

  No

  N/A

• Has this been issued to the intended works order?

  Yes

  No

  N/A

• Is the issued length / quantity correct to the physical items?

  Yes

  No

  N/A

• Is the material correct to the works order it is allocated to?

  Yes

  No

  N/A

• Is there any unused material to be returned to stock?

  Yes

  No

  N/A

• Is this identified correctly?

  Yes

  No

  N/A

• Can the items be traced to the correct raw material batch?

  Yes

  No

  N/A

Bought in Parts

• Has anything been allocated for Assembly?

  Yes

  No

  N/A

• Have these items been picked from stock?

  Yes

  No

  N/A

• Are the items correctly identified?

  Yes

  No

  N/A

• Has the correct quantity been picked?

  Yes

  No

  N/A

• Have these been issued to the works order?

  Yes

  No

  N/A

• Are these correct to the works order?

  Yes

  No

  N/A

• Once audit has been completed review the above findings and complete the following sections.

• ISO 13485 - 7.4.1 Purchasing Process

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 7.4.2 Purchasing information

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 7.4.3 Verification of purchased product

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 7.5.2 Cleanliness of product

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 7.5.8 Identification

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 7.5.9 Traceability

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 7.5.10 Customer property

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 7.5.11 Preservation of product

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 8.4.1 General - Control of externally provided processes, products and services

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 8.4.2 Type and extent of control

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 8.4.3 Information for external providers

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 8.5.2 Identification and traceability

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 8.5.3 Property belonging to customers or external providers

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 8.5.4 Preservation

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 8.6 Release of products and services

  Compliant

  Non-Compliant

  N/A