VALIDATION

(click to enlarge) This is an example of a table that would be included in a qualification protocol in a prerequisites test section. An official copy of the protocol is printed and the tester fills in results of the procedure for the test section performed.

Equipment qualification is a necessary and critical step in ensuring that a product or service is provided accurately and consistently with requirements aligned with medical device manufacturing and testing. This is especially critical for the medical device industry because the medical device manufactured by a company is considered a piece of equipment and requires qualification, as much as other equipment and instruments involved in manufacturing. Verifying prerequisites before qualification ensures a safe and smooth qualification process. A prerequisite in an equipment qualification is a documented verification intended to demonstrate that everything is in order prior to initiating the execution of the qualification section.

For medical device companies, using prerequisites translates into less time and money spent on avoidable delays. Because the requirements for a piece of equipment or a device can vary widely from company to company and even between pieces of the same type of equipment, it is important to devise a universal set of prerequisites that will address all potential trouble areas. Device OEMs and device-testing facilities need to understand how prerequisites fit into an equipment qualification, and need to know what should be Tested during prerequisite verifications in an equipment qualification. They should also be able to outline a universal set of prerequisites.

Prerequisites in an Equipment Qualification Protocol

Setting up equipment in a medical device manufacturing facility includes ensuring that the equipment will safely and consistently work as intended. To do this, it is necessary to verify the following actions:

• That the equipment is installed according to the manufacturer's instructions.
• That the equipment is operated properly and consistently.
• That the equipment performs within the requirements determined by the facility.

To cover all of the necessary criteria, equipment qualifications are typically organized by separating the protocol into three sections: installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).

Because the IQ, OQ, and PQ are performed separately, each should have its own set of prerequisite verifications. Because the equipment requirements at each of the qualification stages are different, the prerequisite requirements at each of the qualification stages should be different as well.

What to Verify during Prerequisite Testing

The general goal of prerequisite testing is to ensure that items that commonly cause execution to be delayed or repeated are in order prior to starting the qualification. Because of variations in equipment and differences in how facilities operate, using the exact same prerequisite verifications may not always be the best approach.

For prerequisites to significantly help streamline the qualification process, they have to be tailored to fit the specifics of both the equipment and the facility. As a whole, it is easy to overlook potentially important prerequisites. Therefore, it is often helpful to separate them into categories and address them one at a time. With a good understanding of the categories, the process of tailoring the verifications to suit a specific piece of equipment at a specific facility will be much smoother. Although it is nearly impossible to cover all prerequisite verifications, some of the most common prerequisite categories are presented and explained in the following paragraphs.

Procedure Prerequisites

Procedure verification includes any procedure that is required for operation or maintenance of the equipment as well as any sampling or testing procedures required to obtain and analyze the protocol samples. Each of these procedures has typical items that need verification, such as the status of the procedure, the title, and the document number. Specifications vary depending on the section of the protocol the verification is being written for (i.e., IQ, OQ, or PQ). For example, during the IQ, it might be acceptable for the procedures to still be in draft form. But by the time the PQ section is going to be executed, the procedures must be approved documents.

Performing procedure verification could be cost-efficient for a company. For example, a medical device facility brought in personnel to perform the time-consuming task of collecting microbial samples for a qualification. When the samples arrived at the laboratory, they realized that the testing procedure for the samples was still in development. None of the samples taken were usable and the entire collection process had to be repeated once the testing procedure was approved. Because of the delays, the launch of the medical device into the market had to be postponed. The expense of the wasted man-hours and supplies and the delay of the launch could have easily been avoided by a procedure verification prerequisite.

Training Verification

(click to enlarge) Procedure prerequisite specifications in equipment qualification.

The importance of verifying the training of operators and test personnel is a universal prerequisite throughout the various types of validations and qualifications. For equipment qualification, it's important to verify that the personnel operating the equipment (in addition to the personnel executing the protocol) have the training required to successfully perform the necessary tasks according to the currently acceptable method. Additionally, the personnel executing the protocol should be similarly trained.

