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#1 Wowie

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Posted 17 March 2016 - 01:26 PM

Good Morning Folks (or afternoon, evening, etc  :hypocrite: ),

 

I've recently come to a small company as the only meat production facility. So, I'm kind of out here on my own little island.

 

Without completely taking away from the current set up of things, I've found a lot of ways paperwork can be reduced and documents can be improved. I'm working on that now (so this is the first of many questions to come, I'm sure). I'm currently working on the GMP audit format. I've mostly kept their item list, but made it more concise and removed some oddball items (like that smocks, aprons, trousers and shirts worn on the production floor can't be worn outside  :giggle: ). They had a few items that were highlighted in red on the form and listed as CRITICAL. I have previously used a few different systems for designating issues that may potentially, or may have already, resulted in food product issues. However, items like the cleanliness and condition of walls had this designation. I've never seen an area or item to be audited given that type of designation on a GMP audit form prior to an issue being identified. In the instance pointed out, flaking paint at the floor level on a wall would be noted, but with no product reconditioning program, it would hardly constitute a CRITICAL exclamation. It made me pretty uneasy, and I removed the critical designation, opting instead to modify the GMP Auditing procedure to state that items posing an immediate threat to food safety would require immediate line stoppage and corrective action to be documented on the auditing form. 

 

Sorry for the book! I have been looking at these same documents since Friday!  :silly:

 

Does anyone have any history with BRC or customers expecting to see that designation so arbitrarily? I can't find anything in previous audit findings here that would have caused such a remark on the form.


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#2 RMAV

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Posted 17 March 2016 - 03:21 PM

I would be interested in the history (good job researching previous audits) of why they designated the cleanliness of the wall as critical.  As a general practice, I am very slow to make changes when I do not know why it was put into place.  That said, the critical you mention is probably overkill as a dirty wall is not likely to directly contaminate product (product contamination is a "critical" as I define it but you can never go wrong adopting the language of your standard, such as BRC). 


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#3 Wowie

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Posted 17 March 2016 - 03:30 PM

I would be interested in the history (good job researching previous audits) of why they designated the cleanliness of the wall as critical.  As a general practice, I am very slow to make changes when I do not know why it was put into place.  That said, the critical you mention is probably overkill as a dirty wall is not likely to directly contaminate product (product contamination is a "critical" as I define it but you can never go wrong adopting the language of your standard, such as BRC). 

 

 

I agree with product contamination being deemed critical, which is why it made me so uneasy having it plastered on several item points on the GMP form. In addition to walls, ceilings, structural supports, and evidence of pest activity all had CRITICAL (exactly that way) on the form. In my simple mind, these are items which may create a critical condition, if severe enough. If product contamination is not reasonably likely to be a result of these issues currently, then I would balk at having it automatically designated that way. 

 

They have not had a QA Manager here for well over a year, but nobody else can seem to give an explanation as to why it was that way, aside from "Probably because it could have created an issue." The Supervisor has been here for over 10 years and cannot recall an audit finding or foreign material issue that would give any meaning to it.


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#4 Simon

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Posted 17 March 2016 - 06:57 PM

It's all about risk assessment Wowie...the old likelihood x severity.  It takes the subjectivity out of it.  Of course arriving at the decision on L and S can be subjective in itself and if the knowledge isn't there the result can be flawed, but at least it's a basis for challenge and discussion.


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#5 mgourley

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Posted 17 March 2016 - 09:50 PM

Maybe I am in the minority, but I have been around long enough to make my own determination as to what is or is not critical.

Obviously, some situation directly above or in very close proximity to a product zone should be immediately corrected. Of course evidence of pests as well.

Is the flaking paint, debris or dirt on the wall a direct threat to the the product? 

 

Then again, and maybe I am wrong here, but I do not have an audit checklist when I do my inspections. If I had never audited a food facility before, I might find a generic checklist helpful. But there is absolutely no way I could ever come up with an all inclusive checklist.

Auditors, when walking around a facility to not have checklists. They rely on their experience and observational skills to look at things and when something strikes them as odd, they look deeper.

 

This is not to say that you should not have some generic list that says "look here, look there", but if you are having people doing audits that have to be told to do that, I would respectfully submit that you have the wrong people doing the audits.

 

There is much to be said for a blank piece of paper an a pen.

 

Marshall


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#6 Wowie

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Posted 17 March 2016 - 10:24 PM

Then again, and maybe I am wrong here, but I do not have an audit checklist when I do my inspections. If I had never audited a food facility before, I might find a generic checklist helpful. But there is absolutely no way I could ever come up with an all inclusive checklist.
Auditors, when walking around a facility to not have checklists. They rely on their experience and observational skills to look at things and when something strikes them as odd, they look deeper.
 
