Pharma CAPA management is a crucial competent of your quality management system (QMS). Without robust control of your corrective and preventive actions (CAPAs) you open your pharmaceutical QMS up to intense scrutiny.
Stamping out your non-conformances and preventing them reoccurring is at the heart of continuous quality improvement, offering a range of core benefits including:
- Improved process efficiency and patient safety
- Fewer defects, reworks and out-of-specs
- Simplified adherence to quality and regulatory demands
- A ‘right-first-time’ approach
In short: an effective, repeatable process to put things right, and keep them right is a must-have for your quality team. Sub-optimal pharmaceutical CAPA management accounts for around 40% of FDA 483 submissions.
Struggling with your current CAPA system? Read our guide to managing CAPA in pharma below:
How should I structure my CAPA system? The 4 ‘I’s
A closed-loop CAPA methodology should be put in place to deliver a standardised approach for your pharmaceutical CAPA management.
The number of individual steps and the complexity of your documented CAPA system is up to you – but several core ingredients should be in place, following a Plan Do Check Act framework.
Here are the 4 ‘I’s which should be baked into your pharmaceutical CAPA system.
The most important component of your CAPA plan?
Pinpointing and evaluating non-conformances in the first place.
Failure to properly identify non-conformances (NCRs) as they arise can be fatal for any pharmaceutical operation, with market recalls and regulatory fines easily stretching into seven-figure territory.
As such, your primary focus should be frequent operational checks and reviews to ‘catch’ NCRs for CAPA treatment. These should include:
- Robust internal auditing
- Process performance monitoring
- Management reviews and QA inspections
- Staff issue and observation reporting
- Failure mode analysis
- Trend analysis
Other identification sources might be external, such as third-party audits and regulatory inspections. You should also ensure you have a robust process for receiving customer complaints and feedback; consider running Voice of Customer (VoC) surveys.
Getting the systems in place for NCRs to be flagged is crucial. Equally, don’t rush into instant firefighting mode. Take the time to thoroughly collect all available information about the non-conformance in question, ensuring you:
- Determine the full extent of the non-conformance event
- Understand if it’s occurred one time or multiple times
- Know who and what has been affected, and how (impacted areas could include customer satisfaction, product safety, unanticipated costs, and so on)
Evaluating the magnitude of the fault is important for a measured and appropriate CAPA response.
However, for some serious non-conformances, it’s important to remember that an immediate response might be unavoidable – for instance, recalling or quarantining a set of non-conforming products.
You’ve found a pharmaceutical non-conformance and gauged its impact. Now it’s time to pinpoint why it occurred with a thorough root cause investigation.
A range of quality tools and techniques can be applied at this stage, which we’ve detailed below. Assemble a cross-functional investigation team to ensure different perspectives and insights are taken into account.
The objective of this stage is to consider all possible circumstances connected to the emergence of the non-conformance. Think about areas such as:
- Personnel: human error, operational mistakes
- Equipment: inaccurate calibration, system faults, or incorrect application
- Procedures: unclear steps, overly high complexity, missed actions
- Training: incomplete or inappropriate training, inadequate competency
- External factors: supplied materials, loss of power
Fully document the data you collect at this stage, then apply it for…
Investigating and uncovering your root causes will naturally set up a series of actions to correct the non-conformance and prevent its reoccurrence.
Put together a detailed CAPA action plan to implement. List each action and task to be completed, along with any necessary changes to your processes, procedures or information streams – making sure the outcome and rationale for the change is fully documented.
This could include:
- Switching materials or equipment to a more reliable variant
- Scheduling training to plug a competency gap
- Adding an additional step to an SOP, such as an extra review stage
Assign personnel and timeframes – then kickstart the implementation of your CAPA plan.
4. Internal review
Has the root cause of the initial non-conformance been addressed?
Has the non-conformance reoccurred?
Have all steps of the CAPA action plan been actioned – and might they have any adverse effects on other areas of the business?
Has the corrective and preventive action(s) worked?
Answering these questions is the crux of the 4th ‘I’ – the internal review. In short, the efficacy of your CAPAs should be checked and rechecked before close-off.
Put in place any long-term monitoring you feel is appropriate. Then it’s time to move onto the next NCR.
What tools and techniques should I apply to my pharmaceutical CAPA system?
There a range of classic quality management tools and methodologies which will strengthen your pharma CAPA system – particularly in the first two (and most complex) stages, identification and investigation.
For identification of NCRs, consider histogram charts. Histograms represent how numerical data is distributed over time and can be used to pinpoint a historical peak in issues or events which might warrant a CAPA investigation.
Use a Pareto chart to ‘group’ issue types and identify issues with the highest frequency or impact.
Use an Ishikawa (or ‘fishbone’) diagram and the 5 Whys to support your root cause analysis.
And make use of interviews, surveys, brainstorm sessions and process mapping to continually keep your finger on the pulse and uncover underlying weaknesses or flaws which can be strengthened with corrective quality control.