The Grocery Store Epiphany

The first article in a multi-part series about the value of validation

Manufacturers who validate their equipment / processes will ultimately enjoy many benefits from the fruits of their effort. Many of those benefits come in the form of easy to recognize, hard-cost savings / operational efficiencies. For instance, executing an installation qualification (IQ) parallel to construction will significantly reduce the amount of costly rework that would need to be performed if the (IQ) didn’t occur until the equipment was completely installed. Or, for instance, process validations often afford the opportunity a lot of operational deficiencies that can be tuned in order to drive higher throughput.

But perhaps a little more esoteric, yet significantly more critical, is the fact that validations drive perhaps the greatest factor of all, consumer trust and safety.

The next time you find yourself taking a stroll through a grocery store, I’d encourage you to consider this…

A grocery store may have, on average, anywhere from (25,000 – 38,000) unique items in stock. The majority of these items, would be considered to be a product that is regulated by the FDA, in the sense that they would likely fall in to one of three categories: food & beverage, medical device, and lastly, pharmaceuticals.

So consider the last time you went grocery shopping for just a moment…

As you perused the store, did you at any point give any consideration or thought to how your items were manufactured? Did you worry that a manufacturing defect could present itself in your food? Were you at all concerned that the prescription, or over-the-counter drug you picked up was mis-branded or mis-labeled? The fact of the matter is, most reasonable consumers don’t bat an eye at any of this, much less give it any thought. And although it may seem trivial, I think it’s a fascinating concept. So why is that?

For starters, we live in a society where consumer trust and safety are paramount. Manufacturers that operate in an FDA regulated space have to exercise extreme due diligence and care, in the interest of producing the highest quality product that is safe for consumers. And this is where process / equipment validation comes in to play.

I was introduced to the concept of equipment and process validation as a young engineer nearly a decade ago. I had been asked to oversee the installation of a multi-million-dollar piece of equipment that was the first step in the manufacturing process of the company I worked for at the time. Unfortunately, I hadn’t been an integral part of the design of the equipment, so I spent my first couple days on the jobsite pouring over diagrams, schematics, as well as manuals to develop an intimate sense of how the equipment was intended to operate.

My professional mentor at the time assisted me in drafting an extremely robust validation document that consisted of an installation qualification (IQ), operational qualification (OQ), and lastly, a performance qualification (PQ). The document went in to excruciating detail, some of which I thought was overkill. After all, why would an engineered piece of equipment need to be scrutinized this much? Wouldn’t a year of prior design work and planning have ironed out all the details / potential issues? Unfortunately, this is a pitfall that many organizations could find themselves succumbing to when it comes to considering their validation needs.

The fact of the matter is this…

New equipment and processes begin their lives as two-dimensional designs that live on paper or in computer software / modeling. These two-dimensional concepts are then rendered in to three-dimensional, engineered pieces of equipment. These pieces of equipment must then be field-fit (installed), and integrated. The opportunity for error is extremely high. The likelihood that “design” conditions do not mirror actual “field conditions,” is extremely high. And the likelihood that the system, process, or piece of equipment will need to be tuned for operational efficiencies, is also extremely high. And this is where validation comes in to play... and how the grocery store “epiphany” came to be.

Consumers expect (whether they’re aware of it or not), that manufacturers operating in an FDA regulated space have executed their due diligence whenever they make a change to their process / equipment that “fits the bill” for validation. They expect that the manufacturers of those (25,000 – 38,000) items in their local grocery store all share the same vision of what validation means.

When I wrote this blog post, I debated for quite some time about which benefit I should cover first. I have a plethora of white papers, studies, and cost benefit analyses that are all focused on the “hard-savings” associated with validations. But at the end of the day, all of that comes second if you can’t deliver on the most important overarching principle; consumer trust and safety.

With all of that being said, Path Forward Consulting LLC would love the opportunity to discuss your process / equipment validation needs in greater detail. We have the expertise, understanding, and knowledge, to comprehend what validation means to you, your organization, and your customer.