By Londa Ritchey
We’ve heard many times how important culture is to the successful execution of strategy. Certainly, pharma and biopharma leaders understand how a strong quality culture accelerates the path to strategic success. To drive improvements in quality culture, industry needs tangible measures of the seemingly intangible behaviors related to culture. The result is checklists and assessments of what to look for when evaluating quality culture among internal and external parties. Generally, mitigating these assessments includes creating policies, procedures, and even new organizational roles to attempt to improve and sustain a strong quality culture.
I propose this is only half the answer. To build and sustain a strong quality culture, the organization must understand the critical skills needed to assure all employees can act in the patient’s best interest when making decisions on product quality and usability. Once skills related to quality culture are formally defined, evaluating gaps in skills among current staff allows the organization to build a tangible path to quality culture improvement. Adding these skill requirements to the new hire evaluations enhances the ability to sustain a positive quality culture. Therefore, defining the key skills relating to quality culture and completing skills assessments for current and new staff are key drivers of overall strategic success.
Defining Critical Skills That Contribute To Quality Culture
To improve product quality, companies set metrics, tighten specifications, improve process capability, and continuously emphasize the importance of quality. Yet, somehow this is not enough. An authentic quality culture is a way of thinking and responding when things do not go as planned. It is a desire to do the right thing, no matter what is measured or who is watching, all with a focus on what is best for the consumer – in this case, patients.
How do we empower every team member to own this dedication to doing the right thing with respect to the patient? We start by assuring team members have the skills/knowledge needed to enable decision-making focused on the patient’s best interest. First, define key areas of focus that relate to quality culture. For example, a continuous improvement mindset is fundamental in preventing product quality issues before they occur, thereby protecting the patient from harm. Utilizing a cross-functional team to define these core areas is best practice. Expand each one of these areas further to specific skills that contribute to success in each area. A non-exhaustive example is provided in Table 1.
Not everyone in the organization is an expert in each of the quality culture related skill fields. There is a need to determine which level of skill proficiency is needed for each role in the organization. This further requires defining unique levels of proficiency. A nonexhaustive example is provided in Table 2. The number of levels is flexible; however, it is essential to provide a unique definition for each proficiency level. This will aid in the individual assessments that rely on these definitions.
Of course, defining the skills needed for the organization to sustain a strong quality culture only builds the foundation for guiding the quality culture. The next step involves identifying the gaps across the organization through skills assessments. Be aware that implementing a new skills assessment at the individual level may cause alarm for some team members. Providing a full explanation of the purpose of the activity before starting can alleviate apprehension.
Messaging should center around development and growth. Performing an individual skills evaluation leads nicely into a conversation on a personal development plan including specific skills to acquire. Understanding the skills and levels expected for each role in the organization can also contribute tangible steps for functional career ladders.
Area managers can assess the skills of their direct staff but should be careful to do this with additional input. Generally, managers are aware of the skills their team members exhibit in their current roles but may not be aware of previous work experiences. Managers should review employees’ skill level ratings directly with each employee to assure agreement and to capture all experience. Additionally, performing a cross-manager review of skill ratings assures the ratings are calibrated across the organization. This is especially important when the skill levels are tied into career ladders.
Capture definitions and assessments in a format to archive for later reflection and adjustment. Using spreadsheets to capture ratings allows for simple data analysis. Overlaying radar plots of a team member’s current skill levels with a radar plot of the expected skill levels for the team member’s role provides a visual of the gaps. An example is provided in Figure 1. Where the plots overlap completely, the skill level matches expectations exactly. The focus is on where the plots do not overlap. Obviously, where there are negative gaps, mitigation is expected. However, the positive gaps indicate areas where an individual may become a leader for the team, perhaps even leading training opportunities for the skill.
Mitigation And Sustainability
The assessments may result in two areas requiring mitigation: 1) gaps identified for individuals in a specific skill, and 2) gaps identified for the entire team in a specific skill. As mentioned earlier, individual gaps flow well into the creation of a development plan since most organizations already utilize personal development planning. These individual plans engage team members by investing in their growth in areas important to the business. On-site training programs help to mitigate skill gap(s) identified across a larger group. Training opportunities should use positive quality culture examples from within the organization or patient experiences when available.
To assure a strong quality culture is sustained, embed the quality culture skills into the processes for interviewing and onboarding new hires. Many companies use situational questions for behavioral interviews. Adjust or supplement these to include the quality culture skill. For example, “Consider a time when you used statistics to evaluate and improve a situation/problem. What was the problem/situation, what statistical techniques/software did you use, and how did you interpret the data?” Additionally, some skills call for specific testing or core training as part of the onboarding process. Performing this training as part of onboarding sets expectations and the importance of such core skills at the start for team members.
Recognition programs should focus on positive use of quality culture related skills. Reinforcing positive behaviors and growing skills to support quality culture are essential. The skills should be reviewed on a periodic basis and enhanced as the organization makes progress on the quality culture mindset. Incorporating the voice of the patient in as many training and communications areas as possible is a constant reminder of the overall purpose of everyone’s contributions.
A strong quality culture depends on empowering everyone within the organization to make decisions based on patient risk. Defining the key skills relating to quality culture and completing skills assessments for current and new staff are key contributions to overall strategic success. Sustaining the positive quality culture by evolving the skills expectations and the connection with the patient is essential.
About The Author:
Londa Ritchey is principal consultant at LRitchey GMP Services, LLC, focusing on risk-based solutions for quality systems implementation and remediation. She has more than 25 years of experience in pharmaceutical quality assurance including supplier quality management, data integrity, quality culture assessments, and aseptic quality operations and contamination risk management. Ritchey has a passion for coaching others and challenging current thinking in the compliance and quality risk management areas.