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Preventive action regarding incorrectly filled records?

REcords preventative action corrective action audit SQF

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#1 cmarchand

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Posted 21 October 2014 - 03:39 PM

Hi,

During our SQF certification audit, we had a minor on records, because some of the records were filled out incorrectly (scribbles and no initial, that kind of ''usual" things). 

We retrained everybody and explained how to correctly fill records and this was my action plan for the non conformance but the auditor came back asking how we were going to prevent this from re-occurring....

What am I supposed to answer on this? Has anybody found a way to prevent human mistakes and prevent people to NOT follow procedures ? I'd like to know what the magic recipe is, please share...

Thank you very much for any and every comment

 

Carole

 


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#2 Mr. Incognito

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Posted 21 October 2014 - 03:45 PM

Carole,

 

I've had a heck of a time working on this... I've got a good feeling we are going to have more issues with it as well.

 

We've tried having other operators verify the form... but they weren't even verifying it correctly.  I bring it up at food safety team meetings, make copies for one of the managers in charge of the operators to discuss it with them, we've written up a few of them... nothing really has worked 100%. 

 

However we can show that it's getting better.  I don't know how far that'll get us but it's all we've got.  You can try to address it with a verification signature / date that one of the on shift operators verifies that the other person filled it out fully and correctly that way there is another set of eyes on the form but it may not work... it's hard to get these guys to fill everything out sometimes.


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#3 cmarchand

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Posted 21 October 2014 - 03:52 PM

Mr. I,

 

Totally agree with you, but I wonder if even doing this will please the auditor ? He considers our action a CORRECTIVE action not a PREVENTIVE one.... a check done by somebody else remains a corrective action, doesn't it ?


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#4 NicoleHowell

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Posted 21 October 2014 - 03:56 PM

Do you have QA checks throughout the process?  I have used my QA to check and make sure that the paperwork is being filled out correctly on a schedule so that no one leaves for the day without having their paperwork verified.  Will something like that work for your process?


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#5 Setanta

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Posted 21 October 2014 - 04:05 PM

If the group in question is small enough, could you do training and provide a quiz to show that they know how to correctly fill the forms out?


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#6 fgjuadi

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Posted 21 October 2014 - 04:20 PM

corerctive action = what you do to fix the problem

preventative action = what you do to stop the problem from happening

 

Let's be frank - it probably isn't training.  You employees probably know how to fill out the form.  They probably do not want to be bad employees.  So why aren't they filling out the form? Maybe they're too busy, maybe equipment is missing.  Maybe you have to stand on the floor & watch the employees for a while before you can see the root cause.

 

So maybe you can translate the form to their language.  Maybe you can move the form closer to the point the check is being performed (or maybe it's too high / far away).  Maybe you can introduce a procedure to physically stop the line until the check is completed.  Maybe their chemicals aren't being filled every shift.  Maybe they ran out of forms and can't find new ones.   Maybe the pens are locked up & only day shift can get them and they hide them.  Etc.

 

They will make mistakes - just teach them to cross them out with a single line instead of a scribble.

 

If you know it will not affect business or it's a food safety record, you can put product without correct documentation on hold - depending on the paperwork in question, you can't release without it being correct, etc. 


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#7 Mike Green

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Posted 21 October 2014 - 05:20 PM

Hi,

During our SQF certification audit, we had a minor on records, because some of the records were filled out incorrectly (scribbles and no initial, that kind of ''usual" things). 

We retrained everybody and explained how to correctly fill records and this was my action plan for the non conformance but the auditor came back asking how we were going to prevent this from re-occurring....

What am I supposed to answer on this? Has anybody found a way to prevent human mistakes and prevent people to NOT follow procedures ? I'd like to know what the magic recipe is, please share...

Thank you very much for any and every comment

 

Carole

 Maybe a drastic action for 'a minor'  (but if you really want it resolved with a preventative action)..... how about linking it  to the operators pay! -if you a generous company -a small additional payment for correctly filled in forms- or if you are not so generous...... a deduction in pay/bonus for incorrect forms!!!   :rofl2:

 

 

Mike


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I may sound like a complete idiot...but actually there are a couple of bits missing

#8 cmarchand

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Posted 21 October 2014 - 05:26 PM

Thank you for all the comments.

My current issue is the auditor is not satisfied with the corrective action being to re-train personnel on how to properly fill records. What kind of preventive measure can I put in place to prevent them from scribbling on them or not initialing ?


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#9 Mr. Incognito

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Posted 21 October 2014 - 05:35 PM

Mr. I,

 

Totally agree with you, but I wonder if even doing this will please the auditor ? He considers our action a CORRECTIVE action not a PREVENTIVE one.... a check done by somebody else remains a corrective action, doesn't it ?

