What's the difference between ISO13485 and FDA/QSR?

Marcelo

Inactive Registered Visitor
#11
This castration was not that successful, for me the preventative actions are contributing to the continuous improvement of the organization and as such, they were luckily survived.
Preventive action is action to prevent an error, meaning, the system from doing the wrong thing.

Improvement is related to capability.

They are totally unrelated, in fact, although ISO 9001 seems to put them into the same basket.

But in the next revision ISO 9001 will probably remove preventive action anyway and focuses in risk management.
 
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sagai

Quite Involved in Discussions
#12
That's interesting.
So ... when one of the preventative action stipulates changes to the QMS itself in order to prevent the occurance of a non conformity, than you would consider it as a non continuous improvement related activity? Why is that? Or have I misunderstand your saying?
Many thanks!
 

Marcelo

Inactive Registered Visitor
#13
So ... when one of the preventative action stipulates changes to the QMS itself in order to prevent the occurance of a non conformity, than you would consider it as a non continuous improvement related activity? Why is that? Or have I misunderstand your saying?
It's not improvement. It's prevention of the system doing something wrong.

Improvement is related to system capability.

Example: I have a machine that was created to output 30 parts/hour (meaning, this is the system requirement).

If it begin outputting only 20 parts/hour, it's a NC (the system is not working as intended/required/designed).

Action to correct it's behavior ( meaning, making the machine output the required 30 parts/hour) is corrective action.]

Action to prevent this behavior is preventive action. It prevents the system from not working intended/required/designed).

These are actions to maintain/correct the status quo. They are not related to capability as they do not increase the ability to fulfil quality requirements. They only maintain what was required

A improvement action would be, for example, action to the machine outputs 60 parts/hour. This improves the increasing the ability of the process to fulfil quality requirements.
 

sagai

Quite Involved in Discussions
#14
I am letting your thoughts to invade my mind ... but being in a pure R&D organization I mostly see preventions relate to processes of the QMS and experiencing extreme difficulties to see distinction between improving process efficiencies and the terminology called continuous improvement.
Let me have a read of ISO9000/9001 :rolleyes:
Many thanks, Cheers
 

sagai

Quite Involved in Discussions
#15
I should admit reading your example, yes, not all preventative actions are necessarily contributing to continuous improvement, so I am okay with using "could" instead of "are" in that context.
Let me have an illuminating example.

There is "Company A" , subject to ISO9001, and as part of their continuous improvement program they decide to minimize the administrative burden on the activities carried out as part of the Document control.
As a result of it, they have identified and executed actions like:
1., have minimized the review rules for documents,
2., optimized the approval procedure,
3., electronic document management system is identified to be implemented,
4., etc. etc.
As result of it, they have managed to reduce the time spent on documentation administration with X%, documents are more accurate, customer satisfaction survey also shows some improvement, blablabla.

There is "Company B", subject to ISO13485 only, do not really plan to do anything particular for continuous improvement.
One of the internal audit identified deviations from the procedure defined in the QMS for document control and the practice carried out on a regular basis.
Investigation and root cause analysis were carried out and it was identified that (next to people were not well trained, etc.) there are far more burden on the document control process than it is needed based on regulatory needs and business needs and this is due to the fact that the document process was never evaluated whether or not suitable for the changed environment and it has survived like a dino from the medieval times of the company.
So ... the corrective action was about how to retrospectively carry out activities if needed and to maintain appropriate knowledge transfer about document control procedure, AND in order to kill the additional root causes they've identified further actions as part of the corrective actions:
1., have minimized the review rules for documents,
2., optimized the approval procedure,
3., electronic document management system is identified to be implemented,
4., etc. etc.

Now ... can we say, that even for Corrective Actions, we can not talk about continuous improvement?

Many thanks, Cheers!
 

Marcelo

Inactive Registered Visitor
#16
One of the internal audit identified deviations from the procedure defined in the QMS for document control and the practice carried out on a regular basis.
Investigation and root cause analysis were carried out and it was identified that (next to people were not well trained, etc.) there are far more burden on the document control process than it is needed based on regulatory needs and business needs and this is due to the fact that the document process was never evaluated whether or not suitable for the changed environment and it has survived like a dino from the medieval times of the company.
So ... the corrective action was about how to retrospectively carry out activities if needed and to maintain appropriate knowledge transfer about document control procedure, AND in order to kill the additional root causes they've identified further actions as part of the corrective actions:
1., have minimized the review rules for documents,
2., optimized the approval procedure,
3., electronic document management system is identified to be implemented,
4., etc. etc.
I don't see a NC here, so there's no corrective action.

Now ... can we say, that even for Corrective Actions, we can not talk about continuous improvement?
In my opinion yes, corrective actions (actions to prevent the recurrence of NCs) are really not improvement (although the standards say they are :)). They just correct something that should have been done right on the first place.
 

sagai

Quite Involved in Discussions
#17
Okay ... more elaboration ...

For example the NC raised because there were review rules defined in the QMS document control procedure and the people were interviewed including the documents proved the fact that the specified control was not kept.

In this hypotetical example it raised against 4.1:
"The organization shall establish, document, implement and maintain a quality management system and maintain its effectiveness in accordance with the requirements of this International Standard."

The effectiveness of the Document Control procedure of the QMS is not maintained.

Now, we have it, for the first part.

Actually, I distinguish correction and corrective action.

Is it really not obvious that the result are just the same regardless the second case does not deliberately targeted improvement?

Many thanks, Cheers!
 
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