Documenting Historical Preventive Action at a Daycare

F

FrameReader

#1
Hi Everyone,

This post is rather long so I thank in advance anybody willing to take a look at this.

I'm hoping to get some insights/comments you might have about Preventive Action, specifically whether it is appropriate to document Preventive Action that was undertaken long before the company sought ISO certification, or if the company should only document Preventive Action that has been undertaken since they began to seek ISO certification.

For example, suppose that a daycare has been operating for 20 years, and they are only now seeking to be certified to the Standard. Supposing that before they opened their doors 20 year ago, they realized that stairs could be dangerous for toddlers, so they installed safety gates near their stairs - 20 years ago.

Now suppose the same daycare is now seeking ISO certification. One (obvious) customer 'requirement' would be for the parents' kids to be returned to safely at the end of the day. This, of course, was always a 'requirement', only now that they're seeking ISO certification, the daycare has formally defined it as such. And the safety gate was always a 'Preventive Action' that had been taken, only now that they're seeking ISO certification, it is only now that they formally define it as such - or do they?

So the daycare had this 'preventive action' in place. And, let's suppose the daycare had also already taken 300 other preventive actions (plugs in the electrical receptacles, emergency contact numbers posted on the fridge, first aid kits on hand, etc). Now that they are seeking ISO certification, should they document the fact that the safety gate (and all the other safety things) were installed a long time ago? Or would that not be appropriate since the safety gate, etc., had been installed prior to seeking ISO certification?

And supposing that going through the ISO process made the daycare really think hard about Preventive Action, which led them to decide to have an epinephrine pen on hand in case a kid suffers an allergic reaction to peanut butter or a bee sting or whatever. Would it be appropriate to only document the epinephrine pen as a corrective action, since that was the only corrective action to have been implemented since the daycare began to seek compliance to the Standard?

And going back to the already-installed safety features, like the safety gate, would the idea be to document (as Preventive Action) things like - checking that the safety gate is still attached securely, they've ensured that the elctrical plugs haven't been pulled out of the sockets, that a bunch of clutter hasn't been posted over the emergency contact numbers on the fridge/bulletin board, things like that?

Any thoughts would be greatly appreciated.

Thank you!
 
Elsmar Forum Sponsor

BradM

Staff member
Admin
#2
Re: Documenting Preventive Action

Hi there!!:bigwave:

Generally when I think of preventive action, it's action involved with an identified failure. Something failed or was deficient. We fix it. And to assure that never happens again, we initiate preventive action.

So I'm not sure you ever had an identified failure, so I don't know why you would want to write all the things up as a preventive action.

However, I (as a parent talking) would be keenly interested in knowing what that facility has done, above and beyond the law, to go out of the way for my child's safety and security. So, maybe I would document all those things as a marketing document or something. Be able to demonstrate how proactive you are on keeping kids safe.
 

Paul Simpson

Trusted Information Resource
#3
Re: Documenting Preventive Action

Hi Everyone,

This post is rather long so I thank in advance anybody willing to take a look at this.

I'm hoping to get some insights/comments you might have about Preventive Action, specifically whether it is appropriate to document Preventive Action that was undertaken long before the company sought ISO certification, or if the company should only document Preventive Action that has been undertaken since they began to seek ISO certification.
Phew. What a great second post. Firstly there is no benefit in rewriting history so IMHO there is no benefit in 'documenting' what was done in the past. That said it is always worth keeping these examples as to what you understand Preventive Action (PA) to be and what the organization has done in the past. More later ...

For example, suppose that a daycare has been operating for 20 years, and they are only now seeking to be certified to the Standard. Supposing that before they opened their doors 20 year ago, they realized that stairs could be dangerous for toddlers, so they installed safety gates near their stairs - 20 years ago.

Now suppose the same daycare is now seeking ISO certification. One (obvious) customer 'requirement' would be for the parents' kids to be returned to safely at the end of the day. This, of course, was always a 'requirement', only now that they're seeking ISO certification, the daycare has formally defined it as such. And the safety gate was always a 'Preventive Action' that had been taken, only now that they're seeking ISO certification, it is only now that they formally define it as such - or do they?

So the daycare had this 'preventive action' in place. And, let's suppose the daycare had also already taken 300 other preventive actions (plugs in the electrical receptacles, emergency contact numbers posted on the fridge, first aid kits on hand, etc). Now that they are seeking ISO certification, should they document the fact that the safety gate (and all the other safety things) were installed a long time ago? Or would that not be appropriate since the safety gate, etc., had been installed prior to seeking ISO certification?

