Effectiveness of Preventive Actions

Ronen E

Problem Solver
Staff member
Moderator
#31
Not specifically replying to anybody, but as a general reflection on various posts in this thread, I'd like to suggest a different approach.

Originally, as much as I got, the issue was "How do you verify the effectiveness of a preventive action?". A PA is directed at eliminating a root cause of an undesirable happening that has not occured yet (otherwise it's a CA). So, it's effectiveness should be measured by the removal of that specific defined root cause, not by the prevention of the undesirable happening.

If we accept that approach, it does become quite a simple issue. We simply check whether that pin-pointed thing we set off to eliminate was actually eliminated. To go back to the railing example - the undesirable happening was falling over the edge. A root casue (not THE root casue, because there are more than one) is the lack of a physical barrier accross the edge. PA: installation of a railing. Was the root cause we set off to eliminate actually eliminated? Yes. So that particular PA was effective.

Cheers,
Ronen.
 
Elsmar Forum Sponsor
J

JaneB

#32
Originally, as much as I got, the issue was "How do you verify the effectiveness of a preventive action?". A PA is directed at eliminating a root cause of an undesirable happening that has not occured yet (otherwise it's a CA). So, it's effectiveness should be measured by the removal of that specific defined root cause, not by the prevention of the undesirable happening.
Sounds good & I like some of your idea.

Not sure it can be applied across the board. Agree with your railing example, but at times the potential risk or the potential cause of a potential problem (chee! what a topic for a Friday afternoon here!) is beyond our control.

Yes, we can install a safety railing. But we cannot, alas, wave a wand and eliminate a Global Financial Crisis which may impact our business. We can take steps to mitigate or manage the potential impact, but we cannot eliminate the cause.

I think aiming for 100% verification of effectiveness of PA is impossible. But we can review it and determine if we think it's been effective. Which is, I believe, all you can reasonably hope to do when talking about things which haven't happened and may not.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#33
Re: ISO 9001's difficult words

In a world of caos, people look for reassurance and confidence. PFMEA sometimes creates an illusion that we can predict and control the future. True, it is a very useful tool in making sure that you have thought through some of the risks, and sometimes even most of the significant ones, but in my opinion it is quite poor in making sure ALL the risks are covered.
I am not sure we can, or should always plan to control all risks. Some may be determined to be nearly inconsequential or too difficult to control through mechanical means - there are cases where the need for discipline is a critical factor and can't be automated away.

I am interested to learn what it is about the PFMEA tool that prohibits/is less than adequate for a thorough risk management process.
 
J

JaneB

#34
Re: ISO 9001's difficult words

I am not sure we can, or should always plan to control all risks.
I am sure that we cannot do so. It just is not always possible and/or it may not be practicable. cost-effective to do so. One of the keys in sound risk management is to consider the context of risks and also to consider 'risk appetite' ie, how much risk is considered acceptable by the organisation.

As you say
Some may be determined to be nearly inconsequential or too difficult to control through mechanical means - there are cases where the need for discipline is a critical factor and can't be automated away.
Yes. Or it might not be cost-effective.
I am interested to learn what it is about the PFMEA tool that prohibits/is less than adequate for a thorough risk management process.
Me too.
 

Ronen E

Problem Solver
Staff member
Moderator
#35
Re: ISO 9001's difficult words

I am interested to learn what it is about the PFMEA tool that prohibits/is less than adequate for a thorough risk management process.
If I knew the answer I'd write a book about it and retire... :lol:

I've simply seen too many projects where a neat and thorough, by-the-book, risk management process was applied by average healthy companies; risks were cost-effectively mitigated, according to well-established criteria, to an acceptable level; and then and unpredicted risk struck... :(

Managing risks we can percieve is relatively simple. It's always that risk you haven't thought about that brings you down... Well, not always but definitely sometimes.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#36
Re: ISO 9001's difficult words

If I knew the answer I'd write a book about it and retire... :lol:

I've simply seen too many projects where a neat and thorough, by-the-book, risk management process was applied by average healthy companies; risks were cost-effectively mitigated, according to well-established criteria, to an acceptable level; and then and unpredicted risk struck... :(

Managing risks we can percieve is relatively simple. It's always that risk you haven't thought about that brings you down... Well, not always but definitely sometimes.
If people don't think of everything that's important, we shouldn't blame the tool without examining if the tool constrained the people somehow.

