Deconstructing Process Validation vs. Process Verification

Process Verification vs. Validation: Building the Right Thing vs. Building the Thing Right

The terms verification and validation are often confused — their meanings are accidentally interchanged or used for the same purpose. 

Understandably so — they are both critical elements of guaranteeing the quality of a manufacturing process. 

But how are they different?

Learn what differentiates process verification and validation as we examine what these concepts mean and what sets them apart. 

What Is the Difference Between Verification and Validation of a Project?

Verification aims to answer the question, “Are we building the product right?” It is the process to ensure that the product is developed correctly.

Validation aims to answer the question, “Are we building the right product?” It is the process of ensuring whether the software meets the requirements and expectations of a customer or not. 

Process Validation

Process validation is the dynamic testing that begins as soon as the project starts. It is the collection and evaluation of data gathered throughout the entire process of the design and manufacturing of a product. 

The purpose of process validation is to ensure that the process — given the varied inputs — consistently leads to a high-quality output or product.

Process validation is one of the most important aspects of a quality management system. It assesses whether the processes and procedures are effectively achieving the goals that are set, and it establishes scientific evidence that the process is trustworthy and repeatable.

More importantly, process validation provides a way to figure out how the process is repeatable and leads to uniform and reliable results every time. 

Some industries that often use process verification include:

• Manufacturing

• Environmental 

• Healthcare

• Education

• MedTech

• Government

• BioTech

• Pharmaceutical

In any highly regulated industry, manufacturing processes must undergo either process verification or process validation to be sure they are producing correct results. The big question is — which one should you choose?

When you can’t use process verification to prove your process is working as intended, process validation can be used to identify some vulnerabilities that are too difficult to find. 

Let’s use the MedTech industry as an example.

Here are some scenarios when the MedTech industry might choose process validation vs. process verification:

• Numerical control cutting processes

• Certain human assembly processes

• Certain cleaning process

• Certain filling processes

Process validation can pinpoint potential areas of resource inefficiencies and enhance the cost-effectiveness of production. It can identify potential risks and deviations that may compromise the end product’s safety. 

The right computerized maintenance management system (CMMS), like UpKeep, can help tackle the compliance regulations your organization must follow. 

UpKeep’s user-friendly Asset Operations Management System can help with process validation by interpreting historical data connected to:

• Equipment performance

• Maintenance records

• Past validation results. 

UpKeep can streamline and optimize maintenance operations to ensure your organization is compliant with regulatory standards and that your product is safe for consumers.

For a personalized demo or more information, you can request a free demo here.

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Process Verification

In 820.3(aa) of the Quality System Regulation (QSR), the FDA defines process verification as “confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.” 

Process verification is about processes, standards, and guidelines. 

Process verification plays a role in almost every stage, from initial development to production and upscaling. It is the static testing that checks whether the software conforms to specifications or not. 

Process verification is an ongoing quality assurance system that ensures that all processes remain in control — it is a critical step in the validation process that assures you’re producing your product correctly. 

Verification is performed by a human, not by computer software. Therefore, the opinion of the reviewer may change from person to person. 

The decision to use process validation vs. verification resolves around two questions:

• Is the process output verifiable?

For example, the length of a bone screw can be verified by measuring it with calipers; the weight of an instrument can be verified by weighing it on a scale.

• Is verification sufficient and cost-effective?

In other words, verification alone must be adequate enough to eliminate unacceptable risk and the cost must be justifiable. 

Industries such as pharmaceutical manufacturing and medical device manufacturing use process verification extensively.

Here are some examples of processes covered by verification:

• Manual cutting process

• Testing for color, turbidity, or pH for solutions

• Visual inspection of printed circuit board

To help with process verification, you can utilize UpKeep's Asset Data Platform — UpKeep DataHub. 

UpKeep DataHub is designed to collect asset data, standardize data into common data models, and automate data-driven asset operations. This platform enables you to have a systematic approach to verifying processes and ensures data accuracy across your maintenance operations.

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The 3 Stages of Process Validation

Process validation involves a series of activities taking place over the lifecycle of the product and process. This FDA guidance describes process validation activities in three stages designed to achieve a high degree of assurance of the manufacturing process that will consistently produce products relating to:

• Identity

• Strength

• Quality

• Purity

• Potency

Step #1: Process Design

Process design is considered the research and development phase — it defines a process for the manufacturing product based on knowledge gained through development and scale-up activities.

In this stage, you might be using already existing processes or designing brand-new ones. Either way, you can use the data from this stage to optimize your production process, create efficiency, and troubleshoot problems. 

As process development progresses towards production, it involves:

• Risk assessment

• Experiments and demonstrations

• All other product development processes

Examples of process design documents you’ll also be creating include:

• Block Flow Diagrams (BFD) 

• Process Flow Diagrams

• Piping and Instrumentation Diagrams

Step #2: Process Qualification

During process qualification, the process design is evaluated to determine if the process is capable of reproducing consistent and reliable levels of quality. 

When reviewing the design process, you should be asking questions like:

• Does it fit the goals of your entire process? 

• Is it repeatable and reproducible? 

• Can you maintain this level of quality management?

• What compliance processes must be considered?

A useful component of this stage is the opportunity to develop contingency plans for situations when things go wrong. 

During process qualification, it is essential to document details such as: 

• Sampling plans

• Data collection metrics 

• Product testing plans and methods

• Specifications for production batches

Step #3: Continued Process Verification

Continued process verification involves ongoing validation during production to ensure that the process that was designed and qualified in the previous stages continues to deliver consistent quality. 

