Preventive Action - confusing

rlangeZMC

Starting to get Involved
#1
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..."? :nope:

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. :D :thanx:
 
Elsmar Forum Sponsor

John Broomfield

Staff member
Super Moderator
#2
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..."? :nope:

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. :D :thanx:
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
 

Golfman25

Trusted Information Resource
#4
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..."? :nope:

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. :D :thanx:
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

Looking for Reality
Trusted Information Resource
#5
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.

:2cents:
 
Thread starter Similar threads Forum Replies Date
R Non conformance (NC) or Corrective & Preventive action (CAPA) CE Marking (Conformité Européene) / CB Scheme 7
C If it doesn't prevent a non-conformance, is it a preventive action? IATF 16949 - Automotive Quality Systems Standard 13
R Evaluating the need for preventive action Preventive Action and Continuous Improvement 3
B Stakeholder Initiated Corrective and Preventive Action Misc. Quality Assurance and Business Systems Related Topics 5
B Corrective and Preventive Action (CAPA) A Key Process of the Quality Management System Dec 17... Training - Internal, External, Online and Distance Learning 0
M Training in 8D Problem Solving as a Preventive Action? Problem Solving, Root Cause Fault and Failure Analysis 9
J If Corrective and Preventive Action were truly Effective IATF 16949 - Automotive Quality Systems Standard 3
Q Preventive Action - How to call the prevention when there is not a clause ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
somashekar The Preventive Action Demystified ISO 13485:2016 - Medical Device Quality Management Systems 8
Q Evaluating Effectiveness of a Preventive Action after Closure Preventive Action and Continuous Improvement 7
A Preventive Action and Risk Assessment Audit Process Audits and Layered Process Audits 5
K CAPA (Corrective and Preventive Action) - ISO 13485 Nonconformance and Corrective Action 1
J Software and Methods for Tracking CAPA (Corrective and Preventive Action) items US Food and Drug Administration (FDA) 3
A Preventive Action or Corrective Action - Paper cuts Nonconformance and Corrective Action 14
M Corrective and Preventive Action - Prevent Recurrence is not Preventive Action? Nonconformance and Corrective Action 24
K Definition Correction, Corrective Action and Preventive Action - Definition of terms Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 28
F Software recommendations for corrective and preventive action Quality Assurance and Compliance Software Tools and Solutions 2
K Corrective and preventive action for Non Conformance on PFMEA FMEA and Control Plans 30
B Struggling With Writing PA (Preventive Action) Procedure Preventive Action and Continuous Improvement 11
E Can anyone share a Preventive Action Form or Template ? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
W Compliance to 8.5.2 Corrective action 8.5.3 Preventive action ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
P Customer Complaint Preventive Action Assistance Preventive Action and Continuous Improvement 3
T Corrective Action and Preventive Action in a Holding Company Nonconformance and Corrective Action 6
M What is Preventive Action taken as part of a Corrective Action? Nonconformance and Corrective Action 5
MarilynJ6354 Definition Improvement Suggestion vs. Preventive Action - Clear Definitions and Differences Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 6
C The prudence of combining non-conformance reports with corrective/preventive action Nonconformance and Corrective Action 10
N Corrective and Preventive Action in 8D Problem Solving Nonconformance and Corrective Action 21
B Near Miss = Preventive Action Request (PAR)? Miscellaneous Environmental Standards and EMS Related Discussions 1
M Boosting a Preventive Action System Quality Manager and Management Related Issues 2
D CAPA (Corrective and Preventive Action) Flow Chart example wanted Preventive Action and Continuous Improvement 3
J Can Corrective Action be the same as Preventive Action? Nonconformance and Corrective Action 33
sagai Preventive Action vs. Corrective Action as defined by 21CFR820 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
R Does FDA require monitoring competitor device failures for preventive action? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
C Nonconformance, Corrective and Preventive Action Procedure(s)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
Q Recommendations for criteria on creating a CAPA (Corrective and Preventive Action) ISO 13485:2016 - Medical Device Quality Management Systems 8
L How to deal with too many CARs (Corrective Action Requests), PARs (Preventive Action) Nonconformance and Corrective Action 25
B Certification Body insist on evidence of Preventive Action during Stage 2 audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
P Lessons Learned Identification - Potential Preventive Action Responsibilities Preventive Action and Continuous Improvement 4
N Combining both Corrective Action and Preventive action procedures into one SOP Nonconformance and Corrective Action 4
T Action plan: How to manage actions, preventive actions and opportunities of improv? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
sagai Should Corrective Action be segregated from Preventive Action? ISO 13485:2016 - Medical Device Quality Management Systems 10
B Electronic Corrective/Preventive Action Report for our Customer Service Department Nonconformance and Corrective Action 9
B Corrective and Preventive Action Procedure for Customer Service Nonconformance and Corrective Action 5
Q Recover a Damaged CAPA (Corrective and Preventive Action) Project Preventive Action and Continuous Improvement 6
P FDA Part 820 Clause 820.100 Corrective and Preventive Action 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Preventive Action Process question - ISO 9001 Clause 8.5.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
C Corrective Action and Preventive Action for Operator Error (Cosmetic - Handling) Preventive Action and Continuous Improvement 15
6 Preventive Action - Help Needed. Input for Training and Sustenance Preventive Action and Continuous Improvement 3
L Non Conformity (Nonconformance) Report & Preventive Action Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
A SFI x PA (Suggestion for Improvement x Preventive Action) How to register them ? Preventive Action and Continuous Improvement 4

Similar threads

Top Bottom