20 replies to this topic

[Cthulhu]

Hello all, I'm sure the struggle is a normal one but it is grinding me down a bit and some of the burden is a moral dilemma (to me at least). I was hired in late February as a QA and FS Manager because this is a burgeoning(should be) company. I am the only person here with any Quality background. This is new to me, I'm not going to lie. I've been in QA/QC as a tech, lead and a microbiologist for 7+years before I found this position. I have never been in a position to start/write all these prerequisites/HAACP so this is all new to me. I'm obviously over my head a bit but I also know I am more than capable of doing this. Since late February I've got the documentation of all everything this entails laid out. I have written over 100 SOPs, about 50 forms created, and all the HACCP plans/Prerequisites. I have been fighting to actually start all this paperwork and to get these programs validated. Anyways, my issue is that the owner and the production manager do not want to run our smaller volume products through our only metal detector(gravity feed) because it would take far too much time to clean and changeover the line for the product, so they just seal the product off to the side. They either can't afford or won't spend the money for another metal detector. I mentioned what happens during an audit if they ask to see our batch records for said product and we have no paperwork showing that the metal detection is being done. Their response was that they'll just write in the records like its being done. I'm 110% against this, obviously. I know falsification of documents happen, hell when I was a production operator for a plastic factory, I would fake a small test here and there when I was super busy. But, this is different. I want nothing to do with this but I need a job and out here there just are not that many jobs that isn't physical labor. Also, this job is a great resume builder if I can follow through on this certification and have it completed, because if there are jobs that come up like this, I don't have the resume currently to really compete. I feel I got really lucky snagging this job, well I felt lucky, now not really sure. I'm not sure if I should even be putting this out there but whatever, we're not SQF certified yet and there is no documentation started here at this moment anyways so its not falsification.....yet.

Edited by Jacob Timperley, 29 June 2021 - 11:25 AM.

[PQAManager]

You can make the smaller things that the metal detector not being used on out of scope through the certification body.  You will still be SQF certified, but them products will not be covered under SQF.  Now for them not using a metal detector you will need a separate food safety plan for FDA and you would need to do a hazard analysis to make sure leaving the metal detector out is OK.  Do not falsify for no one.

[TaraMcKinzie]

I 100 percent agree.  Metal detection and magnet checks are two things I will not bend on.  The one time the CEO dug her heels in I made her write and sign the deviation and I made sure to note that they did not run metal detection against the advice of Quality.  I don't envy her new Quality Manager that has to explain that one if that batch record is ever pulled for an audit.  

 

You can make the smaller things that the metal detector not being used on out of scope through the certification body.  You will still be SQF certified, but them products will not be covered under SQF.  Now for them not using a metal detector you will need a separate food safety plan for FDA and you would need to do a hazard analysis to make sure leaving the metal detector out is OK.  Do not falsify for no one.

[Scampi]

Is there any way that some volume orders can be run with/after other products that have the same allergens?  Perhaps this is just about finding a way to keep production running AND use the MD

 

Offline production is always really expensive to do, so perhaps explain to them both just how much extra this is costing over a year?

 

to assist you, I'm wondering why they want to become SQF certified?  What is the motivation-----SQF isn't cheap.........

[FoodSafetyAPP]

Not good.

 

I agree - if this is definitely how it's going to be have the big boss sign confirming their decision! Also when audit day comes, or recall day comes, let them deal with it. 

 

Are they aware how expensive recalls can be? (and detrimental to rep) Maybe working out some figures would put this into perspective. 

 

I personally wouldn't think twice about whistleblowing to an external body if things don't get solved. (I just hate businesses with the custom and money who don't want to do things right)

 

I have started to realised this QC malarkey is definitely a job you do for yourself and for your career and not for the love of a business because the business care way less!

[Charles.C]

I assume you don't run the main products 24 hours a day.

 

Options

 

(1) Look for a 2nd hand MD which can take finished cartons of small volume products (SVP).

 

(2) Develop a haccp plan for SVP which does not require a MD.

 

Unless the amount of SVP is truly insignificant, yr currently proposed scheme will likely be counter-productive for yourself.

 

You can see various, analogous, dilemmas previously discussed on this Forum, the frequent consensus has been to RUN, not WALK, away.

[Cthulhu]

Is there any way that some volume orders can be run with/after other products that have the same allergens?  Perhaps this is just about finding a way to keep production running AND use the MD

 

Offline production is always really expensive to do, so perhaps explain to them both just how much extra this is costing over a year?

 

to assist you, I'm wondering why they want to become SQF certified?  What is the motivation-----SQF isn't cheap.........

