I was planning to describe how document based approaches can impact Contract Manufacturing, but I saw a slew of Undeclared Allergen recall notices. For most manufacturers or brand owners, the root cause is the supplier’s material substitutions. Since there are no laws mandating suppliers to notify you on changes to materials, what can you do? This article provides some additional insight into beefing up your quality agreements.
Since there are no laws mandating suppliers to notify you on changes to materials, what can you actually do? Here are some steps that leading companies and retailers are taking to minimize such risks:
While the above steps help reduce risks, one critical issue is that the Supplier Roles that control Material Substitutions often never see these documents! As part of these processes, add Material Change Control Documents that are signed off by Role or Roles owning Supplier Material Changes.
If the supplier or their Supply Chain ship from riskier regions, you might require regional testing of shipment before approving shipments, or have internal controls to test before accepting shipments.
While there are no laws to control Material Change notification, most legitimate Supplier will do as much as they can to minimize your risks. Get started by focusing on the material categories and the supplier with the highest level of risk.
A recent post provides a strategic view of the future of Systems of Engagements. Most of you can get started, incrementally implement it and evolve into this vision.
Using a Copacker or Toller example, I will describe getting started with a System of Engagement and a phased approach to strategic implementation of a System of Record.
Over the next few weeks, I will continue to share my PLM Odyssey, “better practices” and business strategies for agile innovation and compliance strategies. No two process companies or PLM implementations are ever the same, but many are remarkably similar. Stay tuned to find out how you might benefit from the PLM journey of others.