Manufacturing and inspection processes are normally qualified by performing a relatively short, statistically designed production campaign, within and beyond the proposed process limits. The product is then inspected thoroughly to determine whether it meets the specified level of product quality. As the process matures, subsequent changes to the process may require requalification.
This practice, standard at all suppliers, must be audited to ensure that the effort accurately reflects the operational process conditions and is statistically appropriate. This is achieved through an audit of the qualification process and Qualification Plans. The qualification activities are then audited to assure that the product was properly manufactured, inspected and characterized. Finally, the results of the qualification program (in the form of Qualification Reports) are also reviewed to ensure the product meets the specification and drawing requirements.
This practice, standard at all suppliers, must be audited to ensure that the effort accurately reflects the operational process conditions and is statistically appropriate. This is achieved through an audit of the qualification process and Qualification Plans. The qualification activities are then audited to assure that the product was properly manufactured, inspected and characterized. Finally, the results of the qualification program (in the form of Qualification Reports) are also reviewed to ensure the product meets the specification and drawing requirements.