When a product fails in the field, enterprises face immense pressure to resolve the failure as quickly as possible for the customer. Done correctly, this also means implementing a corrective and preventative action (CAPA) plan to ensure there is no recurrence of the issue. A CAPA’s importance in a product’s lifecycle spans from following governmental regulations, to avoiding lawsuits, to just fixing a product when it fails.
But implementing a CAPA is not just a reactionary measure, it also ensures the processes that fix the problem are extended beyond addressing the problem and hopefully preventing the same issue in the future. Let's take a closer look:
So how do CAPAs work within the broad umbrella of quality assurance? By implementing robust processes that span the value chain to effectively change how an enterprise produces a product, CAPAs address the question, “How do you know if this issue will happen again if we do not address the issue properly?”
The value of CAPA standard ISO 9001 workflow within general quality assurance is that the methodology for identifying and prioritizing critical factors not only improves a faulty product but improves the processes surrounding that one fault. It is therefore important that the CAPA process be integrated with the bills of materials, parts, and documents as well as change control. By linking all quality inputs (design history, complaints, etc.), not only is it faster to determine root cause but it is also easier to monitor for effectiveness and create auditable records.
Implementing processes that track how things are fixed allows enterprises to enable stakeholders working within a product’s lifecycle to not only ensure quality parameters are met but extend the improved quality long after the initial issue is fixed.
By reporting specifically what an issue is at its onset, stakeholders can easily implement and track repair measures that extend down the value chain all the way to the customer. Quality assurance ensures that the actionable and preventative measures of a CAPA are effectively implemented from start to finish, closing the quality loop, and putting processes in place to ensure that the issue does not repeat itself.
Learn more about closing the quality loop through our Quality Management page.
Derek Koziol has over 20 years as an experienced Continuous Improvement leader with deep expertise in Six Sigma, lean, change management and program management.
With an MBA and LSSMBB, he has led global enterprise Product Lifecycle Management (PLM) initiatives in several industries ranging from technology and automotive, to complex pharma and medical devices.