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Manufacturing C-Suite Leadership News
Volume I, Issue 2
August 3, 2015
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Intellectuals solve problems, geniuses prevent them.
Albert Einstein
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CAPA at the C-Level
Michael Rapaport insists that CAPA is (still) a very time-consuming process. He is correct that not too long ago CAPA - and all quality management processes for that matter - were wholly based upon manual, paper-driven processes. The fact that CAPA touches so many different aspects, from engineering to production and beyond can have a profound impact on the deliverables that are typically associated with its successful implementation, such as engineering change orders, control plans and rework orders, and often in ways that are far from apparent and only reveal themselves upon implementation and validation testing.
CAPA, consisting of two separate but very related processes, are not one dimensional, flat quality processes. Rappaport puts it succinctly, plant-level CAPA can have a very different scope and context than enterprise-level CAPA, which may not necessarily share the same point of view. Consider the example of an in-line production process deviating from specification. On the shop floor, this issue would need immediate attention, which a C-suite executives would not know about one minor issue at one particular plant on one particular day.
C-level executives see one of the main challenges with CAPA as defining scope and context within a large company. For a global manufacturer, one plant site may literally speak a different language than another plant site, but this comparison is also applicable internally, too. One department may use a different vernacular than another department, which can introduce unnecessary complexity into CAPA. Likewise, it is not uncommon to find different software tools in place within the same company to manage the same quality process, which only makes it more difficult to achieve consistent CAPA internally when scope and context remain amorphous and undefined.
Some CAPA software are simply modules for enterprise resource planning systems or product life cycle management (PLM) solutions; some are stand-alone solutions that require their own IT resources. In the absence of a concerted strategy to streamline CAPA, it is easy to choose a software that may not be the best solution based on your needs. Often, CAPA software is used as an extension of PLM because many manufacturers have invested very heavily in these systems, so it makes sense to manage CAPA in this manner. However, it is not necessarily need to manage CAPA through PLM; there are many, many other possible deployments. Rapaport correctly identifies that the accurate and timely flow of information is the key - and with the integration abilities of specialized software systems today, there are many choices.
Certainly, the challenges with CAPA are numerous, but these are the most common pain points. The key lesson you can take away is that CAPA does not have to be a lengthy, manual quality process if you define scope, context and deploy the right software. Learn more.
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