Picture executing a performance qualification of an autoclave for which the operator doesn't know how to control the equipment, and the importance of verifying operator training becomes clear. What may not seem as clear is why it is important to verify the training of the qualification test personnel. A medical device manufacturer learned the importance of test personnel training during the qualification of a freezer. The freezer qualification included a 72-hour temperature mapping, which required monitoring and recording the temperature in different quadrants of the freezer at specified time intervals for a three-day period. During an audit, it was discovered that the data were not collected for the full 72 hours. An investigation concluded that the error was due to the fact that the testers who set up the mapping were trained on an earlier revision of the protocol and didn't realize the time interval had changed. For this company, the small amount of time that would have been needed to execute a prerequisite seems well worth it after being set back three or more days because of the need to investigate and repeat the test.

Utilities Verification

Although not actually a part of the equipment, utilities are essential to its operation. Equipment cannot run without electricity, compressed air, gas, water, etc. Utilities that should be Tested include any utility that is required to execute the protocol and has the possibility of not being available or not being available at the required level.

An example of the benefit of performing utility verifications was seen during the qualification of equipment designed to weld the seam of a medical device. For the equipment to produce a successful weld, it was critical that the laser power supply meet very specific electrical requirements. During the qualification, multiple unsuccessful welds were observed. After a lengthy investigation, it was discovered that the problems were caused by a variation in the electricity feeding the laser. Although the problem was identified, the time needed to correct the problem and rerun the test was costly and could have been avoided had the utility qualification of the electrical system been performed prior to starting the testing.

Test Instrument Prerequisites

Instituting test instrument prerequisites is a simple way to eliminate costly delays and misunderstandings. The items that should be tested in this section include any instrument or piece of equipment that is required during the execution of the protocol. Some examples of instruments or equipment that are typically Tested in test instrument verification include voltage meters, particle counters, and scales. Testing and sampling instruments and equipment are often used by many people and often require calibration. Typical items that benefit from prerequisite testing include the availability or location of the instrument or equipment and its calibration status for the expected duration of the qualification execution. Just imagine the headache it would cause, if, when it came time to start a qualification, you realized that your scale was out of calibration or the particle counter you ordered a month ago never arrived. Making arrangements for calibration or tracking down an order often involves time-consuming activities (e.g. getting approvals, contacting customer service representatives, and tedious paperwork). Such tasks are time-consuming in general, so don't add to the burden by waiting to do them until it's too late to resolve the issue without holding up the qualification. Performing prerequisites allows you to address the items before they start causing delays.

An incident during a qualification of an incubator at a contract testing laboratory shows how test instrument verification can make a difference in a timeline. Temperature mapping was included as part of the qualification. After completion of the qualification, it was discovered that some of the data loggers used during the mapping were out of calibration. The calibrations were scheduled and performed, but the mapping had to be repeated once the data loggers were received back from calibration. The hassle of additional scheduling and the delays incurred could have been avoided had the contract testing laboratory performed a test instrument verification that included the data loggers.

Equipment Status Prerequisite

The purpose of equipment status prerequisite testing is to ensure that the equipment being qualified is installed and ready for qualification. As with procedure verification, different requirements or specifications are typically desired for different sections of the qualification. For example, it might be necessary for the equipment to be set up, calibrated, and ready to run during a PQ. However, for the IQ, it's only necessary for the equipment to be installed. Another possible inclusion in equipment status verification is the availability of the equipment for use. Unlike process validation, which cannot begin until a process has been developed, equipment qualification protocols are sometimes written before the equipment is even received. As a result, a protocol can be ready for execution long before the equipment has arrived and been installed.