And supposing that going through the ISO process made the daycare really think hard about Preventive Action, which led them to decide to have an epinephrine pen on hand in case a kid suffers an allergic reaction to peanut butter or a bee sting or whatever. Would it be appropriate to only document the epinephrine pen as a corrective action, since that was the only corrective action to have been implemented since the daycare began to seek compliance to the Standard?
Again - keep the 'old' ideas as examples of current practice for preventive action. These are things that are currently in place and working and continue to prevent harm to the children.

The thought process you have described (for the epi pen for example) is the current process and should be covered a) by a documented procedure and b) recorded as evidence of the procedure in operation - but bear in mind this could be a simple action tracking log, purchase order and then physical evidence the epi pen is in place.

And going back to the already-installed safety features, like the safety gate, would the idea be to document (as Preventive Action) things like - checking that the safety gate is still attached securely, they've ensured that the elctrical plugs haven't been pulled out of the sockets, that a bunch of clutter hasn't been posted over the emergency contact numbers on the fridge/bulletin board, things like that?

Any thoughts would be greatly appreciated.

Thank you!
Exactly - Any monitoring of current condition (housekeeping, stair gates, epi pen etc. then counts as ongoing PA.
 

SteelMaiden

Super Moderator
Super Moderator
#4
Re: Documenting Preventive Action

IMHO, documenting something that you identified as a potential problem, and fixed, 20 years ago is not a valid preventive action because it is now an implemented process. Nor do I agree that the monitoring of said gates are a new preventive action. This is preventive maintenance, again an already established process that is used to ensure that the gates are working, and in place.:2cents:
 

Paul Simpson

Trusted Information Resource
#5
Re: Documenting Preventive Action

Hi there!!:bigwave:

Generally when I think of preventive action, it's action involved with an identified failure. Something failed or was deficient. We fix it. And to assure that never happens again, we initiate preventive action.
Where is the 'high horse' emoticon when you need it? :) Please excuse me, Brad, if this comes over as preachy but this is such a common misconception.

By definition if an incident has already occurred you cannot take preventive action. All you can do is take action to prevent recurrence (all part of corrective action). Some see this as a bit of semantics but you have to go back to the origins of QA and the emphasis on planning as a core element of PDCA. This planning and anticipating problems before they occur is preventive action and exactly what the OP is trying to capture. The problem of understanding is exacerbated by ISO lumping a before the event improvement activity (preventive action) with an after the event activity (corrective action) - and worse still they put PA (8.5.3) after CA (8.5.2) - where is the logic there? I am one of a few here lobbying ISO to put 8.5.3 in with quality planning (5.4).

BTW preventive action is another clause that is generally not well implemented. Many organizations do not capture their planning activities in documented procedures.

So I'm not sure you ever had an identified failure, so I don't know why you would want to write all the things up as a preventive action.
Agreed - as I mentioned - no benefit in going back in time.


However, I (as a parent talking) would be keenly interested in knowing what that facility has done, above and beyond the law, to go out of the way for my child's safety and security. So, maybe I would document all those things as a marketing document or something. Be able to demonstrate how proactive you are on keeping kids safe.
Some good advice in marketing your preventive approach.
 

BradM

Staff member
Admin
#6
Re: Documenting Preventive Action

By definition if an incident has already occurred you cannot take preventive action. All you can do is take action to prevent recurrence (all part of corrective action). Some see this as a bit of semantics but you have to go back to the origins of QA and the emphasis on planning as a core element of PDCA. This planning and anticipating problems before they occur is preventive action and exactly what the OP is trying to capture. The problem of understanding is exacerbated by ISO lumping a before the event improvement activity (preventive action) with an after the event activity (corrective action) - and worse still they put PA (8.5.3) after CA (8.5.2) - where is the logic there? I am one of a few here lobbying ISO to put 8.5.3 in with quality planning (5.4).

BTW preventive action is another clause that is generally not well implemented. Many organizations do not capture their planning activities in documented procedures.
Some good points made. The activities need to be documented. I just don't tend to see them as PA within a QMS; as you're not really preventing anything. :D

Although to your point, they could be construed as preventing a safety issue maybe.

To me, this daycare is primarily concerned with presenting a good image to their clients. If I walked in and saw a bunch of stuff written up as Preventive Action, I might tend to think you've had a lot of problems, and you're having to compensate for them.

