When collaborating with my clients, I like to know if they have organizational support, particularly from other departments that are directly or indirectly impacted by the quality system we are addressing. Unfortunately, there is not much discussion or participation from these other teams.
This is important as one department cannot manage the quality system alone. Like others say, “It takes a village,” it is more like “It takes a Stanley Cup Championship team.”
While I have no athletic ability, I love watching hockey and nothing is better than the Stanley Cup playoffs. This is my favorite season, particularly the first round when there are four games a night and all sixteen teams are ready to go for their best of seven series.
These teams are more than six players on the ice (some say five because they do not count the goalie). There are the coaches, equipment managers, and athletic trainers just to name some of the groups or “departments” that are part of the team. None of them can exist by themselves.
But let us focus on the players themselves for the moment. One player cannot win the game for the team no matter how great the player is. If this was the case, then the Edmonton Oilers would have won the Stanley Cup every year for the last eight years. In fact, they have not won the Stanley Cup since 1990.
So, who wins the Stanley Cup? It is the team that works best as a team. The players on champion winning teams communicate freely with each other and practice their passes to the point that they can pass the puck to each other without looking in that direction.
Okay, I can go on about hockey, but what does this have to do with my client’s organization?
A Fully Bought in Quality Policy Is the Best Policy
Pharmaceutical and Medical Device companies create and adopt their own Quality Policy. It clearly states the company’s commitment to meeting the required regulations and applicable industry standards, to provide the best quality product for the safety of their customers.
Everyone in the company from the CEO to entry level employees train on the Quality Policy, but only the great companies (like a successful hockey team) have employees in all departments at all levels fully understand and perform their role to the Quality Policy daily.
Practice Your Skills
Hockey players work on their skills by practicing with their teammates. Pharmaceuticals and Medical Devices companies do the same. Employees require training, including skills training for key, critical activities to ensure that the process steps are performed the same way each time. Some activities require retraining or requalification on a regular basis.
But there are also other training activities that occur based on the quality system that is cross-department based. Yes, I am talking about the R-word (recall). No one wants to do a recall, but companies on a regular basis (usually annually) will practice a recall on paper to ensure that the company and its process is prepared if the need arises. Team trainers and medical staff do not want to stitch up a hand cut by a skate blade, but they are trained and qualified to perform when the need arises (this happened at least once this NHL season).
The FDA or other regulatory body does not want to hear that a company is not prepared to perform a recall when one is needed. So, the company must be prepared … just in case.
Risk Input is Needed by All
On a hockey team, there are forwards, defensemen and of course, goalies. While each group of players has their specific role on the team, they must work together to win the game and the championship. While defensemen’s primary focus is keeping the puck outside their defensive zone, they also pass the puck and help score goals. The same is true for forwards. Their primary objective is to score but they are expected to create turnovers and block shots. In fact, goalies can get in on goal scoring too (see Boston Bruins at Vancouver Canucks, February 25, 2023).
Many quality systems require participants from multiple departments such as deviations, CAPA, complaint handling. What do these quality systems have in common? The need for risk management. A company’s risk management program cannot be performed by one department.
Typically, Quality Assurance owns the program, but Manufacturing, Quality Control, R&D, Engineering and Medical Affairs need to provide input in identifying, assessing, and mitigating the risk. Each of these departments come with different expertise and perspectives to make the risk management program effective.
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