In this, the fourth and final installment of this series, I will address the third step to chemical-related compliance:
- Comply With or Exceed Regulatory and Market Requirements
Now, assuming you know what the substances and materials are that comprise your products and you know what the requirements are for your markets, you are prepared to ensure compliance. As I noted in the first installment, this is really the first step you should be taking in your journey to development of a compliance management framework.
It’s not all about what software database you put in place to collect and manage the data, though that’s a significant part of it. Knowing what the requirements are, defining your goals regarding those requirements (e.g., be compliant, get ahead of regulation, or go for competitive advantage) and – in fact – how you are going to use the information you collect will drive the design of your framework as well as help determine which software system best fits with your framework and needs, along with how you will actually collect the data you need.
The key aspect of a well-defined compliance framework is that it integrates compliance requirements into how you already do business. You do not need to invent new approaches because you should already have business processes in place that ensure that the products you produce and sell in the market comply with other types of requirements. These can include, for instance,
- Volume, and
How do you do that today? You have a phase-gate-based Product Lifecycle Process. Integrating environmental/human health-related requirements (and social – regulations like the SEC’s Conflict Minerals rule exercise a very similar part of your supply chain in a very similar manner) into that existing system is accomplished by, in short,
- Identifying and defining responsibilities
- Identifying, defining and maintaining requirements, and
- Integrating these requirements into existing business processes across the product lifecycle as necessary
This is a significant project so treat it that way. Get management buy-in, support and funding as well as a champion, if you can. You will have to work across many departments and silos – in fact, every organization that has any involvement with the Product Lifecycle Process must be part of it – so support from upper management will be critical to its success.
First, there are two levels of responsibility: responsibility for ownership of the compliance function and responsibility for ownership of the project to define how it will be implemented and integrated into existing processes and systems. Identify the owners – they may be the same person but these are two different roles: one permanent and the other temporary, respectively (though implementation will have to be reviewed periodically and maintained – that may be a third role).
Second, in the previous installment I discussed understanding and collecting market and customer requirements. Many electronics manufacturers document this knowledge in the form of an “environmental specification”. Such companies as IBM, HP, Sony, and Agilent place their environmental specs on the web for all to see. These specs can define a wide range of environmental and human health-related requirements, including substances and materials that are restricted or disclosable (as well as exemptions to those requirements), labeling, declaration, energy use, producer responsibility, packaging and documentation requirements. The primary purpose of these specs is twofold:
- An internal document for engineering to reference while specifying parts, materials and substances for use in products, and
- An external document for suppliers to reference so they understand your requirements when you are not specifying materials and substances (such as when you specify a component, sub-assembly or finished good).
Note that the environmental specification requires maintenance as regulatory and market requirements change and morph over time. Note that each of the examples above has a relatively recent release date as well as a history of maintenance and revisions.
Third, the crux of the matter is integration into how you operate. Think about how you must use your knowledge of market compliance requirements and product material content at every phase of the product lifecycle. Here’s a (simplified) example set of key integration points:
- Concept: you’re defining a new product (or maybe a major change to an existing one) – look at the markets you’re targeting: what are the environmental requirements? Are there any showstoppers? Are there opportunities for competitive advantage based on environmental, human health, or social performance? At this stage you’re also defining the Market Requirements Document and the Product Specification. Are there substances that, based on how your product operates, could be problematic in certain markets? For instance, if you use cadmium in optics or for corrosion resistance, are there application-specific exemptions for its use or is it restricted? Are future restrictions possible over the expected product ion lifetime? Are there other approaches you can take or is this a showstopper?
Track these issues and create Phase Exit criteria that confirm you’ve reviewed environmental/human health/social requirements based on your product ideas and markets.
- Product Development: now you’re taking the design spec and translating it into a physical product. In doing so you will need to confirm compliance of parts and materials as well as supplier capabilities, particularly for new suppliers. The environmental spec represents additional design constraints for engineering as well as for your suppliers. Its requirements should be treated like any other design constraint.
- Existing parts and suppliers: Are the previously-approved parts still compliant with our environmental spec and market requirements? Have existing suppliers’ capabilities been validated (see the second installment of this series for thoughts on supplier validation for information provision capabilities)?
- Almost inevitably new products mean new suppliers and new parts. For new parts from existing suppliers, you must assess whether they comply with your requirements.
- New supplier qualification and approval procedures must be expanded to validate their ability to comply with your requirements, provide you with the information you need in a timely manner and remain in control over time (EU RoHS requires “that procedures are in place for series production to remain in conformity”. You want it to be anyway, but be sure that includes substance control in your supply base as well). Again, this is pretty similar to what you should already be doing for new suppliers. Manufacturers often deal with it by adding a section or two to the existing supplier approval checklist that will cover these issues.
Phase exit criteria should cover whether all parts and suppliers are approved or (based on how you operate) are considered to be approvable by the time you reach the production phase. While this should not require a change to existing phase exit criteria, it does require a change to the criteria used to determine whether a supplier or part is approved.
- Pre-production: you have to make sure you have all your “ducks in a row” before you go into production:
- All suppliers and parts approved
- All required labels and documentation completed and correct (vs. the spec and market requirements)
- You know which markets have producer responsibility requirements that require registration (not all require registration before you start selling new products but you should make sure you know what’s required in all your markets)
- You have importers and/or distributors under contract to cover registration and producer responsibility for you in markets where you need them (such as markets where you do not have a legal presence)
- You have planned for spares; not all markets will allow the use of existing parts and materials that are not compliant to current requirements to repair new products.
Phase exit criteria includes verification and evidence that all parts and suppliers are, in fact, approved; required documentation is in place (e.g. EU RoHS technical documentation and EU Declaration of Conformity); producer responsibility requirements and a related plan is in place; and, if needed, a spares plan is defined and ready to execute.
- Production: As you roll out the production of your new product, you are of course aware that the supply chain is never static and things will change whether you want them to or not. Parts go obsolete, suppliers are acquired or go out of business, new suppliers come on the scene, existing parts change to reduce cost or improve performance or quality, etc. This is the normal course of affairs, but continually expanding compliance requirements incrementally increases the frequency of any and all of the above occurring.
The scope of sustaining engineering will also be impacted by changes to your environmental requirements. Parts that were compliant may no longer comply and may need to be replaced, for instance. Make sure you plan for the added impact and effort this may require.
Based on your product type and markets, you may have ongoing reporting requirements for producer responsibility and other (e.g. Form SD for conflict minerals) regulations and customer demands. Consider setting up a calendar for these requirements and be sure the data you’re collecting enables you to correctly and accurately report against these requirements. If that sounds like “periodically audit your compliance management system” to you then you’re reading me correctly!
When you’ve defined the information you need, the touch points of your compliance framework within your existing Product Lifecycle Process framework, and the reporting requirements needed, you’ll have what you need to determine the resources necessary to support it. This includes internal human resources, external consultants and service providers (where needed), and a data management system that will support your requirements.
That’s it for this series. You may want to view a recent webinar I did for Compliance & Risks on this topic as well. Please send me an email if you have any comments or questions.