The coronavirus pandemic is causing hiring uncertainties. It may become more difficult to conduct face-to-face hiring interviews. Also, laws, regulations, standards, and guidance documents are changing worldwide. Expectations are, too. Yet an encouraging, long-standing, and reassuring truth remains that can help with these challenges. Identify specific, key qualifications so that your team can be strengthened. Now more than ever, employees working within the medical device or IVD industries are increasingly becoming targets during audits (or inspections) to verify that they are qualified to do their job. This has led employers to either (i) spend more time re-training their workforce, (ii) redeploying existing headcounts, or (iii) hiring new staff to better align personnel talent with evolving job functions or roles. Clinical, regulatory, and quality teams are all affected. There are many factors to consider when hiring, but this article focuses on qualifications that target competencies and skills.
Because the landscape is evolving, finding those treasured candidates is challenging partly because competent authorities, notified bodies, manufacturers, and consulting groups are all seeking similarly qualified candidates. The talent pool is shrinking. Organizations are all transforming, either searching outside their ranks to find those hidden, veiled gems, or shifting those employees within their organizations into new roles or positions. The hope is that they will transform to be (i) competitive, (ii) highly effective, and (iii) aligned with changing business strategies. Thus, it becomes crucial to reassess current teams to identify specific qualifications that are needed for upcoming challenges and opportunities.
The purpose of this article is to highlight the importance of visualizing where your team is now, making future decisions based on robust, easy to understand information and then linking their qualifications to quality system documents that become targets during audits or inspections. How do you currently answer this simple question, “What qualifies that person to do their job?” A straightforward, fun, and clever solution is presented.
The ‘To-Do’ List Grows
The message from her manager said, “I need your help. Can you stop by?” Kai-Lin, an employee at Mythical Medical (see previous articles), had just started working on her revised ‘to-do’ list, and she felt overwhelmed.
The last thing she wanted today was another ‘to-do.’ Little did she know that additional help was on its way. She eventually learned that her manager had just received approval to hire several employees who would be added to her team. In this fictional story, I’ll guide her through an active, proven process that provides a framework to organize thinking around hiring employees. The initial focus will begin by agreeing on qualifications that are needed to meet upcoming expectations, then performing an assessment of the current team and finally to highlight those qualifications and skills she needs to be looking for as she hires for the future.
Qualifications of the Team
During our first meeting, I learned that Kai-Lin did not want to repeat the mistake that happened last time, hiring the candidate that had the best face-to-face interview. This time would be different. She wanted to take a new approach. Her eventual desire was to build a talented team to meet increasing clinical, regulatory, and quality requirements. I asked her to put together a list of skills and competencies of her ideal future team and then to create three levels of criteria for each that could be used as a color code “heat map” of red, yellow, and green.
Using the potential skills list above, she selected several skills and developed relevant three-level criteria. The first one she picked was clinical investigation design, conduct, and analysis because she expects there will be more clinical investigations in the future. The criteria she created were (i) red for no direct experience, (ii) yellow for experience in < three clinical studies, and (iii) green for > than three clinical investigations. The design control process was chosen next. The criteria were (i) red for no experience, (ii) yellow for attending design control meetings, and (iii) green for presenting at design control meetings. Biostatistics was next with (i) red if only coursework experience, (ii) yellow if experience included interpreting stat tables for a report, and (iii) green if they participated in the development of statistical analysis plans. After going through the rest of her list, a ‘heat map’ was developed and applied to the six current employees and their administrative assistant. This map immediately and clearly showed the capabilities of the current team and where gaps exist. These results helped identify competencies and skills to target during the upcoming hiring process. It even provides insights into the cross-functional team.