However, if all those activities are written up and called "Proactive Safety Improvements" or something else catchy, I can see that this daycare seems to have an eye for improvement and true care for the kids.

I certainly am not the auditor involved with this QMS implementation, and the one that is involved may recommend it being documented as such. But I don't see any value in writing them up as such in this case.

QMS systems need to be kept simple and effective.
:2cents:
 

Paul Simpson

Trusted Information Resource
#7
Re: Documenting Preventive Action

<snip>Nor do I agree that the monitoring of said gates are a new preventive action. This is preventive maintenance, again an already established process that is used to ensure that the gates are working, and in place.:2cents:<snip>
I'd agree that monitoring of stair gates and the like is preventive maintenance - a classic form of preventive action along with training in my book.

So what we have here is a couple of business processes that satisfy a number of requirements of the standard.
  • Preventive maintenance - Infrastructure (6.3), Work Environment (6.4), Control of production (7.5.1) and Preventive Action (8.5.3)
  • Training - competence (6.2.2), Preventive Action (8.5.3)
You can also add 4.1.c about controlled conditions for processes and you may even cover some of the other standard requirements for processes where specialist training is provided.
 

Paul Simpson

Trusted Information Resource
#8
Re: Documenting Preventive Action

Some good points made. The activities need to be documented. I just don't tend to see them as PA within a QMS; as you're not really preventing anything. :D
Thanks, Brad. I am happy to just disagree on this one. My take on this and I believe the approach of the OP is that a fundamental measure of the quality of the daycare service is that you look after the customer supplied product (7.5.4, :D) and ensure it gets home safe. Anything you put in place to do that is PA. I accept there is a bit of a crossover with Health & Safety / OSHA requirements but IMHO this is acceptable. Personally I can't think of another 'quality' requirement you could apply PA to. Anyone else?
 

bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
#9
Re: Documenting Preventive Action

By definition if an incident has already occurred you cannot take preventive action. All you can do is take action to prevent recurrence (all part of corrective action). Some see this as a bit of semantics but you have to go back to the origins of QA and the emphasis on planning as a core element of PDCA. This planning and anticipating problems before they occur is preventive action and exactly what the OP is trying to capture. The problem of understanding is exacerbated by ISO lumping a before the event improvement activity (preventive action) with an after the event activity (corrective action) - and worse still they put PA (8.5.3) after CA (8.5.2) - where is the logic there? I am one of a few here lobbying ISO to put 8.5.3 in with quality planning (5.4).
That would be pretty interesting, because once you are past your advance quality planning and started production, there would never be any new preventive actions. You could pretty much wrap that up, walk away from it, and everything from then on is corrective. So, basically everything in the initial FMEA is preventive, after production start, any improvement is corrective.

Fact is, the semantics are wearing. Fix things that break, apply lessons learned...expect that you can not predict every possible thing that can go wrong....because it has not happened yet. What real difference does it make what "bucket" you put it in? None....none at all. Only to those that have to follow a rote path to an international standard.
 

BradM

Staff member
Admin
#10
Re: Documenting Preventive Action

Thanks, Brad. I am happy to just disagree on this one. My take on this and I believe the approach of the OP is that a fundamental measure of the quality of the daycare service is that you look after the customer supplied product (7.5.4, :D) and ensure it gets home safe. Anything you put in place to do that is PA. I accept there is a bit of a crossover with Health & Safety / OSHA requirements but IMHO this is acceptable. Personally I can't think of another 'quality' requirement you could apply PA to. Anyone else?
:agree1:

Again... good points made, here. I think there is merit in your philosophy here; so we are probably closer than you might think. I would just approach it differently; that's all.

But hopefully we can both agree that it is nice to see someone like our OP interested in their QMS, and having an eye towards such things like this. With someone this keen on the subject, they have a great chance of having an excellent QMS that will bring their organization and their customers, value.:)
 
