5 Things You Should Do When Developing Your Food Safety Plan

Amanda:  Welcome, everybody, to this episode of Food Safety Chat. Today on the podcast I have got Michael Kalish and Charlie Kalish from Food Safety Guides. Welcome, guys. How are you going?

Michael:  Well, hello.

Charlie:  Hey, good to be here.

Amanda:  So today we want to get into something that it may sound a bit basic but it's an area that a lot of people do struggle with, and it's really important to make sure that you get this part right when developing your food safety plan as it informs other compliance issues around the human foods and animal foods standards.

To start off, we want to talk around these five preliminary steps of HACCP, all these requirements what we say for FSMA is going to inform how we comply with the rest of the standard.  Michael, do you want to give us a bit of an idea around what these five preliminary steps are?

Michael: Sure. Well, there are five steps, I like to group them into three things - who are you, what are you making and how do you do it? Pretty much captures those three things. So if we were to break them down individually it'd be assemble the team, describe the food and its distribution, describe the intended use and intended consumer, develop a process flow diagram and verify that flow diagram.

So there are five steps, but really you're trying to explain who are you, what are you making and how do you do it. And there are different reasons for doing that, but, Charlie, Amanda, maybe you guys can kick it off by addressing kind of what's the meaning behind these terms.

Is it mandatory by FSMA to complete the 5 preliminary steps of HACCP?

Amanda:  When we talk about assembling the food safety team, first up before we jump into that though, is it mandatory for food businesses complying with FSMA to actually do these steps?

Charlie: Well, they're explicit in the guidance and also in the PCQI training courses that the preliminary steps are regarded as optional and useful but not required. Could you draft a food safety plan without having a flow diagram? I guess it's conceivable if the FDA says so, but I wouldn't want to do that. I think that it would be very valuable to have a flow diagram whether it was required or not. Same thing would apply to having a team. And when you're getting inspected, I imagine that they're going to want to see this. Mike, would you like to elaborate on that?

Michael: I agree. You wouldn't want to build a house without a scaffolding or knowing who it is that's going to be qualified to build your house. There are all sorts of practical reasons to be able to engage first in these preliminary steps, but the regulations, whether it'd be for preventive controls for human food, animal food, intentional adulteration - they are simply not required in the regulatory text. And there's nothing in the laws also that speak to that requirement.

Amanda:  If you are requiring SQF or BRC or FSSC 22000 certification that it is mandatory that you do the five preliminary steps. But Michael, what about for traditional HACCP in the US? Is it mandatory for the juice, seafood, dairy industry to do those preliminary steps?

Michael:  No, it is not. Right now it's been a long time since I read Appendix K for dairy, but for seafood for example it's not obligatory. So seafood and juice would be the other one, and then meat and poultry I'm not familiar with it being required but certainly it would be an interest of the inspector to see it to help them understand what is going on in that facility explicitly - who they are, what they're making and how they do it.

Step 1 – Assemble the HACCP Team

Amanda:  So Charlie, you went through those five preliminary steps before, can you just expand a bit around this assemble the food safety team? So if you are complying with codex HACCP again with those GFSI standards they draw that requirement from codex HACCP that you have to assemble a food safety team. What makes a good food safety team?

Charlie:  Sure. I mean, the typical talking points for a great food safety team would be that it's cross-functional or multi-functional so that you have people representing different aspects of your business who may provide different points of view, maybe provide a different wealth of information. So, for example, it may be useful to have somebody from QA on the team because they're going to be overseeing the implementation of the food safety plan, they might be involved in doing the trainings and revisions.

But it may also be useful to include say somebody from the sales and marketing team who's deeply familiar with the customer base and what the intended use is or if there was some problem where you had to recover food they would know where the food went and they could locate it. Having somebody from management on the team is really great in order to successfully implement a HACCP plan, right? Because willpower, we all know willpower alone can't do it, right? So, it takes a culture and it takes investment from the top to really pull all this off. So, having management involved in the food safety team is really ideal.

And we could go on about more details about that, but I think that that is sort of the main talking points.

Is it mandatory for the QA department to drive the HACCP process?

Amanda:  Just on something you said then, do you think it's mandatory that the QA department drives this whole process? Is there anything written, or have you guys seen that it's not actually run by the QA department or the head of QA? Is it run by another department just because of that knowledge?