We have said it's not possible or feasible to plan away all risk. It's practical to plan away the serious risk. That way, if something bad does happen (and it probably will, possibilities are infinite) the outcome won't be disastrous.

And so it seems worthwhile to make plans for emergency protocols, and for recovery as well as risk.
 
H

Hanr3

#37
Preventive action is a pretty simple idea.

You have a process/procedure, what potential things could cause a negative outcome?
You build in steps to prevent or an alarm when that situation is triggered. A preventative step.

Example:
Here in the Mid-West most people have a basement. In that basement is a sump pump. The pump is plugged into a wall outlet. The pump removes water from around teh foundation so the basement doesn't flood during storms. A potential negative outcome is a power failure, thus stopping the pump from working and your basement flooding. Your preventative action is the installation of a battery back up system to keep the pump working when the power goes out.

The potential risk was a power outage when the pump is supposed to be working.
The preventative action was the installation of a battery back up so the pump will continue to work if the power goes out.

Emergency exit signs are a preventative action.
Sprinkler systems, battery powered computer back-up, etc. All preventative.
Tornado shelter, and the list goes on and on.

The preventative action does not garuntee that the event won't happen, it applies a suitable action to reduce the risk of the event. It gives you time to react if need be. Escape from a fire, seek shelter from a tornado, run to the store and buy another battery, save your work on the pc, etc. Your not going to stop the event, however your goal is to minimize the effect it will cause to your operations. That is a preventative action. :cool:

Now lets use it in terms of a noncomformity.
Paint process.
Your customer require a specific color of Yellow, Caterpillar yellow for example.
You receive a shipment of yellow from your vendor like always, and add it to the paint tank. Spray the parts and realize its the wrong shade of yellow.
A simple preventative step would be to compare the paint label to the job requirements. Or pull a color comparison swatch and compare it to the standard color swatch on the computer. That is a preventative step in your procedure.
 
Last edited by a moderator:

Helmut Jilling

Auditor / Consultant
#38
Preventive action is a pretty simple idea.

You have a process/procedure, what potential things could cause a negative outcome?
You build in steps to prevent or an alarm when that situation is triggered. A preventative step.

Example:
Here in the Mid-West most people have a basement. In that basement is a sump pump. The pump is plugged into a wall outlet. The pump removes water from around the foundation so the basement doesn't flood during storms. A potential negative outcome is a power failure, thus stopping the pump from working and your basement flooding. Your preventative action is the installation of a battery back up system to keep the pump working when the power goes out.

The potential risk was a power outage when the pump is supposed to be working.
The preventative action was the installation of a battery back up so the pump will continue to work if the power goes out.

Emergency exit signs are a preventative action.
Sprinkler systems, battery powered computer back-up, etc. All preventative.
Tornado shelter, and the list goes on and on.

The preventative action does not garuntee that the event won't happen, it applies a suitable action to reduce the risk of the event. It gives you time to react if need be. Escape from a fire, seek shelter from a tornado, run to the store and buy another battery, save your work on the pc, etc. Your not going to stop the event, however your goal is to minimize the effect it will cause to your operations. That is a preventative action. :cool:

Now lets use it in terms of a noncomformity.
Paint process.
Your customer require a specific color of Yellow, Caterpillar yellow for example.
You receive a shipment of yellow from your vendor like always, and add it to the paint tank. Spray the parts and realize its the wrong shade of yellow.
A simple preventative step would be to compare the paint label to the job requirements. Or pull a color comparison swatch and compare it to the standard color swatch on the computer. That is a preventative step in your procedure.
You are interpreting "preventive action" very broadly. While many do that, I think it goes broader than what is defined in the standard. This topic always generates a lot of discussion based on views and opinions.

The ISO standard describes Preventive Action using mostly the same requirements as Corrective Actions. Some preventive things fit better under preventive maintenance, under training, under safety or other sections of the ISO standards.

