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 (i.e., 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.