Recently, the qualification of a building management system at a medical device facility was scheduled to begin, and consultants were hired to execute the protocol. When the consultants arrived at the facility to begin the qualification, they found out that an ancillary electrical panel had not been installed because it was on back order. If the equipment status had been Tested prior to the qualification, the cost and time of the additional on-site visit by the consultants in order to reassemble the team could have been avoided.

Additional Benefits of Prerequisites

Documentation of prerequisites creates a system that actively tracks future problems, not just problems that have already occurred. When combined with the existing methods of identifying trouble areas of the quality system, prerequisites provide a little extra help in meeting the overall goal of preventing problems rather than just reacting to them.

Adding prerequisites to a validation or qualification program also helps OEMs prepare before an audit. By performing these simultaneous “spot checks” or verifications of the quality system, it is possible to generate trends in the quality system. The additional method of locating such holes and inconsistencies helps a company understand the areas to focus efforts prior to an audit instead of after an auditor has found the problems.

Conclusion

Incorporating prerequisites into an equipment qualification ensures that equipment is ready to run consistently and reliably. Moreover, it ensures that the equipment can pass the testing outlined in the protocol with fewer failures, investigations, or retesting. The ability of prerequisites to streamline the execution of a qualification, with the added bonus of the ways that they benefit a quality system, demonstrates the value of incorporating prerequisites into an equipment qualification. Having a clear understanding of the benefits and being able to apply them to your facility can ensure smooth, cost-effective qualification efforts.

Jennifer Medlar is a consultant for Advanced Biomedical Consulting LLC (ABC; St. Petersburg, FL), and Nancy Cafmeyer is a project manager at the company. Contact them at [email protected] and [email protected].

Copyright ©2009 Medical Device & Diagnostic Industry

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Timothy Porter is an Army veteran of 10 years. He achieved the rank of Sergeant First Class within 7 years. After being involved in a bomb explosion, Porter was medically retired and began pursuing his passion: technology. In 2009, after teaching himself how to develop mobile apps, Appddiction Studio was formed. In 2011, Appddiction Studio was nationally recognized by the USA Network Channel. Porter was one of their USA Character Unite Award winners for developing an award-winning anti-bullying App for schools. Appddiction Studio has developed well over 200 commercial mobile apps and has become a leader in Enterprise transformations focusing on Agile and the SAFe Framework.

Porter has multiple degrees in Management Information Systems and holds an MBA. He is an SPC and RTE and has performed roles for Appddiction Studio as Scaled program Consultant, Enterprise Coach & Trainer, Agile Coach, Release Train Engineer to Scrum Master. Appddiction Studio has been performing for programs supporting Gunter AFB as a Prime Contractor in: Agile Coaching, EODIMS JST & EODIMS Backlog Burndown and now as a subcontractor on ACES FoS.

Porter has taught over 50 public/private SAFe classes and has submitted his packet for consideration to become SPCT Gold Partner. He is certified at all levels of SAFe Framework and teaches Leading SAFe, SAFe Scrum Master, Advanced Scrum Master, Lean Portfolio Management, Product Owner/Product Management, SAFe DevOps, SAFe Architect in addition to Agile courses like ICAgile Agile Fundamentals, ICAgile Agile Team Facilitation, ICAgile Agile Programming & ICAgile DevOps Foundations.

Focusing on SATs, LSATs or even the bar test seems unthinkable today as the world grapples with a global pandemic. Yet students are continuing to prepare in spite of the myriad other challenges they face during this crisis.

The choices these students are making now will drastically change the future of the test preparation industry. That's a market predicted to reach more than $30 billion by 2021 while posting an expected 6% compound annual growth rate (CAGR) through 2024.

As a test preparation company CEO, I'm making a bold prediction for my industry: Test preparation will never return to physical classrooms. I believe the current pandemic will finally erase all significant demand for classroom-based test prep. Here's why.

