Navigating the strained chain
Manufacturing has grown globally at break‐neck speed. The chain of control is increasingly stretched, creating new challenges and throwing companies into reactive mode. At the same time, regulatory bodies everywhere are taking a harder line on quality issues. Regulators are keeping the pressure on when it comes to pre‐market quality and are forcing quality mandates further down the supply chain. Existing continuous process improvement systems have to be replaced or updated to align with ISO/TS 16949, FDA, GMP and other standards. “The buck stops here” is the policy, meaning that simply passing the blame onto a supplier is unacceptable.
You have to take responsibility for the quality of components produced elsewhere, no matter where they come from.