Across virtually all industries, CAPA–or Corrective and Preventive Actions–is a widely used term. A central concept within ISO standards and Good Manufacturing Practices, the CAPA process essentially describes a set of steps undertaken to improve work processes and minimize risk, mitigating the occurrence and recurrence of non-conformances.
However, there seems to be different uses of the term when we get to specifics: Just as different industries have different definitions of CAPA, so can different process owners in the same company.
Enterprise CAPAs are most often owned by the corporate quality department, with the VP of quality at the top. Continuous improvement at the plant level, alternatively, can be the responsibility of a variety of different roles, depending on the organization. We have found that often people don’t differentiate between these varying uses of the CAPA term and process, and this disconnect creates some degree of confusion when it comes to vendor selection and evaluation.
In all instances, the basic framework of a CAPA is the same: from a high-level perspective it’s a comparatively simple workflow that evolved from the Plan-Do-Check-Act cycle. The devil, as it were, is in the details.
In this article, we’ll clear the air on CAPA. There’s certainly a need for clarification in the solutions markets, but before we get into that let’s discuss a little background on how CAPA confusion arises.
Industry-based CAPA Confusion
In certain industries that are heavily regulated by federal agencies–particularly Life Sciences and, increasingly, Food and Beverage–CAPA processes are very clearly defined. In these areas it is a critical component of federally administered product quality audits and an essential part of maintaining compliance.
Within these tightly controlled industries, individual businesses can even have different tiers of enterprise CAPA processes, further adding to the confusion. For example, the CAPA process mandated by regulatory bodies as well as a second tier process for non-conformance issues that are executed in the spirit of achieving operational excellence or fulfilling the requirements of voluntary standards frameworks like ISO 9001 and SQF (Safe Quality Food).
One tier is comprised of legally mandated business requirements while the other is made of self-imposed processes pursued in the name of continuous improvement. In either case, the specific nature of a CAPA process will mean something completely different to a corporate quality leader in an FDA regulated industry as opposed to his or her counterpart in automotive or electronics manufacturing.
CAPA Confusion between Process Owners and CAPA Scope
Another key reason we seem to be working with different uses of term is because people aren’t differentiating between plant and enterprise CAPA processes, and between varying scopes of CAPA processes. Different process owners in a business are responsible for different CAPAs based on the scope of the non-conformances managed by the CAPA process.
For example, from an enterprise-level perspective, a VP of quality might be concerned with a supplier that consistently has out-of-spec defect rates. At the shop-floor level a plant manager, depending on how process ownership is structured in the organization, will be more preoccupied with increased downtime on a specific line or piece of equipment.
Both would want look to CAPAs to resolve the issues. However, supplier risk and approval across the enterprise is not something a plant manager is going to lose sleep over, just as downtime on one piece of equipment isn’t a detail Corporate Quality necessarily needs to know about.
Know your Solution CAPA-bilities
So what’s the problem with all of this? Well, when it comes to reviewing and selecting the most appropriate vendor for CAPA management, this confusion can result in a misunderstanding over which types of vendors are the most appropriate for serving various job roles and business functions.
We’ve seen three general classes of CAPA processes managed by software:
- Enterprise-level CAPA (regulations driven)
- Enterprise-level CAPA (standards driven)
- Plant-level CAPA (operational excellence driven)
In the example from the last section, Enterprise Quality Management Software (including stand-alone as well as some PLM- and ERP-based offerings) has a long history of managing enterprise-level CAPA processes but might not be as strong at tracking and resolving plant-level non-conformances around equipment availability. Though it should be noted that recently we have seen some EQMS evolve to handle CAPAs at the plant level by integrating with MOM software systems as the source of identifying non-conformances.
Similarly, as Manufacturing Operations Management (MOM) software systems have added Business Process Management (BPM) capabilities, plant-level CAPA processes have also been added to the traditional non-conformance detection and quality inspections. However, most of these vendors still lack the enterprise-level CAPA management capabilities required by the VP of quality.
That said, here at LNS Research we are seeing some convergence in the space. Solutions are coming to market that may demonstrably be able to achieve ‘complete’ CAPA management. The movement we’re seeing is two-way but generally there are more EQMS vendors than MOM vendors moving to be able to address all types of CAPA processes. This of course is not surprising, given that the EQMS vendor space has been focused on CAPA automation for a decade longer or more than the MOM vendor space.
Know What Kind of CAPAs You’re Talking About
A key takeaway is that we have to remain aware of the difference between how the term CAPA is used based across both different industries and process owners, particularly when it comes to solution evaluation and selection discussions.
When engaged in such discussions, keep in mind the differences in the term with the following tips:
- Clarify the driver of the CAPA process. Is it regulatory compliance, standards-based compliance, or operational excellence?
- Clarify the types and scope of non-conformances being managed. Are they impacting the whole organization or a single issue in manufacturing?
- Clarify the process owner in the organization. Is it corporate quality leaders, corporate manufacturing leaders, or plant leaders?
Tell us about your experiences discussing CAPA and implementing CAPA management solutions. Keep this discussion going in the comments section below or tweet to us @LNSResearch with the hashtag #CAPA.