Charlie:  That's a great out-of-the-box question because I've actually never even thought of that, I always thought like for national security in the US, for example, you would want somebody from within national security to be responsible for national security issues, right? So, it's kind of like that, with HACCP you have your QA and that is right there in the scope of what they do, it's in their job definition.

But certainly, if you have somebody in another division that is really competent, that could be trusted to oversee and really implement these systems then why not, why not have it from somewhere else?

Michael:  I'd like to play devil's advocate here then, because there's something called a preventive controls qualified individual or PCQI and this person is responsible for overseeing the development and implementation of the food safety plan, the hazard-based food safety plan under the preventive controls for human food and animal food.

This person like an SQF practitioner you would expect to be somewhere in the organizational chart where the role would be significant, would be able to have an impact, and ideally from a risk management standpoint be removed from the operations team and so that they can have a voice and perspective that is not influenced by what the ops team needs to be able to get the job done that day or what the sales team needs to be able to make the number of sales they need that day.

The fact that the quality department itself is its own department and generally doesn't report to anyone responsible for operations is one of the sort of key distinguishing features, and for that reason I would say that an SQF practitioner or a preventive controls qualified individual which certainly just because all you need is training to be one of those two things it could be anywhere in the organization, but I would stress that it belongs to QA because of the kind of role that QA plays within the larger organizational structure which is to be independent, to be as free from bias as possible.

Charlie:  To Amanda's point, Michael, if I may, to Amanda's point she's saying there's nothing written that you must be. I mean, we all appear to be in agreement that it would be wisest, the most conventional choice would be somebody in QA but there's nothing that prohibits the person that's overseeing the food safety plan implementation, all that, from being in another division, right?

Can you have multiple PCQI’s allocated within a business?

Amanda:  And the reason I asked this question, just to throw a cat among the pigeons, that when I do the PCQI training, when I'm delivering that training, I have multiple people from one organization coming and doing the training. They're having several people in the organization doing the training, they don't just have the one PCQI.

've got maintenance managers, I've got laboratory managers, there's supply chain people, there's cleaners. I've had the wrath of them all within the one organization doing this particular job or being as we say a PCQI, preventive controls qualified individual. So I suppose in the context, it really comes back to what the business is and the structure of that business, because you may have a small business that only has three staff and it's the operations manager or the business director who is the PCQI, they may have somebody that helps them.

Charlie:  So the PCQI is not like by definition the person who runs the whole food safety operations, right? I mean that is just somebody who is qualified to perform certain tasks related to implementing these plans and doing verification activities and stuff like that. PCQI is not the same thing as saying director, right? Whoever it is that's responsible for making sure everybody is doing anything that they're supposed to.

I mean, there's some managerial experience and skill set that has to be there that's sort of independent of whether or not you're a PCQI. Would it be useful for that person to be a PCQI? Absolutely.

Michael:  I qualified my initial response as a devil's advocate position, but I will say that I agree, I've trained PCQI, I've trained people to understand the role and responsibility of PCQI that worked for pest control service providers. So they're not going to be developing a food safety plan, they're likely not going to be implementing any preventive controls or being engaged necessarily in any verification of these controls or validation of the plan, but it's good of them to feel informed and that's fact of being informed will allow them to participate and collaborate with other folks that are informed to execute the plan.

I think absolutely anybody can undergo the training. And the more the merrier, especially for those involved in handling the food or managing the food operational space. But ultimately, I would say that the person that fulfills the responsibilities of the PCQI or SQF practitioner should be in QA or if there is a QA department, and should be as free from influence as possible from other competing departments.

Charlie:  Agreed. And it's funny that the devil's advocate would be preaching to the choir about this, because we all agree about that. But I don't want to split hairs too much, but what ... I feel like where we're sort of going is equating the PCQI with the SQF practitioner saying this sort of one is the equivalent of the other, except an SQF system versus FDA. And the SQF practitioner, that person is more sort of like a supervisory almost position, right? Whereas, the PCQI could be just somebody who's tasked with reviewing records that might not be in a supervisory position at all.

A cross-function team is essential

Amanda:  It really comes back as I said to the individual businesses, the job descriptions of those people. But probably the key thing that we're looking is, and great point that you made, Michael, that whoever becomes the PCQI on that HACCP team or if they're a HACCP team member they have to have at least enough knowledge around the product and its distribution.

