Shelly Blackwell Senior Director of Dietary Supplement and Tobacco Services EAS Consulting Group
The US Food and Drug Administration’s acronym for Corrective and Preventive Action (CAPA) can fill cGMP manufacturers with dread. Phrases like “death by CAPA” and “ineffective CAPA” are common in the manufacturing world. However, a well developed CAPA can be a useful tool organizations can wield to prevent repeat errors and ensure continuous improvement.
But the term doesn’t carry the same weight of dread in every context. For example, the medical device industry requires formal CAPA plan development for systems and procedures. However, other regulations reference CAPA as well. The dietary supplement cGMP regulations (21 CFR Part 111)1 require that corrective action plans be implemented when an established specification is not met (ref. 21 CFR 111.75)1 and ICH Q10 (Pharmaceutical Quality System)2 lists CAPA as one of the four quality system elements. A corrective action aims to prevent a problem’s recurrence after detection. Preventive actions intend to head off problems before they occur by using data, trends, or potential non conformances to identify risks.
How does one develop an effective CAPA? First, identify the problem. If the issue you are trying to solve is not well defined, the CAPA plan can creep beyond the original scope, and ultimately prove ineffective. When defining the problem, stick with facts (not opinions or guesses) and write a clear, concise statement that describes the problem and elaborates on its impacts. The problem definition phase is not the time to guess at a root cause. Instead of a problem statement that reads “Foreign softgels are being found on Line 6 because of the design of the equipment”, try “In the past 6 months (from 10/2022 – 3/2023), a 50% increase of foreign softgels have been found during line clearances on Line 6”. The second problem statement includes the pertinent (what, where, when) information and accurately defines the issue that needs to be addressed without jumping to conclusions.
Next, conduct a root cause investigation. The team investigating the issue needs to be well trained in root cause methodology. Note that I mentioned a team; often complex problems can not be properly investigated by an individual. Team members should have adequate training in tools such as Five Whys, Fishbone Diagram, and Is/Is Not. The team should chose the most applicable to the issue at hand—not necessarily the easiest to learn or use. For example, Five Whys may seem the simplest, but when there is a complex problem, such as the foreign softgel example above, a Fishbone diagram may be more appropriate.
Also, don’t immediately assume “human error” is the root cause. A thorough root cause will analyze “why” the human made the error and address that root cause. An organization with numerous “human error” root causes is a red flag to investigators and an indication that the true cause of the issue is not being properly investigated or addressed. As Dr. W. Edwards Deming wrote in his book “The New Economics”3: “People can’t perform better than the system allows”. Consider if your processes and systems are setting employees up for success or failure and address accordingly.
Once your team identifies a root cause and the reasons or conditions driving it, they can develop a CAPA plan to address it. If the plan aims to prevent reoccurrence, the team must develop corrective action(s). Preventive action plans focus on potential issues, where action will be taken before a problem occurs. For a corrective action plan, the actions need to be developed in such a way that they will eliminate the root cause or reduce it to an acceptable level to prevent reoccurrence.
As an example, assume the root cause investigation for the softgel issue earlier identified that, for line 6, the hopper design allowed softgels to spill over when being loaded and fall under a belt in a hard-to-see area. One corrective action might involve a hopper redesign that prevents this situation. Installing additional lighting to illuminate inconspicuous areas could address a secondary root cause. Reviewing and addressing similar risks on other lines could serve as preventive actions. These actions need a due date and a responsible individual assigned. Everything should be documented and tracked to completion.
Once a CAPA plan has been developed, the work is not done! Establish an effectiveness check with predefined criteria to review for repeat issues. The effectiveness check should allow enough time to properly determine whether the CAPA plan has truly eliminated the root cause, but it should not be too long to allow ineffective CAPAs to persist. Also, set a “trigger” so that the person charged with checking the CAPA’s efficacy remembers to conduct the evaluation. Newer electronic systems can notify responsible individuals of an upcoming effectiveness check. However, something as simple as an email or calendar reminder may be appropriate for manual systems. If the CAPA works, you should have a few less headaches in your future. If it does not, you may need to re-evaluate the root cause as it may not have been correctly identified.
One final note on CAPAs: not every issue needs a CAPA. Organizations should define in a written procedure what level of deviation, nonconformance, etc. requires a true CAPA plan. This level should be defined by risk and should consider the severity, occurrence, and detection of the issue. Initiating CAPAs for the most critical issues will allow proper allocation of resources and more effective CAPAs. Taking the time to develop a CAPA that uses a well-defined problem statement paired with an accurate root cause will ultimately save companies money through eliminating rework and improve their cGMP compliance.
References
1. Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. https:// www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-111
2. Guidance for Industry: Q10 Pharmaceutical Quality System. https:// www.fda.gov/media/71553/download
3. “The New Economics” (3rd edition, 2018): Book by the late W. Edwards Deming
About the Author Shelly Blackwell has over 22 years of quality and compliance experience in highly regulated environments. She’s been involved in providing supplier qualification programs, sourcing and implementing electronic QMS systems, and implementing inspection readiness programs resulting in improved regulatory standing, among others. She has lead FDA and other regulatory inspections throughout her career. She holds certifications form the American Society of Quality and the Institute of Food Technology and has a Biology degree from James Madison University. Contact Shelly at shelly.blackwell@easconsultinggroup.com or call EAS Consulting Group at (571) 447-5500.