Hi all,

We are a manufacturer of medical devices and currently are looking for the requirements / guidelines when to initiate a CAPA.

As discussion topic, I'd say a CAPA shall be initiated in case the product quality and/or safety is endangered, either direct or indirect. It can be either a process or product issue, or both.
Typical sources where CAPAs are initiated, are:
- field issues;
- complaints;
- internal non conformities;
- internal audits;
- metrics / trending of both process and product indicators;
- SCARs;
- management reviews.

Gaps in procedures are not reasons for initiating a CAPA, unless the product safety is endangered.

Any feedback is welcome! Thanks.

Hi, You have covered things which are need to be followed for raising CAPA. Apart from this CAPA is a process of making systems (ISO) & Business run smoothly and consistently. So in broad, it can be classified where ever the deviations found from agreed or laid or set goals / targets / procedures. At the end of the the day it is the decision of Management and MR to decide on CAPA. Again many company club various small issues by one general CAPA than making simply CAPA reports which dont add value.

well, for me I see that the CA is a stage and the PA is another stage. you might not need to do both each time . Perhaps you need to do a correction every time but I think it is not easy to convince the employees to get use to do a preventive action in each NonCon, it needs open minded culture though.

Another thing should be considered from my view that...
CA is a short term plan{many time immediate plan}..and PA is a long term plan.

Proper PA should be done when you do not have a NonCons or a specific problem, in which you come to a point in your quality system that you expect what could be the worst case scenario then you build up a plan to prevent it from even happening!

If you just have a problem...then fix it (CA) then think of how not to do that again, so, do not convince your self that this is a pure preventive action :thedeal:
:2cents:

Hi, You have covered things which are need to be followed for raising CAPA. Apart from this CAPA is a process of making systems (ISO) & Business run smoothly and consistently. So in broad, it can be classified where ever the deviations found from agreed or laid or set goals / targets / procedures. At the end of the the day it is the decision of Management and MR to decide on CAPA. Again many company club various small issues by one general CAPA than making simply CAPA reports which dont add value.

Thanks for the quick feedback. :applause:
I do recognize your last statement about the numerous small issues... that's what we're actually dealing with.
Some managers tend to not identify a certain issue as a CAPA in the FDA sense. What argument / criteria shall be used to define this?
What do you think about the following: "any direct (product) or indirect (process) influence on product quality and/or safety, shall be treated as a CAPA in FDA sense."?

Hi Gooofii,

Thanks for the reply. About your remark that CA and PA are two different stages: can we state that the CA is to be on the process level where the issue occurred (eg. production area) and the PA is to be decided upon on managerial level (eg. management review, production meeting with staff members, management team meetings)?

Hi Gooofii,

Thanks for the reply. About your remark that CA and PA are two different stages: can we state that the CA is to be on the process level where the issue occurred (eg. production area) and the PA is to be decided upon on managerial level (eg. management review, production meeting with staff members, management team meetings)?

well yea, however you still need the "managerial level" for a CA aswell though. I believe that the CA is to be upon the process level as this will assure the quality of the production line as the famous qoute says "Inspect the Process NoT the Product". you can find more thoughts about this issue on this thread aswell
http://http://elsmar.com/Forums/showthread.php?t=30472

I guess we could be getting into the question of what you term 'Management'. We assign CAPA's to 'Department Heads' These people may or may not be members of 'Top Management'. Very often they are 'Supervisors' responsible for a particular process and therefore 'subject matter experts'

As far as our system goes 'Top Management' are copied on CAPA decisions but are not necessarily involved in their resolution. Obviously, CAPA is reported at Management Review but to be honest, the less Top Management are directly involved in CAPA resolution, the better.

When to raise CAPA's? Easy - When something HAS or MIGHT go wrong.

Corrective actions are for when something HAS gone wrong resulting in a nonconformance and Preventive actions are for when the POSSIBILITY of a nonconformance has been identified

Thanks for the quick feedback. :applause:
I do recognize your last statement about the numerous small issues... that's what we're actually dealing with.
Some managers tend to not identify a certain issue as a CAPA in the FDA sense. What argument / criteria shall be used to define this?
What do you think about the following: "any direct (product) or indirect (process) influence on product quality and/or safety, shall be treated as a CAPA in FDA sense."?

Directly from FDA would be THIS (http://www.fda.gov/CBER/tissue/hctpreg012407mm2.htm) - if you are looking for medical devices, refer Section 820.100 that is mentioned towards the bottom of the page and mentions the following -

CAPA 820.100

(a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for:

(1) Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems;
(2) Investigating the cause of nonconformities relating to product, processes, and the quality system;
(3) Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems;
(4) Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device;
(5) Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;
(6) Ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems; and
(7) Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.

(b) All activities required under this section, and their results, shall be documented

In relation to (1), actions resulting from your risk management programme could also be appropriately handled via your CAPA system.

Hi, Im developing a CAPA software which can be used in medical devices and other allied industries. Im looking for beta testers who can implement the software in their company.

Im ready to give that software free of cost. And also do the modifications and customize the software to suit your needs. Please note that this is a free software and Im giving this for free. It is not for sale.

Im ready to provide full support for the software. If you are interested I can show a demo of the software to you.

regards,
Satheesh

Hi, Im developing a CAPA software which can be used in medical devices and other allied industries. Im looking for beta testers who can implement the software in their company.

Im ready to give that software free of cost. And also do the modifications and customize the software to suit your needs. Please note that this is a free software and Im giving this for free. It is not for sale.

Im ready to provide full support for the software. If you are interested I can show a demo of the software to you.

regards,
Satheesh

Hi Satheesh,

Pl note that I have deleted your email address from the post as it violates the TOS. Any one interested will contact you through the Private Messaging.

To be more specific on the criteria to initiate a corrective action,

I would say when a systematic (recurring) process or design problem has
• Increased FMEA risk classification due to hazard severity and/or probability change.
• Adversely affected the customer related processes (customer order processing, complaint handling, contract review etc.).
• Caused deviation from product performance specifications (design inputs) and/or regulatory requirements.
• Resulted in significant rejection of the products/raw material.
• Significantly and adversely affected manufacturability/cost of the product.

Any comments or suggestion on the criteria to initiate corrections? I would appreciate for feedback from the subject matter experts.