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 likely will 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 typically is not effective because the agencies are not tuned into the needs of the medical device industry. As a result, GW Plastics hires workers from temporary agencies that are not ISO 13485-certified. This means 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 possibly could arise if non-qualified personnel were operating in the clean room.