CAPA introduction: getting employees on board

CAPA is a concept from quality management. CAPA stands as an abbreviation for 'Corrective Action and Preventive Action'. Corrective action refers to actions that eliminate the cause of a detected defect. Preventive Action, on the other hand, is preventive measures that apply the findings from Corrective Action to transferable processes or systems in order to avoid similar errors from the outset. In short, it is about systematically eliminating sources of error and getting better and better. CAPA is a quality tool that is mainly used in the pharmaceutical and medical technology industries and is less well known beyond these sectors. Yet! It is also worthwhile for other industries to take a closer look at this very interesting tool.

Ms. Schroetter, what constitutes a successful CAPA for you? Beatrice Schroetter:
With a good CAPA, you can see from the documents at hand what the problem was and

The organization should establish strict rules on when to open a CAPA

how it was solved - and understandable for everyone! In addition, no further problems may arise from the changes made. This sounds simple, but must meet the highest standards, because all details must be illustrated with objective evidence. As few questions as possible should be left unanswered. Documenting a CAPA in a way that meets the requirements of the authorities means meticulous detail work that is usually not even on the expert's radar screen because he takes it for granted. For an outsider, however, this can raise questions.

Does it happen that people complain that everything is changing again?
Yes, CAPA is a process with strong potential for improvement and such processes are subject to change. Not every employee can cope with change. The CAPA process is a cross-departmental process that only works if everyone is rowing in the same direction. Ultimately, it's about getting everyone on board. To do that, you sometimes have to row back.

How do you get everyone on board if there is resistance to the introduction of the CAPA system?
Most resistance arises because the CAPA system is seen as too costly and too time-consuming. In particular, the document effort is seen as pedantry. Yet the CAPA system is all about ensuring that the investigations and measures carried out are comprehensible to everyone, not just the authority's inspector. Particularly in the medical device industry, where the European GMP standard has not yet become universally accepted, the CAPA system should be pursued more intensively. CAPA serves as an enabler for better quality - not only in terms of investigated defects.

So, as a quality manager, you need tact?
Yes. As an experienced QM consultant, I don't even ask the question of blame. Otherwise the true cause could be covered up, for example out of fear of losing one's job. It happens that employees conceal errors in order not to produce too many rejects. A cautious approach is essential. I know from experience that the people on the line often know or at least suspect why an error occurs. A collaborative and motivating approach can shorten the path to solving the problem. That's why I present the general problem to the respective employee teams and turn it into a joint brainteaser. In this way, I create a basis of trust with a good atmosphere, which should pull everyone into the same boat.

What should the organizational structure look like for the CAPA implementation to be successful?
Common organizational structures provide for a CAPA Owner, Task Owner, CAPA Coordinator, and a CAPA Review Board. The CAPA owner, as project manager, drives all CAPA tasks - investigations, plan development, implementation of measures, monitoring of effectiveness and reporting to the CAPA review board. The Task Owner works through his or her specific tasks. The CAPA Coordinator has organizational responsibilities and maintains the CAPA system. The CAPA Review Board (CRB) reviews the CAPA with respect to regulatory requirements as well as the set requirements of the QM system of its own organization. The CRB should meet regularly to ensure that a CAPA is incorporated into the daily workflow.

What do you recommend about how often the CAPA review board should meet?
It depends on how many CAPAs are opened in the organization. In order for a CAPA to progress quickly and at the same time remove obstacles, I recommend weekly meetings. This provides a regular structure and integrates the CAPA into the daily work routine. However: The organization should establish strict rules for when to open a CAPA and when it results in non-compliance - but not indiscriminately give every problem the name CAPA. This leads to an overload of the organization, because a CAPA swallows up considerable resources.

What is part of the compulsory programme when a CAPA system is to be introduced?
Before the system is rolled out, initial work instructions, role assignments and the review structures must be precisely coordinated within the organization - regardless of whether the organization starts with the paper version or with an electronic system. Then the general CAPA introduction starts for all affected employees by training the assigned employees for the specific tasks and accompanying them over time.

How important is training in CAPA implementation and what do you recommend as a Capa trainer?
As an experienced CAPA manager, I conduct the training in the companies on site or as an external trainer. In the first training phase, members of the review board as well as some CAPA owners and the CAPA coordinator are intensively trained. The second training phase concerns the potential task owners. In this way, everyone first learns their role in the system and can later rehearse it in practice.