As a Documentation Specialist, I have spent over a decade implementing and managing large and small engineering documentation projects including end-of-life and data cleanup for 8,000 parts, RoHs (Restricted Use of Hazardous Substances) documentation, classification of 4,000 parts according to their safety characteristics, supplier transfers and Global Unique Device Identifications required for the FDA. My experience includes work for Fortune 10 companies in the medical device and electronic industries.
Hopefully, my experience will help you maintain clean, healthy data.
Out with the old
Before starting a large data project, it is best to first clean up the old data. It may be a dirty job but it’s well worth it. Retaining parts that are duplicated or no longer used wastes valuable resources. Obsolete or end-of-life those parts you haven’t ordered or used in the last 3-5 years. Yes, storage and memory may be cheap, but the resources to maintain those old parts? Not cheap.
Clean up that old data to free up the hours your team/company uses to maintain the obslolete data.
A good guesstimate on how many hours will be spent to maintain 1 part is approximately 7-15 hours per part per instance or change. This includes the person writing the Engineering Change Order and the other resources including engineers, quality, purchasing/sourcing, manufacturing engineering, sales and marketing. Multiply this by the number of parts you need to update in your Product Data Management System (PDM System).
With the RoHS (Restriction of Hazardous Substances) 2/Directive 2011/65EU deadline of July 22, 2019 fast approaching, now is the perfect time to clean up your PDM System.
The current Restrictions include:
- Cadmium(Cd): 0.01%
- Mercury: 0.1%
- Lead(Pb) : 0.1%
- Hexavalent chromium (Cr6+) : 0.1%
- Polybrominated biphenyls (PBB): 0.1 %;
- Polybrominated diphenyl ethers (PBDE): 0.1 %
- Bis(2-Ethylhexyl) phthalate (DEHP): 0.1% (added in 2015);
- Benzyl butyl phthalate (BBP): 0.1% (added in 2015);
- Dibutyl phthalate (DBP): 0.1% (added in 2015);
- Diisobutyl phthalate (DIBP): 0.1% (added in 2015).
Phthalates will be added to that list and will be restricted startingJuly 22, 2019 for all electrical equipment and electronic equipment except for medical devices (category 8) and monitoring and control equipment (category 9). These two categories will have until July 22, 2021 to comply. The restricted plasticizers which are used to soften plastic include DEHP, BBP, DBP and DIBP.
The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI).
For medical device industries, the UDI Rule is fast approaching for direct labeled Class II and Class I products.
“The UDI Rule is intended to create a standardized identification system for medical devices used in the United States that makes it possible to rapidly and definitively identify a device and some key attributes that affect its safe and effective use. Establishing standardized, uniform identification of most devices through distribution to the point of use is intended to reduce medical errors that result from misidentification of a device or confusion concerning its appropriate use (78 FR 58786, Sept. 24, 2013).”
Per the FDA website the deadlines for UDI compliance are:
Five years after publication of the final rule (September 24, 2018)
- A class II device that is required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.
- The labels and packages of class I medical devices and devices that have not been classified into class I, class II, or class III must bear a UDI. § 801.20.
Dates on the labels of all devices, including devices that have been excepted from UDI labeling requirements, must be formatted as required by § 801.18.
Data for class I devices and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300.
- Class I stand-alone software must provide its UDI as required by § 801.50(b).
Seven years after publication of the final rule (September 24, 2020)
- Class I devices, and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI, must a bear UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.
Plan, Plan, Plan!
With proper planning and implementation from experienced professionals, cleaning up and maintaining your PDM System won’t be as daunting. Those large Engineering Documentation Projects, such as RoHs or UDI, will be a walk in the park.