Bayer Change Notification Process For Raw Material Supply Encourages Supplier Collaboration And Transparency

By Trisha Gladd, Editor, Life Science Connect

When it comes to raw material supply, increased regulatory focus on the raw material supply chain is creating a transformational change in the industry. Because of this, quality agreements create a responsibility among suppliers to notify their partners with advanced notice any time a change is made to the raw materials those partners are receiving. To ensure change notifications are handled properly and evaluated thoroughly, Bayer Healthcare utilizes an internal process that allows notifications to be filtered to the appropriate stakeholder and reviewed thoroughly before action is taken. Albert Obrero, Jr., Senior Project Specialist at Bayer HealthCare, recently presented the Bayer process to an audience at Bioprocess International 2014, where he outlined how it works as well as its benefits.

The Bayer Process For Change Notifications

Obrero, who has been in charge of overseeing change notifications for over a year, said on average, Bayer receives anywhere from 25 to 35 notifications per month. To facilitate the review of these, Obrero and his colleagues came up with a process that provides an audit trail for the notification and any emails exchanged about it, as well as the ability for relevant stakeholders within the company to review and assess the impact of the change. To start the process, Obrero and his team utilize SharePoint. The SharePoint system is not linked to their internal change control system, which not everyone has access to, and it is within SharePoint that anyone within the company can check the status of a change. There is also the ability to include any related attachments or email chains.

Once the change is loaded into SharePoint, Obrero says the notification is sent to procurement and supply chain, so they can assess what materials are impacted by the change. Upon completion, the notification is updated to a review status and is sent to an internal materials management review board. This board is made up representatives from various divisions within Bayer, such as regulatory, research, procurement, and supply chain. The team meets bi-weekly to discuss the changes and determine who will be working on them, just as a project manager would do. From there, they create their change controls and the next step for the notification depends on whether or not it has regulatory impact. “If it’s a change that requires regulatory involvement, it gets routed through our SAP system to Bayer Global Regulatory Affairs, where contacts there will tell us what further requirements are needed for the change,” explains Obrero. “They let us know what sort of information we need to provide and whether or not we need to do this pre-implementation, post-implementation, or both.”

The change then takes the same path as those that have non-global impact, which is to be circulated throughout the company to affected stakeholders using change control. “Once all stakeholder assessments are complete, the change is routed back to the project manager, where all of the assessments are organized into one implementation plan,” explains Obrero. The implementation plan offers details around what requirements are needed to implement the change, such as what documents will need to be updated, whether or not master data will need to be obtained and/or changed, and if the material will need to be qualified and validated. If necessary, the project manager for that change will go back to the supplier for additional information requested in the assessments. Finally, the change is considered for approval. According to Obrero, the Bayer process for initiating change notification assessments can take anywhere from six to fifteen weeks, depending on how quickly the necessary information is obtained, how quickly questions are answered, and when the changed is pushed through.

Facilitate Management Of Notifications Through Supplier Engagement

Obrero highlighted some of the challenges he has faced with change notifications. He says sometimes they tend to be blanket statements directed at all customers or could even be as short as five sentences. Others could even be completely unrelated to raw material supply. “We once received a notification about a company hiring a new CEO and another about an update to the company’s HR database for hiring new employees,” he says. “Obviously, this has no impact on materials, but because our process states we have to assess everything, we still have to take time out to review it.”

While acceptance timelines can vary anywhere from 90 days to 120 days, Obrero says companies don’t always wait that long. “As I stand here before you, I have a change that was implemented immediately by the supplier,” he explains. “We received notification saying that our orders would not be filled, and that we would have to accept this change in order to get the new material, which happened to be a critical raw material,” To resolve this, he says it’s important to stay in constant contact with suppliers to answer stakeholder inquiries. If things get too complicated, Obrero says they will schedule conference calls in order to avoid communication that ends up being like the telephone game, where important information is misstated or even forgotten.  

With the increase in regulatory agency awareness, Obrero says inquiries from regulators have become more frequent and questions are being asked about the certification for materials that have been used for over 20 years. While it’s nearly impossible to avoid any of these challenges, especially regulatory inquiries, Obrero says one way to facilitate the management of them is to engage with suppliers. “Determine how your suppliers can support you in a change and engage with them,” he tells the audience. “They don't want to put you into a position where you can't manufacture anymore, so involve them in your work stream. Determine how they can help and what they can provide.”

Through work with the Biophorum Operations Group (BPOG), Obrero hopes to standardize Bayer’s process for the industry, which he believes would also streamline the process and bridge the gap between local site changes and changes requiring regulatory approval. However, he reiterates again that achieving these goals requires engagement with suppliers. “We want to get our suppliers involved so they understand how these changes affect us as companies, and what it is we’re doing to assess these changes.”

While he realizes the assessment can be a laborious process, it has given him and his team the ability to organize the notifications while keeping internal shareholders in the loop. It is this type of collaboration and transparency that was encouraged throughout the BPI conference and that many believe is essential to making an effective and lasting change, not just with regard to the raw material supply chain but to the industry as a whole.