When the ISO standard describes Preventive Action, it refers to identifying potential failures and eliminating the root causes. For corrective action it describes identifying actual failures and eliminating the root causes. So, staying close to that definition, when an actual failure occurs, you identify the cause and eliminate the cause. You verify effectiveness when the cause is eliminated and can no longer occur. The same principle applies to preventive actions. They are verified as effective when the causes are verified as eliminated.
 
Last edited by a moderator:
S

samsung

#39
Emergency exit signs are a preventative action.
Sprinkler systems, battery powered computer back-up, etc. All preventative.
Tornado shelter, and the list goes on and on.
The term 'Preventive Action' as defined by most management standards isn't (so far) part of Planning. The examples cited above are either part of planning/ project design or regulatory requirements that one is obliged to implement even before establishing a structured management system e.g. 9001. But the Preventive Actions, as required by ISO 9001 (or other simililar standards) should result out of the 'Check' phase (Improvement) of the PDCA based system. An action must be attributable to the management system that the organization adopted for overall improvement.

So in the above examples, the true preventive action would be the actions taken beforehand to prevent problems related to operation of the sprinkler (nozzle jamming, no water in the reservoir etc.) or to prevent problems of exit (in case the Emergency Exit itself is at fire/ obstructed/ unapproachable)

The preventative action does not guarantee that the event won't happen, it applies a suitable action to reduce the risk of the event.
If a preventive action cannot prevent a potential problem (aka Nonconformity), then why should it anyway be regarded as a Preventive (or preventative) Action? It's rather a simple action having no rationale behind it's administration. How would you satisfy the effectiveness of a PA? If the action didn't work and further action had to be taken, it should better be regarded as a Corrective Action.
 
H

Hanr3

#40
Changing the oil in your car every 5,000 miles is no garuntee your engine wont fail from an oiling issue.
However if you dont change the oil, it will most certainly fail.

The standrad states; " The organization shall determine action to eliminate the causes of potential nonconformities..."
I dont see anything in there about it relating to Corrective Action.
Dont confuse the two by assuming they are related.

Yes, most preventive actions are the result of the PDCA cycle. Whether it is part of the design process, production process, or some other process, it doesn't matter.

On a realistic side, failures can occur from numerous sources, design flaw, casting flaw, manufacturing flaw, age, nautral occurance (fire, earthquake, tornado, etc), human error, and the list goes on and on.
Trying to design and evaluate a preventive action for all those potential causes is next to impossible, if not unrealistic due to cost.

To me the best approach is some sort of alarming step. SPC is an alarming step, if you approach the upper or lower limit, your almost out of tolerance, action is taken to correct the situation and bring you back to normal readings. Your preventive action was effective, and you have evidence of it. This by no means quarantees you will never have a failure because your out of tolerance.

Murphy will eventually visit your facility too.
 
