Maintaining measurement traceability is a challenge for any organization that must comply with industry-specific regulations for maintenance and testing. However, for those that operate in multiple countries, traceability becomes even more complex.
The European Union (EU) acts as a centralized regulatory body for its 27 member countries, but there are still many differences across borders. Variations in documentation and test procedures can present roadblocks for industries like pharmaceuticals, food and beverage, and industrial manufacturing that must conduct regular calibration of precision instruments and sensors.
The ramifications of not being able to reliably trace measurements can be severe and costly. For example, failed audits and missed compliance benchmarks can incur fines or force the shutdown of a plant.
Here, we’ll discuss the traceability challenges that multi-country operations face due to their geographical footprint, how those challenges compound at scale, and the solutions companies use to overcome them.
3 Reasons Why Multi-Country Operations Struggle With Traceability
When your operations span multiple sites across multiple countries in the EU, complexities will arise throughout all facets of business — traceability included. Some of the most common sources of roadblocks to achieving and maintaining proper measurement traceability for multinational sites include:
- Variations in local standard operating procedures (SOPs)
- Language barriers and translation issues
- Distinct documentation practices between locations
Let’s review each of these challenges in more detail.
1. Differences in Local SOPs
Standard operating procedures are the backbone of reliable, effective operations. Ensuring everyone is on the same page and understands the ins, outs, and whys of your SOPs is challenging enough at the site level. Scaling that up to the enterprise level of a multinational organization is proportionally more difficult.
For instance, say a country has facilities both in Germany and Italy. While both sites would strive to adhere to testing guidelines put forth by the International Organization for Standardization (ISO) (such as ISO/IEC 17025 and ISO 9001), there will likely be differences in specific documentation in each country. Workers at a German site might follow regional equipment standards and procedures set by the Deutsche Akkreditierungsstelle (DAkkS), the German accreditation body. Meanwhile, workers at a site in Italy might follow SOPs that adhere to processes aligned with its own country’s accreditation body, Accredia.
Managing differences in SOPs and recognizing what they mean for the organization’s ability to maintain traceability would be difficult enough with just a few sites to manage. At scale, those differences become a tangled web that can feel nearly impossible to make sense of.
2. Language Differences
Not all countries across multinational organizations use the same language, and documents often exist in the native language of each site. Aside from SOPs, traceability adherence requires staff to track and reference a multitude of other documents, including, but not limited to, records of any in-house calibrations of devices under test (DUTs), proof of accreditation of outsourced calibrations, and calibration certificates.
If an organization with sites across the EU lacks a way to centralize and standardize SOPs and other documentation critical to ensuring traceability, it can make it near impossible to successfully pass an audit. Eventually, linguistic differences will result in regional drift in operations that will leave organizations open to risks such as non-compliance and using potentially faulty standards and metrological equipment.
3 Varied Documentation Practices
How organizations in various countries approach their documentation practices can also impact a multinational business’s equipment traceability efforts. In the EU, the legislative framework is multifaceted. In addition to other forms of legislation, the EU has issued a multitude of directives that lay out goals that the union legally requires member countries to achieve. However, directives don’t dictate how to achieve those goals; instead, member countries transpose those directives into their own national laws. Therefore, countries have the freedom to define their own processes to achieve compliance with directives. In many instances, these processes aren’t the same across different EU member countries.
For example, the Measuring Instruments Directive (MID) 2014/32/EU, which concerns metrological instruments such as meters that measure water, gas, electricity, dictates multiple conditions for these instruments to be considered MID-compliant. One condition is that member countries should ensure instruments bear the CE mark (short for the French phrase “Conformite Europeenne”).
While all EU member countries are required to ensure instruments conform to the MID requirements, their approach to documenting measurement results can differ. For instance, in Germany, national metrological regulations place an emphasis on ensuring traceability data is machine readable. Therefore, German manufacturing sites typically produce digital calibration certificates (DCCs) that are formatted in XML, which is easy for machines and software platforms to read. Meanwhile, an Italian site might format their conformity documentation as PDFs wrapped in a P7M file secured with a digital signature. This formatting style helps ensure that, per Italy’s regulations, calibration certificates are secure and can legally hold up to an audit.
On their surface, these differences don’t seem like they would make much difference. But for an organization that needs data files from different countries, the lack of conformity in documentation practices clogs up operations and makes obtaining traceability data a disjointed, overly complex process.
How Operational Differences Between Countries Lead to Large-Scale Breakdown in Traceability
Taken together, these differences in language, SOPs, and documentation between EU member countries quickly compound to negatively affect a multinational organization’s ability to prove equipment traceability.
Inspectors should be able to look at data from multiple countries where an organization’s sites are located and see clear, consistent audit trails that provide full maintenance histories for any asset. But if each site does things slightly differently , gaps in maintenance and calibration histories appear and enterprise-level traceability quickly falls apart.
How To Improve Consistency Across Sites To Improve Traceability
Despite the struggles that come with operating sites across multiple EU member countries, there are ways to clean up operational disparities and improve compliance with traceability regulations and requirements.
- Centralize documentation: Utilize a platform like a CMMS that houses documentation for all your sites. Creating a singular location for documents like SOPs, maintenance records, and calibration certificates makes it easier to determine where data gaps exist. It also makes it easier to spot opportunities to standardize documentation where possible to help eliminate procedural drift across sites.
- Use a multilingual CMMS: Ensure you use a CMMS that’s multilingual, so you don’t have to silo operations into different software that are only available in one or a handful of languages in use across your sites.
- Implement a platform that provides audit trails: When it comes to traceability, centralizing documentation with a CMMS is a good start, but using a CMMS that can automate the creation of audit trails is key. Automatically tracking changes to work orders, maintenance time stamps, and the personnel behind each change significantly reduces the administrative burden that’s typical of traceability and compliance documentation.
- Utilize localization: In addition to the above strategies, organizations should also ensure their CMMS offers international localization. Translations are helpful, but some things can get lost in a literal translation. And when it comes to traceability compliance, it’s important to ensure communications are as clear as possible. Localization helps eliminate awkward, ambiguous, or otherwise unclear translations that could lead to process drift. Plus, it automatically adjusts to local time zones and currency, further smoothing operations.
The right CMMS is critical to maintaining equipment traceability across multinational sites. eMaint CMMS offers all of the functions a multi-site organization in the EU needs to scale up traceability successfully, from centralized documentation to automated audit trails.
Want to learn more about how eMaint can help your operations prove traceability at an international scale? Visit our website or take a tour.