And that's cross-functional across the organization, so just because you work in production you should at least know or have some level of idea I think of around other products that's produced and where it goes even though you have your sales person and the salesperson should have enough knowledge to know, "Well, actually how is that product produced?" So, when we're talking about this cross-functional team that kind of leads us into the next preliminary step around describing the product and its distribution.

Charlie, did you have anything more you wanted to kick on that?

Charlie:  Yeah. If I could actually be the devil for a minute in the PCQI course one of the first questions we asked as instructors is like, "Which of these PCQI responsibilities do you feel comfortable performing? Which do you think you'll rely on somebody else to do for you? And which ones do you think you hope to learn over the course of the class how to do?" And then we go over review of records, drafting the food safety plan, validating controls, all this kind of stuff.

And a lot of the people in my classes say, "Oh, I'm just going to do this thing. I'm not going to do those things.": And so by being a PCQI certainly you'd be a very well-rounded PCQI if you were able to perform all the job functions of the PCQI. But is it necessary that a PCQI would be able to perform all of those by themselves?

Amanda:  Well, this is my response to that - if the regulation states this is the role of the PCQI, I'm not sure, but please correct me, does it say if you're competent to do that part or does the regulation state these are the requirements that a PCQI has to perform.

The PCQI is responsible for overseeing certain activities

Charlie:  Well, actually the fine text is really that they must do or oversee. So if they don't feel qualified to perform any of the things like for example they don't feel qualified to validate a control because they're not a scientist, they can oversee someone else to validate that control for them and then they can say, "Oh, okay, that looks good. I'll sign off on that." And they can also outsource PCQI responsibilities to people outside the company, maybe it's a laboratory, maybe it's a process authority, something like that who can sort of stand in.

So again, it would be really valuable for a PCQI to be a very well-rounded PCQI that could do all those things. If you go to some of the big leading businesses out there that are huge multi-million dollar conglomerates that have people with PhD's in food science that are PCQI's, they have really well-rounded individuals. But a lot of small businesses actually have people who are not going to be as rounded and are going to have to rely on other people or other entities that help them sort of fill gaps on the PCQI responsibilities.

Michael:  And as a devil's advocate to that, I've seen a lot of large businesses ...

Amanda:  Double devil's advocate.

Michael:  Right, it's a double.

Charlie:  Which one's the evil one?

Amanda:  That's right. So, if you don't know Michael and Charlie, they're twins, so we're getting the whole Jekyll and Hyde maybe thing, I don't know what's going on, but we're double deviling it there.

Michael:  I'll state my own position which is in my experience I've seen a lot of large businesses where they do break up the responsibilities because they can afford to have a larger more diverse team while smaller businesses may run operations entirely on their own.

Charlie and I have worked with businesses as small as one person, in that case they asked me often, "Well, what should I do? Like, if I'm monitoring who's going to verify?" And I say, "You know what? You get a mirror and you look in the mirror and you say tell that person to verify," right? Obviously, you can't have glass in the operating ... you can't have glass in the facility so it's going to have to be in the break room. But there are very small businesses ...

Amanda:  That's a dad joke.

Michael:  Yeah, they have to wear a lot of hats.

Getting outside help to perform PCQI responsibilities

Amanda:  So, is this where your business would go in and help or be that secondary person to help with that process when you've got very small business?

Michael:  We generally ... we'll avoid at all costs performing any PCQI responsibilities for a business as a consulting company, because we want them to be empowered and survive after ... like, what happens if I got hit by a bus, right? Well, Charlie will probably work with them. But what if we both get hit by a bus? You don't want to rely on anybody outside your business if you can avoid it, and so we really ... to put the pressure on, we do not offer those services. Not to mention there's a lot of liability around it.

Charlie:  Yeah, we will help a lot with drafting the food safety plan, with helping them understand how to review records and sign off for them. So I mean, we'll help in big ways. But what we try to avoid is people saying, "I want you to be the PCQI for my company. If I just pay you X amount per month will you be my PCQI?" It's hard. If we're not in the facility, we're not there, we don't know all the risks that are involved and all that stuff - it's a lot of liability.

Amanda:  So how does that extend then for ... you spoke before about other people outside the organization doing certain parts of the PCQI role, do they have that same or is this just something for you guys, do they have that same level of liability let's say if they've been brought in to validate CCP's and things like that?

Michael:  Attorneys are going to sue everyone that they can in any way who are involved in the operation. So, whether it be a consultant, a trainer, a service provider of some kind, a contractor, a part-timer, a temp worker - really anybody, everybody involved in the food business would carry some form of liability. It's really about how do you contain that liability.

