Help answering noncompliance with regulation 416.1

Hey i am fairly new to HACCP and i recently got an NR. I know to answer it all you have to do is write down what ever you did to address the problem. I could do that i just need a little help with the vocabulary. If any one has a moment of their time and could help me out i would really appreciate it. Here is the NR i got.

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10. Description of Non Compliance

at 1230 hours the following non compliance were observed and show to Mr..., plant manager:
1)in the freezer - chunks of meat products are strewn about the floor and under the pallets which are stored along the left wall from the entrance.
2)Cardboard pieces and box tops are on the floor in the poultry cooler.
3)cardboard, papers, box straps and other debris are visible under the pallets in the front storage cooler.

the above listed items are noncompliance with regulation 416.1 which requires each official establishment to be operated and maintained to prevent the creation of unsanitary conditions.

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to address the problem what i did was

1) everything that was in the floor was picked up and the floor was cleaned and washed
2)cardboard pieces and box tops were picked up and thrown in the garbage
3)Everything in the floor was picked up from the floor and thrown in the garbage and then the floor was cleaned and washed.

Now how do i make this into an appropriate response. And what could be a further planned action for this.

any help would be appreciated.

Hi Maxspeed, Your actions so far have corrected a potentially unsafe situation, but if you have an effective Food Safety Management System in place how could that situation have occurred in the first place? I am sure the auditor will not be satisfied with your response and will be looking for preventive action. This could include reviewing, developing or improving some of the following:

- Cleaning policy
- Handling and storage procedures
- Audit procedure
- Training procedures

The idea being that this situation isn't repeated.

If you let us know why you think the situation occurred and what systems you have in place maybe we can help you further.

Regards,
Simon

Hey Simon thanks for your response.
The reason this happened was because the person that is assigned to make sure the freezer and the coolers stays clean had to take a few weeks of dew to a death in his family out of the country. So we didn't really have a chance to train anyone before he left. He is back so this won't happen again. And our is inspector is aware of this and he will accept something like what i wrote on the opening thread since he was the one who advised me on what i should write. Am just really bad with wordings and am not sure of the correct format to respond. Any help would be appreciated.

This could include reviewing, developing or improving some of the following:

- Cleaning policy

Regards,
Simon

Suplemented by a doumented cleaning procedure, cleaning record and cleaning schedule.

Regards,

Tony

this is gonna be my response. Is this good or should i add something else or write it another way. Any thoughts would be appreciated.

12. Plant Management Response (Immediate Action(s)):

The above mentioned noncompliance's were corrected as follows:

1) The chunks of meat products that were strewn about the floor and under the pallets were picked up and thrown in the garbage and the floor was washed and cleaned.
2) The cardboard pieces and box tops that were on the floor were picked up and thrown in the garbage. The floor was then cleaned and washed.
3)The cardboard,papers,box straps and other debris under the pallets were picked up and thrown in the garbage. The floor was then cleaned and washed. The old pallets were also removed and replaced with clean pallets.

13. Plant Management Response (Further Planned Action(s)):

Upper management had a meeting with the assigned employee that handles the cleaning of the cooler and freezer. The assigned employee was reminded of the importance of keeping the cooler and freezer as clean as possible to comply with regulation 416.1. The assigned employee was also retrained on the proper procedure for maintaining the cooler and freezer clean.

I hope this NR was coded under the sanitation performance standard and not sanitation SOPs. It should be an O6-D01. If not - consider asking that to be changed. Even though there was no product risk or product contact concern, I would write your response to ensure this is clear. Remember - answers to NRs become part of the public record. Write that "No product was afffected by this incident". Also - if you disagree with the description of what was observed, or if you think it makes it look worse than it was - you should clarify it. If the description is accurate - that's fine. But = if there were only 2-3 pieces of meat - indicate this in your answer as well. Otherwise - a reader would assume conditions may have been worse than they were. Your immediate corrective actions are fine. It would help to add that after cleaning it was inspected and verified as clean. The further planned action is fine as well - retraining is often an acceptable route.

Upper management had a meeting with the assigned employee that handles the cleaning of the cooler and freezer. The assigned employee was reminded of the importance of keeping the cooler and freezer as clean as possible to comply with regulation 416.1. The assigned employee was also retrained on the proper procedure for maintaining the cooler and freezer clean.

Maxspeed,

I thought you said the responsible employee was off work because of a family bereavment. Or are you saying that there was a responsible person on site but they didnt do their job properly.

I wouldn't be satisfied with the response without more meat on the preventive action to be taken. Then again I have no experience of FDA, so maybe your response is ok by them.

Simon - Just a quick note - this is not FDA - it is a USDA / FSIS issue and the way responses are done can be different between the two - although fundamental concepts about corective and preventive action still apply.