Thread starter Similar threads Forum Replies Date
S Documenting Design Verification Test Results (ISO 9001) Design and Development of Products and Processes 1
adir88 Documenting Risk Control Option Analysis ISO 14971 - Medical Device Risk Management 4
M Defining and Documenting Record Retention CE Marking (Conformité Européene) / CB Scheme 4
J Documenting a Calibration Interval Extension Calibration Frequency (Interval) 7
B Documenting hardware on Form 2 of AS9102 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
bryan willemot Documenting past problem history for fasteners for AS9100 Rev D AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
Q Documenting Customer Complaints (Records) Customer Complaints 6
R Documenting Expiration Date Extension for a specific lot ISO 13485:2016 - Medical Device Quality Management Systems 12
J ISO 13485:2016 Section 6.2 - Documenting the process for establishing competence ISO 13485:2016 - Medical Device Quality Management Systems 6
S Does IEC 62304 require documenting unresolved anomalies for all safety classes? IEC 62304 - Medical Device Software Life Cycle Processes 4
C Documenting Cleaning Production Lines in Medical Device Pkg facility ISO 13485:2016 - Medical Device Quality Management Systems 1
C Documenting Cleaning Production Lines in Medical Device Pkg facility 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
C Documenting Cleaning Production Lines in Medical Device Pkg facility 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
L Problems while documenting the SOUPs used for the software we are developing IEC 62304 - Medical Device Software Life Cycle Processes 4
R Documenting Self-Training and Effectiveness - ISO 13485:2016 Training - Internal, External, Online and Distance Learning 4
C Documenting Software Safety Classifications IEC 62304 - Medical Device Software Life Cycle Processes 4
B Approaches to Documenting an ISO 22000 FSMA Food Safety - ISO 22000, HACCP (21 CFR 120) 3
G Process for Product Safety - Ideas for Documenting Process for 4.4.1.2 IATF 16949 - Automotive Quality Systems Standard 3
dubrizo Are you documenting Internal Audit findings as NCRs? Internal Auditing 18
M What is the value of documenting in-process rework for easily-detectable issues? Quality Manager and Management Related Issues 4
R What is the typical industry standard for documenting Usability Risk? Human Factors and Ergonomics in Engineering 16
C Importance of Documenting NCP's and CA/PA's ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
D Documenting Meetings through Meeting Minutes or a Form ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Colin Objectives Form - Format for Documenting Information Security Objectives IEC 27001 - Information Security Management Systems (ISMS) 2
O Documenting Processes requiring Customer Notification Misc. Quality Assurance and Business Systems Related Topics 2
M Documenting Vendor (Supplier) Issues Document Control Systems, Procedures, Forms and Templates 4
V Documenting Exceptions and use of Deviation Request Form APQP and PPAP 2
K AS9100 Clause 7.2.2 - Documenting "Special Requirements" and risks AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
K Competence, Training and Awareness - Documenting Training and Confidentiality Aspects ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
Q Documenting the Review of Adverse Effects from Rework ISO 13485:2016 - Medical Device Quality Management Systems 4
A Formal Way for Documenting Design Input Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A Documenting 5S Guidelines in the Sales Department (Office 5S) Quality Tools, Improvement and Analysis 4
C Training Planning - Using Summary Sheet for Documenting Training Activities Training - Internal, External, Online and Distance Learning 3
J Requirements for Documenting Lifetime of a Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 5
A Best Practice for Documenting Design Reviews 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
N Documenting Medical Device Complaints 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
R Documenting Quality Inspections - Material Released prior to Lot Acceptance Quality Manager and Management Related Issues 10
V Documenting the Root Causes for Internal Audit Non-Conformance Findings Problem Solving, Root Cause Fault and Failure Analysis 5
V Approach towards defining/documenting Requirements COTS vs. New-Product Software Quality Assurance 1
Crusader New Documenting Methods for Manufacturing Process Audits? Process Audits and Layered Process Audits 9
M Documenting an outsourced process - Distribution company with some manufacturing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
P Process Map vs. User Guide - Documenting business procedures Process Maps, Process Mapping and Turtle Diagrams 3
T Documenting Effectiveness of Corrective/Preventive Action Nonconformance and Corrective Action 8
M Customer Format - Documenting Customer Software Requirement Specification and DDD Software Quality Assurance 10
D Documenting Machine Shop In-Process Checks Records and Data - Quality, Legal and Other Evidence 9
Crusader Continuous Improvements - How are you documenting them? Preventive Action and Continuous Improvement 66
R Documenting Processes such as Receiving Inspection, and Auditing to Turtle Diagrams Process Maps, Process Mapping and Turtle Diagrams 20
Gert Sorensen Requirement for specified agendas and meeting minutes when documenting projects? Document Control Systems, Procedures, Forms and Templates 2
A Submit a 510(k) to an existing device vs. Just Documenting a Change ISO 13485:2016 - Medical Device Quality Management Systems 2
D Documenting Revision History - Single ?Revision Record? Document Document Control Systems, Procedures, Forms and Templates 4
Similar threads


















































Top Bottom