For example, if you're working in a consulting capacity and you see something that you disagree with you might memorialize that in an email and send it to the person, maintain a copy of that record yourself. But there may be things where you provide consulting and then they manufacture the business and you have no insight as to how they do it, normally you manage that liability in the form of contract prior to engaging with that client.

But ultimately you do carry some liability, there is some risk that you may not be able to really effectively limit your liability. You may be on the hook some way or another, and it really is just demonstrating to the court that you have done everything in your power to behave responsibly and influence the client to make the right decisions.

What is the ‘intended use’ of your food product?

Amanda:  As the PCQI or the person on the HACCP team within the business, having an idea of what the third preliminary step is around the intended use and the consumer of the food, because this is one thing I have seen over time that sometimes that consumer changes because someone in the organization decides, "Okay, now we're going to make a gluten-free product. We've got this product, but now we're making it gluten-free."

So your consumer base is going to change but they're not informed with everything else you're doing, the business may be doing, other departments aren't told about that and that intended use, and we've seen that before in court cases around people not understanding the directions for use around what's put on the label. "I didn't know I had to cook that. I thought I could just eat it straight from the freezer."

Michael:  I've seen cases with coffee where folks didn't know or grains, people were soaking the grains overnight and sprouting them and the provider of grains thought people were just going to boil them. And so a grain which is normally in a sack in a warehouse and other times maybe an aggregator's facility in less hygienic conditions they're really depending on the consumer to heat that grain.

Consumers, like I said before, maybe a marketing manager might be more keen on the fact that consumers of their product may in fact be cold soaking overnight and sprouting their product. So, these unforeseen uses of the product ought to be considered in that preliminary HACCP step.

Amanda:  So, Charlie, as an organization how would we find out how our consumers are using our product?

How are your customers using your product?

Charlie:  I think that the biggest challenge here is when your customer is going to process your ingredient and it might be a basic ingredient that tons of processors might make into any variety of different products with any variety of different consumers, target consumers. From that point of view it's like it's kind of hard to know what ... you don't even know what products your ingredients can end up in to some extent. So that could be really hard.

But if you're a processor that's making a food and that finished product goes directly to consumers via retailer or something like that, just going to eat them, then, I mean, I think it's on you to understand consumer behaviors because it's important to your own sales of your product, how you market it. But also, I mean, you might look at leading publications or digital media related to your types of products and see what people are doing out there.

I mean, ultimately FDA or whatever agency is regulating you is going to say it's on you. If you're not aware of the consumer behaviors and somebody gets sick it's still on you, so it's up to you to do that research.

And it's funny, I've done a lot of consulting to food service and retail and there's these chefs that are just doing the most amazing creative things that are just from a food safety point of view terrifying. And they're not even trying to hide it, it's on the front page of all these trendy food magazines and stuff like, "Look what this chef is doing with their own thing that they grew on their basement or whatever." And so it's like they're not even hiding it. So you can just ... you don't even have to really look, you literally just tumble over all the stuff.

Amanda:  That's a whole another episode I think, what chefs are doing with ingredients that make food safety professionals cringe with what they're doing.

When we have a full understanding of our intended use, so how people should be using the product and who those people are, the fourth step we had was putting or developing this flow diagram. And an important second part which is something that I don't usually see is this actual description or describing each of those steps.

I've been auditing for just over 30 years, and not very often do I actually see full descriptions written for each step in the process. And that's auditing SQF, BRC and the other, GFSI standards. So what's the benefit of that, Michael, of actually going through and describing the process as opposed to just putting a nice picture of the steps joined by lines and things like that?

Supporting your flow process chart with a written process description

Michael:  Yeah, oftentimes it feels redundant but there is real value to creating what's I've heard generally called a process flow narrative. I generally like to approach it using a table format, so I can say I don't want them just to list the step and describe what's happening, I normally have a column specifically for what equipment is being used at this step. Another column for who's handling the product at this step or whether or not it's exposed or unexposed product at that step. There are folks that could create many more columns and graphs than that, but generally those are the ... that's the information that I would like to know to be fully informed on the process when I visit the facility.

