Are you and your team inundated with an overload of corrective and preventive actions (CAPA’s)?
Do you see a continuous history of improvement projects not delivering the results you aim for?
Do you struggle to get the right people and departments involved in addressing your improvement activities?
In other words: do you feel that your improvement and CAPA system is not working for you at all?
Too often we encounter organisations that have a comprehensive approach and even automated systems to manage CAPAs, but with limited or no success. Task overload and too little involvement throughout the company will prevent you from achieving the results you’re aiming for.
This article will show you the five critical steps to manage improvements and CAPAs efficiently. It’s a relatively simple approach but it will take perseverance and even a small leap of faith to implement it.
For ease of reading we will refer to CAPA when we mean the combination of improvement activities (or projects) and corrective and preventive actions.
Stop doing everything
A lot of quality management systems are set up to define CAPAs for everything. This will most certainly cause work overload. It’s important to focus on those that will deliver the biggest value to the organization and to perform those that are mandatory as part of the company’s certification scheme or are legally required. In most cases, these will be related to severe issues about:
- CCP / OPRP breaches
- food safety-related complaints
- food safety-related blocked stock
- major and critical observations from external audits
- repeated issues (complaints / blocked stock issues)
- critical or food safety internal audit findings
- safety issues and incidents
- environmental issues and incidents
This means that you won’t have to define CAPAs for every complaint, blocked stock issue, internal audit or daily inspection round. If your system is set up that way, perform a one-time assessment to separate critical CAPAs from non-critical ones. You still might want to execute the improvement actions though! This is a much lighter approach, as no full-fledged investigation is necessary anymore.
Prioritize your CAPA’s
When prioritizing CAPAs there are two aspects to consider:
Compliance – those related to external audits often need to be performed within a certain time frame in order not to compromise the continuation of the certification.
Risk – those related to food safety issues or large amounts of stock / value pose a higher risk to the company and should have a higher priority.
The next important concept is execution. We can divide CAPAs into two parts: the root cause analysis (RCA) and the execution of the corrective / preventive actions. For compliance-based CAPAs, RCA is the time-critical part.
Very often certification schemes and customers will allow you the time you need to realistically take improvement actions. But the RCA, including the definition and communication of the improvement actions must be done within the set time frame.
This also holds true for risk-related CAPAs: you want to perform the RCA as soon as possible so you can further prioritise improvement tasks based on the (financial) risks that those actions could reduce, by starting with those with the biggest impact.
There is no need to create an elaborate structure for priority management. A simple high-medium-low approach will work fine: just assign high priority to RCA for compliance and high-risk issues and implement a similar structure for the improvement actions. Read our article on RCA as well to learn a powerful method for this.
Define one or two big wins
Even though you have identified your priorities, it’s still wise to select one or two (no more!) big wins to achieve within a certain period (for a start just take one year). These big wins should be linked to an area that is creating big issues at the moment.
To find out what these are, break down all the complaints and reasons for blocked stock and perform a Pareto Analysis on them. You should then take either the biggest item or the second or third biggest one that you feel will be easiest to solve.
The reason for taking this approach is that you want to change the mentality in the organization towards a truly pro-active attitude. At the same time, you need to get the attention and buy-in of management to invest time, money and other resources into addressing this or these two big issues. It will be difficult to convince management to take a lot of actions, especially those where saving potential it too little or unclear.
Picking only one or two big wins also allows you to shape the measure of your success. If you’re able to deliver on the targets that you have for these items, you and your team will receive a very positive evaluation at the end of the year, and that will make it easier to continue this approach in the subsequent years.
Involve the right people
The third crucial element is to involve the right people in each of the improvement activities.
Very often, for example, quality managers and their teams are seen as the ones responsible for improving quality and food safety in the organization. This is a false perception, often strengthened by another one: that improvement actions are necessary for certification purposes only. In reality, the quality department is not the process owner of areas like production, purchasing, warehouse management, or finance, hence the right people within these departments need to be involved in the improvement activities. In some cases, they might even have to take the ownership of them.
The manager who sets the improvement process in motion (whether of the quality department or not), should discuss this new approach with the managers of the respective departments, or – even better – the entire management team.
The message to convey here is that focussed improvement (as we described it here) is the corner stone of quality that created profits for the company. Based on the insights gained from the failure cost data, you can even give a rough value of the benefits of this approach.
No matter how well you prioritise your issues: things will change during the year and more pressing issues might arise. The approach we described is easily adaptable, and you can change priorities of the improvement actions as dictated by business needs.
However, this comes with one big caveat: do not change the one or two big improvements you are working on. These are still big contributors to improving the department’s and /or the company’s (financial) performance and must be addressed structurally.
Similarly, do not down-prioritize the execution of the RCA for critical issues. These must still be executed in the shortest term possible.
The main area where you can and must be adaptive is how quickly you execute and prioritise improvement actions, especially those with medium and low priority. If the organization workload is still too high after shifting the medium and low priority actions, you can re-prioritise those with high priority by downgrading the least important one to a medium level.
You should discuss any change in priorities with the management team in order to have its full buy-in and ensure they stay in the loop and co-own the improvement program. This way you can also manage expectations of the delivery of your annual plan with the group of crucial stakeholders.
Another advantage of having this formal discussion, is that you can designate it as an intermediate management review of your certification scheme and legal requirements and have this logged as a formal change of priorities. This way you assure you are compliant with these at all times.
By creating a more focussed approach toward CAPAs in the organization and setting one or two big wins, you will generate continuous value and show the true benefit of continuous improvement to the entire organization. Whenever needed, you will need to involve all relevant managers and also the rest of the management team to decide changes in priorities.