06 - Internal Audit - Inspection and Test Process

• Site conducted

  Select

• Audit Number

• Conducted on

  Date

• Auditor

• Auditee

• Audit covering the various inspection processes conducted and any testing requirements. This audit also covers the QC department controls and operations. This audit covers the requirements of both ISO 9001 and ISO13485.

Types of Inspection

• What types of inspection do you conduct?

• What do you do differently if a FAIR inspection is required?

• How do you know when this is required?

• Do you monitor the shop floor to help with any planning?

  Yes

  No

  N/A

• Who would normally conduct in-process inspection?

• When would inspection conduct a First off?

• What do you do for Laser Marking inspection?

Final Inspection and Reporting

• How do you know what items are due for inspection today?

• How do you prioritise these through inspection?

• How is the work flow managed into the department?

• Do you know what type of Inspection is required for each customer?

  Yes

  No

  N/A

• Is this documented?

  Yes

  No

  N/A

• What would trigger CTQ's being produced?

• How are CTQ's documented if required?

• How do you know what measurements are CTQ measurements?

• What quantity is inspected for CTQ reports?

• What would trigger FAIR's to be created?

• What information is captured for a FAIR?

• How is this documented?

• How many items do you inspect for the FAIR?

• How are CTQ's and FAIR's communicated to the customer?

• Where is the CTQ and FAIR information stored?

• Do you know at the time of inspection if there is a CMM or Keyence Program?

• How do you know what inspection equipment to use during the inspection process?

• How is the normal inspection requirements captured as complete?

• Where are the Q074's stored once scanned?

• Check a sample of completed works orders for stored Q074's. Are these available?

  Yes

  No

  N/A

• How do you know if the tools for measurement have been calibrated when you are using them?

• Can you see on the system when these were last calibrated?

  Yes

  No

  N/A

• Can you see how many times these have been used since the last calibration?

• Can you see a list of items coming up for calibration?

• How do you decide if an item is calibrated internally or sent out for calibration?

• How is internal calibration conducted?

• How are the results logged in the system?

• What do you do if the item fails internal calibration?

• Yes

  No

  N/A

• How are items externally calibrated?

• Who do you send the items to?

• Are these UKAS approved or reference back to national standards?

• How is externally calibration items captured on the system?

• Are calibration certificates available for a sample of items?

• What do you do is these fail during calibration?

• What items are inspected at goods inwards?

• What information do you need to conduct any goods inwards inspection?

• How do you know what the material is when booking it in?

• What do you do if the documentation is incorrect or not available?

• What do you do if the items are incorrect or damaged on receipt?

• Can you see what is expected to be delivered today?

  Yes

  No

  N/A

• How are the items booked in?

  Yes

  No

  N/A

• Where are the items stored once booked in?

  Yes

  No

  N/A

• How is this communicated to production?

  Yes

  No

  N/A

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

• ISO 13485 - 4.2.5 Control of records

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 7.1 Planning of product realisation

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 7.2.3 Communication

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 7.5.1 Control of production service

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 7.6 Control of monitoring and measuring equipment

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 8.2.2 Complaint handling

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 8.2.5 Monitoring and measurements of process

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 8.2.6 Monitoring and measurements of product

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 8.3 Control of nonconforming product

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 8.3.3 Actions in response to nonconforming product detected before delivery

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 8.3.3 Actions in response to nonconforming product detected after delivery

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 8.5.1 General - Improvement

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 8.5.2 Corrective action

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 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 - 7.1.5 Monitoring and measuring resources

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 7.5.2 Creating and updating

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 7.5.3 Control of documented information

  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 - 8.5.1 Control of production and service provision

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 8.6 Release of products and services

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 8.7 Control of nonconforming outputs

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 9.1.1 General - Monitoring, measurement, analysis and evaluation

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 9.1.2 Customer satisfaction

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 10.1 General - Improvement

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 10.2 Nonconformity and corrective action

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 10.3 Continual improvement

  Compliant

  Non-Compliant

  N/A

• Compliant

  Non-Compliant

  N/A