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Write It Down: Validation Will Prove You Aren’t Getting Short Changed

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There are few things more frustrating than getting something you wanted and having it not live up to the expectations you’d built up for it in your mind. The last thing that anyone wants is the disappointment and frustration of being sold a bill of goods. That’s why the ability to validate is critical in today’s society.

A great, and albeit extreme, example where validation would have been advantageous is the Fyre Festival that took place last year in the Bahamas. It was billed as a luxury music festival, costing more than $12,000 for a weekend on the islands. The show promised luxury accommodations, high-end meals, and performances by some of the top musical acts in the world. Instead, attendees were treated to cheese sandwiches served in styrofoam boxes, limited performers, and relief tents that looked nothing like the magical and luxurious family tents that JK Rowling had imagined in Harry Potter and the Goblet of Fire on the inside. Instead of having the time of their lives, concertgoers were scrambling to hop on planes back home, thousands of dollars poorer than when they’d arrived.

Today, validation tools are all around us as consumers. In the simplest form, they’re called review sites. They validate whether or not the decisions we’re about to make are right. Want to try a new restaurant? Check yelp. Want to visit a new destination? Visit TripAdvisor. Want to buy a new product? Check out the Amazon reviews.  

True validation, in a business sense, goes much deeper than having someone tell you that a product works as intended. It’s about documented proof that proves, without a shadow of a doubt, that every nuance, from the biggest of features to the smallest bit of code, works as expected. For our customers that face the most stringent regulations, compliance often means ensuring everything, from the machines in operation to the systems that run them, has validation documentation attached to it.

Documenting that something works as intended isn’t as easy, though, as watching to see if it works. It means testing every aspect, and ensuring no small detail is overlooked because the smallest detail could cause the rest of what’s being validated to work in a way that makes it appear to be functioning normally, but, in reality, it’s not. As such, there are three areas to validation that exist to prove the working order of a piece of equipment or system you’re using known as IQ, OQ, and PQ.

Installation Qualification (IQ)

In order to ensure something works properly, one of the things you need to have documented is a baseline of the installation parameters. This gives you something to look back on to understand if what you’re getting consistently matches the expectation you put in place when first setting up a system. In the process of qualifying the installation, you’re also documenting to ensure that it’s been put in place properly and all required supporting utilities and periphery equipment is installed as outlined by the manufacturer’s specifications. This process provides documented evidence that the installation was performed correctly and this ensures that, prior to functionally testing the equipment/software, it has been set up correctly.

Operational Qualification (OQ)

The next stage of the validation process is about verifying your new equipment and system operate as intended according to the specifications. As with an IQ, documentation is paramount. Testing in the OQ generally allows you to test the different pieces that make up the equipment to ensure they are are functioning correctly.  These test most likely differ from equipment to equipment, but gives you documented evidence that the equipment functions correctly. This allows you to verify in an audit that the system used meets the required criteria for being up to code and the system is ready to be challenged in your operations.

Performance Qualification (PQ)

The final part of a validation package, performance qualification, ensures that your equipment or software is capable of running in your environment at the given specifications of your operation.  This is where you will simulate process parameters and challenge your equipment to function at the extremes of your operation. Can I make 1000 widgets in a production run that meet my specifications and can my equipment handle this? You will typically use some statistical sampling to determine if you can meet your quality requirements. Other PQ tests may challenge the business process programmed into your software. Does it work as intended? Or, can my environmental chamber handle a partial and full load of product and still deliver uniform environmental conditions? PQ will tell you that your equipment or software is capable of working reliably in your processing environment and within your specifications.

Validation can be a time-consuming process. It’s not something that occurs simply by turning on a machine and ensuring it runs. It involves a lengthy checklist within the confines of a protocol to ensure that every part of the system is working as it is intended because if a single button, or algorithm is firing incorrectly, your system, data, and product are all at risk. This ensures you are making quality products, consistently reducing the chance for rejected products and recalls, and increasingly satisfying customers. Additionally, if you are finding issues with your equipment or software during validation this can be addressed with the manufacturer well before it’s used in operations. This ensures you are not getting short changed on your purchase and you have the documentation to prove it.

Through the validation process, Dickson’s Services Team is able to document the proper working order of your equipment or software system. It’s just another way we ensure that not only does every point matter, but every point is captured, cataloged, and verifiably defendable in an audit. That means, if you pick up the phone to call Dickson, you can be sure that what’s delivered acts as intended. That’s a bill of goods we can all be satisfied with.

If you’re interested in learning more about Dickson’s validation services, visit dicksondata.com/validation to learn more, or dial 630.563.4202 to set up a consultation with a validation specialist today.

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