I mentioned earlier the preliminary steps as being who are you, what are you making, how do you do it. So there are a number of different roles that that information would be valuable to - it would be valuable to the team making the food safety plan, that's generally how we perceive it, but then it would also be valuable for anyone that's new to your company who you need to rapidly share with who we are, what we're making and how we're doing it. And then there's inspectors and there are also auditors, these people, anybody that needs to join your facility and hit the ground running on the day one would benefit from knowing those three things.

And so, for me a process flow narrative is a great way to very quickly and conveniently share information to folks that need to hit the ground running. In the absence of a process flow narrative it can be fairly difficult to understand what the risks are to a process at first glance, especially if you're an auditor and you only have a day or two or an inspector in which case you may only have a couple of hours, maybe up to five days. Regardless, the more information the better. But I think the key is being efficient so you can get that message across quickly.

And so even though it is a narrative it shouldn't be ... it shouldn't start with it's the best of times and the worst of times and just be a ...

Amanda:  Yes.

Michael:  You know, like a (model?).

Amanda:  I think too like even just if we take an example of a step of cooking, cooking could mean so many different things. If you just have that on a flow chart, the word cooking in a box, what does it actually mean? What temperature you're cooking to? Is it a low temp cook, a high temp cook? Do they actually mean pasteurization when they talk about cooking? What's their definition of cooking and what does that look like in that particular organization?

Charlie, when people put together these flow charts do you recommend any particular software or any way to actually do that?

Software to document your flow process chart

Charlie:  The best software that I've come across has been Lucid Chart, like you see lucidly or clearly, and it's just really easy drag and drop software, very user friendly. You can easily insert your diagrams into Word Documents or Google Docs. Often at my trainings I'll actually demo it for everybody. Lucid Chart doesn't pay me for it, I don't get invited to their annual conferences or their penthouse if they have one. It's just super useful.

And other people come to me and say, "Well, I use Vizio or ..." There are other ones out there, and great, whatever works for you. But I think that it's useful to try one of those softwares rather than try to just bootstrap it in PowerPoint or Excel, it's too painful.

Amanda:  I always say to kind of mind map it out first just on a whiteboard because then you can at least erase stuff off the whiteboard or use magnet pieces where you can go, "Oh, that step actually happens there but not there," where you can actually write on the magnet and throw that up on the wall as well.

There's heaps of different softwares out there, you've just got to find one that works for you. But notwithstanding that, you can actually just write it on a bit of paper, there's no requirement to say that you have to ... it's got to be used in a particular piece of software or in Excel or Word or anything like that. That's one thing the regulation doesn't state is the format in which you have to document any of this stuff especially around the preliminary steps.

Charlie:  Yeah, and whatever format you use that you really want to be flexible because things change, you're going to be going through different iterations of it as you draft it and so the more flexible it is to changing it, modifying it - the better. And Lucid Chart's been really, really great for that for me.

One of the biggest things, problems, that I encounter when I'm teaching the five preliminary steps is people making flow ... like you got like 10 people in a room to make ... and you're all going to diagram the same process and you're going to get like 15 different flow diagram.

The importance of documenting the flow process diagram

Amanda:  And so that leads us into that fifth step which is around that verifying the flow diagram on site. If you've got 10 different people with their own opinion of what the flow actually looks like at an organization, how do we agree with what the right one is, Michael?

Michael:  Yeah, I've been in situations where I met with a couple of team members, they provided me with extremely different views as to what the process was and it blew up from a like a 9-step process to like a 45-step process. I feel like a lot of people struggle too with like how granular do you go and do you like pinch salt, lift your hand, move over to the cooking utensil, drop salt. I mean, how granular are you going? Obviously, there's a line where you cross and you've gone too far. And then there's also do you include testing, for example, and other background operations that are happening concurrently during the processing of the food?

Charlie:  Sanitation.

Michael:  Yeah.

Charlie:  Some people will include sanitation.

Michael:  Yeah, people start throwing in everything including quality steps. So I find often that it requires almost like a snake charmer or somebody to like sort of like help someone understand their dreams and talk them through and produce something lucid and linear.

Amanda:  I think, Charlie, as you were saying people putting in cleaning steps and then testing steps. I think the biggest thing that people need to remember is especially if you're doing this for GFSI or for codex HACCP whatever step you put in that process you have to perform a hazard analysis on that step.

If you put a cleaning step in every piece of equipment that you use, you have to perform the hazard analysis at that step because that's quite defined in those pieces of requirements and things like that. I suppose if we're trying to find this line in the sand, try and bring it back to what is the purpose of documenting your process in the first place and knowing what that process then goes on to inform.

