PCB007 Magazine

PCB-Apr2018

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APRIL 2018 I PCB007 MAGAZINE 41 The organization shall demonstrate the com- petence of the auditors undertaking the sec- ond-party audits. When supplier monitoring requires periodic second party surveillance au- dits, the audits shall be conducted at least an- nually. Records of the second-party audit re- ports shall be retained. Supplier Development This section adds an emphasis on perfor- mance-based suppli- er development activi- ties. Supplier monitor- ing processes should be considered an input to the supplier devel- opment activities and consider both short- term and long-term goals. Short-term ef- forts focus on supplier products and would re- quire defining suitable methods to assure the quality of purchased product from each sup- plier. Long-term efforts focus on the supplier's QMS and manufacturing processes to reduce risk. Preservation Preservation controls include: the preserva- tion of identification during the product shelf life; a contamination control program appro- priate to identified risks; design and develop- ment of robust packaging and storage areas; adequate transmission and transportation con- siderations; and measures to protect product integrity. Control of Reworked Product This increases the scope of control of re- worked product requirements to include: cus- tomer approval, risk assessment, rework con- firmation, traceability, and retention of doc- umented information. The risk analysis and customer approval requirements are interrelat- ed; FMEAs should identify and address risks related to each possible rework of the charac- teristics stated in the control plan. Supplier Selection Process Automotive specifically calls out supplier se- lection process criteria, in addition to clarify- ing that it is a comprehensive process much more detailed than ISO. The assessment used to select suppliers needs to be extended be- yond typical QMS au- dits and include aspects such as: risk to product conformity and uninter- rupted supply of the or- ganization's product to their customers, etc. Type and Control of External Providers Simple scorecards are not adequate as this re- quirement implies a constant monitoring of performance and as- sessment of risk based on the established crite- ria, triggering the actions to increase or reduce the types and extent of control. This applies to all Suppliers. Statutory and Regulatory Requirements Identification of applicable statutory and regulatory requirements needs to consid- er the country of receipt, shipment, and de- livery. Consideration should be developed for the product "Life Cycle". When special con- trols are required, the organization must im- plement these requirements and flow those re- quirements down to their suppliers. Supplier Monitoring Organizations should continuously review inputs and introduce improvement actions re- garding supplier monitoring data, as needed. Documented and non-documented yard holds and stop ships should be considered custom- er disruptions, and the number of premium freight occurrences need to be monitored. Second-Party Audits You will need to ensure that supplier moni- toring includes a second-party audit process.

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