Struggling With Writing PA (Preventive Action) Procedure

[BubbaDog56]

I am trying to write a PA procedure that meets the requirements of ISO 9001:2008 6.5.3 a-e, and reflects our actual environment. Virtually all of our PAs are currently based on daily business processes such as:

- Preventive maintenance
- Calibration
- Design review/FMEA
- Disaster planning
- Various standing meetings reviewing design status, production planning, sales forecasting, etc.

These are all items that we can show records and evidence for, but it seems like the standard still looks towards a 'fill out a PA form' mentality. The minimalistic procedure I have fleshed out is below, trying to stay flexible and reflect our actual business practices. Feedback and inputs are greatly appreciated, I have a serious case of writer's block right now, and have registrars arriving for an initial doc review and gap analysis within a few days....

Procedure -

6.1 Preventive actions may be initiated and implemented via a number of sources, including but not limited to:

- Ongoing established business processes
- Departmental initiatives
- Analysis of data
- Customer feedback
- Employee suggestions

6.2 Potential preventive actions shall be reviewed for validity and appropriateness of taking action. This may include the perceived severity of the problem, cost versus return on investment, timeframe to implement, and/or other factors.

6.3 Records of preventive actions and their results shall be kept. Records may include, but are not limited to:

- Reports
- Logs
- Records
- Meeting Minutes
- Task Lists

6.5 Preventive actions taken shall be reviewed to determine effectivity. This may be demonstrated by, but not limited to:

- Examination of objective evidence & records
- Monitoring of processes
- Ongoing meeting minutes and/or task lists

 

[John Broomfield]

I am trying to write a PA procedure that meets the requirements of ISO 9001:2008 8.5.3 a-e, and reflects our actual environment. Virtually all of our PAs are currently based on daily business processes such as:

- Preventive maintenance
- Calibration
- Design review/FMEA
- Disaster planning
- Various standing meetings reviewing design status, production planning, sales forecasting, etc.

These are all items that we can show records and evidence for, but it seems like the standard still looks towards a 'fill out a PA form' mentality. The minimalistic procedure I have fleshed out is below, trying to stay flexible and reflect our actual business practices. Feedback and inputs are greatly appreciated, I have a serious case of writer's block right now, and have registrars arriving for an initial doc review and gap analysis within a few days....

Procedure -

6.1 Preventive actions may be initiated and implemented via a number of sources, including but not limited to:

- Ongoing established business processes
- Departmental initiatives
- Analysis of data
- Customer feedback
- Employee suggestions

6.2 Potential preventive actions shall be reviewed for validity and appropriateness of taking action. This may include the perceived severity of the problem, cost versus return on investment, timeframe to implement, and/or other factors.

6.3 Records of preventive actions and their results shall be kept. Records may include, but are not limited to:

- Reports
- Logs
- Records
- Meeting Minutes
- Task Lists

6.5 Preventive actions taken shall be reviewed to determine effectivity. This may be demonstrated by, but not limited to:

- Examination of objective evidence & records
- Monitoring of processes
- Ongoing meeting minutes and/or task lists

BubbaDog,

I suggest you adapt your CAR form to work as a PAR form to define the problem to be solved, record the root causes and verify their removal from your system. Better than scattering your records far and wide.

PARs coming out of management reviews can be a lot more effective than minutes of meeting. Likewise with the setting of new quality objectives so your system is changed to be assured they will be fulfilled.

John

 

[BubbaDog56]

John,
One of the reasons this is being written is that we are splitting our current CAPA procedure into two independent procedures. In our existing environment, they function as two completely different animals. The CA side is more cut and dried, with a electronic form-based system working well. The PA side is all based on existing business processes, not things that lend themselves to a one-size fits all form. It may not be perfect, and may change in the future, but I need to write a procedure that reflects what we do today.

 

[John Broomfield]

John,
One of the reasons this is being written is that we are splitting our current CAPA procedure into two independent procedures. In our existing environment, they function as two completely different animals. The CA side is more cut and dried, with a electronic form-based system working well. The PA side is all based on existing business processes, not things that lend themselves to a one-size fits all form. It may not be perfect, and may change in the future, but I need to write a procedure that reflects what we do today.

BubbaDog,

Agreed, I am not recommending use of the CAR procedure.

