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What are the Software Validation Requirements for ISO 13485:2016 for medical devices companies?
6th December 2019

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4th November 2019

CAPA - 12 Common Mistakes
23rd October 2019

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CAPA - 12 Common Mistakes

12 Common Mistakes in CAPA 

A very interesting article about 12 common mistakes in CAPA (Corrective and Preventive Action) systems and how to address them was featured on the website Quality Progress.com. (The article was authored by Josť Perez-Rodriguez and Manuel E.Pena Rodriguez). 
The key points of the article are as follows: 

CAPA is a Leading Cause of 483s Corrective and Preventive Action 

(CAPA) continues to be one of the top two causes of 483s from the FDA. One of the main causes of companies receiving a CAPA 483 from the FDA is a failure by the company to fully understand the FDAís expectations of a well-run CAPA system. 

Preventive Action is Frequently Misunderstood 

One of the most misunderstood aspects of CAPA is that corrective actions are intended to prevent recurrence and therefore donít require preventive actions. Preventive actions are intended to be separate activities that are taken to prevent failures, not in response to failure. This issue is addressed by the authors in Mistake #8 Common mistakes in CAPA System Investigations.

Key Points of the CAPA - 12 Common Mistakes article.

 1. Lack of an Investigation Plan. 
 2. Lack of Adequate Time. 
 3. Lack of Adequate Trending (Incidents are seen as isolated events). 
 4. Lack of Adequate Root Cause Analysis. 
 5. Lack of a Corrective Action for every identified Root Cause. 
 6. Symptoms are corrected instead of the Cause. 
 7. Lack of Interim Action when an immediate CA isnít possible. 
 8. Lack of true Preventive Actions. 
 9. Lack of Verification of Effectiveness (V0E) of the CA taken. 
 10. There are multiple CAPAs (within an organisation) with no correlation between them.  
11. Abuse of human error and retraining (Human error is often a symptom and not a cause). 
12. Too much focus on the CAPA software, not enough focus on the investigation and the CAPA itself. 

View the full article here. (Note: you will need to register on the destination website in order be able to view the text version of this article). 

CAPA for the Medical Device Industry Training Course 

Would your staff benefit from CAPA training? Find out more about our CAPA training course run through our training partner SQT Training Ltd. The course covers the Seven CAPA Steps approach to fulfilling the CAPA related requirements of 21 CFR part 820, ISO 13485 and, FDA and European Guidance Documents. 

John Lafferty is the tutor for the above training course. John also delivers courses in areas such as Quality Systems, Process Validation, Software Validation and Quality Risk Management on behalf of SQT. John runs the Quality Management Consultancy, Northridge Quality & Validation, which specialises in providing assistance to the Medical Devices and Pharmaceutical sector.

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