Looking at FSMA, Charlie, what is the purpose of that flow chart then? We've said people get an understanding, but what is the regulatory implications moving forward to comply with? I think it's sub-part C of human foods. What happens around that?

What is the purpose of the flow process chart?

Charlie:  FSMA or the preventive controls for human food role or animal food role does not require creating a flow diagram, so they actually aren't going to address that fully. But they do recommend in the guidance in it and also FSPCA and the trainings that you cover all necessary process steps. So if you focus on the word process, you can eliminate sanitation steps and testing steps, things like that - they're not directly related to your process. And so really focus on the process of making the product - everything from receiving through shipping, from when it's under your control, including rework, recycling, things like that. FDA as well as the GFSI benchmark schemes are all explicit about that.

This is one reason why I feel like food safety, particularly the kinds of tasks you have to ... the kind of things that you have to do to draft a HACCP plan, it's more of like not knowing what to do but more of a discipline, because it's something that you refine over time, you learn what works, what doesn't, what the do's and don'ts are.

Michael:  I was going to say, Charlie, you had a client where you produced like 45 different flows, I think they're manufacturing Indian ... prepared Indian food. An additional challenge is if you have a ton of different processed flows, how can you integrate them so that you can have a single food safety plan address multiple different types of products that share at least generally or similarly enough a flow.

Charlie:  In some cases, especially the businesses that have not actually launched yet but they're planning to launch and so they need to drop their food safety plans like ahead of time and they have 40 different flows, maybe you're not really ready to do that. I mean, you can try to consolidate them as much as you can in maybe 5 flows or 10 flows or whatever, but if you're doing that many products sometimes it's like, "Well, I don't know if you have the bandwidth or the investment capability or whatever to actually pull that off." So sometimes that can also be a warning.

How many process steps actually exist within food production?

Amanda:  Talking about this holistically then, you did mention before, Charlie, that it's all around documenting the process steps. Now we know that there's only so many process steps in making something, whether it be Indian food or loaf of bread or a can of pineapple, whatever, you're going to have key process steps. So really you should be able to slot whatever you're doing, it doesn't matter how many products you're making, you should be able to slot in a step to each of those things quite easily.

I wouldn't expect that you would have let's say 40 different steps in a process. You may have doubling up a step, so you might have a storage at step one but a storage at step five and a storage at step eight and a storage at step 10 and a storage at step 43, it's still all storage when we start getting into that next phase of HACCP around the principles HACCP and what FSMA requires is doing that hazard analysis at each of those steps, you're not going to really get too many different hazards because it's still storage.

Charlie:  That's right. When you start getting into listing out your CCP's at all those storage steps it might be the same CCP.

Amanda:  So suppose a lot of people do get overwhelmed as you were saying before that when you start then throwing in all this sanitation and testing and all this other stuff that's when I think people become quite paralyzed with that entire process. Instead of just taking it back to basics, and that's something I'm very big on, I just like things to be simple, don't make it complicated.

If you had to explain to someone ‘how do I make this product,’ yes, I cook it, so this is where the process description comes in quite well. What does your cooking look like? You might have two cooking steps, one might be one type of cooking, another might be another type of cooking.

Consider investing in an external food safety consultant

Charlie:  Yeah, if this is so paralyzing it might be worth the investment to hire a consultant to help you, because how many times are you going to need to create a food safety plan? Maybe just one time for your company, just one time. You're not going to change your company very much, you're not going to change your products very much. Maybe you should hire somebody who has made all the mistakes before in the past and has learned and can help you rather than you have to go through it all yourself just for this one plan.

Amanda:  If you are struggling with getting your food safety plan and even just doing these five preliminary steps, just reach out to consultants to be able to help you with that process. That's really important, especially for people who are just starting out or they've just decided to buy a food business as people do, it sounds like a good idea at the time until they get in and then realize how much hard work it actually is.

Putting together that flow diagram, like I said, it goes through and does inform future steps as a requirement of FSMA around that you do have to do that hazard analysis at each step in your process. There's a requirement there legally to do that. So we want to make sure that that flow diagram is correct and that's where our fifth step comes in around verification or verifying that flow diagram.

So Michael, what are the general ways that you see people or what's the best way that you would recommend people verify their flow diagram?

How do you verify your process flow diagram?