 

The owner struck a deal with massive customer(think opposite of SAVECO) waiting in the wings that requires us to be SQF certified for them to sell our products. They are still mom and pop so they don't understand what they are getting themselves into. I was QA in a  P&G company before this so I have a pretty good idea on what needs to happen and the follow through by management that needs to take place. It just isn't here yet. 

[Cthulhu]

I assume you don't run the main products 24 hours a day.

 

Options

 

(1) Look for a 2nd hand MD which can take finished cartons of small volume products (SVP).

 

(2) Develop a haccp plan for SVP which does not require a MD.

 

Unless the amount of SVP is truly insignificant, yr currently proposed scheme will likely be counter-productive for yourself.

 

You can see various, analogous, dilemmas previously discussed on this Forum, the frequent consensus has been to RUN, not WALK, away.

I have brought up option 1 a few times and I get rebuffed fairly fast. I have not brought up or thought of option 2.

 

The SVP is just another flavor that is not under a big customer label that we pack on the side so they don't fall behind (I.e name brand vs our brand). Its the same process except they fill the bags by hand and just seal them and totally ignore the metal detector. My question for option 2, if its the exact same product, just garnish changes how do you justify having to use the MD on one but not the other.

[Scampi]

so if Saveco isn't one of the off line customers-------------separate flow for small volumes may just be your best plan

 

What was your determination to have the MD and is it set as a CCP?

 

Also, just because your not SQF certified doesn't mean the docs aren't technically falsified as yet (assuming you're governed by FDA or USDA both of which require a PCP)

 

I'm going to second Charles comment about RUNNING ----you're situation is not likely to improve

[TimG]

 I was QA in a  P&G company before this so I have a pretty good idea on what needs to happen and the follow through by management that needs to take place. It just isn't here yet. 

 

P&G, as in Procter and Gamble? I've had them audit me a couple times, they are pretty tight.

Back to the falsification of records thing. That's not just a violation against an SQF code, but I'm pretty sure it would also be against FDA or USDA code (sounds like you'd be under FDA). There are times I've had to bring light to FDA code violations as well as the min/max/expected fallout from those violations. Usually, showing an owner that it's not just disobeying some second parties code but breaking an actual food law with possible criminal repercussions, it helps them frame it in a more serious light.

If you go that route, be tactful but firm. And BCC any correspondence on it to your personal email address..

[Cthulhu]

so if Saveco isn't one of the off line customers-------------separate flow for small volumes may just be your best plan

 

What was your determination to have the MD and is it set as a CCP?

 

Also, just because your not SQF certified doesn't mean the docs aren't technically falsified as yet (assuming you're governed by FDA or USDA both of which require a PCP)

 

I'm going to second Charles comment about RUNNING ----you're situation is not likely to improve

 

The records are not falsified yet because they haven't used any yet!  I have nearly everything ready to implement but getting a lot of pushback because of the time/work/cost it will be adding to their business. Also the SVP we still be part of Saveco, they pack them on the side so they can keep up with demand. They only run one 8-10 hour shift daily because we're so small and the workforce is roughly 15 employees total, with us as "Sr. Management"(Owner, Production Manager, and myself are 3 of them).

[Cthulhu]

 

 I was QA in a  P&G company before this so I have a pretty good idea on what needs to happen and the follow through by management that needs to take place. It just isn't here yet. 

 

P&G, as in Procter and Gamble? I've had them audit me a couple times, they are pretty tight.

Back to the falsification of records thing. That's not just a violation against an SQF code, but I'm pretty sure it would also be against FDA or USDA code (sounds like you'd be under FDA). There are times I've had to bring light to FDA code violations as well as the min/max/expected fallout from those violations. Usually, showing an owner that it's not just disobeying some second parties code but breaking an actual food law with possible criminal repercussions, it helps them frame it in a more serious light.

If you go that route, be tactful but firm. And BCC any correspondence on it to your personal email address..

 

Yes, P&G as in Proctor & Gamble. Our QA department worked very closely with them for a few years when they acquired us in 2012. We actually earned the quality promise award from P&G during my tenure there. So the buy in has been a very stark difference from what I had experienced before.

Edited by QAFSerik, 29 June 2021 - 02:47 PM.

[Charles.C]

I have brought up option 1 a few times and I get rebuffed fairly fast. I have not brought up or thought of option 2.

 

The SVP is just another flavor that is not under a big customer label that we pack on the side so they don't fall behind (I.e name brand vs our brand). Its the same process except they fill the bags by hand and just seal them and totally ignore the metal detector. My question for option 2, if its the exact same product, just garnish changes how do you justify having to use the MD on one but not the other.

 

Hi QAFS,

 

The answer is that the necessity for a MD depends on the hazard analysis, ie the specific Process.

 

However customers/auditors rarely complain if you "choose" to use a technically "stricter" option than HACCP-necessary, eg due customer compatibility, volumes, labour  involved, etc.

