In our constantly evolving, data-rich universe, collecting, interpreting, and understanding process data can be tricky. But it is increasingly important if we want to maintain sustainable quality across product development and manufacturing processes. This challenge is particularly evident in the life sciences arena, where pharmaceutical, biotechnology, and medical device manufacturers constantly strive to build quality processes that deliver “fit for purpose” output.

Process data typically come from a collection of diverse sources in varying formats. These data are dynamic, which often means they have a short shelf life. The longer a piece of data sits, the greater chance that it loses relevancy. Data often are also coming from an extremely complex supply chain that may include development or manufacturing partners’ systems and processes.

(Zontec: Cincinnati, OH) -- Zontec Inc., global leader in statistical process control (SPC) software, is expanding its software purchase options to include e-commerce subscription software. Starting today, Synergy 100 and Synergy 100+ are available to purchase and download without long-term commitments or contracts.

This new e-commerce subscription provides a positive shift in the way manufacturer’s access and use SPC software. The ability to subscribe with a single user minimum and floating license is very practical for companies who previously thought SPC software was unattainable. This software subscription delivers results and creates value from the start without a lump sum payment up front. Because this software is so cost-effective, companies can expense the monthly subscription instead of navigating the capital expense approval process that is commonplace when purchasing on-premise software. This makes purchasing Synergy 100 or Synergy 100+ a simple, easy business decision.

“Even though we still offer SynergySPC software without subscriptions, we want to give manufacturers a new, cost-effective way to engage with us and implement SPC software,” says Benjamin Ha, vice president of operations, Zontec. “Fast to download and install, our new e-commerce subscription gives companies the flexibility to scale according to their needs.”

The martial arts rank, Shodan, for a first-degree black belt, does not mean “expert”; it means “first step.” ISO 9001:2015 is similarly a valuable and vital first step toward world-class performance, but it is only that—a first step. It covers only by implication many of the risks and opportunities that IATF 16949 covers explicitly, such as six of the Toyota Production System’s (TPS) Seven Wastes as well as crippling supply-chain interruptions, inadequate metrology systems, and more.

IATF 16949 is actually ISO 9001:2015 plus additional requirements, which makes it easy for ISO 9001 users to implement relevant clauses of IATF 16949. ISO 9001 users don’t need to implement all the additional clauses—if they did, they might as well register to IATF 16949—but many of IATF 16949’s key clauses are as relevant to nonautomotive applications as they are to automotive ones. This article will cover what look like the most important ones, although others also might be helpful.