Manufacturing is always challenging, and complex manufacturing means a lot of complicated data. Making quality products, operating profitably, maintaining growth, and sustaining one’s position require effective systems for archiving manufacturing data. This is especially true in a competitive global marketplace, where the need to innovate places severe operational and financial pressures on development and execution. However, for companies in highly complex and regulated manufacturing sectors (e.g., medical device, aerospace and defense, nuclear, and industrial equipment), the task is even more daunting due to the growing role of governmental regulatory agencies such as the FDA, EPA, and SEC and the burden of meeting their manufacturing compliance requirements.
The Importance of Compliance for Ongoing Competitive Advantage
A report from the global management consultant A.T. Kearney highlighted the importance of compliance for ongoing competitive advantage: “An effective compliance system is vital to being competitive in markets that demand adherence to regulations that are likely to get even tighter in the future. The best systems have sound governance, documented processes, and clearly delegated responsibilities—sheltering the entire company from compliance breaches and their consequences.”
Documenting processes is a key part of compliance, and in an age where manufacturing data is proliferating at astonishing rates, having the ability to deliver essential data to government auditors without undue complexity is important. “Manufacturers have to keep records going back years about how items were produced: when, how, and who was involved in the product’s manufacture,” says Toby Partridge, Product Analyst at iBASEt. “Archiving manufacturing data puts it into a format that makes it easy for auditors to examine the information needed to verify compliance without going into the manufacturing system itself—offline, easily searchable, and highly accessible.”
Archiving Manufacturing Data: What Should an Archiving System Do?
Any effective archiving system needs to perform a number of basic functions around creation and storage of the archive artifact. These include:
- Preserve records in a long-term archival format that is technology neutral and application independent.
- Utilize accepted international standards for long-term records archiving.
- Preserve records in a format independent of the manufacturing system’s version.
- Retain high fidelity to the original presentation structure and format of the manufacturing data.
- Enable smart records management, including searching based on metadata.
- Allow access, retrieval, and viewing of archived content independent of the manufacturing system application.
- Facilitate records management of archive artifacts (including searching, integrity verification, and backup) via the manufacturer’s content management system.
“It’s really basic functionality,” explains Partridge. “You want to be able to tell the system what records you want to archive, then it finds data in the tables and copies it into a system-agnostic format.”
She emphasizes that the format must not allow changes to be made to the record; it cannot be editable. “For this reason, a format like PDF/A is ideal, as the file type is specifically built for archiving purposes,” notes Partridge. “Also, it needs to be able to handle the various portions of the manufacturing record that aren’t text; things like images and attachments also need to be able to be written to the archive file. Manufacturers should be familiar with what the auditors of the regulatory agencies they deal with are looking for, and then create the templates to write the archives accordingly.”
One Additional Benefit of Proper Archiving
A final benefit of archiving manufacturing data is that it allows the manufacturer to purge data from the manufacturing system after it is archived. “Over the years, there has been a widespread belief that when you’re archiving, you’re purging the data,” says Partridge. “While that may be true in some instances, it’s not necessarily so. A best practice is for the manufacturer to choose if and when to purge the data after it has been archived. In many cases, a manufacturer may want to wait a certain period after archiving, which could be a number of years, before deciding to purge that data.” No matter when purging archived data occurs, it reduces long-term storage needs and improves performance of the manufacturing system.
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