Preventive Action (PA) and Corrective Action (CA) - One or Two Procedures?
- Thread starter CarolX
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J
joshua_sx1
…combining them or not, will be your organization decision… and no auditor can force you to do what you don't want as long as you satisfy the requirements of clauses 8.5.2 & 8.5.3…
…to share more, I have seen more than 2 companies include their “Corrective Action” procedure into their “Control of Nonconforming Product” procedure… their point is, they’ll only have corrective action when there is nonconformance… so, it is a complete process to combine them… and it’s quite effective as they claim..
…to share more, I have seen more than 2 companies include their “Corrective Action” procedure into their “Control of Nonconforming Product” procedure… their point is, they’ll only have corrective action when there is nonconformance… so, it is a complete process to combine them… and it’s quite effective as they claim..
C
ChuckHughes
I am of the "two procedure" school for a couple of reasons:
Correction and Prevention have different points of initiation, that is to say different motivations start the action. Complaints and failures happen and correction should follow. Prevention starts with a realization that some risk is present. Safety programs, Preventive maintenance programs, EMS, all start with a risk assessment and actions follow. In fact these programs I include in my preventive action "system".
Correction and prevention involve different groups in the organization. Correction focuses on the product and processes that make it. QA, Engineering and Operations lead the corrective charge.
Prevention follows the changes being comtemplated for the business. Top Management should be leading the preventive charge. Planning should be the primary source for preventive action targets. "Install this new machine but prevent the interruption of current production".
"Maintain the project within budget".
"Production scheduling prevents additional set ups and cleaning".
Correction and Prevention have different points of initiation, that is to say different motivations start the action. Complaints and failures happen and correction should follow. Prevention starts with a realization that some risk is present. Safety programs, Preventive maintenance programs, EMS, all start with a risk assessment and actions follow. In fact these programs I include in my preventive action "system".
Correction and prevention involve different groups in the organization. Correction focuses on the product and processes that make it. QA, Engineering and Operations lead the corrective charge.
Prevention follows the changes being comtemplated for the business. Top Management should be leading the preventive charge. Planning should be the primary source for preventive action targets. "Install this new machine but prevent the interruption of current production".
"Maintain the project within budget".
"Production scheduling prevents additional set ups and cleaning".
W
winchm
Sounds like the 3 ONs to me - ON time, On Spec, On Budget - If it's not you need to put a CA in place. If you included the Risk Assessments in your PLM and included in Management Review you could use this as evidence of PA (as suggested by Jane). I don't think it makes a difference if it's one or two procedures. My company formerly had two and now we have one for both CA and PA, as well as Document Control and Records Control. I'm just catching up as I've been on the road for the past 3 months. 
R
reaganmom
Hi all...I'm new here. I just got audited for our 1st Continuous Assessment for ISO 9001 and the only issue the auditor found was an OFI for our corrective and preventive actions being together in one procedure. I disagree with the idea of needing two separate procedures, but unfortunately my top management would like this implemented.
I guess I'll just write the same basic procedure for both!
Also, does anyone ever get that ping pong sense when dealing with auditors? Our first Registration auditor had us add the fact that we don't outsource to our quality manual, and this auditor wants us to remove that! Arrrghh!
Thanks!
Susan
I guess I'll just write the same basic procedure for both!Also, does anyone ever get that ping pong sense when dealing with auditors? Our first Registration auditor had us add the fact that we don't outsource to our quality manual, and this auditor wants us to remove that! Arrrghh!
Thanks!
Susan
C
ChuckHughes
Hi Susan
I think I would hold off writing the same procedure twice. I have the dissenting opinions on "one versus two". I adhere to the notion that Prevention has a different start point from Correction. We all know when it is time to do Correction. Something broke and all the signals, including customers, are pointing to it. Prevention is not self starting, you have to remember to do it.
Some thoughts/Strategies:
1. A preventive action "system" can consist of:
a. The Safety Program (prevent injuries)
b. The maintenance program (prevent some types of failures)
c. The EMS program (prevents contamination to soil, air and water)
d. The production scheduling system (prevents late delivery and excess costs)
e. The training program (prevents inefficient operations and defects)
2. Elevate prevention to the top managers as part of their planning activities. They manage resources so things get done within budget and with minimal interference with product manufacture. Have them begin to establish a "I don't want that[fill in the blank] to happen when we make this change" list. In the US Army I assigned "assumption control" officers on my staff to manage what planning assumptions we made and to keep track of things we didn't want to happen.