Skills Assessment Visual
Organizations are uniquely built and require serious reflection to identify the qualifications and skills needed to perform the job as a team. This tool is flexible to create more relevant skills if these do not apply. There is value in having this information, in part, because you discover immediately where strengths are. For example, who is the strongest employee on the current team? What criteria did you use? If you based it off of core skills you get one answer but using another lens or perspective, you will gain insights into another employee. What two core skills do the team need to focus on during this hiring process? What three skills are the weakest on the current team? What are the overall strengths and vulnerabilities of the current team? How can the administrative assistant be leveraged to improve the team? Are there opportunities for professional development?
How do internal stakeholders complement the team? Which stakeholder might you consider interviewing? There may be value in promoting employees internally within the organization. Sometimes an internal candidate gets considered when an employee is deserving of a promotion that supports their professional development. Using this tool, you can see how they might affect the overall qualifications of the team. It’s often more cost-effective to train internal talent.
There is also something to be said for the institutional knowledge that a person brings to the role, not to mention established relationships with other stakeholders within the organization that might make for a much more seamless transition. One of the great strengths of many organizations is the depth and breadth of talent. Companies sometimes aim to develop their leaders internally, so it is not only appropriate that Mythical Medical be able to fill these new positions from within, but it is also proof of a successful human resources function.
What to Present to the Auditor (or Inspector)?
Qualifications should be documented in their curriculum vitae (CV) and should align with their job description (which might need to be updated), work instructions, and training records. It needs to be clear how this is all linked together. When employees earn a certificate for CAPA training or design control, for example, ensure training records are updated and added to their CV, too. The goal would be to use their education, training, skills, and experience to build the story about their competency. Now you need to link processes with people.
Process documents (SOPs) will need to be revised to incorporate a new section that addresses the skills or competencies required within the process. List the function responsible and skills required using a table format. Then, when you write the report that will become part of the technical documentation, state employees’ names along with the skills or competencies they will need to perform the job, ensuring it aligns with process documents. Sometimes more than one person will be listed to fulfill the qualifications of the role. The use of tables works great here, too.
Finally, it is common for auditors/inspectors to interview employees performing the work and their manager. As you prepare them, ensure they storyboard around education, training, skills, and experience. Highlight how their processes align with their qualifications. This framework or structure allows for easy, brilliant, and factual storyboarding when managers are asked the question, “What qualifies your employees to do their job?”
Closing Thoughts
Although there are hiring frustrations in general, assessing potential candidates during a health crisis like the coronavirus pandemic only raises those frustrations. Adding to this is that auditors (or inspectors) have renewed their efforts to assess employee qualifications.
Some have said that hiring employees is one of the most important things leaders do. Yet, your fulltime job remains while another “to-do” is added to your list. When Kai-Lin first contacted me, she informed me her initial goal was to hire them as quickly as possible. There were audits to prepare for, new submissions to be created, and responses to be written from previous questions received from their Notified Body. She was also expecting to hear back from a Competent Authority next month, and those responses would also need to be turned around quickly to meet an internal company milestone. Plus, she had two trainings due by the end of the month. Nevertheless, using this tool helped her to screen candidates efficiently and then target questions focusing on skills and competencies to do the job. Although one candidate had travel restrictions due to the health crisis and could not participate in a face-to-face interview, Kai-Lin and the interview team confidently conducted a virtual interview, focusing, in part, on the competencies and skills she had previously identified. Using this method, she found it was a more effective process, and it prevented someone from being hired simply because they “interviewed well.”
Renewing a focus on candidate qualifications can assist hiring managers to be more efficient and will also support online, virtual interviewing during a health crisis without jeopardizing your team. It also sets you up for success during audits (or inspections) so you can leave those closing meetings with smiles on your faces. Hiring the right person is hard work, but understanding the skills you need within your team just got easier.
David R Rutledge, Pharm.D., FCCP, FAHA, President & CEO, Global Strategic Solutions, LLC, Silicon Valley in California.
david.rutledge@globalstrategicsolutions.com +1 (630) 846-0350 cell. The homepage is www.globalstrategicsolutions.com.
Please contact me if you are facing hiring challenges too. As the talent pool is shrinking, it is critical to act fast even during times of global health pandemics.