ESD is more than the “static shock” we experience in our everyday lives. As micro-circuit architecture becomes smaller and more complex, ESD sensitive devices become more susceptible to damage resulting from an electrostatic event. For electronics manufacturers, an ESD event may cause damage to the product, rendering it useless or dramatically reducing the performance life.
What is ESD S20.20
Electronic component handlers, manufacturers and distributors need to be aware of and apply effective ESD controls when handling, manufacturing, marking, packaging and labeling these sensitive devices. The product realization process must be robust if it is to prevent a static event and product damage throughout the product realization chain.
The first step is external control of inbound product at the supplier. An organization needs to be vigilant in determining the nature of their supplier’s ESD program. Evidence of the program’s reliability should be readily available. The next step is to assess all areas in the organization’s internal product realization chain, where product is or may become vulnerable to an
ESD event. These must be clearly identified and properly controlled. It should be noted that one complaint from a field failure could have a devastating effect on the company’s ability to maintain operations, jeopardizing future success. ESD can impact:
- Production yields
- Manufacturing costs
- Product reliability
An independent, third party assessment can help organizations not only identify areas of weakness, but help to prevent ESD occurrences. ESD audits are typically 1 day and occur annually. They are easily integrated with any current QMS certification assessment and can be performed simultaneously, prior or subsequent to this assessment. There are a number of benefits of implementing the ESD program and having it certified by a third party registrar. A key benefit is reduced risk of damage to an ESD sensitive device. An ESD program will help reduce product failure and improve product reliability. Improved ROI is the result of reduced work-in-progress from test failures and reduced warranty liabilities from field failures.
The process starts with the client’s needs and expectations. DQS wants to learn about the client’s organization, its management system, size and types of operation. Together both parties will define objectives for the assessment and/or certification, including applicable standards and specifications.
DQS will provide a detailed offer for assessment and certification services, tailored to individual client needs, based on the information provided initially. A written contract will specify all relevant deliverables as well as applicable assessment and certification criteria.
A pre-audit can serve as initial performance or gap analysis, identifying strengths and areas for improvement. For larger assessment and certification projects a project planning meeting provides a valuable opportunity for the client to meet the lead assessor and develop a customized assessment plan for all functions and locations involved. Both services are optional.
The assessment procedure itself begins with review and evaluation of system documentation, goals, results of management review and internal audits. During this process, it will be determined whether the client’s management system is sufficiently developed and ready for certification. The assessor will explain findings and coordinate any required activities to prepare for the on-site system assessment.
The assigned auditor team will audit the client’s management system at the place of production or service delivery. Applying defined management system standards and specifications, the assessment team will evaluate the effectiveness of all functional areas as well as all management system processes, based upon observations, inspections, interviews, review of pertinent records, and other assessment techniques. The audit result, including all findings will be presented to the client during the closing meeting. Required action plans will be agreed upon as necessary.
The independent certification function of DQS will evaluate the audit process and its results, and decide independently about issuance of the certificate. The client receives an audit report, documenting the audit results. When all applicable requirements are fulfilled the client also receives the certificate.
Either semi-annually or at least once per year, there will be an on-site audit of the critical components of the management system. Improvement potential will be identified, with a focus on continual improvement and sustained effectiveness.
A management system certificate is valid for a limited period of time, frequently for a maximum of three years. At the end of this cycle, a re-audit will be carried out to ensure the ongoing fulfillment of all applicable requirements. Subject to this fulfillment, a new certificate will be issued.
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