 

At one time, MDs were a rarity due cost. Times change, but not always.

[Bacilus why so cereus]

You aren't the only person struggling with this kind of situation, trust me. I've stepped into a similar capacity but we are defending our certification and it's a miracle we've had the score we have for this long. 

 

I'll echo others' statements for lining up an exit plan asap. It's taken my current place of work 8 years to go from what was apparently a nightmare to simply bad, things do not change if the money continues to come in.

 

For the time being I'd try to document everything you can and present your findings to management as you see fit, however record everything you can in detail. Begin recording shift start time, timestamped daily tasks, conversations etc in a personal notebook or something if you can keep up with it. 

 

My personal strategy is trying to exert soft power by being the bridge for management and production. We have a lot of behavioural issues with food safety and I'm hoping to change things by really learning what workers need, and putting issues to management in a way they actually understand beyond it costing them hundreds of dollars. So far it's been small wins like getting a couple hundred $ in cleaning supplies, new waste containers etc that are currently designated as "for the audit", however perhaps some of our staff might take them out by accident without realising it's only for the audit 

 

I think you may need to be plain about some things to them and explain it could put your certification at risk if they fail to comply. I haven't had to pull that card yet though. Shoot me a PM sometime if you want to commiserate or swap strategies while we're in the thick of things!

[Ryan M.]

I thought SAVECO did not require SQF, but you had to use the addendum if you were SQF certified?  SAVECO has their own audit requirements and if you don't have SQF certification they will send someone to audit your facility, at your cost of course.  Check with the customer on this.  Their food safety team is actually a really good group of people.  I've contacted them on several things over the years.  Doesn't hurt to call them and ask about compliance options.  I really think they do not require SQF, but rather you meet their food safety manual requirements. 

 

FYI...they REQUIRE metal or x-ray detection, unless you have a strong case as to why it is not needed.  Their audit would be focused only on their products thought, not other items they do not purchase from you.

[Cthulhu]

I thought SAVECO did not require SQF, but you had to use the addendum if you were SQF certified?  SAVECO has their own audit requirements and if you don't have SQF certification they will send someone to audit your facility, at your cost of course.  Check with the customer on this.  Their food safety team is actually a really good group of people.  I've contacted them on several things over the years.  Doesn't hurt to call them and ask about compliance options.  I really think they do not require SQF, but rather you meet their food safety manual requirements. 

 

FYI...they REQUIRE metal or x-ray detection, unless you have a strong case as to why it is not needed.  Their audit would be focused only on their products thought, not other items they do not purchase from you.

The owners said when they hired me that they needed certification for them to be a client. They gave us till the end of the calendar year to be certified.

 

As for the SVP, it is also going to be sold to SAVECO also. The reason they have this SVP is it allows them to be flexible and change the toppings on the fly if an new order comes in. SO, if flavor B all of a sudden needs 500 packages they can swap out flavor A and produce 500 bags of flavor B. Basically our main product line is the same except for the toppings, and our production is faster than our packaging machine so when they need Flavor B they start packaging it off to the side without the MD and they continue with Flavor A. I'm trying to get them to go away from this entire process and be more proactive for sales/inventory, but I am apparently a terrible salesperson because I can't get them to budge. So I approached them to purchase a MD, if they want to continue this way. 

[Cthulhu]

Hi QAFS,

 

The answer is that the necessity for a MD depends on the hazard analysis, ie the specific Process.

 

However customers/auditors rarely complain if you "choose" to use a technically "stricter" option than HACCP-necessary, eg due customer compatibility, volumes, labour  involved, etc.

 

At one time, MDs were a rarity due cost. Times change, but not always.

I'm not going to pull any punches here, This is my first time dealing with HACCP. I was QA in Dietary supplements and even though I have taken the HACCP training course (SQF one also) when I started here, I am not confident that it has even been done correctly. I literally have no way of knowing until somebody comes in and tells me I'm an idiot   (Nobody here really has a clue either).Hence, why I mentioned that I am a little over my head. Also with 7 years of QA in the dietary supplement field there maybe some things that seems to be stricter on the production floor and the production manager is saying I'm asking for too much. I don't think I am, as I'm straight reading from audit checklists from certain customers and SQF. But, again I could totally be wrong since I am very green in the Food Sector.

Edited by QAFSerik, 30 June 2021 - 06:21 PM.

[Charles.C]

I'm not going to pull any punches here, This is my first time dealing with HACCP. I was QA in Dietary supplements and even though I have taken the HACCP training course (SQF one also) when I started here, I am not confident that it has even been done correctly. I literally have no way of knowing until somebody comes in and tells me I'm an idiot   (Nobody here really has a clue either).Hence, why I mentioned that I am a little over my head. Also with 7 years of QA in the dietary supplement field there maybe some things that seems to be stricter on the production floor and the production manager is saying I'm asking for too much. I don't think I am, as I'm straight reading from audit checklists from certain customers and SQF. But, again I could totally be wrong since I am very green in the Food Sector.

