Quality is No One’s Job?

If quality is everyone’s job, then one could make the claim that it is actually no one’s job!  Even our home lives are rife with examples.  If everyone is supposed to clean up after themselves, why is the hamper always overflowing and the counter full of dishes when I come home after a long work day?  Is a clean house only possible with severe penalties and fines?  I am rethinking the platitude:  “Quality is Everyone’s Job!” This blog post was triggered by a gritty discussion I recently had with a manufacturing consultant that I respect greatly.  He stated:  “Spending money on an after-the-fact, global CAPA system is ineffective.   Developing processes and systems that support right-first-time processing is the best investment!”  He argued that building a solution like an electronic batch history record system creates more value than a CAPA system.  Our discussion left me somewhat speechless.  Let’s assume for the moment, that a CAPA system is not a required component of an FDA compliant quality system.  For those of you in life sciences manufacturing, please put down the sharp-edged instruments before reading further.

A Corrective and Preventive Action Software system essentially tracks when a significant corrective action is required to address a defect in a defined process.  If we take my esteemed colleague’s approach, CAPA systems add little value because they deal with issues after the cow is out of the barn.  While I agree with a “building quality in” mindset, we humans are imperfect.   We all struggle with our fragmented processes, existing tools and the dynamic nature of companies. Our organizations suffer layoffs, reorganizations, new product introductions, new customer startup, new supplier on-boarding, new hires, temporary work forces, new processes, etc.

While we attempt to streamline and error proof our lives, even our best systems break down.  By tracking nonconformances and enforcing disciplined problem solving processes, we capture critical learning.   I hear many customers say: “We fix our mistakes … many times over!”  Without tracking and reviewing our errors, we have no systematic focus on what to improve.  Hence, we gravitate to what is often easy or low-hanging fruit.

Keeping score works.  When a mistake happens, forcing a thoughtful situation review and developing a plan to prevent recurrence is good business.  Quality is like golf - the lower the CAPA score, the better.  If your CAPA score is 0, you aren’t playing.   If you don’t keep score, you’ll never understand your common pitfalls and mistakes and improve your game.  Continuous process improvement occurs when common mistakes are systematically prioritized and resolved.  While a perfect design is preferred, it is seldom achieved.

With emerging technology trends and a growing, global supply chain manufacturing processes will become much more intricate and complex.  We must assuredly develop more automated processes and tools to prevent manufacturing errors from occurring, but errors will happen.   The key is to identify common mistakes, accelerate learning, and avoid wasting time relearning the same lessons.   Avoiding CAPA system investments is as if you are admitting your quality game is perfect.  And we all know that no one is  perfect.

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