Realizing business benefit and inspection readiness with a solid CAPA framework

IRP and the Windsor Framework seek to ensure timely access to new medicines in the UK

Authentic management oversight and active engagement is an important determinant for an effective and robust CAPA process.

Senior management support for a quality culture should begin with investment in training, awareness that quality is everyone’s responsibility, and the importance of reporting issues and the mechanisms for reporting. It should be made easy to report potential issues e.g., “good catch programs” 1 , 2 and recognize and reward the behavior for highlighting such issues. Invest time and effort in targeted CAPA Workshops reviewing regulatory requirements, supplemented with examples of practical applications from real-life occurrences at the organization and strengthen the training with comprehensive Root Cause Analysis techniques (complemented with Lean Six Sigma methodologies3 where appropriate).

The level of complexity in a CAPA should be commensurate with the significance and risk of the nonconformity. 4, 5  By providing the necessary resources (clear alignment on roles / responsibility along with a time commitment), funding and support, organizations can comprehensively address the root cause and implement robust corrective and preventive actions.

Avoid timeliness metrics as a closure exercise and knee-jerk rush jobs to meet a timeline and instead set deadlines commensurate to the level of risk and complexity. Product quality issues should be reported as soon as they are identified (what, when, where, who etc.) with as much information as possible at the time. Whilst many organizations will set internal targets for the completion of various CAPA phases, timelines should be aggressive yet realistic and achievable. Also, acknowledge that sometimes unplanned delays happen. The impact of such a delay should be appropriately justified, with a new timeline established and approved.

Having meaningful key performance indicators (KPIs) and making them visible throughout the organization and in department-specific areas can instill a sense of ownership and accountability. Metrics can include recurrence of similar issues, number of open / overdue CAPAs, and criticality. Discuss the metrics and communicate the business benefit of an effective CAPA – e.g. reduction in defects, improved yield, increased cycles times, reduction in customer complaints, reduction in deviations due to human error etc. CAPAs generally require investment, however, in many cases organizations fail to communicate the return on investment. CAPAs can be win-win and it’s ok to applaud such benefits.

Promote the reporting of issues and suggestions for improvement, lessons learned and translate to employees how their contributions influenced positive change to overall product quality and business benefits by fully addressing issues, reducing risk, preventing reoccurrence, and improving customer satisfaction. Invest in advanced technology such as

    • “Statistical Process Control”6 to provide early signals as to when a process begins to trend toward pre-defined control limits as this enables proactive preventive action to be defined before a trend becomes an issue.
    • Validated electronic batch record systems and Laboratory Information Management systems (LIMS) that drive efficiency and minimize human error 7.


What about the Inspection?

Having robust CAPA documentation that follows a systematic process can give organizations greater confidence in their data. However, inspections can be stressful, and it is useful to have clear processes and documentation.  These include:

  • Keeping the training files current and including any supplemental development training such as root cause analysis, six sigma training etc.
  • Being able to explain the CAPA governance process and KPIs, e.g.
    • CAPA review board – content, frequency, decision-making log and follow-up of action status, including an assessment of potential delays.
    • What is monitored as part of your CAPA Inputs – internal trends, customer feedback and complaints, outputs from external / internal audits etc.
    • How are CAPAs effectively prioritized and what decision logic is employed? e.g., criticality / impact on product quality, regulatory findings (critical / major / minor), aging CAPAs, repeat CAPAs, complexity etc.
  • Determine whether CAPAs address a specific problem statement, prevent reoccurrence, and continuously improve the QMS. Check for scientifically defendable statements or conclusions with evidence to support the statement.
  • Be alert if a CAPA action cross-references another CAPA or quality system element, as this could be an early signal that actions are delayed or not comprehensively addressed.
  • Demonstrate that you got to the root cause, (with data to recreate the failure mode if necessary) and confirm that the corrective actions implemented did not have an adverse or unintended consequence to product quality and were effective in preventing reoccurrence. As part of the effectiveness check, avoid the frequently used option of monitoring customer complaints to demonstrate reduction or elimination.
  • Deploy standard methodical RCA tools, ideally by a cross functional team. Based on experience, using a standard methodology provides a comprehensive and documented structure but also removes the potential for bias, assumptions or jumping to conclusions.
  • Keep an evidence file that systematically points to all the CAPA information, so you have confidence the information is available and ready for inspection. This file should be organized in a structured and systematic manner so that it is self-explanatory and easy to navigate. Ensure that CAPA files open at an investigation stage are current with available information, including a documented assessment regarding the necessary controls to support continued manufacture and a risk assessment documented as appropriate for distributed products.
  • Prepare a storyboard presentation. Set the context of the CAPA for the inspector with a high-level overview summary, including a problem statement, containment, root-cause investigation, CAPAs, and effectiveness checks. Include pictures / diagrams if possible. Rehearse the storyboard with an independent peer.
  • Crucially, always remember there is a patient waiting for this medicine and demonstrate an understanding of the impact of the non-compliance from a patient perspective, including risks to the patient, how quickly the team got to the true root cause, robust CAPAs taken, and any delays in implementing action.


Embracing a proactive quality culture and rethinking the CAPA process

An effective and robust CAPA process is not a tick-the-box exercise, but the concerted outcome of an engaged and high-performing team who embrace a proactive quality culture and rethink CAPAs as a continuous improvement tool8. Senior leadership should instil a sense of accountability and ownership and ensure the necessary support infrastructure is provided.

Foundations of a proactive quality culture are built on a strong CAPA process using risk-based principles 5 where learning from mistakes is the norm, CAPA teams are recognized and rewarded and the CAPA process is integral to the organization’s operating philosophy. This can lead to product and process improvements.


What issues are you struggling with in building your CAPA process? Has your organization put a proactive quality culture and CAPA process in place? We would be interested in hearing about your experience.


About the author: Annette Boland is a consultant at PharmaLex, Ireland, focused on quality operations. She is an experience quality assurance professional with 30 years of experience in pharmaceutical, biologics, medical devices and tissue-based products, having worked in both generic and branded multinational companies. Annette has a BSc (Hons) in Analytical Science & a Post Graduate Diploma in Pharmaceutical Manufacturing Technology (Qualified Person status).



1 Promote a Culture of Safety with Good Catch Reports | Advisory (

2 How to Improve Patient Safety with a Good Catch Program (

3 Six Sigma Definition – What is Lean Six Sigma? | ASQ

4 Corrective and Preventive Actions (CAPA) | FDA

5 ICH guideline Q9 (R1) on quality risk management (

6 What is Statistical Process Control? SPC Quality Tools | ASQ

7 (4) How LIMS Can Help Reduce or Eliminate Human Errors in Your QC Laboratory? | LinkedIn

8 Make CAPA ‘cool’: FDA gives thumbs-up to framework that retools CAPA process for device makers | RAPS





This blog is intended to communicate PharmaLex’s capabilities which are backed by the author’s expertise. However, PharmaLex US Corporation and its parent, Cencora, Inc., strongly encourage readers to review the references provided with this article and all available information related to the topics mentioned herein and to rely on their own experience and expertise in making decisions related thereto as the article may contain certain marketing statements and does not constitute legal advice. 

Contact us for more information

Scroll to Top