 

Hi QAFS,

 

The reality is that FS Standards/audits/auditors all have certain potential areas of flexibility/matters of opinion. This is particularly the case regarding HACCP which is intrinsically a subjective (eg Risk assessment) topic.

 

Unfortunately knowing the specific areas and degrees of flexibility often requires experience. You can rapidly get some idea by looking at certain threads on this Forum.

 

Auditors similarly often develop their own rules-of-thumb by comparing the responses/validations of different (Grade?) factories. If yr response is significantly out-of-line with other processors having similar flowcharts, an explanatory justification may be auditorially anticipated.

 

Just as an example, many, many Consultants like to use the famous Codex tree/Table to teach customers how to "find/justify" CCPs in traditional HACCP because it's relatively easy to understand and routinely apply. Consequently auditors also become familiar/comfortable  with this method when auditing haccp plans. However Codex clearly states that the method is just one tool and other solutions can be equally acceptable. I have always used an alternative Procedure which IMO is simpler/reduces the labour but also guarantees an auditorial discussion.

[Ryan M.]

Honestly, it is worth a call to the customer because it is very easy to just say "SQF certification is required" when it actuality it may not be at all.  If you DON'T need SQF certification your will save yourself A LOT of headache.

 

But, you may also need SQF for other customers down the road.  Really, it is up to you, but if I were in your position I would call the customer and ask what they really require at this time.

 

The owners said when they hired me that they needed certification for them to be a client. They gave us till the end of the calendar year to be certified.

 

As for the SVP, it is also going to be sold to SAVECO also. The reason they have this SVP is it allows them to be flexible and change the toppings on the fly if an new order comes in. SO, if flavor B all of a sudden needs 500 packages they can swap out flavor A and produce 500 bags of flavor B. Basically our main product line is the same except for the toppings, and our production is faster than our packaging machine so when they need Flavor B they start packaging it off to the side without the MD and they continue with Flavor A. I'm trying to get them to go away from this entire process and be more proactive for sales/inventory, but I am apparently a terrible salesperson because I can't get them to budge. So I approached them to purchase a MD, if they want to continue this way. 

[Cthulhu]

Hello All,

 

After a few months of even more lack of cooperation I'm thinking it's time to cut and run! After creating the environmental monitoring program they have no interest in doing it with any quality in mind. I had it as food contact surfaces as zone 1 and to be test daily and they want it lowered to one month (they prefer quarterly)at the most frequent. Zones 2 and 3 every 6 months and zone 4 yearly.

 

I have been taking finished product for micro testing randomly throughout the run and shipping it out to the lab with the last day of producing that lot. I grab roughly 1200g worth of product throughout the run( day 1 I grab a finished product and the last day i grab one and randomly through the weeks production of the lot I grab 4 other bags). They now want to grab the first 6 packages and ship it out for testing. Sometimes the results will be back before the production run is finished! We tend to run 1-2 week long lot numbers.

 

There's been a few other instances of things that have annoyed me. One of the products have been failing the free fatty acids test since before I was here. I started micro track and trending and noticed that it has always failed. I asked the owner if the customer has changed the spec or gave us a pass on it and she said she has no intention on letting them know until they find out and then she'll deal with it since free fatty acids isn't a big deal.

 

She has no intention on doing the compressed air (blows open food contact packaging) testing we need to do because the product has been fine and there hasn't been any complaints or micro failures. We still haven't updated our basic walmart scales that basically cant be calibrated.

 

We have also fallen behind due to other reasons and now we might be sending product out to be co packed at another facility and I asked if they had any intention on doing any QA at all (HACCP update and any other documentation we would need to have) and I was told that they have a clean facility and it'll be fine,

 

Am I being overly sensitive? I feel like I don't want my name attached to any of these forms or programs if its going to be ran like this. It's too bad because it is an awesome product and I want this place to succeed but I feel like it isn't worth the headache.

[Scampi]

It is a shame, but happens all the time. 

 

I think you've made the right decisions,  their kind of thinking sounds oddly similar to the peanut corporation of america disaster, and no, you don't want your name attached to that

 

It's one thing to agree to disagree on frequencies for enviro testing, it's quite another to lie by omission to your customers, that alone speaks volumes about the lack of integrity and ethics your employer has

 

Scales are actually governed by weights and measures, they protect ALL consumers from being hosed , so another strike against them

 

Basically, business' like this example are the reason we have so many rules, because people just can't be trusted

 

You'll land on your feet, that much wiser and know what to ask when being interviewed !