Note the differences in focus with these ideas. The five items above all have some type of risk assessment to failure that is key to good prevention.
One or Two? Your call. I think you have all of these pieces already working in the company. You can repackage it and monitor for effectiveness.
I think I would hold off writing the same procedure twice. I have the dissenting opinions on "one versus two". I adhere to the notion that Prevention has a different start point from Correction. We all know when it is time to do Correction. Something broke and all the signals, including customers, are pointing to it. Prevention is not self starting, you have to remember to do it.
Some thoughts/Strategies:
1. A preventive action "system" can consist of:
a. The Safety Program (prevent injuries)
b. The maintenance program (prevent some types of failures)
c. The EMS program (prevents contamination to soil, air and water)
d. The production scheduling system (prevents late delivery and excess costs)
e. The training program (prevents inefficient operations and defects)
2. Elevate prevention to the top managers as part of their planning activities. They manage resources so things get done within budget and with minimal interference with product manufacture. Have them begin to establish a "I don't want that[fill in the blank] to happen when we make this change" list. In the US Army I assigned "assumption control" officers on my staff to manage what planning assumptions we made and to keep track of things we didn't want to happen.
Note the differences in focus with these ideas. The five items above all have some type of risk assessment to failure that is key to good prevention.
One or Two? Your call. I think you have all of these pieces already working in the company. You can repackage it and monitor for effectiveness.
Helmut Jilling
Auditor / Consultant
Chuck, whether one or two procedures, I would like to see the Preventiove discussion mentioning the structural format that CA follows. That often gets lost when the preventive action process becomes too holisitic.
Helmut Jilling
Auditor / Consultant
Hi all...I'm new here. I just got audited for our 1st Continuous Assessment for ISO 9001 and the only issue the auditor found was an OFI for our corrective and preventive actions being together in one procedure. I disagree with the idea of needing two separate procedures, but unfortunately my top management would like this implemented.
Also, does anyone ever get that ping pong sense when dealing with auditors? Our first Registration auditor had us add the fact that we don't outsource to our quality manual, and this auditor wants us to remove that! Arrrghh!
Thanks!
Susan
I understand your confusion and frustration. Speaking as an auditor, I offer many improvement possibilities to my clients. Some are verbal observations that pop up during the interviews, more significant ones are actually documented in the report.
However, as an auditor, I don't want my clients to implement every suggestion and observation I make. Soem are intended to make them think about certain problems from another angle, but only they can decide what is appropriate for their systems and needs.
Please consider the usefulness of your auditor's suggestions, but don't just blindly flip-flop, either.
R
reaganmom
Thank you both for your valuable advice!
I decided to bring the topic up with the entire Management Team during our next meeting. It's only one supervisor who asked me to go ahead and make the 2 actions separate procedures.
Since the company I work for is very small (about 20 employees) and do not have any Environment or Safety issues to date, our preventive action requests are on a much lesser scale. This is why we combined them into one procedure.
Once again, thank you so much!
Susan
I decided to bring the topic up with the entire Management Team during our next meeting. It's only one supervisor who asked me to go ahead and make the 2 actions separate procedures.
Since the company I work for is very small (about 20 employees) and do not have any Environment or Safety issues to date, our preventive action requests are on a much lesser scale. This is why we combined them into one procedure.
Once again, thank you so much!
Susan
N
nharris840
CarolX,
As a committee of one, I recommend one procedure in almost every case. The more procedures, the more cross referencing required, the less likely they will be read, understood and most important, followed. Keep them simple, complete and include flowcharts in all of them. Do the Flowchart first and eliminate the waste in the procedure/process.
Norm
As a committee of one, I recommend one procedure in almost every case. The more procedures, the more cross referencing required, the less likely they will be read, understood and most important, followed. Keep them simple, complete and include flowcharts in all of them. Do the Flowchart first and eliminate the waste in the procedure/process.
Norm
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