Key Points

The Full Volume Confirmation Audit Results document shows the results of a full volume confirmation audit carried out by the supplier prior to the start of production.

Minimum Content Requirements

The document content shall provide evidence that:

• All personnel associated with the manufacture of the product (production staff, material handling & warehouse staff, inspection staff etc.) are fully trained to the required skill level
• All raw materials, components and sub component assemblies are controlled.
• All production and inspection facilities and equipment are maintained and calibrated
• All process documentation is in place and reflects the correct product design level.
• All necessary packaging materials are available
• The manufacturing location and its surroundings have no negative impact on the product
• The actual cycle times for all processes match the predicted cycle times quoted in the Production Capacity Plan
• The manufacturing output (straight through ratio, OK ratio etc.) matches the required manufacturing output detailed in the Supplier Production Preparation Monitoring Plan
• The actual tool change and set-up times match the predicted times quoted in the Production Capacity Plan

If any concerns are identified during the Full Volume Confirmation trial, they should be documented in the Full Volume Confirmation Audit Results document. Countermeasure actions including implementation timing, responsibilities and confirmation activities must be documented for all concerns.

For rules related to document submission, refer to the Submission Rules page.