Peter Bigelow

How verification and validation add time and cost, but not value, to production.

Maybe it takes a bizarre presidential election to make one realize that what was conventional and assumed is giving way to a variety of new paradigms, some good, and some not so much.

An example of the good is the universal realization that “50 is the new 30.” This change in attitude acknowledges that with better food and exercise, today the physical and mental mind set of people in their 50s is more like those in their 30s just a generation ago. Another such new norm is the use of email as a primary source of communication today, versus telephones or “snail” mail of a generation back.

Some new paradigms seem to be more of a throwback to the past, and decidedly inefficient at that.

For generations from Deming through Jobs, it seems industry has worked at a hyper pace to add value through efficiency. In my multi-decade career, so many efficiencies have been developed and incorporated into the day-to-day operating mantra of business, specifically manufacturing. Deming was first to work on making process more visual and less reliant on written instructions. Through color codes and shapes, for instance, he ushered in the age of simplified process management that focused on data as a metric to ensure improved quality, efficiency and overall reduced costs.

Computerization assisted and then drove increased opportunities to further the value stream by reducing repetitive documentation that took time and treasure to drag through the manufacturing process and then record and store. The move toward a visual PC user interface simplified much of the record-keeping required in manufacturing by making it easier for non-geek shop floor employees to operate computers, while also cutting their cost to a level affordable for companies large and small. That’s an improved new normal.

More recently, that paradigm has again pivoted, this time not in such a good way. Today, more often than not, the momentum of good efficiencies seems to have been hijacked by the non-value-added, time-consuming, and paper-intense current “new norm” demanded in the name of verification and validation.

Efficiency, and metrics-based measurement of that efficiency, is good. The ability to improve first-pass yield, overall quality, cycle-time reduction and on-time delivery, and the continual cost reductions through good process management based on solid metrics, verified and validated, has been the bedrock for modern manufacturing over the past 50 years. But some often large organizations and/or independent consulting firms have decided that if a little documentation is necessary to verify a process, product or quality system, then a lot of documentation is that much better.

I question this new trend. When it takes as long – or in some cases even longer – to complete the various FAI, C of Cs (certificate of compliance), certifications, and overall data packages that many customers now demand be provided with each order as it takes to actually produce the product being shipped, that is the poster child for inefficiency! Yes, it is important to be able to verify that manufacturing processes produce good product the way it should be, and yes, it is important to be able to validate product was built to specification, but when production and manufacturing efficiencies are offset by the bureaucracy of providing repetitive documentation containing often non-critical – or meaningful – data, then the “new norm” is setting everyone back.

Most frustrating when dealing with this sort of inefficiency is trying to harmonize the reason this new norm has gained the legs it has vs. the purpose and objective of verification and validation. In manufacturing, verification and validation serve two distinct purposes. Verification is taking the steps to develop a process, and then prove – verify – that process will produce the expected and desired results. The fact that product makes it through the plant and meets print in effect has self-verified the process.

Validation is providing data the product has been produced per expected and desired specification. Here, basic inspection reports historically have been all that is required as data to confirm the obvious. The exponentially more onerous reporting that manufacturers are increasingly demanded to provide as part of the “new norm” verification and validation protocols indicates maybe the customer is pushing much of its incoming inspection – effort and cost – onto its supply base to save money.

It’s a little like one other well-intended, albeit not so good, new norm: when you are required to print documents, such as bills, bank statements, etc., that the supplier and/or bank once did but now refuses to do and/or charges for. They claim this is good for the environment and saves everyone money. While nice to think this will leave a smaller carbon footprint, in reality the paper is still printed, usually less efficiently at greater overall cost. Result: a misguided cost-reduction effort that actually costs everyone – including the cost-cutting instigator – money.

In the case of excessive verification and validation documentation requirements, the cost – and inconvenience – is even more egregious. The time is real; time is spent, and time costs money, which means someone inevitably will pay the bill. That cost may be in the form of a line item add-on fee or, more likely, buried by the party making the effort in the pricing. Where it really costs everyone is in the lost time (waste) that could otherwise be deployed to make product and improve process and efficiencies to further reduce costs.

And while computerization has yielded many data collection, retention and distribution advances, one thing that has not changed is someone must input the data to the system – manual or computerized. And make no mistake, the data for the metrics that most verification and validation reporting demand require an individual – or individuals – to set, measure, record and assimilate that data in the desired format. Efficiencies from computerization or automation are minimal when it comes to chronicling a specific job or part number’s journey from raw material to final product.

The additional documentation and reporting to provide customers the protocol desired for verification and validation they received what they ordered is truly one of the more inefficient and outright costly “new norms” of our time. Hopefully this trend will subside as larger companies realize they are not reducing risk, effort or cost, but instead only making them less desirable customers. Equally, while 50 is the new 30, maybe one adage should remain the same, at least when requiring documentation for orders: “Less is more!”

Peter Bigelow is president and CEO of IMI (; This email address is being protected from spambots. You need JavaScript enabled to view it.. His column appears monthly.

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