Manufacturing companies face relentless pressures building competitive products and operate profitably in an increasingly complex global market. These are challenging enough, especially for smaller organizations. However, manufacturing companies are also subject to an unrelenting torrent of standards, regulations, due diligence requirements and practices they must comply with in order to produce and market their products. The complexity of managing and ensuring compliance and the risk of non-compliance are a major concern for manufacturers, especially for global companies, due to the increasing toll by local standards and regulations.
A common misconception is that compliance is a problem for the large brand-owner companies. But, in practice, most regulations don’t differentiate between large and small businesses. In fact, one could make the argument that small and medium sized businesses (SMB) are at greater risk of being out of compliance because they may not have the tools and expertise to manage and demonstrate compliance, not to mention the deep pockets and legal wherewithal should those be needed.
For example, when British Petroleum’s oil spill occurred in the Gulf of Mexico, it was not just BP that was investigated; other companies, many of them small manufacturers and suppliers had their records subpoenaed.
Moreover, OEM companies, which carry a heavier burden of regulatory compliance and a greater financial and brand image risks, expect their suppliers – no matter how small – to demonstrate the same level of diligence. See, for example, the supplier guides from Apple, HTC and Whirlpool.
Manufacturing companies of all sizes must be able to substantiate adherence to compliance by documenting and retaining an audit trail for a range of technical and procedural decisions, including designs, design reviews, engineering change orders (ECOs), manufacturing process and work instructions, and many more. Some regulations are very specific in regards to what information must be captured and retained and for how long. Below are three examples of different regulations in different industries.
Must keep the Declaration of Conformity and technical documentation demonstrating compliance with RoHS2 at the disposal of the national surveillance authorities for 10 years following the placing on the market of EEE [electrical or electronic equipment].
Must keep the Declaration of Conformity and technical documentation demonstrating compliance with RoHS2 at the disposal of the national surveillance authorities for 10 years following the placing on the market of EEE.
(e) Design history file (DHF ) means a compilation of records which describes the design history of a finished device.
(f) Design input means the physical and performance requirements of a device that are used as a basis for device design.
(g) Design output means the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record.
(h) Design review means a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.
(i) Device history record (DHR ) means a compilation of records containing the production history of a finished device
FAA AC 20-179
Data retained by you must be made available to the FAA when requested… for any official purposes such as production inspections, technical oversight of designees, design reviews, continued operational safety oversight, or any other reasons deemed necessary by the FAA… You are also responsible for providing the FAA with all data in a format that is readable by the FAA … You must ensure the FAA has the means to access all previously submitted data as well as new data submitted to the FAA.
Although the FAA directive cited above does apply to non-aerospace manufacturers, it accentuates the challenge in ensuring long term access to CAD files and other product information. CAD vendors issues a new version every 6 to 12 months and a new “generation” of CAD tools appears every 5-10 years. The new generation invariably introduces incompatibility issues that potentially leaves behind design iterations that are no longer accessible by the current toolset.
Compliance Strategy
Meeting the challenge of manufacturing regulatory compliance requires establishing a consistent top-down strategy, process and tools that ensures compliance across the enterprise.
Although regulations and compliance laws do not show special leniency towards SMBs, small organizations do have certain advantages: they have smaller data sets and fewer personnel with access to that data. On the other hand, SMBs may not have the necessary compliance expertise and focus, and IT personnel to manage and secure the data repositories.
PDM and Compliance
Any manufacturing company should implement a PLM or PDM software to centralize design information. The benefits of centralized product management, especially for CAD data management, even for small organizations are almost self-evident.
The same centrally managed repository of all design information and related artifacts such as design documents, CAD models and ECOs is equally beneficial to establishing and substantiating regulatory compliance.
It’s not likely that PDM alone can address the breadth and complexity of regulatory compliance (and I am not offering a legal advice here), but exploiting PDM to govern as broad a set of lifecycle activities as possible will improve overall efficiency and accuracy and, at the same time, will provide a good foundation for implementing an enterprise compliance strategy.
Although compliance is not negotiable, the means to implement it can be, especially when considered early enough in the design cycle when designers can gauge the compliance parameters of design alternatives, select suppliers with the necessary compliance practices and solid track record, and so forth.
The Buyer's Guide for PDM
Every class of technology undergoes an era of innovation and disruption. For PDM systems, we’re in such an era today. Lifecycle Insights' Principal Analyst Chad Jackson put together the perfect buyer's guide to help you weigh your options.