Ok thanks for the clarification Cathy. But from an auditor point of view would you be happy with the response, it doesn’t add up to me.

From an SQF standpoint - job descriptions are supposed to include how to cover for absences - and this seems to be the main failure here. Corrective action should address that point or better yet back up one step farther and determine why there was meat on the floor (etc) in the first place.

Dear All,

As suggested in the original responses, I don't see any refs to related documented procedures before or after the incident.

Surely the complaining body expect information on this ????

Rgds / Charles.C

Believe it or nor - there is no federal regulatory requirement for a documented cleaning program for non-contact areas. So - the regulatory Agency shouldn't quote or demand existing procedures. Almost all plants have these documented but it is not a regulated issue - it is only a Performance standard ...unless it deals with a product contact surface or product adulteration - for those - written programs are mandatory and must be followed to the letter.

Dear cathy,

Amazing !

Actually, complaint item (1) appeared to refer to potentially unwrapped product (?) in a freezer. Contact surface ? All depends on the process of course. The cooler (No.3) is unclear.

Rgds / Charles.C

Thank you everyone for all your help specially Cathy. I submitted the response today and my inspector said that it was good. Thank you all again

Thank you everyone for all your help specially Cathy. I submitted the response today and my inspector said that it was good. Thank you all again

You're welcome Maxspeed, any time.

Glad it went well. Be sure to complete and document your corrective and prevetive actions.

Hey i am fairly new to HACCP and i recently got an NR. I know to answer it all you have to do is write down what ever you did to address the problem. I could do that i just need a little help with the vocabulary. If any one has a moment of their time and could help me out i would really appreciate it. Here is the NR i got.

----------------------------------------------
10. Description of Non Compliance

at 1230 hours the following non compliance were observed and show to Mr..., plant manager:
1)in the freezer - chunks of meat products are strewn about the floor and under the pallets which are stored along the left wall from the entrance.
2)Cardboard pieces and box tops are on the floor in the poultry cooler.
3)cardboard, papers, box straps and other debris are visible under the pallets in the front storage cooler.

the above listed items are noncompliance with regulation 416.1 which requires each official establishment to be operated and maintained to prevent the creation of unsanitary conditions.

-----------------------------------------------

to address the problem what i did was

1) everything that was in the floor was picked up and the floor was cleaned and washed
2)cardboard pieces and box tops were picked up and thrown in the garbage
3)Everything in the floor was picked up from the floor and thrown in the garbage and then the floor was cleaned and washed.

Now how do i make this into an appropriate response. And what could be a further planned action for this.

any help would be appreciated.

What you had done is only short term solution to make a long term one, i think it should be mentioned on your GMP or any work procedure that all, food contact items should not be placed directly on the walk floor. This include packaging materials, raw materials, equipment parts and tools. A poster of materials on floor with "X" will also help your employee to recognized the instruction even if his new.

Hi Maxspeed,
As an auditor I wouldnt accept your response. Regardless of the standard applicable, even basic Codex requirements include corrective actions which include longer term actions to prevent recurrence. If the root cause analysis of the issue is that the responsible staff member was absent then the appropriate preventive action would include back up plans for absence of staff such that the appropriate standard is maintained in the premises regardless of staff absenteeism.
Cheers,
Margaret.

Hey i am fairly new to HACCP and i recently got an NR. I know to answer it all you have to do is write down what ever you did to address the problem. I could do that i just need a little help with the vocabulary. If any one has a moment of their time and could help me out i would really appreciate it. Here is the NR i got.

----------------------------------------------
10. Description of Non Compliance

at 1230 hours the following non compliance were observed and show to Mr..., plant manager:
1)in the freezer - chunks of meat products are strewn about the floor and under the pallets which are stored along the left wall from the entrance.
2)Cardboard pieces and box tops are on the floor in the poultry cooler.
3)cardboard, papers, box straps and other debris are visible under the pallets in the front storage cooler.

the above listed items are noncompliance with regulation 416.1 which requires each official establishment to be operated and maintained to prevent the creation of unsanitary conditions.

-----------------------------------------------

to address the problem what i did was

1) everything that was in the floor was picked up and the floor was cleaned and washed
2)cardboard pieces and box tops were picked up and thrown in the garbage
3)Everything in the floor was picked up from the floor and thrown in the garbage and then the floor was cleaned and washed.

Now how do i make this into an appropriate response. And what could be a further planned action for this.

any help would be appreciated.

Hi there Maxspeed.

I think you need to have a better plan to prevent the non-compliance in your report.

1) need to do a pre-op of freezers before / or after shift to ensure temps, sanitary conditions, ice buiid up...
2) Address why the employees didn't react, and waited for someone to tell them to do it... which is training and communication and recognition of crtical controls (HACCP)

Keep the dialogue open with your Auditors,, they should help out