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Insight Report Vol. 5 No.6
Corrective Action - Preventive Action…
aren’t they really the same?
CAPA, Corrective Action Preventive Action is a major area of the FDA
and the ISO9000’s concern. One critical aspect of a Quality System is how
it is monitored and maintained to provide continuous improvement to the
System. This is a true litmus test of management’s seriousness in the
oversight of the implementation of the Quality System: it shows the
strength of their commitment to their policy statement.
In the QSIT auditing procedures, CAPA follows the Management Review and
Design Control. Here is where the FDA takes a serious look at how CAPA is
used, not only to correct a problem but, to gauge what is being done to
monitor the system and to come up with Preventive Actions that will
prevent future problems.
Working with many companies, one area that seems to be the most
confusing is in how they separate the CA from the PA. It appears that CAPA
has become its own procedure; and, not exactly understanding the
difference, companies have taken the road of least resistance and do a
CAPA investigation -- which is neither a Corrective Action nor a
Preventive Action.
During a recent audit at a relatively large company, the form they used
for Corrective and Preventive Actions was labeled CAPA. This is not
unusual in that most companies use one form for both CA and PA. But, in
the action box, they filled in both the Corrective Action and the
Preventive Action for every situation.
Was this wrong? Perhaps not, but because they had a hard time
determining the differences between a CA and a PA, they figured that if
they covered both the CA and PA on each situation, they could not get into
trouble with either the FDA or the certifying body.
Doing what they did may or may not actually help them avoid problems
with the FDA or their notified body, so I wouldn’t recommend that your
company use that approach. This is not the intent of the ISO Standard or
the FDA QSR. And, you must be aware that if you follow this procedure you
may not, in fact, be addressing PA part of the CAPA correctly.
The first place to start in separating the CA from the PA would be
agreeing to some definition of what a CA and a PA is.
The best definition I have come across that provides a clear
understanding between a CA and a PA can be found in the ISO13485 standard.
In section 8.5.2 Corrective Action it states that:
The organization shall take action to eliminate the cause of
nonconformities in order to prevent recurrence. Corrective actions shall
be appropriate to effects of the nonconformities encountered.
In section 8.5.2 Preventive Action it states that:
The organization shall determine action to eliminate the causes of
potential nonconformities in order to prevent their occurrence. Preventive
actions shall be appropriate to the effects of the potential problems.
The definitions are very similar except when you read on and see what
is expected of the organization in dealing with each action.
For a CA it is expected that:
* Review the nonconformities (including consumer complaints)
* Determining the causes of the nonconformities
* Evaluating the need for action to ensure that nonconformities do not
recur
* Determining and implementing the action needed
* Records of the results of any investigation and the action taken
* Reviewing corrective action taken and its effectiveness
For a PA it is expected that:
* Determine potential nonconformities and their causes
* Evaluating the need for action to prevent occurrence of nonconformities
* Determining and implementing action needed
* Records of results of any investigation and of action taken
* Reviewing preventive action taken and its effectiveness
So, what is the main difference between a CA and a PA?
In reading the above, and when you see what actions have to be taken
when investigating a CA or a PA, I think that the difference is quite
clear.
A CA requires that a nonconformity exist where a PA requires a
potential nonconformity. That seems reasonable.
Let’s give an example of a CA and a PA and see if you could pick out
which is which?
Example 1. The service unit has had an increase over the last 3 months
of complaints related to late shipments. There were 30 cases of returned
products in April, 35 situations in May and 40 in June. The management
team met and assigned the Quality Department to investigate and come up
with solutions to reducing the number of future nonconformances.
Example 2. The Receiving Department received a shipment of widgets that
were out of specification. This was the first time the widgets from this
new vendor had a problem. The widgets were labeled not to use and placed
into quarantine. The management team met and assigned the Quality
Department to investigate and come up with an action for this
nonconformance.
In Example 1, there was no specific non-conformance that had to be
dealt with but an upward trend in returns. It was viewed by the management
team that this trend represented a potential problem and if it was not
addressed may lead to additional problems in the future. In this case this
would be a Preventive Action not a Corrective Action.
In Example 2, there was a specific non-conformance, the widgets were
out of specification, and these out of spec. components had to be dealt
with. This would be a Corrective Action, though the company may also
conduct an investigation to determine what happens in this case and design
a method prevention for future problems.
A company can also look to long term capital expenses as a possible
Preventive Action. An example would be when the management team decides to
purchase a new piece of equipment to replace an old unit. If this decision
was made as a result of loss of productivity, increase in breakdown and
quality issues, this could most definitely be reviewed as a Preventive
Action on the company’s part and should be documented as such. A large
number of companies do not view many of their decisions as a Preventive
Action though many are just that.
There is an apparent difference between a Corrective Action and a
Preventive Action that is not hard to differentiate. It is important to
understand the distinction and to implement your CAPA procedures correctly
or you may be doing a lot of extra work and not getting the full benefit
of actions.
So, remember - CAPA does not just have its own identity. It does stand
for two different actions.
All comments of this or any of our Insight Reports are read and you
will get a reply. So please let us hear from you.
The next Insight Report – To Be Announced
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