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Difference between 2.4.6 NC Equipment & 11.2.9 Maintenance?


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fsweet

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Posted 21 December 2016 - 05:44 PM

Hello! I've stumbled upon another confusing aspect, in which I keep confusing myself further, therefore I need your help. I've scoured this awesome website to try to find answers on related topics, but I haven't found what I was looking for. 

 

Alright, so I understand (or maybe I don't :helpplease:) 2.4.6 as far as non-conforming product or equipment and using a hold tag / hold log, determining disposition...etc.  What I am confused about is 11.2.9 Maintenance records. My understand of maintenance and preventive maintenance is: Maintenance - if the sealer on the machine isn't working correctly, so they will stop production and get it fixed asap. Preventive Maintenance - the heating elements on the sealer needs to be replaced annually, so we schedule it to be replaced.  

 

So would the maintenance example fall under 2.4.6 and need a hold tag OR do I need to create a work order sheet under the maintenance and use that? Also, how would I verify maintenance records if I infact do not need a "work order" sheet under 11.2.9? Would I just use the Hold Tag, listed under 2.4.6 to verify maintenance for equipment? I'm trying to create the verification / validation schedule and I'm having trouble figuring out what I need to list. 



Tporter

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Posted 21 December 2016 - 07:24 PM

Great questions! As always, the exact solutions will depend on your process, risk factor, industry specific requirements, etc. I can give examples of how these elements were addressed when I worked in a confectionery company and hopefully this will help.

 

For 11.2.9, we created written Maintenance Activity Requests for both scheduled maintenance and any equipment breakdowns. These MARs were tracked and filed in a binder when completed. The form included a description of the equipment, the problem (or scheduled maintenance to be performed), description of corrective action taken and date, etc.

 

For 2.4.6, we had a separate Non-Conformance form that was used to document any equipment or product non-conformances, outside of the realm of typical mechanical failures. For example, metal shavings found by the metal detector traced back to metal on metal contact on bucket elevator in a form-fill machine, high Coliform testing results traced to a degraded seal in a CIP system, etc. These non-conformances were tracked separately from the MARs and had more detailed information that included root-cause analysis, corrective actions, preventive actions, product affected and disposition, etc. 



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fsweet

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Posted 21 December 2016 - 07:50 PM

We're a low risk facility - dry beverage blends (no allergens) for distributers. 

 

Well that makes sense. Thank you for the explanation! Should I note in the 2.4.6 SOP that equipment non-conformances are not defined as typical machine failures / errors? Another question just so I understand- Say we have a weight checker mounted on one machine, but it's broken, so we bring in another weight checker and place it on a table on the side to use. Where would this need to be notated / recorded? Because technically the broke weigher is mounted to the machine, so would that mean the whole machine has to be shut down or would we be able to use the machine and just use the side weigher? 



RMAV

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Posted 21 December 2016 - 08:19 PM

I see your original post as a both.  In your example, if your weigher is down and your line is down I don't see a hold tag being needed (for a temporary condition while actively working to fix it).  If you move a temporary weigher one into place, you would tag the weigher that is down and track in your hold program and probably your maintenance program as well.



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Tporter

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Posted 21 December 2016 - 09:12 PM

We're a low risk facility - dry beverage blends (no allergens) for distributers. 

 

Well that makes sense. Thank you for the explanation! Should I note in the 2.4.6 SOP that equipment non-conformances are not defined as typical machine failures / errors? Another question just so I understand- Say we have a weight checker mounted on one machine, but it's broken, so we bring in another weight checker and place it on a table on the side to use. Where would this need to be notated / recorded? Because technically the broke weigher is mounted to the machine, so would that mean the whole machine has to be shut down or would we be able to use the machine and just use the side weigher? 

 

It would be a good idea to define equipment non-conformances in your SOP to avoid confusion. 

 

For the second question, I agree with RMAV. Tracking through both the non-conformance/hold program and the maintenance program would work. You could note on the non-conformance that the second scale was used as a temporary correction and close it out when the equipment scale is fixed.



charbear

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Posted 23 March 2017 - 01:18 PM

I too am confused about 2.4.6. This is for a food contact packaging plant and I'm wondering how detailed this should be. Our maintenance sheets are considered PM"s (preventative maintenance) but contain information such as the equipment that needs repair, why the pm is being submitted along with the date it was submitted, and the corrective action and date the action took place and the article was deemed ready for use. Is this sufficient? When it comes to non-conforming product do we need to list the truckline/customer making the return, the reason for the return along with the date of the return? Does this need to be performed weekly, or monthly? Any help would be appreciated! 



Tony-C

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Posted 24 March 2017 - 11:25 AM

2.4.6 relates to how you manage faulty equipment. 11.2.9 relates to how you manage the repair of faulty equipment. See below:

 

 

2.4.6 Non-conforming Product or Equipment
2.4.6 Implementation Guidance  
This element also includes how the supplier deals with non-conforming equipment.

What do I have to do?
The supplier must also document a procedure for equipment that has been found to be non-conforming. 
This procedure may be combined with, or separate from, that for non-conforming product. 
The equipment must be identified and placed out of production until it is repaired or otherwise disposed of.
The means of identification of non-conforming product and equipment must be communicated to relevant staff. 
This can be a system of tags, signs, designated storage locations, system holds or other methods that meet the intent of this section. 
The supplier is required to keep all records of the disposition of non-conforming product and equipment including product that is reworked, repackaged, condemned and/or disposed of.

11.2.9 Premises and Equipment Maintenance 
ii. Failures of plant and equipment shall be documented, reviewed and their repair incorporated into the maintenance control schedule;

 

Kind regards,

 

Tony






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