From Bob Ablondi:
Here is how I wrote in the QA manual how we implement the process measurables of 8.2.3: The company performs process studies on all new manufacturing (including assembly or sequencing) processes to verify process capability and to provide additional input for process control. The results of process studies are documented with specifications, where applicable, for production, measurement and test, and maintenance instructions. These studies include objectives for manufacturing process capability, maintainability and availability, as well as acceptance criteria. The organization maintains manufacturing process capability or performance as specified by the customer part approval process requirements or the procedures identified in the AIAG, Production Part Approval Process (PPAP) Reference Manual. The organization ensures that the control plan and process flow diagram are implemented according to the applicable sections of the AIAG Advanced Quality Planning and Control Plan (
APQP) Reference Manual, including adherence to the specified:
a) measurement techniques;
b) sampling plans;
c) acceptance criteria;
d) reaction plans when acceptance criteria are
not met.
Significant process events such as tool change, machine repair are noted on the SPC charts in accordance with the guidelines of AIAG Statistical Process Control (SPC) Reference Manual. Production Management initiates a reaction plan for characteristics that are „out of control i.e., CpK is less than 1.33‰ or exceeds the upper or lower specification limits. These reaction plans include containment of product and 100% inspection as appropriate. The Production Management, indicating specific timing and assigned responsibilities to assure that the process becomes stable and capable, and if necessary, will complete a corrective action plan. The plans shall be reviewed with and approved by the customer when so required. The organization shall maintain records of effective dates of process change resulting from the corrective taken.
