August 29, 2024
How can a quality manager secure stakeholder engagement and hold individuals accountable for the quality of their work throughout the CAPA cycle?
With the burden of quality and compliance on their shoulders, it can be tempting for a quality manager to gather information from the necessary stakeholders and then move forward with each stage of the CAPA process on their own.
But the strategy of CAPA in a silo typically backfires as stakeholders see the quality manager as solely responsible for addressing or preventing an issue. More effective is a collaborative approach where stakeholders understand quality is an enterprise-wide responsibility; therefore, they must play active roles in the process.
Stakeholders that have “skin in the game” so to speak, working together with the quality manager to provide input on the CAPA process and help carry it through to completion, are more likely to have a sense of ownership.
Fostering ownership is one thing, holding individuals accountable is another. That’s why, when it comes to stakeholder engagement, securing C-suite support is critical to CAPA success.
When quality managers take the time to communicate to their company’s executives the importance of the CAPA program and the risks of compliance failures, leadership is more likely to intervene and help managers hold stakeholders accountable for their actions.
How Highline Warren, a $1B manufacturing organization, went from a paper & pencil CAPA system software to digital with AssurX.
Read the Case Study
CAPA Process Challenges: How to minimize risks
Establishing relationships and engaging stakeholders in a collaborative CAPA process is just the beginning. At each stage, there are risks for individuals to miss deadlines, perform poorly, or skip critical steps. Here are some of the common pitfalls of which quality managers should be aware so they can manage effectively through them.
Documentation of the Details
The initial work to determine exactly what went wrong from a quality perspective – who was involved, and when and where it happened – can be an uphill battle, namely because no one wants to be blamed for making a mistake. While an effective CAPA relies heavily on the quality manager understanding the details, responsible parties might withhold information in fear of being reproached or reprimanded.
Investigation and Root Cause Analysis
In most cases, identifying the root cause of a quality issue isn’t a straightforward A-Z path. Rather, it requires stakeholder dedication, a level of detective work, and digging below the surface to uncover the source.
While managing the day-to-day responsibilities of their roles, stakeholders might find it challenging to dedicate time and resources to investigation. After conducting an initial review of the situation, an individual might surface a problem related to the nonconformance and name it as the root cause while the underlying issue remains.
Failure to ask enough questions and perform a deep dive to get to the heart of a quality issue can have far-reaching implications. For example, while a CAPA is focused on addressing a contributing factor, the core upstream nonconformance continues, posing risks for even more issues downstream.
Corrective Action Plan Development
A quality manager, armed with the details of a thorough investigation and root cause analysis, has the information they need to develop an effective plan. No matter how targeted the steps are, if the manager assigns tasks to teams and not to dedicated individuals, there is a good chance completion of those tasks will fall through the cracks.
It can become a “kicking it down the line” game where missed deadlines result in team members pointing fingers at each other assigning blame and not taking responsibility.
Another challenge in the planning process comes with the proposed timeline. Quality managers must strike a balance between assigning unrealistic deadlines that set stakeholders up for failure and setting due dates far into the future where individuals push off their assigned tasks and forget the critical details when attempting to complete them months after the fact.
Plan implementation
A CAPA open 12 months or longer can signal the failure of the quality manager to keep on top of stakeholders, continuously monitoring progress, reminding individuals of upcoming deadlines, and breaking down barriers and roadblocks.
A quality manager, faced with their own responsibilities, can find it challenging to keep a pulse on everyone else’s tasks and timelines. Furthermore, many people shy away from what can be perceived as “pestering” team members, choosing instead to let things slide. However in the realm of quality management, delayed action commonly results in greater downstream consequences of the nonconformance at hand.
Effectiveness Check
Even if a CAPA is carried out effectively and on schedule, and the deployed action appears to have corrected or prevented a quality issue, poor timing of the effectiveness check can derail the program.
The quality manager and other stakeholders, after spending considerable time and effort to carry out each stage of the CAPA, might be tempted to quickly check the boxes, close it out, and move along to the next project. However in performing an effectiveness check too soon, they could miss issues that take time to develop and present themselves and run into the same quality problems again.
Conclusion
Effective quality management, including targeted and efficient issue identification and resolution, are essential for companies across all industries. Where CAPA programs often fail are in stakeholder engagement and accountability.
Quality managers who build their CAPA programs and teams on a foundation of stakeholder engagement and accountability and guide their processes with advanced technologies, set up their companies for short-term quality improvements and long-term QMS success.
Check out a demo video of the AssurX CAPA management solution
About the Author
Stephanie Ojeda is Director of Product Management for the Life Sciences industry at AssurX. Stephanie brings more than 15 years of leading quality assurance functions in a variety of industries, including pharmaceutical, biotech, medical device, food & beverage, and manufacturing.