 

Well... I think I would argue that the training is a corrective action - trying to correct the problem and having a verification signature is a preventative action - someone real time that can see there is a problem and have it taken care of immediately.  "Hey Johnny I noticed you forgot to initial that you performed this CCP check and you know Mr. Incognito just talked to us about this a few days ago at our last training."

 

I don't know if that is the right way to do it but honestly, being frank, some of the paperwork I've put out is IDIOT proof and they still screw it up.  I even defined what verification was ON THE FORM and they were signing it while vital information was missing... What else can I do other than pray some of them get fired.


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#10 it_rains_inside

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Posted 21 October 2014 - 06:33 PM

I had a problem similar to this with one of our corrective actions. Not necessarily records, but .... similar. 

 

The corrective action was lack of adherence to procedure ( =  HUMAN ERROR )

The preventative action was training AND education. We tried to submit with just training and it was rejected. This does not fix the problem just shows them what was done wrong. Educating the staff and raising awareness as to why it was a problem and/or what problems it could lead to fulfilled the preventative measure portion. 

 

I do agree with Magenta, it probably wouldn't hurt to spend some time looking into WHY they were being filled out incorrectly (not enough time, too hurried, no pens) and if you come up with nothing - then like Mr. I said

 

I don't know if that is the right way to do it but honestly, being frank, some of the paperwork I've put out is IDIOT proof and they still screw it up.  I even defined what verification was ON THE FORM and they were signing it while vital information was missing... What else can I do other than pray some of them get fired.

You can't fix stupid. You aren't alone though - I'd venture to say that a lot of manufacturing facilities have a hard time with record completion, because some people just dont care about their work, and you can't fix that.


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#11 Mr. Incognito

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Posted 21 October 2014 - 06:58 PM

A long time ago at a position in a factory far far away... (kinda)

 

Before I ever worked in a GFSI facility we used to send paperwork back to the operators via their supervisor to have them fill out things they missed or forgot to fill out... back then we didn't know that was bad!  Ignorance was bliss back then.  All our paperwork was perfect unless there was an actual documented CCP deviation (too long between checks) then we held the product and had it passed back through the metal detector.

 

Now, knowing better, I see this problem all too often and some of the people don't seem to understand why I can't let them do that anymore even though I've trained it to death that if you didn't write something down you didn't do it...


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#12 Snookie

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Posted 21 October 2014 - 08:22 PM

This is one of those constant challenges that will drive you to drink, which surprisingly doesn't make the problem better.  I have often training and monitoring for consistency. 


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#13 clbernard

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Posted 22 October 2014 - 06:27 PM

Carole

 

You have some good input on this discussion, I would like to add, involve your employees in the root cause analysis to find why their paperwork has mistakes, but be sure to do it following formal root cause or problem solving analysis techniques or they will not give good input.  Some additional thoughts for tools would also include a pre-filled form to check against with notes that scribbles, or whatever are not acceptable, or perhaps go electronic with drop-down selections where possible.


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#14 nd01ken

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Posted 22 October 2014 - 06:41 PM

What was suggested to me by an auditor is to create a signature sheet with their name typed and then have them print, sign and initial the sheet as they would when when required to. Keep the sheet and update as needed as new associates join the team. this solution helps to Identify the associate with the bad handwriting.


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#15 srose

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Posted 22 October 2014 - 06:56 PM

I agree with Magenta - perform a root cause analysis. Only after identifying and fixing the root cause of the problem can you correct the issue.

 

Performing a root cause analysis will also allow you to objectively find out the source of the problem and facilitate documentation of your corrective action.


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#16 avy100

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Posted 23 October 2014 - 09:04 PM

I agree that a root cause analysis needs to be performed here to truly fix the problem.

Perhaps the issue could be the form itself; too much data to fill in. We have had cases where we had to revise our forms and replace some of the fill in spaces with checkboxes to make the data entry easier for our operators, the downside is that some operators were now checking boxes blindly whether it was applicable or not.

We also have the supervisors review and sign off the forms on a daily basis and that helps to curb the improper completion of records.

The actions to be taken to correct and prevent recurrence depends on the root cause.


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#17 sbailey

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Posted 24 October 2014 - 03:46 PM

Hi All,

 

This appears to be an issue across the board. I've tried retraining, submitting to the Dept Mgr and returning for correction. Of course, then you run the risk of the record not returning at all. All employees have been trained to death on proper documentation and all records are reviewed by the shift Supervisor prior to my verification. Let's face it, it starts at the top. If the employees can't be bothered and there are no repercussions the job won't get done. My next step will be a formal CAR to the Management questioning their committment to ensuring all documentation relevant to the production is completed properly and accounted for. This is more to cover my butt for the Auditors but it's as far as I can go.