This is not to say that you should not have some generic list that says "look here, look there", but if you are having people doing audits that have to be told to do that, I would respectfully submit that you have the wrong people doing the audits.
 
There is much to be said for a blank piece of paper an a pen.
 
Marshall


Actually - I agree! I was very frustrated with the checklist. First, items were very specific and written to include so many things that it immediately yielded two questions:

1- Is that really what we are doing? (In the case of not wearing your shirts and trousers outside, as well as things " All equipment and containers covered and sanitary" for the grounds portion of the audit.)

And

2) If we're only observing what is listed, what is being missed?

I made it more generic to say things like "Walls and structural support". They also had a scoring system, which was odd in and of itself. 10, 7, 5, 3, 0. 10 being acceptable, 3-7 being Needs Improvement, and 0 being unacceptable. Very odd to me

What I found was that a certain customer (the main one) likes to see lists, but clarified with others in the business group that it didn't have to be a list that hindered the program.

I hope that makes sense, but I am very open to any additional comments, questions, and opinions! I actually have seen several comments from you on these forums and I think we come from a similar way of thinking.
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#7 mgourley

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Posted 17 March 2016 - 11:10 PM

I do my inspections, and then funnel them into a summary sheet that has some specificity, which is then graphed for trends.

But the observations are the observations. They are, by design, not checklists.

Reality trumps pre-designed checklists. Checklists, at least for GMP audits, can never assume a tick box for all possible observations.

 

Marshall


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#8 mgourley

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Posted 17 March 2016 - 11:26 PM

For example: Three bolts on the inside of Mixer 3 cover were non-ferrous.

This was transferred to the audit report under "Equipment - Equipment is designed to prevent food safety hazards.

Obviously, ferrous bolts are not appropriate, thus got a low score and a work order submission to swap out with stainless steel

 

Marshall


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#9 Wowie

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Posted 18 March 2016 - 12:47 PM

I do my inspections, and then funnel them into a summary sheet that has some specificity, which is then graphed for trends.

But the observations are the observations. They are, by design, not checklists.

Reality trumps pre-designed checklists. Checklists, at least for GMP audits, can never assume a tick box for all possible observations.

 

Marshall

 

 

That is how I've always done it in the past. My forms have always been relatively blank with just each area spelled out. Any observed issues were noted and communicated, with verification of completion all on the same original form. I've gotten as close to that as the Food Safety Team here is willing to take it. (Ex: on the facility portion it's broken down into areas, then has general items to observe. For example, the Processing Area has 1) Equipment 2) Walls and structural supports 3) Floors)

 

It's still a work in progress, and perhaps we'll get more to used to. I think the upcoming third party and customer audits will allow for some more discussion and resolution in this area.

 

Until then, I've found that it's my second week here, and no internal audits of any sorts have been performed since July. :helpplease: That is taking precedence over making further changes to the format at this point. I need a stiff drink.


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#10 mgourley

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Posted 18 March 2016 - 01:18 PM

Well, given that no audits have been done since July, it does not much matter what the format looks like, does it?  :shades:

 

Marshall


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#11 RMAV

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Posted 18 March 2016 - 01:40 PM

I do my inspections, and then funnel them into a summary sheet that has some specificity, which is then graphed for trends.

But the observations are the observations. They are, by design, not checklists.

Reality trumps pre-designed checklists. Checklists, at least for GMP audits, can never assume a tick box for all possible observations.

 

Marshall

That's what I did, and that is a very good point, Marshall.  My predecessor tried to do the all-inclusive checklist.  The person spent a full week each month doing inspections.  At the end, the inspection reports were so difficult to read, "non-conformances" so numerous, severity unknown, it took too long for managers to figure out what to correct. 


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#12 Charles.C

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Posted 18 March 2016 - 02:54 PM

(slightly OT from the OP)

 

IMO the audit procedure is dictated somewhat by its specific objective, eg client-driven vs private standard.

 

Regardless, IMEX it is always useful to do a first cursory walk-through the whole plant just to get an impression of the general layout and then recycle  to concentrate on details. Not always an auditee-appreciated technique of course.

 

I have always used a (generic/customised), one page, supplementary checklist which contains items which (based on Regulatory / Experience) I consider potential Critical/Serious(GMP/HACCP) requirements plus a few Major. (Not to claim that no factories succeed in exhibiting significant defects outside-the-box).

 

Reasons -

 

(1) hopefully prevents serious omissions from the auditor's side ( process complexity can vary enormously).

