Qualification and Validation Fluency: A Must Have for Highly Regulated Industries

June 20, 2022
In highly regulated industries, quality and validation procedures can be make or break, and getting them right requires working with system integrators who have industry-specific experience.

My first high school foreign language class was an eye-opening experience. I remember knowing a few words of the language from my middle school years but not at all expecting what I was to encounter: an accomplished teacher who ONLY spoke her native language, and she was fast. Those first weeks felt like an eternity as I struggled to make sense of what she said and her expectations on each of us to ONLY speak a language that was second to most of us English speakers.

The exception was one student who usually sat in the corner. For him this was home. His first language was German too and so in this place he felt confident, knew the idiosyncrasies and cadence and was fluently able to translate and articulate everything he was expected to produce for this class. It was easy. What a benefit to speak the same language and to effectively produce results seamlessly.

So many years later, long after I’ve forgotten the few words that escorted me through that class with an A, I still see it play out in business every day. Agility is the name of the game these days in all businesses across the globe and when it comes to highly regulated industries with multiple layers of compliance, speaking the same language is vitally important.

Much of that compliance comes in the form of qualification and validation, so let’s start there.

Defining Qualification & Validation

“Qualification is the act of planning, carrying out, and recording the results of tests which are performed on equipment to confirm its working capabilities and to display that it will perform routinely as intended and against predefined specification or acceptance criteria which is mentioned in supplier’s recommendation / design specification and manuals/ supplier’s documents / guidelines/ etc.

Validation is the process of establishing documentary evidence of the consistency of any process or system, and it is the collection and evaluation of data from the process design stage which establishes scientific evidence that a process is capable of consistently delivering a quality product.” 1

Some might say qualification and validation are two pieces of the same puzzle. Qualification is normally used for systems or equipment and validation is referenced for processes and methods. Many aspects of qualification arise in the beginning stages of validation, but they are fundamentally different concepts, relatives of compliance.

In regulated industries providing a necessary service to the living population; fresh water, consistent electricity, effective vaccines and medicine, or food products among others, it is especially important to be laser-focused on qualification and validation.

Meeting of the Minds from the Start

Coordination amidst multiple teams is a must to ensure a strong program of documentation around qualification and validation. Often if an independent system integrator with the understanding of both the automation systems from the plant floor and the validation requirements can be brought in on the front end of a project, they can pull the quality/validation and engineering teams together to share ideas on the scope of the project. Working together from the same template with an understanding of what every stakeholder needs is a fundamental step toward success. This sounds like a simple first step, and it is, but it’s an important one. 

Conversation in the early stages of conceptualizing a process allows discussion on requirements for validation documentation, an operations process for documenting change control and an opportunity to define all the personnel who may need to sign off on equipment and processes. 

User and functional specifications come in all shapes and sizes, but an appropriate partner with decades of experience can help you achieve one common result—consistency in quality, operation, performance, and validation.  Although that can look different between pharmaceutical manufacturers and wastewater management plants, the goal is still the same; to provide consistent proof of performance.

No matter the size of the company, good communication between teams simplifies the entire process.  Larger companies can have divisions that have never even spoken to one another, meaning that understanding the full scope of the project can be missed. The risk in smaller teams is that they simply don’t have the resources to effectively tackle the work.

That’s where qualified experiences with regulated industries from water, wastewater and electrical utilities to pharmaceutical, life science and food and beverage companies can be of use. Intimate knowledge of the changing regulations from the FDA, EPA or USDA allows systems integrators to design, author and execute all validation documents required by law as they build the systems.

This not only equates to time savings and efficiency for the validation group, but also frees up that part of the team to hold more of a supervisory role in the overall project execution.

Installation, Operation and Performance

Following the engineering design phase where user requirements and functional specifications lead design thinking, a solid system of installation, operation, and performance must follow. IQ, OQ, and PQ test documentation leads to a smooth transition from a control systems automation engineer to high-quality performance on the plant floor.  And it’s not just about the handoff to the customer. Ten minutes or ten months down the road, knowing you can trust the partnership you’ve built with your system integrator is imperative for the time when a plant machine isn’t running as it was intended. Clear documentation and traceability matrices along with user-friendly interfaces allow partner system integrators to quickly assess the problem and diagnose a solution, minimizing down time for the plant floor.

Working with a control systems integrator without experience in this complicated and ever-changing road is like walking into foreign language class on the first day of school. The learning curve is steep and often slow and in today’s manufacturing environment, where speed and efficiency are vital, those two just don’t add up.

In the News: Avoid Devastating Consequences

Consequences of not validating systems and processes can be devastating. Not only can you produce poor product, but the risk of reputation to your quality, your brand, and ultimately your bottom line can be devastating for a company. 

We’re seeing this play out right now when we look at the baby formula shortage. One Michigan plant that effectively produces nearly 80 percent of the specialized baby formula for Abbott Nutrition, the nation’s largest provider of baby formula, is shut down due to recalled contaminated products. 2

This shutdown is creating a major supply issue for parents, and we’re seeing it play out all over the media. 

Several strategies can be put into place by a qualified system integrator to mitigate the risk of missing an element of your validation documentation, and they begin with good communication. The ability of an engineering firm specializing in certified systems integration to author customized validation documents for customers is invaluable. That ability comes with experience.

Changing Regulations

What Huffman Engineering knows from decades of experience is that regulations can change like the wind and even simple adjustments in compliance can unleash a tidal wave of change throughout an organization. From the operations on the plant floor to the documentation housed in the quality department, we have witnessed this more than a few times especially in pharmaceutical companies where the results of getting it wrong can be devastating.

Consequences of a weak quality and validation system are swift and harsh and hindsight is always twenty-twenty. 

The bar has been set high for qualification and validation standards across all regulated industries, especially as threats and attempts at cybersecurity breaches targeting continue to escalate. As these ever-evolving standards continue to increase, having a qualified system integrator to navigate those sometime treacherous waters might be your best move yet, ultimately allowing the end user to ensure results promised are results delivered.

Then the proof is in the production. Consistent, quality production, all the time.  While many engineering firms can deliver automation processes, the experience with working in regulated industries pays off in spades simply because from the beginning of the project, they are speaking the same language.

Toby Varner, PMP Industrial Manager at Huffman Engineering Inc.http://panaceatech.com/, certified members of the Control System Integrators Association (CSIA). For more information about Huffman Engineering, visit its profile on the Industrial Automation Exchange.