Manufacturer Account

Automatic download to in-house IT systems

Manufacturer members of BOMcheck can request zip files which contain:

• Java wrappers for the BOMcheck API
• PHP wrappers for the BOMcheck API
• html page which you can use to investigate the options to download substance declarations files
• html page which you can use to investigate the integration data available on BOMcheck

The programming code in the wrappers uses the concept of inheritance and includes a Parent Class BomcheckAPI and two Child Classes - BomcheckDownload and BomcheckIntegration. The Guide to using the BOMcheck APIs to automate data download to in-house IT systems explains the variables / actions that each wrapper supports and provides best practice recommendations for how to download Regulation Compliance Declaration data files and Full Material Declaration data files, and how to load these data against the manufacturer's part numbers in your in-house IT system. Many companies have used the wrappers to build their own BOMcheck integrations to their in-house IT systems, for example Carestream Health. Some software solutions providers include out-of-the box BOMcheck integration, other software solution providers offer BOMcheck integration as an additional service and a growing number of third parties are providing maintained integration products for software solutions. Alternatively, some companies use the Assembly Tools in the Super User Account to store their BOM parts lists and use BOMcheck to roll up the declarations data from their suppliers in BOMcheck to calculate the compliance for their assembled products.

BOMcheck Assembly Tool

Philips and other leading OEMs encourage you to make a Full Materials Declaration (FMD) because then you do not need to update your declaration every six months when more substances are added to the REACH Candidate List and other regulatory requirements. A FMD provides the % weight of each individual material in the part and the % weight of each substance which is intentionally added to each material (i.e. no need to declare impurities in the material). For example, a FMD for a PVC coated copper wire will contain two materials - the PVC coating and the copper wire. The PVC coating will include all intentionally added substances (e.g. stabilisers, plasticisers, flame retardants etc).

BOMcheck uses your FMD to re-calculate an RCD for your parts when the list of regulated and declarable substances changes. The FMD tool includes over 524,000 chemical names, synonyms and trade names that you can choose from. BOMcheck shows you whether each substance is currently restricted or declarable or is included in an industry list such as GADSL, JIG, CMR Category 1 or 2, or ESIS PBT or vPvBT.

You can choose to make the FMD confidential to certain customers and allow other customers only to see the RCD which BOMcheck calculates from your FMD. For example, a plastics manufacturer can choose to allow certain customers to see the FMD for the plastic, but only allow other companies (e.g. the moulders) to see the RCD that BOMcheck calculates for the plastic.

Electronic Signatures

Title 21 CFR Part 11 of the US Code of Federal Regulations became effective on 20 August 1997 and defines criteria under which the FDA accept: "electronic records and electronic signatures as trustworthy, reliable and equivalent to paper records and handwritten signatures executed on paper"

To ensure that a supplier's electronic records stored on BOMcheck comply with Title 21 CFR Part 11 requirements, there need to be two types of controls in place:

• Administrative and procedural controls which must be implemented and maintained by the supplier. These administrative and procedural controls are contained in the BOMcheck Member Rules for Suppliers. Failure to comply with these Member Rules can result in termination of the Membership by BOMcheck.
• Technical controls which are provided by the BOMcheck database.

The document below explains these two types of control in detail, and how compliance with the Supplier Member Rules ensures that a Supplier's electronic records comply with Title 21 CFR Part 11 requirements, and are equivalent to paper records with handwritten signatures executed on paper.

Request a Manufacturer Agreement

A manufacturer account is free-of-charge provided your company agrees to send a letter to your suppliers requesting them to provide standardised, high quality compliance declarations for RoHS, REACH and other regulated substances around the world by using BOMcheck. The Manufacturer Agreement requires your company to agree to pilot BOMcheck with a limited number of suppliers and, on successful completion of the pilot to your satisfaction, then request your hardware suppliers to join BOMcheck, at your discretion. BOMcheck provides a standard letter which your company can adapt and send to these suppliers as part of a phased implementation approach. This letter is provided as a draft email which you can edit and send to suppliers that are not already members of BOMcheck by using the 'Invite suppliers to join BOMcheck' tools which are provided in a Super User Account. For avoidance of doubt, your company is not responsible or liable in case any suppliers decide not to join BOMcheck.