(2) the list provides a convenient "comment-jotting" form.

(3) IMEX factory QA's tend to be more "interactive" on seeing a documented audit approach. And also appreciate blank freebies.

 

However it is unarguable that the choice of Critical/Serious etc can be subjective. Auditing has an intuitive component IMO.

 

PS - @Wowie - I didn't think there were many purely GMP audits anymore ?  IMO "Critical" defects need to be placed in context, ie Critical based on what criteria ? Nonetheless there are GMP-based defects which are routinely considered "Critical"  IMEX, eg an unsafe Process Water Supply.


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#13 mgourley

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Posted 18 March 2016 - 08:27 PM

Charles,

 

I think what Wowie is talking about and what I AM talking about are internal facility walkthroughs. These are done on a schedule (in my case, I divide up the facility into four sections and do one section per week so that the entire facility is done once per month).

These audits look for NC's in GMP's, Equipment, Security, Structures, Hygiene, Pest Control, etc. 

 

So they are not strictly a GMP audit.

 

Marshall


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#14 Charles.C

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Posted 18 March 2016 - 11:03 PM

Hi Marshall,

 

I guess it really was OT. :smile:

 

For want of an "internal"   .........

 

To briefly answer the OP -

 

I suggest that for the previous QA Mngr, there may well have been a good reason why the CRITICAL items were so marked. Possibly of such a heinous nature as to have occasioned a unilateral agreement for expungement  from records / memories. One might say CRITICAL by default.

 

I suggest that a meaningful interpretation of CRITICAL resides in the possession of context, eg as compared to, say, Serious/Major/Minor/Whatever. IMEX, as used in a Scoring/Decision format, it typically equates to Totally Unacceptable/Unforgivable, ie audit  :thumbdown: .  It would be sufficient to request/justify an immediate cessation of XYZ (eg see my previous Post).

 

PS - I would be cautious regarding Supervisors'  memories of  past events. Maybe try some of the workers in a suitably relaxed environment..

 

"Arbitrarily"  is a somewhat contentious term.  Unvalidated is perhaps less overtly disagreeable. And Yes, many Times, many Places, many Arguments.


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#15 Wowie

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Posted 18 March 2016 - 11:28 PM

PS - @Wowie - I didn't think there were many purely GMP audits anymore ? IMO "Critical" defects need to be placed in context, ie Critical based on what criteria ? Nonetheless there are GMP-based defects which are routinely considered "Critical" IMEX, eg an unsafe Process Water Supply.


You're correct, (as you and Marshall have discussed now), this us really covering facilities, personnel hygiene practices, equipment, etc. Sorry for the nomenclature confusion!
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#16 mgourley

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Posted 19 March 2016 - 02:00 AM

Charles and Wowie..

 

I would guess that the previous person or two (or three) simply had no clue, or did not want to take the time to change things. 

 

Marshall


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#17 Tony-C

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Posted 19 March 2016 - 03:18 AM

Charles,

 

I think what Wowie is talking about and what I AM talking about are internal facility walkthroughs. These are done on a schedule (in my case, I divide up the facility into four sections and do one section per week so that the entire facility is done once per month).

These audits look for NC's in GMP's, Equipment, Security, Structures, Hygiene, Pest Control, etc. 

 

So they are not strictly a GMP audit.

 

Marshall

 

So you saying you do GMP audits as well?

 

The original post was regarding GMP audits, I see no reason why someone shouldn't use a checklist, in fact I would think most people do. There should also be space on the form to make additional observations. I also think that checklists help if with consistency if you have a team of auditors, if you are doing all the audits yourself then that isn't a consideration.

 

Clearly whether a wall is clean or not is not a critical item, a glass gauge in an open product area yes.

 

I personally like to use a scoring system and use that for trend analysis. (BRC - Inspection records can provide useful information to identify trends and drive improvements through, for example, the use of scored inspection results). Items that keep cropping up would also be identified.

 

I like to do periodic 'walk throughs' as well and for that I wouldn't feel the need for a checklist.

 

Kind regards,

 

Tony


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#18 Charles.C

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Posted 19 March 2016 - 03:26 AM

Hi Tony,

 

I once audited a factory (not an "internal") where the paint on the wall was visibly flaking off near a Processing Table.

 

I oscillated between Se/Cr and eventually put 0.5Cr with a mental reservation as to it's upgradeability based on subsequent data. A chlorine injector which had run out of supply sealed the fate.

 

Perhaps it depends on what one means by "clean" and the average condition of  the OP's facility


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Charles.C






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