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.  

Supply Chain Leadership 

Deloitte recently look at the C-level suite leadership qualities needed to manage manufacturing operations. The study concluded that Supply Chain leadership required distinctive approaches to innovation, collaboration, and talent alignment. Deloitte surveyed more than 400 executives in manufacturing and retail across the globe and found that organizations with superior supply chain capabilities demonstrate significantly above average performance on both revenue growth and EBIT measures when compared to industry average:

• 79 percent of organizations with superior supply chain capabilities ("supply chain leaders") achieve revenue growth that is significantly above average
• Only 8 percent of the organizations with lower performing supply chains ("supply chain followers") have above-average revenue growth
• 69 percent of supply chain leaders have an EBIT margin that is significantly above average compared to only nine percent of supply chain followers
• Several qualities separate leaders from followers. Supply chain Leaders are more likely to:
• Recognize the importance of innovation: 96 percent identify innovation as "extremely important" to growth (vs. 65 percent of followers)
• Be early adopters of disruptive technologies such as 3D-Printing: 48 percent of leaders use 3D-Printing "extensively" (vs. 13 percent of supply chain followers)
• Use analytics extensively: 75 percent of leaders utilize optimization software (vs. 34 percent of followers), visualization software (67 percent vs. 28 percent), mobile technologies (75 percent vs. 30 percent), and radio frequency identification tags (65 percent vs. 27 percent)
• Empower executive level leadership: 56 percent of supply chain leaders have a senior executive heading their supply chain function, compared to just one-third of supply chain followers
• Connect the organization: Roughly 50 percent of SC leaders own all of the six "links" frequently associated with supply chain management - product development, demand planning, supply planning, sourcing and procurement, manufacturing, and logistics and distribution
• Develop talent strategies: 88 percent are more likely to actively recruit supply chain professionals with analytics expertise and cross-functional experience and 83 percent are more likely to recruit those with global experience

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