For manufacturing professionals, quality and consistency are paramount. In today’s manufacturing environment, there’s no room for assumptions: creating and monitoring meaningful, precise and verifiable metrics is essential.
While virtually all manufacturers are gathering data on a day-to-day basis, the quality of the captured data varies dramatically. And because that data isn’t always reliable, it’s subsequently not useful.
Fortunately, the ALCOA+ framework outlines a specific set of principles designed specifically to ensure data integrity.
What is ALCOA+?
The ALCOA+ acronym stands for the following attributes that all data must share (if it is to be considered compliant both with accepted best practices for data collection and data management, as well as with specific regulatory guidelines):
- Attributable – every piece of data is directly traceable to a person, date and circumstances
- Legible – data must be clear enough to read (and that clarity must be maintained over time)
- Contemporaneous – data must be recorded/documented as it is generated (i.e. when the event it describes took place)
- Original – data must be a wholly original record or a certified copy of the first instance the data was recorded
- Accurate – data must be correct, error-free and unedited—down to the last detail (incidentally, this is where blockchain technology can help)
The “+” in ALCOA+ represents additional characteristics that must be present to ensure optimum data integrity. It stipulates that data must also be:
- Complete – data (and all relevant supporting source materials) must be comprehensive
- Consistent – no inconsistencies can be present in the order of events or the method with which data was recorded
- Enduring – data must be permanently preserved in approved formats and systems
- Available – data must be readily (and indefinitely) accessible for auditing or review
How Are ALCOA+ Standards Used?
ALCOA+ standards are particularly essential in heavily regulated industries, such as the medical field, where data integrity and regulatory compliance take on heightened urgency.
While collecting and managing quality data is important to any manufacturer, it is absolutely critical in industries like medical and aerospace, where questions of quality and consistency can quite literally be a matter of life and death. Medical manufacturing is still a highly manual space, which makes ALCOA+ principles especially valuable as products travel through their build cycles with handwritten records.
It’s worth noting that ALCOA+ compliant documentation in and of itself remains a challenge for many manufacturers. In 2016, approximately four out of every five FDA warning letters were issued because of data integrity concerns. The primary reason cited was incomplete data.
While ALCOA+ applies to both digital and printed/handwritten data, continued innovation in the development and availability of sophisticated digital process management systems makes it dramatically easier to achieve ALCOA+ objectives.
Most industries still rely on some manual, non-automated work, where records are not kept for many operations or are manually entered. Even with automation, there are still manual loading, cleaning and repairs that present challenges to adhering to ALCOA+ standards. This is an area where AR technology presents a uniquely powerful solution.
What Does AR Technology Have to Do With ALCOA+ Data Standards?
AR technology platforms, like LightGuide Systems (LGS), provide extraordinarily detailed monitoring, tracking and verification functionality built right into the system. Every step in the manufacturing process is monitored and recorded, with digital “birth certificates” generated for every part and product. This granular detail makes it easy to pinpoint issues and identify procedural bottlenecks, and, because LGS fully digitizes the process, it eliminates the need for manual note-taking or supplemental data-gathering technology.
This kind of comprehensive single-source, data storage and management solution is fully compliant with ALCOA+ standards for data collection and data management. And with integrated ALCOA+ principles, you can count on reliable, useful data that ensures compliance, streamlines and optimizes processes, and provides the kind of meaningful insights you can use to make smarter and more strategic decisions.
To learn more about the capabilities of our AR software, including data collection, quality assurance and more, send us a message!