But you may want to adapt the form to work as a PAR where and when needed.

The two processss are separate anyway and it is good for your documented PA procedure to reflect what actually happens. But it probably will not capture all of the preventive actions delivered by your process-based management system.

For it to do so would be repetitive.

John

 

[harry]

................., not things that lend themselves to a one-size fits all form. ..............

I can see where you are coming from. Many of our PAs are carried out as 'projects'. We issued our standard PA form (modified from CA form as John mentioned) to enable the project to start and upon satisfactory completion of the project, attached the project report and enter it into the relevant section of the form to close the PA.

 

[insect warfare]

John,
One of the reasons this is being written is that we are splitting our current CAPA procedure into two independent procedures. In our existing environment, they function as two completely different animals. The CA side is more cut and dried, with a electronic form-based system working well. The PA side is all based on existing business processes, not things that lend themselves to a one-size fits all form. It may not be perfect, and may change in the future, but I need to write a procedure that reflects what we do today.

I remember a while back being advised to split up our combined procedure. In our case it was a good thing, because it let us see how different the preventive action process really was from the corrective action process, even though there are similar characteristics shared in both processes. While others may prefer to combine theirs in the same document, I personally found it easier to digest as a separate procedure.

I have attached a sample procedure that I came up with that may be what you're looking for. The table on page 2 will be of great importance as it allows you to list your preventive action activities (inputs and outputs). The registrar auditor we used saw this as a vast improvement over our previous iteration, and does not require us to resort to a "PA form" methodology. Let me know if this is up your alley....

Brian

 

[PaulJSmith]

We have separate procedures written for CA and PA, but we use the same form for both, with a simple check box to note which one. For us, the processes are not so different, except in how they begin.

 

[John Broomfield]

I remember a while back being advised to split up our combined procedure. In our case it was a good thing, because it let us see how different the preventive action process really was from the corrective action process, even though there are similar characteristics shared in both processes. While others may prefer to combine theirs in the same document, I personally found it easier to digest as a separate procedure.

I have attached a sample procedure that I came up with that may be what you're looking for. The table on page 2 will be of great importance as it allows you to list your preventive action activities (inputs and outputs). The registrar auditor we used saw this as a vast improvement over our previous iteration, and does not require us to resort to a "PA form" methodology. Let me know if this is up your alley....

Brian

Brian,

I like it even though it is text but it is just one page. I particularly value the table. This reminds users that most of the preventive action is coming from everyone using and improving their organization's process-based management system.

The PAR form remains useful for managing preventive action projects, driven by the desire for change and not specifically covered by the management system.

After all, unless the system is changed, a new objective may not be fulfilled.

John

 

[BubbaDog56]

I remember a while back being advised to split up our combined procedure. In our case it was a good thing, because it let us see how different the preventive action process really was from the corrective action process, even though there are similar characteristics shared in both processes. While others may prefer to combine theirs in the same document, I personally found it easier to digest as a separate procedure.

I have attached a sample procedure that I came up with that may be what you're looking for. The table on page 2 will be of great importance as it allows you to list your preventive action activities (inputs and outputs). The registrar auditor we used saw this as a vast improvement over our previous iteration, and does not require us to resort to a "PA form" methodology. Let me know if this is up your alley....

Brian

Brian,
We're on the same page, I'd created a similar matrix which also included ongoing CI efforts and standing meetings which also serve as CA/PA opportunities. I attached it as an Appendix to the procedure, and updated the procedure to indicate these were examples of existing PA efforts.

We'll see what the registrar thinks tomorrow, at least there's something there for review now....

 

[element79]

I remember a while back being advised to split up our combined procedure. In our case it was a good thing, because it let us see how different the preventive action process really was from the corrective action process, even though there are similar characteristics shared in both processes. While others may prefer to combine theirs in the same document, I personally found it easier to digest as a separate procedure.

I have attached a sample procedure that I came up with that may be what you're looking for. The table on page 2 will be of great importance as it allows you to list your preventive action activities (inputs and outputs). The registrar auditor we used saw this as a vast improvement over our previous iteration, and does not require us to resort to a "PA form" methodology. Let me know if this is up your alley....

Brian

Hi Brian,

Thanks for sharing your PA procedure. It's very straightforward and simple enough to use. I also like how the table has provided the means of verification for the resulting preventive actions.