Preventive Action vs. Corrective Action as defined by 21CFR820

sagai

Quite Involved in Discussions
#1
:mad: :frust: :mad:

What is the difference if any for you between the preventative action and the corrective actions only based on the requirements in the 21CFR820?

Many thanks, Cheers!
 
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I

isoalchemist

#2
:2cents: To me the definitions from 21CFR820, ISO 13485 and ISO9001 for Corrective and Preventative actions all are the same.

My quick guide is if it's noncompliant (i.e. broken) it is a corrective action. If you have no clear evidence of noncompliance, but research a potential issue it's preventative.

On a simplist level ( which can easily lead to many arguments over effective root cause analysis) if you find a process that is causing a nonconformance in Product A fixing it is a corrective action.

Looking beyond and seeing the same process is used in Product B would be a preventative action for Product B if the same fix is implemented.

It is a fine line at times.
 

sagai

Quite Involved in Discussions
#3
Thank you very much for sharing your thoughts!

Let me add the definition itself based on the CFR820

Sec. 820.100 Corrective and preventive action.
(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
.
Is it really the same than the definition given in ISO? :eek:

:rolleyes:
 
Last edited:
M

mehtagaurav_2004

#4
I think they both different ...please find the below examples.....


1. Non-conformance Identified - root cause analysis takes place - corrective action is taken to correct the issue - and also preventive action is taken so that the non conformance do not happen again ...make sure that the preventive action is solving the root cause...

2. A potential adverse trend or abnormal trend is identified ...root cause analysis takes place ...and in this case any action identified will be preventive action....which is again solving the root cause....

Regards,
G
 
I

isoalchemist

#5
:2cents: In this case:

(3) Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems;

My take is that they are really talking about "effectiveness" of the solution not "preventative action".
 
K

KathySmith

#6
ISO9001-2008 - is formal PAR form required? We have the CAR form and are engaged in all types of PAR activities, FMEA, PPAP's, customer/employee feedback, but do not have a defined PAR procedure or form.
 

sagai

Quite Involved in Discussions
#8
Thanks Aphel, it was very helpful !!!
Do you mind if I ask how you get this presentation?
Cheers!
 
Last edited by a moderator:

Marcelo

Inactive Registered Visitor
#10
The main difference is:

In ISO, after an NC occurs, you need to apply correction, and then evaluate the need for corrective action. Preventive action should be performed before an NC occur, by risk analysis or trending evaluation or whatever.

21 CFR 820 glues correction to corrective action (Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems). This is not in line with requirements from ISO (not even for the ISO 9001-1996/ISO 13485/1996 version, for which 21 CFR 820 was originally harmonized).

Why did this happen? From the preambles of 21 CFR 820, FDA was worried that people would treat a NC with only superficial rework (a type of correction) and not evaluate the need for corrective action. So, they required that every correction was tied to a corrective action.

From the standpoint of quality systems, this is a mess because not all NCs need corrective action, although all needs correction.
 
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