Managing temporary workers, which has become a fact of life for many medtech companies, has unique challenges.
Medical device companies and their manufacturing service partners frequently leverage temporary labor in order to keep their operations efficient and cost-effective. It’s also common for projects to ramp-up so quickly that the only way a medical device company can effectively accommodate the needs of their clients is by using temporary labor.
If the temporary labor force is not sufficiently trained to understand and meet specific medical device quality and regulatory requirements, however, the medical device manufacturer puts themselves, and their clients, at risk.
Meeting quality and regulatory requirements is no easy feat even for experienced medical device professionals. The heat is on when it comes to medical device quality citations. According to a recent evaluation of FDA inspection records, the number of warning letters issued to medical device manufacturers by the FDA has steadily increased since 2009.
FDA warning letters are not only embarrassing to medical device companies, they are also bad for business. One approach that many device companies have taken to reduce their regulatory risk is to encourage all of the key companies along their supply chain (especially those that affect the quality and safety of a product) to have an ISO 13485:2003 certification. ISO 13485 is an internationally recognized quality standard that outlines the Quality Management System requirements for companies involved in the design, development, and production of medical devices.
The primary objective of ISO 13485 is to harmonize medical device regulatory requirements for quality management systems, so it makes sense for medical device companies to strongly recommend that their suppliers get ISO 13485 certified. What’s interesting (and rather disconcerting) is that most medical device companies don’t seem to hold one of their key supply chain partners to this same standard: temporary labor companies.
For example, if a medical device company audit or an FDA inspection finds a manufacturer to be noncompliant because of an error caused by a temporary worker, the manufacturer risks damaging their business relationship with existing and future customers. Hiring untrained temporary labor also increases the likelihood that a medical device will be improperly manufactured and that the adulterated product will find its way to a patient.
For far too long, medical device manufacturers have contracted with temporary labor companies that do not sufficiently train their temporary employees in important medical device processes and protocols. As a result, temporary workforces have little to no concept of how to adhere to the FDA’s requirements for current good manufacturing practices (cGMP) and are unaware of what role they play in an ISO 13485 environment.
Some medical device companies will take it upon themselves to provide their temporary labor with some minimal on-the-job training (such as how to perform a three-step process). They remain at risk for noncompliance, however, because they usually don’t have the time or resources to adequately train temporary employees on quality system regulation and other relevant medical device requirements.
Because FDA inspections and medical device company audits will continue and are likely to rise as a result of increased supplier surveillance, ISO 13485 will continue to be an important supplier and risk management tool. It’s critical for medical device companies to reassess how their temporary labor is prepared for the manufacturing environment prior to bringing them onto the production floor. Unless the medical device manufacturer is willing to allocate sufficient time, money, expertise, and resources up front to comprehensively train all of their temporary workers to ensure that they comply with the quality and regulatory standards for medical devices, then it’s crucial that they work with a temporary labor company that does.
Having an available inventory of trained and capable labor to absorb the ebb and flow of manufacturing projects is critical from business and regulatory standpoints. But how that temporary labor is used in medical device manufacturing can significantly influence product safety, purity, effectiveness, and total cost. For these reasons, it’s essential to carefully evaluate your temporary labor providers and assess whether or not they have the following medical device expertise, resources, and training capabilities in place:
1. Have an In-Depth Screening Process
Medical device manufacturing requires workers to have some fundamental skills, knowledge, and aptitudes. For example, if temporary workers are needed to carry out production-related work in accordance with a process document (work instruction, Device History Records, etc.), then it is vital that they be screened by the temporary labor provider to ensure that they can read and comprehend English. If the job requires measurements to be taken, candidates should be screened for basic math and critical thinking skills, as well as how to use measurement devices.
Candidates who are expected to assemble devices and work with color-coded parts need to be evaluated for visual acuity, color-blindness, and manual dexterity. Objective tools should also be used by the temporary labor provider to validate a candidate’s mechanical aptitudes, attention-to-detail, and efficiency.
