5 Ways to improve your Material Compliance Processes!
Picture this scenario. Emma is working in sales. Her customer just called about an upcomming audit and that they really need some compliance statements from all of their suppliers. Minutes later a two-liner with the summary of the discussed request is in her inbox. She goes on to forward it to RA and insists that this must be answered within a week.
Two weeks go by and Emma is called by her customer again. She has to find an excuse and promisses to follow up. Emma follows up with RA and requests a status. The answer: „The request is still in progress. We forwarded it to procurement to gather supplier certificates.“
Emma writes a one-liner two procurement to ask for the status of this request. Procurement replies immediately: „Which request are you talking about.“ Emma loses her patience and picks up the phone. During the conversation she realizes she may have over reacted. Procurement first had to figure out all materials involved and some of the components aren’t manufactured in house so they weren’t in the system. Since then they have been chasing suppliers daily and there are several open material compliance requests some of them involving the same customers or topics. Procurement is doing the best they can to get the job done, but they are no material compliance experts. Regulatory who used to take over most of these tasks is now overloaded with MDR / IVDR and good personell is difficult to find. Procurement is coping but this is not satisfying for anyone. Emma politely requests to prioritize this request and thanks procurement for their effort. Two days later she has a statement in her inbox that she quickly forwards to her customer. Job done, she thinks.
Another two weeks later Emma finds an email in her inbox from said customer. It’s a lengthy email explaining their dissatisfaction about the long response time and incorrect formulation of the statement. Their auditor got a hold of some statements from the past and compared it to the newer version. The statements not only contradict eachother but also do not fullfill the audited requirements. They were asked to clarify and to get their process in order. The only upside was, that they didn’t get a deviation because of it. Emma is asked to escalate this to management in order to improve the material compliance process.
Can you picture this? How far is it from the reality in your company? Mail ping-pong, superficial knowledge and a corporate game of „telephone“ on top of that a wide variety of regulations such as MDR, REACH / SVHC, RoHS, TSCA, California Proposition 65 and many more restrict and regulate how substances can be used. This makes material compliance complex and work intesive. Neither procurement, the development nor the quality department usually have the experience, education or ressources to tackle the topic in a appropriate way. So what should Emma propose to management?
Here are 5 things Emma could suggest improvment on!
1. Develop a Product Compliance Policy
A list of the most important regulations and substances that need to be covered is necessary. It seems obivouse when stated so plaintly but this strategic choice has to be made by management. There are obviouse choices to consider. If you manufacture medical devices under the MDR: REACH / SVHC, Phthalates, Endocrine Disruptors, CMR Substances, Nanomaterials and Animal Derived components are the standard. RoHS, California Proposition 65, TSCA and other may be added depending on the indented use, the markets and the nature of your device. Some other topics besides material compliance have to be considered such as labelling. It is also very important to define norms and regulations you are not complying to or substances that can be contained. If your product is not indendet for the california market you do not have to comply with California Proposition 65. Other topics that can or cannot be part of your companys strategy is if your products can be considered vegan. There needs to be a rule book and management has to decide on what the rules shall be.
2. Get your Masterdata right
Your enterprise resource planning (ERP) is the life-blood of your material compliance process. If you don’t know the bill of materials (BOM) for each and every subarticle in your portfolio, you increase the work for material compliance requests by a manyfold. Your ERP needs to be able to spit out the BOM of a article list, with a few clicks down to the raw material grades used for each component. To get to this point a lot of work is needed. Your component suppliers and your subcontractors need to be integrated. This can potentially be a lot of work. If you have done your homework however, your requests are much easier to answer!
3. Set up a proper Document Management
After fixing and preparing your ERP data as a base, you need material certificates to base your statements on. The golden rule of material compliance is to never confirm something you don’t know. Does your plastic contain animal derived components? You might think: „That’s easy! It’s plastic, plastic is made from petrochemicals (or even better from recyceled or biobased ressources). There are no animal derived components in there!“. Well, you would be wrong to think that. Many additives use or are based on tallow (animal fat). The tallow is processed under high heat and pressure to ensure no diseases can be transmitted through it, but there are animal derived components used. Therefore, you need proof and a basis for your statements. Ideally you set this up in your document management system. Where you can store, search and update material certificates, safety datasheets, even technical data about your raw materials used. This material compliance knowledge database is immensly important and the base for your statements. Of course you need to procure, updated and maintain this database and it is a considerable amount of work. But the detour rentability is huge! In the beginning it is alot of work, but soon you will be able to answer requests with much less effort. It is advisable to set up the database in an initial effort and to then maintain it in the process.
4. Clarify the responsibilities and empower your employees
You have a database from which to work on requests and statements. But you need to clarify the responsibilites. You need a standard operating procedure and maybe some work instructions on how to do the material requests. All stakeholders need to be considered in order to get buy in from all parties and you need to define the roles and responsibilities within the team. After that you need to empower the team members to do their job properly. They need to be firm in the most important regulations and their requirements. They need to be able to move within the different regulative frameworks with ease and deduct statements from them. A basic technical understanding of your products is important too. If your struggeling with the know-how build up for material compliance and plastic materials, contact Gradical for more info about trainings and workshops.
5. Explore Digital Solutions
As you are increasing your proficiency with the process and building up know-how, you will come across ways to improve the response time for your customers. Because that should be the goal, to have a fast and accurate response to complicated material compliance questions. You may want to explore tools for answering material compliance requests such as BOMCheck. These tools require a buy-in from suppliers and customers alike, but can help to drastically improve the response time while automating the repetitive tasks of the material requests. For more info on the process improvements and material compliance know-how contact your Gradical Expert.