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SMT007-Oct2020

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84 SMT007 MAGAZINE I OCTOBER 2020 A New Approach to Supplier Qualification After COVID-19 Traditional supplier qualification processes have been forced to rapidly change to new approaches as suppliers have been affected by shelter-in-place directives across the globe. On-site supplier audits are no longer a viable method to review a supplier's facility and con- trols. Customers have been forced to rely on the supplier self-audit checklist, resulting in higher scrutiny of supplier quality procedures and increased incoming quality inspection of first article or pilot production lots. These mitigation steps add a higher level of administrative burden to customers by cre- ating non-value-add activities that may not result in proper risk assessment. The need to reconfigure supplier qualification processes is a top priority for many manufacturing organi- zations. Before we discuss process effective- ness qualification reviews, let's go over the fundamentals of assessment definitions of con- formance, effectiveness, risk, and intellectual property (IP). Conformance vs. Effectiveness The traditional ISO-based self-audit check- lists, where quality system documentation is provided by a supplier, confirms that the sup- plier has a quality system in place. Confor- mance to a quality system standard is impor- tant, as it informs the supplier qualification team that procedures are in place and objec- tives have been defined. However, it does not indicate that procedures have been effectively implemented nor if the process is monitored to achieve process or quality objectives. The def- inition of "effectiveness" is the ability to meet objectives and be successful in producing the desired result. Thus, supplier qualification requires an effectiveness review to properly assess the risk of working with a supplier [1] . Process Effectiveness Qualification Operational Excellence by Alfred Macha, AMT PARTNERS

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