Everything Is Changing, But Test Prep Will Change More

As I argued in my latest Forbes article, the current, forced transition to distance learning will reveal many lasting benefits of remote education and reshape how we teach. For test preparation, however, I expect an even more drastic change. Classroom courses have irreplaceable benefits for students in some programs of study (e.g., the physical sciences). The value of any test preparation course, however, is dependent largely on just two factors: instructor quality and curriculum quality.

Online Test Prep Means More Consistent Instruction

Instructor consistency has long been a weakness of the test preparation industry. In 2008, before online prep was common, college admissions expert Richard Montauk wrote: "The major (LSAT prep) companies inevitably (given the huge numbers they employ) take on many instructors of less than stellar intellect…provide them with limited training and suffer from high instructor turnover."

If you don't have classrooms, you don't have to hire subpar instructors to fill a classroom in a market where no top-notch candidates are available. While instructors whose test scores were as low as the 90th percentile or even below may be hired to teach classroom-based LSAT courses, online-first companies can afford to restrict hiring to 99th-percentile scorers (that's especially important for the LSAT, where many top law schools' lowest-scoring admittees reached the 97th percentile).

A High-Quality Curriculum Works Anywhere

As for curriculum quality, standardized tests are a known entity. The most drastic changes to the SAT in years had less to do with the test than with attempts to correct for intrinsic biases in testing. The LSAT may be doing away with logic games, but analytical reasoning will remain, albeit in a different form.

The challenge, therefore, in creating an effective curriculum is twofold: First, you need to create a simple method that leads learners to correct answers, and second, you need to deliver course content in such a way that learners are able to acquire that knowledge.

The research says, and has said for years, that online learning is as good as classroom learning and sometimes even better for knowledge acquisition. So, any high-quality test preparation curriculum should serve students as well or even better online vs. in-person.

Market Manipulation Helped To Keep Classroom Test Preparation Afloat

If remote test preparation is as good or better than classroom-based prep, why hasn't this transition already occurred? The answer may be that large companies don't want change. Take, for example, the massive 2007 class-action lawsuit accusing two dominant companies of illegally creating a monopoly to drive out smaller, higher-tech competitors.

If the biggest players in any market collude to keep it from changing, change will be delayed until external factors intervene. Enter coronavirus. Industry giants will now have to scramble to catch up with online-first companies.

The Other Side Of The Coin

This industry shift carries with it a call to action for test prep companies to better serve their most economically vulnerable students. The New York Times found that absences increased more for poorer students following the forced transition to distance learning. Students of lower socioeconomic status own less reliable devices and lack access to broadband internet.

If we, as an industry, shift away from the classroom and onto the internet completely, we must address these socioeconomic disparities. Otherwise, test prep will become exactly what critics claim it is: just another way for wealthy students to get an unearned leg up. Some suggestions for my peers in the test preparation industry:

• Don't just offer scholarships — make them automatic. For students who have qualified for need-based assistance, like LSAC's fee-waiver, don't make them apply all over again. Just verify they've already qualified and then grant a scholarship.

• Test your product offerings on low-cost devices. The Huawei P20 Lite, priced under $350, is among the world's most-used smart devices. If your course isn't usable on a cheap Android phone, it is inaccessible to much of the world.

• Make your course work without data. What if a student's data plan is disconnected for nonpayment? Can they still use your app effectively by downloading enough course content from a Wi-Fi connection at school or work to later prep at home?

• Provide free access to live instruction. It doesn't cost you much to offer office hours with top instructors via Zoom, but it can benefit your students enormously.

• But don't use 'live online' as a stopgap. "Live online" requires students to log in at set times and watch instructors deliver content in real time via a webinar. By forcing students to learn at the same pace and on set schedules with limited access, this "innovation" actually shares many of the inefficiencies that plague the in-class model. Instead of this half-baked live online format, take the time to thoughtfully balance self-paced learning with free, live instructor support.

Final Thoughts

These are unprecedented times. In many ways more important than any standardized test score, the world has already changed for good. Both in test prep and in business in general, we must learn to adapt to a dramatically altered landscape.

