Not all money and time saving can be quantified. Any advice for this situation?
Let’s consider the example we discussed during the session regarding deviations. Often, we don’t track the exact time it takes to resolve a deviation; we just note the start and end points and risk level.
The first step is to collect time data. Once you have that, you can apply an estimated hourly rate to quantify the cost in your metrics. This allows you to assign a monetary value to the time spent.
Another approach is to consider senior leaders' concerns. What objections do they have? Is it about cost, time, or bottlenecks? Focus on addressing these specific concerns and working on changing their perception of the value compliance brings.
This approach takes time—it’s not an overnight shift. But as you develop in your role, you’re also stepping up as a quality leader.
Our company is designing and building a new facility. How can I get involved in the planning?
It depends on your starting point. Do you already have compliance-driven processes and procedures in place, or are these still being developed?
If these processes are established, you have a stronger foundation to leverage. If not, you may face an uphill challenge, but making your case is still possible.
Access to senior leadership is key. If you’re not in those meetings, start having conversations with those who are. Show them that compliance adds business value.
Learn to communicate in a way that resonates with senior leaders. Building relationships and finding business influencers with similar views can also help you gain access to these discussions.
Top management always objects to resourcing for strong compliance efforts. What should we do?
Understand why they don’t see the value of compliance. Identify their core objections. Demonstrate that compliance can save time, reduce costs, and minimize waste. If direct engagement with top management isn’t effective, consider working with a middle manager who can support your position.
Do you use an average when calculating the cost of people’s time? The costs for different roles in a process can vary widely.
Using an average can be effective. For example, you could categorize critical, major, and minor deviations and calculate the average time each type takes. Critical deviations generally require more time, so you can apply an average hourly rate accordingly.
You could separate rates by role, such as manager versus operator, for more precision. While you won’t have exact wages, this method demonstrates the cost impact of deviations on business time.
How can we demonstrate that compliance and OpEx are aligned?
Start by tracking and displaying key metrics. Post a summary in a visible area or include it in your department’s monthly report. Highlight monthly costs related to deviations, complaints, CAPAs, document updates, and change controls.
For example, track the target versus actual time for RFS completion and report any delays to the market.
What should you do if you don’t have routine access to senior leaders? How can you positively position compliance?
Begin the change by reframing compliance as part of OpEx in your daily work. Understand your QA metrics in relation to business goals. Build relationships and engage with influencers within the organization to support your position on compliance.
