Preventive Action - confusing

[rlangeZMC]

I've read many posts on here about PA and how confusing it is. Some users seem to think they have it all figured out and others are just as confused as me.

I'm trying to decide when to open PAs. Do we need to open a PA for EVERY document change? We fill out a Procedural Change Authorization form any time a document needs to be updated. We used to fill out a generic PA for every PCA. I mean really, it was the SAME words just a different PA number each time. It was really silly and ridiculous to fill out PAs like that. Now that we are having our ISO 13485:2016 audit SOON, we are trying to use PAs better. Only for things that really PREVENT a problem, not EVERY single document change.

With that said, if a Preventive Action is to prevent a nonconformance, how do you know what type of document changes would have progressed to a nonconformance? Risk Assessment? Do I say "If this document wasn't updated it could have led to a nonconformance..."?

How do we define Preventive Action in this way? How does everyone else deal with document changes in terms of PAs or no PAs? I appreciate any help as I'm new to this field.

 

[John Broomfield]

I've read many posts on here about PA and how confusing it is. Some users seem to think they have it all figured out and others are just as confused as me.

I'm trying to decide when to open PAs. Do we need to open a PA for EVERY document change? We fill out a Procedural Change Authorization form any time a document needs to be updated. We used to fill out a generic PA for every PCA. I mean really, it was the SAME words just a different PA number each time. It was really silly and ridiculous to fill out PAs like that. Now that we are having our ISO 13485:2016 audit SOON, we are trying to use PAs better. Only for things that really PREVENT a problem, not EVERY single document change.

With that said, if a Preventive Action is to prevent a nonconformance, how do you know what type of document changes would have progressed to a nonconformance? Risk Assessment? Do I say "If this document wasn't updated it could have led to a nonconformance..."?

How do we define Preventive Action in this way? How does everyone else deal with document changes in terms of PAs or no PAs? I appreciate any help as I'm new to this field.

rlange,

Yes, it can be confusing. Your management system is developed, used and continually improved to prevent nonconformity while realizing opportunities.

Updating the documented parts of your management system to reflect changes to the system’s processes is an integral (normal) part of using and improving the management system so no PAR is required. In any case, the new or changed process is trialed and verified before its documented procedure is issued or updated. Some organizations use Document Change Requests for this.

Reserve PARs for invoking proactive work on the system (organization) and its management system such as may arise from risk assessments, data analysis, planning or management review. These events bring new new challenges to light for the organization and its management system.

Then, of course, your colleagues will be defining the problem to be prevented and determining the changes that need to be made to their organization and management system so it prevents the occurrence of nonconformity. They may issue a PAR or establish a project to bring about the necessary changes.

Be careful to avoid CAPA thinking that tends to use PA to prevent recurrence of nonconformity. That, of course, is corrective action that follows the correction.

Best wishes,

John

 

[gpainter]

Separate CA from PA.

 

[Golfman25]

I've read many posts on here about PA and how confusing it is. Some users seem to think they have it all figured out and others are just as confused as me.

I'm trying to decide when to open PAs. Do we need to open a PA for EVERY document change? We fill out a Procedural Change Authorization form any time a document needs to be updated. We used to fill out a generic PA for every PCA. I mean really, it was the SAME words just a different PA number each time. It was really silly and ridiculous to fill out PAs like that. Now that we are having our ISO 13485:2016 audit SOON, we are trying to use PAs better. Only for things that really PREVENT a problem, not EVERY single document change.

With that said, if a Preventive Action is to prevent a nonconformance, how do you know what type of document changes would have progressed to a nonconformance? Risk Assessment? Do I say "If this document wasn't updated it could have led to a nonconformance..."?

How do we define Preventive Action in this way? How does everyone else deal with document changes in terms of PAs or no PAs? I appreciate any help as I'm new to this field.

I would say stop over documenting things. Filling out a "form" to make a minor change to a "form" is nuts. Sometimes you just got to "get er done." Only document major things -- say over a certain dollar amount or activity level. What you call them -- preventive actions, opportunities, improvements, etc. -- is of minimal value. So don't get too caught up in that. Good luck.

 

[Ninja]

At some point you just have to draw a line...above which you document it as a PA, below which you just do it.

PA happen every day in every workplace...stuff you do to make things better/more efficient/error proofing/avoid hazards...
It simply isn't worth calling (and documenting) them all as formal PA.

Writing "Copiers" in white out on the stapler that should be kept at the copiers...seen that in every workplace I've ever been. If you wanted to, you could call this a PA...
Granted, a way weak and questionable one...given more as exaggeration to prove the rule.

Moving the water cooler away from the power strip (or vice versa).
Revising the shipping workflow to give a double check on addressee.
Installing a computerized visual system for hazard labeling.
Raising the A/C duct that people keep banging tall rolling shelves on.
Color coding the quick disconnects for air, vacuum and N2.
...its endless.
You could pretty much take everything in 5S as a PA if you wanted...

If you wanted to, you could write them all up as PA...but who would bother?

Draw a line somewhere...
Things reported to upper management, projects involving at least three people, projects that have out of pocket cost, efforts that take over a week, whatever...
Call those PA and formalize them. Take all the tiny simple ones and leave them paperwork free...

If you are in any kind of normal company, there are PA's flying all around every day...just pick the shades of grey where you put time into formalizing it.

 

[gpainter]

training, calibration are both PA.