In my last blog post, I discussed how manufacturers are beginning to consider their lifecycle data model for managing issues and corrective and preventative action processes. The argument I made was based on the fact that this domain was best situated for touching the key control points required for a sound CAPA solution.
To be honest, that’s just one aspect of why this direction is gaining traction. To be really honest, that was just a teaser blog post to get you thinking… there are several reasons why the lifecycle domain is the perfect place to manage these activities. This post and my next will outline two more, but I don’t like leaving my audience hanging; check out this article I wrote for Quality Digest explaining how PLM connects to the critical control points of a CAPA solution.
Back to the task at hand; another reason a PLM-based issue and CAPA management solution is a good idea; prevention.
When a product’s lifecycle is managed, the thousands of decisions needed to define requirements, engineer the product and produce it are really all about prevention; preventing the wrong requirements, preventing the wrong materials and dimensions, features, software, electronics, even the wrong equipment and methods for manufacturing. At its core, a PLM solution’s value proposition is about making smarter decisions through the process of bringing product to market even as the product evolves through frequent change. The faster we can communicate, analyze and accommodate for change, the fewer issues we’ll discover later in this process where it becomes very costly to correct.
A product’s quality has a lifecycle as well. From engineered requirements to inspection strategies, from materials and functional specifications to production ramp-up and control, each product has a lifecycle of quality information that starts as design intent that must be delivered in the end product. When the product lifecycle decisions are managed separately from the product quality lifecycle decisions, the preventative value of PLM is degraded, increasing the risk of non-conformances and discrepancies.
Because the real world is not perfect; machines breakdown, tools wear-out, humans get tired and even robots need maintenance, some method of quality control will always be a part of the production strategy in an attempt to catch non-conformances before they make it to a consumer. However, when we leverage the value of a PLM solution to manage change throughout the product and quality lifecycles, we certainly mitigate (i.e. prevent) a significant percentage of the risk of non-conformances.
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