ISO 13485, the FDA and the MHRA all require medical device manufacturers to have documented corrective action management procedures (also known as CAPA) underpinning their whole approach to quality. But where do these procedures most commonly fail?
CAPA a vital part of the proactive mindset demanded by regulators all over the world:
“The purpose of the corrective and preventive action subsystem is to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence” - FDA
But there are several areas where CAPA management commonly comes unstuck - endangering not only the customers who use the devices being manufactured but the efficiency and profitability of the companies who manufacture them.
Fine tuning your processes to address these potential points of failure, could help you realise more of CAPA’s commercial benefits, while avoiding fines and other regulatory sanctions in the future.
Where CAPA management goes wrong
The CAPA process is triggered too often or not enough
Either way, there’s a problem. If every single complaint is turned into a CAPA you could become overwhelmed and start wasting valuable resources on errors that don’t merit investigation. At the same time, if you’re seeing few if any CAPAs triggered, then maybe the bar for triggering a CAPA process is being set too high. This could mean you will end up missing a potentially serious problem that will come back to bite you, or miss the opportunity to optimise a wasteful or ineffective procedure that is compromising the overall quality of your approach.
The rule is that CAPA is intended to address systemic issues - so the way your processes go about filtering and detecting these issues should reflect this. Systemic issues can create ongoing loops of waste and error, they are replicated over and again because the error is embedded in the ‘way you do things’.
CAPA is not just the responsibility of one department
If the proactive requirement for ‘collecting and analysing information’ related to potential CAPA issues only falls to one individual or department in a business (i.e. the quality function) this can be an area of weakness for the CAPA process as a whole. Frequent cross functional management reviews to talk about potential CAPA issues can bring insights and issues to the attention of everyone sooner and ensure nothing is missed. These meetings might typically discuss
- Customer feedback gathered formally and informally
- Complaints gathered and logged via the required channels
- Results from audits
Doing this analysis at regular intervals and involving stakeholders from across the business, will help you more accurately understand when issues are systemic and need addressing through formal CAPA process. They will also ensure everyone is aware of the issues and help the business as a whole become involved in their resolution.
Thinking holistically across the business will also help you stay on top of any potential problems. So, if the CAPA for one product is likely to have implications for the quality of another, CAPA’s could be raised for that product, too, before it fails as well.
Root cause analysis
Within a CAPA process defining the root cause of an issue is one of the key steps. And while it is not easy to do so, it is pivotal to correcting a problem and preventing it from happening again in the future. But it’s common for busy companies to simply restate or describe a problem in their documentation, rather than analyse its cause.
Understanding why a product has failed instead of simply ‘how’ is a key part of CAPA and often it can only be done with contributions from a number of departments and individuals in a business.
This process involves collecting supporting data, documenting and evidencing the cause of the issue that is being investigated - and it will need to be in such a way that your approach can be audited in the future.
A vital part of CAPA processes, of course, is how it is documented.
The FDA and other regulators require pharmaceutical and medical device companies to have CAPA processes in place that can be followed and audited effectively. But CAPA documentation often falls short of these objectives in a number of ways making life more difficult for those trying to solve issues as well as instigate appropriate preventative action as a result:
- Lack of detail: As discussed above, generic descriptions of issues are not enough for CAPA purposes, you should include specifics on things like timing, batch information and precisely where in the process a problem occurred.
- Making assumptions: Often CAPA reports lack sufficient detail because they assume a shared understanding of a businesses’ quality processes. When it comes to auditing and for the sake of a clearer, unambiguous document trail, CAPA reports should contain relevant background on your processes and systems to help all readers understand the context of problems. This, in turn, will help everyone including auditors understand the way an issue was handled and the reasons for the recommendations that arose from it.
- Inadequate training: Writing a CAPA report is a skilled task. Those who write the documentation will require training to do it effectively.
Corrective Management processes can go wrong when they are not clearly documented and understood across a business, meaning the correct sequences for triggering them are not observed, and the right criteria for raising them are not applied.
Installing a Document Management System that can help automate the necessary workflows for a CAPA process, is one way to ensure they are being followed correctly. They can also help ensure that CAPA activity is a cross-functional pursuit, with all stakeholders in a business participating in the identification of issues, as well as their correction and future prevention.
An electronic Document Management System that is a ‘single source of truth’ for an organisation can help you manage record, update, and review CAPAs collectively in the highly disciplined way that the regulation requires.
But it’s not just a matter of having the right tools, the people who are actioning CAPA requests need to have the training to avoid the common pitfalls that make these processes ineffective. Training teams to write up and investigate CAPAs properly will help insulate your organisation from the risk of these pivotal processes going awry.