Priority steps for the QMS – getting the CAPA framework right first time

Corrective and preventive actions (CAPAs) are often met with fear and trepidation. Many organizations simply see these as a regulatory requirement, yet the reasons why health authorities require them are equally reasons the business will benefit from them.

Manufacturers are required to have a robust quality management system (QMS) and meet the ISO 9001 global standards[1] for their QMS. An intrinsic element in the QMS is the establishment of CAPA processes[2].

According to the US Food and Drug Administration (FDA), the purpose of a CAPA 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[3]”.

In its overview of comprehensively designed and correctly implemented QMS, the European Commission calls for an appropriate level of root cause analysis during investigations into deviations, suspected product defects and other problems[4].

While CAPA is a regulatory requirement, it is also to the benefit of the business to embed a robust CAPA process. As experience shows, making CAPA an integral compliance and continuous improvement tenet of the organization’s core operating philosophy instills confidence and pride with CAPA owners and helps manufacturers to be inspection ready.

Changing perceptions

When working with clients to prepare them for a CAPA, we often hear comments such as “This is going to take too much time,” “This is way too complex for me,” and “I really don’t have the time for this with my day job.”

Changing these perceptions requires a cultural shift, which can be aided by a SMART approach. That is, specific, measurable, achievable, relevant, and time-bound. The idea behind these five principles is to take a step-by-step approach rather than being tempted to rush into what you think the fix is. The FDA provides a clear framework with any CAPA process, which can be addressed by taking the following methodical steps based on  the Code of Federal Regulations (CFR) 820.100 5, 6 :

  1. Analysis – what inputs are you using to identify the cause of the non-conforming product, e.g. work instructions, complaints, audit reports, concessions, QC testing or any other sources of quality data? Have a clear and unambiguous problem statement. Be cognizant of immediate containment action(s) that may be necessary once a non-conformity is detected to prevent further issues e.g. quality hold, quarantine. Also, be pragmatic, not every quality incident requires a CAPA, a correction may be sufficient with the appropriate justification documented.
  2. Investigate – what caused the non-conformance. Use structured investigation techniques to comprehensively get to the root cause – e.g. 5-Whys, Failure Mode and Effect Analysis (FMEA), Fishbone Diagrams, Affinity Diagrams, Pareto Charts, Fault Tree Analysis, general group brainstorming, etc.7, 8 :
  3. Identify Actions – what is needed to correct (CA) the cause and prevent (PA) recurrence of a nonconforming product and / or other quality problems. Use a structured action plan – What, Who, When. This ensures alignment on deliverables and commitment of resources.
  4. Verify and validate. This is a crucial step to confirm that the actions defined are effective and do not adversely affect the finished product.
  5. Implement – Document and implement the defined actions, ensuring the necessary records are retained.
  6. Communicate –ensure information related to quality or nonconforming products is disseminated to individuals directly responsible for assuring the quality of such products. As part of your active quality culture, let your extended team know about the quality problems, the impact to patients, how the issue was detected and how the organization fixed the issue and prevented recurrence. Collaborate and solicit input for suggestions regarding further opportunities to improve.
  7. Management oversight – ensure the information on CAPAs is included in periodic management review forums to confirm that the CAPA input in the quality system is adequate, suitable, and effective.

The FDA has also highlighted the imperative of data integrity, referring to its completeness, consistency and accuracy, and underscored the importance of following ALCOA (attributable, legible, contemporaneous, original, and accurate) principles9. ALCOA cements all the hard work put into the CAPA process by verifying everything is documented.

Having a solid CAPA framework established helps to support inspection readiness and engaged and authentic management oversight can help companies to recognize CAPAs as a continuous improvement tool rather than just a regulatory requirement.

Are you struggling with CAPA complexities? Are time pressures a concern for you with the CAPA? Do you approach CAPA with trepidation? We would be interested in hearing your concerns.


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 ISO 9001:2015 – Quality management systems — Requirements

2 Q10 Guideline.pdf (

3 Corrective and Preventive Actions (CAPA) | FDA

4 GMP Guide Chapter 1 Q10 implementation final (

5 CFR – Code of Federal Regulations Title 21 (

6 CDRH-Learn-Presenation–Corrective-and-Preventive-Action-Basics.pdf (

7 ispe-pda-guide-to-improving-quality-culture.pdf

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

9 Guidance for Industry (





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. 

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