A long-time client of ours called us recently, asking for help. The client found itself under a consent decree by the FDA. It turned out that the decree was issued mainly because of repetitive problems with their CAPA investigations.
When we visited the client, we ended up rewriting their CAPA process. However, implementing the new process resulted in resistance. The client’s training department believed all that was needed is to put SOPs online and have employees sign off that they had read them.
This didn’t work. The employees didn’t change how to investigate and addressed CAPA issues, which for years was to simply address symptoms of the issue and close it. Eventually, the FDA ordered the decree, and the company started to look the real answer to a serous compliance problem.
Our consulting approach was an example of how successfully managing the human element of change management can lead to wonderful results.
Clearing the failure rate
Many companies are not fully compliant nor their Quality System processes work effectively and efficiently, and pharmaceutical, biotech and medical devices are no exception from that. Overall, there is about 70 percent failure rate of all change management programs to meet business objectives.
This failure rate happens because companies have a difficult time balancing the three pillars of change management; technology, process, and people. For the healthcare and bioscience industries, this is a particularly acute problem because of the fast-changing nature of the industry—between 30 and 175 changes a month, depending on the size of the company.
Add to that constant restructuring, mergers, outsourcing, and reductions in staff, and you end up with managers scrambling around to cobble together staff to do core functions correctly. Too often, managers never have time to do things right the first time. They end up taking short-cuts or don’t document correctly the changes and sometimes even don’t notify the FDA correctly– until the FDA catches them.
This lively pace will force pharmaceutical and other manufacturers to focus on products and processes, but not on people. Contrary to popular opinion, people generally don’t resist change. They resist being changed when they don’t know why.
The answer is that they start too late and they have no structured process for leading people through a change. This is necessary to engage people in the process of changing their behavior, instead of focusing on the changes associated with producing the product.
We can get the technology right, we can get the processes right, but if the people aren’t embracing and adopting how you do things (or how you should), then the probability of achieving business objectives are slim.
How things go right
What do the other 30 percent (who achieved their business objectives) do right? They sponsor engagement, and have a structured process with dedicated resources to manage the change:
- Help people understand why the change is necessary. People become saturated with change or over-whelmed with change, resulting in a sense of helplessness.
- Identify and manage resistance. Technology employees may not often talk back, but will also not easily change their work behaviors.
- Get structured. There’s very little time to learn from your mistakes, because it’s just change after change after change. It becomes much more important to get it right the first time.
What worked for our client
For our client with the consent decree, success started by setting up a training session. This was a two-day, instructor-led class on the CAPA process, tools for root cause analysis, how to practically eliminate root causes of problems, how to determine you are on the right track. This required every employee to involve the change management process as part of the company’s quality system. In our training, we explained what’s in it for them, and why these practices were beneficial in the long run.
These intensive, interactive classes helped them buy into what we were telling them. They now knew why CAPA and rooting out root causes was important, and not just a checklist exercise. As a result, their way of looking at nonconformities had completely changed. They identified causes of issues, and recommended practical and scientifically justified changes in their products and the processes that make these products. If they hadn’t had a clear understanding of what’s in it for them, they would keep doing the same thing, over and expecting different results that will never come.
For this client, the “people” part of change management was implementing an effective and results oriented training program, in addition to our coaching and mentoring program which was one on one basis.
For other clients, the solution may be different. But whatever the solution, you need to make sure managers, employees, key contractors, etc., are clear on the change from an organizational point of view and how it affects the individual, and then you need to help managers understand how individuals go through change . . . and equip them to be able to coach individuals through a change.
If this sounds like your staff, contact Synergy Bioscience. Synergy’s consultants are experts in evaluating the reasons and rationale and have the expertise on how to help your organization remain compliant with the regulatory requirements. We have the expertise to champion these efforts and make the change management process an integral part of your quality system to ensure sustainable compliance. Our consultants are Six Sigma Black Belt certified. As you may know the Six Sigma philosophy is the foundation to a robust CAPA process. We become your trusted advisors who remain objective, bring in culture change and ensure compliance before an issue becomes a problem that may shut your business down.
How well have your change management initiatives been faring? Share with us your challenges and successes! We’d love to hear from you. And contact us for a deeper conversation of how you are handling process, product and people.
