02 - Internal Audit - Enquiry / Quote / Order Processing

• Site conducted

  Select

• Audit Number

• Conducted on

  Date

• Auditor

• Auditee

Order Enquiry

• How do you normally receive enquiry requests?

• How do you know if the enquiry has been actioned - Completed?

• What information do you need to start the enquiry process?

• What do you do if this information is not available?

• What do you do if this is a new customer?

• Is an agreement required with the customer before producing products with them?

  Yes

  No

  N/A

• What is required when setting up a new customer on the system?

• What do you do if this is a new part?

• How would you look at developing the route for the new part?

• How would you develop the bill of materials?

• Would you do anything specific if the part is outside our normal manufacturing knowledge / Customer base?

• What do you do if the material used is not on the system?

• What do you do if there is a Sub-contract process?

• What do you do if our current suppliers can not provide the service we require?

• When is a contract review conducted for the enquiry?

• Check for a completed sample at random, has this been completed?

  Yes

  No

  N/A

• How do we set our lead times to the customer?

• How long are our quotes valid for?

• How is this communicated to the customer?

Quote Production

• What information is required for a quote to be produced?

• Do you produce a quote for all customers orders?

  Yes

  No

  N/A

• Does this include repeat orders?

  Yes

  No

  N/A

• How are repeat orders processed?

• Do you know at this stage if there are any quality documentation requirements?

  Yes

  No

  N/A

• Are these costed within the quote?

  Yes

  No

  N/A

• If the customer has standard quality related requirements are these taken into account on the quote?

  Yes

  No

  N/A

• Are Price lists used for any of the customers?

  Yes

  No

  N/A

• How are these setup and managed?

• Is there any special reductions applied to specific customers?

  Yes

  No

  N/A

• How is this controlled and captured?

• How is the quote sent to the customer?

• Can you tell if it has been sent to the customer?

  Yes

  No

  N/A

• Do you re-quote if any changes are made by the customer and is this documented?

  Yes

  No

  N/A

• Do you have an example?

• Do you review the Quotes produced?

  Yes

  No

  N/A

• What do you review?

Order Received

• How are customer orders normally received?

• What is acceptable as a customer order?

• How do you know if these have been processed and none have been missed?

• What do you check on the customer order?

• Is this recorded?

  Yes

  No

  N/A

• What do you do if this does not match the quote or price list?

• Do you ever decline a customer order at this stage?

  Yes

  No

  N/A

• Why would you decline at this stage and do you have an example?

• How do you communicate this back to the customer?

• How do you create the sales order on the system?

• Who processes the order on the system?

  Yes

  No

  N/A

• Is the customer order contract reviewed before any works orders are raised?

  Yes

  No

  N/A

• What is covered as part of this review?

• Look for a random example of this being completed, has it been completed correctly?

  Pass

  Fail

  N/A

• Who can authorise a contract review once completed?

• How is the delivery date communicated to the customer?

• Is there a way to see if this has been completed?

• How do you calculate when we can deliver the items?

• What do you do if the date changes for any reason?

• How is the sales order communicated to the shopfloor?

Change Control

• How are changes from the customer captured?

• What would you do if the job is already in production?

• How do you communicate this to the business / production?

• How would we communicate a change from our end to the customer?

Documentation / Risk Assessment / Training

• Do you know if control plans are required as part of the customer order?

  Yes

  No

  N/A

• How are PFMEA's triggered if required?

• How are customers specifications communicated to production if provided?

• What training records are available for the processing being conducted?

Customer Satisfaction / Performance

• How do we capture our customers satisfaction?

  Yes

  No

  N/A

• Do we review our performance with our customers?

  Yes

  No

  N/A

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

• ISO 13485 - 6.1 Provision of Resources

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 6.2 Human Resources

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 6.3 Infrastructure

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 7.1 Planning of Product Realization

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 7.2.1 Determination of the requirements related to product

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 7.2.2 Review of Requirements related to product

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 7.2.3 Communication

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 7.4.1 Purchasing Process

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 7.5 Production and service provision

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 7.5.1 Control of production and service provision

  Compliant

  Non-Compliant

  N/A

• ISO 14385 - 8.5.3 Preventive action

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 6.1 Actions to address risks and opportunities

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 7.1.1 General - Resources

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 7.1.2 People

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 7.1.3 Infrastructure

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 7.2 Competence

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 7.3 Awareness

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 8.1 Operational planning and control

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 8.2.1 Customer communication

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 8.2.2 Determining the requirements for products and services

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 8.2.3 Review of the requirements for products and services

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 8.2.4 Changes to requirements for products and services

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 8.4.2 Type and extent of control

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 8.5 Production and service provision

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 8.5.1 Control of production and service provision

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 10.1 General - Improvement

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 10.3 Continual improvement

  Compliant

  Non-Compliant

  N/A