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#18 keithdd

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Posted 27 October 2014 - 02:25 PM

The answer is there already, have QA as a final check of processing documentation and link your product approval process to this. Wrong documentation from production means wrong product...in that way "potential" problems with documentation will be eliminated.

 

Regards, 

 

Keith.


Edited by keithdd, 27 October 2014 - 02:26 PM.

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#19 SriramB

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Posted 28 October 2014 - 09:43 PM

Hi Carole,

 

Firstly, once you have already had an issue categorized as non - conforming, to your stated food safety management systems requirement, everything you can undertake to correct the issue, or prevent it from re occuring would be "Corrective actions"

 

The initial ( first )Training could be thought of as "Preventive action" as it would be aimed at  prevention of the issue happening in the first instance. But,  as in your case, the issue did occur, we can surmise that "Training" might not be the silver bullet "preventive action"

 

Re Training would therefore be only seen as a weak "Corrective action" ( in the absence of any new validation/information); and your auditor would be rightly skeptical of its potency.

 

Now to determine if we can have a preventive action arising from this whole episode, we should try to understand what the underlying factors are via RCA, KT etc. Once we are able to define the real cause , there can potentially be an opportunity to think of preventive actions...

 

My 2 cents worth please...

 

Cheers


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#20 ncorliss

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Posted 04 November 2014 - 09:12 PM

Is there opportunity to shift much of the documentation to digital format to save some of the legibility issues?


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#21 MWidra

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Posted 05 November 2014 - 09:01 PM

In a previous job/life I was a safety officer and manager for a GLP laboratory.  The recordkeeping requirements are pretty much the same.

 

We did all the training, and reminders when the paperwork was not done right.  That's corrective actions.

 

We also made little cards that the techs put up at their lab benches that had all the proper abbreviations for corrections.  That was a preventative action.  You could make cards, laminate them, that had all the problems that you normally see.  Then you could distribute them for the workers to keep as a reference.  You can also put up posters in the work stations that remind workers of the proper way to fill out the problematic areas.  I would think that could be considered preventative actions as well, because it will be a way to help the workers do the task correctly in the first place.

 

Just my $0.02 worth.

 

Martha


Edited by MWidra, 05 November 2014 - 09:02 PM.

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#22 LoredanaM

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Posted 05 November 2014 - 09:35 PM

This is an issue for me too. After refresher trainings in regards to proper documentation, properly filled out and so forth, I still receive for verification incomplete forms, wrongly filled out. Unfortunately, in my case, the supervisors are the ones that are filling out the forms ... and every month, every day, they are reminded it has to be done correctly!

My next approach to this situation is to have the employees involved in a mock recall, traceability exercise - my "way" of trying to show them the "importance" of filling out properly the information.

 

In regards to create forms on the computer - it all depends on the skills of employees in working with the computer (sadly for me they are not "quite" there yet!)

 

While I understand the auditor point of view, it is a daunting task for anyone involved in food safety chain.

 

 

Preventive measures: refresher trainings - do not wait for things to happen and react to it; designate certain employees to fill out the forms (if they do not do it properly in a set time replace them) ... this are just my suggestions.


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#23 mdean1124

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Posted 18 November 2014 - 02:43 PM

Carole,

 

Try using the Human Error Assessment Tool (HEAT) system... 

 

I'm incorporating it into a procedure for my supervisors to use in solving human errors.  It comes from a now-defunct company called Talsico that was based in NJ.  I don't know who to credit it to other than that. 

 

Regards,

Mike

 

 

LEARNING GAP

Employee does not know or does not understand; no training or ineffective training.

ROOT CAUSE

CORRECTIVE ACTION

c Employee did not have prerequisite qualifications

Provide employee remedial training in prerequisites or reassign employee.

c Employee not trained and qualified on task

Reassign employee until trained.  Improve job specifications for task to include the training and qualification missed. 

c First time employee performed task

Improve training to include "team paired" qualification with skill check for first performances.

c Employee did not perform task as trained

Reassign employee until retrained and re-qualified with skill check. 

c Employee did not understand results of deviation from correct procedure

Improve training to include "scenario" to show results of deviation.

c Training was ineffective

 

Review and improve skill checks to show training is effective.

     

 

 

 

DECISION ERROR

Employee made wrong decision or responded with inappropriate behavior or insufficient understanding of result.

ROOT CAUSE

CORRECTIVE ACTION

c Situation not covered in procedure or training, incorrect logic used

 

Improve training to include the situation.

c Employee forced to make a decision without supervision input

Improve training to include "scenario" to show variations.  Create a "decision tree" or "flow chart" for decision making; with feedback channels and embed it in the procedure.

c Situation unclear as to "normal operation" or "troubleshooting"

Improve training to segregate "normal operation" from "troubleshooting" in the task/procedure.

c  Employee failed to make decision based on dilution of responsibility or blind eye ("not my job")

Improve training to include "scenario" for elevation of decision in chain of command.

c Employee did not understand results of decision or failure to make to decision

Improve training to include "scenario" to show results of failure to make decision.  Change balance of results.  Clarify expectations. 