In addition to assessing skill-sets, education level, employment history, and experience, the value of conducting objective aptitude tests is that they help gauge a candidate’s work ethic, ability to focus, overall attitude, and endurance. This helps ensure that the temporary workers will be able to add value to the medical device manufacturer rather than create more work or problems.
2. Training Should Be Thorough and Targeted
The processes, best practices, and job-specific instructions of medical device production are extensive and complex. To prepare temporary workers for the unique, rigorous, and regulated medical device environment, temporary labor companies should provide comprehensive training that is tailored to medical device manufacturing requirements, logistics requirements, and positional needs.
Through the use of classroom training or audiovisual training materials, temporary labor providers should teach their medical device manufacturing workforce about job applicable processes, systems, and equipment requirements. This could include:
Managements systems (ISO 9001/13485/14001/etc.).
- Current Good Manufacturing Practices (cGMP).
- Good Documentation Practice (GDP)
- How to comply with quality systems regulation.
- Gowning and cleanroom protocol.
- Work instructions orientation.
- Device History Record (DHR).
Competent temporary workers must receive training that goes well beyond basic, bare-bones on-the-job instruction. Candidates should be prepared to properly perform their job when manufacturing medical products.
Additionally, since the medical device industry continues to change, it’s important to work with a temporary labor company that stays current on the unique situations facing their clients and creates updated training materials that teach temp workers how to meet client’s individual needs.
3. Be Prepared for Audits
Medical device company audits and FDA inspections can be unannounced. Not only should a medical device manufacturer’s permanent employees be prepared for them, but so should their temporary workers, as they are no different in the eyes of an auditor or inspector. If an auditor or inspector asks a temporary worker questions such as, ‘Tell me what you do for your job?’ and the temp worker doesn’t know how to acceptably answer, it shows a weakness in the manufacturer’s system.
As a result, the auditor or investigator is going to explore that weakness to ensure that it isn’t indicative of a more serious quality or regulatory issue that requires an audit findings report, a write-up of objectionable conditions, or an FDA warning letter.
A temporary labor provider that effectively educates their candidates on how to handle audits or FDA investigations helps medical device manufacturers reduce their risk, meet regulatory requirements, and comply with the FDA’s standards for quality.
4. Have a Tailored Employee Orientation
Every medical device company has their own unique culture, policies, and protocols. By providing temporary workers with specific information about each employer’s work environment, the temporary labor company positions their candidates for success on the job while simultaneously saving the employer time.
For example, this may include providing the temporary worker with information about the manufacturers’ work days, shift times, time-clock process, parking instructions, quality policy, reporting protocols, dress code, rules of conduct, safety procedures, and much more. Although not uniquely a medical device company requirement, it significantly enhances the efficiency and effectiveness of temporary labor application.
Lasting Results of Temporary Work
Medical device companies and manufacturing service partners are under more pressure than ever to ensure that their quality and regulatory systems comply with FDA and International Quality Management System requirements. If a medical device manufacturer wants to minimize their risk of non-compliance (or worse, a product failure), then they must confirm that all suppliers that potentially affect the product’s safety, purity or effectiveness—including their temporary labor providers—meet the medical device regulatory and quality system requirements.
In fact, many medical device manufacturers state directly on their websites that they only partner with companies who are ISO 13485 certified. Therefore, it would seem logical—if not imperative—that temporary labor suppliers be ISO 13485 certified. A temporary labor company that holds an ISO 13485 certification demonstrates that they understand the specific quality and regulatory requirements of the medical device manufacturing environment and have made the commitment to train their temporary workforce to meet those standards.
The typical “business as usual” model of working with a temporary labor company solely because of a long-standing relationship only serves to expose medical device manufacturers to unnecessary liability. With regulatory action on the rise, medical device manufacturers can no longer afford to overlook their temporary labor providers. They are a vital part of the supply chain and should be held to the same standards as other medical device suppliers.
James Ready is the manager of regulatory and quality system at Nypro Inc., a Jabil subsidiary.
|Refresh your medical device industry knowledge at BIOMEDevice Boston, May 6–7, 2015.|
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