It is a vital step to ensure that production means remain in a state of control and requires the involvement of employees with quality control training. 

At various points in the manufacturing process, this stage involves product:

• Sampling

• Analysis

• Comprehensive record-keeping

This step is especially important in the pharmaceutical and biotech industry because they must adhere to FDA guidelines and the International Medical Device Regulators Forum.

Skipping this step may result in penalties from the FDA, such as:

• Suspension of licenses

• Disbarment or disqualification 

• Product seizures

• Injunction

• Criminal prosecution

The 5 Types of Process Validation

#1: Prospective Validation

According to the FDA, prospective validation consists of validation activities that are carried out before you manufacture either a new product or a product made under a revised manufacturing process.

Prospective validation involves these specific steps:

1. Develop a validation plan.

2. Pass through DQ, RA, IQ, OQ, and PH phases.

3. Perform process, computer, analytical, and cleaning validations.

4. Prepare a final report.

5. Subject equipment to preventative maintenance regularly.

Prospective validation creates documented evidence before process implementation that a system works as intended. It ensures that the process meets specific requirements that contribute to overall quality and safety, and also reduces the risk of defective products.

#2: Retrospective Validation

Retrospective validation occurs when the manufacturing process is complete — it’s based on accumulated production, testing, and control data. Retrospective validation is used for facilities, processes, and process controls that have not undergone a formally documented validation process. 

Retrospective validation establishes documented evidence that a system does what it’s supposed to do based on analysis of historical information.

Here are some examples of when retrospective validation may be acceptable:

• The product line was stopped, and you want to restart.

• The original validation was found to be inadequate.

• Your company practices and procedures state that all validation will be reviewed at yearly intervals.

• You want to expand to an FDA-controlled market.

• A recommendation from a reviewing consultant has led to your decision to revalidate.

#3: Concurrent Validation

Unlike prospective validation which occurs before production, concurrent validation occurs simultaneously with production. It ensures that the product will be sold by the operating firms throughout the qualification sequence.

Concurrent validation confirms that manufacturing steps and critical points are effectively monitored during normal production. It also provides documented evidence that a facility and process will perform as intended during actual use.

Concurrent validation involves:

• Full understanding of the process through prospective work.

• Close examination of all process deviations and relevant investigation reports.

• Intensified monitoring of all manufacturing steps and critical points in the first three production-scale batches.

Through rigorous monitoring and testing, concurrent validation plays a crucial role in upholding the integrity and quality of the process — boosting confidence in the quality and consistency of the final product. 

#4: Revalidation

Revalidation involves repeating the original validation either in its entirety or in part. This crucial process checks that all systems are still operating as originally validated and includes a thorough review of existing performance data. 

Revalidation ensures that no unintended changes have affected the process, system, or equipment — it makes certain that the end result remains consistent and meets the specified requirements. 

Some examples of when revalidation should be performed include: 

• Significant changes in batch size

• Sequential batches that fail to meet process or product specification

• Changes to the product, the manufacturing or cleaning princesses, the plant, or other changes that could affect the quality of the product

#5: Periodic Validation

Periodic Validation is the regular process whereby model performance is evaluated for a model that hasn’t been changed. 

This repeat validation process requires routine evaluation to check that the process is working according to the original design.

The primary objective of periodic validation is to safeguard against model decay induced by internal or external environmental changes such as:

• Policy changes — like different origination standards or product parameters

• Market changes — like a significant change in level, volatility, or liquidity

How Preventive Maintenance Is a Vital Component of Process Validation and Verification

Machines and equipment must be routinely recalibrated and maintained to ensure that they:

• Meet the correct parameters during process verification

• Maintain operation during production

• Are consistently and correctly producing a product that is safe, high-quality, and without contaminants

Critical equipment failures may mean that the processes will need to be revalidated, possibly resulting in production delays and product loss.

Maintenance statistics show that preventive and predictive maintenance may extend the life of the equipment and avoid lost productivity due to machine downtime — helping to increase your overall profit margins. 

According to the 2018 maintenance survey, when predictive maintenance rose from 47% to 51%, running equipment to the point of failure dropped from 61% to 57%.

Research also indicates that the total annual losses associated with maintenance are estimated to be on average $222 billion, largely due to inadequate maintenance. The same study shows there are potentially significant benefits to investing in advanced maintenance.

To give you an idea — a run to failure or repair on equipment can cost somewhere between three and ten times as much as a good maintenance program. 

Implementation of the right CMMS and EAM software might not only improve maintenance management but save your organization a substantial amount of time and money. 

Avoid Equipment Failure and Maintain Your Validation and Verification Processes With UpKeep’s CMMS and EAM Software

UpKeep’s maintenance software provides integration tools that ensure that your process validation and verification run smoothly. You’ll have everything you need to simplify, organize, and optimize your maintenance and reliability team and operations — helping you to consistently manufacture the right thing, the right way. 

UpKeep’s mobile CMMS App and EAM software can help modernize your validation activities and maximize your assets for a more cost-effective operation by:

• Enhancing collaboration

• Reducing maintenance response time

• Streamlining communication

• Decreasing equipment and asset downtime by up to 26%

• Extending your asset and equipment lifetime by up to 11%

Avoid downtime due to breakdowns, inefficient work order management, lack of transparency, and the absence of data-driven decision-making. 

Let UpKeep help you to enhance your validation and verification processes. Request a demo today.

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