What are you doing to prepare yourself for change in your industry? If you'd like to chat about it, let's connect. Together, we are all stronger, even at a time when in-person togetherness is impossible.

The MarketWatch News Department was not involved in the creation of this content.

Feb 08, 2023 (The Expresswire) -- Die Prep, Assembly, Test and Qualification Service Market Size 2023-2029 | New Report (126 Pages) | In This Reports Die Prep, Assembly, Test and Qualification Service Market and its business scene, significant issues, answers for relieving the upgrading risk, methodologies, future lookout, and possibilities, Other than the standard design reports, Top Die Prep, Assembly, Test and Qualification Service Companies (Quik-Pak (QP Technologies), Precision Test Services, Majelac Technologies LLC, Skywater, Promex, DPACI, GDSI, Integra Technologies, Globalfoundries, Golden Altos, Micross) with the best facts and figures, definitions, SWOT and PESTAL analysis, expert opinions and the latest trends around the world.

The MarketWatch News Department was not involved in the creation of this content.

The MarketWatch News Department was not involved in the creation of this content.

The MarketWatch News Department was not involved in the creation of this content.

In the ever-evolving landscape of test preparation, a new player has sprouted on the scene – artificial intelligence.

At the forefront of this movement is a Korean start-up, Riiid, founded by YJ Jang, a graduate of the Haas School of Business at the University of California, Berkeley. Riiid has already made a name for itself in the Asian test-prep market for the TOEIC, a measure of English proficiency in the business world. Now, the company has set its sights on the American market with an SAT and ACT prep system called R.Test.

A.I. technology, with its mimicry of the networks of neurons in the human brain, has the potential to revolutionize the way educators approach their craft.

“R.Test makes it easy for students to solve practice problems, as well as read the explanations to help fill gaps in knowledge,” said Kelly Jung, a 9th grade student at Lighthouse International School in Korea who has tried the product. “The post-test analysis was the most helpful part of the test, as it helped highlight both my weaknesses and strengths, allowing me to streamline my studying moving forward."

This is not the first time the world has seen the integration of technology in the classroom. In the 1960s, the earliest forms of computer tutoring systems were developed, but their prohibitive cost and lack of widespread access limited their impact. Decades later, rule-based A.I. systems were implemented, but they failed to live up to their potential due to scalability issues and the high cost of programming extensive domain expertise.

It was at Berkeley where Jang was introduced to the game-changing potential of deep learning. This form of A.I. allows algorithms to learn on their own, drawing from vast amounts of data. Jang recognized the implications of this technology for education, and upon returning to Korea, he founded Riiid in 2014. The company's team of data scientists have developed A.I. algorithms that track student performance, predict scores and anticipate when students may disengage. Through the use of their popular test-prep app, Santa, Riiid has amassed one of the largest public education data sets in the world, known as EdNet.

However, the task of gathering enough data to make A.I. applicable to the broader field of education remains a challenge. For now, Riiid focuses on the lucrative test-prep market, where data is more readily available, easily collectable and has partnered with educational companies around the world to develop test-prep apps.

The company's success has attracted a substantial investment from SoftBank's Vision Fund II, bringing Riiid's funding to over $250 million. With the upcoming release of their A.I.-powered R.test platform for college entrance exams, Riiid has the potential to drastically change the way students prepare for their future.

While there is no shortage of SAT or ACT test-prep offerings, none assess students based on immediate data. Khan Academy’s SAT test prep, for example, connects to College Board, administrator of the SAT, and assesses student weaknesses based on their last test – usually the PSAT. But that data can be months old.

R.Test relies on live data collected as students use the system. With the R.Test, students can quickly get their predicted scores for the full test just answering 30 questions, and learn actionable insights that include weaknesses and even test habits.

R.Test is “very targeted to your current work,” noted Oscar Torres, a high school math teacher in Chicago who has tried Riiid’s system. “That's what I liked.”

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