Process validation and standards compliance
Process validation and standards compliance
Bjarne Møller and Henry Jurgens, Ph.D., P.Eng., Valor Division of Mentor Graphics Corp.
Failing a customer process audit is something no organization wants to be faced with. Ensuring that your manufacturing site continu- ously receives high marks in such audits is critical to retaining the business of key accounts.
Keywords: Process Validation, Standards Compliance,
Manufacturing Process Definition, Build Record, Material Management, Resource Management
Introduction Manufacturers of printed circuit boards and electromechanical systems are con- tinually challenged with validating their assembly and test processes. Aside from the fact that it is good practice to assure that their manufacturing plants are run- ning in an optimal manner and that they are producing high quality products for the market, a manufacturing operation has other drivers, such as compliance with industry standards and passing regular process audits run by their customers. Te ability to prove that a site is certified to a plethora of different standards, such as quality management system standards like
ISO 9001 and the industry specific versions such as AS 9000 for aerospace, ISO/TS 16949 for automotive, TL 9000 for the tele- com industry, and ISO 13485 for the medi- cal industry, can differentiate a manufac- turer from the competition and can be key in opening up potential new markets for their services. Failing a customer process audit is something no organization wants to be faced with. Ensuring that your manu- facturing site continuously receives high marks in such audits is critical to retaining the business of key accounts. In today’s dynamic world of electronic
manufacturing, which is challenged by an ever increasing level of complexity, it is
Figure 1. An MES system needs to be able to present data and controls in real time.
14 – Global SMT & Packaging – February 2011
www.globalsmt.net
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