The functional safety lifecycle management audit is a mechanism used to help reduce systematic problems from appearing in the design of a product. In the case of the manufacturing process, the quality control measures that go into the process dictate the quality of the product coming out. Many of these measures may be procedural in nature, and tied to documentation related to the product specification or functional safety standard to which the product aspires. The functional safety lifecycle management audit looks at those elements of the manufacturer’s process that may impact the quality of the safety of the product being produced.
Functional safety management concerns both the development of new products and the maintenance of safety processes for released products to make sure that any changes in the product or failures in the field are considered carefully and correctly, and, when indicated, prompt modifications in accordance with the functional safety requirements.
“我们为客户进行此审核的主要原因是他们生产了与安全有关的功能安全系统，”承销商实验室（UL）功能安全性的首席工程师Thomas Maier说。“他们需要遵守行业标准才能竞争。”
这个怎么运作
First in consideration are the requirements of the standard itself. (The principal functional safety standard, IEC 61508, and its derivative standards define the requirements being audited for compliance.*) The standard has clear requirements about functional safety management that include those relating to:
“当UL进行安全审计功能,我们马ke sure that all requirements are covered so the customer is in compliance with the standard,” says Maier. “The overall goal is to have the audit as part of the safety case to make sure that functional safety is maintained throughout the complete lifecycle of the certified product.”
UL首先要处理标准中所述的要求，并将其与产品和过程文档，质量管理系统以及制造商组织中的文档进行比较。他们还希望“超越纸质”来识别和查询适当的个人，以评估他们对功能安全要求的理解，不仅可以对文件和演示的准确性和有效性获得信心，而且还对组织和组织使用功能安全原则的使用以及作为其文化的一部分生活。
“审计n integral part of functional safety certification,” says Anura Fernando, research engineer, predictive modeling and risk analysis, at UL. “If you consider the drivers for functional safety certification, you’ll see that they are largely the same for functional safety management audits. But there is a slightly different flavor to functional safety management audits. It is possible to do only functional safety management audits for a company (i.e., perform them without the goal of certification).”
Such audits are typically relevant for organizations, or parts of organizations, that use and operate safety-critical systems (such as refinery plants, offshore oil/gas platforms). IEC 61508 and the derivate standards have functional safety management requirements for both development, operation and maintenance of safety-critical equipment, covering its entire life-cycle in fact.
But functional safety management audits may also have internal quality initiatives as drivers. “The vast majority of the certification projects that I have been involved in have resulted in process improvements for the manufacturers as a result of the audit,” says Fernando. “Going through the requirements in the standards helps identify gaps in the manufacturing process. This leads naturally to process improvement as a result of compliance.”
One of the useful tools in the audit is application of the V-model-based approach to product development. The V-model approach is common good practice in the development of complex systems. On the left side of the V is the development path; on the right side is the verification path. For every step of development, corresponding verification or validation must take place.
“The V-model is concerned with product development; as such, it is an integral part of overall functional safety management,” says Maier. “Functional safety has requirements for—and impacts on—the complete lifecycle of the product or system, not only on the development of the system, but also to functional safety management as it applies to other parts of the system lifecycle: processes and phases before system development, and processes and phases after system development. In fact, the V-model is a very good tool to fulfill the functional safety management requirements as they apply to the development of the product.”
Other Audit Considerations
While the length of a functional safety management audit depends on a product’s and organization’s complexity, typically UL completes the on-site portion of the audit in one to three days. Part of the reason UL conducts the on-site audit is to reduce the impact of the audit on a company’s resources, only calling on personnel when they are specifically needed to address a portion of the audit and minimizing interference with daily operations. To further this goal, UL conducts a gap analysis prior to conducting the actual audit, which helps prepare the customer for the audit, increases first-pass success rates, and minimizes the number of non-conformities.
Maier说：“客户通常会对功能安全管理审核感到惊讶。”“有些人认为这很痛苦；但是，在此过程之后，从运营效率和UL功能安全性列出或认可的商标的营销价值迅速感知到附加的价值。”
Functional safety management is an integral component of the UL Functional Safety Mark, and UL requires that it do an audit triennially. “This matches the revision cycle of the IEC, and also acknowledges how organizations change. These are dynamic times. People leave companies or change positions. So it’s not only reasonable to have regular, repeat audits—it’s in the interest of the organization,” he concludes.
For more information on functional safety management audits, please contact:
Kevin Connelly
631-546-2691
kevin.connelly@us.ul.com
Or go to the web:www.ul.com/functionalsafety
*注意：客户必须指定已发布的标准和安全评级（例如，安全完整性级别[SIL - IEC或EN]，绩效级别[PL - ISO]或类[UL]），以承保实验室的实验室，以测试和评估功能安全。客户应该了解其目标市场或特定用法，因此对目标SIL，PL或类别的班级有期望。