Thread starter Similar threads Forum Replies Date
S How to evaluate the Effectiveness of Corrective and Preventive Actions Nonconformance and Corrective Action 3
Q Evaluating Effectiveness of a Preventive Action after Closure Preventive Action and Continuous Improvement 7
M Measuring Corrective and Preventive Action System Effectiveness Nonconformance and Corrective Action 32
T Documenting Effectiveness of Corrective/Preventive Action Nonconformance and Corrective Action 8
J CAPA (corrective action preventive action) Effectiveness - Medical Device Industry Nonconformance and Corrective Action 3
E Audit Program and CAPA (Corrective Action - Preventive Action) Effectiveness ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D Preventive Action Effectiveness - How can any preventive action be 'proven'? Preventive Action and Continuous Improvement 38
K Visual Inspection Effectiveness Inspection, Prints (Drawings), Testing, Sampling and Related Topics 16
M ISO14971:2019 - Verification of implementation and effectiveness of risk control ISO 14971 - Medical Device Risk Management 3
C Quality, efficiency and effectiveness of daily work routines Misc. Quality Assurance and Business Systems Related Topics 4
V CAPA effectiveness check Nonconformance and Corrective Action 3
N How to monitor the effectiveness of the CAPA system ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
qualprod ISO 9001 5.1.1 - How to measure System effectiveness ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
qualprod Add new action plans in CA, while waiting effectiveness - Same problem reappears ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
qualprod Best criteria to measure Corrective Action effectiveness - Poor Maintenance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
C CMDR Essential (Safety & Effectiveness) Requirements Checklist? Canada Medical Device Regulations 9
J AQL for Effectiveness Check - What AQL tiers to use on this type of sampling? Nonconformance and Corrective Action 9
M Medical Device News FDA - Transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices Other US Medical Device Regulations 0
S Nonconformance to a Note in ISO13485 clause 6.2 Human Resources Effectiveness ISO 13485:2016 - Medical Device Quality Management Systems 13
J Recall Effectiveness - Accessory to Medical Devices shipped through Distributors Customer Complaints 3
qualprod To Evaluate Effectiveness in All Improvements? (ISO 9001:2015) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M Corrective Action Effectiveness Nonconformance and Corrective Action 5
Uriel Alejandro Evaluation of the effectiveness of correction actions General Auditing Discussions 15
L Verifying training effectiveness for procedure changes ISO 13485:2016 - Medical Device Quality Management Systems 4
T Hot dogs and process operation and control effectiveness? 4.1.3 a) ISO 13485:2016 - Medical Device Quality Management Systems 2
S ISO 9001:2015 4.4.1 (c) Process Effectiveness ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
M Effectiveness Measuring and Efficiency Measuring In ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A IATF 16949 - Non-conformity on 5.1.1.2 Process effectiveness and efficiency IATF 16949 - Automotive Quality Systems Standard 5
S What are some ways to demonstrate Effectiveness of Training? ISO 13485:2016 - Medical Device Quality Management Systems 29
B IATF 16949 Cl. 7.3.2 - Documented Process (Effectiveness & Efficiency) IATF 16949 - Automotive Quality Systems Standard 7
R Documenting Self-Training and Effectiveness - ISO 13485:2016 Training - Internal, External, Online and Distance Learning 4
B Auditing Senior Management to determine the Effectiveness of Management Processes IATF 16949 - Automotive Quality Systems Standard 6
J Process Effectiveness and Efficiency (IATF 16949) IATF 16949 - Automotive Quality Systems Standard 29
P Is ISO 9001 Model tested for its effectiveness by ISO before its release? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D Do people read PEARS (Process Effectiveness Assessment Report)? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
B IATF 16949 Cl. 9.3.2.1 - Management Review Inputs - Process Effectiveness and Efficie IATF 16949 - Automotive Quality Systems Standard 14
Colin Effectiveness of IRCA Registered Training ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 4
R ISO 13485:2016 Clause 6.2 - Effectiveness Check ISO 13485:2016 - Medical Device Quality Management Systems 1
M Training Effectiveness TS 16949 Clause 6.2.2c Training - Internal, External, Online and Distance Learning 5
Q Corrective Action Effectiveness also for correction? Nonconformance and Corrective Action 11
S AS9100C 8.2.2 - Selected Tools & Effectiveness of IA Process and Performance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
A Performance vs. Effectiveness - ISO 9001:2015 par. 9.1.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
S How to Monitor Training Effectiveness Training - Internal, External, Online and Distance Learning 13
Q Effectiveness Plan for CAPA initiated from External Audit US Food and Drug Administration (FDA) 3
Buckyb Are KPIs a requirement to determine Process Effectiveness? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
M Auditing ISO9001/AS9100 7.3 Design and Development Quality System Effectiveness Manufacturing and Related Processes 12
I Not having "effectiveness" in the Quality Policy ISO 13485:2016 - Medical Device Quality Management Systems 8
M Can OEE (overall equipment effectiveness) exceed 100%? Manufacturing and Related Processes 2
A Effectiveness of Risk Control Measures ISO 14971 - Medical Device Risk Management 4
M Where does OEE (Overall Equipment Effectiveness) belong? Quality Tools, Improvement and Analysis 11

Similar threads

Top Bottom