The Risk of Using Noncompliant Temporary Labor in Medical Device Manufacturing

No medical device manufacturer wants to put out an inferior product—it’s bad for business. It’s costly. And it often leads to recalls, penalties, litigation and even wrongful-death lawsuits. A bad product is a big deal.

One production risk that tends to be underrated (but can lead to serious process mistakes, poor quality, and regulatory noncompliance) is the use of part-time employees who are not provided current good manufacturing practices (cGMP) training through an ISO 13485-certified employment agency, or do not know how to make medical devices according to 21 CFR Part 820 standards.

Because this temporary labor force is actually making or assembling medical devices or healthcare products, the medical device company is at risk for non-compliance if these workers have not been trained to cGMP or other regulatory requirements. The company with its name on the product is always responsible for the contract manufacturer—if the contract manufacturer releases flawed or dangerous products, the OEM is liable for the fallout, including lawsuits and penalties. Any lack of attention to 21 CFR Part 820 standards by employees (temporary or full-time), of course, can create big problems for the contract manufacturer and tarnish the reputation of the OEM.

Every company wants to reduce costs and maximize profits, but cutting corners on essential knowledge and training for the workers making the products is not the way to do it. The combined costs of poor performance, mistakes, flawed products, rework, and U.S. Food and Drug Administration (FDA) penalties and fines—as well as brand erosion and loss of market share—far outweigh the added cost of using cGMP-trained, part-time employees who have been thoroughly trained to produce and assemble medical devices. These workers can be provided by temporary agencies that specialize in medical-device manufacturing and are ISO 13485-certified. Not only does this improve quality, it reduces risk, lowers overall cost, and creates peace of mind.

A World of Tight Margins

Over the past two decades, with intense competition coming from offshore countries, U.S. employers have tried to reduce their labor costs by spending less time on training. This eventually backfires—sometimes early on, sometimes down the road. Cutting back on worker training and regulatory knowledge is especially dangerous in a complex and highly regulated field such as medical devices. This is particularly true when there is so much emphasis on production and throughput that workers on the manufacturing floor are too overwhelmed to focus on all the regulatory details of what they are doing, and are just trying to keep up. Unless very diligent managers are onboard who understand all the documentation requirements, compliance issues will likely arise. This is why more companies are receiving warning letters or non-conformance letters (483s) from the FDA.

When an OEM is ramping up for a new product, labor requirements typically fluctuate significantly for its contract manufacturer. Most medical device manufacturers rely on temporary labor when those needs are high, especially during development and production phases. Many of these companies, for example, hire entry-level employees from temporary agencies. This can be a hit-or-miss proposition, depending on the screening process and their qualifications. Turnover tends to be high, with some companies losing up to one-third of their temporary staff, often early in the training process. These companies have invested money in training them, but they quit before the training is complete.

Screening for more qualified candidates from temporary agencies is typically not effective because the agencies are not tuned into the needs of the medical device industry. GW Plastics hires workers from temporary agencies that are not ISO 13485-certified. Instead, GW Plastics must train the agencies and the temporaries to the regulations, or hire and train the best workers it can find, which takes time and adds cost. For example, all our production workers must be fully trained before they can enter the clean room. This costs money, of course, but eliminates more expensive problems that could possibly arise if non-qualified personnel were operating in the clean room.

Risks Abound

The risks of using noncompliant temporary labor to make medical devices are plentiful—these include extended learning curves, slow production lines, out-of-control production lines, chronic documentation errors, and absenteeism. Lack of proper screening (for example, not knowing about deficiencies in qualities such as reading comprehension, visual acuity, math skills, as well as certain aptitudes) could place workers in areas for which they lack the requisite skills and aptitude. All of the above risks can compromise the quality of the final product. In turn, this leads to costly rework, or even worse problems if the flawed products are shipped and used.

Other negative impacts resulting from the use of non-compliant temporary labor are:

• Loss of product (scrapped product, rework);
• Loss of revenues;
• Extra administrative/legal costs;
• Cost of recalls, consent decrees, etc.;
• Loss of time (dealing with mistakes, problems, situations);
• Loss of reputation and clients;
• Loss of jobs (downsizing); and/or
• Loss of the company.

The cost of not hiring and/or training the right people, or not following cGMP requirements, can be as devastating as losing an entire company, or being responsible for the accidental deaths of people who chose to trust your products because they thought the products were safe.

The Solution Is Simple

There are two possible solutions to this “readiness” problem: 1) hiring and training your own temporary workers to be certain they meet your own internal requirements, or 2) employing temporary employees from agencies that specialize in providing qualified personnel to the medical device industry.

The first solution is tough—it requires creating your own training protocols and staff, who then screen and train temporary workers as needed. This, however, takes time, so a quick startup is less likely. There is also no guarantee that, after the workers have been trained, used on the project, and let go, they can be rehired for the next project. This could result in constantly training and retraining workers to meet mandated requirements. You could even be training workers for your competition.

The second solution—hiring employees from employment agencies that specialize in providing workers to the medical device industry—is an effective way to meet labor needs, limit risk, and stay focused on production. These workers have been specifically trained to meet the needs of the medical-device manufacturers and can be further screened to meet specific job needs. This means startups can be quick, with short learning curves. Because these agencies are ISO 13485-certified, they know what your workers need to know and can customize a temporary workforce to meet your production needs, and to better match your culture and environment.

Advantages include:

• Overall reduced labor costs;
• Reduced turnover;
• Smoother operations;
• Improved product quality;
• Faster time to market;
• Better validation and documentation; and
• Less risk.

This allows managers to focus on planning for continuous improvement, instead of reacting to unexpected and recurring issues brought on by a poorly prepared workforce. Using knowledgeable, highly skilled workers on the line who know medical device manufacturing regulations speeds up production and eliminates many of the issues that cause line stoppage.

Every step in making medical devices begins and ends with people. Education and training is a never-ending process that is essential for meeting evolving quality standards. Making sure all employees—especially temporary workers—know the regulatory guidelines they must follow is essential for producing the best possible product. An effective way to accomplish this, without losing valuable time to hiring and training temporary workers, is using an employment agency that is ISO 13485-certified and can provide knowledgeable employees who can work in manufacturing, logistics, quality control or other production areas.