Michael:  Well, generally I think the standard is to have folks walk through the process, carrying the process flow diagram copy so they can see that what they do is consistent with what they've written down. But personally what I like to do is engage as many people across the business as I can to see if they can look at the diagram and say, "Oh, that doesn't happen or you're missing a spot." I generally ... but that's maybe step four, it's really engaging as many stakeholders, people with input, as possible so when you do hit the floor you don't have a bunch of people around going, "Oh, we missed that and we missed that and we missed that," and then having to try and verify it again at a later date.

Amanda:  And I think also verifying at different times of the day, different times of the year even, because processes sometimes you don't see them happening through the day because the night shift might do something different. I think going across that 24-hour period if that's the way your business runs just to be able to make sure that people are following the right process.

Charlie:  Oh, I feel like the process narrative that, Michael, described earlier is another way to verify your flow diagram, because I've had many times where I've been working with a company where in the process of writing out and describing what they're doing we go, "Oh, we forgot a step, we got to adjust the flow diagram," or whatever. So that's a really ... that's another great way to verify it. But nothing substitutes actually getting on the floor and walking around and seeing it and saying, "This is what we do." But both are very useful activities.

Amanda:  Absolutely. And it's probably one of the common things that I find when I audit is I take a copy of the company's flow diagram and I walk around as an auditor and I see on their diagram they've got a metal detector, but I get out in production and there's no metal detector or vice versa, it's like, "Oh, we just implemented that metal detector."

Charlie:  So if we're moving into a new facility that has a metal detector, so we have to get for that.

Amanda:  We put that on there, yeah. Well, I actually had one company who had actually lifted the food safety plan from another business they'd found who had a metal detector and they said, "Oh, well, we've never had a metal detector before and we don't intend on because they're too expensive."

Michael:  Or you're like, "Hank, you're the metal detector. Come over here."

Amanda:  Yeah, yes, well, that's right, then we start getting into does a metal detector actually have to be a piece of machinery. You have people come up some wonderful stories around that, that whole stuff around metal detection. Again, that's a time for another episode, that one.

Recapping the 5 preliminary steps

I think just recapping on all of those things, I think we're just about at time, we've got the five steps, we've gone through assembling the team and making sure that we do have a multi-disciplinary team involved, describing the product and its distribution. Again, the team should have a good cross-reference knowledge of where the product goes and what the product actually is and what it's made up of. And you can document this stuff in a ... it could be in your product specification or it could be in a table which then starts to merge into your third step which was describing the intended use and the consumers of the product.

These two steps can be joined together when you're actually documenting that stuff. Remember you don't have to have single documents for all of these things, you can actually have it all in one document. And then we went on to describing and developing that flow diagram and those steps in that, and then finally verifying that flow diagram.

So Charlie, have you got any things that you want to finish off with around the best practice in implementing these steps within your food business?

Best practice for implementing the 5 preliminary steps

Charlie:  I think that this is ... like I said earlier, it's a discipline and you get better at it over time. And so the more that you get involved in this and also the more input you get from others and feedback, the stronger you're going to be and the more confident you're going to get over time in doing and performing these tests.

I really recommend just getting involved. And for some people I've seen they just get really excited about it and then they might help somebody else do it for their company and in the process learn by being the teacher. So I think just getting involved is useful.

Amanda:  Thank you. Michael, what about for you?

Michael:  I echo that really. You're going to get better with experience. And if you do choose to go with someone to help you, whether it's through a training or reaching out to a consultant or an extension, a university extension, make sure that that person is using the opportunity to coach you and not do things for you. That'll help ensure that you do learn and take away as much as you can from the experience and be better at it the next time around.

Amanda:  Okay, awesome. And I'll just finish up on that as well, I'm a big believer in you need to go back and revisit these five preliminary steps. It's not something that you just do once. So every time that you think you're coming out with a new product or a new variation of a product, you need to go back and make sure that these five steps have been covered and that they're still relevant to the new products that you're introducing or the news processes in your business.

There's a real importance even though it's not a requirement, mandatory requirement anywhere in FSMA, that you go back and re-verify or re-check all of this stuff even just around the HACCP team. Still make sure you've got the right people on the team, you may have employed new people who may be more suited to be on the team and who can bring a fresh perspective into looking at the way things are done and hazards and all of that type of stuff.

On that note, thank you very much, Michael and Charlie Kalish.

To find out more about Michael and Charlie Kalish, visit their website at www.foodsafetyguides.com