     

 

 

 

MEMORY GAP

Employee trained, but failed to remember - unable to use skill or knowledge as required (e.g. change in a step/order forgotten).

ROOT CAUSE

CORRECTIVE ACTION

c Extended time since employee last performed task

Improve training and qualification schedule to reduce extended time between task performances.

c Employee forgot or skipped task steps that are regularly performed without error

Improve work area to reduce interruptions.  Confirm working environment is suitable.  Create "error-proof" solution (task can only be performed one way).

c No "job aids" or "visual controls" available

Create "job aids" or "visual controls" to support recognition of tasks.  Confirm they are readily available and changes highlighted. 

     

 

 

 

 

APPLICATION ERROR

Employee knew, but applied incorrect action or information (e.g. slips, wrong outcomes, transcription errors, mistakes).

ROOT CAUSE

CORRECTIVE ACTION

c Several tasks involved simultaneously, i.e. too many things happening at once

 

Reduce or balance cognitive load.   Re-order or re-assign tasks. 

c Not enough resources or incorrect resources to perform task

 

Perform resource gap analysis and confirm employee has the resources to do the task.  Confirm correct items are at hand each time before task begins (e.g. check list). 

c Environment disorganized

Improve organization and structure the environment to the task. 

c Health or fitness issues involved

Confirm employee is physically fit for the task.

c Data input or design of documentation

Error-proof the input system to prevent mistakes.

c Design of equipment

Error-proof the equipment and usage steps.  Upgrade equipment.

c Employee knew the task, but applied the incorrect action/steps (e.g. perceived a color check incorrectly)

Provide symbols/signs/color standards/written descriptions in documentation and job aids. 

     

 

 

 

ATTENTION GAP

Employee believed they did task correctly, but end result was variable or not desired outcome.

ROOT CAUSE

CORRECTIVE ACTION

c Employee relied on "recall" rather than "recognition" 

 

Provide recognition aids rather than relying on recall (e.g. use colors/sounds/symbols/signs).  Prevent interference with operators. 

c Distractions or disruptions present caused "recognition" failure.

 

Improve work area by minimizing distractions and disruptions.  Isolate or rotate the task.   

c Competing priorities caused loss of focus 

Separate in-order tasks of a similar nature and of similar priority.

     

 

 

 

 

OMISSION ERROR

Employee knew, but forgot.  Employee missed or did not verify the steps/actions or used wrong item (e.g. left a field blank).

ROOT CAUSE

CORRECTIVE ACTION

c  Employee had no double check of activity/information/results

 

Improve task an "over check" system.  Have a second qualified person verify the activity/information/results.

c  Distractions or disruptions present in schedule (break, shift change, holiday) caused failure

Improve task with "attention activators" (e.g. job aids, checklists, colored labels/highlighting, auditory/visual alerts, symbols, signs, form design).  Activators must be appropriate in strength, number, and location. 

c  Not enough time in schedule to complete the task

 

Restructure or reschedule the type of task to fit time requirements.

c  Employee perceived higher pressure than normal or concern due to unusual circumstance

 

Reduce pressure (e.g. restructure task with more personnel or other resources).

c  Items required to complete task not available

 

Improve task with pre-work check list for required items.

     

 

 

 

PROCEDURAL ERROR

Ineffective Documentation (e.g. batch records, procedures, job aids).

ROOT CAUSE

CORRECTIVE ACTION

c Documentation not same as actual practice or unclear to employee

 

Improve document to reflect actual practice.  Clarify practices used.

c  Documentation missing step(s) or step(s) out of order

 

Improve document to capture missing steps or reorder steps to reflect actual practice.

c No "job aids" or "attention activators" available

Create a job aid with pictures to accompany the document, or include pictures or "attention activator symbols" in the procedure.

c Terminology of task unclear to employee

Improve document with help and input of end-user employee(s) to confirm clarity of terms.  

c Order of action unclear to employee

Improve document with help and input of end-user employee(s) to confirm clarity of order. 

 


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#24 MWidra

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Posted 18 November 2014 - 03:04 PM

This is fantastic.  We have a lot of workers for whom English is not their first language, so knowing if they really understand the totality of their training is a challenge.  This does a good job of identifying the different root causes and correcting them. 

 

Thanks!

 

Martha


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#25 Snookie

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Posted 18 November 2014 - 05:26 PM

mdean1124  :welcome:   What a wonderful first post!


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